chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: loud ear ringing within hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 19:00 (Lot number: Fh8030) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allegies: Penicillins" (unspecified if ongoing); "Known allergies: gluten" (unspecified if ongoing), notes: other medical history: gluten snesitivity; "Celiac disease" (unspecified if ongoing); "highblood pressure" (unspecified if ongoing); "demylating disease" (unspecified if ongoing); "Joint and muscle pain" (unspecified if ongoing); "Joint and muscle pain" (unspecified if ongoing); "possibly autoimmune from celiac disease" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; AMLODIPIN BESYLATE AND BENAZEPRIL HYDROCHLORI. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8736, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM, Duration: 1 day), administration date: 11May2021, when the patient was 47 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0162, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM), administration date: 19Apr2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "loud ear ringing within hours". Therapeutic measures were not taken as a result of tinnitus.  Additional information: It was reported that 2 months later still have loud ear ringing especially noticeable after laying down and in the evening and during the day at work less noticeable. The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID-19 prior vaccination and the patient had not tested to COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 20:00 (Lot number: Er8736) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing); "gluten snesitivity" (unspecified if ongoing); "highblood pressure" (unspecified if ongoing); "Demylating disease" (unspecified if ongoing); "joint and muscle pain" (unspecified if ongoing); "joint and muscle pain" (unspecified if ongoing); "possibly autoimmune from celiac disease," (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; AMLODIPINE BESYLATE. Past drug history included: Gluten, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0162, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM), administration date: 19Apr2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Headache".  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. After dose 2, headache for 1 day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 30Jan2022.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair thinning/hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Lot number: FD7218) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high", start date: 2018 (ongoing), notes: Verbatim: Blood pressure high, Diagnosed three years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose,/LOT/EXP: Unknown , Dose amount: Unknown , Route: Injected into left arm), administration date: 26Mar2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Second Dose, /LOT/EXP: Unknown , Dose amount: Unknown , Route: Injected into left arm), administration date: 16Apr2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset Jan2022, outcome "not recovered", described as "hair thinning/hair loss". Therapeutic measures were not taken as a result of alopecia.  Additional information: Caller mentioned that her husband had already 3 doses of Pfizer COVID vaccine. On 04Jan2022, her husband received his booster shot/third dose. Caller stated that 2 weeks after, they began noticing "hair loss and hair thinning". Caller was asking for information if "this is a side effect or something else or if it will comeback." Caller also mentioned that they will call their family doctor after asking Pfizer if this is a common side effect. Caller stated that there were comments from website that mentions hair thinning or hair loss after being vaccinated. Response: Spoke as per No Info, "A review of prescribing information of Pfizer BioNTech COVID Vaccine, failed to find any information about hair loss or hair thinning. Please consult with your doctor or health care provider for further guidance, as your doctor/healthcare provider is the most familiar with your medical condition." Mentioned that reported side effects during clinical trial did not include hair loss or hair thinning as well. Provided website for further information about the reported or listed side effects of the vaccine. Caller disconnected before survey was offered. Patient just started freaking out about this last week. Patient got his hair cut and caller initially thought the hairdresser put a divot in his head. Then all of a sudden, the divots kept going all over patient's head. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Emergency Room and Physician Office. Hair loss and hair thinning: Now has bald spots on back of head and the top of his hair. His hair still looks ok, but was really thinning. No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Visual impairment
Clinical narrative: black out for vision for 2 minutes; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 12 years as dose 1,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "black out for vision for 2 minutes"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: Patient can't get the second shot since she experienced a reaction of black out for vision for 2 minutes and dizziness. Caller asking why they can't get the second shot for her son.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: The feeling in her arm comes and goes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date Sep2021. Vaccination history included: Bnt162b2 (Dose 1, Transferring agent states that the caller has received three doses of the Pfizer Covid 19 Vaccine), administration date: Jan2021, for covid-19 immunization; Bnt162b2 (Dose 2, Transferring agent states that the caller has received three doses of the Pfizer Covid 19 Vaccine), administration date: Feb2021, for Covid-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "The feeling in her arm comes and goes".  Additional information: The patient had received the first dose in Jan2021, the second dose in Feb2021, and the booster dose in Oct2021. The patient stated that her and her husband received their annual flu vaccines in Sep2021. The patient also stated that she had all of her vaccines in the same arm and her arm has been bothering her ever since. It bothers her when she moves it up and down. The symptom comes and goes, but is still occurring. Patient stated that her husband rotated sites for his injections and he is not having this problem like she is. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Culture urine, Electrocardiogram, Energy increased
