chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Nasal congestion, Pyrexia
Clinical narrative: Covid test date: 02Feb2022 Covid test result: Positive; Covid test date: 02Feb2022 Covid test result: Positive; high fever; Congestion; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 27 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, Batch/Lot No: EL3247), administration date: 23Mar2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 02Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Feb2022, outcome "unknown" and all described as "Covid test date: 02Feb2022 Covid test result: Positive"; PYREXIA (non-serious) with onset 29Jan2022, outcome "unknown", described as "high fever"; NASAL CONGESTION (non-serious) with onset 29Jan2022, outcome "unknown", described as "Congestion"; FATIGUE (non-serious) with onset 29Jan2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown results; sars-cov-2 test: (02Feb2022) positive. It was unknown if therapeutic measures were taken as a result of pyrexia, nasal congestion, fatigue.  Clinical course was reported as: Adverse event: sx 29Jan high fever congestion and fatigue no known exposure remote worker. The patient had received covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test date: 02Feb2022 Covid test result: Positive; Covid test date: 02Feb2022 Covid test result: Positive; high fever; Congestion; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 27 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, Batch/Lot No: EL3247), administration date: 23Mar2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 02Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Feb2022, outcome "unknown" and all described as "Covid test date: 02Feb2022 Covid test result: Positive"; PYREXIA (non-serious) with onset 29Jan2022, outcome "unknown", described as "high fever"; NASAL CONGESTION (non-serious) with onset 29Jan2022, outcome "unknown", described as "Congestion"; FATIGUE (non-serious) with onset 29Jan2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown results; sars-cov-2 test: (02Feb2022) positive. It was unknown if therapeutic measures were taken as a result of pyrexia, nasal congestion, fatigue.  Clinical course was reported as: Adverse event: sx 29Jan high fever congestion and fatigue no known exposure remote worker. The patient had received covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result=Positive / covid test date=Jan2022; covid test result=Positive / covid test date=Jan2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Jun2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and intramuscular, administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hepatitis b, for Immunization; Flu, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "covid test result=Positive / covid test date=Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  Additional information: The patient was not received any other vaccine in four weeks. The patient was not had Covid prior to vaccination. The patient had no known allergies. The patient tested for Covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events DRUG INEFFECTVE, COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait inability, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: 2 days later I developed acute non vertigo imbalance; I could not walk without assistance.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Jan2021 09:00 (Lot number: EL0140) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 28Oct2020 (unspecified if ongoing), notes: Mild Illness. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Time: 09:00 AM, Batch/lot number: EL0140, Route: Intramuscular, Anatomical sit of injection: Right arm), administration date: 26Dec2020, for COVID-19 Immunization. The following information was reported: BALANCE DISORDER (medically significant) with onset 18Jan2021, outcome "recovered with sequelae" (24Jan2021), described as "2 days later I developed acute non vertigo imbalance"; GAIT INABILITY (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "I could not walk without assistance.". The event "2 days later i developed acute non vertigo imbalance" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (21Jan2021) mild ill defined enhancement; magnetic resonance imaging neck: (21Jan2021) l pons most consistent with capillary telangiectas. Therapeutic measures were taken as a result of balance disorder. Clinical course: Received 2nd dose of vaccine on 16Jan2021. On morning of 18th woke to instability and unable to walk without holding onto something. No vertigo. Urgent consultant with neurology concerned with MS versus reaction to vaccine urgent MRI with findings noted. Repeat MRI 3 mos. later same findings. Symptoms resolved after 1 week. Had acute vertigo beginning of Nov2021. Started seeing OT for lingering symptoms, through evaluation still seeing some imbalance issues.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event Balance disorder. 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: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 34 years as dose 2, single and administered in arm left, administration date 31Jan2021 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Acid reflux" (unspecified if ongoing), notes: Acid reflux; "Acquired hallux rigidus" (unspecified if ongoing), notes: Acquired hallux rigidus; "Insomnia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; LISINOPRIL. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam"; Morphine, reaction(s): "Known allergies: Morphine"; Drysol, reaction(s): "Known allergies: Drysol"; Androderm, reaction(s): "Known allergies: Androderm". Patient reported that prior to vaccination he was not diagnosed with Covid 19 but since the vaccination he was tested for Covid 19. It was also reported that patient did not received any other vaccine within 4 weeks prior to the Covid vaccine. Reporter reported that Sudden instantaneous sensorineural hearing loss in right ear on 14Apr2021 with no concurrent accident, injury or illness. Sudden instantaneous sensorineural hearing loss in left ear on 03May also with no concurrent accidents, injuries or illnesses. Patient received medications within 2 weeks of vaccination is Nexium, Lisinopril.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 14Jan2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive, notes: covid test type post vaccination=Nasal Swab.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness neurosensory, Inappropriate schedule of product administration, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 34 years as dose 2, single and administered in arm left, administration date 31Jan2021 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Acid reflux" (unspecified if ongoing), notes: Acid reflux; "Acquired hallux rigidus" (unspecified if ongoing), notes: Acquired hallux rigidus; "Insomnia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; LISINOPRIL. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam"; Morphine, reaction(s): "Known allergies: Morphine"; Drysol, reaction(s): "Known allergies: Drysol"; Androderm, reaction(s): "Known allergies: Androderm". Patient reported that prior to vaccination he was not diagnosed with Covid 19 but since the vaccination he was tested for Covid 19. It was also reported that patient did not received any other vaccine within 4 weeks prior to the Covid vaccine. Reporter reported that Sudden instantaneous sensorineural hearing loss in right ear on 14Apr2021 with no concurrent accident, injury or illness. Sudden instantaneous sensorineural hearing loss in left ear on 03May also with no concurrent accidents, injuries or illnesses. Patient received medications within 2 weeks of vaccination is Nexium, Lisinopril.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 14Jan2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive, notes: covid test type post vaccination=Nasal Swab.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Sex: F
Vaccine: COVID19
Symptoms: Arterial catheterisation, Blood test, Cardiomyopathy, Echocardiogram, Electrocardiogram
Clinical narrative: Takotsubo cardiomyopathy; This is a literature report for a Pfizer sponsored program.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for COVID-19 immunisation. The following information was reported: CARDIOMYOPATHY (hospitalization, medically significant), outcome "unknown", described as "Takotsubo cardiomyopathy". The patient underwent the following laboratory tests and procedures: arterial catheterisation: (unspecified date) normal, notes: normal coronary arteries without obstruction; blood test: (unspecified date) normal, notes: Blood work was normal; echocardiogram: (unspecified date) estimated ejection fraction (ef) of, notes: estimated ejection fraction (EF) of 30-35%,as well as kinesis of the apical septal, apical inferior and apical myocardium; (unspecified date) improvement in ef (55-60%),, notes: Further, a follow-up TTE after 8 weeks revealed improvement in EF (55-60%), without wall motion abnormality; electrocardiogram: (unspecified date) t wave inversion in the inferior and lateral leads, notes: Normal sinus rhythm with diffuse T wave inversion in the inferior and lateral leads, a new development in comparison; (2017) t wave inversion in the inferior and lateral leads, notes: a new development in comparison to a previous EKG in 2017; troponin: (unspecified date) 0.465, notes: troponin levels of 0.465[unit not stated].  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. 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: Troponin
Clinical narrative: Takotsubo cardiomyopathy; This is a literature report for a Pfizer sponsored program.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for COVID-19 immunisation. The following information was reported: CARDIOMYOPATHY (hospitalization, medically significant), outcome "unknown", described as "Takotsubo cardiomyopathy". The patient underwent the following laboratory tests and procedures: arterial catheterisation: (unspecified date) normal, notes: normal coronary arteries without obstruction; blood test: (unspecified date) normal, notes: Blood work was normal; echocardiogram: (unspecified date) estimated ejection fraction (ef) of, notes: estimated ejection fraction (EF) of 30-35%,as well as kinesis of the apical septal, apical inferior and apical myocardium; (unspecified date) improvement in ef (55-60%),, notes: Further, a follow-up TTE after 8 weeks revealed improvement in EF (55-60%), without wall motion abnormality; electrocardiogram: (unspecified date) t wave inversion in the inferior and lateral leads, notes: Normal sinus rhythm with diffuse T wave inversion in the inferior and lateral leads, a new development in comparison; (2017) t wave inversion in the inferior and lateral leads, notes: a new development in comparison to a previous EKG in 2017; troponin: (unspecified date) 0.465, notes: troponin levels of 0.465[unit not stated].  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. 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: Chest pain, Cough, Decreased immune responsiveness, Dyspnoea, Feeling hot
