chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Joint swelling, Pain in extremity
Clinical narrative: her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has really bad arthritis like she has had a knee replacement/her arthritis is really bad/it just flared up; She had a little pain in her leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (Pfizer BioNTech COVID 19 vaccine, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration on 12Jan2021 09:30 at single dose in Left upper arm for covid-19 immunization. Vaccination Facility Type was at a hospital, they had a vaccine clinic set up. Vaccine Administered at Facility was No. Medical history included arthritis, she has had a knee replacement, she was allergic to anti-inflammatory medicines. Family history was none. There were no concomitant medications. No other vaccines was administered on same date of the bnt162b2. Prior Vaccinations (within 4 weeks) was None. No events occurred following prior vaccinations. Patient was calling about a question with the COVID-19 vaccine. She got it on Tuesday 12Jan2021 and she wanted to know if she could get a reaction now. Yesterday (20Jan2021) she noticed, she had really bad arthritis like she has had a knee replacement and she has it her hands and yesterday she noticed her wrist was swollen and she didn't know if it could have been where she had arthritis or could it be side effect? She just didn't know if she should call her orthopedic doctor. She said the joint at the wrist, it was like the side of her hand, it was the side where your pinky was, just above the bone on her wrist it was swollen. It was swollen normally but it usually didn't hurt like this, it was like a burning but it maybe her arthritis acting up but she did not know. She said the pain and swelling began yesterday 20Jan2021. Her wrist was swollen and it was like a burning was reported as worsened. She had a little pain in her leg the other day on 17Jan2021 but just coughed it up. It was all on the left side which was the same side she got the injection on. She didn't think anything of the leg pain and it went away. The pain in her leg has resolved completely. The only other thing was her arthritis was really bad, it just seemed that it just flared up but she was wondering if it could be a side effect. The events didn't require a visit to emergency room or physician office. The outcome of "She had a little pain in her leg" was recovered in Jan2021, while outcome of other events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sleep disorder
Clinical narrative: excruciating headaches; He had no sleep; This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in left arm, on 20Jan2021 at 08:45, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were none. The patient experienced excruciating headaches on 20Jan2021 at 23:00 with outcome of not recovered, he had no sleep in Jan2021 with outcome of unknown.   The information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; This is a spontaneous report from a contactable Pharmacist. A 45-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), intramuscular on 17Jan2021 at single dose for covid-19 immunisation .  Medical history reported as none.  The patient's concomitant medications were not reported.  The patient experienced left-arm numbness, tingling, itching on 17Jan2021. vaccine administered on right-arm. The outcome of events was recovering.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 20Jan2021at single dose for covid-19 immunization. Medical history included allergies: penicillin, iodine, shellfish; asthma. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications were not reported. Patient experienced migraine on 21Jan2021 07:00 AM with outcome of recovered. No treatment was received for the event.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Cotton ball and ban aid stained but not solid blood and unsure if he got the full vaccine or it came back out with the blood; This is a spontaneous report from a contactable consumer.   This consumer (patient's wife) reported for a 73-year-old male patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL9262, via unspecified route of administration in upper left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure and he was overweight and had a large gut like most men his age. He had previous lung surgery. No further details provided. Concomitant medications were not specified but the patient had high cholesterol and high blood pressure and took medications for those.  The consumer reported that when the patient took cotton ball and band aid off, it was stained and it was not solid blood.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Paraesthesia, Vaccination site pain
