chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Chronic obstructive pulmonary disease, Computerised tomogram, Dizziness
Clinical narrative: numbness is in both hands, but the right hand is worse; developed afib; was told he developed COPD/he had mild COPD years ago; diagnosed with pneumonia; shortness of breath; wheezing; dizziness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration into right arm on 05Mar2021 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Medical history included diabetic, arthritis in hip and back, shingles, ongoing mild chronic obstructive pulmonary disease (COPD) started years ago. There were no concomitant medications. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810) into left arm on 13Feb2021 (at the age of 75-year-old) for COVID-19 immunization and experienced no adverse effect; influenza vaccine (INFLUENZA VACCINE), pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) and tetanus vaccine (TETANUS VACCINE); all on an unspecified date for immunization and patient experienced no adverse effect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the vaccine. On 06Mar2021, patient experienced shortness of breath, wheezing and dizziness. On an unspecified date patient also experienced numbness is in both hands, but the right hand is worse. Patient was brought to the emergency room on an unspecified date where he was told that he developed afib (atrial fibrillation) and COPD (chronic obstructive pulmonary disease) to which the patient stated he had mild COPD years ago. On 09Mar2021,patient had a chest X-ray and was told he has pneumonia. The patient was hospitalized for the events reported from 09Mar2021 to 12Mar2021 and was treated with SPIRIVA RESPIMAT inhaled 2 puffs by mouth 1 time each day, PROAIR HFA two puffs by mouth every 4 hours as needed for shortness of breath, APIXABAN one tab by mouth every 12 hours and some medications (unspecified). The patient underwent lab tests and procedures which included computerised tomogram: no blood clots on an unspecified date, electrocardiogram: unknown results on an unspecified date, SARS-CoV-2 test: unknown results on an unspecified date. Outcome of event dizziness was recovered on an unspecified date; event "numbness is in both hands, but the right hand is worse" was not recovered; while for all other events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Hypoaesthesia, Pneumonia, SARS-CoV-2 test
Clinical narrative: numbness is in both hands, but the right hand is worse; developed afib; was told he developed COPD/he had mild COPD years ago; diagnosed with pneumonia; shortness of breath; wheezing; dizziness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration into right arm on 05Mar2021 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Medical history included diabetic, arthritis in hip and back, shingles, ongoing mild chronic obstructive pulmonary disease (COPD) started years ago. There were no concomitant medications. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810) into left arm on 13Feb2021 (at the age of 75-year-old) for COVID-19 immunization and experienced no adverse effect; influenza vaccine (INFLUENZA VACCINE), pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) and tetanus vaccine (TETANUS VACCINE); all on an unspecified date for immunization and patient experienced no adverse effect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the vaccine. On 06Mar2021, patient experienced shortness of breath, wheezing and dizziness. On an unspecified date patient also experienced numbness is in both hands, but the right hand is worse. Patient was brought to the emergency room on an unspecified date where he was told that he developed afib (atrial fibrillation) and COPD (chronic obstructive pulmonary disease) to which the patient stated he had mild COPD years ago. On 09Mar2021,patient had a chest X-ray and was told he has pneumonia. The patient was hospitalized for the events reported from 09Mar2021 to 12Mar2021 and was treated with SPIRIVA RESPIMAT inhaled 2 puffs by mouth 1 time each day, PROAIR HFA two puffs by mouth every 4 hours as needed for shortness of breath, APIXABAN one tab by mouth every 12 hours and some medications (unspecified). The patient underwent lab tests and procedures which included computerised tomogram: no blood clots on an unspecified date, electrocardiogram: unknown results on an unspecified date, SARS-CoV-2 test: unknown results on an unspecified date. Outcome of event dizziness was recovered on an unspecified date; event "numbness is in both hands, but the right hand is worse" was not recovered; while for all other events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: numbness is in both hands, but the right hand is worse; developed afib; was told he developed COPD/he had mild COPD years ago; diagnosed with pneumonia; shortness of breath; wheezing; dizziness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration into right arm on 05Mar2021 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Medical history included diabetic, arthritis in hip and back, shingles, ongoing mild chronic obstructive pulmonary disease (COPD) started years ago. There were no concomitant medications. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810) into left arm on 13Feb2021 (at the age of 75-year-old) for COVID-19 immunization and experienced no adverse effect; influenza vaccine (INFLUENZA VACCINE), pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) and tetanus vaccine (TETANUS VACCINE); all on an unspecified date for immunization and patient experienced no adverse effect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the vaccine. On 06Mar2021, patient experienced shortness of breath, wheezing and dizziness. On an unspecified date patient also experienced numbness is in both hands, but the right hand is worse. Patient was brought to the emergency room on an unspecified date where he was told that he developed afib (atrial fibrillation) and COPD (chronic obstructive pulmonary disease) to which the patient stated he had mild COPD years ago. On 09Mar2021,patient had a chest X-ray and was told he has pneumonia. The patient was hospitalized for the events reported from 09Mar2021 to 12Mar2021 and was treated with SPIRIVA RESPIMAT inhaled 2 puffs by mouth 1 time each day, PROAIR HFA two puffs by mouth every 4 hours as needed for shortness of breath, APIXABAN one tab by mouth every 12 hours and some medications (unspecified). The patient underwent lab tests and procedures which included computerised tomogram: no blood clots on an unspecified date, electrocardiogram: unknown results on an unspecified date, SARS-CoV-2 test: unknown results on an unspecified date. Outcome of event dizziness was recovered on an unspecified date; event "numbness is in both hands, but the right hand is worse" was not recovered; while for all other events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Illness
Clinical narrative: Bronchitis; Sick; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 (Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included bronchitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced bronchitis, sick on an unspecified date. Therapeutic measures were taken as a result of bronchitis and sick. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Severe Dizziness/it was bad enough if I needed to go lay down/If I lay down by my left side I was nut, dizzy; If I lay down on the right side the whole room spinning; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Patient went to the hospital and the hospital gave her the vaccine. None medical history. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication from 2015 and ongoing. After first shot from the 19Mar2021 to 22Mar2021, patient had severe dizziness and so it was bad enough if patient needed to go lay down but she could only lay on left side. If she lay down by left side she was nut, dizzy. If she lay down on the right side the whole room spinning. The outcome of events was recovered on 22Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bacterial infection, Cough, Nasal congestion, Oropharyngeal pain
Clinical narrative: Strange side effect, I hate this sounds, sounds very mild but it was a sore throat; Kind of mild bacterial; had mild cough; nasal congestion like Asthma symptoms; Kind of mild bacterial; had mild cough, nasal congestion like Asthma symptoms; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2, Pfizer BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in arm on 06Apr2021 (Lot Number: EP7533) as single dose for covid-19 immunisation. Medical history included asthma. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA) taken for asthma. The patient experienced strange side effect, patient hated this sounds, sounded very mild but it was a sore throat, kind of mild bacterial; had mild cough, nasal congestion like asthma symptoms on Apr2021. No treatment received. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Fatigue, Tongue eruption
Clinical narrative: drug ineffective; rash on tongue; feeling tired, decreased strength and difficulty walking; feeling tired, decreased strength and difficulty walking; COVID-19; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number US-AMGEN-USASP2021052584). This case was split from master case #2021402787 to capture a female patient taking BNT162B2 and experienced drug ineffective, COVID-19, and tongue disorder. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 on an unspecified date (Batch/Lot number UNKNOWN) as single dose, dose 2 unknown on an unspecified date (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis,; fluticasone propionate, salmeterol xinafoate (ADVAIR HFA); citalopram hydrobromide (CITALOPRAM HYDROBROMIDE); clotrimazole (CLOTRIMAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM); meclizine hcl (MECLIZINE HCL), methotrexate (METHOTREXATE); omeprazole, sodium bicarbonate (OMEPRAZOLE/SODIUM BICARBONATE); clopidogrel (CLOPIDOGREL); clorazepate dipotassium (CLORAZEPATE DIPOTASSIUM); doxycycline hyclate (DOXYCYCLINE HYCLATE).   The patient stated she has had both the COVID vaccines and developed rash on tongue as a result. Since on an unknown date, the patient was feeling tired, decreased strength and difficulty walking. Patient was using walker. Patient stated she was unable to participate in exercise programs as she would like because of health. Recently, on an unknown date in 2021, the patient was diagnosed with COVID. The patient stated, along with recent COVID diagnosis has caused some anxiety. No treatment information was received. The outcome of the event covid-19 was reported as not recovered/not resolved. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event covid-19. The causal relationship between the event covid-19 and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  No follow-up attempts possible. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac fibrillation, Cardiac flutter, Electrocardiogram ambulatory, Heart rate
