Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Investigation, Off label use, Vaccination site pain
Clinical narrative: Vaccine: Pfizer / BioNTech, Treatment: Covid-19 Treatment, Indication: Treatment of Covid-19; Vaccine: Pfizer / BioNTech, Treatment: Covid-19 Treatment, Indication: Treatment of Covid-19; I still have the pain in my stomach; Besides my left arm being extremely painful the following day; I had the most excruciating pain in my low to mid back; I sweat through my clothing, it was so painful; Vaccine dose number: 4; Vaccine dose number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 27Apr2022 at 11:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic back pain from surgery after a broken back" (unspecified if ongoing), notes: Chronic back pain from surgery after a broken back; "Chronic back pain from surgery after a broken back" (unspecified if ongoing), notes: Chronic back pain from surgery after a broken back; "asthma" (unspecified if ongoing); "Chronic migraine" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Knownn allergies: Morphine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious) with onset 27Apr2022 at 11:45, outcome "unknown", IMMUNISATION (non-serious) with onset 27Apr2022 at 11:45, outcome "unknown" and all described as "Vaccine dose number: 4"; VACCINATION SITE PAIN (non-serious) with onset 28Apr2022 at 00:30, outcome "recovering", described as "Besides my left arm being extremely painful the following day"; BACK PAIN (non-serious) with onset 28Apr2022 at 00:30, outcome "recovering", described as "I had the most excruciating pain in my low to mid back"; HYPERHIDROSIS (non-serious) with onset 28Apr2022 at 00:30, outcome "recovering", described as "I sweat through my clothing, it was so painful"; ABDOMINAL PAIN UPPER (non-serious) with onset 28Apr2022 at 01:30, outcome "not recovered", described as "I still have the pain in my stomach"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine: Pfizer / BioNTech, Treatment: Covid-19 Treatment, Indication: Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: vivid test: (29Apr2022) Unknown Results. Therapeutic measures were not taken as a result of vaccination site pain, back pain, hyperhidrosis, abdominal pain upper.  Clinical information:: Patient was treated for COVID-19. Vaccine received. Antiviral details: Product: COVID 19 Treatment; Brand: Pfizer; Treatment start date: 13May2021; Treatment stop date: 27Apr2022; Indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.