Sex: U
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: Atrial fibrillation, COVID-19 immunisation, Overweight, Somnolence
Clinical narrative: ATRIAL  FIBRILLATION; OVERWEIGHT; PATIENT TOO SLEEPY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer by a other company on 08-JAN-2024 was received on 08-JAN-2024 and concerned a 62 year old of unspecified sex. The patient's weight was 220 pounds, and height was 162.56 centimeters. The patient's past medical history included: long term covid, numbness, tingling, arm pain, and deep pain in the legs starting from the foot to the ankle to the shin to calf and going up to arm, it's like neuropathy, and concurrent conditions included: prediabetes, depression, and hypothyroidism. The patient was previously treated with covid-19 vaccine nrvv ad26 (JNJ 78436735) (Dose number in series 1) for covid-19 prophylaxis and influenza vaccine. The patient experienced arm pain, deep pain in the legs starting from the foot to the ankle to the shin to my calf and going up to my arm, it's like neuropathy, numbness and tingling when treated with covid-19 vaccine nrvv ad26 (JNJ 78436735) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: amitriptyline (form of administration, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for ease the pain. ; and gabapentin (form of administration, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for ease the pain. Non-company suspect vaccine included: tozinameran (98, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. Concomitant medications included fluoxetine for depression, metformin for diabetes, and levothyroxine for prediabetes.  On an unspecified date, the patient received non-company suspect vaccine included: tozinameran (Dose number in series 3) (form of admin, route of admin, and batch number were not reported), dose (dose series 3), start therapy date were not reported for covid-19 prophylaxis. On an unspecified date following vaccination with tozinameran, the patient experienced atrial fibrillation (Dose number in series 3), overweight (Dose number in series 3), too sleepy (Dose number in series 3), and revaccination with different covid-19 vaccine (Dose number in series 3). It was reported that the patient never had a reaction like that to flu shot and the patient got them every single year. shot The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with amitriptyline, and gabapentin was not reported. The outcome of the atrial fibrillation, overweight, patient too sleepy and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20240120603.  Version created to amend previously reported information on 08-JAN-2024. Upon review the following information was amended: Amendment Adverse Event (In the event screen added past events of deep pain in the legs starting from the foot to the ankle to the shin to my calf and going up to my arm, it's like neuropathy, numbness, tingling, and arm pain which were associated with covid-19 vaccine nrvv ad26 (JNJ 78436735) (Dose number in series 1).; Sender's Comments: Follow up received is regarding amendment of the past history event pertaining to pain in legs and dose number. This does not change the previously reported company causality assessment.  Atrial fibrillation. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY(Hypothyroidism increases risk for AF). Therefore, this event is considered inconsistent with vaccine administration.