Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
crummy; fever; chills; constant burping; indigestion; gas/flatulence; abdominal pain; nausea; anorexia; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 2, SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 8 (BOOSTER), SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 9 (BOOSTER), 0.3 ML, SINGLE, In left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy". The following information was reported: ABDOMINAL PAIN (non-serious) with onset 2025, outcome "recovered" (2025); DECREASED APPETITE (non-serious) with onset 2025, outcome "recovered" (2025), described as "anorexia"; ERUCTATION (non-serious) with onset 2025, outcome "recovered" (2025), described as "constant burping"; FLATULENCE (non-serious) with onset 2025, outcome "recovered" (2025), described as "gas/flatulence"; DYSPEPSIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "indigestion"; NAUSEA (non-serious) with onset 2025, outcome "recovered" (2025); MALAISE (non-serious), outcome "unknown", described as "crummy"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of dyspepsia, flatulence, abdominal pain, nausea, decreased appetite, malaise, pyrexia, chills, eructation. Additional information: COVID-19 vaccine a Pfizer product. Patient was supposed to have the Pfizer COVID, but what says on form, maybe caller doesn't understand it, says Comirnaty. Is that the Pfizer product? As far as patient knows the FDA is also closed with the shut down. Patient had side effects for the second time with the Pfizer COVID-19 vaccine. Age: Was 74 years old first time, 75 years old second time. First side effects with the Pfizer COVID-19 vaccine: Patient didn't put two and two together until now. First time had side effects was with the dose caller had in the Spring. Almost always with the COVID and flu shot gets fever and chills, always. But what happened back in Spring was patient had some severe kind of abdominal issues, clarified as indigestion, gas/flatulence, abdominal pain, nausea, and anorexia. First time in the Spring thought was something caller had eaten, side effects lasted about a week. It was right after patient had the Covid shot, had just the Covid shot alone back in the Spring of 2025. Indigestion: Start date: Had COVID shot in the morning, really that night felt really crummy, fever, chills. Next day severe indigestion. Incredible constant burping and indigestion. Stop date, outcome: Not ongoing. All symptoms, indigestion, gas/flatulence, abdominal pain, nausea, and anorexia, resolved after about a week. But then came back again this past Friday when had another COVID shot. Gas/flatulence: Start date: Same time as indigestion, following morning after COVID shot. Abdominal pain: Start date: All indigestion, gas/flatulence, burping, abdominal pain, anorexia, and nausea all came on the following morning after the COVID shot in Spring 2025. No treatment or medical interventions, caller then stated caller just took over the counter remedies herself. COVID-19 vaccine: Caller has always had the Pfizer, has probably had 11 doses so far of the Pfizer COVID-19 vaccine, was working in healthcare before. 1st dose, 2nd dose, 3rd dose, 4th dose, 5th dose, 6th dose, 7th dose, 8th dose, 9th dose. Doesn't have dates handy at time of call, could get if needed. NDC, lot, expiry: Unknown at time of call. Could probably get for early on doses. Dose, route, anatomical location: Thinks all doses were in left arm since caller is right handed. With early doses had no problems, just with the last two doses (10th and 11 dose). With previous doses would feel crummy for a day or two, as people do after any immunization. With the last two doses had the GI symptoms. 10th dose, caller had at another pharmacy. No additional information provided. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Asthma