chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Patient was hospitalized due to pneumonia 6 days after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Lung infection NOS. Concomitant products included IMIPRAMINE for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) (seriousness criteria hospitalization and medically significant). On 01-May-2021, PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Antibiotics and Steroids.  Very limited information regarding this event has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia aspiration, Vaccination complication
Clinical narrative: aspirating lungs due to Pneumonia; vaccination complication; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMONIA ASPIRATION (aspirating lungs due to Pneumonia) and VACCINATION COMPLICATION (vaccination complication) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), PREDNISONE and PENTOXIFYLLINE for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA ASPIRATION (aspirating lungs due to Pneumonia) (seriousness criteria hospitalization and medically significant) and VACCINATION COMPLICATION (vaccination complication) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA ASPIRATION (aspirating lungs due to Pneumonia) and VACCINATION COMPLICATION (vaccination complication) outcome was unknown.            No known allergies were reported Concomitant product include "lymphatics". Treatment information was not  provided. Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-138790 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). The patient was hospitalized on 28-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter. Treatment information was not provided.  Patient doctor suggested to wait for 3 months for the second shot.  Although a temporal association exists, based on the current available information, due to biological implausibility the event of COVID-19  is assessed as not applicable to mRNA-1273.   Reporter did not allow further contact; Sender's Comments: Although a temporal association exists, based on the current available information, due to biological implausibility the event of COVID-19  is assessed as not applicable to mRNA-1273.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Night sweats
Clinical narrative: Night sweats; Tiredness; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), FATIGUE (Tiredness) and MYALGIA (Sore left arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) for Birth control, ZOLPIDEM TARTRATE (AMBIEN), CLONAZEPAM, vitamin D and Multivitamin.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and MYALGIA (Sore left arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL A) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 05-Mar-2021, NIGHT SWEATS (Night sweats), FATIGUE (Tiredness) and MYALGIA (Sore left arm) had resolved.            On an unknown date, chest x-ray and blood work was completed, no results 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.   This case was linked to MOD-2021-138830 (Patient Link).; 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Hepatomegaly, Nausea, Ultrasound scan
Clinical narrative: Significant difference in his crohns where he had been well controlled for all these years; Liver is enlarged, again; Feel nausea pretty regularly after the second vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Significant difference in his crohns where he had been well controlled for all these years) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker (stopped smoking) and Liver enlargement. Concurrent medical conditions included Crohn's (Since 25-30 years).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Significant difference in his crohns where he had been well controlled for all these years) (seriousness criterion medically significant), HEPATOMEGALY (Liver is enlarged, again) and NAUSEA (Feel nausea pretty regularly after the second vaccine). At the time of the report, CROHN'S DISEASE (Significant difference in his crohns where he had been well controlled for all these years), HEPATOMEGALY (Liver is enlarged, again) and NAUSEA (Feel nausea pretty regularly after the second vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) Liver is enlarged.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-138883 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Performance status decreased, Weight decreased
Clinical narrative: turned into a skeleton, all pants got loose; became very week/feeble; acute shortness of breath; Cannot perform daily activities smoothly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (became very week/feeble), DYSPNOEA (acute shortness of breath) and WEIGHT DECREASED (turned into a skeleton, all pants got loose) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (became very week/feeble) (seriousness criterion hospitalization), DYSPNOEA (acute shortness of breath) (seriousness criterion hospitalization), WEIGHT DECREASED (turned into a skeleton, all pants got loose) (seriousness criterion hospitalization) and PERFORMANCE STATUS DECREASED (Cannot perform daily activities smoothly). The patient was hospitalized from 13-Apr-2021 to 17-Apr-2021 due to ASTHENIA and DYSPNOEA. At the time of the report, ASTHENIA (became very week/feeble), DYSPNOEA (acute shortness of breath), WEIGHT DECREASED (turned into a skeleton, all pants got loose) and PERFORMANCE STATUS DECREASED (Cannot perform daily activities smoothly) had not resolved.            