Clinical narrative: heart started quivering/ shaking; jiggling/fluttering/shaking; heart would pound; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 06Mar2021 13:00 (lot number: EN6205), dose 2 on 27Mar2021 13:00 (Lot Number: ER8730), both via an unspecified route of administration, administered in right arm at the age of 79 years old as single dose for covid-19 immunisation. Medical history included environmental allergies. The patient's concomitant medication received prior vaccinations within 4 weeks included allergy shots. Vaccine was not Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Caller had a side effect from the Pfizer COVID shot. Her cardiologist suggested she call. She had the first shot 06Mar2021, and two days later on 08Apr2021, her heart started quivering/ shaking only at night. It would wake her up, or would wake her up in the morning when it was time to get up. It never happened during the day. The doctor said it could have just been because she was busy during the day, and didn't notice it.  She only noticed it at night. This went on for 2 weeks. After the first week, it was still doing it so she went to her cardiologist. The doctor gave her a heart monitor (Mar2021). She wore the heart monitor for 2 weeks. She just got it off a week this Tuesday, but didn't have results yet. She got the second vaccine. The heart issue got better. It was doing it anymore before the second one. Her heart would pound sometimes too (Mar2021), but not for a long time. It would be less than a minute, and it wouldn't happen every time she had the heart shaking. She could hear it. The jiggling/fluttering/shaking got better before she went for her second shot (Mar2021). She got the second shot on 27Mar2021, and it started up again two days later. For three days now she hasn't been awakened by it. Her heart hasn't been pounding. Her doctor thought she should let Pfizer know. She had never felt better now. She would take her heart rate and blood pressure after each episode, and her blood pressure nor her heart rate ever went up (Mar2021). She never felt bad the whole time.  It was just alarming to her when it would happen. She didn't know if it was gone for sure, but it had improved. She noticed it on a Monday the 08Mar2021 two days after the vaccine she got on 06Mar2021. She noticed it both times two days later. The events did not require a visit Emergency Room, but required Physician Office, didn't go first week was doing it regularly went to cardiologist made appt and went. The outcome of the event Heart pounding was recovered on an unspecified date, of the other events was recovering.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart started quivering/ shaking; jiggling/fluttering/shaking; heart would pound; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 06Mar2021 13:00 (lot number: EN6205), dose 2 on 27Mar2021 13:00 (Lot Number: ER8730), both via an unspecified route of administration, administered in right arm at the age of 79 years old as single dose for covid-19 immunisation. Medical history included environmental allergies. The patient's concomitant medication received prior vaccinations within 4 weeks included allergy shots. Vaccine was not Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Caller had a side effect from the Pfizer COVID shot. Her cardiologist suggested she call. She had the first shot 06Mar2021, and two days later on 08Apr2021, her heart started quivering/ shaking only at night. It would wake her up, or would wake her up in the morning when it was time to get up. It never happened during the day. The doctor said it could have just been because she was busy during the day, and didn't notice it.  She only noticed it at night. This went on for 2 weeks. After the first week, it was still doing it so she went to her cardiologist. The doctor gave her a heart monitor (Mar2021). She wore the heart monitor for 2 weeks. She just got it off a week this Tuesday, but didn't have results yet. She got the second vaccine. The heart issue got better. It was doing it anymore before the second one. Her heart would pound sometimes too (Mar2021), but not for a long time. It would be less than a minute, and it wouldn't happen every time she had the heart shaking. She could hear it. The jiggling/fluttering/shaking got better before she went for her second shot (Mar2021). She got the second shot on 27Mar2021, and it started up again two days later. For three days now she hasn't been awakened by it. Her heart hasn't been pounding. Her doctor thought she should let Pfizer know. She had never felt better now. She would take her heart rate and blood pressure after each episode, and her blood pressure nor her heart rate ever went up (Mar2021). She never felt bad the whole time.  