chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Her father also got the vaccine, and 1 day after had heaviness in his chest. He felt like his chest was trembling; Her father also got the vaccine, and 1 day after had heaviness in his chest. He felt like his chest was trembling; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (father) that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported her father got the vaccine, and 1 day after had heaviness in his chest, he felt like his chest was trembling (medically significant) on an unspecified date with outcome of unknown.  Information about lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: cough; Temperature of 99.8; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.   An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration injected in the right arm on 16Jan2021 at a single dose as COVID vaccine to avoid getting the virus. Medical history included high blood pressure. The patient had no other patient history. Concomitant medications included warfarin which started maybe 10 years ago and an unspecified medication for high blood pressure. The reporter took her mother, who's 83, and herself, on Saturday morning and got the COVID vaccine. Her mother woke up Sunday with a 99.8 temperature and she has been coughing real bad (cough) on 17Jan2021. The reporter asked if this was a side effect of the vaccine. This was her mother's first dose. Her underlying question was, after all this, she heard the second dose was worse, so the reporter wanted to know,  should her mother get the second one if her mother has these symptoms, the reporter heard the second dose was worse and would give some symptoms. Investigation assessment was noted as no. The outcome of 'temperature of 99.8' was recovered on Jan2021 as she did not have it anymore and of cough was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021072457 same reporter, same product, similar events, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Condition aggravated, Pyrexia, Rash
Clinical narrative: Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened; Rash at injection site; This is a spontaneous report from a contactable consumer, the patient. This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1685), single dose via intramuscular route of administration in the left arm between 5:30-6pm on 15Jan2021 (at the age of 49 years-old) for COVID-19 vaccination.  Relevant medical history includes ongoing nervous bad anxiety attacks, spinal stenosis (diagnosed 2-3 years ago), two stomach surgeries, so she had problems going to the bathroom and experienced bloody discharge, hiatal hernia surgeries (one surgery was 4 years ago and the other was 3 years ago), appendix taken out 3 years ago, ongoing insomnia diagnosed 10-11 years ago, shellfish allergy to lobster, pinched nerve and nerve issues and took Krill pills and had an allergic reaction. Relevant drug event  included increased anxiety and her hands would fall asleep when she took trazodone and quetiapine (SEROQUEL). The patient did not receive any concomitant medications. On 17Jan2021, the patient experienced rash at the injection site.  On 18Jan2021, the patient experienced a fever of 101 and more anxiety each day after the shot. Anxiety was reported as worsened. On an unknown date the patient experienced rash. The patient was treated for rash with diphendydramine (BENADRYL). The clinical outcome of fever was recovered on 19Jan2021, recovering for rash at injection site, unknown for rash and not recovered for anxiety.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened; Rash at injection site; This is a spontaneous report from a contactable consumer, the patient. This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1685), single dose via intramuscular route of administration in the left arm between 5:30-6pm on 15Jan2021 (at the age of 49 years-old) for COVID-19 vaccination.  Relevant medical history includes ongoing nervous bad anxiety attacks, spinal stenosis (diagnosed 2-3 years ago), two stomach surgeries, so she had problems going to the bathroom and experienced bloody discharge, hiatal hernia surgeries (one surgery was 4 years ago and the other was 3 years ago), appendix taken out 3 years ago, ongoing insomnia diagnosed 10-11 years ago, shellfish allergy to lobster, pinched nerve and nerve issues and took Krill pills and had an allergic reaction. Relevant drug event  included increased anxiety and her hands would fall asleep when she took trazodone and quetiapine (SEROQUEL). The patient did not receive any concomitant medications. On 17Jan2021, the patient experienced rash at the injection site.  On 18Jan2021, the patient experienced a fever of 101 and more anxiety each day after the shot. Anxiety was reported as worsened. On an unknown date the patient experienced rash. The patient was treated for rash with diphendydramine (BENADRYL). The clinical outcome of fever was recovered on 19Jan2021, recovering for rash at injection site, unknown for rash and not recovered for anxiety.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself.  A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Rhinorrhoea, Vomiting
Clinical narrative: Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself.  A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Disease recurrence, Inappropriate schedule of product administration, Laboratory test, Pain in extremity
