chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion missed, Appendicitis, Colitis, Lymphoedema, SARS-CoV-2 test
Clinical narrative: Missed miscarriage; appendicitis; colitis; unilateral lymphedema of entire left leg (unable to walk/pain); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: El3247) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Latex and rubber sensitivity" (unspecified if ongoing); "known allergies: nickel" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Date of last menstrual period: 12Dec2020. The patient was 6 weeks pregnant at the time of exposure to bnt162b2. The patient was 8 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 08Sep2021. The patient took concomitant medications (prenatal vitamins). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ej1685, Location of injection: Arm Left), administration date: 24Dec2020, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: ABORTION MISSED (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "Missed miscarriage"; APPENDICITIS (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "appendicitis"; COLITIS (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "colitis"; LYMPHOEDEMA (hospitalization) with onset 10Feb2021 12:00, outcome "recovered" (2021), described as "unilateral lymphedema of entire left leg (unable to walk/pain)". The patient was hospitalized for abortion missed, appendicitis, colitis, lymphoedema (hospitalization duration: 2 day(s)). The events "missed miscarriage", "appendicitis", "colitis" and "unilateral lymphedema of entire left leg (unable to walk/pain)" were evaluated at the physician office visit and emergency room visit. The patient reported missed miscarriage, which then led to colitis and appendicitis with need for appendix removal, then some type of unilateral lymphedema of entire left leg (unable to walk/pain) ruled out DVT/infection of leg, no fracture or break. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Feb2021) negative. Therapeutic measures were taken as a result of abortion missed, appendicitis, colitis, lymphoedema and included IV Antibiotics, IV fluids, appendectomy.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever/ fever persisted for 14 days now; Muscle pain; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 15:00 (Lot number: FL3209) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left), administration date: 28Dec2020, when the patient was 45 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of injection: Arm Left), administration date: 14Jan2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 09Jan2022 06:00, outcome "not recovered", described as "Fever/ fever persisted for 14 days now"; MYALGIA (non-serious) with onset 09Jan2022 06:00, outcome "recovered", described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 09Jan2022 06:00, outcome "recovered", described as "Joint pain". The events "fever/ fever persisted for 14 days now", "muscle pain" and "joint pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative, notes: Nasal swab. Therapeutic measures were taken as a result of pyrexia, myalgia, arthralgia.; Sender's Comments: The event of Pyrexia is assessed as possibly related to the suspect drug bnt162b2 based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she managed to get Covid even after being vaccinated; she managed to get Covid even after being vaccinated; 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 female patient received bnt162b2 (BNT162B2) (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 (Manufacturer unknown, Dose number unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she managed to get Covid even after being vaccinated". Clinical course: Withheld called in asking where to get a prescription Paxlovid or a list of doctors who's prescribing it. She also mentioned that she, her husband and son have all been vaccinated and boosted and that her husband has cancer and heart disease and her son has an autoimmune disease. She also said she managed to get Covid even after being vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Neoplasm malignant
Clinical narrative: cancer; heart disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (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 (Dose number: unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart disease". Clinical course: Withheld called in asking where to get a prescription Paxlovid or a list of doctors who's prescribing it. She also mentioned that she, her husband and son have all been vaccinated and boosted and that her husband has cancer and heart disease and her son has an autoimmune disease. She also said she managed to get Covid even after being vaccinated. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease; 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 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: unknown, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease". Clinical course: Withheld called in asking where to get a prescription Paxlovid or a list of doctors who's prescribing it. She also mentioned that she, her husband and son have all been vaccinated and boosted and that her husband has cancer and heart disease and her son has an autoimmune disease. She also said she managed to get Covid even after being vaccinated.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Myocarditis
