chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate decreased, Immunisation, Palpitations
Clinical narrative: Weak pulse (under 50 bpm); Weak pulse (under 50 bpm); heart palpitations/pounding; PVC on ECG; Dose Number: 3; This is a spontaneous report received from a contactable reporter (Consumer). A 40-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 40 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: Comirnaty (Dose Number: 1, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 39 years old, for Covid-19 immunization; Comirnaty (Dose Number: 2, Location of injection: Arm Left), for Covid-19 immunization.  The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PULSE ABNORMAL (medically significant), HEART RATE DECREASED (medically significant) all with onset 04Dec2021, outcome "recovering" and all described as "Weak pulse (under 50 bpm)"; IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose Number: 3"; PALPITATIONS (non-serious) with onset 04Dec2021, outcome "recovering", described as "heart palpitations/pounding"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 04Dec2021, outcome "recovering", described as "PVC on ECG". The events "weak pulse (under 50 bpm)", "weak pulse (under 50 bpm)", "heart palpitations/pounding" and "pvc on ecg" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram (ECG): (04Dec2021) PVC; pulse: (04Dec2021) under 50 beats per minute (bpm), notes: Weak pulse.  Therapeutic measures were not taken as a result of pulse abnormal, palpitations, palpitations, ventricular extrasystoles. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Ventricular extrasystoles
Clinical narrative: Weak pulse (under 50 bpm); Weak pulse (under 50 bpm); heart palpitations/pounding; PVC on ECG; Dose Number: 3; This is a spontaneous report received from a contactable reporter (Consumer). A 40-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 40 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: Comirnaty (Dose Number: 1, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 39 years old, for Covid-19 immunization; Comirnaty (Dose Number: 2, Location of injection: Arm Left), for Covid-19 immunization.  The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PULSE ABNORMAL (medically significant), HEART RATE DECREASED (medically significant) all with onset 04Dec2021, outcome "recovering" and all described as "Weak pulse (under 50 bpm)"; IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose Number: 3"; PALPITATIONS (non-serious) with onset 04Dec2021, outcome "recovering", described as "heart palpitations/pounding"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 04Dec2021, outcome "recovering", described as "PVC on ECG". The events "weak pulse (under 50 bpm)", "weak pulse (under 50 bpm)", "heart palpitations/pounding" and "pvc on ecg" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram (ECG): (04Dec2021) PVC; pulse: (04Dec2021) under 50 beats per minute (bpm), notes: Weak pulse.  Therapeutic measures were not taken as a result of pulse abnormal, palpitations, palpitations, ventricular extrasystoles. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Maternal exposure during pregnancy, Spinal cord injury, Spinal meningioma benign
Clinical narrative: Maternal exposure during pregnancy, third trimester; Baby born with spinal cord tethering due to a lipomeningioma of sacrum.; Baby born with spinal cord tethering due to a lipomeningioma of sacrum; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A neonate patient was exposed to bnt162b2 (BNT162B2), transplacental, administration date 23Oct2021 (Lot number: FF2588) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 33 years old at the time of vaccination. The mother's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The mother was 36 weeks pregnant at the event onset. The mother's concomitant medications were not reported. The mother's past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. The mother's vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19, Brand: Pfizer, Lot number: El1284, vaccine location: Left arm), administration date: 10Jan2021, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Product: COVID 19, rand: Pfizer, Lot number: El 3247), administration date: 02Feb2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 23Oct2021, outcome "unknown", described as "Booster"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Maternal exposure during pregnancy, third trimester"; SPINAL MENINGIOMA BENIGN (congenital anomaly, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Baby born with spinal cord tethering due to a lipomeningioma of sacrum."; SPINAL CORD INJURY (congenital anomaly) with onset 22Nov2021, outcome "not recovered", described as "Baby born with spinal cord tethering due to a lipomeningioma of sacrum".  Follow up information has been requested.; Sender's Comments: As per available information, the causal association between the event immunisation, MEDP, spinal meningioma benign and spinal cord injury 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-202101723580 Mother/baby case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Sciatic nerve injury, Sciatic nerve neuropathy