Clinical narrative: Arm aching/arm started aching on 20Jan2021, little by little and was worsen on 21Jan2021; arm aching, it is just like when got a flu shot three months ago, arm hurts happened; Got the COVID Vaccine on 20Jan2021. second dose will be on 17Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL929), via an unspecified route of administration at site of left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing Type 2 diabetes (diagnosed about 10 years ago) and ongoing high cholesterol (diagnosed about 10 years ago). Concomitant medications included ongoing unspecified blood pressure medication to protect her organs. She did not have any issues with her blood pressure. The only thing she was experiencing is her arm aching. But it was just like when she got a flu shot, her arm hurts happened. She got the flu shot on Oct2020 (about 3 months ago), along with the shingles shot and the pneumonia shot. Her second dose will be on 17Feb2021. Her arm started aching on 20Jan2021 little by little and was worsen on 21Jan2021. No treatment received for adverse events. She did not like to take medication and pain pills. The outcome of events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous report from a contactable consumer. This 67- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL3246), via intramuscular route of administration, on 19Jan2021 at 10:30AM (at the age of 67-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The medical history included: Blood pressure high, Diabetes, Hypothyroidism, High cholesterol, all from unspecified dates and ongoing. Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Concomitant medications included FLUTICASONE PROPIONATE (FLONASE) and montelukast sodium (SINGULAIR), both for Allergy. The patient received first dose BNT162B2 on 28Dec2021, (Lot: EJ1685, Expiry/NDC: Unknown), in right arm (Her arm hurt for about a week). Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Prior vaccination included: Pneumonia vaccine - States that her arms swelled up and turned red the day she got the vaccine. The next day she had chills, fever, and body aches; and she had a rash on her arm that started the day after the vaccine. Her doctor told her not to get the vaccine again. She does not have the Lot/NDC/Expiry to provide because it was many years ago. Prior vaccination: Flu shot - She swells up and turns red at injection site; she also gets fever, chills, and body aches with it as well. She does not have the Lot/NDC/Expiry to provide; she got it back in Oct2020 at the Hospital where she works.  On 20Jan2021 03:00 AM, the patient experienced fever, aches, chills, and feels miserable. States that she reacts to the flu shot too, but nothing like this. Stated that all the events started in the early hours of the morning, around 3:00AM. She pushed herself to go to work, and it just got worse throughout the day.  States that she has been alternating Tylenol and Ibuprofen since early this morning. The outcome of events fever, aches, chills, and feels miserable was not recovered, got worse through the day was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm discrete soreness; This is a spontaneous report from a contactable Other HCP.  A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1283, via an unspecified route of administration on 15Jan2021 18:45 at SINGLE DOSE  Vaccine location: Left arm, dose number: 1 for covid-19 immunisation. Medical history is none. Concomitant medication included bisoprolol (BISOPROLOL), rosuvastatin (ROSUVASTATIN), asa (ASA). The patient experienced left arm discrete soreness on 15Jan2021 21:30 with outcome of recovered in Jan2021. The action taken was not applicable.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: Fever; Chills; Joint pain; Headache; Body Aches; Swelling of the Throat; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Ulcerative colitis, no Known allergies. No concomitant medication. The patient previously took the first dose of bnt162b2 in right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. No Other medications in two weeks. On 19Jan2021 08:00, the patient experienced Fever, Chills, Body Aches, Joint pain, Headache and Swelling of the throat. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia
Clinical narrative: Fever; Chills; Joint pain; Headache; Body Aches; Swelling of the Throat; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Ulcerative colitis, no Known allergies. No concomitant medication. The patient previously took the first dose of bnt162b2 in right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. No Other medications in two weeks. On 19Jan2021 08:00, the patient experienced Fever, Chills, Body Aches, Joint pain, Headache and Swelling of the throat. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm, not too bad, maybe a little worse than other vaccines; This is a spontaneous report from a non-contactable consumer (patient). This This adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. It was unknown if other vaccine was in four weeks; other medications in two weeks were unknown. Known allergies was unknown. If covid prior vaccination was unknown. If covid tested post vaccination was unknown. Patient experienced sore arm, not too bad, maybe a little worse than other vaccines. No treatment received. The outcome of 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: Vaccination site joint erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; This is a spontaneous report from a contactable Nurse. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL0142, intramuscular on 18Jan2021 14:45 at SINGLE DOSE second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The first dose of vaccine bnt162b2 was administered on 28Dec2020 lot number=EJ1685 vaccine location left arm. The patient reported that "right deltoid where the injection site has a local redness, it is warm touch and appears swollen and is getting bigger everyday" on 18Jan2021 16:00 with outcome of not recovered.  The action taken was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After injection, patient was lightheaded for a brief period of time; This is a spontaneous report from a contactable consumer reporting for a patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included covid-19 (had COVID prior vaccination) from an unknown date. The patient's concomitant medications were not reported. After injection, patient was lightheaded for a brief period of time on 21Jan2021 12:00. Feeling went away fairly quickly. The patient was not pregnant at the time of vaccination. It was unknown if COVID was tested post vaccination. There was no treatment for the event. The event outcome was recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Chills with body shaking; Chills with body shaking; Body soreness; Nausea; Fatigue; Swollen lymph nodes; Headache; Joint pain; This is a spontaneous report from a non-contactable other health professional reporting for herself. A 27-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration in left arm, on 20Jan2021 at 12:15, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Patient did not have COVID-19 prior to vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL0140) on 30Dec2020 at 11:00 AM in left arm. The patient experienced chills with body shaking, body soreness, nausea, fatigue, swollen lymph nodes, headache and joint pain all on 21Jan2021 at 12:00 with outcome of recovered on unknown date. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) on 21Jan2021 (pending result).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test, Tremor
Clinical narrative: Chills with body shaking; Chills with body shaking; Body soreness; Nausea; Fatigue; Swollen lymph nodes; Headache; Joint pain; This is a spontaneous report from a non-contactable other health professional reporting for herself. A 27-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration in left arm, on 20Jan2021 at 12:15, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Patient did not have COVID-19 prior to vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL0140) on 30Dec2020 at 11:00 AM in left arm. The patient experienced chills with body shaking, body soreness, nausea, fatigue, swollen lymph nodes, headache and joint pain all on 21Jan2021 at 12:00 with outcome of recovered on unknown date. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) on 21Jan2021 (pending result).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Myalgia; Low-grade fever (100.4F); Headache beginning 8 hours after 2nd dose administration; This is a spontaneous report from a non-contactable Nurse (patient). A 28-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation, lot number: EL5247. Medical history was reported as none. Concomitant medications were not provided. Patient had no known allergies (NKA). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation, lot number: unknown. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date patient experienced Low-grade fever (100.4F), chills, myalgia, headache beginning 8 hours after second (2 nd) dose administration. Resolved in 48 hours. No treatment was received for the events. Patient was tested for Covid post vaccination with Covid_test (Other) with negative result on 20Jan2021. Patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills; Myalgia; Low-grade fever (100.4F); Headache beginning 8 hours after 2nd dose administration; This is a spontaneous report from a non-contactable Nurse (patient). A 28-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation, lot number: EL5247. Medical history was reported as none. Concomitant medications were not provided. Patient had no known allergies (NKA). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation, lot number: unknown. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date patient experienced Low-grade fever (100.4F), chills, myalgia, headache beginning 8 hours after second (2 nd) dose administration. Resolved in 48 hours. No treatment was received for the events. Patient was tested for Covid post vaccination with Covid_test (Other) with negative result on 20Jan2021. Patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nauseous; This is a spontaneous report from a contactable consumer (patient's daughter).  This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899 with Expiration Date 31Mar2021), via intramuscular, on 05Jan2021 at 0.3 mL single dose on the right arm for COVID-19 immunisation. Relevant medical history included ongoing thyroid problems (did not remember but she thought it was about 4 years ago that this was diagnosed), and menopause from  Aug2020. No relevant concomitant medications were provided. On 06Jan2021, the patient developed headache. She had a really bad headache for about 9 days she ended up going to urgent care because of that, she was nauseous and went to the urgent care and they said they were side effects from the vaccine, she said the headache was extreme. She is wondering if it is okay to even take the second dose after having side effects. The patient had recovered from 'nauseous' on 10Jan2021 and from headache on 14Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Movement disorder, Myalgia, SARS-CoV-2 test negative
