chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: Pain at injection; muscle aches; chills; fatigue; joint pain; low fever; nausea; loss of appetite; second dose of the Pfizer Covid-19 Vaccine on 15Jan2021, but the first dose was received on18Dec2020; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old patient of an unspecified gender received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 15Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included depression, anxiety and known allergies to IVP dye. The patient was not diagnosed with Covid prior to vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and vitamins NOS (MULTIVITAMINS reported as MULTI VITAMIN). The patient did not receive other vaccines in the last 4 weeks. The patient previously took cefalexin monohydrate (KEFLEX) but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 18Dec2020 16:00 at a single dose for covid-19 immunization but had pain at injection, chills, fatigue, nausea, joint pain, headache, brain fog and diarrhea. The patient received the second dose of the Pfizer Covid-19 Vaccine in a pharmacy or drug store on 15Jan2021, but the first dose was received on18Dec2020. The patient experienced pain at injection, chills, fatigue, muscle aches, joint pain, low fever, nausea and loss of appetite on 15Jan2021 19:00 which did not received treatment. The patient has not been covid tested post vaccination. The outcome of the event pain at injection, chills, fatigue, muscle aches, joint pain, low fever, nausea, loss of appetite were recovering while the outcome of the other event was unknown.  The following information on the batch/lot number has been requested.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection; muscle aches; chills; fatigue; joint pain; low fever; nausea; loss of appetite; second dose of the Pfizer Covid-19 Vaccine on 15Jan2021, but the first dose was received on18Dec2020; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old patient of an unspecified gender received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 15Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included depression, anxiety and known allergies to IVP dye. The patient was not diagnosed with Covid prior to vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and vitamins NOS (MULTIVITAMINS reported as MULTI VITAMIN). The patient did not receive other vaccines in the last 4 weeks. The patient previously took cefalexin monohydrate (KEFLEX) but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 18Dec2020 16:00 at a single dose for covid-19 immunization but had pain at injection, chills, fatigue, nausea, joint pain, headache, brain fog and diarrhea. The patient received the second dose of the Pfizer Covid-19 Vaccine in a pharmacy or drug store on 15Jan2021, but the first dose was received on18Dec2020. The patient experienced pain at injection, chills, fatigue, muscle aches, joint pain, low fever, nausea and loss of appetite on 15Jan2021 19:00 which did not received treatment. The patient has not been covid tested post vaccination. The outcome of the event pain at injection, chills, fatigue, muscle aches, joint pain, low fever, nausea, loss of appetite were recovering while the outcome of the other event was unknown.  The following information on the batch/lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dry throat, Feeling abnormal, Gait disturbance
Clinical narrative: feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; stiff neck; severe shivering; I needed assistance to walk safely to avoid falling; Intense pain in my left arm; dryness in my throat/severely dry throat; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration in right arm on 23Dec2020 17:15 at single dose for COVID-19 immunization. Medical history included acid reflux from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first Pfizer vaccine on 23Dec2020 at approximately 5:15 PM. The patient felt fine until about 11 PM at night, the patient stated, "when I began experiencing intense pain in my left arm and dryness in my throat" on 23Dec2020. I took a Benadryl and went to bed. At approximately 1 AM (24Dec2020) I woke up feeling like I was 500 lbs (I am about 175 lbs). I also had swollen lymph nodes in my neck, a stiff neck, a severely dry throat, and severe shivering. I attempted to navigate to the bathroom and felt like I needed assistance to walk safely to avoid falling. I felt like an impending sense of doom, and called my mom who is a nurse. She told me to contact the Pfizer #, but nobody was answering the phone at that time. I then started looking up on the internet if anyone else had experience what I was feeling after the vaccine and if the feeling passed, as I was not sure if I should go to the ER. I ended up falling asleep." The outcome of the events was recovering. The patient took Benadryl for events "intense pain in my left arm and dryness in my throat" as treatment. No treatment was given to the patient from the remaining events.