chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Flea infestation, Hypersensitivity, Pruritus
Clinical narrative: was diagnosed with severe reaction to the2nd vaccine; chest pains; itching on my hands; my arms with welts; my neck turned extremely red and whole body became red; my head felt like fleas were in my head,; threw up twice; This is a spontaneous report from a contactable consumer (patent). A 70-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: en6201) via an unspecified route of administration in left arm on 01Mar2021 13:00 (at age of 70-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Patient had no allergy. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: el9262) via an unspecified route of administration in left arm on 08Feb2021 at 01:00 PM as single dose for COVID-19 immunisation. Concomitant medication was not reported. Patient not had Covid prior vaccination. Patient was not tested for Covid post vaccination. It was reported that on 03Mar2021, 2nd Day after 2nd dose of vaccination, patient starting with itching on her hands, then up arms with welts, her neck turned extremely red, and whole body became red, and her head felt like fleas were in her head, threw up twice before going to the doctor. Patient went to her family doctor and was diagnosed with severe reaction to the 2nd vaccine. Patient's doctor stated 1 percent of patients will have this severe reaction. She was having chest pains which started while she was waiting for her appointment. The doctor prescribed a treatment of prednisone and advised her if she had trouble breathing to go to the emergency room. After taking the medication on 3/3 the itching has stopped, but still had some red marks on her skin. Hopefully the medication treatment (9 days) would clear up skin marks. The outcome of the events was recovering.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: was diagnosed with severe reaction to the2nd vaccine; chest pains; itching on my hands; my arms with welts; my neck turned extremely red and whole body became red; my head felt like fleas were in my head,; threw up twice; This is a spontaneous report from a contactable consumer (patent). A 70-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: en6201) via an unspecified route of administration in left arm on 01Mar2021 13:00 (at age of 70-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Patient had no allergy. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: el9262) via an unspecified route of administration in left arm on 08Feb2021 at 01:00 PM as single dose for COVID-19 immunisation. Concomitant medication was not reported. Patient not had Covid prior vaccination. Patient was not tested for Covid post vaccination. It was reported that on 03Mar2021, 2nd Day after 2nd dose of vaccination, patient starting with itching on her hands, then up arms with welts, her neck turned extremely red, and whole body became red, and her head felt like fleas were in her head, threw up twice before going to the doctor. Patient went to her family doctor and was diagnosed with severe reaction to the 2nd vaccine. Patient's doctor stated 1 percent of patients will have this severe reaction. She was having chest pains which started while she was waiting for her appointment. The doctor prescribed a treatment of prednisone and advised her if she had trouble breathing to go to the emergency room. After taking the medication on 3/3 the itching has stopped, but still had some red marks on her skin. Hopefully the medication treatment (9 days) would clear up skin marks. The outcome of the events was recovering.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature abnormal, Chills, Dizziness
Clinical narrative: Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp of 99.3; sweats then a temp of 99.3; I had to crawl in order to move from place to place; This is a spontaneous reporter from a contactable consumer (patient). This 83-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in right arm via unknown route of administration on 17Feb2021 at 10:30 am as single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Medical history of patient was reported as osteoarthritis, rheumatoid arthritis, penicillin allergy, allergies from components of Epinephrine Solution and AVALOX. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin B1 nos, vitamin B12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), ascorbic acid, retinol, tocopherol (OCCUVITE), cholecalciferol (D3) and aspirin. No covid prior vaccination. No covid tested post vaccination. No vaccine in four weeks. On 18Feb2021 at 07:30 AM, 20 hours after the injection the patient experienced severely dizzy and weak unable to stand. She had to crawl in order to move from place to place. This lasted about 15-20 minutes. She vomited and developed severe chills and sweats then a temperature of 99.3. No treatment was given. The outcome of events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Hyperhidrosis, Movement disorder, Vomiting