Clinical narrative: bilateral sharp leg muscle pain; difficulty to move around; severe fatigue; This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for herself.   An adult female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 04Jan2021 for Covid-19 immunisation, administered at hospital.  Medical history included corticosteroid lower lumbar injections. Patient was healthy. Vaccine Facility information available. Concomitant medication within 2 weeks of vaccination included 1 dose of over the counter ibuprofen (manufacturer unknown) on 03Jan2021 a day prior to vaccination.  The patient experienced bilateral sharp leg muscle pain, difficulty to move around, severe fatigue in Jan2021. The events lasted daily for more than 1 week. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were considered non serious by reporter. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for Sars-cov-2 test nasal swab: negative in Jan2021. As result of the events the patient took TYLENOL after vaccination. The outcome of recovered in Jan2021. the 2nd dose will be administered the week of 25Jan2021.   Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Lymphadenopathy, Pain in extremity
Clinical narrative: Big toes hurt, gout; Big toes hurt, gout; Glands in her neck on the right side swollen; Arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) via an unspecified route of administration in left arm on 20Jan2021 mid-afternoon at single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation diagnosed about 25 years ago, Canker sore on 18Jan2021 (she did go the doctor for that and the doctor urged her to rinse it with salt water to she's been doing that), some soreness in her month on 18Jan2021, gout reaction. The patient concomitant medications were not reported. No Pfizer vaccine was administered on the same date. Prior Vaccinations (within 4 weeks) was none. The patient got a reaction that she thought should be noted. She has had a very slight history of gout. She woke up this morning on 21Jan2021 and her big toes hurt. She knew that this was a symptom of what she had had in the past which was gout. The patient confirmed her big toes hurting was pretty much staying the same. It's not that uncomfortable. She knew from past experience that this was what happens, like when she ate certain foods like seafood or whatever, she would have this kind of gout reaction. This morning on 21Jan2021, she also felt the glands in her neck on the right side were swollen. The swelling seemed to have gone down. Her arm was also very sore. She stated the soreness began last night, in the evening on 20Jan2021. The soreness had pretty much stayed the same. She expected the soreness, but she didn't expect her toes to hurt. It was important to note "she is able to able the gout". She had only had gout really bad time once and then she's had a little bit every so often. The gout just seems to be connected to the vaccine- she could not say nothing that she ate would indicate other wise. The events did not require visit Emergency Room or Physician Office. She had an appointment for 10Feb2021 to get the second COVID-19 vaccine. The outcome of event glands in her neck on the right side swollen was recovering, outcome of events was not recovered.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Investigation, Irritable bowel syndrome, Off label use, Product use issue
Clinical narrative: Diarrhea; irritable bowel syndrome; Medical history included ongoing HIV positive; Medical history included ongoing HIV positive; This is a spontaneous report from a contactable consumer reported for himself. This 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Jan2021 at 14:00 PM at single dose in left arm for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date for 26 years, ongoing AFib from an unspecified date for 8 years, ongoing diabetes from an unspecified date for 15 years. Concomitant medications included lisinopril for the heart, warfarin as blood thinner, cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) for HIV, atorvastatin as a statin. The patient experienced diarrhea on 17Jan2021. The patient started to get like irritable bowel syndrome, diarrhea on 17Jan2021 like 2 AM. He stated he felt good all day long, but then at night he has the bouts of these bowls. The diarrhea got okay after imodium, but then it continued. He was calling to see if this was a side effect. It was reported no emergency room and physician office involved. He is scheduled to get second vaccine on 05Feb2021. The patient mentioned in Dec2020 he had a complete lipid panel and everything was within range except one or two things. However, he was informed it was not that bad. The outcome of the events irritable bowel syndrome, diarrhea was not resolved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling hot, Hyperhidrosis
