chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Syncope, X-ray
Clinical narrative: fainted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2020 (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: SYNCOPE (medically significant) with onset 2020, outcome "unknown", described as "fainted".  Clinical Course: Patient got 1st dose of vaccination on Apr2020. After receiving the 1st dose patient fainted and primary care doctor told to contact to Pfizer before taking the 2nd shot. So patient wanted to know was this common phenomenon or it was a rare case. The 2nd dose was very important to the patient's job and for future travel so patient was seeking advise. The patient took the vaccine in the evening around 6PM and drank spinach juice in morning and ate 1/2 lb chicken breast in afternoon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Impaired quality of life
Clinical narrative: Severely altered and impacts my every day functioning; not had recovery of my smell/taste; not had recovery of my smell/taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, 2 step vaccination I had done in Jan/Feb of last year.), administration date: Jan2021, for COVID-19 immunization.  The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "not had recovery of my smell/taste"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "Severely altered and impacts my every day functioning".  Additional information: Forwarded as an Adverse Event by the team on 03Feb2022 Reporter provided verification of contact address on 03Feb2022. Subject: Patient Assistance "Customer Verbatim: Hello, I'm reaching out with concerns in response to the 2 step vaccination I had done in Jan/Feb of last year. Following the 2nd dose 18Feb I have not had recovery of my smell/taste which has been severely altered and impacts my every day functioning. I have been seen by my primary physician without resolution. This concern in on my medical records. Is there guidance, compensations, answers to help bring back my quality of life! I was hopeful time would help heal, it's not!".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Investigation
Clinical narrative: grand mal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 07Nov2021 (Lot number: FJ1611) at the age of 20 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Grand mal seizure", start date: 01Aug2021 (ongoing); "Grand mal seizure", start date: 14Jun2021 (ongoing), notes: (Name withheld) had her first seizure near 1month after dosage. She has continued to have then. Dates are from seizure related ER visit. She is still following up with neurologist'. Concomitant medication(s) included: LEVETIRACETAM taken for generalised tonic-clonic seizure, start date: Dec2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 2, Anatomical location: Arm, Route of administration: Intramuscular, Lot number: EW2167), administration date: 11May2021, when the patient was 19 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1, Anatomical location: Bicep, Route of administration: Intramuscular, Lot number: EW0170), administration date: 17Apr2021, when the patient was 19 years old, for COVID-19 immunization; Flu, administration date: 11Jul2021. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovering", described as "grand mal". The patient was hospitalized for generalised tonic-clonic seizure (start date: Dec2021). The event "grand mal" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: unknown result. Therapeutic measures were taken as a result of generalised tonic-clonic seizure. Clinical information: Pertinent details: (Name withheld) had her first seizure near 1month after dosage. She has continued to have then. Dates are from seizure related ER visit. She is still following up with neurologist. No family history of seizure or epilepsy. Relevant test: Variety during ER visit. Specific relevant test for thromboembolic events with thrombocytopenia: Unknown. The patient's mother is completing this as I am the one who pays (Name withheld) medical bills, have been responsible for transport now she cannot drive. (Name withheld) had her 1st seizure in 1 month after her vaccine. She has had light seizure plus several grand mal seizures in the last year. She is now on anti-seizures meds but not allowed to drive for 6 months after the most recent seizure, she has had to move her college classes to online only and stop working until she can drive.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria
Clinical narrative: I had a cerebral stroke; some times my speech gets a bit slurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Stroke" (unspecified if ongoing), notes: I had one 7 months ago. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 03Feb2022, outcome "unknown", described as "I had a cerebral stroke"; DYSARTHRIA (non-serious) with onset 03Feb2022, outcome "unknown", described as "some times my speech gets a bit slurred".  Clinical course: The patient Called to check on mothers enrollment status. During the call, it was stated that it was unclear if the patient had a stroke in June, it has nothing to do with vaccine. The patient had a cerebral stroke and some times speech got a bit slurred.The following information was not confirmed during the call, but retrieved from the system: Reporter phone No.,The following information was not provided during the call: Patient gender. On 7Feb2022, during the phone call, the patient confirmed that, the stroke was not related cause to the stroke that had been one 7 months ago. It was also stated that the patients date of birth was not provided on the phone call.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Pelvic pain, SARS-CoV-2 test
