chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 25-year-old female patient received bnt162b2 (BNT162B2), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Verbatim: Allergy. Concomitant medication(s) included: MONTELUKAST taken for hypersensitivity. Vaccination history included: Flu shot (I got my flu shot like 2 months ago), administration date: 2021. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Aug2021, outcome "unknown" and all described as "I got my COVID Vaccine like back in December and January then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back"; AGEUSIA (non-serious) with onset Aug2021, outcome "unknown", ANOSMIA (non-serious) with onset Aug2021, outcome "recovering" and all described as "I got my COVID Vaccine like back in December and January then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Aug2021) negative, notes: I got COVID on the 4Aug and then literally after 14 days my result came negative. Therapeutic measures were not taken as a result of suspected covid-19, ageusia, anosmia. Patient was 24-years old at vaccination. She is Physician Assistant student. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that she got covid Vaccine like back in December and January like it was Pfizer vaccine and then she actually got covid in August, this year August and then she had all the senses, then she also lost smell and taste with it and was barely getting her smell back and as soon as patient got the booster, she lost her smell again and noticed the concerned thing she was getting her smell back and as soon as she got the covid, she thought in 48 hours couldn't smell those things again.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Immunisation
Clinical narrative: I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; I got my COVID Vaccine like back in December and January  then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 25-year-old female patient received bnt162b2 (BNT162B2), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Verbatim: Allergy. Concomitant medication(s) included: MONTELUKAST taken for hypersensitivity. Vaccination history included: Flu shot (I got my flu shot like 2 months ago), administration date: 2021. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Aug2021, outcome "unknown" and all described as "I got my COVID Vaccine like back in December and January then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back"; AGEUSIA (non-serious) with onset Aug2021, outcome "unknown", ANOSMIA (non-serious) with onset Aug2021, outcome "recovering" and all described as "I got my COVID Vaccine like back in December and January then I actually got COVID in August, I also lost smell and taste with it and I was barely getting my smell back". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Aug2021) negative, notes: I got COVID on the 4Aug and then literally after 14 days my result came negative. Therapeutic measures were not taken as a result of suspected covid-19, ageusia, anosmia. Patient was 24-years old at vaccination. She is Physician Assistant student. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that she got covid Vaccine like back in December and January like it was Pfizer vaccine and then she actually got covid in August, this year August and then she had all the senses, then she also lost smell and taste with it and was barely getting her smell back and as soon as patient got the booster, she lost her smell again and noticed the concerned thing she was getting her smell back and as soon as she got the covid, she thought in 48 hours couldn't smell those things again.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Drug ineffective, Headache, Nasal congestion
Clinical narrative: Cold symptoms; Sinus pressure; congestion; dizziness; headache; positive Rapid COVID test; positive Rapid COVID test; 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 received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "positive Rapid COVID test"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Sinus pressure"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. The patient was fully vaccinated with 3 Pfizer shots. The booster was given on 24Aug2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Cold symptoms; Sinus pressure; congestion; dizziness; headache; positive Rapid COVID test; positive Rapid COVID test; 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 received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "positive Rapid COVID test"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Sinus pressure"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. The patient was fully vaccinated with 3 Pfizer shots. The booster was given on 24Aug2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic carcinoma, SARS-CoV-2 test
Clinical narrative: tumor on my pancreas; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 (Lot number: ER8727) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Allegra-D [Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 10Apr2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: PANCREATIC CARCINOMA (hospitalization, medically significant) with onset 22Oct2021, outcome "not recovered", described as "tumor on my pancreas". The patient was hospitalized for pancreatic carcinoma (hospitalization duration: 2 day(s)). The event "tumor on my pancreas" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative; (14Nov2021) negative. Therapeutic measures were not taken as a result of pancreatic carcinoma. The patient otherwise healthy but recently developed a tumor on her pancreas. The biopsy left her with some complications and while in the hospital, the patient had a conversation with a nurse about the strange findings followings vaccination for covid-19. The patient fully vaccinated and shared the patient had her first abnormal mammogram since being vaccinated and that while navigating the additional testing, learned that the radiology department at her hospital was experiencing a notable utick in young woman especially, ages 18-23, presenting with breast cancer who had been vaccinated as well. Patient received within 2 weeks of vaccination: Allegra-D, multi-vitamin  She and the patient both had the Pfizer vaccine. Prior to the vaccination, the patient did not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible, No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Drug ineffective, Headache, Immunisation