Clinical narrative: Coughing; Fever; her head has been hurting/Headache; she started to feel hot; She has high blood pressure; She has kidney disease; Chest pain; Shortness of breath; She is an immune, her immune system is low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2022 18:00 (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COUGH (non-serious) with onset Feb2022, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "her head has been hurting/Headache"; FEELING HOT (non-serious) with onset Feb2022, outcome "unknown", described as "she started to feel hot"; HYPERTENSION (non-serious) with onset Feb2022, outcome "unknown", described as "She has high blood pressure"; RENAL DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "She has kidney disease"; CHEST PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious) with onset Feb2022, outcome "unknown", described as "Shortness of breath"; DECREASED IMMUNE RESPONSIVENESS (non-serious) with onset Feb2022, outcome "unknown", described as "She is an immune, her immune system is low".  Additional information: Clinical course: It was reported that patient was 11 and she got her vaccine yesterday in the afternoon, like 6:00 pm and she was a patient, she has kidney disease. In the middle of the night, she started coughing, she developed a cough that she didn't have before all these symptoms started after the vaccine. So, cough, fever she went to school like normal, it was just regular cough but she just, she said she feels, she started to feel hot. So, now she has fever, and she said her head has been hurting and could have a meeting with the nurse. She said she just thought maybe it was going to go away. So, concern is she has kidney disease, and she has high blood pressure. She has all these other concerns; she takes a lot of medications. She is an immune, her immune system is low. Reporter stated, whatever they could when, I guess there is, she is 11. So, they put the one that they have been putting to, if they are under 12. Reporter want to know whether need to take her to the ER, like is this like normal because it says the side effects are headache and fever and chest pain, shortness of breath and cough think, believe, to call that number, the number that reporter calling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Pyrexia, Renal disorder
Clinical narrative: Coughing; Fever; her head has been hurting/Headache; she started to feel hot; She has high blood pressure; She has kidney disease; Chest pain; Shortness of breath; She is an immune, her immune system is low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2022 18:00 (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COUGH (non-serious) with onset Feb2022, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "her head has been hurting/Headache"; FEELING HOT (non-serious) with onset Feb2022, outcome "unknown", described as "she started to feel hot"; HYPERTENSION (non-serious) with onset Feb2022, outcome "unknown", described as "She has high blood pressure"; RENAL DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "She has kidney disease"; CHEST PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious) with onset Feb2022, outcome "unknown", described as "Shortness of breath"; DECREASED IMMUNE RESPONSIVENESS (non-serious) with onset Feb2022, outcome "unknown", described as "She is an immune, her immune system is low".  Additional information: Clinical course: It was reported that patient was 11 and she got her vaccine yesterday in the afternoon, like 6:00 pm and she was a patient, she has kidney disease. In the middle of the night, she started coughing, she developed a cough that she didn't have before all these symptoms started after the vaccine. So, cough, fever she went to school like normal, it was just regular cough but she just, she said she feels, she started to feel hot. So, now she has fever, and she said her head has been hurting and could have a meeting with the nurse. She said she just thought maybe it was going to go away. So, concern is she has kidney disease, and she has high blood pressure. She has all these other concerns; she takes a lot of medications. She is an immune, her immune system is low. Reporter stated, whatever they could when, I guess there is, she is 11. So, they put the one that they have been putting to, if they are under 12. Reporter want to know whether need to take her to the ER, like is this like normal because it says the side effects are headache and fever and chest pain, shortness of breath and cough think, believe, to call that number, the number that reporter calling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: she had muscle aches in arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cerebral Palsy" (unspecified if ongoing), notes: She does have underlying issue of Cerebral Palsy. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "she had muscle aches in arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; headache; muscle aches on arm; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 Immunization, reaction(s): "muscle aches in arm". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches on arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood immunoglobulin G, Blood immunoglobulin M, Disseminated varicella zoster virus infection, Immunohistochemistry
