chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: a person who has received the covid vaccine but tested positive to the infection; a person who has received the covid vaccine but tested positive to the infection; This is a spontaneous report from a contactable pharmacist. This pharmacist reported that an 85-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) intramuscular at single dose on 21Jan2021 for COVID-19 immunisation. The patient received the first dose on unknown date. Relevant history and concomitants drugs were not reported. Per reporter, the patient was not seeing anything crazy on her chart. The patient got the second dose of the COVID vaccine on 21Jan2021. On 22Jan2021, she had been tested positive for COVID-19 (COVID-19 Rapid test).  The patient had cough and low grade fever since unknown date. Relevant test was none. Outcome of event was unknown. The nurse practitioner wanted to do a monoclonal antibody infusion and the pharmacist was wondering if they could do that?   When probed for causality, the pharmacist responded: "I guess not I'm not going to comment on that, I don't know. I don't have the patient's actual file."  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nervousness, Pain in extremity, Pruritus, Skin irritation
Clinical narrative: nervous; back started to itch/There was irritation; back felt itchy; back felt itchy and pinkish red/back was red; Arm soreness; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history included steel rods in back from 2006 and ongoing. The patient's concomitant medications were not reported. The patient was vaccinated and felt fine. She experienced arm soreness on 20Jan2021 originally. Then today, it was so bizarre, about an hour and a half ago, her back started to itch on 22Jan2021. There was irritation. She checked in the mirror, and her back was red on 22Jan2021. She was wondering if this was a reaction from the vaccine. She was getting nervous. A medical student gave her the vaccine. She didn't have a prescribing doctor. Twenty minutes after getting the vaccine, she noticed the arm soreness. It was worse yesterday, but today she thinks it is the same or maybe a little better. The irritation on her back seems a little better since she first noticed it. The outcome of the events back felt itchy and pinkish red and irritation was recovering. The outcome of the event arm soreness was not recovered. The outcome of the event nervous was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site inflammation
Clinical narrative: she felt pain in the arm and body; she felt pain in the arm and body; inflammation in the injections site; fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Jan2021, she felt pain in the arm and body, inflammation in the injections site and fever and had taken 6 Tylenol tablets as treatment, but the fever has not been fully controlled. The outcome of event fever was not recovered; for other events was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle spasticity
Clinical narrative: extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthcare professional (patient herself). A 62-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 16:15 at single dose for covid-19 immunization. Medical history included MS (multiple sclerosis); kidney disease. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included glatiramer acetate (COPAXONE) from 19Jan2021, escitalopram oxalate (LEXAPRO) and antihistamine, magnesium. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme weakness and an increase in her spasticity related to MS on 20Jan2021 12:00. Since the vaccination, the patient had not been tested for COVID-19.  The events were reported non-serious. Outcome of events were recovering. No treatment was received for the events.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site it was sore; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN) on 11Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medication were not reported. patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 11Jan2021, he was scheduled to receive the Moderna vaccine however the Pfizer vaccine was available and he received it (he was originally scheduled for Moderna and Moderna is 28 days where Pfizer is 21 days and he's having a hard time moving his 2nd appointment). He's scheduled to receive the second dose of the vaccine on 08Feb2021, which is 28 days after the first dose instead of the 21 days recommended. He would like to know if there's a problem with waiting because he doesn't want to lose the effectiveness of the vaccine. He wanted to know what happens if he can't get it on the 21st day. He also stated that he had no side effects, no pain, the only thing was when he pushed around the injection site it was sore, like when one got a normal shot. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Caller is a consumer who received his first Pfizer-Biontech Covid19 vaccine, yesterday, and is reporting a sore throat that "just feels raw"; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first Pfizer-Biontech Covid19 vaccine, yesterday (21Jan2021), and is reporting a sore throat that "just feels raw".  He wanted to know if this is normal. He also stated that the weather was poor yesterday and might have contributed to his symptom. The patient got the shot about 24hrs ago; the patient stated, "sore throat - raining and kind of nasty sore - just raw". The outcome of the event was unknown.  