chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Lightheadedness; Shaking really bad and was frozen; Shaking really bad and was frozen; Headache; Sore arm; Wasn't feeling good; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm on 21Feb2021 (age at vaccination 81 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing essential tremors (started in her twenties), shoulder replacement; left shoulder two years ago and right shoulder ten years ago and mild Covid in Dec2020. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported, Expiration Date: 30May2021) via an unspecified route of administration, administered in right arm, on 31Jan2021 as DOSE 1, SINGLE, for COVID-19 immunisation The patient's concomitant medications were not reported. The patient reported that after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, she experienced some side effects. On 21Feb2021 22:30 she was shaking really bad, and was frozen She also had headache, sore arms. She also mentioned that on her card, she saw a sticker with the expiration date, 30Jun2021. The patient wanted to know if this was the expiration date for the vaccine, and if she needs to take another dose of the vaccine after the vaccine expires. She read all the information. She was fine until bedtime. She went to bed early because she was not feeling good. She woke at 10:30pm and was shaking so bad and was frozen. She keeps the heat at 70. She turned it up to 72 degrees and had two sweaters on and she was still cold. She guesses that was to be expected. She also had a headache and a sore arm. She was lightheaded this morning on 22Feb2021. She guesses that goes with it. Therapeutic measures were taken as a result of shaking really bad and was frozen. Outcome of the events Light-headedness recovered on 22Feb2021, event of not feeling good was unknown and other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Diarrhea; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6201) intramuscular, administered in left arm on 21Feb2021 09:00 (at the age of 73-year-old) as dose2, single for COVID-19 immunization. Medical history included stroke since 2012. The patient's concomitant medications were not reported. The patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot: EL9263, Expiry: unknown) intramuscular, administered in left arm on 29Jan2021 (at the age of 73-year-old) for COVID 19 Immunization. The patient did not had any additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021, the patient experienced dizziness and diarrhoea. The patient experienced some dizziness last night that he reports was much better on the day of report. The patient reported that he had the shot yesterday morning (21Feb2021) and by last night around 10 or 11pm, he experienced dizziness. The dizziness lasted through the night sometime and by this morning it has subsided quite a bit. He felt some slight dizziness but nothing like it was last night. The patient also had a small occurrence of diarrhea during the day yesterday, probably around 10 am (an hour after receiving the shot). Vaccination Facility Type was reported as Clinic. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient confirmed that it was just one occurrence of diarrhea. The adverse events did not require a visit to emergency room and physician office. The clinical outcome of dizziness was resolving and diarrhoea was resolved on 21Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Sore arm; Feel a little punky in my head and light headed; Dizzy sort of like my brain is pause; brain feels fuzzy; dizziness; light headedness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021), via intramuscular route, administered in Arm Left on 20Feb2021 09:00 as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included hypertension, blood cholesterol, gastro oesophageal reflux disease, anxiety, depression, and sleep disorder. Concomitant medication(s) included indapamide (INDAPAMIDE) taken for hypertension, atorvastatin (ATORVASTATIN) taken for blood cholesterol, omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastro oesophageal reflux disease, alprazolam (XANAX) taken for anxiety, escitalopram oxalate (LEXAPRO) taken for depression and amitriptyline (AMITRIPTYLINE) taken for sleep disorder. The patient previously took erythromycin for drug hypersensitivity. On 20Feb2021 09:00 the patient experienced dizziness, light headedness, and dizzy sort of like her brain was paused. On an unspecified date patient developed sore arm and felt a little punky in her head and lightheaded. The patient underwent lab tests and procedures which included blood test: unknown.  The event outcome for dizziness, light headedness, and dizzy sort of like her brain was paused was reported as not recovered. The events outcome for sore arm and felt a little punky in her head and lightheaded was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body height, Body temperature fluctuation, Fatigue, Malaise
Clinical narrative: Body wasn't regulating temperature; unsettled stomach; Overall tired and fatigue; Aching; Feeling unwell; Aching in legs; arm soreness was in the right arm, which was the injection arm; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: C13248), via an unspecified route of administration, administered in Arm Right on 13Feb2021 (at the age of 74-years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension , ventricular tachycardia, blood cholesterol abnormal. Concomitant medication included lisinopril (LISINOPRIL) taken for hypertension, atenolol (ATENOLOL) taken for ventricular tachycardia, simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal. Patient received her first dose of Pfizer-Biontech Covid-19 vaccine 13Feb2021 and reports AEs starting on 19Feb2021. Her symptoms include unsettled stomach, overall tired and fatigued, aching, body just wasn't regulating its temperature She was hot and then cold, no fever reported, started feeling unwell, aching in legs, and just unwell. It has been on and off over the weekend. arm soreness was in the right arm, which was the injection arm. Patient was feeling a little