chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Diarrhoea, Immunisation
Clinical narrative: three doses on the Pfizer vaccine; Bell's palsy; non-stop diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 (first dose), for Covid-19 Immunization; Bnt162b2 (second dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "three doses on the Pfizer vaccine"; BELL'S PALSY (medically significant), outcome "unknown", described as "Bell's palsy"; DIARRHOEA (non-serious), outcome "not recovered", described as "non-stop diarrhea". The event "bell's palsy" was evaluated at the emergency room visit. The patient received three doses on the Pfizer vaccine and a few days later, developed Bell's palsy. Not knowing what it was and thinking it was a stroke, the patient went to the emergency room and was told this was a direct effect of vaccine. Along with the non-stop diarrhea this has also caused.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac valve disease, Electrocardiogram
Clinical narrative: The 2nd day the valve on her heart was acting funny for 3 days and it was kinda scary; Her shoulder was barely sore at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in deltoid left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2003 (unspecified if ongoing), notes: lowered her medication because she changed her diet.; "Heart murmur" (unspecified if ongoing), notes: it was a slow heart and being young to keep a watch on it; "pregnancy" (unspecified if ongoing), notes: first kid at 15. The patient took concomitant medications. There were no additional vaccines administered on the same date of the suspect vaccine. There were no prior vaccinations (within 4 weeks) of the vaccine. There were no AE(s) following prior vaccinations. The following information was reported: CARDIAC VALVE DISEASE (medically significant) with onset Mar2021, outcome "recovered" (2021), described as "The 2nd day the valve on her heart was acting funny for 3 days and it was kinda scary"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Her shoulder was barely sore at all". The patient underwent the following laboratory tests and procedures: electrocardiogram: (2021) fine. Clinical course of events was further described as follows: On the 2nd day the valve on her heart was acting funny for 3 days. It was beneath her left breast and she could tell it was there and what is scary is that it didn't do it overnight, it was 3 days and subsided gradually. It started messing with her heart a little and it was not severe but she noticed it acting funny like sticking and it didn't feel normal and it was on and off. It did it for an hour straight and it would do it again. It was like a little tap on her heart and her doctor didn't force her to get the 2nd shot, it was up to her. The event did not require visit to Emergency Room or physician office. She waited and mentioned it to her doctor on 25Jun2021. Her heart suffered a little to help build immunity is how she is looking at it. Her symptoms have been gone since then and had to have been from the vaccine. She is scheduled to do one of the calcium tests.   The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: getting the Prevnar 13 vaccine this year and reports flu like symptoms lasting 1-2 weeks (2nd time in a few years; 1st occurrence led to hospitalization); This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "getting the Prevnar 13 vaccine this year and reports flu like symptoms lasting 1-2 weeks (2nd time in a few years; 1st occurrence led to hospitalization)".  The lot number for pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors  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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Costochondritis
Clinical narrative: costochondritis; chest pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30- year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection administered in arm right, administration date 21May2021 (Lot number: WAQ4579) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Wheat" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: WAQ4579, Location of injection: Arm Right), administration date: 30Apr2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: COSTOCHONDRITIS (hospitalization) with onset 06Jun2021, outcome "not recovered", described as "costochondritis"; CHEST PAIN (hospitalization) with onset 06Jun2021, outcome "not recovered", described as "chest pain". The patient was hospitalized for costochondritis, chest pain (hospitalization duration: 1 day(s)). The events "costochondritis" and "chest pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of costochondritis, chest pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, SARS-CoV-2 antibody test
Clinical narrative: I was sick before with flu; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Oct2021 09:00 (Lot number: FH8020) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flublok qiv pis (Batch/lot#: QFAA2103, Route: IM, Anatomical of injection: left arm, No. of Previous doses: 1, Manufacturer: Sanofi pasture), administration date: 11Sep2021, when the patient was 61 years old, for Immunization. The following information was reported: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "I was sick before with flu". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: I was sick before with flu but this was very close to the minute to call (withheld).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she had Covid; likely it was thought she had Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EN6198) as dose 1, single and administration date 20Apr2021 (Lot number: EW0164) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "she had Covid"; SUSPECTED COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "likely it was thought she had Covid". The patient reported that she got desperately ill with the first shot. Then when she got the second dose, she called the hospital and they said that more than likely it was thought she had COVID. Her doctor told her that she was thought she had it before COVID had a name. The patient confirmed it was thought she had it but she was not tested and never had a positive test for COVID. The events did not require emergency room or physician office visit.