Clinical narrative: Severe pelvic pain; Inability to move legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 17:30 (Lot number: FD0809) at the age of 18 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing); "COVID-19" (not ongoing), notes: covid prior vaccination. Concomitant medication(s) included: ZOLOFT; WELLBUTRIN; PROPRANOLOL; AMANTADINE. Vaccination history included: Bnt162b2 (First dose received in the right arm, at 05:30 PM. Lot. FH8027), administration date: 10Dec2021, when the patient was 18 years old, for COVID-19 immunisation. The following information was reported: PELVIC PAIN (hospitalization, disability) with onset 12Jan2022 07:00, outcome "not recovered", described as "Severe pelvic pain"; PARALYSIS (hospitalization, disability) with onset 12Jan2022 07:00, outcome "not recovered", described as "Inability to move legs". The patient was hospitalized for pelvic pain, paralysis (hospitalization duration: 15 day(s)). The events "severe pelvic pain" and "inability to move legs" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Jan2022) negative. Therapeutic measures were taken as a result of pelvic pain, paralysis. Treatment: Gabapentin, magnesium, morphine, Toradol, Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood urine present, Fatigue, Nausea, Pyrexia
Clinical narrative: Blood in Urine; Acute Kidney Injury; Blurry vision; Fever; Fatigue; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 27Apr2021 (Lot number: Ew0171) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: Ew01s1), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: BLOOD URINE PRESENT (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Blood in Urine"; ACUTE KIDNEY INJURY (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Acute Kidney Injury"; VISION BLURRED (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Blurry vision"; PYREXIA (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Fever"; FATIGUE (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Fatigue"; NAUSEA (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Nausea". The events "blood in urine", "acute kidney injury", "blurry vision", "fever", "fatigue" and "nausea" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results; urine analysis: blood in urine. Therapeutic measures were taken as a result of blood urine present, acute kidney injury, vision blurred, pyrexia, fatigue, nausea.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urine analysis, Vision blurred
Clinical narrative: Blood in Urine; Acute Kidney Injury; Blurry vision; Fever; Fatigue; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 27Apr2021 (Lot number: Ew0171) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: Ew01s1), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: BLOOD URINE PRESENT (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Blood in Urine"; ACUTE KIDNEY INJURY (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Acute Kidney Injury"; VISION BLURRED (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Blurry vision"; PYREXIA (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Fever"; FATIGUE (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Fatigue"; NAUSEA (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Nausea". The events "blood in urine", "acute kidney injury", "blurry vision", "fever", "fatigue" and "nausea" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results; urine analysis: blood in urine. Therapeutic measures were taken as a result of blood urine present, acute kidney injury, vision blurred, pyrexia, fatigue, nausea.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had COVID I was tested positive for COVID and I have had all my vaccinations (COVID-19 Vaccine); I had COVID I was tested positive for COVID and I have had all my vaccinations (COVID-19 Vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Verbatim: Blood pressure high" (unspecified if ongoing); "Urinary tract infection" (unspecified if ongoing); "I had a mild heart attack", start date: Nov2020 (unspecified if ongoing), notes: I had a mild heart attack in Nov2020, and I think that's about it.". The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had COVID I was tested positive for COVID and I have had all my vaccinations (COVID-19 Vaccine)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: I had COVID I was tested positive for COVID (PC Filed Conservatively) and I have had all my vaccinations before that.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: was postmenopausal/ On 14Nov I started spotting blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 30145BA) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "perimenipause" (unspecified if ongoing), notes: for the past 5 years. periods every 3 weeks and very light. Mar2021 was last period. Concomitant medication(s) included: SYNTHROID. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 14Nov2021, outcome "not recovered", described as "was postmenopausal/ On 14Nov I started spotting blood". The event "was postmenopausal/ on 14nov i started spotting blood" was evaluated at the physician office visit. Patient went to the Gynecologist in Sep2021 for a checkup and all was well. She said patient was postmenopausal. Patient had her first shot on 29Oct. On 14Nov, she started spotting blood. It lasted 3 days and then the spotting happened again on 30Nov for 3 days. (Patient had the second shot on 26Nov). No covid prior vaccination and no Covid tested post vaccination. Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: started a period, it was heavy and lasted 6 days/period had been heavier and lasted longer than periods have in the last 7 years; spotting blood; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 (Lot number: FG3527) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "perimenopause" (ongoing), notes: periods every 3 weeks and very light, last period in Mar2021. No COVID prior vaccination, no COVID tested post vaccination. No known allergy. Concomitant medication included: SYNTHROID. Vaccination history included: BNT162B2 (dose 1, lot number: 30145BA, left arm), administration date: 29Oct2021, when the patient was 52 years old, for COVID-19 immunization, reaction: "spotting blood". No other vaccine in four weeks. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 30Nov2021, outcome "recovered" (03Dec2021), described as "spotting blood"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Dec2021, outcome "not recovered", described as "started a period, it was heavy and lasted 6 days/period had been heavier and lasted longer than periods have in the last 7 years". The patient reported that she had been in perimenopause for the past 5 years. Periods every 3 weeks and very light. Mar2021 was her last period. She went to the Gynecologist in Sep2021 for a check up and all was well. She said she was postmenopausal. She had her first shot on 29Oct2021. On 14Nov2021 started spotting blood. It lasted 3 days and then the spotting happened again on 30Nov2021 for 3 days (had the second shot on 26Nov2021). On 06Dec2021, after 9 months with no menstrual cycle, she started a period. It was heavy and lasted 6 days. She had not had a period like that for over 7 years. 27 days later on 04Jan2022, she had another one and 27 days later on 02Feb2022, she got another period. On all occasions, the period has been heavier and lasted longer than her periods have in the last 7 years. It is 04Feb2022 now and her bleeding continues to be heavy. She is 53 years old and this should not be happening. The events "spotting blood" and "started a period, it was heavy and lasted 6 days/period had been heavier and lasted longer than periods have in the last 7 years" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of postmenopausal haemorrhage, heavy menstrual bleeding.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Illness
Clinical narrative: Got so sick that the caller thought patient would die; Patient has a rare blood disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 2022 (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: ILLNESS (life threatening) with onset 2022, outcome "unknown", described as "Got so sick that the caller thought patient would die"; BLOOD DISORDER (life threatening) with onset 2022, outcome "unknown", described as "Patient has a rare blood disease". Consumer had a daughter who was the patient who just got the first shot of Pfizer Covid-19 Vaccine. The patient had a rare blood disease and got so sick that the consumer thought patient would die. Now the patient was scheduled to get the second dose of Pfizer Covid-19 Vaccine on 18Feb2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Expiry Date of COVID-19 Vaccine: Unknown), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The niece of reporter just had received the second dose yesterday from Pfizer and she has like a fever today. So, I think she had like a, at one point she had 103 temperature and now it came dropped to 102. Just wanted to know if it does, like does it concern and if we should take her to the hospital right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Drug ineffective, Feeling abnormal, Headache
Clinical narrative: positive for covid; positive for covid; felt like she got hit by a truck; neck aches; back aches; Night sweat; Headache; 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.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for covid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt like she got hit by a truck"; NECK PAIN (non-serious), outcome "unknown", described as "neck aches"; BACK PAIN (non-serious), outcome "unknown", described as "back aches"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweat"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: The patient had the Pfizer covid vaccine but has not had her booster dose yet. The patient was positive for covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Night sweats, SARS-CoV-2 test
Clinical narrative: positive for covid; positive for covid; felt like she got hit by a truck; neck aches; back aches; Night sweat; Headache; 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.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for covid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt like she got hit by a truck"; NECK PAIN (non-serious), outcome "unknown", described as "neck aches"; BACK PAIN (non-serious), outcome "unknown", described as "back aches"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweat"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: The patient had the Pfizer covid vaccine but has not had her booster dose yet. The patient was positive for covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: there has been a good side effect from your vaccine. I have not had a cold sore, (herpes simplex), since Mar2020; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "herpes simplex", stop date: Mar2020, notes: I have not had a cold sore, (herpes simplex), since Mar2020.; "Cold sore", stop date: Mar2020, notes: I have not had a cold sore, (herpes simplex), since Mar2020. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "there has been a good side effect from your vaccine. I have not had a cold sore, (herpes simplex), since Mar2020".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After one week of booster shot, I was lab tested positive for covid.; After one week of booster shot, I was lab tested positive for covid.; After one week of booster shot, I was lab tested positive for covid. Almost the same time, I was confirmed pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 19:00 (Lot number: 330258D) at the age of 31 years as dose 3 (booster), single, administered in arm left, administration date 18Apr2021 09:00 (Lot number: EW0162) as dose 2, single and administered in arm right, administration date 27Mar2021 11:00 (Lot number: ER8730) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "After one week of booster shot, I was lab tested positive for covid."; MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 27Dec2021, outcome "unknown", described as "After one week of booster shot, I was lab tested positive for covid. Almost the same time, I was confirmed pregnant". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab.  