chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache only; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730 and expiry date not reported), intramuscular on the right arm on 22Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus (reported as "diabetic"), gastrooesophageal reflux disease (GERD), and neuropathy peripheral. Concomitant medications included tramadol, alprazolam, cyclobenzaprine, celecoxib, losartan, ropinirole, oxybutynin, gabapentin, metformin hydrochloride (METFORMIN ER), pantoprazole, cetirizine, hydrochlorothiazide, calcium, magnesium, and iron. The patient previously took erythromycin and experienced drug allergy. The patient experienced headache only on 22Dec2020 10:00. Clinical outcome of the event was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Fever 102, shakes, chills, headache and nausea; Fever 102, shakes, chills, headache and nausea; Fever 102, shakes, chills, headache and nausea; Fever 102, shakes, chills, headache and nausea; Fever 102, shakes, chills, headache and nausea; This is a spontaneous report from a contactable Nurse reporting for herself.  A 55-years-old female patient  received  bnt162b2 (BNT162B2; Lot # EJ1685) vaccine  , via an unspecified route  of administration in the left  arm on  18Dec2020 09:15 at single dose for covid-19 immunisation .  Medical history included , coeliac disease from an unknown date and hypertension from an unknown date.  Concomitant medication included progesterone (PROGESTERONE), nebivolol hydrochloride (BYSTOLIC), vitamin d3 (VITAMIN D3).  The patient previously took codeine and experienced drug hypersensitivity.  The patient experienced fever 102°F, shakes, chills, headache and nausea  on 18Dec2020 19:15 with outcome of recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: vertigo; dizziness; nausea; This is a spontaneous report from a contactable physician.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 21Dec2020 at 10:00 AM at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 41-years-old. Medical history and concomitant medications were unknown. On 22Dec2020 at 12:30 PM, the patient experienced abrupt onset vertigo, dizziness nausea - self resolved but then second wave of similar symptoms also self resolved. Th events were reported as non-serious. No treatment was received for the events. Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neurological examination abnormal
Clinical narrative: Headache over the front of the head; This is a spontaneous report from a contactable unspecified healthcare professional reporting for herself. This 60-year-old female patient received on 22Dec2020 11:15 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) at single dose intramuscular in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. She denied any history of previous adverse reactions to vaccines. On 22Dec2020, during her 15 minutes waiting period after the injection, the patient began to experience headache over the front of the head. The event required an emergency room visit. Outcome was unknown. Neurogical examination was positive on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), via an unspecified route of administration the right arm on 22Dec2020 12:30 at a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced headache on 22Dec2020 14:30. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovered on an unspecified date.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: slight nasal congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJI685), intramuscularly in left arm on 22Dec2020 13:45 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. The patient experienced slight nasal congestion (non-serious) on 22Dec2020 14:30 with outcome of recovering. No treatment received for the event.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Fever of approx 101 F; body chills; injection site pain; This is a spontaneous report from a contactable unspecified healthcare professional reporting for himself. This 45-year-old male patient received on 21Dec2020 13:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs and hypertension. Prior to vaccination, the patient was diagnosed with COVID 19. Concomitant medications were not reported. On 22Dec2020 03:00 am, the patient had fever of approximately 101 F, body chills, injection site pain. No treatment was provided. Outcome was not recovered. Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: headache; pain in arm; dizziness; This is a spontaneous report from a contactable consumer. A female patient (wife) of unknown age received on 21Dec2020 11:15 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Dec2020, she reported headache, pain in arm and dizziness. Outcome was unknown. Information on the batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Severe crushing headache in bilateral temporal lobes; Severe fatigue day after; This is a spontaneous report from a contactable nurse which is also the patient. A 36-year-old non-pregnant female patient received 1st dose of bnt162b2, intramuscular in the left arm on 18Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included polycystic ovaries (PCOS), anxiety, depression and attention deficit hyperactivity disorder (ADHD). The patient has no known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN), and escitalopram oxalate (LEXAPRO). It was reported that the morning after vaccine, 19Dec2020 08:00, the patient awoke with severe crushing headache in bilateral temporal lobes that resolved in a couple hours with acetaminophen  (TYLENOL) and rest. The patient also had severe fatigue day after. Added that there's also fatigue on 2nd day after vaccine but much more mild than 1st day. All symptoms resolved at 48hrs. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. The events were assessed as non-serious. Therapeutic measures were given for the events. Outcome of the events was recovered in Dec2020 after 48hrs.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in lower arm and hand that lasted from time of vaccine until the following morning.; This is a spontaneous report from a non-contactable other health care professional. A 30-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Dec2020 13:00 at SINGLE DOSE at right arm for COVID 19 immunization. Medical history included allergies: sulfa drugs. The patient's concomitant medications were not reported.  On 20Dec2020 13:00, the patient experienced Tingling in lower arm and hand that lasted from time of vaccine until the following morning. The patient did not receive treatment. No COVID prior vaccination. The patient has not been tested for COVID-19 since the vaccination. The event was assessed as non-serious. The outcome of the event was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Malaise, Pain