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; stiff neck; severe shivering; I needed assistance to walk safely to avoid falling; Intense pain in my left arm; dryness in my throat/severely dry throat; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration in right arm on 23Dec2020 17:15 at single dose for COVID-19 immunization. Medical history included acid reflux from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first Pfizer vaccine on 23Dec2020 at approximately 5:15 PM. The patient felt fine until about 11 PM at night, the patient stated, "when I began experiencing intense pain in my left arm and dryness in my throat" on 23Dec2020. I took a Benadryl and went to bed. At approximately 1 AM (24Dec2020) I woke up feeling like I was 500 lbs (I am about 175 lbs). I also had swollen lymph nodes in my neck, a stiff neck, a severely dry throat, and severe shivering. I attempted to navigate to the bathroom and felt like I needed assistance to walk safely to avoid falling. I felt like an impending sense of doom, and called my mom who is a nurse. She told me to contact the Pfizer #, but nobody was answering the phone at that time. I then started looking up on the internet if anyone else had experience what I was feeling after the vaccine and if the feeling passed, as I was not sure if I should go to the ER. I ended up falling asleep." The outcome of the events was recovering. The patient took Benadryl for events "intense pain in my left arm and dryness in my throat" as treatment. No treatment was given to the patient from the remaining events.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal discomfort, Pyrexia
Clinical narrative: Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration in left arm on 15Jan2021 at 08:30 AM at single dose for COVID-19 immunization. Medical history included CAD (coronary artery disease), mild COPD (chronic obstructive pulmonary disease) and GERD (gastroesophageal reflux disease). Patient had Covid prior vaccination. Patient was not pregnant. Patient has no known allergies. No other vaccines in four weeks. Concomitant medications included rosuvastatin calcium (CRESTOR), carvedilol (COREG) and vitamins (unspecified). On 16Jan2021 at 01:00 PM, the patient experienced fatigue, joint discomfort, mild fever, and mild headache. Patient did not receive treatment for the events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Haemoptysis, Headache, Myalgia
Clinical narrative: temp 103/temp 99.9; severe headache; severe fatigue; muscle soreness; yellow nasal secretions; yellow and bloody sputum; yellow and bloody sputum; This is a spontaneous report from a contactable nurse. A 59-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284, expiry date unknown), intramuscular (right arm) on 12Jan2021 15:45, at single dose, for covid-19 immunization. The patient had no medical history and had no known allergies. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), on 21Dec2020 14:00 for covid-19 immunization, vaccine location left arm, at 59 years old. After 18 hours of obtaining shot, on 13Jan2021 09:00 the patient experienced temp 103, severe headache, severe fatigue, muscle soreness, yellow nasal secretions, yellow and bloody sputum. Now on day 4 after shot, 16Jan2021, the patient still had temp 99.9, headache, fatigue, nasal secretions and, sputum secretions less. No treatment was received for the adverse events reported. The patient was recovering from the events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post-vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sputum discoloured
Clinical narrative: temp 103/temp 99.9; severe headache; severe fatigue; muscle soreness; yellow nasal secretions; yellow and bloody sputum; yellow and bloody sputum; This is a spontaneous report from a contactable nurse. A 59-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284, expiry date unknown), intramuscular (right arm) on 12Jan2021 15:45, at single dose, for covid-19 immunization. The patient had no medical history and had no known allergies. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), on 21Dec2020 14:00 for covid-19 immunization, vaccine location left arm, at 59 years old. After 18 hours of obtaining shot, on 13Jan2021 09:00 the patient experienced temp 103, severe headache, severe fatigue, muscle soreness, yellow nasal secretions, yellow and bloody sputum. Now on day 4 after shot, 16Jan2021, the patient still had temp 99.9, headache, fatigue, nasal secretions and, sputum secretions less. No treatment was received for the adverse events reported. The patient was recovering from the events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post-vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Lymphadenitis, Lymphadenopathy, Swelling of eyelid
Clinical narrative: left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue; Shortness of breath; Chest pain; Cough; This is a spontaneous report from a contactable consumer. A 22-year-old female patient (daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her daughter had a reaction to the COVID vaccine. The patient received the first dose of the vaccine on 23Dec2020. The adverse reaction has lasted the past three weeks to include fatigue, shortness of breath, chest pain, and cough on unspecified date. The patient is now on inhalers and she was not on inhalers before. The reporter stated that her daughter has been tested for COVID multiple times. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Health Care Professional (patient).    A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL0142) at single dose, in the left arm, on 01Jan2021 at 09:00 PM, for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history was unknown. Concomitant medications included levocetirizine. On 12Jan2021, after receiving first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) the patient resulted positive to COVID-19. Post the vaccination, the patient has been tested for COVID-19 on 12Jan2021 and resulted positive. COVID-19 test type post vaccination: Nasal Swab (COVID-19 PCR test). No treatment received. Clinical outcome was unknown at time of this report.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age (age: 21; unit: unknown) and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that one of her colleagues tested positive for COVID after the first dose of the vaccine on an unspecified date. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling hot, Flushing, Palpitations
