chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nervousness
Clinical narrative: fever started. 4:30AM - fever so high I thought I could fry an egg on the tops of my thighs; chills began as I got into bed; quite cold and shaky; quite cold and shaky; Heart rate hit 100 just lying in bed; lethargy; headache; feeling slightly tired but functional; Sweaty all day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EP7534, second dose) solution for injection intramuscular in the left arm on 20Mar2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history dyshidrotic eczema, rosacea, severe seasonal allergies (grass, tree pollen, etc), oral allergy syndrome ((raw tree-based foods, sensitive to nickel, sensitive to some nuts (almonds)), cholesterol tends to be high but is managed and sensitive to nickel. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), biotin, polycarbophil calcium (FIBER) and FLO PMS vitamin. Historical vaccine included BNT162B2 (first dose, lot EN6198, administration time 08:15AM, vaccination location: left arm) for COVID-19 vaccination on 27Feb2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Mar2021 at 23:30, the patient had fever started, chills began as got into bed, quite cold and shaky, heart rate hit 100 just lying in bed, lethargy, headache, feeling slightly tired but functional. On 20Mar2021, the patient was sweaty all day. At 4:30AM on 21Mar2021, the fever so high I thought I could fry an egg on the tops of my thighs. Lab tests included BMI of 32 at time of shot (2021). Cholesterol tends to be high but was managed on an unknown date. There was no treatment for the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness. The outcome of the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness was recovered on 23Mar2021. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up needed; further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got virus after 2 weeks; Got virus; This is a spontaneous report received from a non-contactable pharmacist via a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2, Solution for injection (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient got virus 2 weeks later on an unspecified date. First time calling Pharmacist has a patient who received first vaccine and 2 weeks later got virus. She was asking how to proceed for the second vaccine. At this point lost the call and could hear her but she was unresponsive. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; 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. It is unlikely that the patient would have fully developed immunity with only first dose of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: sensation of swelling of the throat; there being no physical signs of swelling only a sensation; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sensation of swelling of the throat; there being no physical signs of swelling only a sensation. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366943
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was exposed to covid a day before first dose and tested positive a week later after receiving the vaccine and patient was tested again yesterday and was still positive; patient was tested again yesterday and was still positive; This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program . A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration as single dose for COVID-19 immunisation. Patient received  Cortisporin via unspecified route for unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date, patient exposed to Covid a day before first dose and tested positive a week later after receiving the vaccine and patient was tested again yesterday and was still positive and wanted to know what to do about her second dose tomorrow. Patient underwent Lab test and procedure which included SARS-CoV-2 test positive in March. The outcome of the events was unknown.  Follow-up (04Apr2021): New information from spontaneous report received from a contactable consumer (patient) includes: Medical Information Potential AE.  Follow up (05Apr2021): New information from spontaneous report received from a contactable consumer (patient) includes: Suspect Product: Cortisporin  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: patient developed ITP; This is a spontaneous report from a Pfizer-sponsored program via a contactable other health professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed Immune thrombocytopenic purpura (ITP). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as relationship between  the suspect drug BNT162B2 and reported event immune thrombocytopenic purpura cannot be excluded until further information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Headache, Malaise, Muscular weakness, SARS-CoV-2 test
Clinical narrative: aftereffects lingered for over 2 weeks and I am still somewhat compromised; headaches; weak legs- arms and shoulders more dominant on left side.; weak legs- arms and shoulders more dominant on left side.; This is a spontaneous report received from a contactable consumer (patient).   A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 17Feb2021 14:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:78 years.Medical history included guillain-barre syndrome from Oct1986 and ongoing. The patient's concomitant medications were:None.The patient received first dose dose of the same vaccine 27Jan2021 at 01:45 P.M on left Arm via IM and developed headache and very weak legs on 27Jan2021 at  1:45 P.M. Vaccination Facility Type where the vaccine was administered was reported: Nursing Home/ Senior Living Facility. No other vaccines were received in the previous 4 weeks. The patient reported : Both shots resulted in days of headaches and very weak legs- arms and shoulders more dominant on left side. Second shot's aftereffects lingered for over 2 weeks and I am still somewhat compromised although, much, much improved. Onset date /time of the events was reported:17Feb 02:15. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 2020 (Between summer and winter of 2020). Outcome of the events was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021245697 Same reporter,patient/different dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Dysarthria, Euphoric mood, Fatigue