No concomitant medications were provided by the reporter.   Patient condition got worst by 12 Apr 2021. Patient discharged from the hospital with no improvement in health condition. Patient was suffering badly and could not perform daily activities smoothly. Treatment medications were not reported.  Very limited information regarding this events has been provided at this time. However, this patient's advanced age remains a confounder. Further information can't be  requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, this patient's advanced age remains a confounder. Further information can't be  requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Mobility decreased
Clinical narrative: Massive stroke; Still trying to get back his mobility; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criteria hospitalization, medically significant and life threatening) and MOBILITY DECREASED (Still trying to get back his mobility). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) and MOBILITY DECREASED (Still trying to get back his mobility) outcome was unknown.            Patient had a massive stroke a few weeks after receiving the second shot and was hospitalized. He was still trying to get back his mobility. Patient has had complications with any past surgery, commonly occurring as blood clots in his lungs.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding this event has been provided at this time. However subject's history of blood clots in his lungs can be a confounding factor. No further information is expected at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-142295 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. However subject's history of blood clots in his lungs can be a confounding factor. No further information is expected at this time. US-MODERNATX, INC.-MOD-2021-142295:crosslinked; niece
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: High heart rate/Heart rate 130-140; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (High heart rate/Heart rate 130-140) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HEART RATE INCREASED (High heart rate/Heart rate 130-140) (seriousness criterion hospitalization). The patient was hospitalized from 13-May-2021 to 17-May-2021 due to HEART RATE INCREASED. The patient was treated with METOPROLOL TARTRATE ongoing since an unknown date at a dose of 25 mg; APIXABAN (ELIQUIS) ongoing since an unknown date at a dose of 5 mg and FUROSEMIDE ongoing since an unknown date at a dose of 40 mg. On 13-May-2021, HEART RATE INCREASED (High heart rate/Heart rate 130-140) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 130-140 (High) 130-140.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEART RATE INCREASED (High heart rate/Heart rate 130-140) to be possibly related.    Concomitant product use was not provided by the reporter. Doctor stated that the event happened due to the vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram thorax, Cough, Dyspnoea, Full blood count normal
Clinical narrative: Large R pleural effusion; Worsening shortness of breath; cough; This spontaneous case was reported by an other health care professional and describes the occurrence of PLEURAL EFFUSION (Large R pleural effusion) and DYSPNOEA (Worsening shortness of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer in 2007, Restless leg syndrome, Tobacco user, Neuropathy, Hyperlipidemia and Radiation therapy in 2010. Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus (TYPE 2). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), GABAPENTIN, IRBESARTAN, ROPINIROLE, INSULIN GLARGINE (LANTUS), METOPROLOL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PLEURAL EFFUSION (Large R pleural effusion) (seriousness criterion hospitalization), DYSPNOEA (Worsening shortness of breath) (seriousness criterion medically significant) and COUGH (cough). The patient was hospitalized for 1 day due to PLEURAL EFFUSION. At the time of the report, PLEURAL EFFUSION (Large R pleural effusion), DYSPNOEA (Worsening shortness of breath) and COUGH (cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Confluent right hilar lymphadenopathy and a large effusion was seen. On an unknown date, Computerised tomogram thorax: abnormal (abnormal) abnormal. On an unknown date, Full blood count normal: normal (normal) normal. On an unknown date, Metabolic function test normal: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Cytology was significant for reactive mesothelial cells and negative for any malignancy. confluent right hilar lymphadenopathy and a large effusion was seen.  Company Comment: 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.   This case was linked to MOD-2021-162944 (Patient Link).; 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Pleural effusion, SARS-CoV-2 test