Clinical narrative: Heart racing/Palpitations; Hot and flush feeling; Hot and flush feeling; Weakness; Dizzy; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3248), intramuscular in the right arm on 15Jan2021 at 12:30 PM as a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant, did not receive any other vaccine within four weeks, did not have any other medications in two weeks, had no known allergies, and did not have COVID prior to the vaccination. The patient experienced heart racing, palpitations, hot and flush feeling, weakness, and was dizzy on an unspecified date. Therapeutic measures were taken as a result of the events which included Benadryl. The patient was not COVID tested post-vaccination. Outcome of the events was recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Congenital anomaly, Exposure during pregnancy, SARS-CoV-2 test negative
Clinical narrative: Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; This is a spontaneous report from a contactable nurse reported for herself. This 33-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Es1686), via intramuscular at left arm on 11Jan2021 08:00 am at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 21Dec2020 10:15 AM for COVID-19 immunisation. The patient had no known allergies. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient was pregnant. Last menstrual date was 14Dec2020. Delivery due date was 16Sep2021. Gestation period was 3 weeks. The patient experienced miscarriage on 16Jan2021 after 2nd vaccine. AE resulted in congenital anomaly or birth defect. The patient had no COVID prior vaccination. The patient had COVID tested/nasal swab post vaccination with negative results on 11Jan2021 and 13Jan2021. Outcome of the events was unknown.; Sender's Comments: Based on the available information, a causal relationship between event  miscarriage after the second COVID-19 vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dysphagia, Eye pain
Clinical narrative: High grade fevers up to 104.0; shivers/rigors; unable to eat or drink 24-36 hours due to rigors; headache; eye aches/ eye movements painful; extensive drenching sweats x 3 days; head shakiness; dizziness; Body aches; This is a spontaneous report from a contactable Physician (patient). A 58-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL1283), intramuscular on left arm on 07Jan2021 12:15 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 07:00 via intramuscular on left arm. No other vaccine in four weeks. On 07Jan2021 at 22:00, the patient had high grade fevers up to 104.0, shivers, rigors, headache, eye aches and eye movements painful, extensive drenching sweats for 3 days then slowed down, head shakiness and dizziness, unable to eat or drink 24-36 hours due to rigors. The patient reported that he experienced body aches, confined to bed 48 hours, then gradually and fully recovered by the end of day 4. No nausea or vomiting, and no cough. The patient took Acetaminophen 500mg x 1 oral (PO) as treatment to the events. No COVID prior vaccination. The patient was COVID tested post vaccination with 'POC test' (covid test type post vaccination=Nasal Swab) on 11Jan2021 which showed negative result. The outcome of the event body ache was recovered on 11Jan2021 and other events was recovered on unspecified date in Jan2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Head titubation, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: High grade fevers up to 104.0; shivers/rigors; unable to eat or drink 24-36 hours due to rigors; headache; eye aches/ eye movements painful; extensive drenching sweats x 3 days; head shakiness; dizziness; Body aches; This is a spontaneous report from a contactable Physician (patient). A 58-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL1283), intramuscular on left arm on 07Jan2021 12:15 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 07:00 via intramuscular on left arm. No other vaccine in four weeks. On 07Jan2021 at 22:00, the patient had high grade fevers up to 104.0, shivers, rigors, headache, eye aches and eye movements painful, extensive drenching sweats for 3 days then slowed down, head shakiness and dizziness, unable to eat or drink 24-36 hours due to rigors. The patient reported that he experienced body aches, confined to bed 48 hours, then gradually and fully recovered by the end of day 4. No nausea or vomiting, and no cough. The patient took Acetaminophen 500mg x 1 oral (PO) as treatment to the events. No COVID prior vaccination. The patient was COVID tested post vaccination with 'POC test' (covid test type post vaccination=Nasal Swab) on 11Jan2021 which showed negative result. The outcome of the event body ache was recovered on 11Jan2021 and other events was recovered on unspecified date in Jan2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: High grade fevers up to 104.0; shivers/rigors; unable to eat or drink 24-36 hours due to rigors; headache; eye aches/ eye movements painful; extensive drenching sweats x 3 days; head shakiness; dizziness; Body aches; This is a spontaneous report from a contactable Physician (patient). A 