Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: Covid-19 treatment/symptoms were mild/thought was getting pneumonia again, stated that sinuses were real bad, had sore throat, body aches; energy level was really low; Covid-19 treatment/symptoms were mild/thought was getting pneumonia again, stated that sinuses were real bad, had sore throat, body aches; energy level was really low; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (batch/lot number: 6H9753) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (batch/lot number: EN6206), on 25Mar2021 as dose 2, single (batch/lot number: ER8733), on 11Oct2021 as dose 3 (booster), single (batch/lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (batch/lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: from 10 or 12 years ago; "COPD" (ongoing), notes: when turned 55 years old, was checked everything and said patient COPD; "asthma" (ongoing), notes: since in day school; "pneumonia" (unspecified if ongoing), notes: last year; "psoriasis" (unspecified if ongoing); "kidneys weren't functioning really great" (unspecified if ongoing); "never smoked" (unspecified if ongoing), notes: never once smoked in life, lungs don't handle it. The patient took concomitant medications. The patient informed that he has high blood pressure and was taking medicine for it (no product name provided), he was taking a steroid inhaler (no specific product name provided) and was taking it once a day every morning. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "unknown" and all described as "Covid-19 treatment/symptoms were mild/thought was getting pneumonia again, stated that sinuses were real bad, had sore throat, body aches; energy level was really low". The events "Covid-19 treatment/symptoms were mild/thought was getting pneumonia again, stated that sinuses were real bad, had sore throat, body aches; energy level was really low" required emergency room visit. Therapeutic measures were taken as a result of vaccination failure, covid-19 pneumonia. Clinical course: On 29Aug2023, the patient confirmed that he received a total of 5 doses and all 5 doses were the Pfizer COVID-19 vaccine. The patient informed that all doses were administered with anatomical location "in right shoulder". The patient informed that the 3rd dose NDC, lot, expiry were hard to read, the handwriting on vaccination card looked like all numbers, 30155 or 301SS, or 3018A, not sure. The patient informed that the 4th dose NDC, lot, expiry was FL809, then after the 9 it is either S or 5. The patient informed that all 5 doses were administered at (hospital name withheld). The patient informed that his symptoms were mild like a sinus infection and real bad sore throat and he did go to the hospital and they did give him the prescription for Paxlovid and caller just picked up the prescription 10 minutes ago. The patient clarified that he was not admitted into the hospital, was just seen in the emergency room. The patient informed that he has not started taking the medication yet (Paxlovid), going to wait until he ate something around 6 o'clock. The indication was that he thought was getting pneumonia again, stated that sinuses were real bad, had sore throat, body aches, did not have a fever, but energy level was really low.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 Pneumonia cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information. Linked Report(s): US-PFIZER INC-202300288413 same reporter/patient/drug, different dose/event;