Clinical narrative: Injection site pain; headache; body aches; feeling generally unwell; joint pain; This is a spontaneous report from a contactable other-hcp reporting for herself.  A 35-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH 9899), via an unspecified route of administration in the left arm on 21Dec2020 14:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included celecoxib (CELEXA, 20mg). The patient previously took thimerosal and experienced drug hypersensitivity. The patient experienced injection site pain, headache, body aches, feeling generally unwell and joint pain all on 22Dec2020 03:00 with outcome of recovering. No treatment was performed. The patient did not have COVID prior to vaccination nor COVID test post vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea and diarrhea; Nausea and diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 08:45am at single dose in left arm  for COVID-19 immunization. No known allergy to medications, food or other products. Concomitant medications included Multivitamin (unspecified) received within 2 weeks of vaccination. On 21Dec2020 at 02:00 am the patient experienced nausea and diarrhea. Patient was treated with unspecified medication.The outcome of the events was recovering.  Information about lot/batch number are requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: positive test to the COVID-19 infection; This is a spontaneous report from a contactable Other HCP reporting for herself.   A 35-years-old female patient received bnt162b2 (BNT162B2; Lot# EL0140) vaccine  , via an unspecified route of administration in the left upper arm on 21Dec2020 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient resulted positive to the  test to the Covid-19 infection  on the same day she got the  vaccine 21Dec2020 with outcome of unknown.    The patient was wondering if her symptoms could worsened and if she could receive the second shot as scheduled.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: have a really bad headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL1284), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. Medical history included GERD (Gastrooesophageal reflux disease), obsessive-compulsive disorder. Concomitant medication included omeprazole at 40 mg for GERD, fluoxetine at 40 mg for obsessive-compulsive disorder. The patient had a really bad headache in Dec2020. The reporter stated she was a 22 years old pharmacy intern working in a hospital. She received the covid vaccine yesterday (21Dec2020) and she had a really bad headache. The patient further described this as a 'very, very bad headache.' The patient didn't receive treatment for headache. She was wondering if she could take Tylenol for headache. The outcome was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other health professional (reported for himself). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 17Dec2020 10:00 at single dose on left arm for COVID-19 immunization. Medical history known allergies: PCN (Penicillin). The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab and the test name was PCR with the result of positive on 22Dec2020 (12:00). This wasn't really an adverse event but the reporter thought it may be useful for studies taking place. On 22Dec2020 12:00 PM, the patient was diagnosed with COVID-19 5 days after vaccination and was currently self-isolating. The adverse event result in Emergency room/department or urgent care. No treatment was received for the adverse events. The events were considered as non-serious by the reporter. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product to the development of Drug ineffective and COVID-19 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Spinal pain
Clinical narrative: substantial back pain in her mid back and spine; substantial back pain in her mid back and spine; This is a spontaneous report from a non-contactable Nurse (patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 21Dec2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced substantial back pain in her mid back and spine on an unspecified date.  The outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: substantial back pain in her mid back and spine; substantial back pain in her mid back and spine; This is a spontaneous report from a non-contactable Nurse (patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 21Dec2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced substantial back pain in her mid back and spine on an unspecified date.  The outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Spinal pain