Clinical narrative: pain at injection site; Ten min after dose my arm felt cold. felt my hands to my cheeks, both hands felt same temp but injected entire arm felt a cold sensation like my nerves were cold throughout arm; ten min after dose, tingling also like it was colder than the other arm; This is a spontaneous report from a non-contactable Pharmacist (patient).  A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at 18:00 at single dose in arm for COVID-19 immunisation at the age of 37-year-old. Medical history included anxiety and depression. It was unknown if the patient was pregnant. Concomitant medications were unknown. The patient reported that on 20Jan2021, ten min after dose, arm felt cold; the patient felt her hands to her cheeks (as reported), both hands felt same temp but injected entire arm felt a cold sensation like nerves were cold throughout arm.; tingling also like it was colder than the other arm. It lasted about 30 min, then it got about 50% less intense. Intensity continued till the time of report. The morning of the report on 21Jan2021, the patient woke up with dull pain at injection site. The patient was not treated for the events. The patient did not have COVID prior vaccination, and she was not COVID tested post vaccination. The patient was recovering from the events.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: Chest pain; numb hands; This is a spontaneous report from a contactable consumer, reporting for herself.  A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Jan2021 at 10:30 (at the age of 38 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021, the patient experienced chest pain and numb hands. The patient did not receive treatment for the events. The clinical outcome of chest pain and numb hands was recovering. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours; Injection site red, swollen and warm to touch extending 4"x2"; Injection site red, swollen and warm to touch extending 4"x2; Injection site red, swollen and warm to touch extending 4"x2; This is a spontaneous report from a contactable nurse reporting for herself. A 52-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL0142, via intramuscular route in left arm on 19Jan2021 at 11:45 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Vaccination history included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EJ1685, via intramuscular route in left arm on 29Dec2020 at 12:00 PM, administered in Hospital. Medical history included allergy to sulfa drugs from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID-19 post vaccination. Unspecified concomitant medications were administered. On 20Jan2021 at 03:00 the patient experienced injection site red, swollen and warm to touch extending 4"x2". Twenty-four hours after vaccination the patient experienced chills, low grade temperature at 100.5 and generalized achiness lasting 8-10 hours. No treatment was administered for the reported events. The event "Generalized achiness" resolved on 19Jan2021, whereas the other reported events were resolving at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hard of hearing; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), 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 stated she was hard of hearing that was one of her problems on an unspecified date. Patient reported she made an appointment to receive the bnt162b2 vaccine but now she realized it was 45 minutes away from her house. She wanted to change it. Investigation Assessment was not provided. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3302) at left arm 08:30AM on 20Jan2021 for Covid-19 immunization. The patient had first shot 08:00AM on 30Dec2020 at right arm and experienced sore arm within 12hrs, fatigue, joint pain, skin itch, and enlarged right supraclavicular lymph node. The patient had no known allergies and other medical history was not reported. Concomitant medications included metformin. The patient experienced sore arm within 4hrs, fatigue, joint pain, fever around 12:15PM on 20Jan2021. No treatment received for the events. The patient had no Covid prior vaccination and not Covid tested post vaccination. The event did not resolve at the time of reporting.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron decreased, Epistaxis, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Nose bleed; Anemic; her husband's hemoglobin and hematocrit were low; her husband's hemoglobin and hematocrit were low; low on iron; This is a spontaneous report from a contactable consumer (wife of patient).  An 87-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 16:00 at single dose in right arm for COVID-19 immunisation at the age of 87-year-old. Lot number was EL3249. Medical history included atrial fibrillation, by-pass surgery in 1999 then high blood pressure in 1999, gout (diagnosed before 1999, it was an on and off thing, he had flare ups, the last one was at Christmas time), High cholesterol (diagnosed in 2000 or 2001), diabetes, anemia. Concomitant medications included rivaroxaban (XARELTO) in 2014 for atrial fibrillation. Historical vaccine included flu vaccine in Sep2020 for immunization. On 20Jan2021, the patient was anemic. On 21Jan2021 at 02:30, nose bled. The patient just kept wiping his nose for thirty minutes before it stopped. On 20Jan2021, hemoglobin resulted 12.6, hematocrit was 3.9. The patient went to the hematologist the day before the report who said the patient was low on iron, hemoglobin and hematocrit were low, so he had to get an iron infusion the day of report for that (the patient went every three months and if his iron was low he got an infusion). The patient recovered from nose bled on 21Jan2021, the outcome of other events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient).  A 66-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 13:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient did not get COVID prior vaccination and COVID was not tested post vaccination. The patient experienced extreme tiredness on 21Jan2021.  No treatment was received. The outcome of the event was resolving.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Spinal pain
