chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest (heart) pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2022 12:15 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and administered in arm right, administration date 01Feb2022 15:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 01Feb2022 18:00, outcome "not recovered", described as "Chest (heart) pains". Therapeutic measures were taken as a result of chest pain. The lot number for bnt162b2 was not provided and will be requested during follow up.  Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Endotracheal intubation
Clinical narrative: Name withheld Tell that to my patients who were fully vaccinated and ended up intubated.; This case has been considered invalid as Unidentifiable reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Seizure
Clinical narrative: Seizure; I am scared now, if I have the side effect, it was bad and I don''t know, if I need to get more shot if you say, more difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: FL3197) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TROVAC. Vaccination history included: Bnt162b2 (DOSE: 1, Anatomical location: Left arm), for covid-19 immunization; Bnt162b2 (DOSE: 2, Anatomical location: Left arm), for Covid-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizure"; FEAR (non-serious), outcome "unknown", described as "I am scared now, if I have the side effect, it was bad and I don''t know, if I need to get more shot if you say, more difficult". Clinical course: The patient did not receive any other vaccines within 3 weeks prior to the COVID vaccine. The patient had no family history for event related to the Covid-19 Vaccination. The patient had no medical problems. Consumer stated, "Yes I was taking one medication, I had only one medication "Trovac". Consumer stated, "I probably should have gone to the Hospital but I didn't go because I didn't know at that time what was the problem."  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted covid-19 after her booster shot.; contracted covid-19 after her booster shot.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid-19 after her booster shot.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: contracted covid-19. Patient had no covid prior vaccination and she tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: contracted covid from his significant other post vaccination.; contracted covid from his significant other post vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male 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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid from his significant other post vaccination.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: contracted covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blindness, Cerebrovascular accident, Confusional state, Headache
Clinical narrative: Stroke; Vision loss; Blurry vision; Nausea; Vomiting; Headaches; Confusion; Memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 (Lot number: E1614) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: medical history: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR; BUSPIRONE; ZOLOFT; LISINOPRIL/HCTZ. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, Medically Significant) with onset 15Jan2022, outcome "not recovered", described as "Stroke"; BLINDNESS (hospitalization, disability, Medically Significant) with onset 15Jan2022, outcome "not recovered", described as "Vision loss"; VISION BLURRED (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Blurry vision"; NAUSEA (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Nausea"; VOMITING (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Vomiting"; HEADACHE (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Headaches"; CONFUSIONAL STATE (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Confusion"; AMNESIA (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Memory loss". The patient was hospitalized for cerebrovascular accident, blindness, vision blurred, nausea, vomiting, headache, confusional state, amnesia (hospitalization duration: 5 day(s)). The events "stroke", "vision loss", "blurry vision", "nausea", "vomiting", "headaches", "confusion" and "memory loss" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of cerebrovascular accident, blindness, vision blurred, nausea, vomiting, headache, confusional state, amnesia.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vision blurred, Vomiting
Clinical narrative: Stroke; Vision loss; Blurry vision; Nausea; Vomiting; Headaches; Confusion; Memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 (Lot number: E1614) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: medical history: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR; BUSPIRONE; ZOLOFT; LISINOPRIL/HCTZ. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, Medically Significant) with onset 15Jan2022, outcome "not recovered", described as "Stroke"; BLINDNESS (hospitalization, disability, Medically Significant) with onset 15Jan2022, outcome "not recovered", described as "Vision loss"; VISION BLURRED (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Blurry vision"; NAUSEA (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Nausea"; VOMITING (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Vomiting"; HEADACHE (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Headaches"; CONFUSIONAL STATE (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Confusion"; AMNESIA (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Memory loss". The patient was hospitalized for cerebrovascular accident, blindness, vision blurred, nausea, vomiting, headache, confusional state, amnesia (hospitalization duration: 5 day(s)). The events "stroke", "vision loss", "blurry vision", "nausea", "vomiting", "headaches", "confusion" and "memory loss" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of cerebrovascular accident, blindness, vision blurred, nausea, vomiting, headache, confusional state, amnesia.