Clinical narrative: Large R pleural effusion; Worsening shortness of breath; cough; This spontaneous case was reported by an other health care professional and describes the occurrence of PLEURAL EFFUSION (Large R pleural effusion) and DYSPNOEA (Worsening shortness of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer in 2007, Restless leg syndrome, Tobacco user, Neuropathy, Hyperlipidemia and Radiation therapy in 2010. Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus (TYPE 2). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), GABAPENTIN, IRBESARTAN, ROPINIROLE, INSULIN GLARGINE (LANTUS), METOPROLOL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PLEURAL EFFUSION (Large R pleural effusion) (seriousness criterion hospitalization), DYSPNOEA (Worsening shortness of breath) (seriousness criterion medically significant) and COUGH (cough). The patient was hospitalized for 1 day due to PLEURAL EFFUSION. At the time of the report, PLEURAL EFFUSION (Large R pleural effusion), DYSPNOEA (Worsening shortness of breath) and COUGH (cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Confluent right hilar lymphadenopathy and a large effusion was seen. On an unknown date, Computerised tomogram thorax: abnormal (abnormal) abnormal. On an unknown date, Full blood count normal: normal (normal) normal. On an unknown date, Metabolic function test normal: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Cytology was significant for reactive mesothelial cells and negative for any malignancy. confluent right hilar lymphadenopathy and a large effusion was seen.  Company Comment: 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.   This case was linked to MOD-2021-162944 (Patient Link).; 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: Drug ineffective; COVID-19; fell sick with COVID-19; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient received both doses of vaccine, however before the second dose could achieve full efficacy he fell sick with COVID-19. Now since the second vaccine likely could attain it's full efficacy before getting COVID-19. The reporter asked "what is the recommendation for his vaccine schedule? Should he get 1 more dose, redo the whole schedule of two doses, or no doses? What are you recommending for patients who get COVID-19 despite receiving all two doses and allowing time for immunity? We do not have titers available". The outcome of event was unknown.   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 have been completed and no further information is expected.; Sender's Comments: Based on the strong temporal association and known safety profile of the vaccine, the event COVID-19 is considered related to the vaccine BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma flare up/asthma; This is a spontaneous report received from a contactable consumer (patient's mother). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunization. The patient medical history included asthma. Concomitant medications were not reported. It was reported that patient second dose would be due on 16Feb2021. On an unspecified date in 2021 it was reported as patient was prescribed prednisone in between her first and second dose for her asthma flare up. She wanted to know if that would diminish the vaccine efficacy, prednisone lowers the immunity. Outcome of the event was unknown.  Follow-up (26Feb2021): New information reported includes an update about reporter information.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: headache; nausea; tiredness; muscle pain; feeling unwell; This is a spontaneous report received from a contactable consumer (patient) via medical information team.   A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9264) via an unspecified route of administration in the left arm on 09Feb2021 at 01:45 PM as FIRST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. On 10Feb2021 at 09:15 AM, the patient experienced feeling unwell with headache, nausea, tiredness, and muscle pain. The patient did not receive any treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Impressive muscular pain after heavy, but normal for me, exercise; odd muscular pain in legs after exercise; This is a spontaneous report from a contactable physician (Patient himself). A 55-year-old male patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321) (age at vaccination 55 year) intramuscular in arm,  both as single dose for covid-19 immunisation. Medical history included coeliac disease from 2009 and IgA nephropathy very mild from 2020, both ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient has not received any other vaccine within four weeks and not other medication within two weeks.  The patient experienced odd muscular pain in legs after exercise on 10Jan2021 12:00 and on 11Jan2021 12:00 impressive muscular pain after heavy, but normal for patient, exercise.  The patient underwent lab tests and procedures which included COVID-19 (Nasal swab) test: negative on. The outcome of event leg pain was unknown, of other event was recovered. Reporter consider that the Pfizer product had not had a causal effect to the adverse event.   Follow-up (07May2021): Follow-up attempts completed. No further information expected.  Follow-up (PRD 26Apr2021): New information form a contactable physician (patient) included: route of administration, second dose date of vaccine, non serious event myalgia, reporter's causality.  No Follow up attempts needed. No further information is expected.; Sender's Comments: The events event leg pain  and myalgia considered intercurrent conditions and unlikely related to both both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Hypoaesthesia, Pain, Urticaria