Clinical narrative: booster; sciatic nerve went crazy and hurt for weeks. It appears to be affecting my nervous; sciatic nerve went crazy and hurt for weeks. It appears to be affecting my nervous; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 13:00 (Lot number: Fh8020) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Singulair, reaction(s): "Known allergies: Singulair". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0161, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 14Apr2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Skin paresthesia", "Nerve pain"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ep6955, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 24Mar2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Nerve pain", "Skin paresthesia".  The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021 13:00, outcome "unknown", described as "booster"; SCIATIC NERVE INJURY (medically significant), SCIATIC NERVE NEUROPATHY (medically significant) all with onset 2021, outcome "unknown" and all described as "sciatic nerve went crazy and hurt for weeks. It appears to be affecting my nervous". The event "sciatic nerve went crazy and hurt for weeks. it appears to be affecting my nervous" and "sciatic nerve went crazy and hurt for weeks. it appears to be affecting my nervous" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of sciatic nerve injury, sciatic nerve neuropathy. The patient did not have COVID prior vaccination and post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control, Dizziness, Investigation, Pain in extremity
Clinical narrative: Type 2 diabetes number went from 135 to 200 plus for 3 days return to 135 area readings; head had preciption problems; Sore arm for 1 day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (ongoing); "Cholesterol" (unspecified if ongoing); "High Blood" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing); LISINOPRIL taken for hypertension (ongoing); TAMSULOSIN (ongoing). Vaccination history included: Bnt162b2 (1st dose, Anatomical site of injection: Right arm, Batch/Lot number: Pfizer EN6203), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Sore arm for 5 days". The following information was reported: Diabetes mellitus inadequate control (medically significant) with onset 25Mar2021, outcome "unknown", described as "Type 2 diabetes number went from 135 to 200 plus for 3 days return to 135 area readings"; DIZZINESS (non-serious) with onset 25Mar2021, outcome "recovered" (2021), described as "head had preciption problems"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "Sore arm for 1 day". The patient underwent the following laboratory tests and procedures: investigation: (25Mar2021) 200 plus, notes: Type 2 diabetes numbers went from 135 to 200 plus for 3 days return to 135 area readings; (2021) 135 area readings, notes: Type 2 diabetes numbers went from 135 to 200 plus for 3 days return to 135 area readings. Clinical course:Patient age at vaccination: 76/77 years.Concomitant drugs: Drug name: Metformin,Reason for use: Type 2 diabetes,Route: Mouth Checkbox if ongoing: Ongoing.Concomitant drugs: Drug name: Simvastatin,Reason for use: Cholesterol,Route: Mouth,Checkbox if ongoing: Ongoing.Drug name: Lisinopril,Reason for use: High Blood,Route: Mouth,Checkbox if ongoing: Ongoing.Drug name: Tamsulosin,Reason for use: Prostate,Route: Mouth,Checkbox if ongoing: Ongoing.Patient's medical history: None.Relevant tests: None.Specific Relevant test: None.Comments/narrative: No serious complications 03Mar2021 Sore arm for 5 days.25Mar2021 1) Sore arm for 1 day.2) Type 2 diabetes numbers went from 135 to 200 plus for 3 days returned to 135 area readings.3) My head had preciption problems while driving for 1 months. Could have been medication and Diet? On18Oct2021 Had a temperature raise from 97.7 to 98.5 for 1 day and chills for 12 hours.  No follow-up attempts are possible. No further information is expected. Follow-Up (08Dec2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101725122 Same reporter/ patient, different AE/ drug dose
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Feeling abnormal, Magnetic resonance imaging, Occipital neuralgia
