chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The reporter stated both of her kids got their booster doses too and both of them got COVID-19. The patient had flu-like symptoms for a couple of days but no one ended up needing to go to the hospital and no one ended up dying.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The reporter stated both of her kids got their booster doses too and both of them got COVID-19. No one ended up needing to go to the hospital and no one ended up dying.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200165956 same reporter/vaccine/event, different patient.;US-PFIZER INC-202200165324 same reporter/vaccine, different patient and event.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain Barre syndrome; numbness in the legs; 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 patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain Barre syndrome"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in the legs". The patient had the Pfizer vaccine. The patient experienced numbness in the legs very soon after the shot. The patient was diagnosed with Guillain Barre syndrome. Event took place after use of product. The patient was walking with "walking sticks"/braces type crutches.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Infection, SARS-CoV-2 test, Thrombosis
Clinical narrative: Two weeks later blood clots that stopped in the new.; Fatique; Infection; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 11:30 (Lot number: ER8731) at the age of 65 years as dose 2, single and administered in arm left, administration date 24Mar2021 11:45 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes 2" (unspecified if ongoing), notes: diabetes 2; "hbp" (unspecified if ongoing), notes: hbp; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; PLAVIX; CRESTOR; METFORMIN. Relevant past drug history: Name of Drug as Reported: no; Reaction: Allergy. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "Two weeks later blood clots that stopped in the new."; FATIGUE (hospitalization) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "Fatique"; INFECTION (hospitalization) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "Infection"; HEADACHE (hospitalization) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "headache". The patient was hospitalized for thrombosis, fatigue, infection, headache (hospitalization duration: 4 day(s)). The events "two weeks later blood clots that stopped in the new.", "fatique", "infection" and "headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Mar2021) negative, notes: Nasal Swab; (02Jan2022) negative, notes: Nasal Swab; (06Sep2021) negative, notes: Nasal Swab; (24Jan2022) negative, notes: Nasal Swab. The patient had not received any other vaccine within 4 weeks. Prior to vaccination and since the vaccination, patient was not diagnosed with COVID-19. Patient taken other medications within 2weeks was Gabapentin, plavix, clonazapril, crestor, metformin. Therapeutic measures were taken as a result of thrombosis, fatigue, infection, headache. The patient was hospitalized after first blood clots. Infection. Treatment received for the adverse event includes blood thinners, IV antibiotics  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: My daughter has get through infection; Sore throat; Runny nose; Fever; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INFECTION (non-serious) with onset 29Jan2022, outcome "unknown", described as "My daughter has get through infection"; OROPHARYNGEAL PAIN (non-serious) with onset 29Jan2022, outcome "unknown", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 29Jan2022, outcome "unknown", described as "Runny nose"; PYREXIA (non-serious) with onset 29Jan2022, outcome "unknown", described as "Fever". Therapeutic measures were taken as a result of infection, oropharyngeal pain, rhinorrhoea, pyrexia.  Additional information: The patient received Tylenol (pediatric dose) as treatment of adverse event. The reporter stated bnt162b2 had causal relation with events.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Rash, SARS-CoV-2 test
Clinical narrative: shortness of breath; body rash; allergy confirmed to covid pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jan2021 (Lot number: EL0142) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy-carrot" (unspecified if ongoing); "Known allergy-penicillin" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]. Past drug history included: Morphine, reaction(s): "known allergies : morphine". Vaccination history included: Bnt162b2 (DOSE 1, brand=Pfizer, lot number: EL1284, administration date: 26Dec2020, vaccine location: Right arm.), administration date: 26Dec2020, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "full body red rash", "full body red rash", "slight shortness of breath". The following information was reported: DYSPNOEA (non-serious) with onset 16Jan2021, outcome "unknown", described as "shortness of breath"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "body rash"; ALLERGY TO VACCINE (non-serious) with onset 16Jan2021, outcome "unknown", described as "allergy confirmed to covid pfizer". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, rash, allergy to vaccine.  Additional information: Facility where the most recent COVID-19 vaccine was administered: to the patient was Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had medications within 2 weeks of vaccination tyl 1000mg, 50 mg ben prior to dose 2. The patient had full body red rash with slight shortness of breath on first dose. When he got the 2nd dose a month later he took 1000mg tyl and 50 mg benadryl 1 hour prior to vaccine and still ended up with body rash and shortness of breath. both time this was with in less then 5 minutes of getting the Pfizer vaccine. The patient had treatment for adverse event. The patient was confirmed allergy to covid Pfizer. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient had covid test type post vaccination was nasal swab. The patient had no serious criteria of adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Heart rate increased