Clinical narrative: recurrent idiopathic hives since being vaccinated; recurrent idiopathic hives since being vaccinated; numbness in arm and face for 2 hours after vaccination; Pain when breathing 8 hours after vaccine; This is a spontaneous report from a non-contactable consumer (Patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported) via an unspecified route of administration on 24Feb2021 (at the age of 27-year-old) as single dose for COVID-19 immunization. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported) via an unspecified route of administration in left arm on 21Jan2021 as single dose for COVID-19 immunization.Medical history included psoriatic arthritis, idiopathic autoimmune hives, allergies to bactrim, penicillin, peanuts, shellfish, watermelon. Concomitant medications included Humira, prednisone, Zyrtec. It was reported that 1st dose facial numbness for 13 hours 2nd dose numbness in arm and face for 2 hours after vaccination. Pain when breathing 8 hours after vaccine Now have recurrent idiopathic hives since being vaccinated. AE treatment allergy medication included epi pen, allergy testing. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient has not been tested for COVID-19 post the vaccination as well as prior to vaccination. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose abnormal, Blood glucose decreased, Blood pressure increased, Dyspnoea
Clinical narrative: Blood pressure shot up to 165/110, there were several measurements taken and most of them were in the range of 158/95 to 165/110; Blood sugar level it was 50; Pulse shot up to about 100; Tingling sensation after about 15 minutes at the site of the shot.; tingling was followed by severe shortness of breath; Feeling of numbness in my lower legs; Extreme weakness; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 47-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9264, Pfizer NTEC), via an unspecified route of administration in Arm Left on 22Feb2021 14:45 as 1st dose, single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. The patient do not have COVID prior to vaccination. Since vaccination , the patient was not tested for COVID-19. On 22Feb2021, at 15:00, after about 15 minutes, the patient experienced tingling sensation at the site of the shot, tingling was followed by severe shortness of breath, Pulse shot up to about 100, Blood pressure shot up to 165/110, there were several measurements taken and most of them were in the range of 158/95 to 165/110, feeling of numbness in the lower legs, Extreme weakness. When the emergency staff checked the blood sugar level it was 50, although she had taken lunch before the shot. Adverse events resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for adverse events. The outcome of the events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: Blood pressure shot up to 165/110, there were several measurements taken and most of them were in the range of 158/95 to 165/110; Blood sugar level it was 50; Pulse shot up to about 100; Tingling sensation after about 15 minutes at the site of the shot.; tingling was followed by severe shortness of breath; Feeling of numbness in my lower legs; Extreme weakness; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 47-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9264, Pfizer NTEC), via an unspecified route of administration in Arm Left on 22Feb2021 14:45 as 1st dose, single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. The patient do not have COVID prior to vaccination. Since vaccination , the patient was not tested for COVID-19. On 22Feb2021, at 15:00, after about 15 minutes, the patient experienced tingling sensation at the site of the shot, tingling was followed by severe shortness of breath, Pulse shot up to about 100, Blood pressure shot up to 165/110, there were several measurements taken and most of them were in the range of 158/95 to 165/110, feeling of numbness in the lower legs, Extreme weakness. When the emergency staff checked the blood sugar level it was 50, although she had taken lunch before the shot. Adverse events resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for adverse events. The outcome of the events were recovering.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive/ Not knowing I was already affected, I took the second shot; tested positive/ Not knowing I was already affected, I took the second shot; This is a s spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date and dose 2 on 28Feb2021 via an unspecified route of administration (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient was tested positive on 01Mar2021. He/she took the second shot of vaccine yesterday but already develop symptoms of dry cough that started 27Feb2021 Saturday. Patient was not knowing he/she was already affected, he/she took the second shot. With no fever but mild dry cough on day 3, patient thought it was working.  Outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Myalgia, Pain, Vomiting