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Covid booster; Her arm that she received her injection in, is painful; She has an area of redness where her injection site is; The redness is continuing to get enlarged or get bigger and the area is hot to touch; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program (004756). The reporter is the parent. A 24-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included: METFORMIN; BUSPIRONE; CYCLOBENZAPRINE; CYMBALTA; and FISH OIL. Vaccination history included: Covid-19 vaccine (dose 1 (Manufacturer unknown, lot# not provided), for COVID-19 immunization; Covid-19 vaccine (dose 2 (Manufacturer unknown, lot# not provided)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Covid booster"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2021, outcome "not recovered", described as "She has an area of redness where her injection site is"; VACCINATION SITE WARMTH (non-serious) with onset Dec2021, outcome "unknown", described as "The redness is continuing to get enlarged or get bigger and the area is hot to touch"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Her arm that she received her injection in, is painful". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site warmth, vaccination site pain which included BENADRYL. Additional information: The patient had no prior vaccination (within 4 weeks) and no lab test performed.  The lot number for bnt162b2 was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received covid vaccine last January/got covid in October with mild symptoms; received covid vaccine last January/got covid in October with mild symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "received covid vaccine last January/got covid in October with mild symptoms". Clinical course: He did not have the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective(LOE) cannot be ruled out.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, Pain
Clinical narrative: Severe left lower pain; painful diarrhea for 12 hours; Dose 1 and dose 2 not Pfizer; Dose 1 and dose 2 not Pfizer; booster dose; 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 right, administration date 06Dec2021 11:15 (Batch/Lot number: unknown) at the age of 55 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: Moderna (Dose Number: 2, Lot Number: Unknown. Unable to locate or read the details), administration date: 12Feb2021, for COVID-19 immunization; Moderna (Dose Number: 1, Lot Number: Unknown. Unable to locate or read the details), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Dose 1 and dose 2 not Pfizer"; IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "booster dose"; PAIN (medically significant) with onset 06Dec2021 18:00, outcome "not recovered", described as "Severe left lower pain"; DIARRHOEA (medically significant) with onset 06Dec2021 18:00, outcome "not recovered", described as "painful diarrhea for 12 hours". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative, notes: Nasal Swab. Unspecified therapeutic measures were not taken as a result of pain, diarrhoea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Off label use, Interchange of vaccine products, Immunisation, Pain, Diarrhoea. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe left lower pain; painful diarrhea for 12 hours; Dose 1 and dose 2 not Pfizer; Dose 1 and dose 2 not Pfizer; booster dose; 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 right, administration date 06Dec2021 11:15 (Batch/Lot number: unknown) at the age of 55 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: Moderna (Dose Number: 2, Lot Number: Unknown. Unable to locate or read the details), administration date: 12Feb2021, for COVID-19 immunization; Moderna (Dose Number: 1, Lot Number: Unknown. Unable to locate or read the details), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Dose 1 and dose 2 not Pfizer"; IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "booster dose"; PAIN (medically significant) with onset 06Dec2021 18:00, outcome "not recovered", described as "Severe left lower pain"; DIARRHOEA (medically significant) with onset 06Dec2021 18:00, outcome "not recovered", described as "painful diarrhea for 12 hours". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative, notes: Nasal Swab. Unspecified therapeutic measures were not taken as a result of pain, diarrhoea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Off label use, Interchange of vaccine products, Immunisation, Pain, Diarrhoea. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Immunisation, Palpitations, SARS-CoV-2 test
Clinical narrative: palpitations; Heart arrhythmia; Third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 18:00 (Lot number: FE2593) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, yeast; "Known allergies: yeast" (unspecified if ongoing), notes: Known allergies: yeast. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , prev dose brand: Pfizer, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 02Apr2021, when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE , prev dose brand: Pfizer, Batch/Lot No: EW0165, Location of injection: Right arm, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 15Nov2021, outcome "unknown", described as "Third dose"; ARRHYTHMIA (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Heart arrhythmia"; PALPITATIONS (non-serious) with onset 05Dec2021, outcome "not recovered", described as "palpitations". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab (PCR). Therapeutic measures were not taken as a result of arrhythmia, palpitations.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Physical examination