Clinical narrative: Cold symptoms; Sinus pressure; congestion; dizziness; headache; positive Rapid COVID test; positive Rapid COVID test; booster; 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 received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, (Name withheld) had a positive Rapid COVID test on 18Nov2021., She has Cold symptoms. Sinus pressure, congestion, headache, and dizziness.), for COVID-19 immunization, reaction(s): "positive Rapid COVID test"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "dizziness", "headache", "congestion", "Cold symptoms", "Sinus pressure", "positive Rapid COVID test"; Bnt162b2 (DOSE 2, SINGLE, (Name withheld) had a positive Rapid COVID test on 18Nov2021. She has Cold symptoms. Sinus pressure, congestion, headache, and dizziness.), for COVID-19 immunization, reaction(s): "positive Rapid COVID test"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "dizziness", "headache", "congestion", "Cold symptoms", "Sinus pressure", "positive Rapid COVID test". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "positive Rapid COVID test"; IMMUNISATION (medically significant) with onset 24Aug2021, outcome "unknown", described as "booster"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Sinus pressure"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Cold symptoms; Sinus pressure; congestion; dizziness; headache; positive Rapid COVID test; positive Rapid COVID test; booster; 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 received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, (Name withheld) had a positive Rapid COVID test on 18Nov2021., She has Cold symptoms. Sinus pressure, congestion, headache, and dizziness.), for COVID-19 immunization, reaction(s): "positive Rapid COVID test"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "dizziness", "headache", "congestion", "Cold symptoms", "Sinus pressure", "positive Rapid COVID test"; Bnt162b2 (DOSE 2, SINGLE, (Name withheld) had a positive Rapid COVID test on 18Nov2021. She has Cold symptoms. Sinus pressure, congestion, headache, and dizziness.), for COVID-19 immunization, reaction(s): "positive Rapid COVID test"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "dizziness", "headache", "congestion", "Cold symptoms", "Sinus pressure", "positive Rapid COVID test". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "positive Rapid COVID test"; IMMUNISATION (medically significant) with onset 24Aug2021, outcome "unknown", described as "booster"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Sinus pressure"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: EP7533) as dose 2, single and administration date 08Mar2021 (Lot number: EN6204) 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 Nov2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms". Only symptoms are congestion and runny nose. Tested positive on either 18Nov or 19Nov. The patient underwent the following laboratory tests and procedures: covid-19: (Nov2021) positive, notes: Tested positive on either 18Nov or 19Nov.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after receiving Pfizer vaccine; tested positive for COVID-19 after receiving Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 85 year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19 after receiving Pfizer vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Nasopharyngitis, SARS-CoV-2 antibody test
Clinical narrative: Cold symptoms; Drug ineffective; Positive rapid COVID test on 18Nov2021; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 68 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Aug2021 (Batch/Lot number: Unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure." (unspecified if ongoing). The patient concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown) for COVID-19 immunisation, Covid-19 vaccine (Dose 2, Manufacturer unknown) for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Aug2021, outcome "unknown", described as "Booster", DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "unknown", described as "drug ineffective", COVID-19 (medically significant) with onset 18Nov2021, outcome "unknown", described as "positive rapid COVID test on 18Nov2021", NASOPHARYNGITIS (medically significant), outcome "unknown", described as "cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Brain oedema, Eye haemorrhage
Clinical narrative: cerebral fluid swelling; pressure; hemorrhage behind the eye; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 45 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 31Oct2021 14:00 (Lot number: 320308d) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. It was unknown if patient received concomitant medications within two weeks. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and has not been tested for COVID-19, post vaccination. The following information was reported: BRAIN OEDEMA (hospitalization, medically significant) with onset 02Nov2021, outcome "unknown", described as "cerebral fluid swelling"; BLOOD PRESSURE ABNORMAL (hospitalization) with onset 02Nov2021, outcome "unknown", described as "pressure"; EYE HAEMORRHAGE (hospitalization, medically significant) with onset 02Nov2021, outcome "unknown", described as "hemorrhage behind the eye". The patient was hospitalized for brain oedema, blood pressure abnormal, eye haemorrhage (start date: Nov2021). The events "cerebral fluid swelling", "pressure" and "hemorrhage behind the eye" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of brain oedema, blood pressure abnormal, eye haemorrhage. Clinical course: On 02Nov2021, patient had been diagnosed with cerebral fluid swelling and pressure and hemorrhage behind the eye 2 days following vaccine and stated that never been diagnosed before.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events No follow-up attempts are possible. No further information is expected. 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.