Information on the LOT/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were unknown. The patient got the COVID-19 vaccine yesterday on 21Jan2021, or 24 hours ago, and now he had a sore throat in Jan2021. He asked if a sore throat was a side effect of the COVID-19 vaccine. Outcome of the event sore throat was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Feeling tired; Discovered she was Covid 19 positive; Discovered she was Covid 19 positive; This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer reported that a 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation.  Medical history included Allergies from an unknown date and unknown if ongoing, bad back aches from an unknown date and unknown if ongoing.  Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), mometasone furoate (FLONASE [MOMETASONE FUROATE]).  On 16Jan2021, she had her first dose of COVID vaccine, and two hours later she had a positive COVID test done. She is wondering when she can get the second dose, her doctor said she had to wait 3 months for the second, dose, she is questioning that, and wants to know, should she be retested for COVID, since she thinks it may be a false positive, since she has no symptoms of COVID. She states she didn't really have any symptoms other than feeling tired. The outcome of event fatigue was unknown, while the outcome of the other events was not resolved.  Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in the face; Numbness and tingling in the face; This is a spontaneous report from a contactable consumer reported for herself. A 24-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on right arm on 20Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  Concomitant medications include multivitamins [vitamins nos]. The patient experienced numbness and tingling in the face on 20Jan2021 12: 30 pm. Started after injection, in the lips, spreading to the mouth, chin, and lower face. Within two or three hours, it spread to the ears and upper face, lasting the entire evening. No treatment received for the events. Outcome of the events was recovered. The patient was not pregnant at the time of vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Sore arm; Swollen injection site and halo formation; This is a spontaneous report from a non-contactable consumer reported for herself. A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on 20Jan2021 11:15 on right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. Medical history and concomitant medications were not reported. The patient experienced sore arm within 20 minutes from vaccination on 20Jan2021 11:30, swollen injection site and halo formation at 18h on 20Jan2021. Soreness subsided after 72h. No treatment was received for the events. The outcome of the events were resolving.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Body height, Body height decreased
Clinical narrative: she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125bpm; blurry eyes; dizziness; Her blood pressure was also up; In the morning of the 20Jan2021 I was weak; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 19Jan2021 10:02 at a single dose for Covid-19 immunization. Medical history included ongoing Seasonal Allergies (probably started in the last 4-5 years; reoccurs every year from about Oct through Mar), ongoing high blood pressure since like 2006 or 2004, ongoing Iliac artery stent placed started couple of years ago, anxiety from 2010 and ongoing (her cardiologist put her on Xanax around 2010-ongoing). Concomitant medication included ongoing alprazolam (XANAX) since 2010 for anxiety. She gets the flu shot every year and has never had a problem with the flu shot. She got her last flu shot in Oct2020, no adverse events with that or other flu shots historically. On the second dose of Pneumococcal vaccine, it swelled her arm up from the injection site all the way down to her wrist; she went to the urgent care for that. They gave her some medicine and eventually the adverse event went away. She experienced some side effects following that injection. The patient reported that in the morning of the 20Jan2021, she was weak and just kind of rested. She did not have any other side effects until 21Jan2021. At 5am on 21Jan2021, for the whole day she had a fast heart rate, 125bpm, she woke up with her heart rate up, fast heartbeat, then down to 110 and then just toggled a little bit, she had blurry eyes so she could not really focus her eyes, weakness and dizziness. These events continued all throughout 21Jan2021 but her heart rate came down, it was running in the 90s and she was weak all day. Her blood pressure was also up on 21Jan2021. She thinks the blurry eyes, with her eyes being squirrely was related to her heart rate being up and blood pressure being up. She feels like she recovered completely from these events by this morning 22Jan2021. She feels good, strong and her eyes are clear today, felt better than yesterday but not 100%. She has probably shrunk in height, her last known height was 5' 9. She called to ask if she should or should not get the second dose as scheduled for 12Feb2021 in response to the side effects. Outcome of the event 'she has probably shrunk in height' was unknown while the rest of the events was recovered on 22Jan2021.  No follow-up activities are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Vision blurred