Clinical narrative: she had lost her baby; there was no more heart beat; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the parent.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 320308D) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: no medical history. The patient was 7 weeks pregnant at the event onset. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1, LOT of 1st dose: 301558A), administration date: 04Oct2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 03Dec2021, outcome "unknown", described as "she had lost her baby; there was no more heart beat". The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: physical examination: (03Dec2021) there was no more heart beat, notes: The doctor measured that the baby could be 7 weeks. The patient just had a physical check with the obstetrician but no lab work. The patient received a vaccine on her first trimester and upon checking with her doctor 3 days ago she has lost the child that she is carrying and she had a vaccine second dose on 22Oct2021 (the patient received the first dose 20 days before). The reporter stated that it makes a sense because the baby was still around and the patient just had a check with the doctor to ensure that she was pregnant and that was on 24Oct2021 when she made an announcement that she was pregnant, so the baby was still there. She checked again on 03Dec2021 and there was no more heart beat. The doctor measured that the baby could be 7 weeks. The patient just a physical check with the obstetrician but no lab work.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Abortion spontaneous and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101739119 baby case
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Systemic lupus erythematosus
Clinical narrative: Booster; they are doing testing for lupus she is border line right now; she got two Moderna vaccine; booster was Pfizer; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Lot number: FG3527) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for arthritis. Vaccination history included: Moderna covid-19 vaccine (Dose: 1. Lo t# 030B21A), for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 2 Lot #  008505), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 06Dec2021, INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Dec2021 16:00 and all described as "she got two Moderna vaccine; booster was Pfizer"; IMMUNISATION (medically significant), described as "Booster"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 06Dec2021 16:00, described as "they are doing testing for lupus she is border line right now".  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Injection site pain, Insomnia, SARS-CoV-2 test
Clinical narrative: Generally feel awful; Worse than first shot; Slept all next day; site pain (left sholder) is bad; Keeps me awake; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Apr2021 11:45 (Lot number: EW0158) at the age of 63 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Slight sensitivity to shellfish" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Dyslexia" (unspecified if ongoing); "Dyscalculia" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID]; ADDERALL; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot Number: ER8734, Administration Time: 02:45 PM, Anatomical location: Right Arm), administration date: 31Mar2021, when the patient was 62 years old, for Covid-19 immunization, reaction(s): "Feeling poorly 2 hours after shot", "Slept next 2 days", "Injection site pain worse than broken", "Pain", "Nauseous", "No appetite", "Body, Joint aches", "Body, Joint aches", "Pounding head ache", "Groin ache", "Penis ache", "Testicles ache", "Hot flashes", "Sweating", "Chills", "Light sensitivity", "Orientation and navigation issues (L|R, Up|Down)", "Bouts of intense diarrhea", "site pain (right shoulder) also aches", "Pallet (roof of mouth) puffy. Hurts to touch", "Substantial dry mouth", "Dizzy", "Ringing/hiss in ears", "Wobbling sound". The following information was reported: FEELING ABNORMAL (disability) described as "Generally feel awful"; CONDITION AGGRAVATED, (disability) "Worse than first shot"; SOMNOLENCE (disability), described as "Slept all next day"; INJECTION SITE PAIN (disability), described as "site pain (left shoulder) is bad"; INSOMNIA (disability), described as "Keeps me awake", all with onset date of 2021 and outcome of unknown. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Apr2020) negative; (08Oct2020) negative; (10Feb2021) negative; (19Aug2021) negative.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Generally feel awful; Worse than first shot; Slept all next day; site pain (left sholder) is bad; Keeps me awake; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Apr2021 11:45 (Lot number: EW0158) at the age of 63 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Slight sensitivity to shellfish" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Dyslexia" (unspecified if ongoing); "Dyscalculia" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID]; ADDERALL; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot Number: ER8734, Administration Time: 02:45 PM, Anatomical location: Right Arm), administration date: 31Mar2021, when the patient was 62 years old, for Covid-19 immunization, reaction(s): "Feeling poorly 2 hours after shot", "Slept next 2 days", "Injection site pain worse than broken", "Pain", "Nauseous", "No appetite", "Body, Joint aches", "Body, Joint aches", "Pounding head ache", "Groin ache", "Penis ache", "Testicles ache", "Hot flashes", "Sweating", "Chills", "Light sensitivity", "Orientation and navigation issues (L|R, Up|Down)", "Bouts of intense diarrhea", "site pain (right shoulder) also aches", "Pallet (roof of mouth) puffy. Hurts to touch", "Substantial dry mouth", "Dizzy", "Ringing/hiss in ears", "Wobbling sound". The following information was reported: FEELING ABNORMAL (disability) described as "Generally feel awful"; CONDITION AGGRAVATED, (disability) "Worse than first shot"; SOMNOLENCE (disability), described as "Slept all next day"; INJECTION SITE PAIN (disability), described as "site pain (left shoulder) is bad"; INSOMNIA (disability), described as "Keeps me awake", all with onset date of 2021 and outcome of unknown. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Apr2020) negative; (08Oct2020) negative; (10Feb2021) negative; (19Aug2021) negative.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested postive for Covid-19 following second vaccine shot; Tested postive for Covid-19 following second vaccine shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "Tested postive for Covid-19 following second vaccine shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) postive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COPD; has tested positive for COVID currently; has tested positive for COVID currently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (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) all with onset 2021, outcome "not recovered" and all described as "has tested positive for COVID currently"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "not recovered", described as "COPD". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Therapeutic measures were taken as a result of chronic obstructive pulmonary disease. The patient tested positive for COVID currently and that he found out on the morning of reporting that he had COVID and he drives a school bus and plays ball every other Saturday so he could have gotten from there. Patient stated that he just wanted to get something for treatment because he had COPD and was worried about his breathing. His breathing was fine at the time of reporting as he got a steroid shot of Decadron that morning and he had to get some other stuff. The patient was just scared.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Pain, Pain in extremity, Tremor
Clinical narrative: Started out as shaky hands/full body tremors; torso muscle spasms; severe body pain; couldn't move legs with extreme pain; couldn't move legs with extreme pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:45 (Lot number: EN6199) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; ROSUVASTATIN; PRAMIPEXOLE; METFORMIN; GLIPIZIDE. Past drug history included: Morphine, reaction(s): "drug Allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number=ER8732, administered in the right arm on 10Mar2021 at 05:00 PM), administration date: 10Mar2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: TREMOR (hospitalization, disability) with onset 31Jul2021 08:00, outcome "not recovered", described as "Started out as shaky hands/full body tremors"; MUSCLE SPASMS (hospitalization, disability) with onset 31Jul2021 08:00, outcome "not recovered", described as "torso muscle spasms"; PAIN (hospitalization, disability) with onset 31Jul2021 08:00, outcome "not recovered", described as "severe body pain"; PAIN IN EXTREMITY (hospitalization, disability), MOBILITY DECREASED (hospitalization, disability) all with onset 31Jul2021 08:00, outcome "not recovered" and all described as "couldn't move legs with extreme pain". The patient was hospitalized for tremor, muscle spasms, pain, pain in extremity, mobility decreased (start date: 2021, discharge date: 2021, hospitalization duration: 3 day(s)). The events "started out as shaky hands/full body tremors", "torso muscle spasms", "severe body pain", "couldn't move legs with extreme pain" and "couldn't move legs with extreme pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of tremor, muscle spasms, pain, pain in extremity, mobility decreased. Clinical course: Started out as shaky hands, then couldn't move legs with extreme pain, torso muscle spasms, full body tremors, severe body pain. AE(s) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. No. days hospitalisation: 3. AE(s) treatment received: Anti-seizure meds, Neurologist, Neurologist sub specialist. Additional information included: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Full blood count, Haemoglobin, Haemoglobin decreased
Clinical narrative: with a 3 months period, my hemoglobin shut down to 6.4 from 10; with a 3 months period, my hemoglobin shut down to 6.4 from 10; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: "they don't know what exactly it is, it is not lupus, but it's sclerodermal mixed polymyositis and basically mixed connected tissue disorder"; "sclerodermal mixed polymyositis" (unspecified if ongoing); "mixed connected tissue disorder" (unspecified if ongoing); "hemoglobin low" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: HAEMOGLOBIN DECREASED (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 01Sep2021, outcome "unknown" and all described as "with a 3 months period, my hemoglobin shut down to 6.4 from 10". The patient underwent the following laboratory tests and procedures: full blood count: (unspecified date) low, notes: I have low blood count; haemoglobin: (unspecified date) no higher than 10, notes: so my hemoglobin is always no higher than 10; (unspecified date) bounce between 8-10; (01Sep2021) 6.4. The patient specified that he has an autoimmune disease, "they don't know what exactly it is, it is not lupus, but its scleroldermal mixed polymyositis and basically mixed connected tissue disorder". The patient added "My immune system is always heighted (sounds like not verified to caller) up and I have low blood count, so my hemoglobin is always no higher than 10," "bounce between 8-10." "with a 3 months period, my hemoglobin shut down to 6.4 from 10." The patient specified that on 01Sep2021 hemoglobin was 6.4. The patient wanted to know if there is any evidence or findings about covid vaccine decreasing the hemoglobin.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; 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
