chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: he had high fever of 104; vomiting; headache; He was in bed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's disease" (unspecified if ongoing); "Neck Fusion" (unspecified if ongoing), notes: it has been 3-4 years since he had the Neck fusion.; "had covid virus", start date: 18Nov2020 (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for sjogren's syndrome; PREDNISONE taken for sjogren's syndrome. The following information was reported: PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "he had high fever of 104"; VOMITING (non-serious) with onset May2021, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache"; BEDRIDDEN (non-serious) with onset May2021, outcome "recovered" (May2021), described as "He was in bed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On an unspecified date in may2021, the patient underwent lab test for Body temperature and result was 104 degrees. On 03Aug2021, the patient underwent SARS-CoV-2 test and result was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test
Clinical narrative: painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Mar2021 10:30 (Lot number: EN6204) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibroids/recon surgery uterus", start date: 1995, stop date: 19Jan1995, notes: Fibroids/recon surgery uterus, Uterine-fibroid removal reconstruction. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "painful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, patient had the Pfizer booster 03Nov2021. The injection was more painful that the 2 previous injections he received. Patient do yoga and extremely healthy, run, lift weights, exercise 6 days per week, have excellent weight low/norm BMI, he was vegan with a normal resting HR of 52. He takes no medications and was in very good health before this.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Musculoskeletal stiffness, Nausea
Clinical narrative: Immediate headache; nauseous; couldn't walk without support; fingers in extension and couldn't bend; started sweating; hands pale and face pale; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 16:00 (Lot number: FL3197) 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: HEADACHE (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "Immediate headache"; NAUSEA (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "nauseous"; GAIT DISTURBANCE (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "couldn't walk without support"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "fingers in extension and couldn't bend"; HYPERHIDROSIS (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "started sweating"; PALLOR (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "hands pale and face pale". Therapeutic measures were not taken as a result of headache, nausea, gait disturbance, musculoskeletal stiffness, hyperhidrosis, pallor.  Additional information: Facility where the most recent COVID-19 vaccine was administered: facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Serious: No. Reported Event: Immediate headache, felt nauseous, started sweating, couldn't walk without support, fingers in extension and couldn't bend, hands pale and face pale. Had to be monitored after shot and check vitals. Device Date : 21Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Immediate headache; nauseous; couldn't walk without support; fingers in extension and couldn't bend; started sweating; hands pale and face pale; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 16:00 (Lot number: FL3197) 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: HEADACHE (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "Immediate headache"; NAUSEA (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "nauseous"; GAIT DISTURBANCE (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "couldn't walk without support"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "fingers in extension and couldn't bend"; HYPERHIDROSIS (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "started sweating"; PALLOR (non-serious) with onset 21Dec2021 16:00, outcome "unknown", described as "hands pale and face pale". Therapeutic measures were not taken as a result of headache, nausea, gait disturbance, musculoskeletal stiffness, hyperhidrosis, pallor.  Additional information: Facility where the most recent COVID-19 vaccine was administered: facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Serious: No. Reported Event: Immediate headache, felt nauseous, started sweating, couldn't walk without support, fingers in extension and couldn't bend, hands pale and face pale. Had to be monitored after shot and check vitals. Device Date : 21Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.; administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.; administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 51-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Nov2021 (Lot number: 30155BA) at the age of 51 years as dose 2 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose 1, Lot: 1808978, Route: IM, R deltoid, No. of previous dose: 0), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.".  Additional information: It was reported that, they administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long. Upon Follow-up (03Feb2022), the Updated information included: "Reporter tab" (Reporter email id and Zip code). "Patient tab" (Patient initial, Age). "RMH" (Prior vaccination). "Product tab" (Administration date, Dose number, anatomical location, route of administration, Vaccination facility details). Relevant Test: List other diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, diagnostic imaging, (e.g., chest x-ray, MRH). If COVID-19 testing has been conducted, provide test dates and results. None. Specific relevant test: None. Dose in freezer 5 days too long given to pt. by accident.   Follow-up attempts are completed, and no further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Illness
Clinical narrative: just feels an extreme sense of fatigue and is very tired; feels very, not like her self; was feeling very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 12Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "was feeling very sick"; FATIGUE (non-serious) with onset 21Dec2021, outcome "unknown", described as "just feels an extreme sense of fatigue and is very tired"; FEELING ABNORMAL (non-serious) with onset 21Dec2021, outcome "unknown", described as "feels very, not like her self".  Additional information: Reporter stated regarding the Pfizer vaccine, the second dose. Clarified that she was referring to the Pfizer Covid vaccine, second dose. The patient got her second dose last Sunday (at the time of report) and knew they typically tell them that symptoms would last 1 to 2 days afterward. The next day (at the time of report), she was feeling very sick. Today was Tuesday (at the time of report), so it had been 8 days. She was feeling fine but, then again, she just felt an extreme sense of fatigue and was very tired. She had no loss of appetite but just felt very, not like her self. She was curious if with the Pfizer vaccine, if it was normal to last this long. It was very weird.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation, Tongue pruritus