Clinical narrative: Heart pain/ inflammation; Heart pain/ inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Sep2021 (unspecified if ongoing); "heart pain" (unspecified if ongoing); "heart pain diagnosed as inflammation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), MYOCARDITIS (medically significant) all with onset 18Jan2022, outcome "recovering" and all described as "Heart pain/ inflammation". Therapeutic measures were not taken as a result of angina pectoris, myocarditis. It was reported the patient had contracted COVID in Sep2021 and experienced heart pain that was diagnosed as inflammation caused by the virus. The person had not experienced this side effect with the first two doses. The third dose triggered heart pain/inflammation. No hospitalization was required. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Experienced break through case of covid even after being fully vaccinated with 2 primary doses; Experienced break through case of covid even after being fully vaccinated with 2 primary doses; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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), outcome "unknown" and all described as "Experienced break through case of covid even after being fully vaccinated with 2 primary doses". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event Experienced break through case of covid even after being fully vaccinated cannot be excluded based on temporal association and available information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid-19 infection; Breakthrough Covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Nov2021 (Lot number: EW0217) at the age of 37 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm right, administration date 28Jan2021 (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. No other vaccine in four weeks. No covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "recovered" (Jan2022) and all described as "Breakthrough Covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive, notes: Nasal Swab (covid tested post vaccination reported as Yes). Therapeutic measures were not taken as a result of vaccination failure, covid-19.; 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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for covid; tested positive for covid late on the day 22Jan2022 /symptoms nasal congestion, low grade fever and coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (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 (MANUFACTURER: UNKNOWN, DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Jan2022, outcome "unknown", described as "She tested positive for covid"; COVID-19 (medically significant) with onset 22Jan2022, outcome "unknown", described as "tested positive for covid late on the day 22Jan2022 /symptoms nasal congestion, low grade fever and coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Jan2022) positive, notes: She tested positive for covid.Patient had no underlying health issues. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Psoriasis
Clinical narrative: psoriasis got significantly worse; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 06May2021 (Lot number: EW0168) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Psoriasis" (unspecified if ongoing), notes: Verbatim: Psoriasis; "arthritic problems from psoriasis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL [LISINOPRIL DIHYDRATE]; ASPIRIN (E.C.); METFORMIN [METFORMIN HYDROCHLORIDE]; ATORVASTATIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot ER8737), administration date: 08Apr2021, when the patient was 81 years old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "psoriasis got significantly worse". The event "psoriasis got significantly worse" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of psoriasis.  Additional information: The patient reported that she had psoriasis her whole life, she was diagnosed at 6 or 7 years old. The patient had some arthritis in relation to her psoriasis. The patient was unsure if this was a serious or not. The patient reported that she took two injections of the COVID-19 vaccine and shortly after this, her psoriasis became significantly worse. The patient reported that psoriasis was under pretty good control until this. The patient's psoriasis was breaking out on her hands and it had not done this before. The patient's psoriasis worsening was significant enough she had to go urgent care and was given Prednisone which helped. The patient did not want to take the steroid because she was a diabetic and the cortisone did not help her blood sugar. The caller's psoriasis was under pretty good control until this. The caller knows another person with psoriasis and they had the same thing that happened to them. The caller is unsure of the serious criteria as it wasn't life threatening or anything. The patient reported that it was more of an irritation and it itches. The patient was asking if Pfizer had any evidence of psoriasis worsening after getting the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: breakthrough case; breakthrough case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 36 years 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "breakthrough case". Patient reported that, he had a breakthrough case in fall 2021. He stated that his only symptom was a lack of smell and that he got tested after being unable to smell his baby's diaper, No additional information reported at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported her husband is now sick with COVID 19; her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported his husband is now sick with COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 18Jan2021 (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: VACCINATION FAILURE (medically significant), outcome "unknown", described as "her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported her husband is now sick with COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported his husband is now sick with COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The reporter mentioned that she and her husband were both vaccinated on different dates. It was reported that her husband had got Covid-19 positive now and the she was suspected to have Covid-19.  