58-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL1283), intramuscular on left arm on 07Jan2021 12:15 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 07:00 via intramuscular on left arm. No other vaccine in four weeks. On 07Jan2021 at 22:00, the patient had high grade fevers up to 104.0, shivers, rigors, headache, eye aches and eye movements painful, extensive drenching sweats for 3 days then slowed down, head shakiness and dizziness, unable to eat or drink 24-36 hours due to rigors. The patient reported that he experienced body aches, confined to bed 48 hours, then gradually and fully recovered by the end of day 4. No nausea or vomiting, and no cough. The patient took Acetaminophen 500mg x 1 oral (PO) as treatment to the events. No COVID prior vaccination. The patient was COVID tested post vaccination with 'POC test' (covid test type post vaccination=Nasal Swab) on 11Jan2021 which showed negative result. The outcome of the event body ache was recovered on 11Jan2021 and other events was recovered on unspecified date in Jan2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Chest pain, Hypertension, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 16 Jan 2021 at 12:45 PM at a single dose for COVID-19 immunization in a hospital.  Medical history included high cholesterol, GERD, Barrets esophagus, IBS-C, brain aneurysms, and known allergies to penicillin. The patient also received first dose of other vaccine in left (arm).  Concomitant medications included clopidogrel bisulfate (PLAVIX), pravastatin, amitriptyline, famotidine, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS).  The patient has known allergies to Topamax. The patient experienced burning feeling from chest down to feet, tachycardia, high blood pressure, and chest pain on 16 Jan 2021 at 12:45 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. No treatment received for the events.  The patient is recovering from the events. Information on the batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: Rapid onset vaginal yeast infection; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 13Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient experienced rapid onset vaginal yeast infection on 16Jan2021 12:00. It was treated with Diflucan. The patient reported that she gets this reaction when taking antibiotics but the only thing she received was the vaccine. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Fatigue, Headache
Clinical narrative: headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date was not provided), intramuscular (left arm) first dose on 14Jan2021 12:30 at single dose for covid-19 immunisation. The patient's medical history Asthma, adrenal insufficiency, hypokalemia, chronic migraine, Vit D deficiency, Known allergies: IV Contrast dye, and Covid. The patient was not pregnant at time of vaccination. The patient's concomitant medication includes unspecified drug. On 14Jan2021 13:00, the patient experienced itchy rash, fever, debilitating joint pain, nausea, fatigue, headache, and injection site pain. The patient did not received treatment for the events. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pain
Clinical narrative: Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date was not provided), intramuscular (left arm) first dose on 14Jan2021 12:30 at single dose for covid-19 immunisation. The patient's medical history Asthma, adrenal insufficiency, hypokalemia, chronic migraine, Vit D deficiency, Known allergies: IV Contrast dye, and Covid. The patient was not pregnant at time of vaccination. The patient's concomitant medication includes unspecified drug. On 14Jan2021 13:00, the patient experienced itchy rash, fever, debilitating joint pain, nausea, fatigue, headache, and injection site pain. The patient did not received treatment for the events. The outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Chills; Headache; Nausea; Myalgia; Arthralgia; fatigue; pain at site of injection; Start Date/Time: (2nd dose) 15Jan2021 09:00 AM Start Date/Time: (1st dose) 29Dec2020 09:00 AM"; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at her right arm, via an unspecified route of administration on 15Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose).  The patient experienced chills, headache, nausea, myalgia, arthralgia, fatigue, pain at site of injection; all on 15Jan2021 08:00. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: Chills; Headache; Nausea; Myalgia; Arthralgia; fatigue; pain at site of injection; Start Date/Time: (2nd dose) 15Jan2021 09:00 AM Start Date/Time: (1st dose) 29Dec2020 09:00 AM"; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at her right arm, via an unspecified route of administration on 15Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose).  The patient experienced chills, headache, nausea, myalgia, arthralgia, fatigue, pain at site of injection; all on 15Jan2021 08:00. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events.   Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Nausea