Clinical course: Patient stated, I received the booster vaccine at 27Dec2021, 2 days after I was conceived. After one week of booster shot, I was lab tested positive for covid. Almost the same time, I was confirmed pregnant. Until 29Jan21, I experienced the extreme pain in lower ab and bleeding. Later on, I was confirmed miscarriage by my provider. The patient had no known allergies. No other vaccine in four weeks. Patient took prenatal vitamin medications in two weeks. No covid prior vaccination. Post vaccination patient was COVID tested. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: he tested positive for covid after having the vaccine; he tested positive for covid after having the vaccine; Runny nose; Sore throat; 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. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "he tested positive for covid after having the vaccine"; RHINORRHOEA (non-serious) with onset 2022, outcome "unknown", described as "Runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (07Jan2022) positive, notes: On 07Jan2022 we tested positive for COVID-19 on a PCR test"; (12Jan2022) positive. Investigations: Then the caller tested again 5 days later, and on 12Jan2022 they were still positive. The caller has had the Pfizer covid vaccine. The caller got his booster on 11Dec2021. The caller tested positive for covid after having the vaccine. The caller had a runny nose and sore throat. don't have additional information on a second dose of the Pfizer-BioNTech COVID-19 vaccine for 5 through 11 years of age formulation (orange cap) being administered in an interval longer than 11 weeks". My symptoms were a runny dose sore throat after vaccination. My wife only has received her two doses of the Pfizer-BioNTech COVID-19 vaccine, after the second dose she experienced side effects like her body ached, night sweats got over her. On 07Jan2022 we tested positive for COVID-19 on a PCR test".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hodgkin's disease, Inappropriate schedule of product administration
Clinical narrative: received a diagnosis of Hodgkin's Lymphoma; My third dose of Comirnaty was in Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) at the age of 46 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: Covid-19 vaccine (1st dose of Covid vaccine, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (2nd dose of Covid vaccine, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HODGKIN'S DISEASE (medically significant) with onset 03Feb2022, outcome "unknown", described as "received a diagnosis of Hodgkin's Lymphoma"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Apr2021, outcome "unknown", described as "My third dose of Comirnaty was in Apr2021".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Diarrhoea, Headache, Migraine, SARS-CoV-2 test
Clinical narrative: Increased asthma exacerbation; Wheezing; Severe diarrhea; Headache still is not resolved since the vaccine; Migraine for 4 days; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) receivedBNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 29Jan2022 11:45 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hashimotos disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing); "known allergies: dander" (unspecified if ongoing). Concomitant medication(s) included: IPRATROPIUM BROMIDE; ALBUTEROL [SALBUTAMOL]; PREDNISONE; trazodone hydrochloride (TRAZADOL). Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: ASTHMA (medically significant), outcome "not recovered", described as "Increased asthma exacerbation"; WHEEZING (non-serious), outcome "not recovered", described as "Wheezing"; DIARRHOEA (non-serious), outcome "not recovered", described as "Severe diarrhea"; MIGRAINE (non-serious), outcome "recovered" (Feb2022), described as "Migraine for 4 days"; HEADACHE (non-serious) with onset 29Jan2022 11:45, outcome "not recovered", described as "Headache still is not resolved since the vaccine".  The patient underwent the following laboratory tests and procedures: Binax: (31Jan2022) negative, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of asthma, wheezing, diarrhoea, migraine, headache. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  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 the event asthma is most likely related to the underlying condition hence unrelated to the suspect drug.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Increased asthma exacerbation; Wheezing; Severe diarrhea; Headache still is not resolved since the vaccine; Migraine for 4 days; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) receivedBNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 29Jan2022 11:45 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hashimotos disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing); "known allergies: dander" (unspecified if ongoing). Concomitant medication(s) included: IPRATROPIUM BROMIDE; ALBUTEROL [SALBUTAMOL]; PREDNISONE; trazodone hydrochloride (TRAZADOL). Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: ASTHMA (medically significant), outcome "not recovered", described as "Increased asthma exacerbation"; WHEEZING (non-serious), outcome "not recovered", described as "Wheezing"; DIARRHOEA (non-serious), outcome "not recovered", described as "Severe diarrhea"; MIGRAINE (non-serious), outcome "recovered" (Feb2022), described as "Migraine for 4 days"; HEADACHE (non-serious) with onset 29Jan2022 11:45, outcome "not recovered", described as "Headache still is not resolved since the vaccine".  The patient underwent the following laboratory tests and procedures: Binax: (31Jan2022) negative, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of asthma, wheezing, diarrhoea, migraine, headache. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  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 the event asthma is most likely related to the underlying condition hence unrelated to the suspect drug.