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: developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (age reported as 50 with no units provided) received bnt162b2 (COMIRNATY) (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: "covid prior to vaccination " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter provided the following information: Family of 5 who were all vaccinated with Comirnaty ranging in ages of 50 (received primary series and booster) with other family members receiving primary series (ages 50, 20, 17, 13) all developed mild to moderate COVID. No family member was hospitalized.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200203970 Same reporter, Different patient;US-PFIZER INC-202200204041 Same reporter, Different patient;US-PFIZER INC-202200204042 Same reporter, Different patient;US-PFIZER INC-202200204043 Same reporter, Different patient
Sex: U
Vaccine: COVID19
Symptoms: Chondrocalcinosis pyrophosphate, Oral discomfort
Clinical narrative: had an attack of pseudo-gout that was severe; I had a sensation like my mouth was burned for about three weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization; Bnt162b2 (Dose number: 2), for COVID-19 immunization. The following information was reported: ORAL DISCOMFORT (non-serious), outcome "recovered", described as "I had a sensation like my mouth was burned for about three weeks"; CHONDROCALCINOSIS PYROPHOSPHATE (non-serious), outcome "recovered", described as "had an attack of pseudo-gout that was severe".  Additional information: After third COVID vaccine booster and had some unusual things happen after the injection. A few days later, patient had a sensation like my mouth was burned for about three weeks and had an attack of pseudo-gout that was severe. Patient have never had problems with either of these conditions in the past and the correlation with the injection was interesting to me.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Suspected COVID-19; My husband and I both got the vaccinations and we still got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570; 159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Suspected COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "My husband and I both got the vaccinations and we still got Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: She breast feeds; Tested positive for Covid19; Tested positive for Covid19; She breast feeds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A 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: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "She breast feeds"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter and his wife tested positive for Covid19 just a few days ago and the reporter had two daughters. Eldest 9-year-old had first dose while our youngest 1-year-old daughter doesn't have any. However, she breast feed and has had two doses of Pfizer vaccine. There was youngest also got sick but got better into two days. The reporter believed she developed some natural immunity through breastfeeding. This could a breakthrough for 4 and under Pfizer vaccines.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200132906 baby case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer-sponsored program. The reporter is the parent.  A 24-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, and administration date 13 May 2021 (Lot number: EW0185) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male 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. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "Heart inflammation". The patient's wife called on behalf of the patient to see if Pfizer was offering any reimbursement to cover hospital expenses due to adverse reactions from the Pfizer-BioNTech COVID-19 Vaccine. During the call caller stated that her husband had the Pfizer vaccinations both of them and he had heart inflammation.    Additional Information: Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got COVID/Nasal Swab:Positive; Got COVID/Nasal Swab:Positive; 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 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 18:00 (Lot number: FH8027) at the age of 35 years 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 21Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 21Jan2022, outcome "recovering" and all described as "Got COVID/Nasal Swab:Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Additional information: The patient was not Covid prior to vaccination and tested after the post vaccination. The patient was not taken other vaccine with in four weeks and no other medication was taken in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase increased, Hepatic enzyme abnormal, Hypersensitivity, Illness, Lower limb fracture
