chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 test, Tachycardia, Thyroid disorder, Thyroid function test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 19:00 (Lot number: FK9895) at the age of 37 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Stomach pain", stop date: Mar2011, notes: Appendectomy; "Flu like symptoms", start date: 03Jan2022, stop date: 10Jan2022, notes: Did multiple Covid tests, they were all negative. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0181, Date/time, Date: 19Jun2021, Route of administration: intramuscular [checked], Batch/lot number: EW0181), administration date: 19Jun2021, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "TSH/ abnormal", "free thyroxine/ abnormal"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk9895, Dose: 1st, Date/time, Date: 29May2021, Route of administration: intramuscular [checked], Batch/lot number: PEW0178), administration date: 29May2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: TACHYCARDIA (medically significant) with onset 12Feb2022, outcome "unknown", described as "Tachycardia"; THYROID DISORDER (medically significant) with onset 12Feb2022, outcome "unknown", described as "Thyroid problem"; HEART RATE INCREASED (medically significant) with onset 12Feb2022 14:00, outcome "recovering", described as "Rapid heart rate the next day of the vaccination with resting rate of 100+ bpm and standing rate of 120+ bpm". The events "tachycardia", "thyroid problem" and "rapid heart rate the next day of the vaccination with resting rate of 100+ bpm and standing rate of 120+ bpm" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (12Feb2022) thyroid results, notes: showed that my thyroid results only on 16Feb2022; blood thyroid stimulating hormone (0.35-5.5): (02Feb2022) 0.020 MiU/mL, notes: Abnormal; electrocardiogram: (12Feb2022) tachycardia; free thyroxine index (0.61-1.30): (02Feb2022) 1.44 ng/dL, notes: Abnormal; heart rate: (unspecified date) 100+ bpm; (unspecified date) 120+bpm, notes: while I was sitting and watching TV, the next day around 02:00PM eastern time. Since 02:00 PM-08:00 PM on 12Feb2022 (next day) my heart rate was mostly high at which point; (12Feb2022) mostly high, notes: while I was sitting and watching TV, the next day around 02:00PM eastern time. Since 02:00 PM-08:00 PM on 12Feb2022 (next day) my heart rate was mostly high at which point; sars-cov-2 test: (unspecified date) negative, notes: Did multiple Covid tests, they were all negative; thyroid function test: (Nov2021) normal. Therapeutic measures were taken as a result of tachycardia, heart rate increased. It was unknown if therapeutic measures were taken as a result of thyroid disorder.
Age: 17.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Throat irritation
Clinical narrative: Positive covid test; Positive covid test; scratchy throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): NVSC2022US029492_OS.  A 17 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 05Sep2021 (Lot number: FD8448) as dose 3 (booster), single, intramuscular, administered in arm, administration date 04Apr2021 (Lot number: ER8734) as dose 2, single and intramuscular, administered in arm, administration date 14Mar2021 (Lot number: EL1283) as dose 1, single for covid-19 immunisation;(Batch/Lot number: unknown). Relevant medical history included: "AS- arthritis", start date: 2017 (ongoing). Concomitant medication(s) included: REMICADE taken for arthritis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive covid test"; THROAT IRRITATION (non-serious), outcome "unknown", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken was unknown.  Clinical information: It was reported that the patient had a positive covid test during first few weeks of Cosentyx. There were no reactions to 3 vaccines. There was a weakened immune system and use of medications that suppress the immune system (e.g., high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept).Vaccination Facility Type: Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). An 83-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication included Tylenol. The patient experienced arthropathy (affected forearm), with outcome of unknown. Additional information: After taking the first shot of the vaccine, patient experienced forearm problems/arthropathy. She mentioned she took Tylenol half an hour after getting the vaccine. No follow-up attempts possible.  Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Fall, Vitreous floaters
Clinical narrative: unexpected fall; irregular EKG; black floaters in eye; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, sngle for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "unexpected fall"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "irregular EKG"; VITREOUS FLOATERS (non-serious), outcome "recovered", described as "black floaters in eye". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that the reporter states he had the Covid vaccine the 1st and 2nd shot. The reporter said that there were 3 event that happened that might be related to it, first was an unexpected fall, and irregular EKG, and black floater in the eye. Black Floater is fine now. Physician told him that he should not have the booster. He is now fine. Clarified that this all happened after the second dose.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Fatigue