Clinical narrative: I now have ''Occipital'' Neuralgia because of your stupid vaccine; It feels horrible that I am going through; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 21Sep2021 (Lot number: FC3184) at the age of 38 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FD8448), for Covid-19 immunization. The following information was reported: OCCIPITAL NEURALGIA (hospitalization) with onset Sep2021, outcome "unknown", described as "I now have ''Occipital'' Neuralgia because of your stupid vaccine"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "It feels horrible that I am going through". The event "i now have ''occipital'' neuralgia because of your stupid vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: I had a lot of lab work done; computerised tomogram: unknown results, notes: I have had 4 CT Scans; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of occipital neuralgia. Consumer stated, "I have had so many medicines pumped into me when I was in the hospital. I had 9 different meds (Further clarifications unknown). Now I am on Gabapentin, Baclofen and Imitrex at home".   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Lack of efficacy - patient received 3 doses of Covid-19 vaccine Patient then experienced symptoms and had a positive Covid-19 test; Lack of efficacy - patient received 3 doses of Covid-19 vaccine Patient then experienced symptoms and had a positive Covid-19 test; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant) with onset 03Dec2021, outcome "recovering", COVID-19 (medically significant) with onset 03Dec2021, outcome "recovering" and all described as "Lack of efficacy - patient received 3 doses of Covid-19 vaccine Patient then experienced symptoms and had a positive Covid-19 test". The event "lack of efficacy - patient received 3 doses of covid-19 vaccine patient then experienced symptoms and had a positive covid-19 test" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: flushed face; syncope; chills; profuse sweating; dizziness; vomiting; diarrhea; nausea; fatigue; don't know if elevated temperature, but possible; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Dec2021 10:30 (Lot number: FJ8757) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number EL3247, administrator route Intramuscular, administration time 12:00 PM , dose 2, vaccine location Left Arm), administration date: 13Apr2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (lot number EL3247, administrator route Intramuscular, administration time 12:00 PM , dose 1, vaccine location Left arm), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 immunization; Flu vaccine VII (dose 1, vaccine location Left Arm), administration date: 04Nov2021, when the patient was 62 years old, for immunization. The following information was reported: IMMUNISATION (medically significant) with onset 03Dec2021 10:30, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 03Dec2021 20:00, outcome "recovering", described as "syncope"; CHILLS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "profuse sweating"; DIZZINESS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "dizziness"; VOMITING (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "vomiting"; DIARRHOEA (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "diarrhea"; NAUSEA (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "don't know if elevated temperature, but possible", based on chills and sweating; FLUSHING (non-serious) with onset 06Dec2021 (on day 3 after shot), outcome "recovering", described as "flushed face". Therapeutic measures were not taken as a result of syncope, chills, hyperhidrosis, dizziness, vomiting, diarrhoea, nausea, fatigue, body temperature increased, flushing.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Immunisation, Nausea, Syncope
Clinical narrative: flushed face; syncope; chills; profuse sweating; dizziness; vomiting; diarrhea; nausea; fatigue; don't know if elevated temperature, but possible; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Dec2021 10:30 (Lot number: FJ8757) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number EL3247, administrator route Intramuscular, administration time 12:00 PM , dose 2, vaccine location Left Arm), administration date: 13Apr2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (lot number EL3247, administrator route Intramuscular, administration time 12:00 PM , dose 1, vaccine location Left arm), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 immunization; Flu vaccine VII (dose 1, vaccine location Left Arm), administration date: 04Nov2021, when the patient was 62 years old, for immunization. The following information was reported: IMMUNISATION (medically significant) with onset 03Dec2021 10:30, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 03Dec2021 20:00, outcome "recovering", described as "syncope"; CHILLS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "profuse sweating"; DIZZINESS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "dizziness"; VOMITING (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "vomiting"; DIARRHOEA (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "diarrhea"; NAUSEA (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "don't know if elevated temperature, but possible", based on chills and sweating; FLUSHING (non-serious) with onset 06Dec2021 (on day 3 after shot), outcome "recovering", described as "flushed face". Therapeutic measures were not taken as a result of syncope, chills, hyperhidrosis, dizziness, vomiting, diarrhoea, nausea, fatigue, body temperature increased, flushing.