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Delta breakthrough infection; Delta breakthrough infection; 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 72 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Undifferentiated connective tissue disease tending", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility; "Toured for me Frusta CREST syndrome", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility; "Raynaud's and abnormal esophageal motility", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility; "Mild persistent symptoms including Raynaud's and abnormal esophageal motility", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); ATIVAN taken for sleep disorder (ongoing); TEMAZEPAM taken for sleep disorder (ongoing). The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Jul2021, outcome "recovered" (2021) and all described as "Delta breakthrough infection".  Clinical information:The patient had a Delta breakthrough infection on 28Jul2021. Had mild flu-ish symptoms lasting about 8 days. The patient did not need a doctor hospitalization and seemed to recover without sequelae.Illness/AE: Undifferentiated connective tissue disease tending towards for the patient frusta CREST syndrome Onset Date: Approx. Mar2017. Stop Date (check box if ongoing): Ongoing. Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, Product dose omission issue
Clinical narrative: Got Covid-19 seven months after their first and only dose of Comirnaty; Got Covid-19 seven months after their first and only dose of Comirnaty; Got Covid-19 seven months after their first and only dose of Comirnaty; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191).  A female patient received bnt162b2 (COMIRNATY) (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), PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown" and all described as "Got Covid-19 seven months after their first and only dose of Comirnaty". The patient underwent the following laboratory tests and procedures: antibody test: still had antibodies.  Clinical course: Caller states the family member ended up getting an antibody test 6 months after and it showed she still had antibodies. Caller states her family member subsequently got Covid-19 seven months after their first and only dose of Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Rash
Clinical narrative: 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), administered in arm right (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "neuropathy"; RASH (non-serious), outcome "recovered", described as "rash"; PAIN (non-serious), outcome "unknown", described as "great deal of pain while working". Therapeutic measures were taken as a result of rash. Clinical Course: Reporter mentioned that experiencing what I believe are negative side effects following my COVID-19 vaccine booster. I had a rash and neuropathy one day after the vaccination that appears to be following the ulnar nerve on the right side of my arm where I had the shot. The rash was resolved with prescription steroid cream, but the neuropathy remains. This is causing me a great deal of pain while working. This in addition to the more common side effects that I also had. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was a breakthrough case since I'd had two Moderna shots and a booster.; I was a breakthrough case since I'd had two Moderna shots and a booster.; 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 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I was a breakthrough case since I'd had two Moderna shots and a booster." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose 1), for COVID-19 immunization; Moderna vaccine (Dose 2), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was a breakthrough case since I'd had two Moderna shots and a booster.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Feb2022) positive; (23Feb2022) positive; (25Feb2022) negative, notes: I had a negative rapid test; (25Feb2022) negative, notes: a negative PCR test. Therapeutic measures were taken as a result of covid-19. doctor prescribed Paxlovid, and within twelve hours of the first dose, I felt 100% better. I tested positive both Sunday night, 20Feb2022, and Wednesday morning, 23Feb2022 By Friday, 25Feb2022, I had a negative rapid test and a negative PCR test. I am convinced it was the efficacy of your drug that shortened the duration and lessened my symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: Occupational exposure; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 2 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Feb2022 13:58 (Lot number: P221455-0013L, Expiration Date: 30Jun2022) at the age of 2 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2;placebo (Regimen dose number: Dose 1, Lot number: P221455-0007L, Expire date: 01Aug2022, Route: IM, Anatomical location: Left Thigh, Time of vaccination: 13:28), administration date: 23Jul2021, when the patient was 1 years old, for COVID-19 immunization; Bnt162b2;placebo (Regimen dose number: Dose 2, Lot number: P221455-0007L, Expire date: 01Aug2022, Route: IM, Anatomical location: Left Thigh, Time of vaccination: 13:25), administration date: 16Aug2021, when the patient was 1 years old, for COVID-19 immunization; Bnt162b2 (Regimen dose number: Dose 3, Lot number: P221455-0011L, Expire date: 30Jun2022, Route: IM, Anatomical location: Left Deltoid, Time of vaccination: 13:57), administration date: 07Feb2022, when the patient was 2 years old, for COVID-19 immunization.The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (medically significant) with onset 28Feb2022 12:40, outcome "recovered" (28Feb2022), described as "Occupational exposure".  