Clinical narrative: a lot of fatigue; has a lot of heart issues; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 85 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Pfizer covid shots), for COVID-19 immunization; Bnt162b2 (Dose 2, Pfizer covid shots), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a lot of fatigue"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "has a lot of heart issues". Therapeutic measures were taken as a result of cardiac disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis within 48 hours of second dose; This is a spontaneous report received from a contactable reporter (Physician). A 12-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, 30 ug single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Single; Comirnaty 10ug; Lot Number: Unknown) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient had COVID-19. Post vaccination, it was unknown if the patient had COVID-19 or tested for COVID-19. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis within 48 hours of second dose". It was unknown if therapeutic measures were taken as a result of myocarditis.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the compatible temporal association and the vaccine's known safety profile, the company considers the reported event myocarditis is possibly related to the vaccination with BNT162B2. 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: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 24Feb2022, this case now contains all required information to be considered valid.   This is a literature report.  An 89 year-old female patient received BNT162B2 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; sars-cov-2 test: positive.  Additional information: We sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 89-year-old female. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event lack of efficacy based on the known safety profile and temporal association ,Linked Report(s) : PFIZER INC-202200381102 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diabetes mellitus, Obesity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "he had a cataract surgery" (unspecified if ongoing), notes: he had a cataract surgery and he's taking Latanoprost drops for his eyes for Glaucoma; "Thyroid" (unspecified if ongoing), notes: he is taking Levothyroxine for Thyroid everyday (100 mcg); "cholesterol" (unspecified if ongoing), notes: he also takes atorvastatin for his cholesterol; "MRSA" (unspecified if ongoing), notes: 4 years ago he was diagnosed with MRSA (Methicillin-resistant Staphylococcus aureus).; "arthritis" (unspecified if ongoing), notes: he has a history of arthritis. Concomitant medication(s) included: LATANOPROST taken for glaucoma; LEVOTHYROXINE taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Covid-19 vaccine (DOSE 1 MANUFACTURER UNKNOWN), when the patient was 77 years old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 2 MANUFACTURER UNKNOWN), when the patient was 77 years old, for Covid-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "onset of Diabetes per his doctor"; OBESITY (non-serious), outcome "unknown", described as "obese". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: On the border for onset of diabetes. Additional information: Patient wanted to know where he can receive a second booster dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there was a clinical trial where he could receive the second booster shot. Patient stated that he was trying to see if a second booster vaccine was available or if he could volunteer for the second booster and had a study done. He got the booster about 3 months or a little more ago from day of report. Patient stated that he did not have the dates or Lot Numbers of his vaccines available at the time of report. Stated that he left his vaccination card at home, he had a picture of it on his phone, but he did not know how to open the picture while he was on the phone. Patient stated that he got the first, second and booster dose. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombosis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jul2021 (Lot number: EW0198) at the age of 15 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Arm Left), administration date: 03Jul2021, when the patient was 15 years old, for COVID-19 immunization, reactions: "blood clots in both legs", "swelling in both legs". The following information was reported: THROMBOSIS (caused and prolonged hospitalization, life threatening) with onset 26Jul2021 12:00, outcome "recovered with sequelae", described as "Blood clots in both legs"; DEEP VEIN THROMBOSIS (caused and prolonged hospitalization, life threatening) with onset 26Jul2021 12:00, outcome "recovered with sequelae", described as "Deep vein thrombosis". The patient was hospitalized and prolonged hospitalization for thrombosis, deep vein thrombosis (hospitalization duration: 7 day(s)). The events "blood clots in both legs" and "deep vein thrombosis" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate, Heart rate increased, Palpitations, Thyroid disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6199) at the age of 59 years as dose 1, 0.3 ml single and administered in arm left, administration date 01Apr2021 (Lot number: ER8732) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Barrett's esophagus", start date: Jun2019 (unspecified if ongoing); "High cholesterol", start date: Dec2008 (unspecified if ongoing), notes: takes Simvastatin 40mg once daily. There were no concomitant medications. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 2021, outcome "unknown", described as "heart  fluttering that was beating"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart pounding and her heart beating fast and hard"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "her heart beating fast and hard"; THYROID DISORDER (non-serious), outcome "unknown", described as "It has affected her Thyroid". The patient underwent the following laboratory tests and procedures: heart rate: fast and hard, notes: her heart beating fast and hard. Clinical course: First, right she got the first vaccine on 11Mar2021, she did not have a fevers or anything like that. At night time, her heart was beating hard and racing. It started either 11Mar2021, or 12Mar2021. It dissipated after 2-3 weeks with first shot, then she got 2nd shot on 01Apr2021, and the same thing happened again and it dissipated within 2-3 weeks. The whole summer was great, and she worked hard and was active. Agent states the caller had her heart beating fast and hard after all of the doses but after the 1st and 2nd dose it had dissipated but after the 3rd it has not dissipated. Agent states the caller found out she has an overactive thyroid which was not a problem before and her doctor believes it is the thyroid that is causing this but the caller believes it is the vaccine. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Dyspnoea, Myocarditis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (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. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CARDIAC FLUTTER (medically significant), outcome "unknown", described as "heart started fluttering"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Clinical course: Within 2 hours of Covid booster, heart started fluttering and by 3 three weeks after shot she had shortness of breath and cardiologist diagnosed as myocarditis. Event took place after use of product. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood lactic acid increased, Cardiopulmonary exercise test abnormal, Chest discomfort, Dyspnoea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (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. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CARDIAC FLUTTER (medically significant), outcome "unknown", described as "heart started fluttering"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Clinical course: Within 2 hours of Covid booster, heart started fluttering and by 3 three weeks after shot she had shortness of breath and cardiologist diagnosed as myocarditis. Event took place after use of product. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Forced vital capacity decreased, Incorrect route of product administration, Palpitations, Pulmonary function test abnormal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (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. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CARDIAC FLUTTER (medically significant), outcome "unknown", described as "heart started fluttering"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Clinical course: Within 2 hours of Covid booster, heart started fluttering and by 3 three weeks after shot she had shortness of breath and cardiologist diagnosed as myocarditis. Event took place after use of product. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome". Patient is in his late 60's or 70's who is healthy. After having the Comirnaty booster shot, he had Guillain-Barre syndrome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Ill-defined disorder
Clinical narrative: I was also diagnosed with diabetes; started getting additional & chronic illnesses that I didn't have before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  An elderly 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "I was also diagnosed with diabetes"; ILL-DEFINED DISORDER (non-serious), outcome "unknown", described as "started getting additional & chronic illnesses that I didn't have before".  Clinical course: The patient was fully vaccinated (fully vaccinated means one shot of Johnson & Johnson vaccine or two shots of Pfizer/Moderna vaccine). The patient started getting additional & chronic illnesses that she didn't have before. Since she was also diagnosed with diabetes around when this pandemic started, it was just too risky for her health to not use any sources against a serious illness to compromise her already poor health. The patient's age/age range was provided as 65+ and other physical / comorbid information was provided as none  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactically allergic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactically allergic". Therapeutic measures were taken as a result of anaphylactic reaction.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Insomnia, Lumbar radiculopathy, Muscle spasms, Sleep apnoea syndrome
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 (Lot number: FF2589) at the age of 66 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Onset date: Unknown, Stop date: Ongoing, Pertinent details: N/A; "Hypercholesterolemia" (ongoing), notes: Onset date: Unknown, Stop date: Ongoing, Pertinent details: N/A; "AV block", start date: Apr2021 (ongoing), notes: Onset date: Apr2021, Stop date: Ongoing, Pertinent details: Pacemaker Insertion (Permanent); "Transient Global Amnesia", start date: 2019, stop date: 2019, notes: Onset date: 2019, Stop date: 2019, Pertinent details: N/A; "CV Prophylaxis" (ongoing); "Back pain/Radiculitis" (ongoing); "Back pain/Radiculitis" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB taken for back pain, radiculopathy (ongoing); LOSARTAN taken for hypertension (ongoing); ATORVASTATIN taken for hypercholesterolaemia (ongoing); BABY ASPIRIN taken for prophylaxis (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 26Feb2021, Route of administration: Intramuscular, Batch/Lot Number: EN6202), administration date: 26Feb2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Date: 19Mar2021, Route of administration: Intramuscular, Batch/Lot Number: EN6204), administration date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Chills". The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "not recovered", described as "erectile dysfunction"; SLEEP APNOEA SYNDROME (non-serious), outcome "not recovered", described as "sleep apnea"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "leg cramps"; LUMBAR RADICULOPATHY (non-serious), outcome "not recovered", described as "lumbar radiculitis"; INSOMNIA (non-serious), outcome "not recovered", described as "insomnia". Therapeutic measures were taken as a result of erectile dysfunction, muscle spasms. Clinical course: There was no relevant test and Specific relevant test done. The patient did not receive any other vaccines within four weeks prior to the vaccination. Pharmacy or drug store was the Vaccination Facility Type. Gabapentin and Tadalafil used as treatment drug for Leg cramps and Erectile dysfunction. Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Fracture, Gait disturbance, Joint swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Aug2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Single, Manufacturer unknown, Lot unknown/Not available), administration date: 06Apr2021, when the patient was 63 years old, for Covid-19 immunization; Covid-19 vaccine (Dose 1, Single, Manufacturer unknown, Lot unknown/Not available), administration date: 16Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: FRACTURE (medically significant), outcome "recovered with sequelae", described as "I got an MRI and that showed thousands of little fractures"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset Aug2021, outcome "recovered with sequelae" and all described as "3 days after the third shot, I had pain and swelling in both ankles."; GAIT DISTURBANCE (non-serious), outcome "recovered with sequelae", described as "Could not walk"; FALL (non-serious), outcome "recovered with sequelae", described as "and fell". The events "I got an MRI and that showed thousands of little fractures", "3 days after the third shot, I had pain and swelling in both ankles", "3 days after the third shot, I had pain and swelling in both ankles", "could not walk" and "and fell." Was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: showed thousands of little fractures. Clinical Information: Patient did not received Covid prior vaccination. It is unknown, if patient Covid tested post vaccination. Patient was recovered with lasting effects. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Aug2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Single, Manufacturer unknown, Lot unknown/Not available), administration date: 06Apr2021, when the patient was 63 years old, for Covid-19 immunization; Covid-19 vaccine (Dose 1, Single, Manufacturer unknown, Lot unknown/Not available), administration date: 16Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: FRACTURE (medically significant), outcome "recovered with sequelae", described as "I got an MRI and that showed thousands of little fractures"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset Aug2021, outcome "recovered with sequelae" and all described as "3 days after the third shot, I had pain and swelling in both ankles."; GAIT DISTURBANCE (non-serious), outcome "recovered with sequelae", described as "Could not walk"; FALL (non-serious), outcome "recovered with sequelae", described as "and fell". The events "I got an MRI and that showed thousands of little fractures", "3 days after the third shot, I had pain and swelling in both ankles", "3 days after the third shot, I had pain and swelling in both ankles", "could not walk" and "and fell." Was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: showed thousands of little fractures. Clinical Information: Patient did not received Covid prior vaccination. It is unknown, if patient Covid tested post vaccination. Patient was recovered with lasting effects. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: positive; covid test date=04/Jan/2022; Nasal Swab: positive; covid test date=04Jan2022; 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 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 (Lot number: EW0185) at the age of 41 years as dose 2, single and administered in arm left, administration date 29Apr2021 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothryoid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient did not received any other Vaccine in four weeks. Patient did not have covid prior vaccination and post vaccination the patient tested for covid. Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jan2022, outcome "unknown", described as "Nasal Swab: positive; covid test date=04/Jan/2022"; COVID-19 (medically significant) with onset 04Jan2022, outcome "unknown", described as "Nasal Swab: positive; covid test date=04Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiomyopathy
Clinical narrative: Cardiomyopathy; diagnosed with heart problems; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: May2021, for covid 19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset Aug2021, outcome "unknown", described as "Cardiomyopathy"; CARDIAC DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "diagnosed with heart problems".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events cardiomyopathy and cardiac disorder and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: "polymyalgia rheumatica" (off label) as result of covid/coronavirus vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as ""polymyalgia rheumatica" (off label) as result of covid/coronavirus vaccine".   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event polymyalgia rheumatica with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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: U
Vaccine: COVID19
Symptoms: Hypertension, Illness, Tremor
Clinical narrative: The first dose that I had the Pfizer I got really sick; I really thought that it might be the last time in my life; My blood pressure went sky high; I didn''t suffer with high blood pressure but my blood pressure went so high; shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "unknown", described as "The first dose that I had the Pfizer I got really sick; I really thought that it might be the last time in my life"; HYPERTENSION (non-serious), outcome "unknown", described as "My blood pressure went sky high; I didn''t suffer with high blood pressure but my blood pressure went so high"; TREMOR (non-serious), outcome "unknown", described as "shaking". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anti-aquaporin-4 antibody, CSF oligoclonal band, CSF test, Diplopia, Investigation