It was just alarming to her when it would happen. She didn't know if it was gone for sure, but it had improved. She noticed it on a Monday the 08Mar2021 two days after the vaccine she got on 06Mar2021. She noticed it both times two days later. The events did not require a visit Emergency Room, but required Physician Office, didn't go first week was doing it regularly went to cardiologist made appt and went. The outcome of the event Heart pounding was recovered on an unspecified date, of the other events was recovering.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Tested positive for COVID; Chills; Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unspecified (EN6205 or EW6205) intramuscular, administered in left arm on 24Mar2021 at  16:30-17:00, as single dose (also reported as 0.3) for COVID-19 immunisation.  Medical history included high blood pressure. The patient was taking an unspecified concomitant medication for high blood pressure and was taking that prior to getting the vaccine. On 25Mar2021, the patient experienced chills, headache, tiredness and fever the day after getting the vaccine. On 05Apr2021, 13:30-14:00, the patient tested positive for covid. He tested positive and his wife also tested positive for COVID. He went and got tested not this past Monday, but last Monday. He later stated his wife received the Moderna vaccine and he did not have any other information to provide. The patient went to the physician's office to get COVID test on 05Apr2021. The patient had no additional vaccines administered on the same date as Pfizer vaccine. The patient had no prior vaccinations (within 4 weeks) and no events following prior vaccinations. He was supposed to take second shot after 14Apr2021. He would like to know if he can still get it or if he needs to wait. Outcome of event tested positive for COVID was recovered on an unspecified date; and outcome of the rest of events was recovering.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Chills; Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unspecified (EN6205 or EW6205) intramuscular, administered in left arm on 24Mar2021 at  16:30-17:00, as single dose (also reported as 0.3) for COVID-19 immunisation.  Medical history included high blood pressure. The patient was taking an unspecified concomitant medication for high blood pressure and was taking that prior to getting the vaccine. On 25Mar2021, the patient experienced chills, headache, tiredness and fever the day after getting the vaccine. On 05Apr2021, 13:30-14:00, the patient tested positive for covid. He tested positive and his wife also tested positive for COVID. He went and got tested not this past Monday, but last Monday. He later stated his wife received the Moderna vaccine and he did not have any other information to provide. The patient went to the physician's office to get COVID test on 05Apr2021. The patient had no additional vaccines administered on the same date as Pfizer vaccine. The patient had no prior vaccinations (within 4 weeks) and no events following prior vaccinations. He was supposed to take second shot after 14Apr2021. He would like to know if he can still get it or if he needs to wait. Outcome of event tested positive for COVID was recovered on an unspecified date; and outcome of the rest of events was recovering.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nervousness, SARS-CoV-2 test
Clinical narrative: scared; Her husband was also positive and is scared/COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported the similar events for two patients. This is the second of two reports.  A 38-years-old male patient (Husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her husband was also positive (Apr2021) and is scared (unspecified date). The reporter asked when it's time for the second dose, if they would benefit from getting it. The reporter got the vaccine because she plans to travel to her country, but she doesn't know if she should get the second dose. Her husband (patient) didn't want to receive it. The patient underwent lab tests and procedures which included COVID-19: positive on Apr2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423321 same reporter/drug, different patient and similar event
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Pain in extremity, Skin erosion, Skin exfoliation
Clinical narrative: about the size of a quarter it is all red; it looked like it took patient skin off; raw skin; noticed it was hurting; looks like it was bleeding; This is a spontaneous report from a contactable consumer reported for herself.   A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Lot Number: ER8729; Expiration Date: 31Jul2021) at age of 58 years old, at single for covid-19 immunisation.  Medical history included Pre-diabetes. The patient's concomitant medications were not reported. The patient got the shot on 09Apr2021, about the size of a quarter it was all red, it looked like it took patient skin off, it is raw skin. It is of the size of a quarter of the skin it is all red, looks like it was bleeding. She just noticed it today(13Apr2021). she did not take the bandage off, today she took the bandage off and noticed it was hurting. So, she took the bandage off off  it is the size of a quarter. It is all red and skin is off. Patient request What should do now. just put 'Pyridoxine'? (further clarification unknown)." The patient had the blood work done after the vaccine. No treatment received for the events. Outcome for events was unknown.   