Clinical narrative: she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125bpm; blurry eyes; dizziness; Her blood pressure was also up; In the morning of the 20Jan2021 I was weak; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 19Jan2021 10:02 at a single dose for Covid-19 immunization. Medical history included ongoing Seasonal Allergies (probably started in the last 4-5 years; reoccurs every year from about Oct through Mar), ongoing high blood pressure since like 2006 or 2004, ongoing Iliac artery stent placed started couple of years ago, anxiety from 2010 and ongoing (her cardiologist put her on Xanax around 2010-ongoing). Concomitant medication included ongoing alprazolam (XANAX) since 2010 for anxiety. She gets the flu shot every year and has never had a problem with the flu shot. She got her last flu shot in Oct2020, no adverse events with that or other flu shots historically. On the second dose of Pneumococcal vaccine, it swelled her arm up from the injection site all the way down to her wrist; she went to the urgent care for that. They gave her some medicine and eventually the adverse event went away. She experienced some side effects following that injection. The patient reported that in the morning of the 20Jan2021, she was weak and just kind of rested. She did not have any other side effects until 21Jan2021. At 5am on 21Jan2021, for the whole day she had a fast heart rate, 125bpm, she woke up with her heart rate up, fast heartbeat, then down to 110 and then just toggled a little bit, she had blurry eyes so she could not really focus her eyes, weakness and dizziness. These events continued all throughout 21Jan2021 but her heart rate came down, it was running in the 90s and she was weak all day. Her blood pressure was also up on 21Jan2021. She thinks the blurry eyes, with her eyes being squirrely was related to her heart rate being up and blood pressure being up. She feels like she recovered completely from these events by this morning 22Jan2021. She feels good, strong and her eyes are clear today, felt better than yesterday but not 100%. She has probably shrunk in height, her last known height was 5' 9. She called to ask if she should or should not get the second dose as scheduled for 12Feb2021 in response to the side effects. Outcome of the event 'she has probably shrunk in height' was unknown while the rest of the events was recovered on 22Jan2021.  No follow-up activities are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Investigation
Clinical narrative: she noticed a little nipple drainage after receiving both doses; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose (first dose); and then via an unspecified route of administration on an unspecified date at single dose (second dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she noticed a little nipple drainage on an unspecified date after receiving both doses of Covid-19 vaccine. The patient wanted to know if this was a side effect of the vaccine. The patient underwent a lab test and procedure which included an unspecified test which was normal on an unspecified date. Outcome of event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: gallbladder attack; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She got the first dose of the vaccine on Wednesday (20Jan2021) and she got a gallbladder attack afterwards (unspecified date in Jan2021). She wanted to report this and also wanted to know if there had been reports about this before. She said that she was not given an appointment for the second dose and wanted to know if Pfizer could help her with that. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus hypersecretion, Sinus headache
Clinical narrative: Sinus headache; Can feel the sinuses draining; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus issues from the past couple of days from an unknown date. Concomitant medications were not reported. It was reported that the patient woke up with a sinus headache, but as the day went on, it's gotten worse and she can feel the sinuses draining. She reported she got the 1st dose of the COVID-19 vaccine at the morning of the report. Outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in the hands; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ED1283), intramuscularly on 15Jan2021 in the Right arm at single dose for COVID-19 immunization in hospital. Medical history included Celiac Disease, Dystonia, Hypothyroid, GERD (Gastrooesophageal reflux disease), Anemia, Ovarian cancer, Migraines, gastroparesis and known allergies with Penicillin. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with prochlorperazine maleate (COMPAZINE), nicergoline, metoclopramide, dihydroergotamine, doxycycline, prochlorperazine, sulfamethoxazole and trimethoprim (SULFAMETHOXAZOLE-TRIMETHOPRIM). The patient experienced tingling in the hands on 18Jan2021. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; sweating; This is a spontaneous report from a contactable pharmacist reported a 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Jan2021 at 33-year-old. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient experienced nausea, vomiting, diarrhea, and sweating; all in Jan2021 and was reported as non-serious. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: significant pain in the arm; headache; Mild lightheadedness; nausea; This is a spontaneous report from a non-contactable healthcare professional. A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, on an unspecified date, experienced significant pain in the arm starting approximately 4 hours after injection lasting into the next day; a headache a few hours within injection; mild lightheadedness and; nausea. No treatment was received for these adverse events and the patient recovered from these events on an unspecified date. The adverse events were assessed as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient has been COVID-tested post vaccination on an unspecified date with unknown results.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever highest of 100.5 F; body aches; headache; This is a spontaneous report from a contactable nurse.  An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 14:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced fever highest of 100.5 f, body aches, headache all on 05Jan2021 with outcome of recovered in Jan2021.  The patient underwent lab tests and procedures which included body temperature: 100.5 fahrenheit highest on 05Jan2021, COVID test: PCR: negative on 19Jan2021. Therapeutic measures naproxen was taken as a result of events. Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever//Next day: Severe Headache and Fever/Day after: Fever; extremely bad headache/Day of: Severe Headache and sore arm; sore arm/Day of: Severe Headache and sore arm; This is a spontaneous report from a contactable other health professional (patient). A 25-year-old female patient received the first dose of BNT162B2 (lot no. and expiry date were not reported), intramuscular in the left arm on 07Jan2021 11:45 at single dose for Covid-19 immunization.  Medical history included COVID-19, Sjrogrens diagnosed last year in 2020, diabetes and breast cancer. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant. The patient had no known allergies. Concomitant medication included levothyroxine. The patient did ot receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered in Nursing Home/Senior Living Facility. On 07Jan2021 at 13:30, the patient had a day of extremely bad headache/severe headache and sore arm. Then the next day on 08Jan2021, the patient had severe headache and fever. Then day after the patient had fever. The events were considered as non-serious. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination included nasal swab and rapid test; both were taken on 08Jan2021 and 15Jan2021 with unknown results. The patient recovered from the events on unspecified date.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Tingley feet; light headed; This is a spontaneous report from a contactable Other Health Professional reported for himself. This 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at right arm on 26Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID. The patient experienced tingley feet and light headed for days after getting the vaccine on 06Jan2021. No treatment received for the adverse event. Events outcome was recovering and reported as non-serious. Patient has not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Autonomic nervous system imbalance, Body temperature, Chills, Heart rate
Clinical narrative: Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient received bnt162b2 with concomitant medication prednisone; patient received bnt162b2 with concomitant medication prednisone; Stomach ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 11:00 am at single dose at left arm for COVID-19 immunisation. Medical history included penicillin allergy, nonspecific myositis, small fiber neuropathy, stroke, neurogenic orthostatic hypotension, hypermobile EDS, osteoarthritis, osteoporosis, Raynauds, esophageal dysmotility from an unknown date. Concomitant medications within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA), gabapentin, prednisone (PREDNISON), tramadol. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On same day after vaccination on 21Jan2021, patient had bad stomach ache. Woke up next day shivering uncontrollably, fever of 102 on 22Jan2021 07:45 am. Also heart rate was erratic (patient had dysautonomia) - 140 then dropped to 53 then back up to 123 all in same minute. This happened repeatedly and maintaining high heart rate. Patient didn't receive treatment for events. The adverse events resulted in emergency room/department or urgent care. Outcome of above events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular, Off label use, Product use issue, Pyrexia
