Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: He has his wife both tested positive.; he has really sick; head ache; coughing and having blood come up/I see some blood in some phlegm; coughing sometimes; I am just distraught/My mind is so scattered right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "He has his wife both tested positive."; MALAISE (non-serious), outcome "unknown", described as "he has really sick"; HEADACHE (non-serious), outcome "unknown", described as "head ache"; HAEMOPTYSIS (non-serious), outcome "unknown", described as "coughing and having blood come up/I see some blood in some phlegm"; COUGH (non-serious), outcome "unknown", described as "coughing sometimes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I am just distraught/My mind is so scattered right now". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: The reporter is a Male consumer who stated that he has had 3 shots and went to get his 4th shot on Thursday and was feeling fine. He stated he wore his mask everywhere and hasn't had any family gatherings. On Friday night he began to feel sick and on Saturday he stated he has really sick and had a headache and a bad time. He has been coughing and having blood come up. On Sunday, he stated it was a little bit better and he tested at home for Covid. He has his wife both tested positive. When enquired about the email address, the patient said that he count not think of it. his mind was so scattered. he really did not know what to think, he was just distraught."  Conclusion of Previously Completed Investigation: 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. (Site name-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.