Clinical narrative: felt itching in her tongue; cough; throat is scratchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "guillen barre syndrome" (unspecified if ongoing); "stroke" (unspecified if ongoing); "BellTs palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TONGUE PRURITUS (non-serious), outcome "recovering", described as "felt itching in her tongue"; COUGH (non-serious), outcome "recovering", described as "cough"; THROAT IRRITATION (non-serious), outcome "recovering", described as "throat is scratchy". Therapeutic measures were taken as a result of tongue pruritus, cough, throat irritation.  Additional information: Reporter mother has h/o guillen barre syndrome and stroke and BellTs palsy She had first dose of vaccine after which she felt itching in her tongue Started cough Felt like her throat is scratchy I gave her prednisone After which she got better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Influenza like illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: I had flu-like symptoms; a fever for approximately ten days; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I had minimal symptoms), administration date: 2021, for COVID-19 Immunization, reaction(s): "only the arm where I got the shot was sore". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "I had flu-like symptoms"; PYREXIA (non-serious), outcome "recovered", described as "a fever for approximately ten days". The events "i had flu-like symptoms" and "a fever for approximately ten days" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient had received two shots of the Pfizer COVID vaccine. After receiving the first shot, he had minimal symptoms--only the arm where he got the shot was sore. After receiving the second shot, he had flu-like symptoms and a fever for approximately ten days. He went to his personal physician and received negative results for a flu test and COVID test.   The follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed period following month so far; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Oct2021 (Lot number: 3203080) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "PCOS" (unspecified if ongoing), notes: PCOS; "SVT" (unspecified if ongoing), notes: SVT; "Migraines" (unspecified if ongoing), notes: Migraines. Concomitant medication(s) included: TOPAMAX; METFORMIN. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot No: ff2589, Location of injection: Arm Right), administration date: 05Oct2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Missed period following month so far". The event "missed period following month so far" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: There are no other vaccine in four weeks and other medications in two weeks: Topomax, metformin. Patient had covid prior vaccination and the patient did not tested for covid post vaccination.patient had no known allergies  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: Inappropriate schedule of vaccine administered; Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 15:00 (Lot number: ER8736, Expiration Date: 31Jul2021) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19,, brand=Pfizer,, brand unknown=False,, lot unknown=True,, lot unknown reason=Not available/provided to reporter at the, time of report completion,, administration time=03:00 PM, dose number=1,, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 14Apr2021, outcome "recovered" (Jul2021) and all described as "Menstrual cycle - increased cramping, heavier than normal bleeding"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Apr2021 15:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, heavy menstrual bleeding, inappropriate schedule of product administration.  Additional Information: It was reported that, the patient had no Known allergies. No other vaccine in four weeks. No other mediation in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any treatment for the adverse event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Speech disorder
Clinical narrative: Dizzy; trouble speaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; SPEECH DISORDER (non-serious), outcome "unknown", described as "trouble speaking".  Additional Information: Caller says he called about the corrupt COVID vaccine, his own mom is dizzy and having trouble speaking etc and they didnt make it a liability, and if she dies he is coming after (withheld), his mom was healthy, she was fine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   Follow-up (19Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: hot body; my arm was also in little pain; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "hot body"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm was also in little pain"; PYREXIA (non-serious), outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: but it was in Mar. Mar and Apr is when I got my first 2 vaccines. (Inaudible) just my arm sore; 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 Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "but it was in Mar. Mar and Apr is when I got my first 2 vaccines. (Inaudible) just my arm sore".  Additional information: Additional information: During the phone call received, the patient stated that patient want to enroll in the program that patient had from the last 2 vaccines. This is my booster. Patient just got it and I texted the thing that texted me all those times and they didn't respond. So Patient got my booster today so. another shot. Patient got mine but it was in Mar. Mar and Apr is when patient got my first 2 vaccines. (Inaudible) just my arm sore. patient never had any side effects except for a sore arm but patient get it on my right side cause patient sleep on my left. The patient did not specify which vaccine they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Nothing debilitating like she experienced with at least one of the first two vaccines; 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 female patient in her 70's received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) 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: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Nothing debilitating like she experienced with at least one of the first two vaccines".  Additional information: Caller received her first Pfizer Covid 19 Vaccine in Feb & her second Pfizer Covid 19 Vaccine in Mar. She received the Pfizer Coivd 19 Vaccine Booster on Sat, 11Dec2021. Caller reported that she was fully functional, wasnt tired. Nothing debilitating like she experienced with at least one of the first two vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: fever; body aches; felt sick after her first dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she had COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; ILLNESS (non-serious), outcome "unknown", described as "felt sick after her first dose of the vaccine".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LUPI21-04373.  A 7 year-old patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Batch/Lot number: unknown) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered", described as "chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nervous system disorder