Clinical narrative: Arrhythmia; Heart rate 120 BPM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jan2022 18:00 (Lot number: FJ5683) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient had no other medical history, no known allergies. The patient took concomitant medications, she received Birth control, Hippo Vegan Complete within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 14Apr2021, when the patient was 22 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 14May2021, when the patient was 22 years old, for Covid-19 Immunization. The patient was not pregnant when vaccination. Prior to vaccination, the patient was not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: ARRHYTHMIA (medically significant) with onset 26Jan2022 20:00, outcome "not recovered", described as "Arrhythmia"; HEART RATE INCREASED (medically significant) with onset 26Jan2022 20:00, outcome "not recovered", described as "Heart rate 120 BPM". The events "arrhythmia" and "heart rate 120 bpm" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (26Jan2022) 120 BPM. Therapeutic measures were taken as a result of arrhythmia, heart rate increased, the treatment was given via IV. The case was reported as Non serious, No Results in death, No Life threatening, No Caused/prolonged hospitalization, No Disabling/Incapacitating, No Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Headache, Migraine, Pain
Clinical narrative: Worsening of alopecia; Body aches; HA; Chills; Arm pain; Severe migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 07:30 (Lot number: F13246) at the age of 44 years as dose 2, single and administered in arm left, administration date 18Dec2020 07:30 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing), notes: hypertension; "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergy induces asthma" (unspecified if ongoing), notes: allergy induces asthma; "endometriosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "alopecia areata" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; HYDROCHLOROTHIAZIDE; LEXAPRO; VYVANSE. Past drug history included: Known allergies; wellbutrin, reaction(s): "Known allergies; Wellbutrin", notes: Known allergies; Wellbutrin; Known allergies; ceftin, reaction(s): "Known allergies; Ceftin", notes: Known allergies; Ceftin.  The following information was reported: PAIN (non-serious) with onset Dec2020, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset Dec2020, outcome "not recovered", described as "HA"; CHILLS (non-serious) with onset Dec2020, outcome "not recovered", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset Dec2020, outcome "not recovered", described as "Arm pain"; MIGRAINE (non-serious) with onset Dec2020, outcome "not recovered", described as "Severe migraines"; ALOPECIA (non-serious) with onset Jan2021, outcome "not recovered", described as "Worsening of alopecia". The events "body aches", "ha", "chills", "arm pain", "severe migraines" and "worsening of alopecia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, chills, pain in extremity, migraine, alopecia.  Follow-up (01Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Worsening of alopecia; Body aches; HA; Chills; Arm pain; Severe migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 07:30 (Lot number: F13246) at the age of 44 years as dose 2, single and administered in arm left, administration date 18Dec2020 07:30 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing), notes: hypertension; "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergy induces asthma" (unspecified if ongoing), notes: allergy induces asthma; "endometriosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "alopecia areata" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; HYDROCHLOROTHIAZIDE; LEXAPRO; VYVANSE. Past drug history included: Known allergies; wellbutrin, reaction(s): "Known allergies; Wellbutrin", notes: Known allergies; Wellbutrin; Known allergies; ceftin, reaction(s): "Known allergies; Ceftin", notes: Known allergies; Ceftin.  The following information was reported: PAIN (non-serious) with onset Dec2020, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset Dec2020, outcome "not recovered", described as "HA"; CHILLS (non-serious) with onset Dec2020, outcome "not recovered", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset Dec2020, outcome "not recovered", described as "Arm pain"; MIGRAINE (non-serious) with onset Dec2020, outcome "not recovered", described as "Severe migraines"; ALOPECIA (non-serious) with onset Jan2021, outcome "not recovered", described as "Worsening of alopecia". The events "body aches", "ha", "chills", "arm pain", "severe migraines" and "worsening of alopecia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, chills, pain in extremity, migraine, alopecia.  Follow-up (01Feb2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient was fully vaccinated but tested positive for covid. He is recovering now. I don't know if he had his booster shot or not.; patient was fully vaccinated but tested positive for covid. He is recovering now. I don't know if he had his booster shot or not.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Jan2022, outcome "recovering" and all described as "patient was fully vaccinated but tested positive for covid. He is recovering now. I don't know if he had his booster shot or not.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical information: Unknown patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown prior to vaccination, was the patient diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Dizziness, Headache, Influenza