Clinical narrative: tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euphoria; minor light head/dizziness/giddiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 09:30 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. 2 hours after shot (03Apr2021 11:30), minor light head/dizziness. 3 hours after shot (03Apr2021 12:30), slurred speech, equilibrium off, feeling of euphoria, giddiness, intoxication, overall felt amazing.  7 hours after shot (03Apr2021 16:30), tiredness, arm pain, muscle weakness. 24 hours after shot (04Apr2021 09:30) no arm pain, feeling normal, still feel a sense of euphoria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive ant list of any other medications within 2 weeks of vaccination. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no allergies to medications, food, or other products. There is no known allergies and other medical history. The outcome of the events was resolving.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Poisoning
Clinical narrative: tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euphoria; minor light head/dizziness/giddiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 09:30 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. 2 hours after shot (03Apr2021 11:30), minor light head/dizziness. 3 hours after shot (03Apr2021 12:30), slurred speech, equilibrium off, feeling of euphoria, giddiness, intoxication, overall felt amazing.  7 hours after shot (03Apr2021 16:30), tiredness, arm pain, muscle weakness. 24 hours after shot (04Apr2021 09:30) no arm pain, feeling normal, still feel a sense of euphoria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive ant list of any other medications within 2 weeks of vaccination. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no allergies to medications, food, or other products. There is no known allergies and other medical history. The outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Product dose omission issue
Clinical narrative: Diarrhoea; missed dose; This is a spontaneous report received from a contactable consumer or other non hcp. A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea and missed dose on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Chills, Echocardiogram, Electrocardiogram
Clinical narrative: prickly feelings; slept all day; felt it right to her stomach; chills; bad anxiety attack; This is a spontaneous report received from a contactable consumer (reporting on herself). A 97-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: HT6955 and Expiration date was not reported), via an unspecified route of administration in Arm Right on 20Mar2021 11:30 (at the age of 97 years-old) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac murmur, chronic kidney disease, hypertension, blood pressure measurement all from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure measurement from an unspecified start date and ongoing; nifedipine (NIFEDIPINE) taken for blood pressure measurement from an unspecified start date and ongoing; losartan (LOSARTAN) taken for blood pressure measurement from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for water pill from an unspecified start date and ongoing; potassium (POTASSIUM) taken for take with the water pill from an unspecified start date and ongoing. It was reported that she got the first shot week ago; clarifies she received the first dose of the Pfizer COVID-19 vaccine on 20Mar2021 at 11:30 in the right arm. States when she got the injection she felt it right to her stomach. The next day she had chills. Patient mentions one night she woke up with a bad anxiety attack in the night, she felt another tiny anxiety attack again yesterday but she told herself you are okay. One day last week she slept all day; and then there was one night were she was just sitting there and she felt prickly feelings all over. Now she was concerned about getting the second shot and was asking how strong was that second shot with regard to her side effects. She called in before to Pfizer the second week to ask about her side effects and left a message for them to call back but no one ever called back. No reference number provided. This will be a follow up. She was planning to receive the second dose on 10Apr2021. Tests: Mentions she recently had an echocardiogram and an EKG but no results are provided.  No follow-up attempts are needed. No further information is expected.