Clinical narrative: disseminated varicella-zoster virus (VZV) infection; This is a literature report.  A 58 year-old male patient received bnt162b2 (BNT162B2) (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: "acute myeloid leukemia" (unspecified if ongoing), notes: for 12 months; "Immunosuppression" (unspecified if ongoing), notes: for 12 months; "blood stem cell transplantation" (unspecified if ongoing), notes: umbilical cord blood stem cell transplantation, 20 months ago. The patient's concomitant medications were not reported. Vaccination history included: Recombinant zoster vaccination (Shingrix,GlaxoSmithKline, 8 months ago), for immunization. The following information was reported: DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (medically significant), outcome "recovering", described as "disseminated varicella-zoster virus (VZV) infection". The patient underwent the following laboratory tests and procedures: biopsy: unknown; blood immunoglobulin g: elevated vzv; blood immunoglobulin m: elevated vzv; immunohistochemistry: positive, notes: varicella-zostervirus; laboratory test: without cutaneous or systemic side effects; 12.14, notes: mild leukocytosis, lymphocyte-predominant, K/uL; pathology test: extensive epidermal ulceration and a florid, notes: mixed dermal inflammatory infiltrate; physical examination: erosions and intact vesicles and pustules, notes: on erythematous bases over the scalp, neck, trunk, genitali and extremities; polymerase chain reaction: varicella-zostervirus dna from blood, and elevated, notes: varicella-zostervirus DNA from blood, and elevated varicella-zostervirus immunoglobulin M and IgG antibody titers; white blood cell count: 12.14, notes: Unit: k/ul lymphocyte-predominant). Therapeutic measures were taken as a result of disseminated varicella zoster virus infection.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. 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: M
Vaccine: COVID19
Symptoms: Laboratory test, Pathology test, Physical examination, Polymerase chain reaction, White blood cell count
Clinical narrative: disseminated varicella-zoster virus (VZV) infection; This is a literature report.  A 58 year-old male patient received bnt162b2 (BNT162B2) (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: "acute myeloid leukemia" (unspecified if ongoing), notes: for 12 months; "Immunosuppression" (unspecified if ongoing), notes: for 12 months; "blood stem cell transplantation" (unspecified if ongoing), notes: umbilical cord blood stem cell transplantation, 20 months ago. The patient's concomitant medications were not reported. Vaccination history included: Recombinant zoster vaccination (Shingrix,GlaxoSmithKline, 8 months ago), for immunization. The following information was reported: DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (medically significant), outcome "recovering", described as "disseminated varicella-zoster virus (VZV) infection". The patient underwent the following laboratory tests and procedures: biopsy: unknown; blood immunoglobulin g: elevated vzv; blood immunoglobulin m: elevated vzv; immunohistochemistry: positive, notes: varicella-zostervirus; laboratory test: without cutaneous or systemic side effects; 12.14, notes: mild leukocytosis, lymphocyte-predominant, K/uL; pathology test: extensive epidermal ulceration and a florid, notes: mixed dermal inflammatory infiltrate; physical examination: erosions and intact vesicles and pustules, notes: on erythematous bases over the scalp, neck, trunk, genitali and extremities; polymerase chain reaction: varicella-zostervirus dna from blood, and elevated, notes: varicella-zostervirus DNA from blood, and elevated varicella-zostervirus immunoglobulin M and IgG antibody titers; white blood cell count: 12.14, notes: Unit: k/ul lymphocyte-predominant). Therapeutic measures were taken as a result of disseminated varicella zoster virus infection.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Myocardial infarction, Pain in extremity