Clinical narrative: received the 1st dose of the Pfizer covid vaccine on 22 Jan 2021/has not received her 2nd dose; neurological issues; 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. Other Case identifier(s): US-PFIZER INC-202101777267 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time: 10:20 am), administration date: 22Jan2021, for COVID-19 immunization, reaction(s): "neurological issues". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "received the 1st dose of the Pfizer covid vaccine on 22Jan2021/has not received her 2nd dose"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological issues".  Additional information: Reporter was received the 1st dose of the Pfizer covid vaccine on 22Jan2021 at 10:20 am. That night, she had an ocular migraine for 7 days straight, ringing in her ear, pressure in the head, tachycardia that lasted 2 weeks, dizziness that turned to vertigo and she still has vertigo till this day She is now seeing a neurologist and taking medications. She was also seeing a vestibular specialist. She has not received her 2nd dose. Reporter was a patient, and a mother looking for advice about whether or not her children should take the Pfizer Covid vaccine. Reporter was stated that after she had neurological issues after receiving the Pfizer covid vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: the coughing slowly started returning; 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 patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry cough" (unspecified if ongoing), notes: Hello I have had a dry cough for about 18 years that no one has been able to find a cure for. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "the coughing slowly started returning".  Additional information: Hello I have had a dry cough for about 18 years that no one has been able to find a cure for. When I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together! A few months after the 2nd dose the coughing slowly started returning. I was disappointed after the booster that my coughing did not stop. What is in your dose that stopped my coughing and how can I get regular use of it?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test
Clinical narrative: Three migraines with Aura in less than a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2021 (Lot number: FE3590) at the age of 72 years as dose 1, single and administered in arm right, administration date 04Feb2021 (Lot number: En5318) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 29Jan2021, outcome "unknown", described as "Three migraines  with Aura in less than a year.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of migraine. No follow-up attempts are possible. No further information is expected.  Additional Information: Three migraines with Aura in less than a year. Excedrin immediately at onset of aura. Patient did not provide information regarding the reported adverse event(s) with the use of the product. Administration date was 14Jan2021 of Dose number 3,Vaccine location was Right arm.If other vaccine in four weeks was Unknown. Other medications in two weeks were taken. Adverse event treatment was Excedrin immediately at onset of aura.covid prior vaccination was no.covid tested post vaccination was yes.Covid test type post vaccination was Nasal Swab. Patient had no Known allergies.Other medical history: Hypertension, arthritis, type 2 diabetes.Updated information included: Reporter slider unchecked. The patient did not provide information regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Achy arm and sore to touch; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 16 year-old male patient received meningococcal group b rlp2086 (TRUMENBA) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Trumenba (1st Dose), for immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Achy arm and sore to touch". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation, Pain in extremity
Clinical narrative: There is normally armpit tenderness; This time my armpit is on fire; moving my arm in any direction HURTS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Lot number: 30135BA) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation at doctor's office/urgent care. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 14Feb2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL9261, Location of injection: Arm Right), administration date: 24Jan2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 05Jan2022 08:00, outcome "unknown", described as "There is normally armpit tenderness"; BURNING SENSATION (non-serious) with onset 05Jan2022 08:00, outcome "unknown", described as "This time my armpit is on fire"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022 08:00, outcome "unknown", described as "moving my arm in any direction HURTS". Therapeutic measures were not taken as a result of axillary pain, burning sensation, pain in extremity.  Additional information: There is normally armpit tenderness. This time my armpit is on fire. moving my arm in any direction HURTS, not just a little tenderness, but it hurts. My armpit is pulsating as I sit, it isn't a little bit tender, it pulsates and is super painful and I have a pretty high pain tolerance, but it is constant, pulsating pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: hardly even sore in my left arm after the first two doses.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: EW0162) as dose 1, single and administered in arm left, administration date 10May2021 (Lot number: EW0179) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No. Varicose Veins is all." (unspecified if ongoing), notes: No. Varicose Veins is all. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "hardly even sore in my left arm after the first two doses.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was Recovering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medication in 2 weeks. On 22Nov2021, the booster dose (Dose 3, lot Number: 363080) was administered on left arm as vaccination anatomical location. She didn't really have any side effects and was hardly even sore in her left arm after the first two doses. On 23Nov2021, patient experienced the events. It was reported that the day after I got my booster, right on time, left breast has been achy and had pain for a month and a half. The left side of my breast, and what feels like inside my breast. It has hurt to sleep on that side to the point that I haven't - until recently, when getting a lymphatic drainage session helped. The discomfort hasn't been constant, but has been a lot of the time, and even me massaging that area hasn't resolved it. The lymph nodes seem to be swollen in my left breast area, and therefore things aren't moving along as they should and there is inflammation. It is concerning. It was treated by Lymphatic drainage. Covid test post vaccination by nasal swab was negative. Case was reported as, non-serious since, no seriousness criteria was met. Device Date was reported as 07Jan2022.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity
Clinical narrative: had the first shot in Mar2021, after that he had pain in the arm that was about a 4 out of 10 on a pain scale/With the second shot, it was the same way; 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 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date Mar2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "had the first shot in Mar2021, after that he had pain in the arm that was about a 4 out of 10 on a pain scale/With the second shot, it was the same way". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that he had the 3 shots, he just had the Booster and confirms the shots were for covid, clarifying the Pfizer covid vaccine. He had the first shot in Mar2021, after that he had pain in the arm that was about a 4 out of 10 on a pain scale. This pain lasted about 4 days or 5 days; it would ease up then come back intermediately. With the second shot, it was the same way. He got a vaccine booster a month and a half ago, and he was in such pain. All the shots he received were in the upper shoulder. He lost weight. The Pain in his arm after this booster was a level 12 out of a pain scale of 1-10, he was in an arm sling for 5 days, says it hurt worse out of the sling. He had to go in to get a X-ray, to see if there were damages but there was no damage (it was negative). A technician told him, that the Pfizer company is not telling people about side effects in the joints of people. His pain was traveling down to the bicep and towards the elbow, and also down around the bottom of bicep its completely black and blue. He still do not have strength in the arm, that got the injection, but that it was on the lower bicep, not in the upper shoulder where he got the shot. It was aching pain. He was wondering if this is all normal side effects. When probed reporter type, caller states that he was basically been taught to be a nurse. His wife got Varicella and the nurse comes 3 days a week, his wife had had shots she would get and a wound on her buttocks, in which they clean it, and he would clean it. His wife fell and broke her back, and so he do not know how to operate the machine that had in which they hook you up, he had the portable one. She cannot eat that good, and she would get saline if she got dehydrated. They gave her Vitamin B or E shot whatever it was he does not know. She had vascular disease. Caller states that he got the vaccine at the community Hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jan 11, 2022, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed a rash (spots all over his face) and erythema (whole face is a little bit red/his face getting red), onset Jan 11, 2022, with outcome of unknown. Additional information: Reporter stated, "My son got the first dose for Pfizer vaccine this morning at the hospital. His whole face is a little bit red and there are spots all over his face. I want to know if this is normal, because I don't see that kind of side effect on the information they gave me this morning." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: her husband felt crappier than she did after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "her husband felt crappier than she did after the first dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling of the lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: LIP SWELLING (non-serious), outcome "unknown", described as "Swelling of the lips".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Leg pain in both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Jan2022 09:15 (Lot number: FKS127) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Influenza A", start date: 10Dec2021 (unspecified if ongoing), notes: Influenza A. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FKS127 , Location of injection: Left Deltoid, Time: 09:45), administration date: 08Dec2021, when the patient was 11 years old, for Covid-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Jan2022 07:00, outcome "recovered" (16Jan2022), described as "Leg pain in both legs". The event "leg pain in both legs" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Serious: No. Relevant tests: None. Specific relevant test for thromboembolic events with thrombocytopenia: None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  No abnormalities found. Treatment: Motion pan, Ice pan, Pt felt better by 16Jan2022.  The patient provided information regarding the reported adverse event with the use of the product and considered the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: now I have had a period every two weeks; I missed my first period after getting vaccinated; had a period and another one 2 weeks later / now I have had a period every two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: EW0173) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin", notes: Known allergies: Amoxycillin. Vaccination history included: Bnt162b2 (lot number=EW0169,, dose number =1,, vaccine_location=Left arm), administration date: 14Apr2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: AMENORRHOEA (non-serious) with onset 05May2021, outcome "unknown", described as "I missed my first period after getting vaccinated"; POLYMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "had a period and another one 2 weeks later / now I have had a period every two weeks"; MENSTRUAL DISORDER (non-serious) with onset 15Dec2021, outcome "unknown", described as "now I have had a period every two weeks". The events "i missed my first period after getting vaccinated", "had a period and another one 2 weeks later / now i have had a period every two weeks" and "now i have had a period every two weeks" were 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 amenorrhoea, polymenorrhoea, menstrual disorder.  Additional information: Patient missed her first period after getting vaccinated, almost 2 months. Then had a period and another one 2 weeks later. Next month normal and now she had a period every two weeks since 15Dec. No other vaccine received in four weeks. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.