chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: However about 16 hours after my booster I also had chest pain and heart palpitations, which I have never had from a vaccine before; However about 16 hours after my booster I also had chest pain and heart palpitations, which I have never had from a vaccine before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 10:30 (Lot number: FL3209) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; FLUOXETINE. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer/ Biontech, prev dose brand unknown: False, prev dose lot number: FE3380, prev dose lot unknown: False, prev dose administration date: 11Aug2021, prev dose administration time: 02:00 PM , prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 11Aug2021, when the patient was 28 years old, for covid 19 immunization, reaction(s): "For the first two doses I had a sore arm, which I expected"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer/Biontech, prev dose brand unknown: False, prev dose lot number: FA1027, prev dose lot unknown: False, prev dose administration date: 16Jun2021, prev dose administration time: 08:45 AM , prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 16Jun2021, when the patient was 28 years old, for covid 19 immunization, reaction(s): "For the first two doses I had a sore arm, which I expected". The following information was reported: PALPITATIONS (non-serious), CHEST PAIN (non-serious) all with onset 09Jan2022 02:00, outcome "recovered" and all described as "However about 16 hours after my booster I also had chest pain and heart palpitations, which I have never had from a vaccine before". Therapeutic measures were not taken as a result of palpitations, chest pain. There were no other vaccine in four weeks. There was no covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation, Intermenstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: heavy vaginal bleeding that lasted 10 days; heavy vaginal bleeding that lasted 10 days; I was spotting again; booster (3rd dose); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 09:15 (Lot number: FA7218) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 20Apr2021, when the patient was 27 years old, for Covid-19 immunization, reaction(s): "Vaginal spotting"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 23Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 09:15, outcome "unknown", described as "booster (3rd dose)"; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 16Dec2021, outcome "unknown" and all described as "heavy vaginal bleeding that lasted 10 days"; INTERMENSTRUAL BLEEDING (non-serious) with onset 16Dec2021, outcome "unknown", described as "I was spotting again". The events "heavy vaginal bleeding that lasted 10 days", "heavy vaginal bleeding that lasted 10 days" and "i was spotting again" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding, menstruation irregular, intermenstrual bleeding. The patient had vaginal spotting for 3-4 days after her 2nd dose and less than 48 hours after her booster (3rd dose) the patient experienced heavy vaginal bleeding that lasted 10 days with no change in volume of blood or color (still heavy, bright red, no clotting on the 10th day) the patient went to the hospital and was prescribed a 10 day prescription of Provera to stop the bleeding. When the patient took this her bleeding was lighter and fully stopped on the 9th day of the prescription, however the patient was spotting again within 48 hours after finishing the prescription. Spotting lasted an additional 2 days, then stopped. The last day of her menstrual cycle in December was 10Dec2021. The patient got her booster on 15Dec. The patient normally had a very regular cycle which was light and lasts no longer than 4 days, and no spotting between periods so this was definitely not normal.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: full body rash; hives, sparing the palms of my hands and soles of my feet; itchy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 20:00 (Lot number: FS1661) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE HYDROCHLORIDE; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose 1, lot number: EL0140, administration time: 08:30 AM, vaccine location: Right arm), administration date: 22Dec2020, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: EL1283, administration time: 08:00 PM, vaccine location: Left arm), administration date: 12Jan2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 08Jan2022 07:00, outcome "recovering", described as "full body rash"; URTICARIA (non-serious) with onset 08Jan2022 07:00, outcome "recovering", described as "hives, sparing the palms of my hands and soles of my feet"; PRURITUS (non-serious) with onset 08Jan2022 07:00, outcome "recovering", described as "itchy". The events "full body rash", "hives, sparing the palms of my hands and soles of my feet" and "itchy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus.  Additional Information: The patient had no known allergies. The facility where the patient received vaccination was reported as Pharmacy or Drug store. The patient received no other vaccine in four weeks. It was reported that, 16 days after receiving booster COVID vaccine, the patient developed a full body rash consistent with hives, sparing the palms of hands and soles of feet. Systemically fine and not to terribly itchy. The patient received Zyrtec as treatment for the events. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Tinnitus
Clinical narrative: Tinnitus in right ear, approximately 18 hours after receiving booster shot; a feeling like my body was on fire.  Not just warm, but literally on fire; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 09:30 (Batch/Lot number: unknown) at the age of 38 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 (Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "Tinnitus in right ear, approximately 18 hours after receiving booster shot"; FEELING HOT (non-serious) with onset Jan2022, outcome "unknown", described as "a feeling like my body was on fire.  Not just warm, but literally on fire".  Additional information: The patient didn't received any other vaccines within four weeks. The patient was not diagnosed with COVID prior vaccination and not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Immunisation, Oral herpes, Rheumatoid arthritis