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: flushed face; syncope; chills; profuse sweating; dizziness; vomiting; diarrhea; nausea; fatigue; don't know if elevated temperature, but possible; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Dec2021 10:30 (Lot number: FJ8757) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number EL3247, administrator route Intramuscular, administration time 12:00 PM , dose 2, vaccine location Left Arm), administration date: 13Apr2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (lot number EL3247, administrator route Intramuscular, administration time 12:00 PM , dose 1, vaccine location Left arm), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 immunization; Flu vaccine VII (dose 1, vaccine location Left Arm), administration date: 04Nov2021, when the patient was 62 years old, for immunization. The following information was reported: IMMUNISATION (medically significant) with onset 03Dec2021 10:30, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 03Dec2021 20:00, outcome "recovering", described as "syncope"; CHILLS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "profuse sweating"; DIZZINESS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "dizziness"; VOMITING (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "vomiting"; DIARRHOEA (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "diarrhea"; NAUSEA (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "don't know if elevated temperature, but possible", based on chills and sweating; FLUSHING (non-serious) with onset 06Dec2021 (on day 3 after shot), outcome "recovering", described as "flushed face". Therapeutic measures were not taken as a result of syncope, chills, hyperhidrosis, dizziness, vomiting, diarrhoea, nausea, fatigue, body temperature increased, flushing.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for COVID-19/had a break through infection PCR; Positive for COVID-19/had a break through infection PCR; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from product quality group. The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Feb2021 14:15 (Lot number: EL3247) at the age of 37 years as dose 2, single and intramuscular, administered in arm left, administration date 28Jan2021 15:15 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Dec2021 15:00, outcome "recovering" and all described as "Positive for COVID-19/had a break through infection PCR". It was reported that Patient was infected due to 5 yo unvaccinated child testing positive after exposure at school- of note the first and second vaccines were given only days apart and that was too early according to EUA. Patient did not have covid prior to vaccination. Patient had no known allergies. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2021) negative, notes: Nasal Swab; (23Jun2021) negative, notes: Nasal Swab; (07Aug2021) negative, notes: Nasal Swab; (22Sep2021) negative, notes: Nasal Swab; (29Nov2021) negative, notes: Nasal Swab; (02Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Conclusion of previously completed investigation was reported as follows: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventa tive actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Severe flare of plaque psorisis on over 70 % of body starting right after second Pfizer COVID 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), administered in arm right, administration date 20Mar2021 11:00 at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Plaque psoriasis (mild)" (unspecified if ongoing), notes: Plaque psoriasis (mild), Had mild psorisis for 40 years prior to COVID vaccine, Skin had been relatively clear of plaque psoriasis for the 5 months prior to the second COVID vaccine.Known allergies: No; "Coronary stent" (unspecified if ongoing), notes: Coronary stent. Concomitant medication(s) included, notes: other medications the patient received within 2 weeks of vaccination: LIPITOR statin 40mg; ASPIRIN [ACETYLSALICYLIC ACID87 mg]; vitimin D 1000. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EH6201, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 27Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: PSORIASIS (medically significant) with onset Mar2021, outcome "recovering", described as "Severe flare of plaque psorisis on over 70 % of body starting right after second Pfizer COVID 19 vaccine". The event "severe flare of plaque psorisis on over 70 % of body starting right after second pfizer covid 19 vaccine" was evaluated at the physician office visit. Never a severe flare like this on all parts of patient's body. Have been put on a psoriasis biologic (Tremfya) in attempt to clear skin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination nor tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Asthma, Drug ineffective, Suspected COVID-19
