Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood iron, Body temperature, Breast pain, Constipation
Clinical narrative: Gut distress; fatigue; I have been suffering with autoimmune symptoms since the second dose; muscle aches; muscle weakness; constipation; diarrhea; indigestion / Full blown indigestion / acidity; excessive menstrual bleeding; GERD; gastritis; stomach pain; irritable bowel syndrome; sore and painful breasts; loss of libido; mental disturbances; depression; anxiety; schizophrenic symptoms; unexplained fever; weight loss; palpitation; iron deficiency; hair fall; loss of appetite; severe neck ache; shoulder ache/joint pain/joint aches; lower back ache; excessive burping; discoloration of teeth; thinning of teeth; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 at 12:00 as dose 2, single (Lot number: EW0176) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Batch/Lot No: EN9581; Location of injection: Arm Left; Vaccine Administration Time: 12:00 PM), administration date: 24Apr2021, when the patient was 25-year-old, for Covid-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 10Jun2021, outcome "recovering", described as "GERD"; AUTOIMMUNE DISORDER (medically significant) with onset 10Jun2021, outcome "recovering", described as "I have been suffering with autoimmune symptoms since the second dose"; ANXIETY (non-serious) with onset 10Jun2021, outcome "recovering"; CONSTIPATION (non-serious) with onset 10Jun2021, outcome "recovering"; DEPRESSION (non-serious) with onset 10Jun2021, outcome "recovering"; DIARRHOEA (non-serious) with onset 10Jun2021, outcome "recovering", described as "diarrhea"; TOOTH DISCOLOURATION (non-serious) with onset 10Jun2021, outcome "recovering", described as "discoloration of teeth"; ERUCTATION (non-serious) with onset 10Jun2021, outcome "recovering", described as "excessive burping"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Jun2021, outcome "recovering", described as "excessive menstrual bleeding"; GASTRITIS (non-serious) with onset 10Jun2021, outcome "recovering"; ALOPECIA (non-serious) with onset 10Jun2021, outcome "recovering", described as "hair fall"; DYSPEPSIA (non-serious) with onset 10Jun2021, outcome "recovering", described as "indigestion / Full blown indigestion / acidity"; IRON DEFICIENCY (non-serious) with onset 10Jun2021, outcome "recovering"; IRRITABLE BOWEL SYNDROME (non-serious) with onset 10Jun2021, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 10Jun2021, outcome "recovering", described as "loss of appetite"; LOSS OF LIBIDO (non-serious) with onset 10Jun2021, outcome "recovering"; BACK PAIN (non-serious) with onset 10Jun2021, outcome "recovering", described as "lower back ache"; EMOTIONAL DISTRESS (non-serious) with onset 10Jun2021, outcome "recovering", described as "mental disturbances"; MYALGIA (non-serious) with onset 10Jun2021, outcome "recovering", described as "muscle aches"; MUSCULAR WEAKNESS (non-serious) with onset 10Jun2021, outcome "recovering", described as "muscle weakness"; PALPITATIONS (non-serious) with onset 10Jun2021, outcome "recovering", described as "palpitation"; SCHIZOPHRENIFORM DISORDER (non-serious) with onset 10Jun2021, outcome "recovering", described as "schizophrenic symptoms"; NECK PAIN (non-serious) with onset 10Jun2021, outcome "unknown", described as "severe neck ache"; ARTHRALGIA (non-serious) with onset 10Jun2021, outcome "recovering", described as "shoulder ache/joint pain/joint aches"; BREAST PAIN (non-serious) with onset 10Jun2021, outcome "recovering", described as "sore and painful breasts"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Jun2021, outcome "recovering", described as "stomach pain"; TEETH BRITTLE (non-serious) with onset 10Jun2021, outcome "recovering", described as "thinning of teeth"; PYREXIA (non-serious) with onset 10Jun2021, outcome "recovering", described as "unexplained fever"; WEIGHT DECREASED (non-serious) with onset 10Jun2021, outcome "recovering", described as "weight loss"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Gut distress"; FATIGUE (non-serious), outcome "unknown". The events "i have been suffering with autoimmune symptoms since the second dose", "muscle aches", "muscle weakness", "constipation", "diarrhea", "indigestion / full blown indigestion / acidity", "excessive menstrual bleeding", "gerd", "gastritis", "stomach pain", "irritable bowel syndrome", "sore and painful breasts", "loss of libido", "mental disturbances", "depression", "anxiety", "schizophrenic symptoms", "unexplained fever", "weight loss", "palpitation", "iron deficiency", "hair fall", "loss of appetite", "severe neck ache", "shoulder ache/joint pain/joint aches", "lower back ache", "excessive burping", "discoloration of teeth", "thinning of teeth", "gut distress" and "fatigue" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood iron: deficiency; Body temperature: Unknown results; all tests: normal; Weight: loss. Therapeutic measures were not taken as a result of autoimmune disorder, myalgia, muscular weakness, constipation, diarrhoea, dyspepsia, gastrooesophageal reflux disease, gastritis, abdominal pain upper, irritable bowel syndrome, breast pain, loss of libido, emotional distress, depression, anxiety, schizophreniform disorder, pyrexia, weight decreased, palpitations, iron deficiency, alopecia, decreased appetite, back pain, eructation, tooth discolouration, teeth brittle. Therapeutic measures were taken as a result of heavy menstrual bleeding which she treated naturally, neck pain, arthralgia which failed to respond even after physiotherapy. Clinical course: the patient was not sure if the second dose of COVID vaccine was bivalent. She was normal and had no weakness before receiving second dose of COVID vaccine, and all of a sudden things changed in two years. It slowly started to effect her after a month from the second dose. The first thing she started noticing was excessive menstrual bleeding, which went on to gut distress. She experienced acidity, diarrhea, and constipation. She had full blow indigestion. She couldn't do anything, had a full loss of appetite, going into an iron deficiency state, had lots of fatigue and severe neck, shoulder and lower back ache. She went to all of the doctors, did all of the tests, but nothing was proof, it has really been a rough time for her, and she was recovering. It has been 1.5 years and a lot has been going on for her since then. In addition to the menstrual cycles, it has continued for a 1.5 years. Finally had her cycles back under control at this point. Doctor couldn't see anything wrong. She was prescribed pills, oral contraceptive pills, and those have a lot of side effects to the gut. The oral contraceptives worsened her gut distress so she chose not to take the medication, she had to wait 1.5 years for it to come back to normal. She did all the tests and it all came down to normal. She thought planning on visiting a few more specific doctors. This has been heavy on her medical bills and finance. She had no other vaccine in four weeks, and no other medications in two weeks. She had no COVID prior to vaccination, and was not tested for COVID after vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Autoimmune disorder and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.