Clinical narrative: Substantial back pain; This is a spontaneous report from a contactable consumer (the patient)  A patient of unspecified age and gender received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced substantial back pain  on an unspecified date with outcome of unknown.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: Substantial back pain; This is a spontaneous report from a contactable consumer (the patient)  A patient of unspecified age and gender received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced substantial back pain  on an unspecified date with outcome of unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a contactable pharmacist, who is also the patient. This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK 5730; expiration date Mar2021) intramuscular in the left arm on 21Dec2020 at 17:30 at the age of 37 years at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history included Major Depressive Disorder (MDD), anxiety and foramen ovale patent. Concomitant medications were not reported. Past drug history included allergy with sulfamethoxazole/trimethoprim (BACTRIM) and aripiprazole (ABILIFY). On 22Dec2020 at 06:00, the patient experienced severe headache resistant to butalbital/caffeine/paracetamol (FIORICET) and ibuprofen, which were taken as treatments. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient was recovering from the event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Diarrhea; Body ache; Spike fever of 99; not a low grade fever; Headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for immunization. When probed for the due date for the next shot, consumer stated it was on 08Jan2021. Medical history included anxiety, acid reflux and eyes just not really great. Concomitant medication included topiramate (TOPAMAX) at 25 mg, daily for weight loss, fluoxetine for anxiety, omeprazole (PRILOSEC) for acid reflux. The patient experienced body aches, spikes fever of 99, it was not a low grade fever, headache on 18Dec2020, and diarrhea on 19Dec2020. Patient received acetylsalicylic acid (EQUATE, lot number: think it was 0B3076C, Expiry Date of Equate: Dec2022, NDC# 4903552378) for events body aches and the headache and the spike fever. It's Equate pain reliever, a (Company name) brand and it was 325 mg. Outcome of events body ache and headache was not recovered, and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Nausea; Chills; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program,. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced nausea and chills on an unspecified date. Clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: she is better but still not good; not to be able to breath; sore right arm; This is a spontaneous report from a contactable nurse (patient herself).  A 62-year-old female patient received bnt162b2 (BNT162B2, lot EK5730), intramuscular on 18Dec2020 at single dose for immunisation. Medical history included asthma (hospitalized on Jan2020 and has not had any issues since that time, referring to her asthma) diabetes, high blood pressure, swelling, sciatica, blood cholesterol abnormal, rosacea, reflux, allergies, sinus congestion, shingles and post carpal tunnel surgery. Concomitant medications included lisinopril, hydrochlorothiazide, gabapentin, rosuvastatin, metformin, glipizide, doxycycline, sucralfate, cetirizine hydrochloride (ZYRTEC), pseudoephedrine, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and tramadol. The patient reported that she not to be able to breath (seriousness criteria-life threatening) on 22Dec2020. She woke up this morning and could not breathe and there was no reason for her to not be able to breath. She thought she may have had a reaction to the COVID vaccine. It was the only thing she could think of that might have caused her not to be able to breathe this morning. As treatment for not to be able to breath, she used Budesonide and Levosalbutamol in her nebulizer.  She had sore right arm on 18Dec2020. She informed that she had done everything she can and she was better but still not good. She planned to take the second dose of the COVID Vaccine because she thought it was more important to be protected. She suspected that the vaccine was related to the events sore right arm and could not breathe. The outcome of the event not to be able to breath was recovering; for sore right arm was recovered on unknown date in Dec2020; for she is better but still not good was unknown.; Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor;  a possible causal association between administration of BNT162B2 and the onset of not being able to breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Headache; pain in her arm; Dizziness; This is a spontaneous report from a contactable consumer (patient's husband). A 45-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: N9899, expiry date: 01Jan2021), via an unspecified route of administration on the right arm on 21Dec2020 at a single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication included ongoing alprazolam for high blood pressure. On 22Dec2020, the patient experienced headache, pain in her arm and dizziness. Clinical outcome of the events was not recovered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Dysphonia
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 17:30 in the left arm at single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient experienced soreness at injection site, cough, body aches on 19Dec2020; sore throat, voice changes from coughing on 20Dec2020; tested positive for covid on 21Dec2020; mild low congestion, loss of taste and smell on 22Dec2020. The nurse stated that he got the vaccine on Friday (18Dec2020). The next day (19Dec2020) he had common side effects: Soreness at the injection site and body aches, which were expected. He also had a cough on top of that, which progressed to the next day. His body aches and coughing were infrequent. The afternoon of Sunday (20Dec2020), he developed sore throat. Yesterday(21Dec2020), he said he could not work because he was still coughing and had a sore throat. His voice was also changing due to the coughing. He was getting better now. The doctor from Employee Heath said that the cough was concerning so he got a COVID swab test yesterday(21Dec2020), and today (22Dec2020) it came back positive. This morning (22Dec2020) he had loss of taste and smell. He no longer had sore throat or cough. He had the vaccine before the test. He wanted to know where they were at with information on this. Was this being monitored? How did this happen? Was it possible that the test was a false positive because he had the vaccine prior? He would like someone to give him an answer, if the test was a false positive due to the vaccine? His doctor could not tell if the test was legit a positive because of the vaccine. He was not able to work right now. He did not even know if the COVID was from the vaccine or not. Will he get compensation for this? Will his workplace cover his absences? In the case he went to the hospital, will this be considered a work related or vaccine related issue?  