Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: people turn up positive COVID tests after the booster; people turn up positive COVID tests after the booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "people turn up positive COVID tests after the booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive.  Clinical information: He mentioned that he had known of 4 cases where people turn up positive COVID tests after the booster, himself, two patients, one received it last Thursday and then had COVID like symptoms throughout the week. He also spoken to a patient this morning a friend also got a bivalent the day after. Personally, He did some research and found an article news where someone also got the booster on 04Oct and got very sick and tested positive for COVID test in the past week. It seemed unusual the frequency of people reporting COVID".  Got his Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well. Next morning woke up with body aches, just didn't feel good. Thought it was maybe a side effect for a day. Throughout this whole week he had other COVID-19 like symptoms such as sore throat, chills, headache, coughing. Positive for COVID-19 Wednesday. Was not exposed to COVID-19. Wondering if there is any possibility the Pfizer COVID-19 Vaccine Bivalent Booster can cause COVID-19 or COVID-19 positive symptoms? He is the 4th case he knows of this happening to. One person reported the same thing to him today and another person reported the same thing to him yesterday about people they knew. Had a patient yesterday who got the booster last Thursday and had the same symptoms Friday. Spoke to another person whose wife's friend tested positive and continues to be sick with COVID-19 symptoms. Read another article where a person recorded similar things after getting the COVID-19 Vaccine Bivalent Booster, getting sick, and testing positive for COVID-19. He clarified he is the 4th case he has been made aware of this week. Doesn't know if this is a known side effect. Other HCP's tell him it is not possible and shouldn't cause a positive test but 4 in a week seems like a lot. Is the bivalent formulation somehow different or does it contain something from the actual omicron variant? In the Pfizer Package Insert there was a line about it containing an omicron component, what does that mean? Declined to report on the other persons he had been aware of experiencing the same events, only wanted to report on himself. Declined to provide additional information on other patients. Reporter Type: Caller provided he is a physician, a psychiatrist. HCP Information: Declined to provide. Does not have one. Didn't feel well: Start Date: 04Nov2022 he got the Pfizer COVID-19 Vaccine Bivalent Booster. Symptoms started 05Nov2022. Has been going through different stages. At first was low back aches, then body aches, energy is a little better today than before. Had a sore throat in the beginning of the week that is now coughing. Developed congestion and runny nose in the last couple of days. Clarified it is persisting and ongoing. Seriousness: Not serious, felt like he had the flu. Pfizer COVID-19 Vaccine Bivalent Booster: Cap Color: Unknown Administered to right deltoid NDC/Formulation/Dose: Unknown, not on his paperwork. Been symptom free and healthy, negative for all COVID-19 tests for last 2 and half years until this dose. His wife tested 09Nov2022 and was negative with no symptoms. Declined to complete Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire. Warm transferred caller (Name withheld), Pfizer Medical Information. Caller provided with number of #, Option 3, with hours prior to transfer, in the event of disconnection. Is there a product complaint to report? Yes Description of Product Complaint: Description of complaint: Tested positive for COVID-19 after receiving Pfizer COVID-19 Vaccine Bivalent Booster. Product strength and count size dispensed: Unknown Additional lot numbers: Not applicable. Is a sample of the product available to be returned, if requested (Y/N): Unknown Packaging sealed and intact? Unknown  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-DRUG INEFFECTIVE and COVID-19