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: high heart rate at rest (approx 150; Chills; fatigue; migraine; pulse ox; shortness of breath; very vivid dreams; sweats like a fever; sweats like a fever; could not function; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: 33030BD) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8735), administration date: 07May2021, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0150), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "high heart rate at rest (approx 150"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovering", described as "fatigue"; MIGRAINE (non-serious) with onset 20Nov2021, outcome "recovering", described as "migraine"; PULSE ABNORMAL (non-serious) with onset 20Nov2021, outcome "recovering", described as "pulse ox"; DYSPNOEA (non-serious) with onset 20Nov2021, outcome "recovering", described as "shortness of breath"; ABNORMAL DREAMS (non-serious) with onset 20Nov2021, outcome "recovering", described as "very vivid dreams"; HYPERHIDROSIS (non-serious), PYREXIA (non-serious) all with onset 20Nov2021, outcome "recovering" and all described as "sweats like a fever"; IMPAIRED WORK ABILITY (non-serious) with onset 20Nov2021, outcome "recovering", described as "could not function". Therapeutic measures were not taken as a result of heart rate increased, chills, fatigue, migraine, pulse abnormal, dyspnoea, abnormal dreams, hyperhidrosis, pyrexia, impaired work ability.  Additional Information: It was reported that name of drug as reported was no with reaction: allergy. Seriousness criteria was reported as no for death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Reporter stated that I had only minimal reactions with the first two shots. I won't be getting a fourth shot! Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Impaired work ability, Migraine, Pulse abnormal, Pyrexia
Clinical narrative: high heart rate at rest (approx 150; Chills; fatigue; migraine; pulse ox; shortness of breath; very vivid dreams; sweats like a fever; sweats like a fever; could not function; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: 33030BD) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8735), administration date: 07May2021, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0150), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "high heart rate at rest (approx 150"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovering", described as "fatigue"; MIGRAINE (non-serious) with onset 20Nov2021, outcome "recovering", described as "migraine"; PULSE ABNORMAL (non-serious) with onset 20Nov2021, outcome "recovering", described as "pulse ox"; DYSPNOEA (non-serious) with onset 20Nov2021, outcome "recovering", described as "shortness of breath"; ABNORMAL DREAMS (non-serious) with onset 20Nov2021, outcome "recovering", described as "very vivid dreams"; HYPERHIDROSIS (non-serious), PYREXIA (non-serious) all with onset 20Nov2021, outcome "recovering" and all described as "sweats like a fever"; IMPAIRED WORK ABILITY (non-serious) with onset 20Nov2021, outcome "recovering", described as "could not function". Therapeutic measures were not taken as a result of heart rate increased, chills, fatigue, migraine, pulse abnormal, dyspnoea, abnormal dreams, hyperhidrosis, pyrexia, impaired work ability.  Additional Information: It was reported that name of drug as reported was no with reaction: allergy. Seriousness criteria was reported as no for death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Reporter stated that I had only minimal reactions with the first two shots. I won't be getting a fourth shot! Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Insomnia, Pain in extremity, Poor quality product administered
Clinical narrative: that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021.  HCP told Caller to watch for infection per Caller; that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021.  HCP told Caller to watch for infection per Caller; arm really hurts; headache; had insomnia for 3 hours last night, and couldn't sleep; booster vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 86 years as dose 3(booster), single for covid-19 immunization. Relevant medical history included: "asthma lung issues" (unspecified if ongoing); "injected Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose, Lot GN5318,), administration date: 11Feb2021, for COVID-19 Immunization; Bnt162b2 (1st Dose, lot number EL1283), administration date: 21Jan2021, for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) all with onset 21Nov2021, outcome "unknown" and all described as "that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021. HCP told Caller to watch for infection per Caller"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "not recovered", described as "arm really hurts"; HEADACHE (non-serious) with onset 21Nov2021, outcome "not recovered", described as "headache"; INSOMNIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "had insomnia for 3 hours last night, and couldn't sleep"; IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "booster vaccine".  Additional information: Prior Vaccinations (within 4 weeks): flu vaccination 4 weeks prior on 19 Oct 2021. She got the flu vaccine in her right arm. The patient stated that had insomnia for 3 hours last night and couldn't sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021.  HCP told Caller to watch for infection per Caller; that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021.  HCP told Caller to watch for infection per Caller; arm really hurts; headache; had insomnia for 3 hours last night, and couldn't sleep; booster vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 86 years as dose 3(booster), single for covid-19 immunization. Relevant medical history included: "asthma lung issues" (unspecified if ongoing); "injected Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose, Lot GN5318,), administration date: 11Feb2021, for COVID-19 Immunization; Bnt162b2 (1st Dose, lot number EL1283), administration date: 21Jan2021, for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) all with onset 21Nov2021, outcome "unknown" and all described as "that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021. HCP told Caller to watch for infection per Caller"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "not recovered", described as "arm really hurts"; HEADACHE (non-serious) with onset 21Nov2021, outcome "not recovered", described as "headache"; INSOMNIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "had insomnia for 3 hours last night, and couldn't sleep"; IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "booster vaccine".  Additional information: Prior Vaccinations (within 4 weeks): flu vaccination 4 weeks prior on 19 Oct 2021. She got the flu vaccine in her right arm. The patient stated that had insomnia for 3 hours last night and couldn't sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Eye swelling, Lymphadenopathy, Muscle spasms
