Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 7+ | — | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | — | LA |
indigestion; Gas/Flatulence; abdominal pain; nausea; anorexia; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 03Oct2025 as dose 11, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 03Oct2025 as 0.5 ml, single, in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 2: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 3: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 4: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 5: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 6: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 7: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 8: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 9: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 omicron (lp.8.1) (Dose 10: in left arm), administration date: 2025, for Covid-19 immunization, reaction(s): "Abdominal pain", "Chills", "anorexia", "Indigestion", "constant burping", "Gas/Flatulence", "felt really crummy", "nausea", "fever". The following information was reported: DYSPEPSIA (non-serious), outcome "recovering", described as "indigestion"; FLATULENCE (non-serious), outcome "recovering", described as "Gas/Flatulence"; ABDOMINAL PAIN (non-serious), outcome "recovering"; NAUSEA (non-serious), outcome "recovering"; DECREASED APPETITE (non-serious), outcome "recovering", described as "anorexia". Therapeutic measures were not taken as a result of dyspepsia, flatulence, abdominal pain, nausea, decreased appetite. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: Second side effects with the Pfizer COVID-19 vaccine: patient confirmed second side effects with the Pfizer COVID-19 vaccine were the same side effects, same things, abdominal issues, clarified as indigestion, gas/flatulence, abdominal pain, nausea, and anorexia. That is when put two and two together, thought oh that's why felt like that after COVID shot last Spring. Had the most recent COVID shot Friday morning, 03Oct2025. Was in bed all day Saturday. All side effects the second time, abdominal issues, clarified as indigestion, gas/flatulence, abdominal pain, nausea, and anorexia, are resolving, not completely resolved at this point, but all are resolving. No treatment or medical interventions, patient then stated she just took over the counter remedies herself. Patient doesn't have dates handy at time of call for previous 1 to 9 doses and patient took 10th dose in spring 20205 also patient believes all doses were in left arm since she is right handed. Patient also had the shingles vaccine, but waited at least 6 weeks ago from the most recent dose of the COVID vaccine, didn't want close together.
Medical History/Concurrent Conditions: Asthma