Clinical narrative: Fifteen to thirty minutes later she was extremely warm inside; Started sweating a little bit; All she can taste is metal; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at 7:15, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, fifteen to thirty minutes later, the patient stated she was extremely warm inside, she started sweating a little bit and all she could taste was metal. She could drink coffee but it tasted like a penny. At the time of the report the events outcome was unknown.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Magnetic resonance imaging abnormal, Mobility decreased, Muscle spasms
Clinical narrative: sciatica; muscle spasms from his lower back to his toes on the right side; This is a spontaneous report from a contactable Consumer (patient's wife). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included twinge in his hamstring in Jan2021. Concomitant medications were not reported. The patient experienced a twinge in his hamstring 2 days before the vaccine but continues to play (reporter mentioned her husband is athletic). He received the first dose of the vaccine on 12Jan2021, played on the 13Jan2021 and could not play on 14Jan2021 two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed (shot was in the left arm). Husband went to the hospital on 16Jan2021 and they discharged him and he went back on 17Jan2021 and did a magnetic resonance imaging (MRI) and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and  gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him Toradol and then additional steroid injections. Husband was able to walk out with a walker. Can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having physical therapy (PT) come for consult. Husband insists on getting second dose. Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the COVID-19 vaccine. The events had not resolved.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058075 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sciatica, Screaming
Clinical narrative: sciatica; muscle spasms from his lower back to his toes on the right side; This is a spontaneous report from a contactable Consumer (patient's wife). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included twinge in his hamstring in Jan2021. Concomitant medications were not reported. The patient experienced a twinge in his hamstring 2 days before the vaccine but continues to play (reporter mentioned her husband is athletic). He received the first dose of the vaccine on 12Jan2021, played on the 13Jan2021 and could not play on 14Jan2021 two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed (shot was in the left arm). Husband went to the hospital on 16Jan2021 and they discharged him and he went back on 17Jan2021 and did a magnetic resonance imaging (MRI) and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and  gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him Toradol and then additional steroid injections. Husband was able to walk out with a walker. Can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having physical therapy (PT) come for consult. Husband insists on getting second dose. Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the COVID-19 vaccine. The events had not resolved.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058075 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: has a problem with her teeth; This is a spontaneous report from a contactable consumer.  A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient said she got the first dose of the Pfizer COVID-19 Vaccine and was doing fantastic. She said she was now getting ready to get her second Pfizer COVID-19 Vaccine dose, but had a problem with her teeth and needs to take an antibiotic, and will need to see a dentist. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began within 1 hour of 2nd vaccination; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3248), via intramuscular route in the right arm on 19Jan2021 16:30 as a single dose for COVID-19 immunization. Historical vaccine data included the first dose of BNT162B2 on 29Dec2020 at 16:30 (at the age of 58-years) via intramuscular route in the right arm. Medical history included rheumatoid arthritis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tofacitinib citrate (XELJANZ XR), methotrexate, atorvastatin (LIPITOR), lansoprazole (PREVACID), and celecoxib (CELEBREX). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2017 at 17:30, the patient experienced sore arm, cough began within 1 hour of 2nd vaccination and persisted 2 days later, mild shortness of breath upon exertion which persisted, and mild fatigue for 24 hours. The patient did not receive any treatment for the events. The patient was not tested for COVID-19 post vaccination. The clinical outcome of the events sore arm, fatigue, shortness of breath, and cough was reported recovering.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site rash
Clinical narrative: Dry rash around injection site; This is a spontaneous report from a contactable Other Health Professional (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at 15:00 at single dose for COVID-19 immunisation. Medical history included known allergies: lavender and trees. Concomitant medications included magnesium, birth control, elder berry. Nasal swab on unknown date was negative. It was unknown if treatment received or not. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Diarrhea; upset stomach; nausea; fatigue; fever; This is a spontaneous report from a contactable pharmacist, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: El3248), via an unspecified route of administration in the left arm on 19Jan2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none; the patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. Concomitant medications included unspecified multivitamins. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Ek5730) on 30Dec2020 at 10:30 (at the age of 50-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks of the vaccination. On 19Jan2021 at 16:00, the patient experienced diarrhea, upset stomach, nausea, fatigue and fever. The patient did not receive treatment for the events. Since the vaccination, the patient was not tested for COVID. The clinical outcome of diarrhea, upset stomach, nausea, fatigue and fever was resolving.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: Metallic taste in my mouth; This is a spontaneous report from a contactable Physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 07:00 AM at single dose in left arm for COVID-19 immunisation. The first dose of BNT162B2 was administered on 22Dec2020 at 06:00 AM at single dose in left arm. The patient was vaccinated at hospital. Patient age at vaccination was 32 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included psoriatic arthritis. The patient has no known allergies. Concomitant medication included adalimumab (HUMIRA). On 13Jan2021 the patient experienced metallic taste in mouth occurring daily but intermittently, started after first dose but now worse after second dose. No treatment was received for the event. The event had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has been tested for COVID-19 (nasal swab performed on 19Jan2021 which resulted negative).   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 101.8 F approx 72 hours after vaccination; This is a spontaneous report from a contactable consumer.  A 51-year-old female patient (not-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 19Jan2021, the patient experienced fever of 101.8 F approximately 72 hours after vaccination.  The patient underwent lab tests and procedures which included SARS-COV-2 test: negative   on 20Jan2021.  The patient outcome of the event was recovered on Jan2021.  The information on the batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Lower left eyelid swelling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249), intramuscular in left arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included calcium, ergocalciferol (VITAMIN D), ascorbic acid, colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN) in two weeks. Historical Vaccine included the patient received first dose of BNT162B2 (lot number: EK9231), intramuscular in left arm at the age of 35-year-old on 02Jan2021 10:00 at single dose for COVID-19 immunization. The patient experienced lower left eyelid swelling on 20Jan2021 19:00. No treatment received for the event. The patient was no pregnant. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate increased
Clinical narrative: racing heart rate around 48 hours after vaccine; Headache for 24 hours (mild); Intermittent shortness of breath for 48 hours; This is a spontaneous report from a contactable consumer, the patient. This 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  2 , single dose via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 55 years-old) for COVID-19 vaccination. The patient was not pregnant.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included allergy to codeine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown ), dose 1, single dose via an unspecified route of administration in the right arm on 29Dec2020 at 03:45 PM.  Concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. The patient did not receive any other medication in two weeks. On 19Jan2021 at 05: 00 PM, the patient experienced mild headache for 24 hours and intermittent shortness of breath for 48 hours. On an unknown date, the patient had racing heart rate around 48 hours after vaccine. There was no treatment received for the events. The clinical outcome of events, mild headache and shortness of breath was recovered on an unknown date in Jan2021.  The outcome of the event racing heart rate was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Genital lesion, Genital ulceration, Pain
Clinical narrative: pain; Non-sexually transmitted severe genital sores; genital aphthous ulcers of unknown etiology with consequent severe dysuria; genital aphthous ulcers of unknown etiology with consequent severe dysuria; This is a spontaneous report from a contactable physician, the patient. A 37-years-old  female patient (physician) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration 13Jan2021  as a single dose  for COVID-19 vaccination. It was Unknown if the patient was pregnant at Time of Vaccination. The facility in which the vaccination was administered was a Hospital. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included Vitamins. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19.  On 14Jan2021 at 22:15, The patient experienced non-sexually transmitted severe genital sores/genital aphthous ulcers of unknown etiology with consequent severe dysuria, pain, disabling from walking, sitting.  The adverse events resulted in a physician's office/clinic visit.  No treatment was given for the events. The clinical outcome of the events non-sexually transmitted severe genital sores/genital aphthous ulcers, severe dysuria, pain, disabling from walking, sitting was not recovered.