Clinical narrative: Unexpected therapeutic effect; energy boost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2022 10:30 (Lot number: FL3209) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "Unexpected therapeutic effect"; ENERGY INCREASED (non-serious), outcome "recovered", described as "energy boost". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have family medical history relevant to events. It was stated that after the vaccination approximately 25 to 30 minutes later the patient felt a tremendous energy boost and when arrived home maybe 45 minutes after the shot was administered the patient  went and shoveled snow off our two driveways and a long sidewalk and didn't break a sweat nor was tired at all. The patient wish to could get second shot earlier. It was amazing.  thought you would like to hear that. The patient did not receive prior vaccinations (within 4 weeks). The patient did not have arm pain, no muscle pain, in injection site experienced boost of energy lasted 24 hours (up to 36 hours), came home shoveled after shot, entire drive way/side walk, no fatigue, no heart palpitation and no ill affect from the shot.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: Unexpected therapeutic effect; energy boost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2022 10:30 (Lot number: FL3209) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "Unexpected therapeutic effect"; ENERGY INCREASED (non-serious), outcome "recovered", described as "energy boost". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have family medical history relevant to events. It was stated that after the vaccination approximately 25 to 30 minutes later the patient felt a tremendous energy boost and when arrived home maybe 45 minutes after the shot was administered the patient  went and shoveled snow off our two driveways and a long sidewalk and didn't break a sweat nor was tired at all. The patient wish to could get second shot earlier. It was amazing.  thought you would like to hear that. The patient did not receive prior vaccinations (within 4 weeks). The patient did not have arm pain, no muscle pain, in injection site experienced boost of energy lasted 24 hours (up to 36 hours), came home shoveled after shot, entire drive way/side walk, no fatigue, no heart palpitation and no ill affect from the shot.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Jun2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Verbatim: Mild asthma; "Peanut allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- unknown, Dose no: 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 30Jan2022, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 30Jan2022, outcome "unknown", described as "Nausea"; OROPHARYNGEAL PAIN (non-serious) with onset 30Jan2022, outcome "unknown", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter Contact Information: Reporter was a minor or child. Description of Event: (withheld) was a 13 year old boy. Pt received second dose of Comirnaty on 17Jun2021. (withheld) began experiencing a headache and nausea and sore throat on 30Jan2022. He tested positive on rapid antigen test on 31Jan2022. Name of Product: Comirnaty. Awareness Date: 31Jan2022. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have had two herpes sensations. However, they never came to be.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: EW0150) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "genital herpes" (unspecified if ongoing), notes: I have had genital herpes for 50 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Batch/Lot Number: EL1283), administration date: 15Jan2021, for covid-19 immunization; Bnt162b2 (Dose: 2, Batch/Lot Number: EL9264), administration date: 05Feb2021, for Covid-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have had two herpes sensations. However, they never came to be.".   Additional information: It was reported that patient had herpes for 50 years. Patient can tell when it was going to activate fully. Since vaccine shots, Patient had 2 that felt coming on. However, they never fully developed post the little tingle stage. This has been only since the vaccine. Perhaps the vaccine was helping with the herpes virus.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Palpitations
Clinical narrative: Swelling of lymph node in left armpit; Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2022 13:30 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 10Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Jan2022, outcome "unknown", described as "Swelling of lymph node in left armpit"; PALPITATIONS (non-serious) with onset 29Jan2022, outcome "unknown", described as "Heart palpitations". The events "swelling of lymph node in left armpit" and "heart palpitations" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, palpitations.   Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adolescent female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore".  Additional information: Causality: Related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: menstrual cycle has increased; menstrual cycle has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 22Nov2021 (Lot number: EW0171) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EN0153,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 01May2021, Previous dose number: 2), administration date: 01May2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: ER8730,, Previous dose lot unknown: False,, Previous dose administration date: 10Apr2021, Previous dose number: 1), administration date: 10Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 2021, outcome "recovered with sequelae" and all described as "menstrual cycle has increased". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, oligomenorrhoea.  Upon follow-Up 04Feb2022: Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, Burning sensation, Dental discomfort, Dry mouth
