Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | — | — |
Spondylosis without myelopathy or radiculopathy, thoracic region; Lumbar radiculopathy; Osteoarthritis of Shoulder, Left; Right subacromial Bursitis/ Left subacromial Bursitis; This is a spontaneous report and received from Consumer or other non HCPs. A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 29Mar2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "heart just started racing", "shortness of breath/Breath", "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area", "constant pain in right side, where he got the shot/Pain on right side/Short right side"; BNT162b2 (DOSE 2, SINGLE), administration date: 10May2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area", "shortness of breath/Breath", "heart just started racing", "constant pain in right side, where he got the shot", "constant pain in right side; towards the lungs, right where he got the shot, right near the buttocks/Pain on right side/Short right side"; influenza (annual), administration date: 02Sep2018, when the patient was 38-year-old, for immunization; influenza (annual), administration date: 15Oct2019, when the patient was 39-year-old, for immunization; mmr, administration date: 01Oct2020, when the patient was 40-year-old, for immunization; mmr, administration date: 14Oct2020, when the patient was 40-year-old, for immunization; mmr, administration date: 10Aug2022, when the patient was 42-year-old, for immunization; pneumococcal polysaccharide (pcv23), administration date: 15Oct2019, when the patient was 39-year-old, for immunization; tdap, administration date: 01Sep2017, when the patient was 37-year-old, for immunization; influenza quad (Influenza Quad, 6 mo - 64 years), administration date: 07Jan2021, when the patient was 41-year-old, for immunization; Bnt162b2 (DOSE 3), administration date: Nov2021, when the patient was 42 years old, for Covid-19 immunization, reaction(s): "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area", "shortness of breath/Breath", "constant pain in right side; towards the lungs, right where he got the shot, right near the buttocks/Pain on right side/Short right side", "heart just started racing", "constant pain in right side, where he got the shot". The following information was reported: SPINAL OSTEOARTHRITIS (medically significant), outcome "unknown", described as "Spondylosis without myelopathy or radiculopathy, thoracic region"; LUMBAR RADICULOPATHY (medically significant), outcome "unknown"; OSTEOARTHRITIS (medically significant), outcome "unknown", described as "Osteoarthritis of Shoulder, Left"; BURSITIS (medically significant), outcome "unknown", described as "Right subacromial Bursitis/ Left subacromial Bursitis". Therapeutic measures were taken as a result of spinal osteoarthritis, lumbar radiculopathy, osteoarthritis, bursitis. Clinical course: The patient experienced Spondylosis without myelopathy or radiculopathy, thoracic region; Lumbar radiculopathy; Osteoarthritis of Shoulder, Left; and Right subacromial Bursitis/ Left subacromial Bursitis. OPERATIVE REPORT 13Feb2025: Pre-op. Diagnosis: Spondylosis without myelopathy or radiculopathy, thoracic region (M47.814). Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Right Thoracic Medial Branch Blocks at T10/11 T11/12 T12/L1 level. Anesthesia: local anesthesia. Details of Procedure: After a discussion of the risks and benefits, the patient consented to the procedure. The patient was taken to the procedure room and placed in the prone position. An AP fluoroscopic scout film was taken to identify the L4 and L5 vertebral bodies, the L4 and L5 pedicles and L5 and S1 superior articulating process. The skin was prepped with chlorhexidine and draped in the usual sterile fashion. The skin and subcutaneous tissue overlying the aforementioned anatomic targets were anesthetized using a 27-gauge 1-1/2 inch needle with 1% preservative-free lidocaine for a total volume of 2 mls. Then a 25-gauge 3 1/2 inch Quincke spinal needle was advanced under fluoroscopic guidance using an oblique view just inferior to the pedicle of the L4 and L5 level on the Left side. Then, utilizing AP and lateral fluoroscopic views, we confirmed the position of the needle tip to be within the neural foramen. After negative aspiration, 1 mls of iohexol 180 mg/ml contrast was injected under AP view at each level with live fluoro and confirmed adequate spread along the nerve root and in the epidural space. There was no evidence of intravascular uptake or intrathecal spread on imaging. A lateral view was also taken confirming adequate epidural spread. At this point, after negative