Clinical narrative: bad flu symptoms; felt light headed; had pain in her upper back; Nausea; severe headache; fever of 102.5; ached all over; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 08:45 (Lot number: FK5618) at the age of 11 years as dose 1 (tris), single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "felt light headed"; BACK PAIN (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "had pain in her upper back"; NAUSEA (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "severe headache"; PYREXIA (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "fever of 102.5"; PAIN (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "ached all over"; INFLUENZA (non-serious) with onset 30Jan2022, outcome "not recovered", described as "bad flu symptoms". The events "felt lightheaded", "had pain in her upper back", "nausea", "severe headache", "fever of 102.5", "ached all over" and "bad flu symptoms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, back pain, nausea, headache, pyrexia, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid prior vaccination and not been tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: bad flu symptoms; felt light headed; had pain in her upper back; Nausea; severe headache; fever of 102.5; ached all over; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 08:45 (Lot number: FK5618) at the age of 11 years as dose 1 (tris), single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "felt light headed"; BACK PAIN (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "had pain in her upper back"; NAUSEA (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "severe headache"; PYREXIA (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "fever of 102.5"; PAIN (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "ached all over"; INFLUENZA (non-serious) with onset 30Jan2022, outcome "not recovered", described as "bad flu symptoms". The events "felt lightheaded", "had pain in her upper back", "nausea", "severe headache", "fever of 102.5", "ached all over" and "bad flu symptoms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, back pain, nausea, headache, pyrexia, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid prior vaccination and not been tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot in right leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose 1), administration date: 26Apr2021, when the patient was 47 years old, for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant) with onset 02Aug2021, outcome "recovering", described as "Blood clot in right leg". The event "blood clot in right leg" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) negative. Therapeutic measures were taken as a result of thrombosis. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient has not been diagnosed with COVID-19. Treatment received included blood thinner.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Suspected myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: MYOCARDITIS (medically significant), outcome "unknown", described as "Suspected myocarditis".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have contracted Covid; I have contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have contracted Covid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Patient was a nurse that worked at the Health Department and she had contracted Covid. She was vaccinated with Pfizer. On an unspecified date, she was prescribed Paxlovid but she was not able to get it filled due to lack of supply. The risk of being hospitalized and not making it was pretty high.   The lot number for bnt162b2 was not provided and will be requested during follow up. ; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events  Drug ineffective, Suspected COVID-19 cannot be completely excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Loss of consciousness, Nausea
Clinical narrative: Passed out; Nauseated; Having hard time in breathing; Made him sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jan2022 13:00 (Lot number: FL3198, Expiration Date: Jun2022) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lungs problem" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Jan2022, outcome "unknown", described as "Passed out"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nauseated"; DYSPNOEA (non-serious) with onset Jan2022, outcome "unknown", described as "Having hard time in breathing"; ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "Made him sick". No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular autonomic function test, Electromyogram, Fall, Magnetic resonance imaging, Monoplegia