No follow-up attempts needed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: about the size of a quarter it is all red; it looked like it took patient skin off; raw skin; noticed it was hurting; looks like it was bleeding; This is a spontaneous report from a contactable consumer reported for herself.   A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Lot Number: ER8729; Expiration Date: 31Jul2021) at age of 58 years old, at single for covid-19 immunisation.  Medical history included Pre-diabetes. The patient's concomitant medications were not reported. The patient got the shot on 09Apr2021, about the size of a quarter it was all red, it looked like it took patient skin off, it is raw skin. It is of the size of a quarter of the skin it is all red, looks like it was bleeding. She just noticed it today(13Apr2021). she did not take the bandage off, today she took the bandage off and noticed it was hurting. So, she took the bandage off off  it is the size of a quarter. It is all red and skin is off. Patient request What should do now. just put 'Pyridoxine'? (further clarification unknown)." The patient had the blood work done after the vaccine. No treatment received for the events. Outcome for events was unknown.   No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: contracted covid-19, tested positive to COVID; contracted covid-19, tested positive to COVID; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 21Mar2021 (batch/lot number: unknown) and first dose on an unspecified date (batch/lot number unknown), both via unspecified routes of administration on an unspecified dates as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported.  The patient experienced contracted covid-19, tested positive to COVID (drug ineffective and COVID-19) on 08Apr2021 with light headaches and cough for 3 days. The patient underwent lab test which included COVID test: positive on 08Apr2021. Patient received her vaccine in Dubai (2nd dose on 21Mar2021), she tested positive to COVID on April 8th (light headaches and cough for 3 days). The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Muscle disorder, Muscle spasms
Clinical narrative: heavy period with blood clots; headache; tired; muscle spasms and pulls; muscle spasms and pulls; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (09:00 AM) (at the age of 33years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced fever, chills, body aches, headache, nausea, lethargic, extremely tired, period (two weeks early) and heavy. The patient's medical history and concomitant medications were not reported. The patient previously took Codeine and Duricef and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Mar2021 (18:00), the patient experienced headache, tired, muscle spasms and pulls, heavy period with blood clots. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscle spasms, Muscle tightness, Neuralgia
Clinical narrative: tightness/tensing of her muscles; muscle cramps, spasms; nerve pain; aches in her shoulder; This is a spontaneous report received from a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness/tensing of her muscles, muscle cramps, spasms, nerve pain, aches in her shoulder, all on an unspecified date with outcome of unknown, all events non-serious. Reported almost immediately following the injection she felt an tightness/tensing of her muscles. She reported that since that time she has experienced muscle cramps, spasms, and what she described as nerve pain, along with aches in her shoulder.  No follow-up attempts are needed. Information on lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Impaired work ability, Limb injury, Pain, Poor peripheral circulation
Clinical narrative: tightness/tensing of her muscles; muscle cramps, spasms; nerve pain; aches in her shoulder; This is a spontaneous report received from a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness/tensing of her muscles, muscle cramps, spasms, nerve pain, aches in her shoulder, all on an unspecified date with outcome of unknown, all events non-serious. Reported almost immediately following the injection she felt an tightness/tensing of her muscles. She reported that since that time she has experienced muscle cramps, spasms, and what she described as nerve pain, along with aches in her shoulder.  No follow-up attempts are needed. Information on lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: tightness/tensing of her muscles; muscle cramps, spasms; nerve pain; aches in her shoulder; This is a spontaneous report received from a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness/tensing of her muscles, muscle cramps, spasms, nerve pain, aches in her shoulder, all on an unspecified date with outcome of unknown, all events non-serious. Reported almost immediately following the injection she felt an tightness/tensing of her muscles. She reported that since that time she has experienced muscle cramps, spasms, and what she described as nerve pain, along with aches in her shoulder.  No follow-up attempts are needed. Information on lot/batch number cannot be requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested Covid-19 Positive; tested Covid-19 Positive; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested covid-19 positive on an unspecified date and reported as medically significant. It was reported that the patient got the first dose of the vaccine last 22Mar2021 and he was tested Covid-19 Positive before he can take his second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and COVID-19 the suspect drug BNT162B2 .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hypersensitivity, Nasal congestion, Pain