Clinical course:RN injected patient with 3 mcg close of BNT162B2 (Dose 4), After being injected with needle, patient pulled away causing needle to dislodge from deltoid muscle. As Child pulled Away. RN injected mediation, however, none went into muscle because needle was already removed. Two drops of vaccine ended up on patient arm and one drop on caregiver shirt. It Was determined from amount hand on patients arm no valine was injected into muscle. Patient dosed again. PI discussed with medical monitor and She advised to submit vaccination SAE. Patient monitored and assessed for 30 minutes post vaccination and assessment WNL.Event did not required visit to emergency room and physicians office.   Additional Information:No prior vaccination was done. No AE for prior vaccination within 4 weeks. Query:Event: as child pulled away, RN injected medication, however, none went into muscle because needle was already removed Response: 1.The SAE is already documented. 2.The narrative should read:It was determined from the amount of liquid on patient's arm, no vaccine was injected into muscle.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event OCCUPATIONAL EXPOSURE TO PRODUCT and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Blood insulin decreased, Therapeutic response unexpected
Clinical narrative: My son has diabetes type one and when he received the COVID vaccine for a period of time his need for insulin decreased significantly; My son has diabetes type one and when he received the COVID vaccine for a period of time his need for insulin decreased significantly; 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 parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "My son has diabetes type one" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD INSULIN DECREASED (medically significant), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "My son has diabetes type one and when he received the COVID vaccine for a period of time his need for insulin decreased significantly". Clinical information included Patient had diabetes type one and received the COVID vaccine for a period of time and the need for insulin decreased significantly. reporter wondering if there was a way to contact the research department with this information. reporter believed the same biotechnology  used in the COVID vaccine could be applied to this type of diabetes. Blocking the virus that attacks the islets of Langerhans in the pancreas. reporter was describing it as a virus for lack of better choice of words.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat tightness
Clinical narrative: I felt my throat begin to close; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 14:00 (Lot number: EW0158) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "complete hysterectomy" (unspecified if ongoing); "orthoscopic knee surgery" (unspecified if ongoing); "bunionectomy" (unspecified if ongoing); "rotator cuff surgery" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; CALCIUM. The following information was reported: THROAT TIGHTNESS (disability) with onset 15Apr2021 17:00, outcome "not recovered", described as "I felt my throat begin to close". The event "i felt my throat begin to close" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of throat tightness.  Clinical information: Patient did not receive other vaccine in four weeks of vaccination. Patient receive Simvastatin, Multivitamin, Calcium other medications in two weeks of vaccination. Patient was diagnosed with COVID, prior vaccination. Patient had been tested for COVID, post vaccination. No Known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I had the two Pfizer and the booster of Pfizer so, cause I had covid last year; I had the two Pfizer and the booster of Pfizer so, cause I had covid last year; 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 63 year-old patient 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) all with onset 2021, outcome "unknown" and all described as "I had the two Pfizer and the booster of Pfizer so, cause I had covid last year". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343007 Same reporter/vaccine/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had all three vaccines/ she got covid, that was after having fully vaccinated; had all three vaccines/ she got covid, that was after having fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient 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) all with onset 25Feb2022, outcome "unknown" and all described as "had all three vaccines/ she got covid, that was after having fully vaccinated".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200342998 Sam e reporter/vaccine/event, differnet patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This Feb I tested positive for Covid; This Feb I tested positive for Covid; 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 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2022, outcome "unknown" and all described as "This Feb I tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Rectal haemorrhage