Clinical narrative: malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Dec2020 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medication included linaclotide (LINZESS), omeprazole, ascorbic acid (VIT C), and ergocalciferol (VIT D).  The patient previously took erythromycin and DEMEROL and experienced allergy. The day after first injection, patient had extreme malaise, weekness and nausea on 20Dec2020 06:00. Outcome of the event was recovered. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (left arm) on 23Dec2020 (14:45) at single dose for Covid-19 immunization.  Medical history was reported as none.  The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, nausea, fever, chills, body aches, and fatigue on 24Dec2020 (12:00AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (left arm) on 23Dec2020 (14:45) at single dose for Covid-19 immunization.  Medical history was reported as none.  The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, nausea, fever, chills, body aches, and fatigue on 24Dec2020 (12:00AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain of skin, Pyrexia
Clinical narrative: Temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5; headache; muscle aches; skin tenderness; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on the left arm on 13Jan2021 07:00 at a single dose COVID-19 immunization. Medical history included none. The patient is not pregnant. The patient's concomitant medication includes an unspecified birth control pill. On 13Jan2021 19:00, the patient experienced a temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5 with ibuprofen 800 mg and Tylenol 1000mg. The patient also experienced headache, muscle aches and skin tenderness x 48 hours. The patient was given treatment for the events. The outcome of the events was recovered on an unspecified date.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Maternal exposure during pregnancy; Maternal exposure during pregnancy; Maternal exposure during pregnancy; Muscle and joint aches in legs; Muscle and joint aches in legs; Shivering; fatigue; This is a spontaneous report from a contactable nurse.  A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9231), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included colitis ulcerative and hypersensitivity to sulfa drugs, tomato, nuts from an unknown date and unknown if ongoing.  Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 15Jan2021 22:00, the muscle and joint aches in legs, shivering and fatigue. The patient was 35 Weeks pregnant at the onset of the event. The patient was due to deliver on 26Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 covid test result of Negative. The outcome of the eventsmuscle and joint aches in legs, shivering and fatigue was recovering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Maternal exposure during pregnancy; Maternal exposure during pregnancy; Maternal exposure during pregnancy; Muscle and joint aches in legs; Muscle and joint aches in legs; Shivering; fatigue; This is a spontaneous report from a contactable nurse.  A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9231), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included colitis ulcerative and hypersensitivity to sulfa drugs, tomato, nuts from an unknown date and unknown if ongoing.  Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 15Jan2021 22:00, the muscle and joint aches in legs, shivering and fatigue. The patient was 35 Weeks pregnant at the onset of the event. The patient was due to deliver on 26Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 covid test result of Negative. The outcome of the eventsmuscle and joint aches in legs, shivering and fatigue was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; headache; This is a spontaneous report from a contactable nurse (patient herself). A 31-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL1283), via an unspecified route of administration in the right arm on 21Dec2020 at SINGLE DOSE, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines in four weeks. She had a sars-cov-2 test via nasal swab on 30Dec2020 and was negative. She was re-tested for sars-cov-2 and she was positive (via nasal swab) on 04Jan2021. The patient had her second dose of bnt162b2 on 15Jan2021. She informed that she had headache that started 30Dec2020 and during the 10 days following the positive test. She received the vaccine in a hospital and had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and a repeated sars-cov-2 test via nasal swab positive on 04Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pustule, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; pus; arm hurt for a few days but it stopped; This is a spontaneous report from a contactable consumer (reporting for herself).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Jan2021, the patient experienced arm hurt for a few days, but it stopped and had puss.  On 15Jan2021, the patient reported that the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch.  Therapeutic measures were taken as a result of the events and included: acetaminophen (TYLENOL).  The outcome of arm hurt for a few days but it stopped was recovered in Jan2021 and of the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch and pus was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; pus; arm hurt for a few days but it stopped; This is a spontaneous report from a contactable consumer (reporting for herself).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Jan2021, the patient experienced arm hurt for a few days, but it stopped and had puss.  On 15Jan2021, the patient reported that the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch.  Therapeutic measures were taken as a result of the events and included: acetaminophen (TYLENOL).  The outcome of arm hurt for a few days but it stopped was recovered in Jan2021 and of the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch and pus was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.