better on Saturday, but still kind of off. Yesterday she was feeling kind of off. It is hard to tell how she is feeling today because she just got up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Body wasn't regulating temperature; unsettled stomach; Overall tired and fatigue; Aching; Feeling unwell; Aching in legs; arm soreness was in the right arm, which was the injection arm; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: C13248), via an unspecified route of administration, administered in Arm Right on 13Feb2021 (at the age of 74-years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension , ventricular tachycardia, blood cholesterol abnormal. Concomitant medication included lisinopril (LISINOPRIL) taken for hypertension, atenolol (ATENOLOL) taken for ventricular tachycardia, simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal. Patient received her first dose of Pfizer-Biontech Covid-19 vaccine 13Feb2021 and reports AEs starting on 19Feb2021. Her symptoms include unsettled stomach, overall tired and fatigued, aching, body just wasn't regulating its temperature She was hot and then cold, no fever reported, started feeling unwell, aching in legs, and just unwell. It has been on and off over the weekend. arm soreness was in the right arm, which was the injection arm. Patient was feeling a little better on Saturday, but still kind of off. Yesterday she was feeling kind of off. It is hard to tell how she is feeling today because she just got up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure became elevated /blood pressure has been up; This is a spontaneous report from a contactable consumer. This consumer reported for male patient (husband):  A 87-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- Unknown) via intramuscularly, in right arm on 03Feb2021 10:00 as dose 1, single (at the age of 86-years-old) for COVID-19 immunization. The patient medical history included rheumatoid arthritis, thyroid, pain and blood pressure. The concomitant medication of the patient included losartan and amlodipine besylate both for blood pressure, levothyroxine sodium (SYNTHROID) for thyroid and tramadol for pain. On an unspecified date the patient experienced blood pressure became elevated /blood pressure has been up. Reporter stated that patient (reporters husband) after receiving the 1st dose, patient blood pressure became elevated. Reporter noticed that the ingredients of the vaccine contain sodium chloride, and dibasic sodium phosphate dihydrate. Reporter queried if these contain salt. Reporter queried if Pfizer-BioNTech Covid-19 Vaccine would work on immunocompromised patients, specifically for those who have rheumatoid arthritis. Reporter stated that she started to notice an increase in his blood pressure of patient more or less the last 2 weeks. On an unspecified date the patient underwent lab tests and procedures which included patient blood pressure readings have been 170/95 (elevated), 183/95, 173/94, 187/97 and 163/93. On 22Feb2021 the patient blood pressure at 2:30 pm and it was 151/89 and at 3:15pm, it was 138/80. Reporter stated that patient was receiving treatment of losartan 100 mg, tablet, by mouth, once a day, Amlodipine besylate 2.5 mg tablet, by mouth, once a day in the morning for the blood pressure. Reporter also mention that patient was taking arthritis medicine, synthroid for thyroid and also tramadol 50mg tablet, by mouth, twice a day for pain. Reporter stated that patient was been on all of these medications for more than 2 weeks prior to receiving the vaccine. Outcome of the reported events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache on the following day; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot: EL3247) via an unspecified route of administration, administered in left arm on 19Feb2021 09:30 AM (at the age of 50-years-old) as dose 2, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine administered within 4 weeks from vaccination. Patient not diagnosed with covid prior vaccination and not tested for covid post vaccination. On 20Feb2021, the patient experienced headache on the following day. No treatment received for the event. The outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a toothache on an unspecified date. The patient scheduled for the second dose of COVID 19 Vaccine tomorrow (21Feb2021) and she asked if Advil could take before the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; Information on lot number, batch number could not be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight pain in the left arm where vaccine was given i; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 61-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 22Feb2021 at 11:30 (age at the time of vaccination was 61-years-old) as DOSE 1, SINGLE dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccines in 4 weeks and no other medications in 2 weeks. The patient did not have COVID-19 prior to vaccination and was not been tested for COVID-19 post the vaccination. On 22Feb2021 (at 20:00), the patient experienced Slight pain in the left arm where vaccine was given i. The clinical outcome of the event was not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: sore arm at site of injection; Fatigue; Body aches; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in the left arm, on 17Feb2021 (Lot number not reported), at age 54 years old, as dose 2, single, for COVID-19 immunisation, at a public health department. The patient was not pregnant at the time of vaccination. Relevant medical history included high blood pressure, controlled from an unknown date, not reported if ongoing or not. The patient has no allergies to medications, foot or other products. Concomitant medications included spironolactone and venlafaxine both taken for unknown indications, start and stop date not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) administered in the left arm, on 27Jan2021 (Lot number not reported), at age 54 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Feb2021 07:00, the patient experienced sore arm at site of injection, fatigue and body aches. No treatment was given for the events. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some soreness in left arm where the injection was made; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 22Feb2021 12:00 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the workplace clinic. The patient medical history included diabetes, high blood pressure, reflux. The patient also had allergy to Penicillin. Concomitant medications included metformin; dulaglutide (TRULICITY); empagliflozin (JARDIANCE); esomeprazole magnesium (ESOMEPRA); and atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported. The patient experienced some soreness in left arm where the injection was made on 22Feb2021 15:00 with outcome of recovered the next day, 23Feb2021 with no treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: little bit achy and achiness type stuff; normal low energy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) on an unspecified date as first dose for covid-19 immunisation. On an unspecified date, the patient experienced little bit achy, and the achiness type stuff, and had normal low energy. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 22Feb2021 at 15:15 (age at the time of vaccination was 49-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site on 22Feb2021 at 15:30. Patient did not receive any treatment to the event. Patient was not diagnosed with Covid-19 prior to vaccination and not tested for covid since vaccination. The outcome was recovered with sequelae for the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Debilitating migraine; This is a spontaneous report from a contactable consumer (patient).   A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Feb2021 10:00 as DOSE 1, SINGLE for covid-19 immunization at the age of 31-year-old. The patient was not pregnant at time of vaccination. Patient denied for any medical history. The patient had no known allergies. Patient denied for any other vaccine in four weeks and denied for any other medications in two weeks. Patient did not had covid prior to vaccination neither tested for covid post the vaccination. The patient's concomitant medications were not reported. On 20Feb2021 at 20:00, the patient experienced debilitating migraine. The patient did not receive any treatment for the event. The reporter considered the event as non-serious. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Productive cough, SARS-CoV-2 test
Clinical narrative: Fatigue and muscle soreness in upper legs lasting 10-14 days. Severe respiratory phlegm white mucus lasting 1 week. Next dose is Feb26 at 3pm. Wondering if I should proceed?; Fatigue and muscle soreness in upper legs lasting 10-14 days. Severe respiratory phlegm white mucus lasting 1 week. Next dose is Feb26 at 3pm. Wondering if I should proceed?; Fatigue and muscle soreness in upper legs lasting 10-14 days. Severe respiratory phlegm white mucus lasting 1 week. Next dose is Feb26 at 3pm. Wondering if I should proceed?; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 05Feb2021 at 15:30 (at the age of 65-year-old), in Arm Left, as dose 2, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Patient known allergies reported as NO'. Concomitant medication(s) included ALA ALC, vitamin D, magnesium, Vitamin C, Amlodipine taken for an unspecified indication, start and stop date were not reported. Historical vaccine of patient included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date (at the age of 65-year-old), as dose 1, single for COVID-19 immunization. Patient did not took any other vaccine within four weeks of COVID vaccine. Patient had not tested COVID prior vaccination and had been tested COVID test post vaccination. On 08Feb2021 08:00 the patient experienced fatigue and muscle soreness in upper legs lasting 10-14 days. severe respiratory phlegm white mucus lasting 1 week. next dose is feb26 at 3pm. wondering if i should proceed. On 21Jul2020 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Patient visited Doctor or other healthcare professional office(or) clinic visit as a result of AE. Treatment was not received. The clinical outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9266 and expiry date was not reported), via an unspecified route of administration, in Arm left on 22Feb2021 at 17:30 (Age at vaccination: 41 years old) as dose 1, single for COVID-19 immunization. The patient medical history included BMI: 35.5, allergies to Penicillins and history of current asthma (ongoing). Concomitant medications included ibuprofen (ADVIL 12 HOUR), received 4 days before vaccine and daily PROBIOTICS. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On 22Feb2021 at 19:00 (night), the patient had Soreness at injection site (severity: mild and no medications required). The patient was scheduled for a second dose date 18 days after first dose (of less than 21 days). The patient didn't realize they had scheduled her for an earlier date until she left the vaccination site, and she cannot find any way to correct this. The case was considered as non-serious. The patient did not receive any treatment for the event. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:30 (age at vaccination: 65-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included treated hypertension. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was clinic. 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. On 22Feb2021, at 19:00, the patient experienced grade 1 severity soreness at site of vaccination following injection. Improved in severity by next day. No interference with activity, no analgesics required. No treatment was received for the adverse event. The outcome of the event was recovering.  No Follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site rash
Clinical narrative: Body aches; Extreme body chills; Rash at injection site; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6200) via an unspecified route of administration, administered in arm left on 22Feb2021 12:00 (age at the time of vaccination was 27 years) as dose 2, single for COVID-19 immunisation at a health clinic. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. There were no known allergies. There was no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient's concomitant medications included Vitamin D3, calcium carbonate/ calcium gluconate/ magnesium gluconate/ magnesium oxide/ zinc citrate/ zinc oxide (CALCIUM MAGNESIUM AND ZINC) and probiotic, all drugs received within 2 weeks of vaccination. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9264) via an unspecified route of administration, administered in left arm on 03Feb2021 13:15 (age at the time of vaccination was 27 years) as dose 1, single for covid-19 immunisation at school or student health clinic. On 22Feb2021, at 22:30, the patient had body aches, extreme body chills and rash at injection site after injection. The patient was not received treatment for adverse events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint range of motion decreased, Myalgia
Clinical narrative: Left deltoid pain - inhibiting range of motion and function; Left deltoid pain - inhibiting range of motion and function; Headache; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:30 (at the age of: 45-years-old) as dose 1, single for covid-19 immunization. Medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine with in 4 weeks prior to the covid vaccination. List of any other medications the patient received within 2 weeks of vaccination was reported as None. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 12:00 the patient experienced left deltoid pain- inhibiting range of motion and function and headache. The patient did not receive any other treatment as a result of events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity
Clinical narrative: Headache; Sore arm; General unwellness; This is a spontaneous report from a contactable consumer. This contactable 60-year male patient consumer reported that:  A 60-years-old male patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EL 3247) via an unspecified route of administration in arm left on 22Feb2021 10:00 am (at the age of 60 years) as dose 1, single for COVID-19 immunisation (workplace clinic). Medical history was not reported. Allergies to medications, food, or other products: no. Concomitant medication was not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Feb2021 at 14:00 patient experienced headache, sore arm and general unwellness. Upon follow up (02Mar2021) report received in response to the mail trail sent regarding the confirmation of awareness date response: 22Feb2021. Patient didn't received treatment for events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This is a spontaneous report from a contactable consumer (Patient) via Regulatory Authority  A 77-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: Not reported) via an unspecified route of administration on 01Feb2021 (at the age of 77-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included thyroid disease, high cholesterol and (COPD) chronic obstructive pulmonary disease). No known allergies to medications, food, or other products. Concomitant medication included rosuvastatin and levothyroxine (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills and fatigue on 01Feb2021. Patient did not receive any treatment as a result of events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are needed. Information about lot/batch numbers cannot obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Head ache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jan2021 (at the of 65-year-old) as dose 1, single and second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Feb2021 (at the of 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease. The patient's concomitant medications were not reported. Allergies to medications, food, or other products were reported as no. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. On 30Jan2021 the patient experienced head ache, sore arm. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient not received any treatment for the events. Outcome of the events was recovered on unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Head ache sore arm for about a day; Head ache sore arm for about a day; This is a spontaneous report from a non-contactable consumer (patient) or other non-health care professional. A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Feb2021 (at the age of 67-year-old) as dose 2, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered on 30Jan2021 as dose 1 single for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced head ache sore arm for about a day. No treatment received for the events. Outcome of the events resolved on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear; This is a spontaneous report received from a contactable other hcp (Nurse). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EM9810) intramuscular on 08Feb2021 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included BPH (benign prostatic hyperplasia), OSA (Obstructive sleep apnea syndrome), Hyperlipidemia, known allergies: Sulfa and Finasteride. The patient previously took finasteride and experienced drug hypersensitivity. Patient did not receive any other vaccines in four weeks. Patient received other medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and since vaccination patient has not been tested for COVID-19. On 08Feb2021 (started 5 hours after vaccine), the patient experienced ringing in ear, lasted for more than 8 days. Patient did not receive any treatment for event. Outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm hurt last night and this morning; This is a spontaneous report from a contactable consumer(patient). A 44-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247; Expiration Date: May2021, at the age of 44 years), dose 1 intramuscular, administered in Arm Left on 18Feb2021 10:30 as dose 1, single for covid-19 immunisation at workplace clinic. The medical history and concomitant medications were not reported. No Prior Vaccinations administered. The patient reported left arm hurt last night and that morning on 18Feb2021 17:00 but it was improving. The event did not require the initiation of new medication/ other treatment/ procedure. The outcome of the event was recovered on 19Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Extreme headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9269) via an unspecified route of administration in the arm left on 20Feb2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included olmesartan medoxomil (BENICAR), venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR), trazodone hydrochloride (TRAZADONE), menthol, capsaicin (ALLEVE) and Motr all for unknown indication from an unknown date and unknown if ongoing. On 22Feb2021, the patient experienced extreme headache.  