Clinical narrative: dry mouth; over salivation; burning syndrome in her mouth and reactions in her mouth; has problems with her teeth; can not wear her nightguard at night because it is too irritating; frustrating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 12:45 (Lot number: ER8731) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; SIMVASTATIN; CLONAZEPAM; SYNTHROID. Vaccination history included: Bnt162b2 (1st dose, LOT#(1st dose): Consumer stated, "ER8734.", Mailing address and telephone#: Consumer stated, "My first vaccination was also at 12:45 PM, (name-withheld) the address is (address-withheld), (telephone number-withheld)."), administration date: 12Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 03May2021, outcome "unknown", described as "dry mouth"; SALIVARY HYPERSECRETION (non-serious) with onset 03May2021, outcome "unknown", described as "over salivation"; BURNING SENSATION (non-serious) with onset 03May2021, outcome "unknown", described as "burning syndrome in her mouth and reactions in her mouth"; TOOTH DISORDER (non-serious) with onset 03May2021, outcome "unknown", described as "has problems with her teeth"; DENTAL DISCOMFORT (non-serious) with onset 03May2021, outcome "unknown", described as "can not wear her nightguard at night because it is too irritating"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 03May2021, outcome "unknown", described as "frustrating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth, salivary hypersecretion, burning sensation, tooth disorder, dental discomfort, frustration tolerance decreased. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Full blood count, Metabolic function test, Red blood cell count, Rheumatoid factor
Clinical narrative: dry mouth; over salivation; burning syndrome in her mouth and reactions in her mouth; has problems with her teeth; can not wear her nightguard at night because it is too irritating; frustrating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 12:45 (Lot number: ER8731) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; SIMVASTATIN; CLONAZEPAM; SYNTHROID. Vaccination history included: Bnt162b2 (1st dose, LOT#(1st dose): Consumer stated, "ER8734.", Mailing address and telephone#: Consumer stated, "My first vaccination was also at 12:45 PM, (name-withheld) the address is (address-withheld), (telephone number-withheld)."), administration date: 12Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 03May2021, outcome "unknown", described as "dry mouth"; SALIVARY HYPERSECRETION (non-serious) with onset 03May2021, outcome "unknown", described as "over salivation"; BURNING SENSATION (non-serious) with onset 03May2021, outcome "unknown", described as "burning syndrome in her mouth and reactions in her mouth"; TOOTH DISORDER (non-serious) with onset 03May2021, outcome "unknown", described as "has problems with her teeth"; DENTAL DISCOMFORT (non-serious) with onset 03May2021, outcome "unknown", described as "can not wear her nightguard at night because it is too irritating"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 03May2021, outcome "unknown", described as "frustrating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth, salivary hypersecretion, burning sensation, tooth disorder, dental discomfort, frustration tolerance decreased. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion, Thyroid hormones test, Tooth disorder
Clinical narrative: dry mouth; over salivation; burning syndrome in her mouth and reactions in her mouth; has problems with her teeth; can not wear her nightguard at night because it is too irritating; frustrating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 12:45 (Lot number: ER8731) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; SIMVASTATIN; CLONAZEPAM; SYNTHROID. Vaccination history included: Bnt162b2 (1st dose, LOT#(1st dose): Consumer stated, "ER8734.", Mailing address and telephone#: Consumer stated, "My first vaccination was also at 12:45 PM, (name-withheld) the address is (address-withheld), (telephone number-withheld)."), administration date: 12Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 03May2021, outcome "unknown", described as "dry mouth"; SALIVARY HYPERSECRETION (non-serious) with onset 03May2021, outcome "unknown", described as "over salivation"; BURNING SENSATION (non-serious) with onset 03May2021, outcome "unknown", described as "burning syndrome in her mouth and reactions in her mouth"; TOOTH DISORDER (non-serious) with onset 03May2021, outcome "unknown", described as "has problems with her teeth"; DENTAL DISCOMFORT (non-serious) with onset 03May2021, outcome "unknown", described as "can not wear her nightguard at night because it is too irritating"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 03May2021, outcome "unknown", described as "frustrating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth, salivary hypersecretion, burning sensation, tooth disorder, dental discomfort, frustration tolerance decreased. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited multiple times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- unknown, Dose number unknown), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomited multiple times". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Premenstrual syndrome, SARS-CoV-2 test
Clinical narrative: PMS; My usual (like clockwork) menstrual cycle hasn't been the same / start date gets later and later every month; cramps and flow has been almost unbearable; cramps and flow has been almost unbearable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Jan2022 at 10:30 am (Lot number: 33025b1) at the age of 41 years as dose 3 (booster), single, administered in arm left, administration date May2021 (Lot number: ew0182) as dose 2, single and administered in arm left, administration date Apr2021 (Lot number: ew0158) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PAXIL [PIROXICAM]. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered with sequelae", described as "My usual (like clockwork) menstrual cycle hasn't been the same / start date gets later and later every month"; DYSMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 2021, outcome "recovered with sequelae" and all described as "cramps and flow has been almost unbearable"; PREMENSTRUAL SYNDROME (non-serious), outcome "recovered with sequelae", described as "PMS". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, menstrual disorder, premenstrual syndrome.  Additional information: Patient stated her usual (like clockwork) menstrual cycle had not been the same since she got her first shot. Sometimes it was long (up to 9 days) and sometimes short (as little as 4 days). The cramps and flow were almost unbearable. And her start date gets later and later every month. It was about 11 days late this time. Lastly, she felt like she was experiencing PMS all the days as it was late late. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Patient had no known allergies and no other medical history. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: Horrific shooting pain in her right ear/it felt like a needle in her ear; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2022 14:15 (Lot number: FL3209) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EM9806, Expiration: unknown), administration date: 10Feb2021, when the patient was 74 years old, for COVID-19 Immunization, reaction(s): "She did not have reactions on first two doses"; Bnt162b2 (Second dose, Lot: EN6205, Expiration: unknown), administration date: 03Mar2021, when the patient was 74 years old, for COVID-19 Immunization, reaction(s): "She did not have reactions on first two doses". The following information was reported: EAR PAIN (non-serious) with onset 09Jan2022, outcome "recovered" (2022), described as "Horrific shooting pain in her right ear/it felt like a needle in her ear"; TINNITUS (non-serious) with onset 09Jan2022, outcome "not recovered", described as "Tinnitus". Therapeutic measures were not taken as a result of ear pain, tinnitus.  Additional information: There were other products and investigation assessment reported. She never had any pain in her ear ever. That pain lasted a minute and knew something was very wrong, it was coincident to the shot. Tinnitus started very shortly after that. No additional vaccines were administered on the same date of the Pfizer suspect. AE(s) did not require a visit to Emergency Room and Physician Office. The patient did not receive any vaccine, prior vaccination (within 4 weeks). There was no AE(s) following prior vaccinations. It was reported, thousands and thousands, over 13,000 people have reported the exact same thing, not just tinnitus, it occurred in a certain time frame, certain tone and escalated after subsequent doses. She was asking why isn't Pfizer is not sharing this.  No follow-up attempts are possible. No further information is expected.  Follow-Up (04FEB2022): Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Headache
Clinical narrative: loss of appetite x 1 month; Headache; belly ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 12:00 (Lot number: FL0007) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: cephalosporin" (unspecified if ongoing), notes: Known allergies: cephalosporin. The patient's concomitant medications were not reported. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicillin; Known allergies: cefdinir, reaction(s): "Drug allergy", notes: Known allergies: cefdinir; Known allergies: keflex, reaction(s): "Drug allergy", notes: Known allergies: keflex. The following information was reported: DECREASED APPETITE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "loss of appetite x 1 month"; HEADACHE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "Headache"; ABDOMINAL PAIN (non-serious) with onset 06Jan2022, outcome "not recovered", described as "belly ache". The events "loss of appetite x 1 month", "headache" and "belly ache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of decreased appetite, headache, abdominal pain.  Additional information: Seriousness reported as No. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received dose 2 vaccine on 27Jan2022 at 01:45 PM in right arm.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in my left Arm that is limiting my capacity to use my left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient.   A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 14:45 (Lot number: FH8030) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type II diabetes" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, single, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 05Feb2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, single, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 15Jan2021, when the patient was 39 years old, for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Dec2021 14:45, outcome "not recovered", described as "Pain in my left Arm that is limiting my capacity to use my left arm.". Therapeutic measures were not taken as a result of pain in extremity.   Additional information: Facility where the most recent COVID-19 vaccine was administered included Public Health Clinic/Veterans Administration facility. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. The patient received medications within 2 weeks of vaccination included Metformin 500 mg and simvastatin20 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, SARS-CoV-2 test
