Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | FF2587 | — |
| COVID19-2 | COVID19 (COVID19 (PFIZER-BIONTECH BIVALENT)) | PFIZER\BIONTECH | 4 | — | — |
My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( the 4th Covid Vaccine dose); vision worsened; shortness of breath; Headaches; inability to sleep; A-fib; mitral valve leaking; loss of appetite; Fell in bathroom; confusion; depression; unable to remember names and common vocabulary; unable to remember names and common vocabulary; loss of consiousness; dizzy; fever; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consiousness), ATRIAL FIBRILLATION (A-fib) and MITRAL VALVE INCOMPETENCE (mitral valve leaking) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Famtozinameran, Tozinameran (Pfizer BioNTech COVID-19 vaccine, bivalent (original and omicron BA.4/5)) for COVID-19 immunisation and Tozinameran (Pfizer BioNTech COVID-19 vaccine) for COVID-19 immunisation. The patient's past medical history included COVID-19 (No smell, no taste slight fever, cough, headaches recovered in 14days. On 21-Jan-2020, symptoms returned but recovered in 5 days) from 03-Jan-2020 to 17-Jan-2020, Dizziness (Hospitalized) in June 2020, Chest pain (hospitalized) in June 2020, Breathing difficult (trouble breathing at night that she elevated her head; hospitalized) in June 2020, Vein disorder NOS (Veins scuttered) on 03-Jan-2020, Respiratory syncytial virus infection, Escherichia coli infection, COVID-19 (had Covid for a week; In Mar-2022, patient had extreme fatigue and no appetite) from 06-Feb-2022 to February 2022, Pernio-like erythema (had Covid toe, all toes went blue, and it resolved except the blue stayed in 2 of toes) on 17-Feb-2022, Fatigue, Physical therapy and Anticoagulant therapy (Blood thinner). Previously administered products included for COVID-19 immunisation: BNT162b2 (Dose 1, single (Lot number: ER9231), in arm) in January 2021, BNT162b2 (Dose 2 (Lot number: EN6201) in arm and rash on arm and doctor office mentioned shingles) on 23-Jan-2021; for Immunization: Flu vaccine VII; for Herpes simplex: Valacyclovir (valacyclovir as needed and 2021 reactivated with 2nd Pfizer shot). Past adverse reactions to the above products included No adverse effect with BNT162b2 and Valacyclovir; Shingles with BNT162b2; and Vaccination failure with Flu vaccine VII. Concurrent medical conditions included Occipital neuralgia (Test concluded with cardiologist following Veins scuttered 03Jan2020; hospitalized. She was discharged to conjugate facility and recovery time was 2 weeks) since June 2020, Pernicious anemia (1996, Congenital; Verification test 1996, Extreme Fatigue) since 1954, Osteoarthritis (Joint pain; bone loss, Physical therapy) since 2009, Osteoporosis (valacyclovir as needed, 2021 reactivated with 2nd Pfizer shot) since 2021, Herpes simplex (valacyclovir as needed, 2021 reactivated with 2nd Pfizer shot) since 1983, Mitral valve prolapse (Test concluded with cardiologist following Veins scuttered 03Jan2020) since 2021, Blood pressure high and Drug allergy. Concomitant products included Acetylsalicylic acid (Aspirine) from 1996 to March 2023 for Anticoagulant therapy, Diphenhydramine hydrochloride (Benadryl) from 2020 to 2021 for Drug hypersensitivity, Atenolol from 2015 to an unknown date for Hypertension, Cyanocobalamin (Vitamin b12) from 1996 to an unknown date and Calcium from 1996 to an unknown date for Pernicious anaemia, Bupropion hydrochloride (Bupropion) for an unknown indication. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, fourth dose of Famtozinameran, Tozinameran (Pfizer BioNTech COVID-19 vaccine, bivalent (original and omicron BA.4/5)) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On 28-Dec-2022, the patient experienced LOSS OF CONSCIOUSNESS (loss of consiousness) (seriousness criterion medically significant). 28-Dec-2022, the patient experienced FALL (Fell in bathroom), CONFUSIONAL STATE (confusion), DEPRESSION (depression), APHASIA (unable to remember names and common vocabulary), MEMORY IMPAIRMENT (unable to remember names and common vocabulary), DIZZINESS (dizzy) and PYREXIA (fever). In March 2023, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criterion medically significant), MITRAL VALVE INCOMPETENCE (mitral valve leaking) (seriousness criterion medically significant), DECREASED APPETITE (loss of appetite), INSOMNIA (inability to sleep) and HEADACHE (Headaches). In April 2023, the patient experienced DYSPNOEA (shortness of breath) and VISUAL IMPAIRMENT (vision worsened). On an unknown date, the patient experienced LYMPHOEDEMA (My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( the 4th Covid Vaccine dose)). The patient was treated with Apixaban (Eliquis) in March 2023 at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (loss of consiousness), ATRIAL FIBRILLATION (A-fib), MITRAL VALVE INCOMPETENCE (mitral valve leaking), FALL (Fell in bathroom), CONFUSIONAL STATE (confusion), DEPRESSION (depression), APHASIA (unable to remember names and common vocabulary), MEMORY IMPAIRMENT (unable to remember names and common vocabulary), INSOMNIA (inability to sleep), DYSPNOEA (shortness of breath), LYMPHOEDEMA (My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( the 4th Covid Vaccine dose)), VISUAL IMPAIRMENT (vision worsened), DIZZINESS (dizzy), PYREXIA (fever) and HEADACHE (Headaches) outcome was unknown and DECREASED APPETITE (loss of appetite) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 1996, Investigation: Positive. In 2007, Investigation: Positive. In June 2020, Antibody test: Negative and Negative. In June 2020, Blood pressure