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: prickly feelings; slept all day; felt it right to her stomach; chills; bad anxiety attack; This is a spontaneous report received from a contactable consumer (reporting on herself). A 97-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: HT6955 and Expiration date was not reported), via an unspecified route of administration in Arm Right on 20Mar2021 11:30 (at the age of 97 years-old) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac murmur, chronic kidney disease, hypertension, blood pressure measurement all from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure measurement from an unspecified start date and ongoing; nifedipine (NIFEDIPINE) taken for blood pressure measurement from an unspecified start date and ongoing; losartan (LOSARTAN) taken for blood pressure measurement from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for water pill from an unspecified start date and ongoing; potassium (POTASSIUM) taken for take with the water pill from an unspecified start date and ongoing. It was reported that she got the first shot week ago; clarifies she received the first dose of the Pfizer COVID-19 vaccine on 20Mar2021 at 11:30 in the right arm. States when she got the injection she felt it right to her stomach. The next day she had chills. Patient mentions one night she woke up with a bad anxiety attack in the night, she felt another tiny anxiety attack again yesterday but she told herself you are okay. One day last week she slept all day; and then there was one night were she was just sitting there and she felt prickly feelings all over. Now she was concerned about getting the second shot and was asking how strong was that second shot with regard to her side effects. She called in before to Pfizer the second week to ask about her side effects and left a message for them to call back but no one ever called back. No reference number provided. This will be a follow up. She was planning to receive the second dose on 10Apr2021. Tests: Mentions she recently had an echocardiogram and an EKG but no results are provided.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eosinophil count, Eosinophil count increased, Neutrophil count, Neutrophil count decreased
Clinical narrative: neutrophils that was low; eosinophils was slightly high; This is a spontaneous report from a Pfizer sponsored Program from a contactable consumer (patient) reported for himself. 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 received second vaccine and had blood work done on unspecified date and noticed that blood cell counts neutrophils that was low and eosinophils was slightly high. Wanted to know if was because of vaccine. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Feeling hot, Headache
Clinical narrative: He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested for covid he thought he was feeling hot; lost sense of smell; He was hungry all the time and when he ate, he noticed there was no taste at all; Tested positive/tested for covid; fever; Headache; Symptoms in my throat ; This is a spontaneous report received from a contactable consumer. This 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration at the left arm on 12Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure (Diagnosed more than 5 years ago and is controlled) and diabetes (controlled). Concomitant medications were not reported. On 16Mar2021, the patient had fever, headache and some symptoms in throat. On 18Mar2021, patient was tested positive for Covid19. On 24Mar2021, the patient had lost sense of smell and lost sense of taste. It was reported that he was hungry all the time and when he ate, he noticed there was no taste at all. It was reported that when he tested positive for covid, the doctor gave him an antibiotic and cough syrup. The patient was taking regular medication for blood pressure and diabetes. He had been taking for years and does not fell it is relevant. Now he is taking a lowered dose of his diabetes medication. When he was tested for covid he thought he was feeling hot but had no temperature when verified. Outcome of fever, headache, symptoms in throat, lost sense of smell, lost sense of taste, covid19 was reported as recovered and outcome was unknown for feeling hot and hunger all the time.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hunger, Oropharyngeal discomfort, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested for covid he thought he was feeling hot; lost sense of smell; He was hungry all the time and when he ate, he noticed there was no taste at all; Tested positive/tested for covid; fever; Headache; Symptoms in my throat ; This is a spontaneous report received from a contactable consumer. This 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration at the left arm on 12Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure (Diagnosed more than 5 years ago and is controlled) and diabetes (controlled). Concomitant medications were not reported. On 16Mar2021, the patient had fever, headache and some symptoms in throat. On 18Mar2021, patient was tested positive for Covid19. On 24Mar2021, the patient had lost sense of smell and lost sense of taste. It was reported that he was hungry all the time and when he ate, he noticed there was no taste at all. It was reported that when he tested positive for covid, the doctor gave him an antibiotic and cough syrup. The patient was taking regular medication for blood pressure and diabetes. He had been taking for years and does not fell it is relevant. Now he is taking a lowered dose of his diabetes medication. When he was tested for covid he thought he was feeling hot but had no temperature when verified. Outcome of fever, headache, symptoms in throat, lost sense of smell, lost sense of taste, covid19 was reported as recovered and outcome was unknown for feeling hot and hunger all the time.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Tachycardia
Clinical narrative: atrial fibrillation; tachycardia; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from pharmaceuticals (as reported). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized due to atrial fibrillation and tachycardia after a week of administration of the first shot of Pfizer-BioNTech vaccine. Hospitalization date was not reported. She believes the adverse events are related to the vaccine. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Headache, Pain, Vaginal haemorrhage