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: High blood pressure. In between 20-40 above normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Oct2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient had no known allergies. Vaccination history included: Bnt162b2 (Dose 1; arm right), administration date: 11Sep2021 12:00, when the patient was 33 years old, for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: HYPERTENSION (medically significant) with onset 01Jan2022 12:00, outcome "not recovered", described as "High blood pressure. In between 20-40 above normal.". The event "high blood pressure. in between 20-40 above normal." was evaluated at the physician office visit and emergency room visit. The patient never had any type of high blood pressure in his life. He had no changes in lifestyle whatsoever except the vaccine. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (01Jan2022) high, notes: between 20-40 above normal; sars-cov-2 test: (15Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of hypertension. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: And now her and her husband have COIVD; And now her and her husband have COIVD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "And now her and her husband have COIVD". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: She states she took the Pfizer COVID-19 vaccine last Apr and was fine after the first dose was okay but after the second dose had a bad reaction 2 days after with heart racing and her right eye had a blood burst. And now her and her husband have COIVD, was diagnosed around 08Jan2022 and their doctor prescribed Paxlovid around the 13th or 14th of Jan2022 and they took it for 5 days and she states she never had high blood pressure in her life and the last 4 days her blood pressure has been like 150 something then 160. It use to be 120/80.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "infection". Therapeutic measures were taken as a result of infection.  Additional Information: The reporter received her Pfizer covid vaccine booster and has a prescription for albendazole and azithromycin. She has been taking this because of an infection but two different types of infections. She was taking this prior to her booster dose but not prior to her primary series. She would like to know if taking azithromycin or albendazole would affect the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: miscarriage; booster vaccine at 27Dec2021, 2 days after I was conceived; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 19:00 (Lot number: 330258D) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 14Dec2021. The patient was 2 days pregnant at the time of exposure to bnt162b2. The patient was 2 weeks pregnant at the event onset. The patient was expected to deliver a baby(s) on 20Sep2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 18Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 27Mar2021, when the patient was 31 years old, for COVID-19 Immunization. The patient had not received any other vaccines in 4 weeks and was not diagnosed with COVID prior to vaccination and had no known allergies. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 27Dec2021, outcome "recovering", described as "booster vaccine at 27Dec2021, 2 days after I was conceived"; ABORTION SPONTANEOUS (medically significant) with onset 29Jan2022 12:30, outcome "recovering", described as "miscarriage". The event "miscarriage" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of abortion spontaneous. The patient reported she received the booster vaccine at 27Dec2021, "2 days after I was conceived." After one week of booster shot, she was lab tested positive for COVID; almost the same time, she was confirmed pregnant. Until 29Jan2021, she experienced the extreme pain in lower "ab" and bleeding. Later on, she was confirmed miscarriage by her provider. The events did not require hospitalization.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed covid the day I was suppose to get second dose 23Aug2021; Diagnosed covid the day I was suppose to get second dose 23Aug2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single and administration date 01Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing); "PAH" (unspecified if ongoing); "DM2" (unspecified if ongoing); "CKD stage 3" (unspecified if ongoing); "non - smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Aug2021, outcome "unknown" and all described as "Diagnosed covid the day I was suppose to get second dose 23Aug2021". The patient underwent the following laboratory tests and procedures: antibody test: (unspecified date) got monoclonial antibiodies; sars-cov-2 test: (23Aug2021) diagnosed covid; (03Feb2022) diagnosed covid. Therapeutic measures were taken as a result of covid-19.  Clinical course: She got her first dose in Jun2021. Diagnosed covid the day she was suppose to get second dose 23Aug2021. Got monoclonial antibiodies. Received 2nd dose 01Dec2021. Diagnosed covid again 03Feb2022. Had CHF, PAH, DM2, CKD stage 3. 62 year old non - smoker, female. Maybe info could help with studies. Could not get booster until Jun2022. She was a retired nurse and keep a mask on in, public and wash her hands, most of the time she wear gloves. Follow safety protocols.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events  "Drug ineffective" and "Covid-19" and the administration of the vaccine cannot be excluded
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Oct2021 (Lot number: FF3389) at the age of 32 years as dose 3 (booster), single, administration date 08Feb2021 (Lot number: EL3247) as dose 2, single and administration date 20Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunization at workplace clinic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "recovered" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient took no other vaccine in four weeks. No covid prior vaccination  Follow-up attempts are completed. No further information is expected.