chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: severe flu like symptoms; felt sluggish for first 24 hours; low grade fever; severe lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms), SLUGGISHNESS (felt sluggish for first 24 hours), BACK PAIN (severe lower back pain) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had chronic breathing issues. Patient had to go to a pulmonologist and a physical therapist to get better.) on 15-Dec-2020, Ovary removal (Patient had  surgery to get, her left ovary and  fallopian  tube, removed.) in September 2020 and Salpingectomy (Patient had  surgery to get, her left ovary and  fallopian  tube, removed.) in September 2020.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (severe lower back pain). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms), SLUGGISHNESS (felt sluggish for first 24 hours) and PYREXIA (low grade fever). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms) had resolved and SLUGGISHNESS (felt sluggish for first 24 hours), BACK PAIN (severe lower back pain) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, X-ray: normal (normal) Normal.         No concomitant medication was reported. Reported that the patient went  to her primary care physician and he  gave her anti-inflammatory and muscle relaxer, not other wise specified.   This case was linked to MOD-2021-291036 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second shot >36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot >36 days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 091B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot >36 days). On 02-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot >36 days) had resolved.            Treatment information was not reported
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered after 48 days of first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered after 48 days of first dose) and EXTRA DOSE ADMINISTERED (Additional dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 036B21A and 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered after 48 days of first dose). On 18-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Additional dose). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered after 48 days of first dose) had resolved. On 18-Aug-2021, EXTRA DOSE ADMINISTERED (Additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was mentioned.   This case was linked to MOD-2021-290978 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax
Clinical narrative: collapsed lung; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMOTHORAX (collapsed lung) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMOTHORAX (collapsed lung) (seriousness criterion medically significant). At the time of the report, PNEUMOTHORAX (collapsed lung) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. Patient was 24 or 25. Three days after the vaccine patient had a collapsed lung. Patient mother mother, thought it was from the vaccine. No treatment was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Company comment: Very limited information regarding the dates of administration of the product and the serious unexpected event of Cerebrovascular accident has been provided at this time.   This case was linked to MOD-2021-294128, MOD-2021-294118, MOD-2021-294118 (Patient Link).; Sender's Comments: Very limited information regarding the dates of administration of the product and the serious unexpected event of Cerebrovascular accident has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: feel crappy; Vaccination site pruritus; Vaccination site swelling; left arm was very sore; low grade fever; Vaccination site pain; anaphylaxis reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis, Scleritis, Migraine, Headache, Asthma, Diaphragmatic hernia, Antiphospholipid syndrome, Hypertension, ANA, Hashimoto's disease and Anaphylaxis (Anaphylaxis reaction in the past to Levaquin, sulfa, flu shot, latex gloves, pineapple, shrimp, lobster tail, raw tomatoes, most adhesives, and gadolinium contrast dye.). Concurrent medical conditions included Peanut allergy (anaphylaxis reaction - There was twice). Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), DABIGATRAN ETEXILATE MESILATE (PRADAXA), LEFLUNOMIDE, PREDNISONE, MONTELUKAST SODIUM (MONTELUCAST), LEVOTHYROXINE SODIUM (SYNTHROID), SALBUTAMOL SULFATE (VENTORLIN [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), DULOXETINE HYDROCHLORIDE (DULOXETINE [DULOXETINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOPIRAMATE, LOSARTAN, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced FEELING ABNORMAL (feel crappy), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), MYALGIA (left arm was very sore), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), FEELING ABNORMAL (feel crappy), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), MYALGIA (left arm was very sore), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Lab data was not provided Treatment product was not provided by the reporter.  Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: feel crappy; Vaccination site pruritus; Vaccination site swelling; left arm was very sore; low grade fever; Vaccination site pain; anaphylaxis reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis, Scleritis, Migraine, Headache, Asthma, Diaphragmatic hernia, Antiphospholipid syndrome, Hypertension, ANA, Hashimoto's disease and Anaphylaxis (Anaphylaxis reaction in the past to Levaquin, sulfa, flu shot, latex gloves, pineapple, shrimp, lobster tail, raw tomatoes, most adhesives, and gadolinium contrast dye.). Concurrent medical conditions included Peanut allergy (anaphylaxis reaction - There was twice). Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), DABIGATRAN ETEXILATE MESILATE (PRADAXA), LEFLUNOMIDE, PREDNISONE, MONTELUKAST SODIUM (MONTELUCAST), LEVOTHYROXINE SODIUM (SYNTHROID), SALBUTAMOL SULFATE (VENTORLIN [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), DULOXETINE HYDROCHLORIDE (DULOXETINE [DULOXETINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOPIRAMATE, LOSARTAN, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced FEELING ABNORMAL (feel crappy), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), MYALGIA (left arm was very sore), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), FEELING ABNORMAL (feel crappy), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), MYALGIA (left arm was very sore), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Lab data was not provided Treatment product was not provided by the reporter.  Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration in arm on 27Aug2020 as dose 1, single, on 15Sep2020 as dose 2, single for COVID-19 immunization. Medical history included Heart disease, Diabetes, Hormone therapy, Underactive thyroid, all from an unknown date and unknown if ongoing. Concomitant medications included estrogens conjugated (PREMARIN) taken via topical (cream) route for hormone therapy; levothyroxine sodium (SYNTHROID) taken via oral (pill) route for hypothyroidism; both from 2011 and ongoing. Prior vaccination (within 4 weeks) was reported none. On 19Jun2021 the patient experienced bell's palsy. The AE required visit to Emergency room/Physician office. The seriousness of the event was reported as serious (persistent/Significant disability/ Incapacity/Medically Significant). The patient underwent lab tests and procedures which included Blood work: unknown, and computerised tomogram (CT scan): unknown on 19Jun2021, Blood work: unknown on 21Jun2021. Therapeutic measures were taken as a result of bell's palsy, the patient was treated with Prednisone. The clinical outcome of the event was not recovered.  Follow-up attempts completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Mastocytosis
Clinical narrative: Diagonised with  a form of Mastocytosis.  Never taken any medication other than the vaccine. Only trigger described from this disease is medication ie Covid Vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207, expiry date was unknown) dose 1 via an unspecified route of administration arm left on 11Mar2021 12:00 PM (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Facility type vaccine was other. Medical history included asthma (asthma as a child) from an unknown date and unknown if ongoing, allergies: tree nuts from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had no other medications in two weeks. On 31Mar2021, the patient experienced being diagnosed with a form of mastocytosis, never taken any medication other than the vaccine, only trigger described from this disease is medication i.e., covid vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; and patient had hospitalization for 3 days. No treatment was given for event. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533 expiry date was unknown) via an unspecified route of administration at arm left on 01Apr2021 12:00 PM as a dose 2, single for COVID-19 immunisation. Outcome of the event was not recovered.  Information has been requested in follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Extra dose administered, Headache, Off label use
Clinical narrative: Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; DOSE NUMBER 3; DOSE NUMBER 3; This is a spontaneous report from a contactable consumer(patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, in the left arm on 14Aug2021 at 11:15 (at the age of 70-years-old) as dose 3, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. Medical history included diabetes, thyroid disease, high blood pressure all from an unknown date and unknown if ongoing. Known allergies reported for narcotics, opioids. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, cyanocobalamin (VITAMIN B12), vitamin d3 (VITAMIN D3) all taken for an unspecified indication, start and stop date were not reported. Historical vaccines included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, on an unspecified date, as dose 1, single and dose 2, single both for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 15Aug2021 at 19:30 the patient experienced fainted, dizziness, pain at injection site, headache, chills, body aches, and dose number 3 (extra dose administered and off label use). The patient did not receive any treatment for the event. Outcome of the events was recovering.  Information on lot/ batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Syncope, Vaccination site pain
Clinical narrative: Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; Fainted,  Dizziness,  pain at injection site, headache,  chills, body aches,; DOSE NUMBER 3; DOSE NUMBER 3; This is a spontaneous report from a contactable consumer(patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, in the left arm on 14Aug2021 at 11:15 (at the age of 70-years-old) as dose 3, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. Medical history included diabetes, thyroid disease, high blood pressure all from an unknown date and unknown if ongoing. Known allergies reported for narcotics, opioids. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, cyanocobalamin (VITAMIN B12), vitamin d3 (VITAMIN D3) all taken for an unspecified indication, start and stop date were not reported. Historical vaccines included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, on an unspecified date, as dose 1, single and dose 2, single both for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 15Aug2021 at 19:30 the patient experienced fainted, dizziness, pain at injection site, headache, chills, body aches, and dose number 3 (extra dose administered and off label use). The patient did not receive any treatment for the event. Outcome of the events was recovering.  Information on lot/ batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache
Clinical narrative: Headache; vaccine was expired by one day; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 13Aug2021 (Lot Number: EW0196; Expiration Date: 12Aug2021) (at age of 37-year-old )as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took amoxicillin and Aspirin and experienced drug allergies.  The patient experienced vaccine was expired by one day and headache on 13Aug2021. reporter stated that she considered this Medically Significant because even though she gave the expired vaccine, she had the patient stay for 15-20 minutes and the patient still had a headache. Treatment: There was No further treatment needed. The outcome of the event  headache was not resolved. Causality: Yes related, the patient was not having any headache before the vaccine.  Information on the Batch/Lot number has been requested.  Follow-up (16Aug2021): New information reported from a contactable pharmacist includes: reporter updated,patient age, gender, suspect drugs details and event 'headache' added. case was upgrade as serious now.; Sender's Comments: Based on the available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event headache cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block left, Dizziness, Loss of consciousness, Seizure
Clinical narrative: Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; Im now having dizzy spells and passing out and Seizures and I now have a left Bundle Branch Blockage that I know was not the December 31st when I had a hernia surgery. None of these symptoms showed up; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 22Mar2021 at 15:45 (Lot Number: EN6203) at the age of 58-year-old as single dose for COVID-19 immunization. Medical history included anxiety and depression. The patient didn't receive other vaccine in four weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient received medications in two weeks. Known allergies was none. Concomitant medication was not reported. On 03Apr2021 at 14:00, the patient had dizzy spells and passing out and Seizures and had a left bundle branch blockage that the patient was not the 31Dec2021 when he had a hernia surgery. None of these symptoms showed up till after the patient received the Pfizer shot. It was about two weeks after the first shot he started passing out. The events resulted in doctor or other healthcare professional office/clinic visit and hospitalization. Treatment included: Monitored heart and blood pressure took nitro. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: My legs were very achy after covid  after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand.  It comes and goes but when it strikes I can't stand it  the pa; My legs were very achy after covid  after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand.  It comes and goes but when it strikes I can't stand it  the pa; I can't stand it  the pain is terrible; My legs were very achy after covid  after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand.  It comes and goes but when it strikes I can't stand it  the pa; This is spontaneous report from contactable consumer (patient).  A 70-years-old female (pregnant: No) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EK3247) at Left arm as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included covid-19, Penicillin allergies. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Jan2021 09:00 AM (at age of 70 years old) (Lot Number: EK4176) as single dose for covid-19 immunisation.  There were no concomitant medications in two weeks.  Clinical course as reported: My legs were very achy after covid after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand. It comes and goes but when it strikes I can't stand it the pain is terrible and I have a high pain threshold. Adverse event start date was 05Feb2021 08:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment received for events.  Outcome for events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test(Nasal Swab, Rapid test weekly at work): negative on 01Mar2021 (post vaccination).  Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeding disorder, Inappropriate schedule of product administration, Insomnia, Malaise
Clinical narrative: received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021; fever; seizure; I feel so terrible but cannot afford to go to the hospital.; violently shaking; Now over 48 hours later I cannot eat or sleep; Now over 48 hours later I cannot eat or sleep; I have a terrible rash on my right arm where injected; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021 (Lot Number: CUS8955) at the age of 22-year-old as single dose for COVID-19 immunization. Medical history included Celiac and IBS. Known allergy include gluten. The patient didn't receive other vaccine in four weeks. The patient previously received Gluten and experienced allergy. The patient COVID prior vaccination. The patient didn't  perform COVID test post vaccination. Concomitant medication included multivitamin once a day. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021 at 04:00 PM at the age of 22-year-old as single dose for COVID-19 immunization. On 15Aug2021 at 03:00 AM, with the second dose however, he woke up violently shaking almost seizure like at 3 am the morning after receiving second dose. Now over 48 hours later he cannot eat or sleep. The patient have a terrible rash on right arm where injected. He had difficulty breathing and worse symptoms than previously contracting COVID 19; when it first began In February. This was he being a voice advocating for those without healthcare assistance. He felt so terrible but cannot afford to go to the hospital. The only symptom that has subsided has been the fever. Everything else was just as bad as when it first began. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of inappropriate schedule of vaccine administered was unknown. The outcome of fever was recovered. The outcome of other events was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Tremor, Vaccination site rash