Clinical narrative: Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp of 99.3; sweats then a temp of 99.3; I had to crawl in order to move from place to place; This is a spontaneous reporter from a contactable consumer (patient). This 83-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in right arm via unknown route of administration on 17Feb2021 at 10:30 am as single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Medical history of patient was reported as osteoarthritis, rheumatoid arthritis, penicillin allergy, allergies from components of Epinephrine Solution and AVALOX. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin B1 nos, vitamin B12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), ascorbic acid, retinol, tocopherol (OCCUVITE), cholecalciferol (D3) and aspirin. No covid prior vaccination. No covid tested post vaccination. No vaccine in four weeks. On 18Feb2021 at 07:30 AM, 20 hours after the injection the patient experienced severely dizzy and weak unable to stand. She had to crawl in order to move from place to place. This lasted about 15-20 minutes. She vomited and developed severe chills and sweats then a temperature of 99.3. No treatment was given. The outcome of events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: High fever (39C); Headache; Body pain; Chills; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration in left arm on 03Mar2021 at 12:00 AM as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient had no known allergies. Patient did not receive other vaccine in four weeks. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination the patient was diagnosed with COVID -19. Since the vaccination, the patient was not tested for COVID-19. On 04Mar2021, the patient experienced headache, body pain, chills and high fever at 39C. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Horrible pains in both shoulders/ a friend in (State name) that hers lasted a month-Eben Pain spreaded to other joints; This is a spontaneous report from a contactable consumer. This contactable consumer reported for female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9267), via an unspecified route of administration administered in arm left on 18Feb2021 at single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9263), via an unspecified route of administration, administered in arm right on 21Jan2021 10:00 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included arthritis, HBP and chronic boreliosis, all from an unknown date and unknown if ongoing. The patient previously took NSAIDs, LEVAQUIN, latex and experienced hypersensitivity. Concomitant medications included Oxycodone 7.5 mg; Carvedilol 20 mg; Gabapentin 300. was reported that the No adverse effects first 4 days. The patient experienced horrible pain in both shoulders, samnitska m up dcery houf on 23Feb2021 06:00. Could not lift a cup of water, pull her pants up or shirt on. Because patient heard from a friend in a different state that hers lasted a month I was waiting. After three weeks, Eben Pain spreaded to other joints patient visited her family doctor. He prescribed Medrol- steroid pack and to stop Simvastatin. Pain subsided after 24 hours. The outcome of patient was recovered.   No follow-up attempts are possible; no further information are expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; feeling tired; This is a spontaneous report from a contactable consumer (parent). A 20-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 17Mar2021 at 17:15 (at the age of 20-year-old) as 1st DOSE, SINGLE in left arm for COVID-19 immunisation. The patient's medical history included known allergies from amoxicillin. Patient was not pregnant at the time of vaccination. Concomitant medications included Tri Femynor 28 Tablet and doxycycline hyclate 100 mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 09:00 AM, the patient experienced sore arm and feeling tired. Therapeutic measures included ibuprofen taken for sore arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The clinical outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Stiff neck; sore arm at injection site; This is a spontaneous report from a contactable consumer (patient's wife). The 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955 expiry date: unknown) via an unspecified route of administration in right arm on 17Mar2021 01:15 PM, as a single dose for Covid-19 immunisation. Medical history included high cholesterol. The patient has no known allergies medications, food, or other products. Concomitant medications in two weeks included fexofenadine hydrochloride (ALLEGRA); atorvastatin (LIPITOR [ATORVASTATIN]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where COVID-19 vaccine was administered was at a clinic. Patient not tested for COVID-19 prior to vaccination. On 19Mar2021, the patient experienced stiff neck and sore arm at injection site. He did not receive treatment for events. Patient not tested for COVID-19 after the vaccination. The outcome of the events of stiff neck and sore arm at injection site was reported as recovering.  No follow-up attempts were needed. No further information was expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Migraine, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sleep disorder
Clinical narrative: dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Feeling hot, Hypoacusis, Malaise
Clinical narrative: Remained in waiting room for 15 minutes as per instructions from medical staff. Within approximately 10 minutes of administration, I experienced a wave of warmth that led to a feeling that I would pass out. Called out to nursing staff that I was feeling "dizzy" (didn't know what else to call it). It was not like normal dizziness. Remained seated with legs stretched out to try to combat the feeling I would pass out. Nurses checked my blood pressure and it was in the low 70's. Along with low blood pressure, I experienced temporary hearing loss in left ear, nausea (feeling I could throw up), feeling I could diarrhea/defecate immediately (but held it in for obvious reasons), mental confusion. Nurses called the Emergency Department at my local hospital and told me I should (based on symptoms) be admitted to the hospital. Nurse said my blood pressure wasn't stabilizing at a normal rate of a typical vasovagal reaction. Nurse withheld administering Epipen and monitored the course of my symptoms. EMTs arrived and checked my vitals again in the Ambulance. In the Ambulance, I recall the technician saying my blood pressure was somewhere around 140. This reading is abnormally high for me (my typical blood pressure is around 110). I declined admission to the hospital due to my horrible medical insurance and worry about exorbitant costs. Symptoms did not resolve until approximately 50 minutes after the start of the incident (approx. 9:22 AM).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Remained in waiting room for 15 minutes as per instructions from medical staff. Within approximately 10 minutes of administration, I experienced a wave of warmth that led to a feeling that I would pass out. Called out to nursing staff that I was feeling "dizzy" (didn't know what else to call it). It was not like normal dizziness. Remained seated with legs stretched out to try to combat the feeling I would pass out. Nurses checked my blood pressure and it was in the low 70's. Along with low blood pressure, I experienced temporary hearing loss in left ear, nausea (feeling I could throw up), feeling I could diarrhea/defecate immediately (but held it in for obvious reasons), mental confusion. Nurses called the Emergency Department at my local hospital and told me I should (based on symptoms) be admitted to the hospital. Nurse said my blood pressure wasn't stabilizing at a normal rate of a typical vasovagal reaction. Nurse withheld administering Epipen and monitored the course of my symptoms. EMTs arrived and checked my vitals again in the Ambulance. In the Ambulance, I recall the technician saying my blood pressure was somewhere around 140. This reading is abnormally high for me (my typical blood pressure is around 110). I declined admission to the hospital due to my horrible medical insurance and worry about exorbitant costs. Symptoms did not resolve until approximately 50 minutes after the start of the incident (approx. 9:22 AM).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Feeling hot, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Dark urine 5 days Tinitus ongoing Low grade fever hot feeling inside ears resolved 3 days Lymph node swollen R armpit and both sides of throat resolved 5 days Pain overall intense off the charts body pain I had to take medication resolved 3 days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Dark urine 5 days Tinitus ongoing Low grade fever hot feeling inside ears resolved 3 days Lymph node swollen R armpit and both sides of throat resolved 5 days Pain overall intense off the charts body pain I had to take medication resolved 3 days
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Skipped historically regular period for the first time ever, with multiple negative pregnancy tests
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenia, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 37 year old male arrived to observation area.  Pt. stated feeling nauseated, weakness.  Observed to be sweating.  Two episodes of emitus with clear fluid vomitus.  Denies any other pain.   Fire Rescue arrived at scene.  Vital signs rendered.  Pt. declined hospitalization at this time.  Patient recovered from adverse reaction.  PO fluids given as tolerated.  Pt denied any pain or discomfort.  Pt. left observation area at 12:05pm.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died February 12, 2021
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Upon arrival to observation 21 year old female stated she felt nauseous and light headed.  Fire Rescue took vitals and after 10 minutes pt. felt better and refused more treatment and was driven home with instructions to call 911 if symptoms worsen.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Upper arm muscle sore & achy; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206) via an unspecified route of administration, administered in Left Arm on 08Mar2021 02:00 as single dose for covid-19 immunization; tozinameran (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: #EN6206), via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunization. Medical history included diabetes mellitus, chronic kidney disease, thyroid, rheumatoid arthritis from an unknown date and unknown if ongoing , osteoarthritis and high blood pressure. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies were reported for the patient. On 09Mar2021 the patient experienced upper arm muscle sore & achy. No treatment was received for the event. The outcome of event was not recovered. Location of injection information is available for all vaccines received on the same date.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (12May2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in the area of the clavicle post 2nd dose; This is a spontaneous report from a contactable reporter reporting for a 33-year-old male patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the right arm on 15Feb2021 (at the age of 33-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Unknown if any allergies presented. On 15Mar2021, the patient experiencing swollen lymph nodes in the area of the clavicle post second dose. Prior to vaccination, the patient was not diagnosed with COVID-19 and unknown if tested post vaccination. No treatments received. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Unknown if since the vaccination, the patient had been tested for COVID-19 and also allergies to medications, food or other products. Reporter learned of the adverse event that reporter reported on behalf of someone on 26Mar2021, the same day it was reported. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got Covid 19 a few days after my first shot. Test  positive on 09Mar; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6203 and Expiration date not reported) via an unspecified route of administration, in Arm left, on 03Mar2021 (at the age of 60 years) as a 1st dose, single for covid-19 immunization. The patient medical history included diabetes, hypertension and UTI (Urinary tract infection). Concomitant medications included acyclovir [ACICLOVIR] taken for an unspecified indication and ambroxol hydrochloride (ABX) taken for urinary tract infection, for both start and stop date were not reported. Other medications the patient received within 2 weeks of vaccination includes Abx for UTI. The patient received some other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 09Mar2021, she got COVID-19 a few days after her first shot. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the event. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: positive on 09Mar2021. Outcome of the event was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: she thought she was going to die; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that she thought she was going to die on an unspecified date. She stated she was not sure if she is going to get the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia neonatal, Fatigue, Headache, Heart rate increased, Palpitations
Clinical narrative: Fever; Splitting headache; Heart was racing like 100 beat per second and I kept waking with nightmare and just these deep breathing to try and slow my heart down; Average beats per minute all night long was 86 which is normally like 50/Hope that didn't damage my heart by having this racing heartbeat all night long and it's high now; Exhausted; This is a spontaneous report received from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 25Mar2021 at 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 04Mar2021 for COVID-19 immunization. Patient lab data included heart beat results were reported as heart was racing a 100 beat per second all night long/beats per minute all night long was 86 which is normally like 50. On an unspecified date in Mar2021 consumer stated that I had my second Pfizer (captured as Unspecified medication) yesterday morning, my first one was on 04Mar2021 and didn't had any problems or any reactions at all. But the second one I had a fever, splitting headache and my heart was racing a 100 beat per second all night long and I kept waking up with these nightmare and waking up and just these deep breathing to try and slow my heart down. And it was just this thing because I have a fit bit that I was wearing and the average beats per minute all night long was 86 which is normally like 50. So something weird was going on and I was exhausted right now. And I just hope that didn't damage my heart by having this racing heartbeat all night long and it's high now, it's high still, much higher than normal. I normally am a very fit person so I normally have a very low heart rate. I am kind of little worried about it but I wanted to let you guys know and also see if there is a way to just make sure that I don't need to go to the doctor". Outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Splitting headache; Heart was racing like 100 beat per second and I kept waking with nightmare and just these deep breathing to try and slow my heart down; Average beats per minute all night long was 86 which is normally like 50/Hope that didn't damage my heart by having this racing heartbeat all night long and it's high now; Exhausted; This is a spontaneous report received from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 25Mar2021 at 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 04Mar2021 for COVID-19 immunization. Patient lab data included heart beat results were reported as heart was racing a 100 beat per second all night long/beats per minute all night long was 86 which is normally like 50. On an unspecified date in Mar2021 consumer stated that I had my second Pfizer (captured as Unspecified medication) yesterday morning, my first one was on 04Mar2021 and didn't had any problems or any reactions at all. But the second one I had a fever, splitting headache and my heart was racing a 100 beat per second all night long and I kept waking up with these nightmare and waking up and just these deep breathing to try and slow my heart down. And it was just this thing because I have a fit bit that I was wearing and the average beats per minute all night long was 86 which is normally like 50. So something weird was going on and I was exhausted right now. And I just hope that didn't damage my heart by having this racing heartbeat all night long and it's high now, it's high still, much higher than normal. I normally am a very fit person so I normally have a very low heart rate. I am kind of little worried about it but I wanted to let you guys know and also see if there is a way to just make sure that I don't need to go to the doctor". Outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 antibody test
Clinical narrative: two days after his first dose of the vaccine He tested positive with the Covid-19; His Doctor advised him to get the second dose only after 60 days before getting his second dose; This is a spontaneous report from a Pfizer sponsored Program. A contactable male consumer reported that; a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 20Jan2021at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced two days after his first dose of the vaccine he tested positive with the COVID-19 and his doctor advised him to get the second dose only after 60 days before getting his second dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 22Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible. No information about lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: I had a routine COVID test at work about 2 pm on Friday, This test came back with positive results; This is a spontaneous report from a contactable consumer. A 23-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 at 02:45 as second dose, single for covid-19 immunisation. Medical history included drug hypersensitivity. Allergies to medications, food, or other products included Zythromax. Concomitant medication included estrogens conjugated (estrin [estrogens conjugated]) birth control.  On 04Mar2021 at 03:45 pm, the patient received first dose of bnt162b2 (Batch/Lot Number: FN6205) administered in right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Mar2021 friday, she had a routine COVID test at work about 2 pm. This test came back with positive results which was very strange considering she had not changed her routine or the people she interacted with for the last month and everyone she had interacted with also tested negative on the same day. She had no reason to test positive between this and the fact that she strictly went from home to work and back daily. For the second dose: About 2 am on 26Mar2021, she woke up with a fever of 100.9. She called out of work and spent entire next day in bed with horrific chills and an off and on fever eventually peaking at 102.8 around 5pm. Sometime after that, she fell asleep and slept until around 7 the next morning and by then her fever had broken. The whole day that she was feverish she had such bad body aches it hurt to walk across her apartment to the bathroom even and she spent the day off and on sleeping. The event assessed as non-serious with outcome of recovered.  No follow up attempts needed; information about batch/lot no. cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; mild headache.; This is a spontaneous report received from a contactable consumer. A female patient of unknown age, received adalimumab (HUMIRA, solution for injection in pre-filled syringe and pen) from unknown date, subcutaneous for Psoriatic Arthritis. Covid-19 vaccine  was also considered suspect. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. Patient experienced headache and sore arm. Outcome of events was unknown.  No follow up attempts are possible. Information related to batch/lot number could not be requested
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: experiencing rather strong flu-like symptoms; This is a spontaneous report from a contactable consumer. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection),via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was not known if patient receive any other vaccines within 4 weeks prior to the COVID vaccine and if there was list of any other medications the patient received within 2 weeks of vaccination. It was unknown if patient was diagnosed with COVID-19, prior to vaccination and if patient has been tested for COVID-19, Since the vaccination. It was not known if patient had allergies to medications, food, or other products. On 02Apr2021, the patient experienced rather strong flu-like symptoms. It was unknown if treatment received for the event. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got covid six days after my vaccination and I'd like to understand what if any are the effects of receiving the second dose. What is the protocol exactly?; This is a spontaneous report from contactable consumer reported for herself. This 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732, expiry date: unknown) in left arm via unknown route of administration on 28Mar2021 at 14:45 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or no other medications received within 2 weeks of vaccination. Medical history and concomitant medications were not reported. She got COVID six days after her vaccination on 03Apr2021 at 09:00 AM and would like to understand what if any are the effects of receiving the second dose. It was also reported that, started having symptoms for COVID-19 on 03Apr2021 and then tested positive for COVID-19. She underwent lab test: SARS- CoV-2-NAT with positive result on 07Apr2021. She did not receive any treatment. She has fully recovered d from COVID-19, has no symptoms and she has completed her required isolation period. Outcome of event was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disease recurrence, Gastrointestinal disorder, Illness
Clinical narrative: Sick; very weak; had a GI condition I had been dealing with return/ 3 days after getting his first vaccine dose the condition he had came back; had a GI condition I had been dealing with return/ 3 days after getting his first vaccine dose the condition he had came back; This is a spontaneous report from a contactable consumer (patient) from Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 at single dose for COVID-19 immunization. Medical history included gastrointestinal disorder from Oct2020. The patient's concomitant medications were not reported. The patient had a regular reaction for a couple of days after receiving the shot but on day three, on 31Mar2021, he had a gastrointestinal condition he had been dealing with return. The patient reports that he has had a gastrointestinal issue since last October and his gastrointestinal physician has been trying to schedule a scope test. Three days after getting his first vaccine dose the condition he had come back, and he was not able to get the scope test until 29Apr2021. The patient was sick on an unspecified date. He reported that he was very weak (unspecified date) and, at the time of the report, he was just trying to stay out of the hospital. Outcome of all events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Headache; soreness at injection site; extreme muscle and joint pain; extreme muscle and joint pain; mild fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 18-year-old female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 08:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included sulfamethoxazole, methylphenidate hydrochloride, and sertraline, all from unknown dates for unknown indications. The patient previously received the first dose of COVID-19 vaccine (lot number EP6955) on 25Mar2021 at 08:15 (at the age of 18-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 15Apr2021 at 16:00 the patient experienced headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue. No treatment was received for the events. The clinical outcomes of headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Mar2021, and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on 01Apr2021, as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he received the first dose on 03Mar2021 and about 10 days to 2 weeks later he experienced diarrhea. It was reported the diarrhea had continued to "this day," as of (16Apr2021) and had still not gotten better two weeks after he received his second dose on 01Apr2021. He reported he was aware that it could be a side effect that may last for one to two days but was wondering if there had been any reports of diarrhea lasting this long of a period. The clinical outcome of diarrhea was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Feeling hot
Clinical narrative: stated patient reported on 8Apr2021 she developed pimples where she was red.; warm to the touch; that her chest, decolletage to her sternal notch, was bright red.; This is a spontaneous report from a contactable physician. A 60-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Mar2021 the patient experienced her chest, décolletage to her sternal notch was bright red. The area was red and warm to the touch. On 08Apr2021 she developed pimples where she was red. She only had about 10 pimples "now" between her breast and her sternal bone. The physician wanted to know if the patient could receive dose 2 of BNT162B2. The outcomes of chest bright red, warm to touch, and pimples were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a mild sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. Medical history included allergic to shellfish, clams, and mussels, Raynaud's and a heart murmur. The patient's concomitant medications were not reported. In Apr2021, the patient did not have any reaction other than a mild sore arm. The patient was scheduled to take the second dose on 30Apr2021 which would have been 3 weeks after the first dose. She asked if she could postpone receiving her second vaccine. She did not have any reaction other than a mild sore arm. The outcome of a mild sore arm was  unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vomiting
Clinical narrative: Fever; chills; malaise; vomiting; This is a spontaneous report from a contactable consumer (patient) via company representative. A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 at the age of 43 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. It was reported that after Second dose of BNT162b2 vaccine (week of 12Apr2021), patient experienced fever, chills, malaise and vomiting on 12Apr2021 for 24 hours and symptoms resolved. Events took place after use of product. The outcome of the events was recovered in Apr2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Bad swelling; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included Mammogram. The patient concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced bad swelling from second vaccine. Had to reschedule Mammogram. She did not get swelling from first vaccine. She Inquired if that was a common side effect. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Condition aggravated, Fatigue, Feeling hot
Clinical narrative: Bad swelling; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included Mammogram. The patient concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced bad swelling from second vaccine. Had to reschedule Mammogram. She did not get swelling from first vaccine. She Inquired if that was a common side effect. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Lymphadenopathy, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Bad swelling; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included Mammogram. The patient concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced bad swelling from second vaccine. Had to reschedule Mammogram. She did not get swelling from first vaccine. She Inquired if that was a common side effect. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Bad swelling; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included Mammogram. The patient concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced bad swelling from second vaccine. Had to reschedule Mammogram. She did not get swelling from first vaccine. She Inquired if that was a common side effect. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: Bad swelling; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included Mammogram. The patient concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced bad swelling from second vaccine. Had to reschedule Mammogram. She did not get swelling from first vaccine. She Inquired if that was a common side effect. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.