chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Blister, Feeling abnormal, Generalised oedema, Immunisation reaction, Pain
Clinical narrative: Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands; hurting and it's painful; weird side effects; Feeling kind of miffy and odd; I have these weird bumps showing up all over my body; I now suffer from 100% combat PTSD; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands), PAIN (hurting and it's painful), VACCINATION COMPLICATION (weird side effects), FEELING ABNORMAL (Feeling kind of miffy and odd) and GENERALISED OEDEMA (I have these weird bumps showing up all over my body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands), PAIN (hurting and it's painful), VACCINATION COMPLICATION (weird side effects), FEELING ABNORMAL (Feeling kind of miffy and odd), GENERALISED OEDEMA (I have these weird bumps showing up all over my body) and POST-TRAUMATIC STRESS DISORDER (I now suffer from 100% combat PTSD). At the time of the report, BLISTER (Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands), PAIN (hurting and it's painful), VACCINATION COMPLICATION (weird side effects), FEELING ABNORMAL (Feeling kind of miffy and odd), GENERALISED OEDEMA (I have these weird bumps showing up all over my body) and POST-TRAUMATIC STRESS DISORDER (I now suffer from 100% combat PTSD) had not resolved.            No concomitant medication information was reported.  Patient stated that they got last dose in January and came up for Booster dose. It was reported that patient was a citizen.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Post-traumatic stress disorder
Clinical narrative: Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands; hurting and it's painful; weird side effects; Feeling kind of miffy and odd; I have these weird bumps showing up all over my body; I now suffer from 100% combat PTSD; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands), PAIN (hurting and it's painful), VACCINATION COMPLICATION (weird side effects), FEELING ABNORMAL (Feeling kind of miffy and odd) and GENERALISED OEDEMA (I have these weird bumps showing up all over my body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands), PAIN (hurting and it's painful), VACCINATION COMPLICATION (weird side effects), FEELING ABNORMAL (Feeling kind of miffy and odd), GENERALISED OEDEMA (I have these weird bumps showing up all over my body) and POST-TRAUMATIC STRESS DISORDER (I now suffer from 100% combat PTSD). At the time of the report, BLISTER (Blisters and they just/Explode everywhere, especially through my feet, but now they're coming up my but/sides of my legs so we had/couple of my hands), PAIN (hurting and it's painful), VACCINATION COMPLICATION (weird side effects), FEELING ABNORMAL (Feeling kind of miffy and odd), GENERALISED OEDEMA (I have these weird bumps showing up all over my body) and POST-TRAUMATIC STRESS DISORDER (I now suffer from 100% combat PTSD) had not resolved.            No concomitant medication information was reported.  Patient stated that they got last dose in January and came up for Booster dose. It was reported that patient was a citizen.  No treatment medications were provided.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature decreased, Chills, Incorrect dose administered
Clinical narrative: Chills all over body after second vaccine; Body aches after second vaccine; Temperature of 97.8 degrees Fahrenheit after second vaccine; 65-year-old patient, First dose in Jul2021, second dose on 11Nov2021; 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 65-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 11Nov2021 as dose 2, single (Batch/Lot number: unknown, Expiration Date: Nov2022) at the age of 65 years for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (first dose), administration date: Jul2021, when the patient was 65 years old, for immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 11Nov2021, outcome "unknown", described as "65-year-old patient, First dose in Jul2021, second dose on 11Nov2021"; PAIN (non-serious) with onset 12Nov2021, outcome "recovering", described as "Body aches after second vaccine"; CHILLS (non-serious) with onset 12Nov2021, outcome "unknown", described as "Chills all over body after second vaccine"; BODY TEMPERATURE DECREASED (non-serious) with onset 12Nov2021, outcome "unknown", described as "Temperature of 97.8 degrees Fahrenheit after second vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. For event Temperature of 97.8 degrees Fahrenheit after second vaccine:  he has not repeated his temperature again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Syncope, Tremor
Clinical narrative: fainted; shaking uncontrollably to the point she couldn't walk; shaking uncontrollably to the point she couldn't walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 17-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (hospitalization, medically significant), outcome "unknown", described as "fainted"; TREMOR (hospitalization), GAIT DISTURBANCE (hospitalization), outcome "unknown" and all described as "shaking uncontrollably to the point she couldn't walk". Reporter stated that, this was the only vaccine approved for patient age group. After the vaccine was administered, withheld faint she slept the rest of the day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: swelling near the injection site; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative. A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization; varicella zoster vaccine rge (cho) (SHINGRIX) (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: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling near the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: arm swelled up really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm swelled up really bad". The event "arm swelled up really bad" required emergency room visit. Additional information: Many years ago she was talked into getting the pneumonia shot by a doctor. She had to go to the Emergency Room because arm swelled up really bad. It was many years ago and not provided with details. Ever since then she never got a shot. Relevant Tests: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) formulation coded under Solution for injection in pre-filled syringe instead of unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Maternal exposure timing unspecified, Palpitations
Clinical narrative: racing heart/heart palpitations; Other symptoms are elbow joint pain on injection arm; patient was pregnant at the time of vaccination, gestation period was 17 (unspecified); This is a spontaneous report from a contactable consumer (patient). This 35-Year-old female consumer reported for herself.  A 35-years-old female pregnant patient (pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number and expiration date: Unknown), via an unspecified route of administration, administered in right arm on 11May2021 at 02:00 PM (Age at vaccination was 35 years) as dose 2, single for COVID-19 immunization. Medical history included Sulfa allergy and COVID (prior to vaccination). Concomitant medication included prenatal vitamins. Patient had COVID prior to vaccination and not COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number and expiration date: Unknown), via an unspecified route of administration, administered in right arm on 20Apr2021 at 03:00 PM (Age at vaccination was 35 years) as dose 1, single for COVID-19 immunization and experienced severe headache, fatigue and rash on feet. On 11May2021, at 05:00 PM, 3 hrs after vaccination, the patient experienced racing heart/heart palpitations, Other symptoms are elbow joint pain on injection arm. On 11May2021, the patient was pregnant at the time of vaccination, gestation period was 17 (unspecified). The patient reported that, After both injections I had reactions similar to my symptoms while I had Covid. My most severe symptoms are racing heart, heart palpitations. Other symptoms are elbow joint pain on injection arm. The patient not received treatment for events racing heart/heart palpitations, other symptoms are elbow joint pain on injection arm. The outcome of the events was not resolved.  Follow-up (24Feb2022): 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: PNC13
Symptoms: Peripheral swelling
Clinical narrative: swelling in her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (002191). The reporter is the parent.  A 20-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "allergy to neomycin " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in her arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Anxiety, Emotional distress
Clinical narrative: Emotional distress and anxiety from the overdose experience; Emotional distress and anxiety from the overdose experience; Received 'six times the usual dose' of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 34-year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2022 (Batch/Lot number: unknown) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ACCIDENTAL OVERDOSE (non-serious) with onset 24Feb2022, described as "Received 'six times the usual dose' of the vaccine".  Additional information: Caller is reporting an inadvertent administration of Pfizer BioNTech Vaccine that was done in a company facility. Caller stated that it was her patient and her patient received 'six times the usual dose' of the vaccine. Agent from Regulatory Authority who transferred the call mentioned that a whole vial may possibly administered to the patient. Upon probing, caller stated that she have no further information with regards to the formulation and she is not the proper person to ask this because she is calling from the clinic where the patient is reporting the administration error. Caller wants to know recommendations that she can provide to her patient after the administration error.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (01Apr2022): This is a follow-up spontaneous report from a contactable consumer (receptionist). This consumer reported in response to HCP letter sent via telephonic follow-up activity which included that: Updated information: No field updated. Additional information: Phone out 4:44 pm. phone answered by receptionist who said the reporter was out of the office and to call back Monday.  Follow-up (04Apr2022): This is a  spontaneous follow-up report from a contactable Other HCP. This Other HCP reported in response to HCP telephonic follow-up activity which included that:  Additional Information: Phone out 3:20 pm. Phone answered by reporter who provided an update. She said she saw the patient recently for something unrelated and the patient didn't seem very interested in following up with Pfizer regarding the overdose event, so she was not sure how much follow up information she'd be able to provide. The patient did not want to contact Pfizer due to the emotional distress and anxiety from the overdose experience, and the reporter did not want to provide specific patient medical information without the patient's consent. The reporter did not recall any obvious physical adverse events reported after the overdose. She would try and contact the patient and asked that we call back in two weeks for an update.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure, Limb discomfort, Mammogram, Swelling