Clinical narrative: muscle aches and pain; 1 day of vomiting; severe pain in stomach and side; severe pain in stomach and side; 3 days of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN 6203), via an unspecified route of administration on 20Feb2021 10:30 (at the age of 72-years) as 2nd dose, single dose in Arm Left for covid-19 immunization. Medical history included anxiety and depression. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included potassium chloride, buspirone hydrochloride (Buspiron), omeprazole and prazosin. The patient previously received first dose of BNT162B2 (Lot number: EL 8982), via an unspecified route of administration on 30Jan2021 at 14:45 (at the age of 72-years) as single dose in the right arm for COVID-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. On 22Feb2021 22:00, the patient experienced muscle aches and pain, 1 day of vomiting, severe pain in stomach and side, 3 days of diarrhea. No therapeutic measures were taken for the events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events was recovered with sequelae on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.  Amendment (19May2021): This follow-up report is being submitted to amend previously reported information: reporter details updated, patient's age captured as 72 years per event's onset 22Feb2021, updated past drug event to historical vaccine (stop date captured as 30Jan2021, age captured 72 years per vaccination date 30Jan2021), stop date of suspect vaccine captured as 20Feb2021 10:30, dose description updated from 2nd dose, unknown to 2nd dose, single; unknown removed from route field, updated Obtain Drug Country/ Drug Authorization Country for concomitants to blank, buspirone was re-coded as BUSPIRON [BUSPIRONE HYDROCHLORIDE], event's treatment captured as no, concomitant therapy: yes was updated as blank and narrative updated.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 12 hrs after receiving the first dose, noticed welts on the same arm as the injection site. About 4 welts carrying in size. Not red or itchy/had hives on her arm, not red or itchy; This is a spontaneous report from a contactable consumer (patient).A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206, expiration date not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 08:45 AM (31 years age at vaccination) as single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Concomitant medications included drospirenone, ethinylestradiol birth control (GIANVI), Health hair product and an unspecified energy supplement, all taken for an unspecified indication. On 17Mar2021, at 9:30 PM, (12 hours of vaccination), the patient experienced hives on her arm which she elaborated as welts on the same arm as the injection site. About 4 welts carried in size and were not red or itchy. She monitored them for 3 hrs and they did not change in size at all. Treatment medication was not received. The outcome of the event was reported as recovered the next morning (18Mar2021).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dry throat, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 22Mar2021; Tested positive for COVID on 22Mar2021; Mild discomfort in throat; Mild discomfort in throat/It was starting to get dry; This is a spontaneous report from two contactable consumer (patient father and patient). This report is to capture information for son. A 20-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6206, Expiration date: 30Jun2021) via intramuscular route in left arm on 16Mar2021 (at the age of 20-year-old) at a 0.3ML single dose, (Lot Number: EN6203, pending clarification) for covid-19 immunization. The patient had no medical history. Concomitant medications were not reported. On 20Mar2021, 4 days after receiving the shot the patient experienced mild discomfort in his throat but had no coughing and was starting to get dry and patient got tested positive for COVID on 22Mar2021. The outcome of the events mild discomfort in throat, it was starting to get dry was recovering and rest of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Ear disorder, Immune thrombocytopenia, Pain in extremity, Platelet count
Clinical narrative: I have ITP; Platelets dropped to 34 before rebounding to just over 100; I also developed a problem in my ankle & foot requiring prednisone within two weeks of the vaccine, then behind my ear; I also developed a problem in my ankle & foot; I also developed a problem in my ankle & foot; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15Feb2021 at 24:00 (Batch/Lot Number: EL3246; Expiration Date: 30Apr2021) as a single dose for covid-19 immunization. Medical history included chronic idiopathic immune thrombocytopenia Purpura, history of cancer and bowel blockage. The patient's concomitant medications were not reported. No other medications taken in two weeks of vaccination. No Covid prior vaccination and not tested for Covid post vaccination. The patient previously took clarithromycin (MACROBID) as antibiotic and experienced drug allergy. On 17Feb2021, the patient had ITP, because she had seen reports of the vaccine triggering the platelet problem, she went to her doctor for a base count a few days before and she was at 84. She went 3 times a week after receiving the shot. Platelets dropped to 34 before rebounding to just over 100. She did not receive the second vaccine. She also developed a problem in her ankle & foot requiring prednisone within two weeks of the vaccine, then behind her ear. She had pictures. No treatment was received. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: I have ITP; Platelets dropped to 34 before rebounding to just over 100; I also developed a problem in my ankle & foot requiring prednisone within two weeks of the vaccine, then behind my ear; I also developed a problem in my ankle & foot; I also developed a problem in my ankle & foot; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15Feb2021 at 24:00 (Batch/Lot Number: EL3246; Expiration Date: 30Apr2021) as a single dose for covid-19 immunization. Medical history included chronic idiopathic immune thrombocytopenia Purpura, history of cancer and bowel blockage. The patient's concomitant medications were not reported. No other medications taken in two weeks of vaccination. No Covid prior vaccination and not tested for Covid post vaccination. The patient previously took clarithromycin (MACROBID) as antibiotic and experienced drug allergy. On 17Feb2021, the patient had ITP, because she had seen reports of the vaccine triggering the platelet problem, she went to her doctor for a base count a few days before and she was at 84. She went 3 times a week after receiving the shot. Platelets dropped to 34 before rebounding to just over 100. She did not receive the second vaccine. She also developed a problem in her ankle & foot requiring prednisone within two weeks of the vaccine, then behind her ear. She had pictures. No treatment was received. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis
Clinical narrative: Pt States flare  after covid vaccine; This is a spontaneous report from a contactable other hcp (nurse, reported for herself. A 59-years old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE for covid-19 immunization. The patient also received tofacitinib citrate (XELJANZ XR), oral from Mar2021 (Lot Number: Unknown; Expiration Date: 30Jan2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. Medical history included leukocytosis, hypertension, staphylococcal infection, Anaphylaxis from an unknown date, the patient had an unspecified surgery for ankle, also had rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. On an unknown date, the patient states flare after covid vaccine. Patient states off medication for 1 week after covid vaccine. The outcome of the event was unknown at the time of report.  No Follow-up attempts are needed. No Information about lot/batch number cannot be obtained.; Sender's Comments: The reported event flare up arthritis is assessed as unrelated to suspected drug BNT162b2 based from known patient's medical history or 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: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received her first dose of BNT162B2 and was scheduled to receive her second dose on 06May2021. The patient stated she was currently at an appointment with a nurse practitioner regarding a sinus infection and the nurse practitioner wanted her to have a steroid injection. The patient reported that sinus infections were a "normal thing for her" and that this had nothing to do with the vaccine. The patient wanted to know if a steroid injection would interact with BNT162B2. The clinical outcome of sinus infection was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information the event sinus infection is attributed to an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Skin burning sensation, Skin discolouration, Skin exfoliation
Clinical narrative: This male patient of unspecified age, reported as 33, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that on his both hands he had a reaction after getting the first dose of the vaccine. He stated that he had something like a chemical burn underneath his skin; his hands turned pink with painful sores, had brown spots around hand and his skin peeled off. He reported that "now" it is bright pink, and skin fell off, further reporting he had one line that was dark that hurt and he thought that it was a muscle. The clinical outcomes of something like a chemical burn underneath his skin, his hands turned pink with painful sores/brown spots around hand/ it was bright pink/one line that was dark, one line that was dark that hurts and he thought that it was a muscle, and skin peeled off were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: This male patient of unspecified age, reported as 33, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that on his both hands he had a reaction after getting the first dose of the vaccine. He stated that he had something like a chemical burn underneath his skin; his hands turned pink with painful sores, had brown spots around hand and his skin peeled off. He reported that "now" it is bright pink, and skin fell off, further reporting he had one line that was dark that hurt and he thought that it was a muscle. The clinical outcomes of something like a chemical burn underneath his skin, his hands turned pink with painful sores/brown spots around hand/ it was bright pink/one line that was dark, one line that was dark that hurts and he thought that it was a muscle, and skin peeled off were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site pain, Skin discolouration, Swelling
Clinical narrative: pain at site and down most of deltoid....dark bruise enlarged for few days and got more spread out. Purple and 7 days later still size of a penny and starting to absorb and look slight yellow within the purple