Clinical narrative: Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient received bnt162b2 with concomitant medication prednisone; patient received bnt162b2 with concomitant medication prednisone; Stomach ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 11:00 am at single dose at left arm for COVID-19 immunisation. Medical history included penicillin allergy, nonspecific myositis, small fiber neuropathy, stroke, neurogenic orthostatic hypotension, hypermobile EDS, osteoarthritis, osteoporosis, Raynauds, esophageal dysmotility from an unknown date. Concomitant medications within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA), gabapentin, prednisone (PREDNISON), tramadol. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On same day after vaccination on 21Jan2021, patient had bad stomach ache. Woke up next day shivering uncontrollably, fever of 102 on 22Jan2021 07:45 am. Also heart rate was erratic (patient had dysautonomia) - 140 then dropped to 53 then back up to 123 all in same minute. This happened repeatedly and maintaining high heart rate. Patient didn't receive treatment for events. The adverse events resulted in emergency room/department or urgent care. Outcome of above events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain in extremity, Periorbital swelling
Clinical narrative: The typical sore arm; puffy around my eyes/little puffy under his eyes; sensation around his eyes/felt a sensation on the side of his eyes; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received his first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient inquired if his symptoms after the first dose of the vaccine are normal, was this a reaction to the vaccine and if he should get the second dose. He mentioned that he got the first dose of the covid vaccine earlier this week (Jan2021) and he had "the typical sore arm" but went on to report that about 3 hours afterward, he felt a sensation on the side of his eyes and below them so he asked his wife, "am I puffy around my eyes". He had no severe reaction or anything like that. He had no shortness of breath or rapid heartbeat or anything. He did not have any of those issues at all. Like any other shot, he had a sore arm. Then about 3 hours after he got it, he noticed a sensation around his eyes that last for about 20 minutes. He thought it had something to do with vaccine. His wife said he looked a little puffy under his eyes. He knows there is a "glad" under the eye area. He reported that he looked at the common side effects but didn't see his reaction so he doesn't know if he should be concerned. In the instructions for the vaccine it said there could be an issue with skin mucosa, but he had no swelling of the lips, throat, face, or anything. He wants the second dose. Obviously if someone had a severe reaction, they would not get the second shot. He inquired if he should be concerned about or not, if this is a side effect. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body aches; headache; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on from 04Jan2021 13:15 (lot number Ek9231 and expiry date unknown) at single dose for Covid-19 immunization in a hospital. Medical history included depression and insomnia. The patient has no COVID prior vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), melatonin, escitalopram oxalate (LEXAPRO), drospirenone, ethinylestradiol betadex clathrate (YAZ), amitriptyline; all from unspecified date for unspecified indication. The patient did not receive other vaccine in four weeks. On 05Jan2021 12:00 AM, the patient experienced body aches, headache, and fatigue. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events body aches, headache, and fatigue was recovered in Jan2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; chills; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via Intramuscular on 20Jan2021 08:00 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number Left arm and Expiration Date unknown) via Intramuscular on 30Dec2020 08:00 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient experienced Headache and chills on 22Jan2021 06:00 AM, without treatment received. The outcome of events was unknown.  Information on the batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost her sense of taste; This is a spontaneous report from a contactable consumer via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the COVID shot on 21Jan2021 and on 22Jan2021 she noticed that she lost her sense of taste starting a few hours ago. She has no other symptoms aside from that. She said she feels fine. She asked if it is normal to lose the sense of taste after receiving the COVID-19 vaccine. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: couldn't move her arm; soreness in the muscle; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization and her arm was sore. The reporter's mother said she couldn't move her arm for a day after receiving the first dose of the Pfizer Covid vaccine on Monday (18Jan2021). She had soreness in the muscle. By the 3rd day after receiving the vaccine, she was feeling fine. Outcome of the events was recovered 21Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid/Nasal Swab: positive; This is a spontaneous report from a contactable nurse. An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included Alzheimer's disease, cough (she has had a cough forever), cellulitis, constipation, dementia, depression, appendicectomy, and right hip replacement surgery. The patient's concomitant medications were not reported. The patient experienced tested positive for COVID on 13Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The reporter was calling for information about administration of the COVID vaccine at an interval greater than the 21 days and recommendations for a patient who tested positive after the first dose of the vaccine. The patient