Clinical narrative: booster; All issues after booster Full blown rheumatoid flare after years of no issues; Cold sore on upper lip within 10 days after 15+ years of no issues. Currently 2nd cold sore upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 13:00 (Lot number: EL8982) as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "CLL observation 20+ yrs." (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Rheumatoid arthritis 8 yrs." (unspecified if ongoing); "Non smoker" (unspecified if ongoing); "Non diabetic" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; TIMOLOL; PREDNISONE. Vaccination history included: Bnt162b2 (Dose 2; Lot Number: EL9269;at 11:00 AM in right arm), administration date: 09Feb2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose1 lot number=FF2590 at 10:00am in Left arm), administration date: 19Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021 1300, outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant) with onset Nov2021, outcome "recovering", described as "All issues after booster Full blown rheumatoid flare after years of no issues"; ORAL HERPES (non-serious) with onset Nov2021, outcome "recovering", described as "Cold sore on upper lip within 10 days after 15+ years of no issues. Currently 2nd cold sore upper lip". The events "all issues after booster full blown rheumatoid flare after years of no issues" and "cold sore on upper lip within 10 days after 15+ years of no issues. currently 2nd cold sore upper lip" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body mass index: 25.1. Therapeutic measures were not taken as a result of rheumatoid arthritis, oral herpes.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Myocardial infarction, Palpitations
Clinical narrative: resembled a panic or heart attack but not as severe; panic attack; Sweating; Increased heart rate; Pounding heart, racing heart; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 18-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 10Jan2022 (Lot number: FL3209) at the age of 18 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: Covid-19 vaccine (Dose 1), for COVID-19 Immunization, reaction: "Had no side effects at all"; Covid-19 vaccine (Dose 2), for COVID-19 Immunization, reaction: "Had no side effects at all". The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 13Jan2022, outcome "recovering", described as "resembled a panic or heart attack but not as severe"; PANIC ATTACK (non-serious) with onset 13Jan2022, outcome "recovering", described as "panic attack"; HYPERHIDROSIS (non-serious) with onset 13Jan2022, outcome "recovering", described as "Sweating"; HEART RATE INCREASED (non-serious) with onset 13Jan2022, outcome "recovering", described as "Increased heart rate"; PALPITATIONS (non-serious) with onset 13Jan2022, outcome "recovering", described as "Pounding heart, racing heart". The patient underwent the following laboratory tests and procedures: heart rate: (13Jan2022) increased. Clinical course: The university the patient went to said needed it unless he wanted to do mandatory testing. Patient received his third dose of bnt162b2 (clarified with caller that it was a booster dose) on 10Jan2022. Randomly today (13Jan2022) when he was sitting on the couch watching videos, he developed an extreme panicky feeling that overtook him. It almost resembled a panic or heart attack but not as severe. There was no pain but patient had sweating, increased heart rate, pounding heart, racing heart and feeling panicked all together. There was nothing that was scaring patient or that could increase his heart rate and it came of no where. It was more of a panic attack. Denied any chest pain. Denied any hx of prior panic attacks. Patient had the vaccine a couple of days ago. Patient didn't know if symptoms could still be there for this long after. Patient didn't know if this is from the vaccine or not but it started after he received that third dose. The first two doses that patient had before the third dose, he had no side effects at all. This panicking feeling was on and off and it came back. When the panic attack came it was lessened and not as bad as the first time it happened on 13Jan2022. It started 30 minutes after he ate lunch around 13:30 on 13Jan2022. Provided qualifying statement that this was in no way a diagnosis (ie myocarditis).  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: resembled a panic or heart attack but not as severe; panic attack; Sweating; Increased heart rate; Pounding heart, racing heart; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 18-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 10Jan2022 (Lot number: FL3209) at the age of 18 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: Covid-19 vaccine (Dose 1), for COVID-19 Immunization, reaction: "Had no side effects at all"; Covid-19 vaccine (Dose 2), for COVID-19 Immunization, reaction: "Had no side effects at all". The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 13Jan2022, outcome "recovering", described as "resembled a panic or heart attack but not as severe"; PANIC ATTACK (non-serious) with onset 13Jan2022, outcome "recovering", described as "panic attack"; HYPERHIDROSIS (non-serious) with onset 13Jan2022, outcome "recovering", described as "Sweating"; HEART RATE INCREASED (non-serious) with onset 13Jan2022, outcome "recovering", described as "Increased heart rate"; PALPITATIONS (non-serious) with onset 13Jan2022, outcome "recovering", described as "Pounding heart, racing heart". The patient underwent the following laboratory tests and procedures: heart rate: (13Jan2022) increased. Clinical course: The university the patient went to said needed it unless he wanted to do mandatory testing. Patient received his third dose of bnt162b2 (clarified with caller that it was a booster dose) on 10Jan2022. Randomly today (13Jan2022) when he was sitting on