Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Seizure, Unresponsive to stimuli, Urine analysis
Clinical narrative: They gave him a COVID test, on 19Nov2022 and it was positive; They gave him a COVID test, on 19Nov2022 and it was positive; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6665, Expiration Date: 12Dec2022) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 05Oct2022, stop date: 05Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Nov2022, outcome "unknown" and all described as "They gave him a COVID test, on 19Nov2022 and it was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Nov2022) Positive; Scan brain: (unspecified date) Negative; Weight: (unspecified date) losing. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: At the start of getting his COVID vaccines, he experienced pain in his right shoulder that radiated down his arm. That was going on for at least 18 months. He got his COVID booster shot. On, 15Nov2022, he had an episode where he couldn't wake from sleep. He went to the Emergency room where he was told it was a seizure. He briefly woke while the police and emt were there. They did brain scans and so one. Everything was negative. He unfortunately wasn't given a COVID test at the ER. That could be a symptom of COVID - not being able to awaken or seizure. So she doesn't know why they didn't test him. Then, two days after he was released on 16Nov2022. He had to go to a (withheld) ER in (withheld) due to a severe sore throat and muscle aches He started experiencing. It was 2 am he went to the (withheld) ER in (withheld). The doctor right away said he had flu and other viruses. He had a sore throat, muscle and joint aches. He had muscle, shoulder, and joint pain. That is why he went to the (withheld) ER on 19Nov2022. They gave him a COVID test, on 19Nov2022 and it was positive. For Country Only: Vaccination Facility Type: Pharmacy. Vaccine was not administered at military facility.   Conclusion of Previously Completed Investigation on 08Dec2022: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ6665. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. (Name) concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The Agency process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.