aspiration, 1.5mL volume per level of treatment injectate (6mL total), consisting of 2mL of 1 mL of dexamethasone 4mg/mL, and 4mL of bupivacaine 0.25% was injected easily. There was no pain or resistance with injection. There was adequate anterior and posterior epidural spread. The needle was then restyletted and removed. The needle insertion site was dressed appropriately. Then the exact same steps and medication was completed on the contralateral side. The patient tolerated the procedure well and was to recovery in satisfactory condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOX3 conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: no JVD. MSK: Pt able to ambulate, limited ROM due to pain . PSYCH: Normal mood and affect. OPERATIVE REPORT 16Oct2024: Pre-op. Diagnosis: Lumbar Radiculopathy (M54.16). Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Bilateral Lumbar Transforaminal Epidural L4-5 and L5-S1. Anesthesia: local anesthesia. Details of Procedure: After a discussion of the risks and benefits, the patient consented to the procedure. The patient was taken to the procedure room and placed in the prone position. An AP fluoroscopic scout film was taken to identify the L4 and L5 vertebral bodies, the L4 and L5 pedicles and L5 and S1 superior articulating process. The skin was prepped with chlorhexidine and draped in the usual sterile fashion. The skin and subcutaneous tissue overlying the aforementioned anatomic targets were anesthetized using a 27-gauge 1-1/2 inch needle with 1% preservative-free lidocaine for a total volume Of 2 mls. Then a 25-gauge 3 1/2 inch Quincke spinal needle was advanced under fluoroscopic guidance using an oblique view just inferior to the pedicle of the L4 and L5 level on the Left side. Then, utilizing AP and lateral fluoroscopic views, we confirmed the position of the needle tip to be within the neural foramen. After negative aspiration, 1 mls of iohexol 180 mg/ml contrast was injected under AP view at each level with live fluoro and confirmed adequate spread along the nerve root and in the epidural space. There was no evidence of intravascular uptake or intrathecal spread on imaging. A lateral view was also taken confirming adequate epidural spread. At this point, after negative aspiration, 1.5mL volume per level of treatment injectate (6mL total), consisting of 2mL of 1 mL of dexamethasone 4mg/mL, and 4mL of bupivacaine 0.25% was injected easily. There was no pain or resistance with injection. There was adequate anterior and posterior epidural spread. The needle was then restyletted and removed. The needle insertion site was dressed appropriately. Then the exact same steps and medication was completed on the contralateral side. The patient tolerated the procedure well and was to recovery in satisfactory condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOX3 conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: no JVD. MSK: Pt able to ambulate, limited ROM due to pain. PSYCH: Normal mood and affect. OPERATIVE REPORT 17Jul2024: Pre-op. Diagnosis: Left shoulder pain; Osteoarthritis of Shoulder, Left. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Fluoroscopic guidance for needle placement and interpretation. Left Glenohumeral (Shoulder) Joint Steroid Injection. Anesthesia: Local. Indications: Shoulder Pain. Details of Procedure: After a discussion of the risks and benefits of the procedure, informed consent was obtained. The patient was taken to the procedure room and placed in a prone position. The Left shoulder was held at slightly internally rotated. The posterior shoulder area was prepped with chlorhexadine and draped in a sterile fashion. Using intermittent fluroscopic guidance, a 25 gauge 2 inch needle was inserted posteriorly approximately 1-2cm under the posterolateral angle of the acromion and was directed anteriorly and medially toward the coracoid process. After the bone (humeral head) was contracted, the needle was slightly withdrawn and redirected into the glenohumeral joint. Omnipague 1-2cc was injected and demonstrated appropriate arthropgram. After negative aspiration for blood, Decadron 4 mg/ml x 2 ml mixed with Bupivacaine 0.25% x 2 ml was injected into the glenohumeral joint without resistance or increased pain. The patient tolerated the injection well and was discharged in stable condition. Complications: None. Pre-procedural Assessment: GEN: AAOX3 conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: Palpable pulse w/ RRR. MSK: Pt able to ambulate, limited ROM due to pain. PSYCH: Normal mood and affect. OPERATIVE REPORT 09Apr2024: Pre-op. Diagnosis: Right shoulder pain; Right Subacromial Bursitis. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Right Shoulder Subacromial Steroid Injection. Anesthesia: Local. Indications: Pain. Details of Procedure: After a discussion of the risks and benefits of the procedure, informed consent was obtained. The patient was placed in a sitting position. The posterolateral edge of the acromion was palpated and marked. The posterolateral acromial area was prepped with chlorhexadine and draped in a sterile fashion. The Right shoulder was held at neutral position. A 25 gauge 1.5 inch needle was inserted towards the subacromial region immediately inferior to the posterolateral edge of the acromion. After negative aspiration for blood, a 4cc volume from a solution containing 1cc methylprednisolone 40 mg/mL mixed with 3cc lidocaine 1% was injected into the subacromial space easily without any resistance or pain. The patient experienced adequate relief (greater than 50%) immediately after the injection. The patient tolerated the treatment well and was discharged in stable condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOx3, conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: Palpable pulse w/ RRR. MSK: Pt able to ambulate, limited ROM due to pain, + shoulder impingement signs. PSYCH: Normal mood and affect. OPERATIVE REPORT 25Jan2024: Pre-op. Diagnosis: Left shoulder pain, Left Subacromial Bursitis. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Left Shoulder Subacromial Steroid Injection. Anesthesia: Local. Indications: Pain. Details! of Procedure: After a discussion of the risks and benefits of the procedure, informed consent was obtained. The patient was placed in a sitting position. The posterolateral edge of the acromion of the Left shoulder was palpated and marked. The posterolateral acromial area was prepped with chlorhexadine and draped in a sterile fashion. The affected shoulder was held at natural position. A 25 gauge 1.5 inch needle was inserted towards the subacromial region immediately inferior to the posterolateral edge of the acromion. After negative aspiration for blood, a 4cc volume from a solution containing 2 cc Dexamethasone 4mg/mL mixed with 2cc Lidocaine 1% was injected into the subaeromial space easily without any resistance or pain. The patient experienced adequate relief (greater than 50%) immediately after the injection. The patient tolerated the treatment well and was discharged in stable condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOx3, conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing, CTAB. CVS: S1, S2 RRR, no murmur, +palpable distal pulse. Abdom: Soft, ND, NT. MSK: Pt able to ambulate, limited left shoulder ROM due to pain, + shoulder impingement signs. PSYCH: Normal mood and affect. OPERATIVE REPORT 12Oct2023: Pre-op. Diagnosis: Lumbar Radiculopathy. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Bilateral Lumbar Transforaminal Epidural L4/5. Anesthesia: Local. Indications: Pain. Details of Procedure: After a discussion of the risks and benefits, the patient consented to the procedure. The patient was taken to the procedure room and placed in the prone position. The back was prepped with betadine and draped in sterile fashion. Local anesthetic wheal(s) were raised using Lidocaine 1% 5 ml. A 25 gauge 3.5 inch spinal needle was advanced toward the Bilateral L4/5 neural foramen until there was adequate placement in the superior aspect of the foramen under AP and lateral fluoroscopy. Omnipaque 180mg/ml x1mL was injected at each level with live fluoroscopy which showed dye spread in the epidural space and along the nerve root without any intrathecal or vascular uptake patterns. After negative aspiration for heme and CSF, I then administered 2mL volume from a solution containing 1mL dexamethasone 4 MG/ML and 3mL Bupivacaine 0.25% at the Right L4/5 neuroforamen and the remaining 2mL at the Left L4/5 neuroforamen. There was no pain or resistance with injection. There was adequate anterior and posterior epidural spread. The patient tolerated the procedure well and was discharged to recovery in satisfactory condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOx3, conversational, in no acute distress. EM: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: Palpable pulse w/ RRR. MSK; Pt able to ambulate, limited ROM due to pain. PSYCH: Normal mood and affect. The patient also received Gardasil 9 (PF) 0.5 ML intramuscular on 25Aug2023 (43 y.o.), on 22Sep2023 (43 y.o.); 30Jan2024 (44 y.o.); Heplisav- Hep B, Adult: 18Sep2023 (43 y.o.); 30Jan2024 (44 y.o.); Pneumococcal Conjugate 20-Valent: 16Aug2023 (43 y.o.)). The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Diabetes