Clinical narrative: acute optic neuritis; Diplopia in the left eye; Blurry vision; This is a literature report.  A 42-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation. The following information was reported: OPTIC NEURITIS (medically significant), outcome "recovering", described as "acute optic neuritis"; DIPLOPIA (non-serious), outcome "unknown", described as "Diplopia in the left eye"; VISION BLURRED (non-serious), outcome "recovering", described as "Blurry vision". The events "acute optic neuritis", "diplopia in the left eye" and "blurry vision" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: anti-aquaporin-4 antibody: negative; csf oligoclonal band: were absent; csf test: was significant for increased protein; investigation: revealed horizontal diplopia in the left eye, notes: cranial nerve 3; revealed horizontal diplopia in the left eye, notes: cranial nerve 4; revealed horizontal diplopia in the left eye, notes: cranial nerve 6; diffuse gray field vision in the left eye was, notes: noted; negative.; 5/5 bilaterally and reflexes 2+ bilaterally; magnetic resonance imaging: revealed left optic nerve enhancement; magnetic resonance imaging head: unremarkable; ophthalmological examination: revealed a positive relative afferent pupillary, notes: defect in the left eye with clear disc margins. Therapeutic measures were taken as a result of optic neuritis, diplopia, vision blurred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Ophthalmological examination, Optic neuritis, Vision blurred
Clinical narrative: acute optic neuritis; Diplopia in the left eye; Blurry vision; This is a literature report.  A 42-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation. The following information was reported: OPTIC NEURITIS (medically significant), outcome "recovering", described as "acute optic neuritis"; DIPLOPIA (non-serious), outcome "unknown", described as "Diplopia in the left eye"; VISION BLURRED (non-serious), outcome "recovering", described as "Blurry vision". The events "acute optic neuritis", "diplopia in the left eye" and "blurry vision" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: anti-aquaporin-4 antibody: negative; csf oligoclonal band: were absent; csf test: was significant for increased protein; investigation: revealed horizontal diplopia in the left eye, notes: cranial nerve 3; revealed horizontal diplopia in the left eye, notes: cranial nerve 4; revealed horizontal diplopia in the left eye, notes: cranial nerve 6; diffuse gray field vision in the left eye was, notes: noted; negative.; 5/5 bilaterally and reflexes 2+ bilaterally; magnetic resonance imaging: revealed left optic nerve enhancement; magnetic resonance imaging head: unremarkable; ophthalmological examination: revealed a positive relative afferent pupillary, notes: defect in the left eye with clear disc margins. Therapeutic measures were taken as a result of optic neuritis, diplopia, vision blurred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: M
Vaccine: COVID19
Symptoms: Body temperature, Crohn's disease, Loss of personal independence in daily activities, Pyrexia, Weight
Clinical narrative: After we gave first dose Of COVID vaccine, his Crohn's symptoms have come back; he has high fever until he was give steroids.; My kid had weight loss; missed school and other activities.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): PFIZER INC-202200333254.  A 9 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "After we gave first dose Of COVID vaccine, his Crohn's symptoms have come back"; PYREXIA (non-serious), outcome "unknown", described as "he has high fever until he was give steroids."; WEIGHT DECREASED (non-serious), outcome "unknown", described as "My kid had weight loss"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "missed school and other activities.". The patient underwent the following laboratory tests and procedures: body temperature: high, notes: he has high fever; weight: loss, notes: had weight loss. Therapeutic measures were taken as a result of pyrexia.It was reported that my kid was suffering from Crohn's and was under inflectra. He was 9 yrs old and was doing okay for few months. After we gave first doze Of COVID vaccine, his Crohn's symptoms have come back and past 2 months he has high fever until he was given steroids. My kid had weight loss and missed school and other activities. Wanted to check if you your sample had Crohn's patients when COVID vaccine was tested. We have suffered a lot and my kid was still dYT.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: After we gave first dose Of COVID vaccine, his Crohn's symptoms have come back; he has high fever until he was give steroids.; My kid had weight loss; missed school and other activities.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): PFIZER INC-202200333254.  A 9 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "After we gave first dose Of COVID vaccine, his Crohn's symptoms have come back"; PYREXIA (non-serious), outcome "unknown", described as "he has high fever until he was give steroids."; WEIGHT DECREASED (non-serious), outcome "unknown", described as "My kid had weight loss"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "missed school and other activities.". The patient underwent the following laboratory tests and procedures: body temperature: high, notes: he has high fever; weight: loss, notes: had weight loss. Therapeutic measures were taken as a result of pyrexia.It was reported that my kid was suffering from Crohn's and was under inflectra. He was 9 yrs old and was doing okay for few months. After we gave first doze Of COVID vaccine, his Crohn's symptoms have come back and past 2 months he has high fever until he was given steroids. My kid had weight loss and missed school and other activities. Wanted to check if you your sample had Crohn's patients when COVID vaccine was tested. We have suffered a lot and my kid was still dYT.   The lot number for bnt162b2 was not provided and will be requested during follow up.