Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
she experienced pain in her arm, redness, itching, a lump was left at the injection site/Having a lot of pain since had the shot; she experienced pain in her arm, redness, itching, a lump was left at the injection site; she experienced pain in her arm, redness, itching, a lump was left at the injection site; she experienced pain in her arm, redness, itching, a lump was left at the injection site; Rising on arm where like a indention cause swollen; itching and pain in her neck as well; itching and pain in her neck as well; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 85-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 14Jun2021 (ongoing), notes: It was placed 14Jun2021; "Blood pressure high" (unspecified if ongoing); "Pain" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: SOTALOL HCL oral taken for cardiac disorder (ongoing); DILT-XR oral taken for cardiac disorder (ongoing); LOSARTAN oral taken for hypertension (ongoing); HYDROCHLOROTHIAZID oral taken for hypertension (ongoing); WARFARIN oral taken for thrombosis prophylaxis (ongoing); ACETAMINOPHEN taken for pain (ongoing); SPIRIVA RESPIMAT taken for chronic obstructive pulmonary disease (ongoing). Vaccination history included: comirnaty (DOSE 1, SINGLE, Location of injection/shot: 0.3ml in arm, probably left arm, lot number: EK9231, Expiry date:30Apr2021, Also sees listed bud. 6hrs at right), administration date: 24Jan2021, when the patient was 81-year-old, for Covid-19 immunization; comirnaty (DOSE 2, SINGLE, Location of injection/shot: 0.3ml in left arm, lot number: EL964, Expiry date:03May2021), administration date: 14Feb2021, when the patient was 81-year-old, for Covid-19 immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE, Location of injection/shot: right arm, lot number: FF8841, quantity 0.3, Expiry date:31Dec2021, Also, sees listed HCP She then stated it might have been the right arm she received all these previous dose), administration date: 09Sep2021, when the patient was 81-year-old, for Covid-19 immunization; comirnaty (DOSE 4 (BOOSTER), SINGLE, Location of injection/shot: think in right arm, lot number: SK9895, Expiry date:30Jun2022), administration date: 02Apr2022, when the patient was 82-year-old, for Covid-19 immunization; comirnaty original/omicron ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Location of injection/shot: Right arm, lot number: GH9697, Expiry date:15Dec2023), administration date: 18Oct2022, when the patient was 82-year-old, for Covid-19 immunization; comirnaty original/omicron ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Location of injection/shot: left arm, lot number: GL0447, Expiry date:31Jan2024), administration date: 23Apr2023, when the patient was 83-year-old, for Covid-19 immunization; comirnaty omicron xbb.1.5 (DOSE 7 (BOOSTER), SINGLE, Location of injection/shot: going to say right arm, lot number: HG4680, Expiry date:31Dec2023), administration date: 10Oct2023, when the patient was 83-year-old, for Covid-19 immunization; comirnaty kp.2 (DOSE 8 (BOOSTER), SINGLE, Location of injection/shot: going to say right arm, lot number: LM2216, Expiry date:10Mar2025), administration date: 01Sep2024, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 09May2025, outcome "not recovered", described as "Rising on arm where like a indention cause swollen"; PRURITUS (non-serious), NECK PAIN (non-serious) all with onset 09May2025, outcome "not recovered" and all described as "itching and pain in her neck as well"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09May2025, outcome "recovered" (May2025), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE MASS (non-serious) all with onset 09May2025, outcome "not recovered" and all described as "she experienced pain in her arm, redness, itching, a lump was left at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 09May2025, outcome "not recovered", described as "she experienced pain in her arm, redness, itching, a lump was left at the injection site/Having a lot of pain since had the shot". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema. Additional information: Patient received a COVID-19 Boost and wants to know if there's anything she can do, if experiencing pain after getting the shot. Her PCP recommended voltaren. Patient got the boost on 08May2025 of this year, and she experienced pain in her arm, redness, itching, a lump was left at the injection site. Patient mentioned having itching and pain in her neck as well. Patient expected her symptoms to last for a week, however her symptoms have being going on since May. Patient Investigations was reported as no. Patient had a lot of pain since had the shot. Patient has a rising on arm where like a indention cause it's swollen. It's like a knot there. Patient had been taking acetaminophen and called the doctor who suggested, Voltaren. Having a lot of pain since had the shot: Arm was sore 09May2025 and then from then on had redness and itching, Redness: Clarified the redness has gone away. This went away like a week later. Treatment/Intervention: patient clarified she had just started the Voltaren. Patient just kept thinking it would go away. The pain had not impaired her. Patient cannot do anything because patient was so sore. The pain was moving up to neck to the top of shoulder. Confirmed the issues that patient had in the right arm. This was where patient was having the issues and the same arm where patient received this dose. The patient received any other vaccines on the same date as the Pfizer vaccine and the patient received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine was reported as no. The patient did not visit Emergency Room/Physician's Office for any of the reported event. The patient was hospitalized was reported as N/A. Any adverse events following the historical vaccination and allergic to any previous vaccination, medications, food or other products were reported as no. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Pacemaker insertion (cardiac) (It was placed 14Jun2021)
Medical History/Concurrent Conditions: Blood pressure high; COPD; Pain
SOTALOL HCL; DILT-XR; LOSARTAN; HYDROCHLOROTHIAZID; WARFARIN; ACETAMINOPHEN; SPIRIVA RESPIMAT