Clinical narrative: brief leg paralysis episodes; acute small fiber sensory neuropathy; lost ability to control legs for under a couple of minutes with fall to ground; neuropathy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EM9810) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT C; VIT D [COLECALCIFEROL]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2021, outcome "recovered", described as "neuropathy"; MONOPLEGIA (medically significant) with onset Nov2021, outcome "recovered", described as "brief leg paralysis episodes"; SMALL FIBRE NEUROPATHY (medically significant) with onset Nov2021, outcome "recovered", described as "acute small fiber sensory neuropathy"; FALL (medically significant) with onset Jun2021, outcome "recovered", described as "lost ability to control legs for under a couple of minutes with fall to ground". The events "neuropathy", "brief leg paralysis episodes", "acute small fiber sensory neuropathy" and "lost ability to control legs for under a couple of minutes with fall to ground" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiovascular autonomic function test: unknown results; electromyogram: unknown results; magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral, monoplegia, small fibre neuropathy, fall including gabapentin.  Course of the event: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In Nov2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in Jun or Jul2021 with very minor burning in front of both thighs, symptoms seemed to peak in Sep2021 (with all of symptoms listed above). In Oct2021 symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, burning on front of both thighs. Started Gabapentin in Nov2021, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet and sometimes mild burning in legs and arms.  Follow up information has been requested
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Small fibre neuropathy, X-ray
Clinical narrative: brief leg paralysis episodes; acute small fiber sensory neuropathy; lost ability to control legs for under a couple of minutes with fall to ground; neuropathy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EM9810) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT C; VIT D [COLECALCIFEROL]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2021, outcome "recovered", described as "neuropathy"; MONOPLEGIA (medically significant) with onset Nov2021, outcome "recovered", described as "brief leg paralysis episodes"; SMALL FIBRE NEUROPATHY (medically significant) with onset Nov2021, outcome "recovered", described as "acute small fiber sensory neuropathy"; FALL (medically significant) with onset Jun2021, outcome "recovered", described as "lost ability to control legs for under a couple of minutes with fall to ground". The events "neuropathy", "brief leg paralysis episodes", "acute small fiber sensory neuropathy" and "lost ability to control legs for under a couple of minutes with fall to ground" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiovascular autonomic function test: unknown results; electromyogram: unknown results; magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral, monoplegia, small fibre neuropathy, fall including gabapentin.  Course of the event: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In Nov2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in Jun or Jul2021 with very minor burning in front of both thighs, symptoms seemed to peak in Sep2021 (with all of symptoms listed above). In Oct2021 symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, burning on front of both thighs. Started Gabapentin in Nov2021, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet and sometimes mild burning in legs and arms.  Follow up information has been requested
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Electric shock sensation, Electromyogram, Feeling cold
Clinical narrative: brief leg paralysis episodes; acute small fiber sensory neuropathy; lost ability to control legs for under a couple of minutes with fall to ground; neuropathy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EM9810) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT C; VIT D [COLECALCIFEROL]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2021, outcome "recovered", described as "neuropathy"; MONOPLEGIA (medically significant) with onset Nov2021, outcome "recovered", described as "brief leg paralysis episodes"; SMALL FIBRE NEUROPATHY (medically significant) with onset Nov2021, outcome "recovered", described as "acute small fiber sensory neuropathy"; FALL (medically significant) with onset Jun2021, outcome "recovered", described as "lost ability to control legs for under a couple of minutes with fall to ground". The events "neuropathy", "brief leg paralysis episodes", "acute small fiber sensory neuropathy" and "lost ability to control legs for under a couple of minutes with fall to ground" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiovascular autonomic function test: unknown results; electromyogram: unknown results; magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral, monoplegia, small fibre neuropathy, fall including gabapentin.  Course of the event: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In Nov2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in Jun or Jul2021 with very minor burning in front of both thighs, symptoms seemed to peak in Sep2021 (with all of symptoms listed above). In Oct2021 symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, burning on front of both thighs. Started Gabapentin in Nov2021, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet and sometimes mild burning in legs and arms.  Follow up information has been requested
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monoplegia, Neuropathy peripheral, Paraesthesia, Small fibre neuropathy, X-ray