got the first dose of the COVID vaccine on 05Jan2021, She tested positive for COVID on 13Jan2021 and then next time she will be seen and tested will be 15Feb2021. Due to this it seems like they can't give her the vaccine this following Monday because she tested Positive and the Next time, the clinic gets vaccines is on 15Feb2021, Caller asks is that too long of a time frame for the second Dose. Or would they have to start over on 15Feb2021 with another first dose. The First Dose was on 05Jan2021. The Positive Covid Test was on 13Jan2021, it was done by a Nasal Swab. Patient won't be due for another COVID test for 14 days after, she is due for her next COVID test on 27Jan2021. If she is Negative on the 27Jan2021, then she will get her next COVID Vaccine on 15Feb2021. This is non-serious report. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), on 05Jan2021, and COVID-19 test, including Nasal Swab, positive on 13Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID 19 test likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . The male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04Jan2021 at SINGLE  DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He received the Pfizer BioNTech COVID-19 vaccine on 04Jan2021 and tested positive for COVID-19 on 11Jan2021. He said he is already back to work and is scheduled for the second dose on 25Jan2021. He asked if he should go forward with the scheduled dose or should he wait 6 more weeks for the second dose. The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Malaise
Clinical narrative: feeling slightly weak; feeling unwell; felt as if she is getting the flu or in the beginning stages of the flu; tired; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247), via an unspecified route of administration on 21Jan2021 20:00 at single dose for COVID-19 immunization. The patient's medical history included uses a walker on a regular basis for spinal stenosis. Concomitant medications were not reported. Patient received first dose of Pfizer COVID vaccine on 21Jan2021 around 8pm, at the vaccination site she was tired and was given a chocolate chip cookie and felt better. On 22Jan2021 morning she was feeling slightly weak nothing violent she is just feeling unwell. She generally feels weak, but said this is hard to explain. She felt as if she is getting the flu or in the beginning stages of the flu. Patient does not have a fever. Generally doesn't get reactions to the flu shot or pneumonia shot, that is very minor. The outcome of tired was recovering, of other events was unknown. Patient would like to know if her symptoms are to be expected after receiving the first dose of the vaccine and how long will her symptoms last, what to do about her symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Pain, Palpitations
Clinical narrative: body aches; heart palpitations that speeded up to 159/110; heart palpitations that speeded up to 159/110; chills; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left shoulder/deltoid left on 20Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing hypertensive diagnosed four years ago. Concomitant medications the medication that she took for her blood pressure. The patient took first dose Covid 19 vaccine two days ago. She started feeling chills on 20Jan2021 and body aches on 21Jan2021. The patient stated two days ago that she had heart palpitations that speeded up to 159/110 all day on 20Jan2021. She was a hypertensive person and her blood pressure will go up. She was told there would be risks. She wanted to know if she should take the second dose on 10Feb. Wanted to know if something will happen to her if she took it. The chills lasted only two hours. The body aches stopped at 5PM. She had heart palpitations with activity and only lasted for 24 hours. The patient had none while laying down. No treatment was received. Outcome of the event chills was recovered on 20Jan2021, of the events body aches and heart palpitations that speeded up to 159/110 was recovered on 21Jan2021.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Disturbance in attention, Feeling abnormal, Vaccination site pain
Clinical narrative: Mild agitation; soreness at injection site; Head/Brain Fog for 24 hours after injection; feeling "out of it" and inability to concentrate fully; This is a spontaneous report from a contactable Consumer. A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 11:00 at left arm at single dose for covid-19 immunization. The patient's medical history had allergic to other vaccine ingredients, particularly influenza vaccine ingredient. The patient's concomitant medication included Dietary Supplements. The patient received the first dose of BNT162B2 on 28Dec2020 14:00 at left arm for covid-19 immunization. The patient was not pregnant. The patient experienced mild agitation, soreness at injection site, head/brain fog for 24 hours after injection and feeling "out of it" and inability to concentrate fully on 19Jan2021 16:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events mild agitation, soreness at injection site and 'feeling "out of it" and inability to concentrate fully' was recovered on an unknown date in Jan2021, the outcome of the event head/brain fog was recovered on 20Jan2021 16:00. Information on the lot/batch number has been requested.