Clinical narrative: Major heart attack; her chest and left arm was hurting; she went to bed she was so hot she couldn't even sweat; chest was hurting/ her chest and left arm was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Lot number: 30135BA) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer Covid 19 Vaccine, 1st dose received on 20Sep2021 by injection in right arm. Lot: FC3184, Expiry: Unknown), administration date: 20Sep2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 20Oct2021, outcome "recovering", described as "Major heart attack"; CHEST PAIN (non-serious) with onset 20Oct2021, outcome "unknown", described as "chest was hurting/ her chest and left arm was hurting"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2021, outcome "unknown", described as "her chest and left arm was hurting"; FEELING HOT (non-serious) with onset 20Oct2021, outcome "unknown", described as "she went to bed she was so hot she couldn't even sweat". The patient was hospitalized for myocardial infarction (start date: 21Oct2021, discharge date: 22Oct2021, hospitalization duration: 1 day(s)). The events "major heart attack", "chest was hurting/ her chest and left arm was hurting" and "her chest and left arm was hurting" were evaluated at the physician office visit and emergency room visit.  Clinical outcome: Vaccination Facility Type was Health Department. Patient had heart attack on 20Oct2021, but she didn't know it. Her chest was hurting, but she overlooked it and went about her day. When she went to bed she was so hot she couldn't even sweat. When she woke up the next day, 21Oct2021, her chest and left arm was hurting her. That's when she went to the doctor's office. The doctor's office put her in an ambulance and sent her to the hospital. She had a stent placed that day, 21Oct2021, and she was admitted to the hospital for 24 hours. Reporter verified that the heart attack was not going, but stated that patient improved since she had the heart attack. Patient had no idea what diagnostic tests might have been done while she was in the hospital. No further clarification was provided. Investigation assessment was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Ophthalmic herpes zoster, Vital dye staining cornea present
Clinical narrative: Herpes zoster reactivation shortly after administration of a mRNA vaccine; This is a literature report.  A 46 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "corneal abrasion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant), outcome "recovering", described as "Herpes zoster reactivation shortly after administration of a mRNA vaccine". The event "herpes zoster reactivation shortly after administration of a mrna vaccine" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: discomfort, notes: the left eye 1 day after the Pfizer/BioNTech vaccine; vital dye staining cornea present: the corneal infiltrates, notes: were again seen. Therapeutic measures were taken as a result of ophthalmic herpes zoster.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Ophthalmic herpes zoster and the suspect drug BNT162B2 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,Linked Report(s) : PFIZER INC-202200174900 Same article/drug/event and different patient; PFIZER INC-202200206631 Same article/drug/event and different patient; PFIZER INC-202200206631 Same article/drug/event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Ophthalmic herpes zoster
Clinical narrative: Herpes zoster reactivation shortly after administration of a mRNA vaccine; This is a literature report.  A 34 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "eczema" (unspecified if ongoing); "skin rash" (unspecified if ongoing); "pseudodendritic lesions" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant), outcome "unknown", described as "Herpes zoster reactivation shortly after administration of a mRNA vaccine". The patient underwent the following laboratory tests and procedures: investigation: she was noted to have a typical v1 rash of herpes, notes: zoster with a marginal upper lid lesion as well. Therapeutic measures were taken as a result of ophthalmic herpes zoster.  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 information in the case report, a causal association between reported event ophthalmic herpes zoster and BNT162B2 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.,Linked Report(s) : PFIZER INC-202200174900 Same article/drug/event and different patient; PFIZER INC-202200206630 Same article/drug/event and different patient; PFIZER INC-202200206630 Same article/drug/event and different patient
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Overdose, Product preparation issue
Clinical narrative: she got pediatric dose 0.2 ml but they didn''t dilute it; she got pediatric dose 0.2 ml but they didn''t dilute it; severe headache; This is a spontaneous report received from a contactable reporter (Physician).  A 11 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19), intramuscular (Batch/Lot number: unknown) at the age of 11 years as dose number unknown (tris), 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "she got pediatric dose 0.2 ml but they didn''t dilute it"; HEADACHE (non-serious), outcome "recovered", described as "severe headache". Additional information: Patient age is 11 years and 5 months of event (vaccination). The patient had not received any other vaccine within 4 weeks. Patient received pediatric dose but the pharmacist forgot to dilute it. Patient had severe headache for 5 to 6 days but right nowshe is doing okay and no other symptom.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: had two doses of the Pfizer Covid vaccine - and tested positive for Covid; had two doses of the Pfizer Covid vaccine - and tested positive for Covid; nasal congestion; cold symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2) (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), COVID-19 (medically significant), outcome "unknown" and all described as "had two doses of the Pfizer Covid vaccine - and tested positive for Covid"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms". It was reported that this is the second time patient has had Covid and event took place after use of product. 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Food allergy, Gluten sensitivity, Hypersensitivity, Impaired quality of life