Clinical narrative: Body ache; Chills; Fever; Nasal congestion; Itching and rash on my arms and legs, left side; swelling and redness of my face; swelling and redness of my face; Tingling of my face and lip; Itching and rash on my arms and legs, left sid; Mild allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8731) via unknown route of administration on 12Apr2021 at single dose in left arm for COVID-19 immunization. Medical history included ongoing high cholesterol in 2017, high blood pressure in 2010 and ongoing, ongoing prediabetes in 2013, overweight was maybe 25 years in 1996, and scoliosis was discovered when I was age 12 around 1970 (patient was taking pills for all the other things except for overweight), ongoing acid reflux. Concomitant medications included atorvastatin 10 mg, once a day for blood cholesterol increased, amlodipine 10 mg, once a day for high blood pressure, metformin 750 mg, once a day for glucose tolerance impaired, omeprazole at 40 mg, twice a day for acid reflux, solifenacin succinate (VESICARE) single for bladder control. Patient stated, "I got the first dose of the Pfizer vaccine yesterday and I just want to report that I had the mild allergic reaction to the vaccine on 12Apr2021", patient stated, "she got fever, chills and body ache on 13Apr2021 in the middle of the night." patient stated, "when I woke up I had nasal congestion too but that was very mild on 13Apr2021. patient further stated, "The allergic reaction it was mild, it was swelling and redness of my face and also tinging of my face and lips on 12Apr2021. And itching and rash on my arms and legs and my, my side, left side on 12Apr2021". Patient was feeling somewhat better because was taking Tylenol 500mg 2 pill 3 times a day just started today for all events. No hospitalization because of any of the events. The outcome of events pain and nasal congestion was unknown, while for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Pyrexia, Rash, Swelling face
Clinical narrative: Body ache; Chills; Fever; Nasal congestion; Itching and rash on my arms and legs, left side; swelling and redness of my face; swelling and redness of my face; Tingling of my face and lip; Itching and rash on my arms and legs, left sid; Mild allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8731) via unknown route of administration on 12Apr2021 at single dose in left arm for COVID-19 immunization. Medical history included ongoing high cholesterol in 2017, high blood pressure in 2010 and ongoing, ongoing prediabetes in 2013, overweight was maybe 25 years in 1996, and scoliosis was discovered when I was age 12 around 1970 (patient was taking pills for all the other things except for overweight), ongoing acid reflux. Concomitant medications included atorvastatin 10 mg, once a day for blood cholesterol increased, amlodipine 10 mg, once a day for high blood pressure, metformin 750 mg, once a day for glucose tolerance impaired, omeprazole at 40 mg, twice a day for acid reflux, solifenacin succinate (VESICARE) single for bladder control. Patient stated, "I got the first dose of the Pfizer vaccine yesterday and I just want to report that I had the mild allergic reaction to the vaccine on 12Apr2021", patient stated, "she got fever, chills and body ache on 13Apr2021 in the middle of the night." patient stated, "when I woke up I had nasal congestion too but that was very mild on 13Apr2021. patient further stated, "The allergic reaction it was mild, it was swelling and redness of my face and also tinging of my face and lips on 12Apr2021. And itching and rash on my arms and legs and my, my side, left side on 12Apr2021". Patient was feeling somewhat better because was taking Tylenol 500mg 2 pill 3 times a day just started today for all events. No hospitalization because of any of the events. The outcome of events pain and nasal congestion was unknown, while for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Little bit of headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 23Feb2021 as single dose for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. She had a sore arm for a few days after the vaccine, but that it was typical. She had a little bit of headache, but it was not a big deal and it went away in less than a day. Scheduled for second dose 19Mar2021, which was canceled because the site closed down. Was rescheduled for 1Apr2021 at a different location. Event outcome of headache was recovered, of sore arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: positive for covid; positive for covid; My daughter lives with me so she may have gotten it from me; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a 17-year-old female patient received a first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 21Mar2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that, his daughter was positive for COVID. On 6Apr2021 his daughter tested negative. The reporter travelled outside the country so he may have gotten COVID because of that his daughter lives with him so she may have gotten it from the reporter. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: Rash around my neck; Right eye swelled up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he/she had the Pfizer vaccine and he/she had his/her last injection on March 12 and day before yesterday (unspecified), he/she started having a rash around neck and right eye swelled up. He/she had a rash and swollen eye. Events outcome was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia
Clinical narrative: Has a burning type stomach ache; Has a burning type stomach ache; This is a spontaneous report from a non-contactable consumer (patient's husband).   A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the second shot, the Pfizer shot and she had a burning type stomach ache today (on 13Apr2021). The consumer asked if that be caused by the shot and If this was from the COVID shot. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored program.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included cardiac pacemaker replacement on 15Mar2021.  The patient's concomitant medications were not reported.  The patient experienced rash on Mar2021 with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: was around her stepson who had COVID-19 and she herself ended up contracting COVID-19; was around her stepson who had COVID-19 and she herself ended up contracting COVID-19; was around her stepson who had COVID-19 and she herself ended up contracting COVID-19; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer stated that friend's wife got her first shot and was around her stepson who had COVID-19 and she herself ended up contracting COVID-19 and was sick for about 3 days on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 on an unspecified date. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye haemorrhage, Maculopathy, Vision blurred
Clinical narrative: right eye went blind for several Minutes; hemorrhage behind eye; when it cleared I had white clouds that were blocking vision; PAMM; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left (unspecified anatomical location) on 12Apr2021 (Batch/Lot Number: ER8734), at the age of 61-years-old, as single dose for COVID-19 immunization. Medical history included overweight and elevated BP. The patient own allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 22Mar2021 02:30 pm (lot number: EP7534), at the age of 61-years-old. There are other unspecified medications in the last two weeks. There are no other vaccines in four weeks. The patient experienced right eye went blind for several minutes and when it cleared, the patient had white clouds that were blocking vision. Ophthalmologist saw hemorrhage behind eye called it PAMM. The events happened 4 hours after vaccine 2nd dose on 12Apr2021 18:00. Retinal specialist believed it may be vascular but could not determine cause. Dr. advised that he was one of several patients who had eye issues after vaccine. Therapeutic measures were taken as a result of the events. The patient had no prior vaccination, the patient was not tested for COVID post vaccination. The outcome of the event was not recovered. The events were reported as serious- disability.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Syncope
Clinical narrative: fatigue; headaches; 5 episodes of micro fainting spells; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), via an unspecified route of administration on 18Mar2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included blood pressure, cholesterol, GI, and anxiety (as reported, for clarification). Patient also experienced some positional and vasovagal fainting spells from Jan2020 to an unknown date (also reported as every 6-8 weeks and had tapered off then on 06Mar2021, had 7 episodes and many near misses, pending clarification). Concomitant medications included metoprolol; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); polycarbophil calcium (FIBER); escitalopram oxalate (LEXAPRO); simvastatin (ZOCOR) and unspecified supplements. The patient previously took the first dose of BNT162B2 (lot number: EN6202) in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. It was reported that patient had 5 episodes of micro fainting spells since 02Apr2021. On an unspecified date, the patient experienced fatigue and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of 5 episodes of micro fainting spells was not recovered; while the other events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: had some slight dizziness again; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (lot number EP6955) on left arm at single dose for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medication included colecalciferol (VITAMIN D) from 2015 and ongoing. Historical Vaccine included first dose of BNT162B2 (lot number EN6199) on 04Mar2021 on left arm for COVID-19 immunization and experienced severe dizziness and If lay down on the right side the whole room spinning. The patient had some slight dizziness again on 12Apr2021 but not a severe as 19Mar2021 after first dose. Treatment was received for the event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.