chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature decreased, Chills, Decreased appetite
Clinical narrative: rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hot flush, Impaired work ability
Clinical narrative: rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Rectal haemorrhage, SARS-CoV-2 test negative, Thirst decreased
Clinical narrative: rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rhinitis, SARS-CoV-2 test positive
Clinical narrative: Contacted COVID-19 and currently with Cory a symptoms; Contacted COVID-19, tested positive; This is a spontaneous report from a contactable physician reporting for himself.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number=EL3246, via an unspecified route of administration on 12Jan2021 14:00 (at the age of 68 years old) as a SINGLE DOSE in the left arm for Covid-19 immunization.  Medical history included Sulfa allergy from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Historical information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730, first dose in the left arm on 22Dec2020 (at the age of 68 Years old) at 02:00 PM for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital.  The patient contacted COVID-19, tested positive on 22Jan2021 and currently with "Cory a symptoms". The events were non-serious. No treatment was received for the adverse events.The patient underwent lab tests and procedures which included post vaccination=Nasal Swab: COVID test result positive on 22Jan2021.   Outcome of the events was unknown. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: joint pain in right shoulder causing issues with using my right arm as normal; joint pain in right shoulder causing issues with using my right arm as normal; This is a spontaneous report from a contactable nurse (patient).  A non-pregnant female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:), intramuscularly in the right arm on 17Dec2020 at 07:30 at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included polycystic kidney disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing.  Concomitant medications included tolvaptan (JYNARQUE), lisinopril (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 17Dec2020 at 07:30, the patient experienced: joint pain in right shoulder causing issues with using my right arm as normal (medically significant). The adverse event resulted in a visit to a doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of joint pain in right shoulder causing issues with using my right arm as normal; which included ongoing physical therapy. The patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140), intramuscularly in the left arm on 07Jan2021 at 07:30. The clinical outcome of the events was not recovered.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association  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: Cardiovascular symptom, Feeling abnormal, Hypersensitivity
Clinical narrative: Symptoms of a heart attack; allergic reaction to the first dose; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first Pfizer vaccine and had a terrible reaction and had to go to the ER. She had symptoms of a heart attack on an unspecified date. Her husband also had his and had no problems. She would highly recommend the vaccine if you do not have certain health issues. She's sensitive to many drugs. She called as she has a question. She received her first dose of the COVID-19 vaccine and she had an allergic reaction on an unspecified date and ended up in the ER. She asked if should she receive the second dose or not because she had an allergic reaction to the first dose. With the first shot, she ended up in the ER, that was just she had symptoms of heart attack and it was awful. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The association between the event "symptoms of heart attack" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Heart rate increased, Hypertension, Tachycardia
Clinical narrative: Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included simvastatin and acetylsalicylic acid (ASPIRIN (E.C.). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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 been tested for COVID-19. The patient experienced hypertension, tachycardia, feels hot and heart rate is high on 13Jan2021. The outcome of the events was recovering. The patient received treatment such as Amlodipine and lisinopril oral for the events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 a week after the first dose of the vaccine; tested positive for Covid-19 a week after the first dose of the vaccine; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age (reported as around 80 with no unit) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller was calling regarding a patient who tested positive for Covid-19 a week after the first dose of the vaccine. The reporter asked what the timing of the second dose was for someone who has active covid. The patient underwent lab tests and procedures which included Covid-19 test with a positive result. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid; Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid; This is a spontaneous report from a contactable physician. A 5-decade-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid. Patient has made a full recovery and the caller would like to know what the guidance was for receiving the 2nd vaccine in series. The patient underwent lab tests and procedures which included COVID-19 virus test: diagnosed with Covid on an unspecified date. The outcome of events was recovered on an unspecified date.  Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chest discomfort, Dyspnoea, Feeling hot
