Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Endoscopy upper gastrointestinal tract, Fibromyalgia, Gastritis, Incorrect dose administered
Clinical narrative: 3rd Booster FM7553; each covid vaccine+boosters caused a flare-up of my fibromyalgia; The 2nd & 3rd boosters caused heartburn + gastritis; The 2nd & 3rd boosters caused heartburn + gastritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia CFS", start date: 1993 (ongoing), notes: take medications for sleep and pain; "Tachycardia", start date: 1995 (ongoing); "Anxiety", start date: 1995 (ongoing); "Heart burn", start date: 2022 (unspecified if ongoing), notes: Heart burn started after receiving 1st Covid booster; "Osteoporosis", start date: 2000 (ongoing); "Fibromyalgia CFS", start date: 1993 (ongoing), notes: take medications for sleep and pain. The patient's family history included: "Cancer" (unspecified if ongoing); "Heart issue" (unspecified if ongoing); "Alzheimers" (unspecified if ongoing); "Strokes" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE oral taken for fibromyalgia, start date: 1995 (ongoing); CLONAZEPAM oral taken for anxiety, sleep apnoea syndrome, start date: 1995 (ongoing); METOPROLOL oral taken for tachycardia, start date: 1995 (ongoing); CELEBREX oral taken for fibromyalgia, start date: 2021 (ongoing); PANTOPRAZOLE oral taken for dyspepsia, start date: 2022 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, Time: 04:00 PM, via an intramuscular, at left arm, Lot number: FA6780.), administration date: 10Aug2021, for COVID-19 Immunization, reaction(s): "falre-up of her fibromyalgia"; BNT162b2 (Dose 2, Single, Time: 10:30 AM, via an intramuscular at left arm, Lot number: FC3182), administration date: 31Aug2021, for COVID-19 Immunization, reaction(s): "falre-up of her fibromyalgia"; BNT162b2 (Dose 3 (booster), Single, Time: 10:15 AM, via an intramuscular at left arm, Lot number: FK9729), administration date: 02Feb2022, for COVID-19 Immunization, reaction(s): "falre-up of her fibromyalgia". The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "3rd Booster FM7553"; FIBROMYALGIA (non-serious), outcome "recovering", described as "each covid vaccine+boosters caused a flare-up of my fibromyalgia"; DYSPEPSIA (non-serious), 20 min after the suspect product(s) administration, outcome "unknown", GASTRITIS (non-serious), outcome "unknown" and all described as "The 2nd & 3rd boosters caused heartburn + gastritis". The event "each covid vaccine+boosters caused a flare-up of my fibromyalgia" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fibromyalgia. Therapeutic measures were taken as a result of dyspepsia.  Clinical information: Booster dose was taken due to high risk of frequent institutional or occupational exposure to coronavirus (and AT risk of serious COVID-19 complications) as her age was over 50. Vaccination Facility Type was Pharmacy or Drug store and not Facility. Fibromyalgia fare up after each Covid vaccine and booster, within 08 hours of shot. It started to resolve itself within one week after vaccine shot. It was recovering with sequelae. The second and third boosters caused heart burn and gastritis. At the time of report, she had to take medication for heart burn and gastritis every day. Medication controlled it but without medication, heart burn and gastritis came back. She was at higher risk for this due to long term use of anti-inflammatory drugs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.