The outcome of event soreness at injection site was recovered on 21Dec2020. The outcome of event tested positive for COVID was not recovered. The nurse considered the cough was disabling as this was not part of the symptoms to watch for after getting the vaccine. All of the symptoms currently besides the cough are not serious as of now, but it has put him out of work. The nurse considered all other events as non-serious except for cough (disabling).  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site pain, Lower respiratory tract congestion, Oropharyngeal pain, Pain
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 17:30 in the left arm at single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient experienced soreness at injection site, cough, body aches on 19Dec2020; sore throat, voice changes from coughing on 20Dec2020; tested positive for covid on 21Dec2020; mild low congestion, loss of taste and smell on 22Dec2020. The nurse stated that he got the vaccine on Friday (18Dec2020). The next day (19Dec2020) he had common side effects: Soreness at the injection site and body aches, which were expected. He also had a cough on top of that, which progressed to the next day. His body aches and coughing were infrequent. The afternoon of Sunday (20Dec2020), he developed sore throat. Yesterday(21Dec2020), he said he could not work because he was still coughing and had a sore throat. His voice was also changing due to the coughing. He was getting better now. The doctor from Employee Heath said that the cough was concerning so he got a COVID swab test yesterday(21Dec2020), and today (22Dec2020) it came back positive. This morning (22Dec2020) he had loss of taste and smell. He no longer had sore throat or cough. He had the vaccine before the test. He wanted to know where they were at with information on this. Was this being monitored? How did this happen? Was it possible that the test was a false positive because he had the vaccine prior? He would like someone to give him an answer, if the test was a false positive due to the vaccine? His doctor could not tell if the test was legit a positive because of the vaccine. He was not able to work right now. He did not even know if the COVID was from the vaccine or not. Will he get compensation for this? Will his workplace cover his absences? In the case he went to the hospital, will this be considered a work related or vaccine related issue?  The outcome of event soreness at injection site was recovered on 21Dec2020. The outcome of event tested positive for COVID was not recovered. The nurse considered the cough was disabling as this was not part of the symptoms to watch for after getting the vaccine. All of the symptoms currently besides the cough are not serious as of now, but it has put him out of work. The nurse considered all other events as non-serious except for cough (disabling).  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 17:30 in the left arm at single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient experienced soreness at injection site, cough, body aches on 19Dec2020; sore throat, voice changes from coughing on 20Dec2020; tested positive for covid on 21Dec2020; mild low congestion, loss of taste and smell on 22Dec2020. The nurse stated that he got the vaccine on Friday (18Dec2020). The next day (19Dec2020) he had common side effects: Soreness at the injection site and body aches, which were expected. He also had a cough on top of that, which progressed to the next day. His body aches and coughing were infrequent. The afternoon of Sunday (20Dec2020), he developed sore throat. Yesterday(21Dec2020), he said he could not work because he was still coughing and had a sore throat. His voice was also changing due to the coughing. He was getting better now. The doctor from Employee Heath said that the cough was concerning so he got a COVID swab test yesterday(21Dec2020), and today (22Dec2020) it came back positive. This morning (22Dec2020) he had loss of taste and smell. He no longer had sore throat or cough. He had the vaccine before the test. He wanted to know where they were at with information on this. Was this being monitored? How did this happen? Was it possible that the test was a false positive because he had the vaccine prior? He would like someone to give him an answer, if the test was a false positive due to the vaccine? His doctor could not tell if the test was legit a positive because of the vaccine. He was not able to work right now. He did not even know if the COVID was from the vaccine or not. Will he get compensation for this? Will his workplace cover his absences? In the case he went to the hospital, will this be considered a work related or vaccine related issue?  The outcome of event soreness at injection site was recovered on 21Dec2020. The outcome of event tested positive for COVID was not recovered. The nurse considered the cough was disabling as this was not part of the symptoms to watch for after getting the vaccine. All of the symptoms currently besides the cough are not serious as of now, but it has put him out of work. The nurse considered all other events as non-serious except for cough (disabling).  