Clinical narrative: started spotting blood; A few hours after i had an unbearable headache that was not relieved until I took 800mg of ibuprofen and then 1000mg of Tylenol an hour later at about 1am; Full body aches; exhaustion; menstrual like cramps for several days; This is a spontaneous report from a contactable consumer (patient), who is also an other Health Professional.   A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of , administration, at age of 25 years, administered in Arm Left on 30Mar2021 11:00 (Lot Number: EP7534) at single for covid-19 immunisation.  Medical history included Hashimotos , adhd (as reported), allergies to: Latex, corn, mint, morphine , beets, tobacco.  Concomitant medication(s) in two weeks included lisdexamfetamine mesilate (VYVANSE), levothyroxine, liothyronine (NP THYROID) and levocetirizine dihydrochloride (XYZAL), all taken for an unspecified indication, start and stop date were not reported. Reported that "A few hours after i had an unbearable headache that was not relieved until I took 800mg of ibuprofen and then 1000mg of Tylenol an hour later at about 1am. Full body aches and exhaustion. I also got menstrual like cramps for several days. Now I just started spotting blood when my period finished two days before I received my vaccine, which is extremely abnormal for me." Events onset date reported as 30Mar2021 15:00. Treatment drugs received for event headache, and no treatment received for other adverse events, The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  Outcome for events was recovering.   No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got red rashes on the right side of the stomach and on the back of the Body; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Mar2021 11:30 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation.  The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications was none. No other vaccine in four weeks. No other medications in two weeks. The patient reported got red rashes on the right side of the stomach and on the back of the body on 28Feb2021 with outcome of not recovered. No treatment was received for the events. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced sore arm and muscle soreness and general fatigue on 22Mar2021. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Nausea
Clinical narrative: Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; body shakes; weakness; fatigue; chills; This is a spontaneous report received from a non-contactable consumer reported for self. This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Mar2021 11:30 AM Left arm as single dose (lot: EP7533) for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Eosinophilic Esophagitis. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. Concomitant medication included Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced Upset stomach on 26Mar2021 02:00 AM. Stomach issues continued for 5 days culminating in an episode of nausea, chills, body shakes, weakness, and fatigue. This episode passed fairly quickly in about an hour. Since the day after this episode have felt fine (approximately 48 hours). Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event Upset stomach was recovered on 31Mar2021 02:00. Outcome of the events nausea, chills, body shakes, weakness, and fatigue were recovered on 28Mar2021 02:00.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; body shakes; weakness; fatigue; chills; This is a spontaneous report received from a non-contactable consumer reported for self. This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Mar2021 11:30 AM Left arm as single dose (lot: EP7533) for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Eosinophilic Esophagitis. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. Concomitant medication included Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced Upset stomach on 26Mar2021 02:00 AM. Stomach issues continued for 5 days culminating in an episode of nausea, chills, body shakes, weakness, and fatigue. This episode passed fairly quickly in about an hour. Since the day after this episode have felt fine (approximately 48 hours). Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event Upset stomach was recovered on 31Mar2021 02:00. Outcome of the events nausea, chills, body shakes, weakness, and fatigue were recovered on 28Mar2021 02:00.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: dry mouth after 5 days of vaccination; This is a spontaneous report received from a contactable Pharmacist. A 43-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Mar2021 as single dose for COVID-19 immunisation. No pregnant at the time of vaccination. Prior to vaccination, was the patient did not diagnose with COVID-19. She experienced dry mouth after 5 days of vaccination on 31Mar2021 which caused/prolonged hospitalization. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: A causal relationship between BNT162B2 and the event dry mouth cannot be excluded based on 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 RAs,  Committees, and Investigators, as appropriate .
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Back pain, Chills, Fatigue, Myalgia
Clinical narrative: It's like brittles on my back through my shoulder blade; Chills; My muscles aching; It hurts my lower back; I am tired; This is a spontaneous report from contactable consumer (patient).  This 48-years-old male patient received the first dose of bnt162b2 (PFIZER BIOTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as single dose for covid-19 immunisation. There has no medical history or concomitant medications. On 26Mar2021, the patient reported it's like brittles on his back through his shoulder blade. The patient had chills and his muscles aching. It hurts his lower back and he was tired. The outcome of the events was not recovered/not resolved..