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Blood test, Polymerase chain reaction, Urticaria, Urticaria chronic
Clinical narrative: Angioedema on both lips; outbreak of hives; chronic urticaria all over body, legs, face back and buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Jul2021 17:30 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Grass, reaction(s): "Allergy"; Wheat, reaction(s): "Allergy"; Dust mites, reaction(s): "Allergy"; New allergies since taking pfizer vax, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: 1906002-05479, Arm Right, at 07:30 PM), administration date: 18Jun2021, for COVID-19 immunization. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine.The following information was reported: ANGIOEDEMA (medically significant) with onset 23Sep2021 16:00, outcome "not recovered", described as "Angioedema on both lips"; URTICARIA (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "outbreak of hives"; URTICARIA CHRONIC (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "chronic urticaria all over body, legs, face back and buttocks". The events "angioedema on both lips", "outbreak of hives" and "chronic urticaria all over body, legs, face back and buttocks" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (06Jan2021) negative, notes: fastep antibody; polymerase chain reaction: (18Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of angioedema, urticaria, urticaria chronic.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Disturbance in attention, Headache, Intrusive thoughts, Malaise
Clinical narrative: it was like having a brain hemorrhage; headache; fever; couldn't focus on anything; Random thoughts were coming and the patient couldn't stop; It didn't feel good at all; This is a spontaneous report received from non-contactable reporter (consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single, Manufacturer unknown, Batch/Lot number: unknown), for COVID-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown," described as "it was like having a brain hemorrhage;" HEADACHE (non-serious) with onset 2021, outcome "unknown," described as "headache;" PYREXIA (non-serious) with onset 2021, outcome "unknown," described as "fever;" DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown," described as "couldn't focus on anything;" INTRUSIVE THOUGHTS (non-serious) with onset 2021, outcome "unknown," described as "Random thoughts were coming and the patient couldn't stop;" and MALAISE (non-serious) with onset 2021, outcome "unknown," described as "It didn't feel good at all." It was further reported that the patient took 2nd dose of the Pfizer-BioNTech vaccine. There was a severe headache with fever for more than 24 hours (hr). It was like having a brain haemorrhage and the patient couldn't even focus on anything; random thoughts were coming and the patient couldn't stop. It didn't feel good at all.  The batch/lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: it was like having a brain hemorrhage; headache; fever; couldn't focus on anything; Random thoughts were coming and the patient couldn't stop; It didn't feel good at all; This is a spontaneous report received from non-contactable reporter (consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single, Manufacturer unknown, Batch/Lot number: unknown), for COVID-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown," described as "it was like having a brain hemorrhage;" HEADACHE (non-serious) with onset 2021, outcome "unknown," described as "headache;" PYREXIA (non-serious) with onset 2021, outcome "unknown," described as "fever;" DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown," described as "couldn't focus on anything;" INTRUSIVE THOUGHTS (non-serious) with onset 2021, outcome "unknown," described as "Random thoughts were coming and the patient couldn't stop;" and MALAISE (non-serious) with onset 2021, outcome "unknown," described as "It didn't feel good at all." It was further reported that the patient took 2nd dose of the Pfizer-BioNTech vaccine. There was a severe headache with fever for more than 24 hours (hr). It was like having a brain haemorrhage and the patient couldn't even focus on anything; random thoughts were coming and the patient couldn't stop. It didn't feel good at all.  The batch/lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ) (Batch/Lot number: unknown) at 2x/day. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". Patient stated, "DVT, I got clot. So, I am wondering what caused it. I wanted to report it but at the same time I do not know it was the medication or it was the Pfizer COVID Vaccine. My doctor just stopped Xeljanz and I was being fine on the program." The patient was taking tofacitinib citrate and also got the Pfizer vaccine, the side effects, does not know which one caused them. Has been taking tofacitinib citrate for so long. The doctor stopped it but at the same time during that period got the Pfizer vaccine for the COVID. Stopped that medication but was not sure if that has caused by the tofacitinib citrate or it was just caused by the COVID vaccine. The patient underwent the following laboratory tests and procedures: blood test: unknown results. The action taken for tofacitinib citrate was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (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) all with onset 29Nov2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. Additional Context: the physician called about the pediatric COVID-19 vaccine. He had a 10-12 year old patient that received the 1st dose of the COVID-19 vaccine about a month ago, and then contracted COVID-19 on 29Nov2021.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. Clinical course: Patient experienced inefficacy after receiving covid vaccine. So, he got Pfizer. The first dose, yeah, he thought was like [Date]. The second was [Date]. Got COVID In August.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.