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast swelling, Injection site pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: Soreness at the site for the first 24 hours; Swelling underneath my right arm; Inflammatory response or immune response from the vaccine; Right breast had swollen areas in it almost being at lymph nodes; Right breast had swollen areas in it almost being at lymph nodes; Around nipple was very swollen and had about three knots; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (lot number not provided), via an unspecified route of administration on an unspecified date at single dose for COVID -19 immunization. Medical history and concomitant medication were reported as none. The nurse stated she had received the first dose of the Pfizer Covid Vaccine on Thursday. It didn't really had anything other than some soreness at the site for the first 24 hours but on the Saturday, she started noticing a bit of swelling like underneath her right arm. She didn't think anything of like that was probably just the inflammatory response or immune response from the vaccine. So, she thought it was all a normal side effect. The next morning, next Sunday morning, she woke up and her right breast had swollen areas in it almost being at lymph nodes and that's kind of where she just thought - Okay the breasts have lymph drainage and vessels and all these things. And she could palpate it like from her arm pits, she could palpate and can find out another one that was the area but it was around her nipple that was the concern because it was very swollen and had about three knots and again she was like probably it's just the lymph nodes. She reported "But they wanted us to report anything. You are at Hospital, like little health area and I was told that you need to call Pfizer too. I am saying that is something out of the ordinary because I am like they are not ordinary, they are in the breast area.  don't want to call it as nothing, it might be something else as it is kind of hard to tell if it related to the vaccine or is it not or something I need to talk to my OB-GYN about. I didn't know if that was something else did anybody else is experiencing". The event onset date was unspecified. The treatment of the events included Motrin. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever; injection site mild pain; This is a spontaneous report from a non-contactable other healthcare professional (patient) via a Pfizer sales representative. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. There were no medical history. Concomitant medications were not reported. The patient experienced fever and injection site mild pain on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported that a 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) , via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications.  The patient experienced rash on 20Dec2020 about an hour after receiving the vaccine. The patient did put some lotion on rash. The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasopharyngitis
Clinical narrative: coughing; chills; cold; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EJ1685, Expiration Date 31Mar2021, via unspecified route of administration, on unspecified date, at single dose for COVID-19 immunization. The patient medical history included blood pressure high. Concomitant medications included unspecified medication for high blood pressure. The patient experienced coughing, chills, and cold on 20Dec2020. The events were non serious. The outcome of the event coughing was unknown. The outcome of the events chills, and cold was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This is a spontaneous report from a contactable physician. A male patient of an unspecified age (age: 43; Unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had muscle soreness for about 24 hours after the shot. The patient stated, "I received the Pfizer vaccine on 16Dec at my hospital, (Institute Name Withheld). I think our hospital management wanted to first vaccinate some key clinicians who felt very comfortable with it - I personally wanted it as soon as possible since I see patients with COVID-19 every day. Twelve hours before I received the vaccine, I took information survey and signed the consent form. At my appointment, I was asked to confirm that I was feeling OK, was given the injection, and then waited about 15 minutes to make sure I didn't experience any side effects. I had a little muscle soreness, sort of like a punch to the arm, for about 24 hours. Other than a little muscle soreness that felt similar to a punch, I felt perfectly fine. The hospital administrator said they'd be in touch to schedule the second dose, which will be within a 96-hour window about three weeks later. I believe the science behind this type of vaccine - the messenger RNA platform - is strong. Understanding the basic science of it, I have very few concerns about the efficacy of the vaccine or the long-term complications. As a mechanism, there is no live COVID -19 virus in the vaccine: It's just giving you the code for spike protein so that your immune system will be able to make antibodies. To me, it's an even safer platform than many previous types of vaccines. Many infectious diseases are managed through vaccines. Infectious diseases that we don't think of as being a big issue anymore, like polio, even chickenpox, have been all but wiped out in the US thanks to vaccines that most people now get as babies. One or two people are not going to stop the COVID-19 pandemic. It's really when we get a good majority of the population fully vaccinated that we'll start to see a major effect.  Until then, I plan to still wear my face mask, practice social distancing, and observe safety and sanitary precautions. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Tachycardia