Clinical narrative: received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021; fever; seizure; I feel so terrible but cannot afford to go to the hospital.; violently shaking; Now over 48 hours later I cannot eat or sleep; Now over 48 hours later I cannot eat or sleep; I have a terrible rash on my right arm where injected; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021 (Lot Number: CUS8955) at the age of 22-year-old as single dose for COVID-19 immunization. Medical history included Celiac and IBS. Known allergy include gluten. The patient didn't receive other vaccine in four weeks. The patient previously received Gluten and experienced allergy. The patient COVID prior vaccination. The patient didn't  perform COVID test post vaccination. Concomitant medication included multivitamin once a day. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021 at 04:00 PM at the age of 22-year-old as single dose for COVID-19 immunization. On 15Aug2021 at 03:00 AM, with the second dose however, he woke up violently shaking almost seizure like at 3 am the morning after receiving second dose. Now over 48 hours later he cannot eat or sleep. The patient have a terrible rash on right arm where injected. He had difficulty breathing and worse symptoms than previously contracting COVID 19; when it first began In February. This was he being a voice advocating for those without healthcare assistance. He felt so terrible but cannot afford to go to the hospital. The only symptom that has subsided has been the fever. Everything else was just as bad as when it first began. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of inappropriate schedule of vaccine administered was unknown. The outcome of fever was recovered. The outcome of other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Neutropenia
Clinical narrative: neutropenia; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had multiple comorbidities. On an unspecified date within 2 weeks of vaccination the patient experienced neutropenia, assessed as medically significant. At the time of the reported the event outcome was unknown.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: The event neutropenia is considered not related to BNT162B2 per current available information.  The event is more likely an intercurrent medical condition. 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer from a program. A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced symptoms of COVID-19 on 07Aug2021 and received two rapid antigen tests and a PCR test to determine presence of COVID-19 infection. Caller stated both rapid tests came back negative, but the PCR test resulted positive on 15Aug2021. The patient 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.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic increased, Blood pressure measurement, Blood pressure systolic increased, Cardiac disorder, Dyspnoea
Clinical narrative: Constant Feeling as if I was going to die because my heart was going to explode; Constant Feeling as if I was going to die because my heart was going to explode; Rapid irregular heartbeat Between 106 and 140 bpm; Increased diastolic and systolic blood pressure 158/114; Increased diastolic and systolic blood pressure 158/114; Shortness of breath; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 26Jul2021 at 12:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 30-year-old. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced rapid irregular heartbeat between 106 and 140 bpm, his normal pulse was about 70 bpm; experienced Increased diastolic and systolic blood pressure 158/114, his normal blood pressure 105/65- 120/75; experienced shortness of breath and fatigue and constant feeling as if he was going to die because her heart was going to explode; all events were on 28Jul2021 at 12:00. The events resulted in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome and treatment were unknown. The events reported as non-serious.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Near death experience
Clinical narrative: Constant Feeling as if I was going to die because my heart was going to explode; Constant Feeling as if I was going to die because my heart was going to explode; Rapid irregular heartbeat Between 106 and 140 bpm; Increased diastolic and systolic blood pressure 158/114; Increased diastolic and systolic blood pressure 158/114; Shortness of breath; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 26Jul2021 at 12:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 30-year-old. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced rapid irregular heartbeat between 106 and 140 bpm, his normal pulse was about 70 bpm; experienced Increased diastolic and systolic blood pressure 158/114, his normal blood pressure 105/65- 120/75; experienced shortness of breath and fatigue and constant feeling as if he was going to die because her heart was going to explode; all events were on 28Jul2021 at 12:00. The events resulted in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome and treatment were unknown. The events reported as non-serious.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Fatigue, Insomnia