measurement: Extremely low. In June 2020, Heart rate: 43. In 2021, Computerised tomogram: Afib, HBP, Arrhythmia valve leak. In 2021, Electrocardiogram: Afib, HBP, Arrhythmia valve leak. In 2021, Magnetic resonance imaging: Afib, HBP, Arrhythmia valve leak. In 2021, X-ray: Afib, HBP, Arrhythmia valve leak. In February 2022, SARS-CoV-2 test: Positive. In 2022, Investigation: Negative. On 28-Dec-2022, Computerised tomogram: no stroke. On 28-Dec-2022, SARS-CoV-2 test: Negative. On 28-Dec-2022, Weight: Rapid loss. Patient was tested for lates in 1996 (positive), 2007 (positive), 2022 (positive). In 2018 and 2021, patient had Dexa scan (bone densitometry), results were unknown. On 03-Feb-2022, exposure to Covid at resident facility not monitored by board of health. On 06-Feb-2022, positive COVID diagnosis. On 17-Feb-2022, COVID presented, and she contacted the cubic RN (no physician available). No treatment was recommended except 5 to 7 days of rest. After 2 vaccines, she recovered in 7 days, but cough and ear infection lingered on months. She was referred to an ENT, physician and cardiologist. On Mar-2022, extreme fatigue and no appetite. The cardiologist was not certain of effects on heart by COVID infection. On Nov-2022, she was re-prescribed with heart meds, but no new tests were ordered. The extreme fatigue continued. On 28-Dec-2022, she had fever, confusion, depression, dizzy, losses of consciousness and causing fall in bathroom. The COVID test results were negative. ER was used for damage to knees, ankles, back elevation and blood pressure due to lack of medication (on floor over 5 hours w/o assistance). She was unable to remember names and common vocabulary very suddenly. Single loss of 20. On Mar-2023, she experienced A-fib, mitral valve leaking, inability to sleep, loss of appetite and very rapid weight loss. She reported stopping aspirin regimen and beginning Eliquis which caused intense headaches. On Apr-2023, her vision worsened, depression, shortness of breath and continued lack of appetite. The papers were sent extremely late as COVID was followed by R.S.V and E-coli infection. Booster continued. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2025: Significant follow-up received: Case was upgraded to serious valid case from non-serious tracking only. Patient's age was added, medical history was updated, added lab data, suspect was updated to SPIKEVAX NOS, co-suspect details updated, additional concomitant medications were added, additional treatment medication was added, event COVID-19 was removed, additional events were added, and narrative was updated. On 15-Apr-2025: Live follow-up received contains non-significant information (reference number was added).; Reporter's Comments: Patients underlying condition in addition with infections with COVID-19 are confounders for Atrial fibrillation and Mitral valve incompetence. Headache is assessed as not related due to long latency and better explained secondary to Eliquis. The benefit-risk relationship of product is not affected by this report.
Blood pressure high; Herpes simplex (valacyclovir as needed, 2021 reactivated with 2nd Pfizer shot); Mitral valve prolapse (Test concluded with cardiologist following Veins scuttered 03Jan2020); Occipital neuralgia (Test concluded with cardiologist following Veins scuttered 03Jan2020; hospitalized. She was discharged to conjugate facility and recovery time was 2 weeks); Osteoarthritis (Joint pain; bone loss, Physical therapy); Osteoporosis (valacyclovir as needed, 2021 reactivated with 2nd Pfizer shot); Pernicious anemia (1996, Congenital; Verification test 1996, Extreme Fatigue)
Medical History/Concurrent Conditions: Anticoagulant therapy (Blood thinner); Breathing difficult (trouble breathing at night that she elevated her head; hospitalized); Chest pain (hospitalized); COVID-19 (No smell, no taste slight fever, cough, headaches recovered in 14days. On 21-Jan-2020, symptoms returned but recovered in 5 days); COVID-19 (had Covid for a week; In Mar-2022, patient had extreme fatigue and no appetite); Dizziness (Hospitalized); Drug allergy; Escherichia coli infection; Fatigue; Pernio-like erythema (had Covid toe, all toes went blue, and it resolved except the blue stayed in 2 of toes); Physical therapy; Respiratory syncytial virus infection; Vein disorder NOS (Veins scuttered)
Atenolol; Vitamin b12; Calcium; Aspirine; Benadryl; Bupropion
Test Date: 202006; Test Name: Antibody test; Test Result: Negative; Test Date: 202006; Test Name: Antibody test; Test Result: Negative; Test Date: 202006; Test Name: Blood pressure measurement; Result Unstructured Data: Extremely low; Test Date: 2021; Test Name: Computerised tomogram; Result Unstructured Data: Afib, HBP, Arrhythmia valve leak; Test Date: 20221228; Test Name: Computerised tomogram; Result Unstructured Data: no stroke; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Afib, HBP, Arrhythmia valve leak; Test Date: 202006; Test Name: Heart rate; Result Unstructured Data: 43; Test Date: 1996; Test Name: Investigation; Test Result: Positive; Test Date: 2007; Test Name: Investigation; Test Result: Positive; Test Date: 2022; Test Name: Investigation; Test Result: Negative; Test Date: 2021; Test Name: Magnetic resonance imaging; Result Unstructured Data: Afib, HBP, Arrhythmia valve leak; Test Date: 202202; Test Name: SARS-CoV-2 test; Test Result: Positive; Test Date: 20221228; Test Name: SARS-CoV-2 test; Test Result: Negative; Test Date: 20221228; Test Name: Weight; Result Unstructured Data: Rapid loss; Test Date: 2021; Test Name: X-ray; Result Unstructured Data: Afib, HBP, Arrhythmia valve leak