Clinical narrative: rectal bleeding; pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RECTAL HAEMORRHAGE (medically significant), outcome "unknown", described as "rectal bleeding"; PAIN (non-serious), outcome "unknown", described as "pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Clinical course: The reporter stated that three people complained of rectal bleeding, pain, and nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343093 same reporter/drug/events, different patients;US-PFIZER INC-202200343092 same reporter/drug/events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported same events under same suspect product for 3 patients. This is 3 of 3 reports.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RECTAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Rectal bleeding"; PAIN (non-serious), outcome "unknown", described as "Pain"; NAUSEA (non-serious), outcome "unknown", described as "Nausea". Clinical course: Reporter mentioned she (reporter) had several friends who had 3 doses of Pfizer COVID-19 vaccine and had severe reactions and also had COVID after being vaccinated. Reporter knew a few people who had reports of palpitations after Pfizer COVID-19 vaccine, and that a couple people complained about having the effects of tinnitus. Reporter told 3 people who had complaints similar to her of rectal bleeding, pain, and nausea. Reporter told she knew one person whose eyesight was blurry and they had been to several doctors who cannot figure out why this persons eyesight was blurry. Reporter confirmed above details during the call, but did not provide any further details about the other people she spoke to. Caller reports that she knows of other people who have had side effects with the Pfizer Covid-19 vaccine (no age or gender information provided)-several friends who have had 3 doses of the Pfizer Covid-19 vaccine and have had severe reactions and were diagnosed with Covid-19 afterwards, a few people who have complaints of palpitations, a couple people who have complaints of tinnitus, 3 people who have complaints similar to her of rectal bleeding, pain, and nausea, and one person with complaints of blurry vision and that persons HCP cannot figure it out.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343091 same reporter/drug/events, different patients;US-PFIZER INC-202200343093 same reporter/drug/events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Rectal haemorrhage
Clinical narrative: rectal bleeding; pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RECTAL HAEMORRHAGE (medically significant), outcome "unknown", described as "rectal bleeding"; PAIN (non-serious), outcome "unknown", described as "pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Clinical summary: The reporter stated that three people complained of rectal bleeding, pain, and nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343091 same reporter/drug/events, different patients;US-PFIZER INC-202200343092 same reporter/drug/events, different patients
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID PCR: 02Dec2021 positive; COVID PCR: 02Dec2021 positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 08Jan2021 (Lot number: EL3246) at the age of 39 years as dose 2, single and intramuscular, administered in deltoid left, administration date 18Dec2020 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 01Mar2013 (ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism, start date: 2013 (ongoing); ORTHO TRI-CYCLEN LO taken for contraception, start date: 2017 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Dec2021, outcome "unknown" and all described as "COVID PCR: 02Dec2021 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Dec2021) positive. There was no family medical history relevant to adverse event. On 28Jan2022 at 21:00, the patient experienced non-stop coughing and on 29Jan2022 patient experienced violent vomiting at 09:00, diarrhoea at 10:00, fever-103, chills at 12:30. Patient was recovered from non-stop coughing, violent vomiting, diarrhoea and fever-103, chills. Patient required to visit physician office for non-stop coughing, violent vomiting, diarrhoea and fever-103, chills. Treatment was not received for non-stop coughing, violent vomiting, diarrhoea and fever-103, chills. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods of Lot EK5730 and EL3246. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch were within specifications. The patient received third dose on 28Jan2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Limb discomfort, Pain, Pulmonary function test, Respiratory disorder
Clinical narrative: flu like symptoms for approximately 3-5 days; breathing issues; pain; foot issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for hypersensitivity (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Extreme flu like symptoms". The following information was reported: RESPIRATORY DISORDER (disability) with onset Apr2021, outcome "not recovered", described as "breathing issues"; PAIN (disability) with onset Apr2021, outcome "recovered", described as "pain"; LIMB DISCOMFORT (disability) with onset Apr2021, outcome "recovered", described as "foot issue"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms for approximately 3-5 days". The patient underwent the following laboratory tests and procedures: pulmonary function test: (Apr2021) 3.6 L, notes: Test to get beselly. Specific Relevant Test for thromboembolic events with thrombocytopenia was reported as none. It was unknown if therapeutic measures were taken as a result of respiratory disorder. Therapeutic measures were not taken as a result of pain, limb discomfort.  