Clinical narrative: mental fogginess; Always tired; shortness of breath (waking in middle of the night unable to catch breath); bad anxiety with problems sleeping; problems sleeping; vision not as clear; dizziness; irregular ekg; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 10:00 AM (Lot Number: EW0150) at the age of 57-year-old as single dose for COVID-19 immunization. Medical history included asthma, type 2 diabetes, IBS & Gerd and psoriasis. known allergy included Codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient perform nasal swab on 03Aug2021 and result was negative. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medication included sitagliptin phosphate (JANUVIA), fluticasone propionate (FLOVENT), ramipril and alprazolam (XANAX). The patient previously received codeine and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 19Mar2021 at 10:00 AM (Lot Number: EN6207) at the age of 57-year-old as single dose for COVID-19 immunization and no events reported. On 15Apr2021 at 10:00, the patient experienced always tired, shortness of breath (waking in middle of the night unable to catch breath), bad anxiety with problems sleeping, mental fogginess, vision not as clear, dizziness, and irregular ekg. Treatment was unknown whether received. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Visual impairment
Clinical narrative: mental fogginess; Always tired; shortness of breath (waking in middle of the night unable to catch breath); bad anxiety with problems sleeping; problems sleeping; vision not as clear; dizziness; irregular ekg; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 10:00 AM (Lot Number: EW0150) at the age of 57-year-old as single dose for COVID-19 immunization. Medical history included asthma, type 2 diabetes, IBS & Gerd and psoriasis. known allergy included Codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient perform nasal swab on 03Aug2021 and result was negative. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medication included sitagliptin phosphate (JANUVIA), fluticasone propionate (FLOVENT), ramipril and alprazolam (XANAX). The patient previously received codeine and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 19Mar2021 at 10:00 AM (Lot Number: EN6207) at the age of 57-year-old as single dose for COVID-19 immunization and no events reported. On 15Apr2021 at 10:00, the patient experienced always tired, shortness of breath (waking in middle of the night unable to catch breath), bad anxiety with problems sleeping, mental fogginess, vision not as clear, dizziness, and irregular ekg. Treatment was unknown whether received. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Lung disorder, Pneumonia, SARS-CoV-2 test
Clinical narrative: lung/coughing issues; Pneumonia; Coughing issues; wheezing; throwing up; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-year-old female patient received BNT162B2 via an unspecified route of administration on 19Apr2021 13:15 (at 59-year-old) (Lot Number: EN6207) as dose 2, single in arm left for COVID-19 immunisation. Medical history included thyroid disorder. Concomitant medication included estradiol; levothyroxine sodium (SYNTHROID); lorazepam (ATIVAN); allium sativum bulb/ ascorbic acid/ colecalciferol/ echinacea purpurea whole plant/ piper nigrum fruit/ sambucus nigra fruit/ zinc citrate (IMMUNETI). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 via an unspecified route of administration in Apr2020 13:15 (at 59-year-old) (Lot Number: EN6199) as dose 1, single in arm left for COVID-19 immunisation. Prior to vaccination, the patient wasn't diagnosed with COVID-19. On 05May2021, doctor diagnosed with pneumonia given two antibiotics ambutral Nasal PE tabs OTC. On 19Jul2021 chest X ray pneumonia in the right lung another antibiotic. Talked with nurse on 05Aug2021, still having lung/coughing issues (lung issue from 19Jul2021), fluticasone 50 Claritin. Coughing only got worse, to the point of wheezing, throwing up from 02May2021. More first thing in the morning and late evening. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received 3 different antibiotic Nasal PE tabs in total as treatment. The patient tested negative for COVID-19 on 12Aug2021 since vaccination. The outcome of the events was not resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wheezing
Clinical narrative: lung/coughing issues; Pneumonia; Coughing issues; wheezing; throwing up; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-year-old female patient received BNT162B2 via an unspecified route of administration on 19Apr2021 13:15 (at 59-year-old) (Lot Number: EN6207) as dose 2, single in arm left for COVID-19 immunisation. Medical history included thyroid disorder. Concomitant medication included estradiol; levothyroxine sodium (SYNTHROID); lorazepam (ATIVAN); allium sativum bulb/ ascorbic acid/ colecalciferol/ echinacea purpurea whole plant/ piper nigrum fruit/ sambucus nigra fruit/ zinc citrate (IMMUNETI). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 via an unspecified route of administration in Apr2020 13:15 (at 59-year-old) (Lot Number: EN6199) as dose 1, single in arm left for COVID-19 immunisation. Prior to vaccination, the patient wasn't diagnosed with COVID-19. On 05May2021, doctor diagnosed with pneumonia given two antibiotics ambutral Nasal PE tabs OTC. On 19Jul2021 chest X ray pneumonia in the right lung another antibiotic. Talked with nurse on 05Aug2021, still having lung/coughing issues (lung issue from 19Jul2021), fluticasone 50 Claritin. Coughing only got worse, to the point of wheezing, throwing up from 02May2021. More first thing in the morning and late evening. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received 3 different antibiotic Nasal PE tabs in total as treatment. The patient tested negative for COVID-19 on 12Aug2021 since vaccination. The outcome of the events was not resolved.