the couch watching videos, he developed an extreme panicky feeling that overtook him. It almost resembled a panic or heart attack but not as severe. There was no pain but patient had sweating, increased heart rate, pounding heart, racing heart and feeling panicked all together. There was nothing that was scaring patient or that could increase his heart rate and it came of no where. It was more of a panic attack. Denied any chest pain. Denied any hx of prior panic attacks. Patient had the vaccine a couple of days ago. Patient didn't know if symptoms could still be there for this long after. Patient didn't know if this is from the vaccine or not but it started after he received that third dose. The first two doses that patient had before the third dose, he had no side effects at all. This panicking feeling was on and off and it came back. When the panic attack came it was lessened and not as bad as the first time it happened on 13Jan2022. It started 30 minutes after he ate lunch around 13:30 on 13Jan2022. Provided qualifying statement that this was in no way a diagnosis (ie myocarditis).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID/ he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well; got COVID/ he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well; This is a spontaneous report received from a non-contactable reporter (Physician) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "heart patient" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "had the booster dose of Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID/ he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well". Clinical course details: Patient reported he got COVID so he is resting at home and not going to the office although he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received a shot of the "Johnson&Johnson" vaccine and one dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) one week before she got COVID-19; received a shot of the "Johnson&Johnson" vaccine and one dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) one week before she got COVID-19; This is a spontaneous report received from a contactable reporter consumer or other non HCP from medical information team.  An 80 year-old female patient (aunt) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; JANSSEN COVID-19 VACCINE, 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: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "received a shot of the "Johnson&Johnson" vaccine and one dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) one week before she got COVID-19". Therapeutic measures were taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Disturbance in attention, Feeling abnormal, Gait disturbance
Clinical narrative: Severe tremors; Muscle twitches; Migraines; Occasional blurred vision; Occasional weakness; Difficulty concentrating; Foggy thoughts; Loss of balance; Difficulty with gait; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 (Lot number: FG3527) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing), notes: other medical history: PTSD; "Tinnitus" (unspecified if ongoing); "back pains" (unspecified if ongoing), notes: other medical history: back pains. There were no concomitant medications. The following information was reported: TREMOR (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Severe tremors"; MUSCLE TWITCHING (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Muscle twitches"; MIGRAINE (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Migraines"; VISION BLURRED (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Occasional blurred vision"; ASTHENIA (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Occasional weakness"; DISTURBANCE IN ATTENTION (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Difficulty concentrating"; FEELING ABNORMAL (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Foggy thoughts"; BALANCE DISORDER (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Loss of balance"; GAIT DISTURBANCE (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Difficulty with gait". The events "severe tremors", "muscle twitches", "migraines", "occasional blurred vision", "occasional weakness", "difficulty concentrating", "foggy thoughts", "loss of balance" and "difficulty with gait" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) negative, notes: Nasal Swab; (28Dec2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of tremor, muscle twitching, migraine, vision blurred, asthenia, disturbance in attention, feeling abnormal, balance disorder, gait disturbance. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle twitching, SARS-CoV-2 test, Tremor, Vision blurred
Clinical narrative: Severe tremors; Muscle twitches; Migraines; Occasional blurred vision; Occasional weakness; Difficulty concentrating; Foggy thoughts; Loss of balance; Difficulty with gait; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 (Lot number: FG3527) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing), notes: other medical history: PTSD; "Tinnitus" (unspecified if ongoing); "back pains" (unspecified if ongoing), notes: other medical history: back pains. There were no concomitant medications. The following information was reported: TREMOR (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Severe tremors"; MUSCLE TWITCHING (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Muscle twitches"; MIGRAINE (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Migraines"; VISION BLURRED (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Occasional blurred vision"; ASTHENIA (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Occasional weakness"; DISTURBANCE IN ATTENTION (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Difficulty concentrating"; FEELING ABNORMAL (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Foggy thoughts"; BALANCE DISORDER (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Loss of balance"; GAIT DISTURBANCE (hospitalization, disability) with onset 02Nov2021, outcome "not recovered", described as "Difficulty with gait". The events "severe tremors", "muscle twitches", "migraines", "occasional blurred vision", "occasional weakness", "difficulty concentrating", "foggy thoughts", "loss of balance" and "difficulty with gait" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) negative, notes: Nasal Swab; (28Dec2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of tremor, muscle twitching, migraine, vision blurred, asthenia, disturbance in attention, feeling abnormal, balance disorder, gait disturbance. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Oropharyngeal pain, SARS-CoV-2 test, Urticaria
Clinical narrative: Developed urticaria over axilla and around eyes; watery eyes; sore throat; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 17:30 (Lot number: FL00007) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (1st dose, Batch/Lot No: FL00007, route of administration: intramuscular), administration date: 16Dec2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: URTICARIA with onset 13Jan2022 22:30, outcome "unknown", described as "Developed urticaria over axilla and around eyes"; LACRIMATION INCREASED with onset 13Jan2022 22:30, outcome "unknown", described as "watery eyes"; OROPHARYNGEAL PAIN with onset 13Jan2022 22:30, outcome "unknown", described as "sore throat". The events "developed urticaria over axilla and around eyes", "watery eyes" and "sore throat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of urticaria, lacrimation increased, oropharyngeal pain (BENADRYL). Additional information: no known allergies.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Urticaria, Lacrimation increased and Oropharyngeal pain due to temporal relationship.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Acute CVA / Brain stroke caused by a small blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 18:30 (Lot number: FL3198) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0151, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 11Jan2022 09:00, outcome "not recovered", described as "Acute CVA / Brain stroke caused by a small blood clot". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "acute cva / brain stroke caused by a small blood clot" was evaluated at the emergency room visit. Therapeutic measures were taken (put on blood thinners and cholesterol medication) as a result of cerebrovascular accident. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Bilateral Feet Swollen for five months now ever since the Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 15:30 (Lot number: FC3182) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PERIPHERAL SWELLING (disability) with onset 24Aug2021 14:00, outcome "not recovered", described as "Bilateral Feet Swollen for five months now ever since the Covid-19 Vaccine". The event "bilateral feet swollen for five months now ever since the covid-19 vaccine" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of peripheral swelling.  Clinical course:  The patient experienced Bilateral Feet Swollen for five months now ever since the Covid-19 Vaccine. Ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. The patient received second dose of bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 12:15 (Lot number: FF2588) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no known allergies. No other vaccine was received in four weeks and no other medications in two weeks.  Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: has covid; has covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 in the afternoon (Lot number: RS737) at the age of 59 years as dose 1, single and administered in arm right, administration date 27Apr2021 17:00 (Lot number: EW0171) intramuscular as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 05Nov2020 (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: had for years since there is something wrong with her blood; "High blood pressure" (unspecified if ongoing), notes: diagnosed more than 20 years ago; "Glucose" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); CETIRIZINE more than 20 years taken for multiple allergies (ongoing); MONTELUKAST taken for multiple allergies; GLIFAGE XR taken for blood glucose. She was diagnosed with covid 14Jan2022, however, her symptoms started Monday 10Jan2022. The patient had a choke and 13Jan2022 or 14Jan2022, cannot breathe in the night. Treatment received. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "has covid". Vein is clean the patient went to the doctor paid lot of money for the doctor to see what is the problem and they say it may be about the vaccine took the Pfizer. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive; (Jan2022) unknown result. Therapeutic measures were taken as a result of covid-19, vaccination failure. Conclusion of Previously Completed Investigation (RA): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0171 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: daughter tested positive for covid; daughter tested positive for covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 39 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant) with onset 08Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "recovering" and all described as "daughter tested positive for covid". The event "daughter tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for covid.  Clinical course: It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient didn't tested for COVID-19.  No follow-up attempts are possible. No further information was expected.; Sender's Comments: Based on the information in the case report, a causal association between reported events vaccination failure, covid-19 and the suspect BNT162B2 is possible.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Severe headache; Fever; itching and small rash at injection site; itching and small rash at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 17:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: covid prior to vaccination: yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, unknown lot number, in left arm, at 04:00 PM), administration date: 20Dec2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 11Jan2022, outcome "recovered with sequelae", described as "Severe headache"; PYREXIA (non-serious) with onset 11Jan2022, outcome "recovered with sequelae", described as "Fever"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE RASH (non-serious) all with onset 11Jan2022, outcome "recovered with sequelae" and all described as "itching and small rash at injection site". Therapeutic measures were not taken as a result of headache, pyrexia, vaccination site pruritus, vaccination site rash. Additional information: Non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Reported Event: Severe headache, fever, and itching and small rash at injection site. No know allergies. The patient has not been tested for COVID-19 since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Tachycardia
Clinical narrative: terrible arrhythmia; atrial fibrillation; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (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 Number: 1 Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "terrible arrhythmia"; ATRIAL FIBRILLATION (medically significant), outcome "not recovered", described as "atrial fibrillation"; TACHYCARDIA (medically significant), outcome "not recovered", described as "tachycardia". The events "terrible arrhythmia", "atrial fibrillation" and "tachycardia" were evaluated at the physician office visit. Therapeutic measures were taken as a result of arrhythmia, atrial fibrillation, tachycardia which includes treatment with Metoprolol. Additional information: The patient did not receive other vaccine in four weeks. No COVID prior to vaccination and not tested for COVID post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Condition aggravated, Tachycardia
Clinical narrative: Developed terrible arrhythmia, atrial fibrillation, tachycardia days after 2nd dose and these symptoms did not go away and were made worse after receiving booster vaccine; Developed terrible arrhythmia, atrial fibrillation, tachycardia days after 2nd dose and these symptoms did not go away and were made worse after receiving booster vaccine; Developed terrible arrhythmia, atrial fibrillation, tachycardia days after 2nd dose and these symptoms did not go away and were made worse after receiving booster vaccine; Developed terrible arrhythmia, atrial fibrillation, tachycardia days after 2nd dose and these symptoms did not go away and were made worse after receiving booster vaccine; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Jan2022 (Batch/Lot number: unknown) at the age of 49-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 (Batch/Lot number: unknown, as dose 1, single), for COVID-19 immunisation and BNT162B2 (Batch/Lot number: unknown, as dose 2, single), for COVID-19 immunisation, reactions: "Terrible arrhythmia", "Atrial fibrillation", and "Tachycardia". The following information was reported: ARRHYTHMIA (medically significant), CONDITION AGGRAVATED (medically significant), ATRIAL FIBRILLATION (medically significant) and TACHYCARDIA (medically significant) all with onset 13Jan2022, outcome "not recovered" and all described as "Developed terrible arrhythmia, atrial fibrillation, tachycardia days after 2nd dose and these symptoms did not go away and were made worse after receiving booster vaccine." The event "Developed terrible arrhythmia, atrial fibrillation, tachycardia days after 2nd dose and these symptoms did not go away and were made worse after receiving booster vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arrhythmia, condition aggravated, atrial fibrillation, and tachycardia and included treatment with metoprolol.  Clinical course: The patient had no prior cardiac issues. Prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 07Jan antigen positive and 10Jan PCR positive; 07Jan antigen positive and 10Jan PCR positive; 03Jan2022 mild ST congestion in the chest; 03Jan2022 mild ST congestion in the chest; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 30 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "07Jan antigen positive and 10Jan PCR positive"; OROPHARYNGEAL PAIN (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset 03Jan2022, outcome "unknown" and all described as "03Jan2022 mild ST congestion in the chest". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive; (03Jan2022) positive, notes: Home Ag, unknown; (10Jan2022) positive, notes: PCR,Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, oropharyngeal pain, respiratory tract congestion. Clinical Course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. 03Jan2022 mild ST congestion in the chest and 07Jan antigen positive and 10Jan PCR positive. Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown.Since the vaccination, has the patient been tested for COVID-19?:Yes. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and covid19 cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: breakthrough cases; breakthrough cases/ irritation in the sinuses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "breakthrough cases"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "breakthrough cases/ irritation in the sinuses". Patient had breakthrough just before the holidays despite being double vaccinated and boosted. Patient had just some irritation in the sinuses that lasted a couple of days. He avoided serious illness due to vaccine. Just wonderful and such a relief to know that he was adequately protected.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073949 same reporter, drug, different patient, similar event
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; breakthrough cases/ despite being double vaccinated and boosted/ mild symptoms; breakthrough cases/ despite being double vaccinated and boosted/ mild symptoms; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough cases/ despite being double vaccinated and boosted/ mild symptoms". The patient (wife) and her husband had breakthrough cases just before the holidays despite being double vaccinated and boosted. She had relatively mild symptoms. They avoided serious illness due to your vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073889 same reporter, product and event; different patients