Age: 77.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Fatigue, Feeling abnormal, Product use issue
Clinical narrative: On the same day also received flu shot; feel very tired; has no energy; feeling very flat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 77 years, in left arm for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: Takes a blood thinner and heart pill to slow the heart down. Takes something else for the heart; "COVID-19" (unspecified if ongoing), notes: first time before the vaccine. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6201), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "positive for Covid after one dose vaccine", "positive for Covid after one dose vaccine", "falling down", "sick"; BNT162b2 (DOSE 2, SINGLE, Lot: EN9581), administration date: 08Mar2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FC3183), administration date: 27Sep2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "feel sick"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM0698), administration date: 04Apr2022, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "felt sick". The following information was reported: FATIGUE (non-serious) with onset Sep2022, outcome "not recovered", described as "feel very tired"; FEELING ABNORMAL (non-serious) with onset Sep2022, outcome "not recovered", described as "feeling very flat"; ASTHENIA (non-serious) with onset Sep2022, outcome "not recovered", described as "has no energy"; PRODUCT USE ISSUE (non-serious) with onset 26Sep2022, outcome "unknown", described as "On the same day also received flu shot". Therapeutic measures were taken as a result of fatigue, asthenia, feeling abnormal.  Product Quality Group provided investigational results on 07Oct2022 for BNT162b2, BNT162b2 omi ba.4-5: The complaint for "PFIZER-BIONTECH 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 GJ5342. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM 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.  Additional information: The patient received the 3rd booster of the COVID-19 vaccine on 26Sep2022, the same day she received the flu shot. The other 2 boosters made her feel sick, but that didn't last long. Now, for this last dose, it still kept hanging on. The patient felt very tired, flat, with no energy. She was hoping it would go away after a while but it was lasting longer than previous doses of the vaccine when she felt sick afterwards. The patient stated the events started probably within a couple of days after taking the vaccine. The patient previously tested positive for COVID-19; she had it really bad, a long time there, she was really sick. She didn't want it again. The first time was down for 6 weeks, then went and got the shot for it. Afterwards, she went back to the doctor because she was falling down. She tested again positive after just one dose of the COVID-19 vaccine and it wasn't as bad as the first time because she had the shot. The events did not require a visit to the emergency room nor the physician office. No relevant tests were conducted. The patient took TYLENOL as treatment.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210413 same reporter/patient/vaccine, different dose/AE;US-PFIZER INC-202201210424 same reporter/patient/vaccine, different dose/AE;US-PFIZER INC-202201210236 same reporter/patient/vaccine, different dose/AE;US-PFIZER INC-202201210237 same reporter/patient/vaccine, different dose/AE;