Clinical narrative: Fatigue; Dizziness; Tachycardia/heart rate is 115 laying down and her heart rate is 123 walking around; patient may be having an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (hcp). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EL0140, NDC number: 59267-1000-1, Expiry Date: 31Mar2021), via intramuscular on 21Dec2020 09:15 at 0.3 mL, single (0.3ml intramuscular injection in arm) for preventative (COVID-19 immunization). There were no medical history or concomitant medications. The patient did not receive any other vaccines prior vaccinations (within 4 weeks) or on the same date. The reporter worried the patient may be having an allergic reaction. The patient experienced dizziness, tachycardia, and fatigue, all on 21Dec2020, started about 45 minutes after receiving the injection around 10:00 am. The patient's heart rate is 115 laying down and her heart rate is 123 walking around on 21Dec2020. It is not life threatening and is kind of minor. The patient does get motion sickness easily. The reporter also received an injection from the same lot number. The patient she was reporting on is the only patient she has had that had an adverse reaction. There had not been any issues with any of her other patients. Treatment: The patient took Advil pm last night and it did not help, states Advil PM has benadryl in it. States it did not help. The outcome of events was not recovered.   The causality between events dizziness, fatigue, tachycardia and BNT162B2 is considered related by Primary Source Reporter per Global Introspection.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives all over her body; Itching; This is a spontaneous report from a contactable Pharmacist.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EH9899, Expiration Date Mar2021, via intramuscular route of administration in right arm, on 18Dec2020 15:55, at single dose for COVID-19 immunization.  The vaccine was administered at Hospital Facility. The patient medical history and concomitant medications were not reported. The patient experienced hives all over her body and itching on 18Dec2020 at 19:00. The events required visit to Emergency Room. The patient was treated with Benadryl PO and Prednisone 60mg PO. The patient did not have any respiratory distress or anything.  They said this was related to the vaccine. The events were non serious. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site paraesthesia, Paraesthesia
Clinical narrative: tingling in her arm at the injection site; hand turned red; soon after had tingling up and down her entire arm; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 24Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in her arm at the injection site, hand turned red, and soon after had tingling up and down her entire arm. Therapeutic measures were taken as a result of the events, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling in her arm at the injection site, hand turned red, and tingling up and down her entire arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a contactable consumer.  An adult female patient (middle-aged) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020, at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced migraine in Dec2020.  The patient was not responding to their usual migraine medicines.  The clinical outcome of migraine was unknown.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: he felt very achy and tired with a sore arm; he felt very achy and tired with a sore arm; he felt very achy and tired with a sore arm; This is a spontaneous report from a contactable physician (patient) via Pfizer Sales Representative.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/Lot number unknown, via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported he felt very achy and tired with a sore arm on 21Dec2020. The events were non serious and the patient completely recovered from the events on 22Dec2020.  Information about batch/lot number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore left arm at injection site. Pain started 8-10 hours after injection; resolved by 3 days after injection; This is a spontaneous report from a contactable physician (patient).   A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EH9899) intramuscular in left arm on 18Dec2020 at 07:45 am at single dose for COVID-19 immunization.  Medical history included Cluster headaches, Osteoarthritis of right shoulder and gastrooesophageal reflux disease (GER). No Known allergies to medications, food or other products. Concomitant medication included ascorbic acid (VITAMIN-C), omeprazole and fish oil. The patient experienced sore left arm at injection site on 18Dec2020 at 04:00 pm; pain started 8-10 hours after injection and resolved by 3 days after injection. Patient was treated with ibuprofen and recovered from the event in Dec2020.  Case is non serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm soreness; This is a spontaneous report from a contactable physician. A 34-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 22Dec2020 14:00 (at the age of 34-years-old) as a single dose in the  left arm  for COVID-19 immunization. Medical history included allergies to medications, food, or other products: shellfish from an unknown date and unknown if ongoing.  Concomitant medication included clomifene citrate (CLOMID), folic acid (FOLATE).  The most recent COVID-19 vaccine was administered in the hospital. It was unknown if the patient was pregnant at the time of vaccination.  On 23Dec2020, the patient experienced mild arm soreness.  The event mild arm soreness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event mild arm soreness was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: He is sleeping a lot of side effect, I mean all day; This is a spontaneous report from a contactable consumer (patient's wife). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: AJ1685), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization.  Medical history was none. There were no concomitant medications.  The patient got his first shot on 17Dec2020 and he was sleeping a lot of side effect, all day. No treatment received and he just slept all day. Due date of next short was 08Jan2021 to 10Jan2021. The outcome of the event was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat tightness
Clinical narrative: throat tightness; sore throat; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that 4 hours later she started to have throat tightness that lasted through the night. Caller reported during the call that the tightness was no longer present but she now had a sore throat. Outcome of event throat tightness was recovered in Dec2020, and outcome of event sore throat was unknown.  Information on the lot/batch number has been requested.