Clinical narrative: started having night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Sep2021 (Lot number: Fc3184) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Backache" (unspecified if ongoing); "Migraine headache" (unspecified if ongoing); "postmenopausal" (unspecified if ongoing), notes: I am 18 years postmenopausal so, they are not related to menopause. Concomitant medication(s) included: ZOLOFT; TRAZODONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer , prev dose brand unknown: False , prev dose lot number: #Fc3183, prev dose lot unknown: False, prev dose administration date: 23Aug2021, prev dose dose number: 1), administration date: 23Aug2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: NIGHT SWEATS (non-serious) with onset 30Oct2021 02:00, outcome "not recovered", described as "started having night sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of night sweats.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. If other vaccine in four weeks was no. Other medications in two weeks: Zoloft, Trazadone, Zyrtec. About a month after the second vaccine I started having night sweats. I am 18 years postmenopausal so they are not related to menopause. I did have occasional night sweats during menopause but the night sweats now occur every night. If covid prior vaccination was no. If covid tested post vaccination was yes.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: Very sore arm; ramped up ringing in ears; increase of parathesia tingling lower legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Jan2022 03:15 (Lot number: FC3209) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I might have rheumatoid arthritis" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "lyme disease" (unspecified if ongoing); "vector bacterial infections" (unspecified if ongoing); "allergy to antibiotics" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Sick". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FC3183, Location of injection: Arm Right), administration date: 22Aug2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0198, Location of injection: Arm Right), administration date: 02Aug2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Paraesthesia", "vaccination site swelling", "headaches", "feeeling dizzy", "developed neuropathy", "most alarming was swelling of supraclaivicular lymph nodes", "General unwell feeling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Jan2022 15:45, outcome "recovering", described as "Very sore arm"; TINNITUS (non-serious) with onset 17Jan2022 15:45, outcome "recovering", described as "ramped up ringing in ears"; PARAESTHESIA (non-serious) with onset 17Jan2022 15:45, outcome "recovering", described as "increase of parathesia tingling lower legs". Therapeutic measures were not taken as a result of pain in extremity, tinnitus, paraesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: loosing her hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 19:00 (Lot number: CVS9665) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None. The following information was reported: ALOPECIA (non-serious) with onset 08Jan2022, outcome "unknown", described as "loosing her hair". The event "loosing her hair" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional Information: The event onset latency was 4 days 5 hrs after vaccination. Facility type vaccine: Pharmacy or Drug Store. The patient had not other vaccine in four weeks. The patient had not taken other medications in two weeks. Hair lost. My daughter was loosing her hair and still loosing her hair as of today 03Feb2022. I took her to the doctor and have blood tested. The doctor said her blood tested ok and the hair lost likely due to the COVID vaccine. The patient had tested covid post-vaccination. covid test type post vaccination=Nasal Swab, covid test name post vaccination=Rapid Test. No known allergies were reported. The patient was covid prior to vaccination and covid tested post-vaccination. The patient was not have known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on the arm on the entry point; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash on the arm on the entry point".  Additional information: Medical Information: NO medical questions addressed by this program forwarded/referred to Medical Information No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump under his armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2022 11:50 (Lot number: FL3209) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "had the Moderna covid vaccines for his first and second dose/third dose of the Pfizer covid vaccine" (unspecified if ongoing), notes: had the Moderna covid vaccines for his first and second dose/third dose of the Pfizer covid vaccine. There were no concomitant medications. Vaccination history included: Moderna (Dose 1), for COVID-19 Immunization; Moderna (Dose 2), for COVID-19 Immunization, reaction(s): "flu like symptoms". The following information was reported: AXILLARY MASS (non-serious) with onset 31Jan2022, outcome "not recovered", described as "lump under his armpit".  No follow-up attempts are possible. No further information is expected.  Follow-Up (09Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she only had a minor sore arm for her 1st two doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 (Lot number: EM9809) at the age of 70 years as dose 2, single and administered in arm left, administration date 25Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CYTOMEL taken for hypothyroidism, stop date: Nov2021. Vaccination history included: Flu vaccine (had a flu vaccine every year since she was probably 20 years old.), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "she only had a minor sore arm for her 1st two doses".  Additional information: The reporter stated that she only had a minor sore arm for her 1st two doses and she was fine. The reporter stated that there was nothing that she had taken that had been changed. The medications that she was on were ones that she had taken for years. The only thing that did change was Cytomel for underactive thyroid was switched to the generic version at the end of Nov2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Fatigue; Headache; Body Aches; Chills; Fever; Brain Fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREVACID; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.