Clinical narrative: Mild tightness in chest and shortness of breath; Mild tightness in chest and shortness of breath; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; This is a spontaneous report from a non-contactable consumer.  A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 20Jan2021 10:00 dose 2 at SINGLE DOSE for covid-19 immunisation. Vaccine location Right arm, Facility type vaccine: Hospital. The patient medical history was not reported. The patient received first dose of vaccine bnt162b2 lot number=EL1284, on 30Dec2020 at 02:45 PM, vaccine location right arm. Concomitant medication included levothyroxine (LEVOTHYROXINE). The patient reporter that " on 20Jan2021 the temperature started rising 10 hours after second dose (at 8:00pm). Patient took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had fever 100.0°. Fever continued to get under control and rise again off and on for the first 36 hours. Mild tightness in chest and shortness of breath began 24 hours after the second dose and continues 6 days later." The action taken was not applicable. Chest discomfort and dyspnoea were not recovered other event were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild tightness in chest and shortness of breath; Mild tightness in chest and shortness of breath; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; This is a spontaneous report from a non-contactable consumer.  A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 20Jan2021 10:00 dose 2 at SINGLE DOSE for covid-19 immunisation. Vaccine location Right arm, Facility type vaccine: Hospital. The patient medical history was not reported. The patient received first dose of vaccine bnt162b2 lot number=EL1284, on 30Dec2020 at 02:45 PM, vaccine location right arm. Concomitant medication included levothyroxine (LEVOTHYROXINE). The patient reporter that " on 20Jan2021 the temperature started rising 10 hours after second dose (at 8:00pm). Patient took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had fever 100.0°. Fever continued to get under control and rise again off and on for the first 36 hours. Mild tightness in chest and shortness of breath began 24 hours after the second dose and continues 6 days later." The action taken was not applicable. Chest discomfort and dyspnoea were not recovered other event were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Posture abnormal, Unresponsive to stimuli, Vision blurred
Clinical narrative: non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional.   An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Computerised tomogram, Eye disorder, Full blood count, Unresponsive to stimuli
Clinical narrative: non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional.   An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, SARS-CoV-2 antibody test negative
Clinical narrative: received two doses of the vaccine had an IgG level of 0.; This is a spontaneous report from a contactable physician. This physician reported for a male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at single dose for COVID-19 immunisation. The patient who received two doses of the vaccine had an IgG level of 0 on unspecified date. The outcome of event was unknown.   Information on the Lot/Batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Dose I received made me feel sick; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 25Jan2021 (12:00) at a single dose on the right deltoid, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included scoliosis; diabetes; mitral valve prolapse (MVP); gastroesophageal reflux disease (GERD); and torticollis. The patient's concomitant medications were not reported. The patient previously took codeine, and had drug allergy. On 26Jan2021 (04:00), the dose of vaccination that the patient received made him feel sick. The patient went to urgent care as a result of the event, and had received an unspecified treatment for the event. The outcome of the event, 'feel sick', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  Information on lot number/batch number was requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash
Clinical narrative: Headache; fatigue; rash on palm of hands (bilateral, began the day after the vaccine, not other place on body other than all fingers); This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E3247), intramuscular on 23Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Patient age at time of vaccination was 48 years. Medical history included asthma, seasonal allergies, scoliosis, and allergy to Sulfa. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), montelukast (MONTELUKAST), fluticasone (FLUTICASONE), fluticasone propionate, salmeterol xinafoate (ADVAIR), bifidobacterium lactis (PROBIOTIC) and multivitamin. On 24Jan2021 at 12:00 AM the patient experienced headache, fatigue, rash on palm of hands (bilateral, began the day after the vaccine, not other place on body other than all fingers). The events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed prednisone and topical hydrocortisone for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 24Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history included asthma, peanut allergy, and latex allergy. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. The patient experienced fever and headache on 25Jan2021. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: Fever (103.2 degrees); chills; muscle aches; fatigue; headache; diarrhea; joint pain; first single dose of BNT162B2 on 23Dec2020 03:30 PM, second dose on 15Jan2021 16:15; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient receive second single dose of BNT162B2 (Solution for injection, lot number: EL3302, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 15Jan2021 16:15 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included Celiac disease, asthma, and allergies to latex and gluten. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication/other medications received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC) and ethinylestradiol, levonorgestrel (SEASONIQUE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first single dose of BNT162B2 (lot number: EL1284) on 23Dec2020 03:30 PM on the left arm for Covid-19 immunization. On 16Jan2021 04:00, the patient experienced fever (103.2 degrees), chills, muscle aches, joint pain, fatigue, headache, and diarrhea. The events were considered as non-serious by the reporter. Treatment received for the adverse events included paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from fever (103.2 degrees), chills, muscle aches, joint pain, fatigue, headache, and diarrhea on an unspecified date in Jan2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Fever (103.2 degrees); chills; muscle aches; fatigue; headache; diarrhea; joint pain; first single dose of BNT162B2 on 23Dec2020 03:30 PM, second dose on 15Jan2021 16:15; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient receive second single dose of BNT162B2 (Solution for injection, lot number: EL3302, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 15Jan2021 16:15 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included Celiac disease, asthma, and allergies to latex and gluten. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication/other medications received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC) and ethinylestradiol, levonorgestrel (SEASONIQUE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first single dose of BNT162B2 (lot number: EL1284) on 23Dec2020 03:30 PM on the left arm for Covid-19 immunization. On 16Jan2021 04:00, the patient experienced fever (103.2 degrees), chills, muscle aches, joint pain, fatigue, headache, and diarrhea. The events were considered as non-serious by the reporter. Treatment received for the adverse events included paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from fever (103.2 degrees), chills, muscle aches, joint pain, fatigue, headache, and diarrhea on an unspecified date in Jan2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia 140- 125; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included myocardial infarction (MI), diabetic diet controlled, open heart surgery, cardiac stents, allergy. The patient experienced tachycardia 140-125 on 17Jan2021 at 06:00. The patient was not treated due to the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Dizziness, Gait inability
Clinical narrative: Cannot walk; Dizzy; Feeling off balance; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in left arm, on 19Jan2021 (Tuesday), at a single dose, for COVID-19 immunization; and pregabalin (Unknown manufacturer), via an unspecified route of administration, on 22Jan2021, at 75 mg, twice daily, for an unspecified indication. The patient had no medical history and concomitant medications. The patient took her first dose of the BNT162B2 vaccine last Tuesday, 19Jan2021 (a week before the reporting). The patient felt fine as of Wednesday and Thursday (20Jan2021 and 21Jan2021) but started to feel dizzy and off balance on Friday (22Jan2021). The patient did start taking the generic medication, pregabalin on Friday (22Jan2021), took one pill that morning, then got extremely dizzy, has not taken any more since, still just feeling off balance. The patient was prescribed pregabalin twice a day but only took 1 pill, it is a new prescription. Medication (pregabalin) was started on the same day as the event but prior to onset of event. The patient had been dizzy ever since, it really feels more like she is just off balance. The patient can function, just an off-balance feeling. The patient read on the information sheet for BNT162B2 that dizziness could occur in the first 15 minutes. The patient was asking and wondering if this is a delayed reaction to the vaccine. This is why she thinks it could be a delayed reaction to the vaccine because she only took one pregabalin pill and it should be out of her system by now. The patient was just going back to the effect today (25Jan2021), the patient was not dizzy (as reported but also reported as not recovered), but she cannot walk, and she was little off balance. The patient was just wondering if that could be a side effect and if there was anything to be worried of. The action taken in response to the events for BNT162B2 was not applicable; and for pregabalin was temporarily withdrawn on 22Jan2021. The patient had not recovered from the events.  Pfizer is a marketing authorization holder of pregabalin in the country of incidence. This may be a duplicate report if another marketing authorization holder of pregabalin has submitted the same report to the regulatory authorities.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: brain fogginess; Short term memory loss; tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 18Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: unknown. Medical history included high blood pressure, asthma, hypothyroidism, prediabetes and allergies to penicillin (possibly), clindamycin, levofloxacin (LEVAQUIN) and environmental allergies. Concomitant medications in two weeks prior to the vaccination included high blood pressure, asthma, prediabetes and thyroid medications. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 19Jan2021 at 09:00 AM patient experienced short term memory loss, repeated same sentences many times in short amount of time (>7x), tired and brain fogginess. No treatment received for the events. It was also reported that post vaccination the patient had been tested for COVID-19. Test Name: PCR (Nasal Swab) on 20Jan2021 with negative results. Patient recovered from the events on unknown date.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), intramuscular in the left arm on 24Jan2021 08:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included temazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine on 25Jan2021 09:00. No treatment was received for the adverse event. Outcome of the event was not recovered. The event was considered non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea
Clinical narrative: nausea, diarrhea, and not feeling well; nausea, diarrhea, and not feeling well; nausea, diarrhea, and not feeling well; This is a spontaneous report from a contactable consumer (daughter of the patient).  A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021at a single dose for Covid-19 immunisation. Medical history and concomitant medications were unknown. On 28Jan2021, the patient was experiencing, nausea, diarrhea, and not feeling well. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue; headache; arm pain from shoulder to elbow; This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (left arm) on 24Jan2021 at 09:30 at a single dose for COVID-19 immunization.  Medical history was reported as 'none'. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medications received within 2 weeks of vaccination. The patient experienced fatigue, headache and arm pain from shoulder to elbow on 25Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment administered for the events. The events were resolving.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: today, the foot is swollen; unusual pain on her left foot that has been worsening; This is a spontaneous report from a contactable consumer (patient's daughter). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm, on 22Jan2021, at the age of 95 years, at a single dose for COVID-19 immunization. Medical history included congestive heart failure diagnosed a year and a half ago, reported as "October last year"; blood pressure abnormal (reported as blood pressure), pain and headaches. Patient had no prior vaccinations within 4 weeks. Concomitant medications included metoprolol 50 mg tablet for blood pressure; amlodipine for blood pressure; and tramadol 50 mg tablet for pain and headaches, patient has been on this about a year and a half. It was reported patient gets anxiety from her concomitant medications. The reporter stated that her mother, the patient, received the first dose of the COVID-19 vaccine on the left arm, last Friday, on 22Jan2021. She explained the next day, Saturday (23Jan2021), her mother experienced some unusual pain on her left foot that has been worsening and today, 26Jan2021, the foot was swollen. She asked if her mother's experience was a reported side effect to the vaccine. The reporter added that yesterday, 25Jan2021, the pain was not quite as bad, but today, 26Jan2021, it has worsened and was now swollen. The reporter clarified again it was just her left foot, not her whole leg, and stated it was just odd. The events were reported as non-serious, and did not require a visit to Emergency Room nor the Physician Office. The outcome of the events was not recovered, reported as worsened.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body height, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer reporting for self. This 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 about noon at left deltoid (reported as left shoulder) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first dose on 07Jan2021. On 21Jan2021 he tested positive for COVID. He was scheduled to receive his second dose of the vaccine today (26Jan2021), and he wanted to know if he can get the second dose as scheduled or did he have to wait since he was still in quarantine. After informing doctor he had tested positive for COVID, he spoke with his doctor and recommended he take diphenhydramine hydrochloride (BENADRYL), Zyterec-D, and Nasal Spray. There were no additional vaccines administered on same date of BNT162B2, and there were no other vaccinations within 4 weeks. The event did not require a visit to emergency room or physician office. Lab data included height: either 5ft 8 inches or 5 ft 9 inches on unspecified date. The outcome of event was unknown.   Information on the lot/ batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer reporting for self. This 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 about noon at left deltoid (reported as left shoulder) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first dose on 07Jan2021. On 21Jan2021 he tested positive for COVID. He was scheduled to receive his second dose of the vaccine today (26Jan2021), and he wanted to know if he can get the second dose as scheduled or did he have to wait since he was still in quarantine. After informing doctor he had tested positive for COVID, he spoke with his doctor and recommended he take diphenhydramine hydrochloride (BENADRYL), Zyterec-D, and Nasal Spray. There were no additional vaccines administered on same date of BNT162B2, and there were no other vaccinations within 4 weeks. The event did not require a visit to emergency room or physician office. Lab data included height: either 5ft 8 inches or 5 ft 9 inches on unspecified date. The outcome of event was unknown.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body height, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received first covid-19 vaccine dose 2 weeks ago(Jan2021), tested positive for covid-19 on 21Jan2021, he was questioning if he should have the second dose of covid-19 today as scheduled. The patient underwent lab tests and procedures, which included tested positive for covid-19 on 21Jan2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received first covid-19 vaccine dose 2 weeks ago(Jan2021), tested positive for covid-19 on 21Jan2021, he was questioning if he should have the second dose of covid-19 today as scheduled. The patient underwent lab tests and procedures, which included tested positive for covid-19 on 21Jan2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Body aches; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration (left arm) on 21Jan2021 at 00:15 at a single dose for COVID-19 immunization. Medical history included sleep apnea, and prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced flu like symptoms and body aches on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unspecified date in Jan2021.