Clinical narrative: now have covid; now have covid; severe asthma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211123000713 (RA).  An elderly patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN),(Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "now have covid"; ASTHMA (non-serious), outcome "unknown", described as "severe asthma"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "cannot taste or smell anything". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Acne cystic, Dysmenorrhoea, Feeling abnormal, Heavy menstrual bleeding, Memory impairment
Clinical narrative: foggy; forgetful; significantly heavier, longer, more painful periods; significantly heavier, longer, more painful periods; Cystic acne; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administration date 14May2021 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 04Apr2021, when the patient was 36 years old, for Covid-19 Immunization, reaction(s): "significantly heavier, longer, more painful periods", "significantly heavier, longer, more painful periods", "Cystic acne". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "significantly heavier, longer, more painful periods"; ACNE CYSTIC (non-serious) with onset 2021, outcome "unknown", described as "Cystic acne"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "unknown", described as "foggy"; MEMORY IMPAIRMENT (non-serious) with onset May2021, outcome "unknown", described as "forgetful". Therapeutic measures were taken as a result of heavy menstrual bleeding, dysmenorrhoea, acne cystic, feeling abnormal, memory impairment.  Additional Information: Prior vaccination within 4 weeks was reported as none. The patient did not have COVID prior vaccination and since the vaccination patient was not tested for COVID. Device Date : 06Dec2021  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 5 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: death (death), outcome "fatal", described as "death". Additional information included: the 5-Year-old patient died four days after the Pfizer shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes 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: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Crohn's disease, Influenza like illness, Pyrexia, Unevaluable event
Clinical narrative: Crohn's disease aggravated; Chills; Unevaluable event; Flu-like symptoms; Fever; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-4170952-00 (RA).  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Aug2021 (Lot number: UNKNOWN) at the age of 33 years as dose 2, single and intramuscular, administration date 09Jul2021 (Lot number: UNKNOWN) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1151978) at unk, citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 15Sep2021, outcome "not recovered", described as "Crohn's disease aggravated"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; UNEVALUABLE EVENT (non-serious) with onset 2021, outcome "unknown", described as "Unevaluable event"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Flu-like symptoms"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever". The action taken for adalimumab was dosage not changed.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Pfizer vaccine caused chills, fever, and flu like feeling onset in 2021, Pfizer vaccine caused chills, fever, and flu like feeling onset in 2021 and Pfizer vaccine caused chills, fever, and flu like feeling onset in 2021 with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of food vergency was not provided. The reporter's causality for the event(s) of Crohn's disease flare up with Humira (Adalimumab) was a reasonable possibility. Causality of events with Pfizer BioNTech covid-19 vaccine was reported as not related.  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 available information aggravation of crohn's disease, chills, influenza like illness and pyrexia cannot be totally excluded for BNT162B2 and unevaluable event unrelated to suspect drug BNT162B2. The case will be reassessed when additional information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Rectal haemorrhage
Clinical narrative: Colitis ulcerative aggravated; increased ulcerative colitis symptoms with rectal bleeding; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till 2021 at 40 mg (40 mg (cf pen)) and second regimen subcutaneous from 27May2021 (Batch/Lot number: unknown) to 01Sep2021 at 40 mg weekly (40 mg, weekly (40 mg, 1 in 1 week)) for colitis ulcerative. Relevant medical history included: "COVID-19 Illness", start date: 01Jan2021, stop date: 15Jan2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Route of Admin: 1) Intra-muscular, Daily Dose: 1) First dose (1 in 1 Once)), administration date: 01Feb2021, when the patient was 69 years old, for COVID-19 Immunization. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 01Mar2021, outcome "recovered" (01Sep2021), described as "Colitis ulcerative aggravated"; RECTAL HAEMORRHAGE (medically significant) with onset 01Mar2021, outcome "recovered" (01Sep2021), described as "increased ulcerative colitis symptoms with rectal bleeding". The action taken for adalimumab was dosage permanently withdrawn on 01Sep2021. Therapeutic measures were taken as a result of colitis ulcerative, rectal haemorrhage. The reporter reported that, after receiving both doses of Covid vaccine on 01Feb2021 and 01Mar2021, patient started having increased ulcerative colitis symptoms with rectal bleeding. Patient's physician increased dose to weekly 40mg Humira. After symptoms continued, patient was instructed to discontinue Humira and patient had surgery to remove his colon on 01Sep2021.  The reporter's assessment of the causal relationship of the colitis ulcerative and rectal haemorrhage with the suspect product BNT162B2 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: As there is limited information in the case provided, the causal association between the colitis ulcerative and rectal haemorrhage with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Colitis ulcerative
Clinical narrative: Colitis ulcerative aggravated; blood sugar increased; MARKETING PROGRAM NOT AVAILABLE  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-163-4180185-00 (Mfr Control No.).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "recovered", described as "Colitis ulcerative aggravated"; BLOOD GLUCOSE INCREASED (non-serious), outcome "not recovered", described as "blood sugar increased". The action taken for adalimumab was unknown.  The reporter considered "colitis ulcerative aggravated" and "blood sugar increased" related to bnt162b2. The reporter causality for blood sugar increased was a reasonable possibility and for colitis ulcerative aggravated was not reported for the suspect HUMIRA.  Clinical information: The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 provided, a possible causal association between the reported events, Ulcerative colitis, blood glucose increased and the suspect product BNT162B2 cannot be totally 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.
Sex: U
Vaccine: COVID19
Symptoms: Face oedema, Facial paralysis, Joint swelling
Clinical narrative: face drooping; Joint swelling; face swelling; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) 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: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "face drooping"; JOINT SWELLING (non-serious), outcome "unknown", described as "Joint swelling"; SWELLING FACE (non-serious), outcome "unknown", described as "face swelling".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Facial paralysis,Joint Swelling, face oedema and the suspect drug BNT162B2   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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cranial nerve palsies multiple, Diplopia, Dizziness, Eye disorder, Eye movement disorder
Clinical narrative: Experienced cranial nerve 3 palsy of the right eye; headache; double vision; nausea; Double vision, right eye fixed and turned outward; dilated pupil; droop of eyelid; inability to move eye past a certain position, difficulty focusing on close-up objects; inability to move eye past a certain position, difficulty focusing on close-up objects; dizziness; 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 49 year-old female patient received bnt162b2 (BNT162B2), administration date 06Aug2021 (Lot number: FC3180) at the age of 49 years as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRANIAL NERVE PALSIES MULTIPLE (medically significant) with onset 2021, outcome "unknown", described as "Experienced cranial nerve 3 palsy of the right eye"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown", described as "double vision"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; EYE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Double vision, right eye fixed and turned outward"; MYDRIASIS (non-serious) with onset 2021, outcome "unknown", described as "dilated pupil"; EYELID PTOSIS (non-serious) with onset 2021, outcome "unknown", described as "drop of eyelid"; EYE MOVEMENT DISORDER (non-serious), VISION BLURRED (non-serious) all with onset 2021, outcome "unknown" and all described as "inability to move eye past a certain position, difficulty focusing on close-up objects"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". It was reported that Description of Event:  Age 49. Experienced cranial nerve 3 palsy of the right eye. Symptoms included: initial onset came on with a headache, double vision and nausea. Double vision, right eye fixed and turned outward, dilated pupil, drop of eyelid, inability to move eye past a certain position, difficulty focusing on close-up objects, dizziness, nausea. She told me about this yesterday and said her eye doctor told her it was caused by the vaccine, so I am reporting it. Name of Product: COVID Vaccine Lot #FC3180 Pharmacy/Store 06Aug2021 Awareness Date: 06Dec2021 Event took place after use of product.  No follow-up attempts are possible. No further information is expected.