Clinical narrative: food allergies/ Allergic to eggs, avocados; intense gut allergies; Allergic to gluten; Allergic to dairy; Making my quality of life miserable/Ever since the day I got my vaccine life has not been the same; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Jul2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: FOOD ALLERGY (disability) with onset 24Jul2021, outcome "not recovered", described as "food allergies/ Allergic to eggs, avocados"; HYPERSENSITIVITY (disability) with onset 24Jul2021, outcome "not recovered", described as "intense gut allergies"; GLUTEN SENSITIVITY (disability) with onset 24Jul2021, outcome "not recovered", described as "Allergic to gluten"; MILK ALLERGY (disability) with onset 24Jul2021, outcome "not recovered", described as "Allergic to dairy"; IMPAIRED QUALITY OF LIFE (disability) with onset 24Jul2021, outcome "not recovered", described as "Making my quality of life miserable/Ever since the day I got my vaccine life has not been the same". The events "food allergies/ allergic to eggs, avocados", "intense gut allergies", "allergic to gluten", "allergic to dairy" and "making my quality of life miserable/ever since the day i got my vaccine life has not been the same" were evaluated at the physician office visit and emergency room visit. No other vaccine in four weeks and no other medications in two weeks. After receiving vaccine patient have developed a long list of food allergies and intense gut allergies she had never had prior to the vaccine. For two months after getting the vaccine, she was bed ridden. She was now allergic to gluten, eggs, dairy, avocados, as well as other items but these are the main. This health complication had led her to hospital visits, countless blood tests, and making her quality of life miserable. Doctor literally told patient he did not know what was wrong with patient. Ever since the day she got her vaccine life had not been the same. The patient underwent the following laboratory tests and procedures: countless blood tests: unknown result; Nasal Swab: negative. Therapeutic measures were not taken as a result of food allergy, hypersensitivity, gluten sensitivity, milk allergy, impaired quality of life. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Milk allergy, SARS-CoV-2 test
Clinical narrative: food allergies/ Allergic to eggs, avocados; intense gut allergies; Allergic to gluten; Allergic to dairy; Making my quality of life miserable/Ever since the day I got my vaccine life has not been the same; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Jul2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: FOOD ALLERGY (disability) with onset 24Jul2021, outcome "not recovered", described as "food allergies/ Allergic to eggs, avocados"; HYPERSENSITIVITY (disability) with onset 24Jul2021, outcome "not recovered", described as "intense gut allergies"; GLUTEN SENSITIVITY (disability) with onset 24Jul2021, outcome "not recovered", described as "Allergic to gluten"; MILK ALLERGY (disability) with onset 24Jul2021, outcome "not recovered", described as "Allergic to dairy"; IMPAIRED QUALITY OF LIFE (disability) with onset 24Jul2021, outcome "not recovered", described as "Making my quality of life miserable/Ever since the day I got my vaccine life has not been the same". The events "food allergies/ allergic to eggs, avocados", "intense gut allergies", "allergic to gluten", "allergic to dairy" and "making my quality of life miserable/ever since the day i got my vaccine life has not been the same" were evaluated at the physician office visit and emergency room visit. No other vaccine in four weeks and no other medications in two weeks. After receiving vaccine patient have developed a long list of food allergies and intense gut allergies she had never had prior to the vaccine. For two months after getting the vaccine, she was bed ridden. She was now allergic to gluten, eggs, dairy, avocados, as well as other items but these are the main. This health complication had led her to hospital visits, countless blood tests, and making her quality of life miserable. Doctor literally told patient he did not know what was wrong with patient. Ever since the day she got her vaccine life had not been the same. The patient underwent the following laboratory tests and procedures: countless blood tests: unknown result; Nasal Swab: negative. Therapeutic measures were not taken as a result of food allergy, hypersensitivity, gluten sensitivity, milk allergy, impaired quality of life. The lot number for bnt162b2 was not provided and will be requested during follow up.