Clinical narrative: brief leg paralysis episodes; acute small fiber sensory neuropathy; lost ability to control legs for under a couple of minutes with fall to ground; neuropathy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EM9810) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT C; VIT D [COLECALCIFEROL]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2021, outcome "recovered", described as "neuropathy"; MONOPLEGIA (medically significant) with onset Nov2021, outcome "recovered", described as "brief leg paralysis episodes"; SMALL FIBRE NEUROPATHY (medically significant) with onset Nov2021, outcome "recovered", described as "acute small fiber sensory neuropathy"; FALL (medically significant) with onset Jun2021, outcome "recovered", described as "lost ability to control legs for under a couple of minutes with fall to ground". The events "neuropathy", "brief leg paralysis episodes", "acute small fiber sensory neuropathy" and "lost ability to control legs for under a couple of minutes with fall to ground" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiovascular autonomic function test: unknown results; electromyogram: unknown results; magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral, monoplegia, small fibre neuropathy, fall including gabapentin.  Course of the event: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In Nov2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in Jun or Jul2021 with very minor burning in front of both thighs, symptoms seemed to peak in Sep2021 (with all of symptoms listed above). In Oct2021 symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, burning on front of both thighs. Started Gabapentin in Nov2021, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet and sometimes mild burning in legs and arms.  Follow up information has been requested
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: brief leg paralysis episodes; acute small fiber sensory neuropathy; lost ability to control legs for under a couple of minutes with fall to ground; neuropathy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EM9810) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT C; VIT D [COLECALCIFEROL]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2021, outcome "recovered", described as "neuropathy"; MONOPLEGIA (medically significant) with onset Nov2021, outcome "recovered", described as "brief leg paralysis episodes"; SMALL FIBRE NEUROPATHY (medically significant) with onset Nov2021, outcome "recovered", described as "acute small fiber sensory neuropathy"; FALL (medically significant) with onset Jun2021, outcome "recovered", described as "lost ability to control legs for under a couple of minutes with fall to ground". The events "neuropathy", "brief leg paralysis episodes", "acute small fiber sensory neuropathy" and "lost ability to control legs for under a couple of minutes with fall to ground" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiovascular autonomic function test: unknown results; electromyogram: unknown results; magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral, monoplegia, small fibre neuropathy, fall including gabapentin.  Course of the event: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In Nov2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in Jun or Jul2021 with very minor burning in front of both thighs, symptoms seemed to peak in Sep2021 (with all of symptoms listed above). In Oct2021 symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, burning on front of both thighs. Started Gabapentin in Nov2021, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet and sometimes mild burning in legs and arms.  Follow up information has been requested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Oligomenorrhoea
Clinical narrative: Light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times.; Light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single and administered in arm left, administration date 22Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: Sulfa drugs" (unspecified if ongoing); "allergies: grapefruit" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: TOPIRAMATE; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Location of injection: Arm Right), for Covid-19 Immunization. The following information was reported: MENSTRUATION DELAYED (non-serious), OLIGOMENORRHOEA (non-serious), outcome "unknown" and all described as "Light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times.". The event "light and late menstrual period which is normally very regular. this also happened after the second vaccine and no other times." and "light and late menstrual period which is normally very regular. this also happened after the second vaccine and no other times." was evaluated at the physician office visit.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced light and late menstrual period which is normally very regular. This also happened after the second vaccine and no other times. Adverse events start date after 3rd dose was 28Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right (Batch/Lot number: unknown) as dose 2, single and administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "eating disorder" (unspecified if ongoing); "mental illnesses" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive. Facility type vaccine reported Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. No Covid tested post vaccination  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 events drug ineffective and vaccination failure  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.