Clinical narrative: Extreme nausea; dizzy; off balance; swollen eyes; red eyes; severe cramps; swollen armpit lymphnode; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FJ1620) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple family members allergy to sulfa" (unspecified if ongoing), notes: Multiple family members allergy to, sulfa. Concomitant medication(s) included: DIFLUCAN; MACROBID [CLARITHROMYCIN]. Past drug history included: Cipro, reaction(s): "Known Allergy: Cipro"; Bactrim for Known Allergy: bactrim; Sulfa antibiotics for Known Allergy: Sulfa antibiotics. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "Extreme nausea"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "dizzy"; BALANCE DISORDER (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "off balance"; EYE SWELLING (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen eyes"; OCULAR HYPERAEMIA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "red eyes"; MUSCLE SPASMS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "severe cramps"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen armpit lymphnode". Therapeutic measures were not taken as a result of nausea, dizziness, balance disorder, eye swelling, ocular hyperaemia, muscle spasms, lymphadenopathy.  Additional information: The patient had no other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination included birth control, difulcan, Macrobid. Device Date was 22Nov2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia
Clinical narrative: Extreme nausea; dizzy; off balance; swollen eyes; red eyes; severe cramps; swollen armpit lymphnode; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FJ1620) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple family members allergy to sulfa" (unspecified if ongoing), notes: Multiple family members allergy to, sulfa. Concomitant medication(s) included: DIFLUCAN; MACROBID [CLARITHROMYCIN]. Past drug history included: Cipro, reaction(s): "Known Allergy: Cipro"; Bactrim for Known Allergy: bactrim; Sulfa antibiotics for Known Allergy: Sulfa antibiotics. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "Extreme nausea"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "dizzy"; BALANCE DISORDER (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "off balance"; EYE SWELLING (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen eyes"; OCULAR HYPERAEMIA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "red eyes"; MUSCLE SPASMS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "severe cramps"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen armpit lymphnode". Therapeutic measures were not taken as a result of nausea, dizziness, balance disorder, eye swelling, ocular hyperaemia, muscle spasms, lymphadenopathy.  Additional information: The patient had no other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination included birth control, difulcan, Macrobid. Device Date was 22Nov2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4160649-00 (RA).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA (Solution for injection in pre-filled pen) (Adalimumab), route of Administration: Subcutaneous. Daily Dose: Citrate free. Indications for Use: Moderate to severe rheumatoid arthritis. Therapy Dates (From/to): unknown. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis flare up". Therapeutic measures were taken as a result of rheumatoid arthritis. The patient was treated with Plaquenil.  Clinical course: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Rheumatoid arthritis flare up was not provided. Causality for Pfizer BioNtech covid-19 vaccine (Tozinameran) (Tozinameran): The reporter's causality for the event(s) of Rheumatoid arthritis flare up was reported as Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the event rheumatoid arthritis and suspected drug cannot be excluded.  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: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary function test, Wheezing
Clinical narrative: difficulty breathing at rest and particularly with activity.; noticed increased wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 16:00 (Lot number: FF8839) at the age of 14 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL].  The following information was reported: DYSPNOEA (non-serious) with onset 03Oct2021, outcome "not recovered", described as "difficulty breathing at rest and particularly with activity."; WHEEZING (non-serious) with onset 03Oct2021, outcome "not recovered", described as "noticed increased wheezing". The events "difficulty breathing at rest and particularly with activity." and "noticed increased wheezing" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, wheezing.  Additional information: No other vaccine in four weeks. The other medications in two weeks was Albuterol inhaler. No prior covid vaccination and not tested covid post vaccination. It was reported that Asthmatic patient well controlled with medications and symptoms improved however worsened after the second vaccine and have continued to be worse than prior to first vaccination. Currently went on prednisone and was taking increased medication due to worsening symptoms. Penicillin was reported as known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Chills, Fatigue, Headache, Limb discomfort
Clinical narrative: Spondylitis ankylosing aggravated; Pressure in limbs; Leg pain/leg achy; Chills; Headache; Fatigue;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4161789-00 (RA).  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (TOZINAMERAN), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single and intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Pressure in limbs"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain/leg achy"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". The action taken for adalimumab was dosage not changed.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of ankylosing spondylitis flare up with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of pressure in legs and leg achy was not provided. The reporter's causality for the event(s) of chills, headache and fatigue with Humira (adalimumab) was no reasonable possibility.  Causality for BNT162B2 (TOZINAMERAN): The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out.  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.