Clinical narrative: my underarms have been swollen; It was difficult to put my arm down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 37-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2021 (Lot number: EL4264, Expiration Date: May2021) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset Feb2021, outcome "not recovered", described as "my underarms have been swollen"; LIMB DISCOMFORT (non-serious) with onset Feb2021, outcome "not recovered", described as "It was difficult to put my arm down". The events "my underarms have been swollen" and "it was difficult to put my arm down" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, limb discomfort.  Additional information: immediately following R under arm swell to the point. It was difficult to put her arm down. It went down a little never completely   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: a red bump at the site of injection; a red bump at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Mar2022 as dose 1, single (Lot number: FJ2601, Expiration Date: Jun2023) at the age of 70 years, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 14Mar2022, outcome "unknown" and all described as "a red bump at the site of injection".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: having seizures way worse than normal for about 3 weeks; This is a spontaneous report received from a contactable other health professional. Other Case identifier was 02130346. A 27-year-old male patient received his first dose of BNT162b2 (BNT162B2), in Apr2021 as single dose (Batch/Lot number: unknown) and his second dose of BNT162b2 (BNT162B2), on an unspecified date as single dose (Batch/Lot number: unknown) for covid-19 immunisation. The patient had a previous medical history of Seizures (unspecified if ongoing). Concomitant medications included: DILANTIN [PHENYTOIN SODIUM]; KEPPRA XR; EPIDIOLEX and ONFI. The patient was given a dose of the COVID mRNA vaccine one year ago in Apr2021. Shortly after receiving the vaccine, the patient began having seizures way worse than normal for about 3 weeks. The patient then received the second dose of the mRNA vaccine and the patient began seizing again at an increased rate for about three weeks after. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event convulsion aggravated with BNT162b2 can not be fully 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID about 2 weeks later; got COVID about 2 weeks later; 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 female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single and administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID about 2 weeks later". Clinical course: reporter asked is it crazy to think that someone could get cancer or something serious happen to them a year or two after receiving the (Pfizer COVID) vaccine, it usually happens within a few weeks if something serious is going to happen, right. Caller states, "I have some concerns. I wound up getting the (Pfizer COVID) vaccine, first one was in Aug2021, second one was in Dec2021 and got COVID about 2 weeks later. I did a ton of research, back and forth. I instantly regretted it after getting the vaccine. I've been reading a lot of articles about recalls with medications and I'm getting nervous. This thing about CEO not divulging information, it feels like he is not being honest, my aunt saw a video where he (the CEO) is caught on tape saying there are more toxins in the vaccine than anticipated but is still putting it through. I don't know there is just something about him that I don't trust. Wouldn't you think it would be weird if the CEO of Pfizer didn't get a Pfizer COVID vaccine but got Moderna or J&J instead. Doesn't that mean he doesn't think it is safe. Why isn't it public knowledge about how many Pfizer employees have received the Pfizer COVID vaccine. Wouldn't Pfizer want the public to know that information to help prove that it is safe. Reporter asked, "could the ingredients in the vaccine still be in the body even after someone's antibodies are gone after they've received the vaccine, for example like a year later. Reporter stated, "I listened to a podcast from a conspiracy theorist about how everyone who received this (Pfizer COVID) vaccine are all going to die within 2-3 years, could that be possible. Reporter asked, "typically when they do trials like for other vaccines, they do it over 5 years, but this one they were able to do quicker is that because they had more people available to run the trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Catheterisation cardiac, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: Vaccine induced myocarditis; This is a literature report.  A 36 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "smoking" (unspecified if ongoing); "prior alcohol use" (unspecified if ongoing); "chronic pancreatitis" (ongoing); "prior COVID-19 infection" (unspecified if ongoing); "median arcuate ligament syndrome (MALS)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Vaccine induced myocarditis". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide (normal high range 100): 4734 pg/mL; catheterisation cardiac: showed normal coronary vasculature; chest x-ray: demonstrated a right pleural effusion; echocardiogram: revealed apical wall akinesis; electrocardiogram: showed a nonspecific st abnormality; epstein-barr virus infection: negative; hiv test: negative; magnetic resonance imaging heart: late gadolinium enhancement (lge) in the basal, notes: anterolateral, mid-anterior and midanterolateral walls; physical examination: rales, abdominal distention and pitting edema; sars-cov-2 test: negative; toxicologic test: negative; troponin (normal high range 17): 19222 ng/L. Therapeutic measures were taken as a result of myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccine induced myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection, HIV test, Magnetic resonance imaging heart, Myocarditis, Physical examination
Clinical narrative: Vaccine induced myocarditis; This is a literature report.  A 36 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "smoking" (unspecified if ongoing); "prior alcohol use" (unspecified if ongoing); "chronic pancreatitis" (ongoing); "prior COVID-19 infection" (unspecified if ongoing); "median arcuate ligament syndrome (MALS)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Vaccine induced myocarditis". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide (normal high range 100): 4734 pg/mL; catheterisation cardiac: showed normal coronary vasculature; chest x-ray: demonstrated a right pleural effusion; echocardiogram: revealed apical wall akinesis; electrocardiogram: showed a nonspecific st abnormality; epstein-barr virus infection: negative; hiv test: negative; magnetic resonance imaging heart: late gadolinium enhancement (lge) in the basal, notes: anterolateral, mid-anterior and midanterolateral walls; physical examination: rales, abdominal distention and pitting edema; sars-cov-2 test: negative; toxicologic test: negative; troponin (normal high range 17): 19222 ng/L. Therapeutic measures were taken as a result of myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccine induced myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Toxicologic test, Troponin
Clinical narrative: Vaccine induced myocarditis; This is a literature report.  A 36 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "smoking" (unspecified if ongoing); "prior alcohol use" (unspecified if ongoing); "chronic pancreatitis" (ongoing); "prior COVID-19 infection" (unspecified if ongoing); "median arcuate ligament syndrome (MALS)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Vaccine induced myocarditis". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide (normal high range 100): 4734 pg/mL; catheterisation cardiac: showed normal coronary vasculature; chest x-ray: demonstrated a right pleural effusion; echocardiogram: revealed apical wall akinesis; electrocardiogram: showed a nonspecific st abnormality; epstein-barr virus infection: negative; hiv test: negative; magnetic resonance imaging heart: late gadolinium enhancement (lge) in the basal, notes: anterolateral, mid-anterior and midanterolateral walls; physical examination: rales, abdominal distention and pitting edema; sars-cov-2 test: negative; toxicologic test: negative; troponin (normal high range 17): 19222 ng/L. Therapeutic measures were taken as a result of myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccine induced myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination Failure; positive for COVID-19 on 17Mar2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: ek9231) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (lot number: 301ssba, route: Intramuscular, administration time: 01:00 PM, dose 1, vaccine location: Left arm), administration date: 11Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (lot number: el3249, route: Intramuscular, administration time: 01:00 PM, dose 2, vaccine location: Left arm), administration date: 03Feb2021, for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Mar2022, outcome "unknown"; COVID-19 (medically significant) with onset 17Mar2022, outcome "unknown", described as "positive for COVID-19 on 17Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2022) Positive, notes: Nasal Swab.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure 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 vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Vaccination Failure; positive for COVID-19 on 17Mar2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: ek9231) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (lot number: 301ssba, route: Intramuscular, administration time: 01:00 PM, dose 1, vaccine location: Left arm), administration date: 11Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (lot number: el3249, route: Intramuscular, administration time: 01:00 PM, dose 2, vaccine location: Left arm), administration date: 03Feb2021, for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Mar2022, outcome "unknown"; COVID-19 (medically significant) with onset 17Mar2022, outcome "unknown", described as "positive for COVID-19 on 17Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2022) Positive, notes: Nasal Swab.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure 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 vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cardiomegaly, Colitis
Clinical narrative: swollen heart; Colitis; stomach problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: CARDIOMEGALY (non-serious), outcome "unknown", described as "swollen heart"; COLITIS (non-serious), outcome "unknown", described as "Colitis"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach problem".  Additional information: Caller stated that she was in line the other day at the grocery store and there was an elderly gentleman in front of her that was telling the cashier that he was going to get his 2nd booster of the Covid vaccine. Caller states that she chimed in the conversation, and he told her that he also had stomach problems which he said was a form of colitis, and he also got a swollen heart after receiving the vaccine. Caller has no further information for this patient. No Lot/Expiry date to provide. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Investigation
Clinical narrative: Graves disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EW0179, Route of administration: Intramuscular), administration date: 24Jul2021, for COVID-19 Immunisation, reaction(s): "trouble sleeping/got out of bed at 2:30AM in the morning and she was wide awake at 4:00AM and not feeling tired, she was wide open", "mood swings up and down, mad, sad, happy", "feels like the wheels in her head are constantly spinning, mind doesn't stop", "headache", "runny nose", "crying", "mood swings up and down, mad, sad, happy", "moodiness", "Wheels in her head are turning", "shaking of the hands and legs", "When confirming side effect with caller, she just added a description stating that the shaking was like if she was nervous". The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "graves disease". The patient underwent the following laboratory tests and procedures: investigation: graves disease.  Clinical course: This report was not related to a study or programme. Caller states that after taking the Pfizer BioNTech covid 19 vaccine she was diagnosed with grave's disease, Patient asked if they have any reports of this side effect? Caller asked if there was somewhere she could report her side effects. Caller displayed frustration that she had been on the phone for 25 minutes and had to listen to a recording for 5 minutes. Consumer stated that she need to find out if there is any reporting of people getting Graves' disease after they had the COVID shot (Pfizer COVID-19 vaccine), as she just recently was diagnosed with Graves' disease. Consumer stated lot number for the second one was EW0172 (clarified and captured in tab), first one EW0179 (confirmed). Product details (Expiration date, NDC and UPC) and other details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. On follow up, patient clarified that Lot, stated, "The first one is EW0179 and second one is exactly the same except there is 0172 (EW0172)." Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Paralysis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown since the vaccination, has the patient been tested for COVID-19. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "Paralyzed"; BLINDNESS (medically significant), outcome "unknown", described as "Lost vision". Clinical course reported: paralyzed, had to get a cochlear transplant, lost vision. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: One of my patient had a Pulmonary embolism after he got vaccinated with Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician).  A male 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: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "One of my patient had a Pulmonary embolism after he got vaccinated with Pfizer vaccine".  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 reported event: "Pulmonary embolism" 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 drug 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: Brain natriuretic peptide, Ejection fraction, Electrocardiogram, Investigation, Magnetic resonance imaging heart
Clinical narrative: Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 39 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 22 pg/mL; ejection fraction: 56 %, notes: Initial; 58 %, notes: Follow-up; electrocardiogram: pr depression, notes: Initial; no st abn, notes: on follow up; investigation (17-37): 32, notes: Units: mL/M2. Initial; 20, notes: Units: mL/M2. Follow-up; investigation: lge along a and l segments, notes: Initial; resolved lge, notes: Follow-up; 970, notes: units: ms; 47, notes: units: ms; magnetic resonance imaging heart: unknown results, notes: Initial. 11 days; unknown results, notes: Follow-up. 200 days; n-terminal prohormone brain natriuretic peptide: 9.6 pg/mL, notes: Follow-up labs; troponin i: 11.0 ng/ml; troponin i: 3.5 ng/L, notes: Follow-up labs; 11.0 ng/ml, notes: Initial labs.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely 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-202200509134 Same article/Event/Drug and different patient;US-PFIZER INC-202200509136 Same article/Event/Drug and different patient;US-PFIZER INC-202200509135 Same article/Event/Drug and different patient
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin I
Clinical narrative: Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 39 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 22 pg/mL; ejection fraction: 56 %, notes: Initial; 58 %, notes: Follow-up; electrocardiogram: pr depression, notes: Initial; no st abn, notes: on follow up; investigation (17-37): 32, notes: Units: mL/M2. Initial; 20, notes: Units: mL/M2. Follow-up; investigation: lge along a and l segments, notes: Initial; resolved lge, notes: Follow-up; 970, notes: units: ms; 47, notes: units: ms; magnetic resonance imaging heart: unknown results, notes: Initial. 11 days; unknown results, notes: Follow-up. 200 days; n-terminal prohormone brain natriuretic peptide: 9.6 pg/mL, notes: Follow-up labs; troponin i: 11.0 ng/ml; troponin i: 3.5 ng/L, notes: Follow-up labs; 11.0 ng/ml, notes: Initial labs.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely 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-202200509134 Same article/Event/Drug and different patient;US-PFIZER INC-202200509136 Same article/Event/Drug and different patient;US-PFIZER INC-202200509135 Same article/Event/Drug and different patient
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Ejection fraction, Electrocardiogram, Investigation, Magnetic resonance imaging heart
Clinical narrative: Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 23 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: Covid-19 vaccine (DOSE 1), for covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 12.1 pg/mL, notes: Initial; ejection fraction: 61 percent, notes: Initial CMR; 62 percent, notes: Follow-up CMR; electrocardiogram: no st abnormality, notes: Follow-up; st-segment elevations, notes: Initial; investigation: notes: mL/m2; Initial CMR; notes: mL/m2; Follow-up CMR; magnetic resonance imaging heart: late gadolinium enhancement; patchy lge a/il segments, notes: Initial CMR; near resolution, lge in mid al segments, notes: Follow-up CMR; magnetic resonance imaging heart: notes: units-ms; Follow-up CMR; magnetic resonance imaging heart: notes: units-ms; Follow-up CMR; n-terminal prohormone brain natriuretic peptide: 6.2 pg/mL, notes: Follow-up; troponin i (normal high range 60.4): 5.2 ng/L, notes: Follow-up; troponin: 16.6 ng/ml, notes: Initial. Clinical course: Intermediate-term (6-month) follow-up demonstrated improvement or resolution of CMR findings of myocarditis.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200508742 Same article/Event/Drug and different patient