Clinical narrative: sicked than a dog, it got worse each day; Liver enzyme over 100- diagnosed with Elevated alkaline phosphatase level; broke my knee; allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENTOCORT EC, start date: 19Feb2021, stop date: 19Feb2021; COREG; ELIQUIS; LIPITOR; NITROSTAT; VITAMIN B-12; LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE]; FOLVITE [FOLIC ACID]; MAGNESIUM POSITIVE.   The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "sicked than a dog, it got worse each day"; BLOOD ALKALINE PHOSPHATASE INCREASED (hospitalization), outcome "unknown", described as "Liver enzyme over 100- diagnosed with Elevated alkaline phosphatase level"; LOWER LIMB FRACTURE (medically significant), outcome "unknown", described as "broke my knee"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". The patient underwent the following laboratory tests and procedures: hepatic enzyme abnormal: over 1000.  Clinical course: Patient was discharged with diagnosis with elevated alkaline phosphatase level. Medication Prescribed as Loperamide (Imodium) 4 times daily as needed for diarrhea (100 doses remaining),Tylenol (acetaminophen 325 MG tablet) 2 tablets by mouth every 4 hours as needed for Pain Maximum allowable Acetaminophen amount = 4 Grams (4000 mg) / 24 hours, ZOFRAN (ondansetron 4 MG tablet) 4 mg by mouth every 8 hours as needed. Ventolin HFA 108 (90 Base) MCG/ACT inhaler (albuterol HFA) Inhale 2 puffs by mouth every 6 hours as needed  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was at a wedding an a guest mentioned that she had a positive COVID test in late December. She did not have the booster shot; I was at a wedding an a guest mentioned that she had a positive COVID test in late December. She did not have the booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) 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) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (2021) and all described as "I was at a wedding an a guest mentioned that she had a positive COVID test in late December. She did not have the booster shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: she had a positive COVID test in late December. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Facility type vaccine was Unknown. Other medications in two weeks were Unknown. If covid prior vaccination was Unknown. If covid tested post vaccination was Yes.  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: Anxiety, Heart rate, Heart rate increased, Heart rate irregular, Muscular weakness
Clinical narrative: Tingling sensation on the lower right side of my face.; Weak feeling in my right forearm.; Increased heart rate; irregular heart rate; feeling extremely anxious.; Ringing in my ears.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11May2021 (Lot number: EW0164) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PARAESTHESIA (medically significant) with onset May2021, outcome "not recovered", described as "Tingling sensation on the lower right side of my face."; MUSCULAR WEAKNESS (medically significant) with onset May2021, outcome "not recovered", described as "Weak feeling in my right forearm."; HEART RATE INCREASED (non-serious) with onset May2021, outcome "not recovered", described as "Increased heart rate"; HEART RATE IRREGULAR (non-serious) with onset May2021, outcome "not recovered", described as "irregular heart rate"; ANXIETY (non-serious) with onset May2021, outcome "not recovered", described as "feeling extremely anxious."; TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "Ringing in my ears.". The patient underwent the following laboratory tests and procedures: heart rate: (May2021) increased; (May2021) irregular. Therapeutic measures were not taken as a result of paraesthesia, muscular weakness, heart rate increased, heart rate irregular, anxiety, tinnitus.  Additional information: The patient had no other vaccine in four weeks, no other medications in two weeks. The patient no tested covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Tingling sensation on the lower right side of my face.; Weak feeling in my right forearm.; Increased heart rate; irregular heart rate; feeling extremely anxious.; Ringing in my ears.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11May2021 (Lot number: EW0164) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PARAESTHESIA (medically significant) with onset May2021, outcome "not recovered", described as "Tingling sensation on the lower right side of my face."; MUSCULAR WEAKNESS (medically significant) with onset May2021, outcome "not recovered", described as "Weak feeling in my right forearm."; HEART RATE INCREASED (non-serious) with onset May2021, outcome "not recovered", described as "Increased heart rate"; HEART RATE IRREGULAR (non-serious) with onset May2021, outcome "not recovered", described as "irregular heart rate"; ANXIETY (non-serious) with onset May2021, outcome "not recovered", described as "feeling extremely anxious."; TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "Ringing in my ears.". The patient underwent the following laboratory tests and procedures: heart rate: (May2021) increased; (May2021) irregular. Therapeutic measures were not taken as a result of paraesthesia, muscular weakness, heart rate increased, heart rate irregular, anxiety, tinnitus.  Additional information: The patient had no other vaccine in four weeks, no other medications in two weeks. The patient no tested covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR test next day positive; PCR test next day positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from agency.