The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Nausea; Headache; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm right on 17Feb2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome(IBS), soy allergy and allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 18Feb2021 at 05:00, the patient experienced nausea, headache and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events nausea, headache and diarrhea was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Myalgia, Vaccination site pain
Clinical narrative: chills; difficult to sleep; headache; pain+soreness in my left arm (injection site); pain+soreness in my left arm (injection site); This is a spontaneous report from a non-contactable consumer (herself). A 26-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EL3247, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 09:30 (Age at vaccination 26-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EL3247, Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 09:15 as dose 1, single for covid-19 immunisation. On 19Feb2021 11:30, the patient experienced about 2 hours after 2nd dose of vaccine, noticed a headache that was gradually increasing and pain + soreness in my left arm (injection site) became apparent. No treatment was taken, the side effects are manageable without medications. About 18-20 hours after my 2nd vaccine dose (20Feb2021), noticed headaches that lasted through the night which made it difficult to sleep, in addition to chills. This lasted about 6-8 hours and then had subsided. Also, I woke up with pain at the injection site and muscle soreness but has since gotten better. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further Information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis
Clinical narrative: Dizzy spells around 23 hours after the vaccine until about 27 hours after the vaccine; Sweats; chills from about 12 hours after the vaccine until about 36 hours after; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EC9265) via an unspecified route of administration in the right arm on 23Feb2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included birth control pill and montelukast sodium (SINGULAIR) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EC3249) via an unspecified route of administration in the right arm on 02Feb2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 24Feb2021 at 02:00, the patient experienced sweats and chills from about 12 hours after the vaccine until about 36 hours after and on 24Feb2021 at 13:00, experienced dizzy spells around 23 hours after the vaccine until about 27 hours after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy spells was recovered on 24Feb2021 (about 27 hours after the vaccine) while the events sweats and chills were recovered on 25Feb2021 (about 36 hours after).   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraine; Headache; This is a spontaneous report from a contactable consumer (patient) received from a female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medication history and concomitant medication were not reported. After receiving the first dose of bnt162b2, the patient experienced migraine and headache. The patient would like to delay getting the second dose instead of getting it on 10Mar2021 and she would like to get it on 12Mar2021. The outcome of migraine and headache was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained.No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a non-contactable consumer. A 77-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, GERD (gastroesophageal reflux disease) and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Feb2021, the patient experienced soreness at injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event soreness at injection site was recovering at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: This is a spontaneous report from a noncontactable healthcare professional. A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot#  EN6203), at the age of 54, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. On an unknown date (during her 15 minutes waiting period after the injection), patient experienced mouth dryness. Therapeutic measures taken as a result of mouth dryness included treatment with antihistamines and water. Follow-up response to treatment was good. The patient was stable to go home when discharged. She was advised follow-up with primary care physician. The outcome of the mouth dryness: unknown (at the time of this report). No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: lightheadedness; feeling weak; This is a spontaneous report from a non-contactable other healthcare professional. A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on an unknown date (at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, during 15 minutes waiting period after the vaccination, the patient experienced light-headedness and felt weak. Therapeutic measures taken as a result of the reported events included water and snacks. It was reported that patient responded good to follow up treatment and the patient was stable to go to home and was asked to follow up with primary care physician (PCP). The differential diagnosis was reported as vaccine related anxiety (included misc mental health, as reported). The clinical outcome of events light-headedness and feeling weak was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.