After each shot extreme flu like symptoms for approximately 3-5 days. Patient had stomach issues with pain, constipation and nausea. Testing does not showed any causes. Paralyzed lower right diaphragm breathing test from 3.3 litres LFT (Apr2021) to 2.6 litres LFT (Dec2021) phrenic nerve not worked per EMG testing. Continuous testing at (withheld) for causes and corrective action. No previous similar problems prior to vaccinations. Patient took many other vaccinations over the life with no issues.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR positive; PCR positive / COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27-year-old female patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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) with onset 25Feb2022, outcome "unknown", described as "PCR positive"; COVID-19 (medically significant) with onset 25Feb2022, outcome "unknown", described as "PCR positive / COVID positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Feb2022) positive, notes: Nasal Swab. Reporter mentioned that Seriousness criteria not Resulted in death, Life threatening, prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Events reported as, Known COVID positive event 17Feb and then out to eat w/e of 19-20Feb so could have been there but PCR positive 25Feb with sx of cough ST and runny nose. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It is Unknown if Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, 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 current available limited information in the case provided, the causal association between the events drug ineffective,COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Mononeuropathy multiplex, Neuropathy peripheral, Paralysis, Vasculitis
Clinical narrative: Autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy; Autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy; Autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy; Autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy; 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 30Apr2021 (Lot number: ER8733) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Autoimmune in remission" (unspecified if ongoing), notes: Autoimmune in remission. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline. Vaccination history included: Bnt162b2 (Lot number: EW0164, Anatomical location: Left arm, Dose Number: 1), administration date: 09Apr2021, when the patient was 52 years old, for COVID-19 Immunization.  The following information was reported: NEUROPATHY PERIPHERAL (hospitalization, disability, medically significant), PARALYSIS (hospitalization, disability, medically significant), VASCULITIS (hospitalization, disability), MONONEUROPATHY MULTIPLEX (hospitalization, disability) all with onset 13Jun2021, outcome "unknown" and all described as "Autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy". The patient was hospitalized for neuropathy peripheral, paralysis, vasculitis, mononeuropathy multiplex (hospitalization duration: 12 day(s)). The event "autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy", "autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy", "autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy" and "autoimmune attack vasculitis resulting in mononeuristis polymutiplex, paralysis and neuropathy" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken included Ivig, Cytoxan, truxima, IV Lasik as a result of neuropathy peripheral, paralysis, vasculitis, mononeuropathy multiplex.  Clinical information: Adverse event reported as Autoimmune attack vasculitis resulting in mononeuritis polymutiplex, paralysis and neuropathy. The patient had not received other vaccine in four weeks. Patient did not had COVID prior to vaccination. Patient was not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Polymerase chain reaction
Clinical narrative: Appendicitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 12:00 (Lot number: EW0151) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CIPRO allergy" (unspecified if ongoing); "Flagyl allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number: EP6955, administration time:12:00 pm, vaccine location: Left arm), administration date: 19Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 19Jan2022, outcome "recovered", described as "Appendicitis". The patient was hospitalized for appendicitis (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (17Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of appendicitis. Clinical course: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Appendicitis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Crohn's disease aggravated; Vaccination site pain; Vaccination site rash; caused sore arm at injection site; fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4287516-00.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single and intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated"; VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "Vaccination site pain"; VACCINATION SITE RASH (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "Vaccination site rash"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "caused sore arm at injection site". The action taken for adalimumab was unknown.  Causality for the  Drug : Pfizer BioNTech covid-19  vaccine(tozinameran)(tozinameran),unknown for the events Crohn's disease aggravated, vaccination site rash,  vaccination site pain, fever was reported as probable and not reported for the event caused sore arm at injection site.  Causality for the Drug : HUMIRA(Solution for injection in pre-filled  pen)(ADALIMUMAB), ,unknown for the events Crohn's disease aggravated, vaccination site rash,  vaccination site pain, fever was reported as no reasonable possibility and not reported for the event caused sore arm at injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate