chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia, Sensory loss
Clinical narrative: numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/numb all over her spine; loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; paresthesia; having trouble with dexterity; This is a spontaneous report from a contactable physician (neurologist) via a Pfizer-sponsored program. A 51-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in left arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced allergy. The physician reported that the patient received the first dose of the vaccine and has been experiencing numbness for 10 day from an unspecified date. This patient received the injection in the left arm and she started experiencing numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine, she's still experiencing ongoing numbness the numbness in her 4th and 5th digit. The patient experienced loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; and felt numb all over her spine, all on unspecified dates. The patient was having trouble with dexterity. The physician ordered an MRI for the patient but does not have the results back yet. The physician asked if it is safe for the patient to get the second dose. The second dose will be on 15Jan2021. The outcome of the event numbness was not recovered, and the outcome of the remaining events was unknown.  Information on the lot/ batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain in arm of injection site; feverish; achy; fatigue
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Swelling face
Clinical narrative: swelling on the face; dizzy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm (upper shoulder) on 11Jan2021 at a single dose for COVID-19 immunisation. The patient has no other medical history and no concomitant medications. The patient stated that she got the first shot for the covid vaccine yesterday in the evening and now she is feeling swelling on the face. When she got up in the morning, she felt swelling on the face. She is asking on what she has to do. She also felt a little dizzy. She was dizzy when she got up in the morning, she did not feel anything yesterday, she felt everything today. The outcome of the events was not recovered. She has had no positive test for covid before the vaccine. She had a negative test a few days ago this month in Jan2021. She got the test on a Monday and got the results on Friday.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule
Clinical narrative: supraclavicular nodule after receiving 1st dose of the Covid vaccine; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number and expiration date not provided), via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient developed supraclavicular nodule after receiving first dose of the COVID vaccine on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, severe chills, severe body ache, fatigue, fever, shortness of breath, pain in location of shot, muscle ache,
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Headache, severe chills, severe body ache, fatigue, fever, shortness of breath, pain in location of shot, muscle ache,
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on30Dec2020 to 30Dec2020 at single dose for COVID-19 immunization. She had a history of pancreatitis and was hospitalized with elevated lipase levels one and a half weeks prior to getting her first dose in Dec2020. When she received the first dose she had recovered and her lipase levels were normal in Dec2020. Her gastroenterologist has scheduled her for a colonoscopy and upper endoscopy but would like for her second dose to be spaced out a week from her first dose. She is asking if there is any data to support efficacy of the second dose of the vaccine between days 28-32. The doctor stated she is okay as long as she gets the second dose of the vaccine within 5 months from the first dose. She had pancreatitis and needs to have a procedure for it. She was scheduled for second dose on 18Jan2021. She has an endoscopy and colonoscopy scheduled for 21Jan2021 and her GI doctor advised to postpone her second dose which she was told she should get 17- 21 days after her first dose since it would coincide with her procedure. She does not have a problem with the vaccine. She had a sore arm on an unknown date and was totally fine. The outcome of the event sore arm was recovered on an unknown date. Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Nausea
Clinical narrative: Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging normal
Clinical narrative: 3-4 out of 10 headache immediately following the vaccine, persisted for over 2 weeks, pt came to ED with 10 out of 10 headache at 2.5 weeks.  all head imagine was negative, including MRI.  pt never gets headaches.  presumed to be migraine
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Fever; Very tired; Achy; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 02:00 AM on 10Jan2021 at single dose for COVID-19 immunization. Medical history included thyroid disorder, reflux, elevated blood pressure and elevated cholesterol. Concomitant medication included lamotrigine, buspirone, levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and others. The patient previously took compazine and experienced drug allergy. The patient experienced swollen, very sore, hot arm by injection site. Fever. Very tired. Achy. Headache at 05:00 PM on 10Jan2021. 3-30 hours after injection. Diarrhea (more than 6 times) 44 hours after injection and ongoing on 11Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Fever; Very tired; Achy; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 02:00 AM on 10Jan2021 at single dose for COVID-19 immunization. Medical history included thyroid disorder, reflux, elevated blood pressure and elevated cholesterol. Concomitant medication included lamotrigine, buspirone, levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and others. The patient previously took compazine and experienced drug allergy. The patient experienced swollen, very sore, hot arm by injection site. Fever. Very tired. Achy. Headache at 05:00 PM on 10Jan2021. 3-30 hours after injection. Diarrhea (more than 6 times) 44 hours after injection and ongoing on 11Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Soreness at injection site at time 0900 1/25/21  Chills, fever (102 F), fatigue, body aches, headache, congestion at time 1900 1/25/21   Tylenol 500mg at 1300 on 1/25/21 and again at 0200 on 1/26/21.   At 0230 on 1/26/21 fever (101.8), headache, body ache, fatigue, congestion, nausea.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Soreness at injection site at time 0900 1/25/21  Chills, fever (102 F), fatigue, body aches, headache, congestion at time 1900 1/25/21   Tylenol 500mg at 1300 on 1/25/21 and again at 0200 on 1/26/21.   At 0230 on 1/26/21 fever (101.8), headache, body ache, fatigue, congestion, nausea.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Received the vaccine 2 weeks ago and came down with COVID; Received the vaccine 2 weeks ago and came down with COVID; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unknown date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine 2 weeks ago, unknown date in 2020 and came down with COVID on an unknown date. The outcome of the event was recovered on an unspecified date.    Information on Lot/Batch number has been requested; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19, TTOX
Symptoms: COVID-19, Feeling abnormal, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunization and tetanus vaccine (manufacturer unknown) via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included COVID diagnosed in Mar2020. Concomitant medication was not reported. The patient received the first dose of the Pfizer COVID Vaccine and then 2 weeks later on 05Jan2021 got COVID again. He wanted guidance as to when he can get the second dose of the vaccine. His vaccination provider refused his second dose and the 21-day interval has passed. He was tested for COVID on 05Jan2021 and was positive. The patient said that his brain is still in a fog on unspecified date. He is normally not this cloudy. It was also reported that around the same time he got a Tetanus shot, and he can not remember which one was given in which side. The outcome of the events was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Body ache, chills diarrhea, fatigue, mild fever, muscle pain, brain foggy
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body ache, chills diarrhea, fatigue, mild fever, muscle pain, brain foggy
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Cough, Pain
Clinical narrative: mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Slight post nasal drip; cough; This is a spontaneous report from a contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:5730), intramuscular in left arm on12Jan2021 19:00 at single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin (PCN). Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously took Levaquin and versed and experienced allergies. The patient received the first dose of bnt162b2 (lot:5730) on 21Dec2020 at 18:30, intramuscularly in the right arm  for covid-19 immunisation. On 12Jan2021 07:00, events started 12 hours of out with mild chills. Temp 99. Body aches. Took Tylenol 0900, symptoms improved to tolerable range. Temp spiked to 101 at 1500. Chills, body aches- especially back/ hips. Slight post nasal drip and cough. The outcome of the events was not recovered
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Slight post nasal drip; cough; This is a spontaneous report from a contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:5730), intramuscular in left arm on12Jan2021 19:00 at single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin (PCN). Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously took Levaquin and versed and experienced allergies. The patient received the first dose of bnt162b2 (lot:5730) on 21Dec2020 at 18:30, intramuscularly in the right arm  for covid-19 immunisation. On 12Jan2021 07:00, events started 12 hours of out with mild chills. Temp 99. Body aches. Took Tylenol 0900, symptoms improved to tolerable range. Temp spiked to 101 at 1500. Chills, body aches- especially back/ hips. Slight post nasal drip and cough. The outcome of the events was not recovered
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: 100.6 fever; chills; body aches; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was administered with first dose of bnt162b2 on unspecified date for COVID-19 immunization (lot/batch number was unknown). On 12Jan2021, the patient experienced 100.6 fever, chills and body aches. It was unknown if treatment was given for the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: the following morning woke up in puddle of sweat; severe rigors lasting approximately 20 minutes followed by fever 103; mild fatigue; fever 103; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received his second dose of BNT162B2 (lot number: EK9231), intramuscular in the left arm on 05Jan2021 at 19:30 at single dose for Covid-19 immunization. Medical history included OSA (Obstructive sleep apnea). There were no concomitant medications. There was no other vaccine in four weeks nor other medications in two weeks. The patient received his first dose of BNT162B2 (lot number: EH9899), intramuscular in the left arm on 15Dec2020 at 19:30 at single dose for Covid-19 immunization. The patient previously took amoxicillin and experienced allergies. On 06Jan2021 at about 13:00 day after vaccine the patient exeperienced mild fatigue, by 19:00 very fatigued, at 22:00 severe rigors lasting approximately 20 minutes followed by fever 103; at 03:30am on 07Jan2021, (the following morning) the patient woke up in puddle of sweat. There was no treatment received for the events. No Covid prior vaccination and not tested for Covid, post vaccination. The events recovered on unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Impaired work ability, SARS-CoV-2 test positive
Clinical narrative: contracted Sars-Cov-2 in the interim/tested positive for vaccine; contracted Sars-Cov-2 in the interim/tested positive for vaccine; This is a spontaneous report from a non-contactable Other HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose 24Dec2020 and is due for 2nd dose 13Jan2020 but contracted Sars-Cov-2 in the interim. She reports that she is currently symptomatic, but her employer will allow her to return to work after a 10-day quarantine. And then 07Jan2021 tested positive and a couple of days to me asymptomatic  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Fatigue, chills, very sore arm from elbow to top shoulder/neck, headache, bone and muscle aches, loss of appetite, hitching of chest area but no rash/sporadic dizziness/unable to sleep.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pruritus, Rash
Clinical narrative: Fatigue, chills, very sore arm from elbow to top shoulder/neck, headache, bone and muscle aches, loss of appetite, hitching of chest area but no rash/sporadic dizziness/unable to sleep.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Fatigue, chills, very sore arm from elbow to top shoulder/neck, headache, bone and muscle aches, loss of appetite, hitching of chest area but no rash/sporadic dizziness/unable to sleep.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Somnolence, Suspected COVID-19
Clinical narrative: not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Pfizer Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Covid vaccine on 04Jan2021. She stated that the first day it was okay but on the second day, she slept the whole day and even when standing up cooking, she was falling asleep and on the third day, she was completely okay. After that day, she was okay until now. She was now feeling unwell, headache (she never gets a headache like this before, a really, really headache) and dizzy (all starting yesterday). She takes Tylenol and will be okay for 8 hours. She further reported that she did not have a fever. She added that on Sunday, she was dizzy and has an on and off headache but not all the time and also for today too. She is not sure if this is a side effect or if it is covid. She inquired if these are side effects or does she need a Covid testing. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Neck pain, Pain in jaw
Clinical narrative: Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248), via an unspecified route of administration in left arm on 08Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included migraines, anxiety, arthritis, EOE, IBS, asthma, possible autoimmune disorder AS, and known allergies with caffeine. Concomitant medications included topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL), montelukast sodium (SINGULAIR), and multivitamin. The patient previously took scopolamine allergies. The patient experienced headache on the left side, left sided ear, jaw and neck pain going on 4 days, extreme fatigue going on 4 days, since 08Jan2021 22:00. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has no COVID prior vaccination, has not been tested for COVID post vaccination. Treatment for the events included MEDROL dose pack and TYLENOL. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Rhinorrhoea
Clinical narrative: Runny nose lasted 2 days. Skin rash and itching at the injection site on day 7. Rash  worsened on days 8, and 9. Got better after taking Benadryl 25 mg but itching lasted 5 days.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Paraesthesia oral, Respiratory rate, Respiratory rate increased
Clinical narrative: heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: sever chills, 101 temp, headache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Migraine, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache  on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell returned quickly but after the 2nd vaccine my taste returned the next day; I had Covid 31Dec-10Jan with both loss of smell and taste initially.; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the first dose of  BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot-number: EL0104), via an unspecified route of administration in the right arm on 21Dec2020 at 03:00 at a single dose, and the second dose (Lot number: EL3249) via an unspecified route of administration in the right arm on 11Jan2021 at 03:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination, did not have any other vaccine within four weeks, and did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took sertraline (ZOLOFT) and experienced drug hypersensitivity. The patient stated that she regained her taste. She had COVID from 31Dec-10Jan (also reported as on 12Jan2021 at 12:00) with both loss of smell and taste initially. Her smell returned quickly but after the second vaccine, her taste returned the next day. The patient underwent lab tests and procedures which included viral test (nasal swab; Sofia COVID test): positive on 04Jan2021. The patient received no treatment for the events. Outcome of the events was recovered.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Pain
Clinical narrative: High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Headache, Nausea, Pain
Clinical narrative: Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BEL-3246), intramuscular in left arm on 10Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included allergies to blue dye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Versed, Parafon Forte and experienced allergies. On 10Jan2021 11:30 AM, the patient experienced dizziness, nausea, headache almost immediately followed by abdominal pain and body aches within 6 hours. No treatment given for the events. The patient recovered from the events on unspecified date. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Urticaria
Clinical narrative: Hives, severe, face and generalized body (arms, trunk, legs). 5 weeks pregnant when vaccine recieved. 7 weeks when adverse effect. Hives required prenisone shot and 5 day course. Edd 8/31/21
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain, swelling and redness; Injection site pain, swelling and redness; Injection site pain, swelling and redness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 09:00 AM at a single dose for COVID-19 immunization.  Medical history included high cholesterol.  The patient has no known allergies. Concomitant medication included simvastatin. The patient received the first dose of COVID vaccine dose yesterday (11Jan2021) and reported that he experienced the following side effects; injection site pain, swelling and redness on unspecified date. The patient did not have other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive treatment for the events. The patient is recovering from the events.   Information on the Batch/Lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Dysstasia, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Illness, Inappropriate schedule of product administration, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pollakiuria
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Asthenia, Fatigue
Clinical narrative: Moderate headache, moderate joint and just all over pain, loss of taste and smell, mouth and tongue soreness, injection site extremely sore, weakness, and fatigue. Muscular cramping at time.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Injection site pain, Muscle spasms, Oral pain
Clinical narrative: Moderate headache, moderate joint and just all over pain, loss of taste and smell, mouth and tongue soreness, injection site extremely sore, weakness, and fatigue. Muscular cramping at time.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Moderate headache, moderate joint and just all over pain, loss of taste and smell, mouth and tongue soreness, injection site extremely sore, weakness, and fatigue. Muscular cramping at time.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and  severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Labile hypertension, Memory impairment, Nausea, Pyrexia
Clinical narrative: Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and  severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and  severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tachycardia
Clinical narrative: Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: full body hives with severe itching; full body hives with severe itching; This is a spontaneous report from a contactable physician (reported for herself). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 10Jan2021 11:30 at single dose for Covid-19 immunization. The patient's medical history reported as none; no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced full body hives with severe itching on 11Jan2021 (16:00). The patient received Loratadine and Benadryl as treatment for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.