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Insomnia, Pain, Pyrexia
Clinical narrative: I could not sleep; Chills; Fever; Pain; feel like probably I am going to die; This is a spontaneous report from contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8733), via unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date after taking the second dose of vaccine, patient could not sleep, had chills, fever and pain. Patient also inquired if there is something that could be taken for the fever and stated that he/she shouldn't have taken the vaccine in the first place because patient felt like he/she was probably going to die. Outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Woke up with hive on her back; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). This patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced woke up with hive on her back on an unspecified date with outcome of unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Lymphadenopathy, Pruritus
Clinical narrative: swollen gland in my neck/swollen from the back, behind my earlobe about 3, 4 inches down; My neck was itching and get swollen; This is a spontaneous report from a contactable consumer (patient) reporting on herself. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 69-years-old) as SINGLE DOSE for covid-19 immunization. Medical history was not reported. Concomitant medications included alprazolam (XANAX), omeprazole magnesium (PRILOSEC), denosumab (PROLIA) for bone every six months. It was reported that, in Mar2021 the patient had her first shot Saturday and last night in the middle of night it started, her neck was itching and get swollen, swollen gland in the neck. It happen 3 or 4 days after the shot. She also stated "It started right now and it's itching and it's swollen from the back, behind my earlobe about 3, 4 inches down. It really don't hurt but itches perfect. stated that "I don't think its feel good, it is swollen, it's kind of hard". The patient underwent lab tests and procedures which included blood count: normal. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disseminated varicella zoster virus infection
Clinical narrative: developed disseminated HZV infection 15 days post his first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a non-contactable physician. A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number Unknown), via an unspecified route of administration on an unspecified date as a single for COVID-19 immunization. Medical history included hairy cell leukaemia from 2006 to an unknown date Hairy Cell leukemia in 2006  remission since 2016. The patient's concomitant medications were not reported. The patient developed disseminated varicella zoster virus infection 15 days post his first dose of the Pfizer COVID-19 vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: While patient risk factors may likely predispose patient to reported event, a possible contributory effect of suspect BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm later in day of injection; Slight fever; Slight fatigue; This is a spontaneous report from a contactable consumer(patient).This 62-year old male consumer(patient) reported for himself that: A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:45 as SINGLE DOSE, via an unspecified route of administration, administered in Arm Left on an unspecified date as an unspecified dose for covid-19 immunisation. Medical history included hypertension hypertension controlled with lisinopril, Allergic to penicillin. Concomitant medications included lisinopril taken for hypertension, the patient experienced sore arm later in day of injection, slight fever, slight fatigue on 30Mar2021 and The events were assessed as serious (medically significant) by health authority.outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: The mother became pregnant while taking bnt162b2; Preterm labor which led to delivery of pregnancy; This is a spontaneous report from a contactable physician (patient).   This physician reported information for both mother and fetus.  This is a fetus report. A 29-year-old female mother received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 06Jan2021 second dose on 27Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  There was no relevant medical history or known allergies for the mother. The mother's concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS), aspirin and cetirizine hydrochloride (ZYRTEC). The mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother did not have covid prior Vaccination and no covid tested post vaccination.The mother became pregnant while taking bnt162b2 on 06Jan2021 and 27Jan2021. The mother last menstrual period date was 27Oct2020, pregnancy due date was 07Jul2021. It was reported that Preterm labor which led to delivery of pregnancy. This occurred 3 weeks after second dose.The event was resulted in Hospitalization from 2021 to 2021 with duration 1 day. No treatment was received.The events outcome was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment.  Based on temporal association, a contributory role of bnt162b2  to the reported events cannot be totally excluded.  Case will be reassessed if additional information is  received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021357940 same reporter, different patient and event
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Feeling abnormal, Fibromyalgia
Clinical narrative: a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Joint swelling, Migraine, Sjogren's syndrome, Somnolence
Clinical narrative: a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Disorientation, Headache, Nausea
Clinical narrative: little bit of pain on my underarm; high fever; bad headache.; Vomiting; body ache; Chills; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 24Mar2021 (received at the age of 39-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever, bad headache, vomiting, body ache, chills, disorientation, nausea, and little bit of pain on underarm on 24Mar2021. The patient stated, "The day after I had the shot, I have very bad headache, fever then high fever, vomit, body aches, chills. It was like disoriented. I have high fever and very bad headache, nausea. It was at night when I took up the shot, at the time they put up the injection the only thing I had was I had little bit of pain on my underarm and in the course of the day, of the night all these symptoms are added.'' The patient described the side effects as really strong. When probed for the outcome of events, she stated, "It is worsening. Some of them are persisting, some of them are the went way. " Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: little bit of pain on my underarm; high fever; bad headache.; Vomiting; body ache; Chills; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 24Mar2021 (received at the age of 39-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever, bad headache, vomiting, body ache, chills, disorientation, nausea, and little bit of pain on underarm on 24Mar2021. The patient stated, "The day after I had the shot, I have very bad headache, fever then high fever, vomit, body aches, chills. It was like disoriented. I have high fever and very bad headache, nausea. It was at night when I took up the shot, at the time they put up the injection the only thing I had was I had little bit of pain on my underarm and in the course of the day, of the night all these symptoms are added.'' The patient described the side effects as really strong. When probed for the outcome of events, she stated, "It is worsening. Some of them are persisting, some of them are the went way. " Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.