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) at the age of 32 years as dose 2, single and administration date 05Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "PCR test next day positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Reporter stated that the patient received other vaccine in four weeks and covid prior vaccination was unknown. Patient had tested with covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a noncontactable other HCP. A 30-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# EL3247), at the age of 29, on Mar 16, 2021, and received the 1st dose of BNT162B2 (Comirnaty), on Feb 23, 2021; both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vaccination failure (medically significant), and COVID-19/nasal swab: positive (medically significant), onset Jan 19, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan 19, 2022) positive; notes: nasal swab. Clinical course: It is not known whether the patient experienced COVID-19 prior to vaccination; or if patient received any other vaccines within 4 weeks. Also it is not known whether the patient received any treatment for adverse event. No follow-up attempts  possible. No further information expected. Sender's comments: Based on known drug safety profile, there is a reasonable possibility of causal association between the events vaccination failure (medically significant), and COVID-19 (medically significant). The suspect drug BNT162B2.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Hyperammonaemia, Retinal neovascularisation, SARS-CoV-2 test
Clinical narrative: PCR test next day positive; PCR test next day positive; thought I was having a stroke; NVD; HA; Killer fatigue; A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL3247, dose number=1), administration date: 05Feb2021, when the patient was 31 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jan2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset 18Jan2022, outcome "recovering" and all described as "PCR test next day positive"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 17Jan2022, outcome "recovering", described as "thought I was having a stroke"; RETINAL NEOVASCULARISATION (medically significant) with onset 17Jan2022, outcome "recovering", described as "NVD"; HYPERAMMONAEMIA (non-serious) with onset 17Jan2022, outcome "recovering", described as "HA"; FATIGUE (non-serious) with onset 17Jan2022, outcome "recovering", described as "Killer fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of sars-cov-2 test positive, cerebrovascular accident, retinal neovascularisation, hyperammonaemia, fatigue. It was reported that severe symptoms 17Jan2022 after work NVD and "killer fatigue and HA". Patient thought was having a stroke" had a PCR test next day positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the LOE events, Cerebrovascular accident, Retinal neovascularization, Hyperammonemia, Fatigue the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: PCR test next day positive; PCR test next day positive; thought I was having a stroke; NVD; HA; Killer fatigue; A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL3247, dose number=1), administration date: 05Feb2021, when the patient was 31 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jan2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset 18Jan2022, outcome "recovering" and all described as "PCR test next day positive"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 17Jan2022, outcome "recovering", described as "thought I was having a stroke"; RETINAL NEOVASCULARISATION (medically significant) with onset 17Jan2022, outcome "recovering", described as "NVD"; HYPERAMMONAEMIA (non-serious) with onset 17Jan2022, outcome "recovering", described as "HA"; FATIGUE (non-serious) with onset 17Jan2022, outcome "recovering", described as "Killer fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of sars-cov-2 test positive, cerebrovascular accident, retinal neovascularisation, hyperammonaemia, fatigue. It was reported that severe symptoms 17Jan2022 after work NVD and "killer fatigue and HA". Patient thought was having a stroke" had a PCR test next day positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the LOE events, Cerebrovascular accident, Retinal neovascularization, Hyperammonemia, Fatigue the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anxiety, Confusional state, Disturbance in attention, Fatigue
Clinical narrative: Extreme brain fog; Extreme confusion; short-term memory delays and losses; thinking issues; no concentration; Extremely exhausted; Anxiety over effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2022 11:00 (Lot number: FJ1614) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXTROAMPHETAMINE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer , prev dose brand unknown=False, prev dose lot number=EW0176,, prev dose lot unknown=False, prev dose administration date=08May2021,, prev dose administration time: 12:00 PM, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 08May2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0158,, prev dose lot unknown=False, prev dose administration date=08Apr2021,, prev dose administration time: 12:00 PM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extreme brain fog"; CONFUSIONAL STATE (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extreme confusion"; AMNESIA (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "short-term memory delays and losses"; THINKING ABNORMAL (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "thinking issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "no concentration"; FATIGUE (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extremely exhausted"; ANXIETY (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Anxiety over effects". Therapeutic measures were not taken as a result of feeling abnormal, confusional state, amnesia, thinking abnormal, disturbance in attention, fatigue, anxiety.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Sandoz dextroampamphetamin 30 mg tab received in two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination since vaccination patient not tested for covid-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.