Clinical narrative: pain at the top of my spine, at the base of my neck; pain at the top of my spine, at the base of my neck; This is a spontaneous report from a non-contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 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 the flu shot for immunization and her arm was sore. The patient got first Pfizer vaccine this morning (reported on 22Jan2021). She had been feeling fine. She didn't even have pain at the injection site. The patient had a pain at the top of spine, at the base of neck. She didn't know if it's related to the vaccine. The patient also stated the site couldn't change her appointment which was exactly 3 weeks from today but unfortunately, she had surgery scheduled that day. Outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Migraine
Clinical narrative: Severe bilateral headache that woke up from sleep; Light and sound affected like a migraine; Also extreme fatigue and weakness (climbing stairs makes short of breath).; Also extreme fatigue and weakness (climbing stairs makes short of breath).; Also extreme fatigue and weakness (climbing stairs makes short of breath).; This is a spontaneous report from a contactable pharmacist (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number El 9262), via an unspecified route of administration from 20Jan2021 14:00 at left arm at single dose for covid-19 immunization. Patient received the first dose of vaccine on 31Dec2020 10:00 AM (lot number Ek5730) at left arm for covid-19 immunization, the first dose age was also 33 years old. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included asthma, eczema. known allergies included Metronidazole, SSRIs. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications included bupropion, birth control, multivitamin, esomepaz. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe bilateral headache that woke up from sleep, treated with ibuprofen and Tylenol but still remained. Light and sound affected like a migraine. Also extreme fatigue and weakness (climbing stairs makes short of breath). The event onset date was reported as 21Jan2021 02: 00 AM. The treatment included ibuprofen and Tylenol. The outcome of events was reported as not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigued; aching; This is a spontaneous report from a non-contactable consumer (patient). A adult female patient received the first dose and second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), all via an unspecified route of administration on an unspecified dates at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient felt fatigued and had aching for several hours after the vaccine was given. Patient was no pregnant. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hot flush
Clinical narrative: After vaccines I get hotflashes all day and night. My temperature has remained normal; This is a spontaneous report from a Non-contactable Other-HCP (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EH9899, via an unspecified route of administration from 21Dec2020 16:00 to 21Dec2020 16:00 (at the age of 56-years-old) as a single dose in the right arm, for COVID-19 vaccination. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 11Jan2021 as a single dose in the right arm lot number EK9231, for COVID-19 vaccination.  Medical history included autoimmune illnesses from an unknown date and unknown if ongoing , many allergies from an unknown date and unknown if ongoing , occasional hot flashes (before vaccines I got only occasional hot flashes) from an unknown date and unknown if ongoing Before vaccines I got only occasional hot flashes.  There were no concomitant medications.  The patient was administered the vaccine in hospital.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced before vaccines she got only occasional hot flashes. After vaccines she got hot flashes all day and night on 22Dec2020. Her temperature has remained normal. No treatment was received for the event. The patient underwent lab tests and procedures which included temperature: remained normal on 22Dec2020. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle fatigue, Tunnel vision
Clinical narrative: tunnel vision; Muscle fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional (HCP) communicated to a Pfizer colleague. A 38-years-old female patient (not pregnant) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on right arm on 04Jan2021 at single dose for covid-19 immunisation.  Medical history was None.  The patient's concomitant medications were not reported.  On 04Jan2021 the patient experienced tunnel vision, muscle fatigue, joint pain. No treatment was received for the events.  The outcome of the events was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of tunnel vision cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; Body aches; fever; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. The 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247, expiry date unknown) on 17Jan2021 15:30 at single dose via an unspecified route of administration in the left arm for COVID-19 immunization. The patient's medical history was not reported. She had received her first dose of BNT162B2 (lot number ECO140, expiry date unknown) on 29Dec2020 at single dose via an unspecified route of administration in the left arm for COVID-19 immunization. She had not had COVID prior to the vaccination, not tested post the vaccination. She had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), ethinylestradiol/etonogestrel (NUVARING). No other vaccine received in four weeks. The patient experienced body aches, fever and chills on 18Jan2021 09:00. No seriousness criterion reported. No treatment for events was received. The events were resolved on an unspecified date in Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Axillary pain, Chills, Diarrhoea
Clinical narrative: Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Weakness; Stomach ache with diarrhea; Stomach ache with diarrhea; Injection site pain; Armpit pain & swelling; Armpit pain & swelling; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3246) solution for injection intramuscular in the left arm on 18Jan2021 at 03:30 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included chronic spontaneous urticaria. Concomitant medications included omalizumab (XOLAIR), lisdexamfetamine mesylate (VYVANSE), famotidine (PEPCID AC), fexofenadine hydrochloride (ALLEGRA), valacyclovir, fish oil, probiotic, medical marijuana. The patient had no known allergies. Historical vaccine included BNT162B2 (Pfizer, Lot EJ1685) in Dec2020 at 06:15 intramuscular in left arm for COVID-19 vaccination for 1st dose with no adverse event. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 11:00, the patient experienced very fatigued, fevers, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. No treatment was provided for the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. The outcome of the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Headache, Myalgia, Pain
Clinical narrative: Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Weakness; Stomach ache with diarrhea; Stomach ache with diarrhea; Injection site pain; Armpit pain & swelling; Armpit pain & swelling; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3246) solution for injection intramuscular in the left arm on 18Jan2021 at 03:30 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included chronic spontaneous urticaria. Concomitant medications included omalizumab (XOLAIR), lisdexamfetamine mesylate (VYVANSE), famotidine (PEPCID AC), fexofenadine hydrochloride (ALLEGRA), valacyclovir, fish oil, probiotic, medical marijuana. The patient had no known allergies. Historical vaccine included BNT162B2 (Pfizer, Lot EJ1685) in Dec2020 at 06:15 intramuscular in left arm for COVID-19 vaccination for 1st dose with no adverse event. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 11:00, the patient experienced very fatigued, fevers, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. No treatment was provided for the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. The outcome of the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Weakness; Stomach ache with diarrhea; Stomach ache with diarrhea; Injection site pain; Armpit pain & swelling; Armpit pain & swelling; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3246) solution for injection intramuscular in the left arm on 18Jan2021 at 03:30 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included chronic spontaneous urticaria. Concomitant medications included omalizumab (XOLAIR), lisdexamfetamine mesylate (VYVANSE), famotidine (PEPCID AC), fexofenadine hydrochloride (ALLEGRA), valacyclovir, fish oil, probiotic, medical marijuana. The patient had no known allergies. Historical vaccine included BNT162B2 (Pfizer, Lot EJ1685) in Dec2020 at 06:15 intramuscular in left arm for COVID-19 vaccination for 1st dose with no adverse event. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 11:00, the patient experienced very fatigued, fevers, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. No treatment was provided for the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. The outcome of the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm got a little sore; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), via an unspecified route of administration on left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, had had all her life. There were no concomitant medications. The patient experienced left arm got a little sore on 20Jan2021. She went for her second dose by 10Feb2021. The patient did not receive any treatment from event. The outcome of event was recovered on 20Jan2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: rash on her stomach/spread to back,neck and arms,trunk; This is a spontaneous report from a contactable other hcp(patient).  The 21-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 12Jan2021 15:00 at single dose for COVID-19 immunization.  Medical history included none. She had no known allergy. Concomitant medication included ethinylestradiol/levonorgestrel (SEASONIQUE), ergocalciferol (VIT D), vitamin b complex (VIT B COMPLEX). There was no other vaccine in four weeks.  The patient experienced a rash on her stomach on12Jan2021 17:00. By the next day, it spread to back. It had now been 8 days since she received the first dose, and it had spread to neck and arms (still on trunk as well). The rash showed no signs of improvement and seemed to be spreading. Event was assessed as non-serious by reporter. Outcome of event was not recovered. There was no treatment. There was no COVID prior vaccination. Lab data included two Saliva PCR tests: negative both on 14Jan2021.  Information on the Lot/Batch Number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin depigmentation, Skin exfoliation
Clinical narrative: skin was bruised; skin was scraping off; skin underneath is super white; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she got the first dose of vaccination two weeks ago (as of 21Jan2021). Supposed to get second dose on Monday. Stated that she was bruised (skin was bruised) and after two weeks skin was scraping off and skin underneath was super white, in Jan2021. Stated was a reaction. Wanted to know if should get it again. Stated that she worked at hospital (stated that she does vascular and echo on heart and legs) and needed to get immune. Wanted to know if there was an email to show her pictures. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: chills; injection site pain; This is a spontaneous report from a non-contactable other hcp. An elderly female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced injection site pain and chills. No therapeutic measures were taken as a result of the events. The clinical outcomes of the injection site pain and chills were resolved on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: tired; achy; chills; stiff neck; can not turn her head; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no problem after receiving the first dose of the COVID-19 vaccine; and felt a little tired and achy, with chills after the second dose. The patient also has a terribly stiff neck and can not turn her head. The outcome of events was unknown.  Information on the Lot/Batch Number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sinus headache
Clinical narrative: sinus headache; Headache; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 76-year-old male patient (husband) received BNT162B2 (COVID-19 VACCINE, Batch/lot number: EL1283) on 19Jan2021 at about 10:30 AM on Arm Left for covid-19 immunization. Medical history was ongoing chronic sinusitis. Concomitant drug was warfarin. Reported that both her and her husband had a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. Reported her husband developed a headache during his sleep the night of receiving the COVID-19 Vaccine. She said her husband and her have chronic sinusitis. She said her husband's headache went away after he started moving around. She said because of having other conditions, her husband's headache was worse than with only his sinus issues. She clarified his whole head hurt. She said his headache was not a frontal headache like a person may get from their sinuses. Reported her husband thinks the COVID-19 Vaccine contributed to his headache, because his headache was a little different from what he normally experiences. She said his headache only lasted 1 day. She clarified her husband had a little sinus headache this morning. She said he blows his nose, and the headache goes away. She said his headache was short lived after getting the COVID-19 Vaccine. She said both her husband's and her headaches were mild. Outcome of the event headache was Recovered on 20Jan2021, for sinus headache was unknown. Reporter considered Related causality.  No follow-up attempts possible. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; first dose was 28Dec2020, wondered when he should get the second dose; This is a spontaneous report from a contactable health professional, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EH9899), via an unspecified route of administration on 28Dec2020 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. On 13Jan2021, the patient tested positive for COVID. The patient was on his 10th day of quarantine "tomorrow" and wondered when he should get the second dose. The clinical outcome of "Tested positive for COVID" and "first dose was 28Dec2020, wondered when he should get the second dose" was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Nervousness
Clinical narrative: Nauseous; nervous; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization, fish oil, lactobacillus casei (RESTORA RX), via an unspecified route of administration from 21Jan2021 08:30 to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was calling in regards to the Covid Vaccine. She had the shot(covid vaccine) on 20Jan2021 at about 10 or 10:15AM. After her First dose, She had a doctor appointment at 11:20, 20Jan2021, the doctor put her on a new medicine, the Restora RX was in capsule form, she started that on 21Jan2021 at 8:30AM. She was nervous. She was nauseous on 21Jan2021 at about 8:30AM. She was a little nauseous and was basically trying to find out which one was causing it, the vaccine or the new medication. The name of the new medication was "Restora Rx". The action taken in response to the event for fish oil, lactobacillus casei was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Hives all over body, itchy all over body, fever
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Feeling abnormal, SARS-CoV-2 test negative, Suspected COVID-19, Upper respiratory tract infection
Clinical narrative: assume she had covid as well; assume she had covid as well; Feeling bad; Upper respiratory infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for two patients (herself and her husband), this is the first of two reports.  A 71-year-old female patient received 1st dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in left arm on 12Jan2021 16:30 at single dose for preventing covid. Medical history and concomitant medications were none. No prior vaccinations (within 4 weeks). She and her husband both received their first dose on 12Jan2021. Stated they both have covid. She was feeling bad last Friday (15Jan2021) and she went to urgent care and had a rapid test done that day that came back negative. Her husband went to urgent care this morning and had a rapid test that came back positive. She was told to assume she had covid as well. When she went to physician office for urgent care last Friday (15Jan2021), she was given medication for what they thought was an upper respiratory infection since her test last week came back negative. She was feeling better. The patient underwent lab tests and procedures which included Covid: negative on 15Jan2021. The outcome of feeling bad was recovering, for the rest of events outcome was unknown. No emergency room visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078480 same reporter/drug, similar events, different patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tinnitus
Clinical narrative: stated that her gland is swollen on her right side; stated that she has a noise in her ear and can hear her jaw moving on her right side; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Batch/lot number: EL3249), via an unspecified route of administration into right arm on 22Jan2021 9:10 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were none. The patient stated that she had the Pfizer Covid 19 vaccine this morning at 9:10 to her right arm. Her gland was swollen on the right side and she had a noise in her ear and can hear her jaw moving on her right side on 22Jan2021 and when she talked and ate that it sounds like someone was crunching rubber. No investigation assessment and no treatment received. She wanted to know if it is something that she should be worried about. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: tired; flu like symptoms after 2nd dose.  Only lasted for 1 day; This is a spontaneous report from a contactable consumer.   A 46-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. On an unknown date, the patient received the first dose of BNT162B2 vaccine.  On Jan2021, after 2nd dose, the patient was tired and had flu like symptoms only lasted for 1 day with outcome of recovered.    Lot and batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Fatigue
Clinical narrative: Fever 102 from 4 hours after vaccine with severe chills, severe bone and joint pain,dizziness, headache, nausea and vomiting and major fatigue from 4 hours after vaccine until Friday Feb 5th for 9 days.  I was in the bed so sick for 9 days could not even sit up in bed without being extremely sick.  Tylenol 1000mg every 8 hours for 9 days. Prescribed Phenergan 25mg and written out of work until 2/6 by physician due to vaccine reaction to first dose of pfeizer covid vaccine. Instructed to not take second dose or any subsequent dose of vaccine. And listed as adverse vaccine reaction in EMR. Was followed by Physician at clinic and health nurse. They also reported this vaccine reaction to hospital.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Mobility decreased, Nausea, Pyrexia, Vaccination complication
Clinical narrative: Fever 102 from 4 hours after vaccine with severe chills, severe bone and joint pain,dizziness, headache, nausea and vomiting and major fatigue from 4 hours after vaccine until Friday Feb 5th for 9 days.  I was in the bed so sick for 9 days could not even sit up in bed without being extremely sick.  Tylenol 1000mg every 8 hours for 9 days. Prescribed Phenergan 25mg and written out of work until 2/6 by physician due to vaccine reaction to first dose of pfeizer covid vaccine. Instructed to not take second dose or any subsequent dose of vaccine. And listed as adverse vaccine reaction in EMR. Was followed by Physician at clinic and health nurse. They also reported this vaccine reaction to hospital.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever 102 from 4 hours after vaccine with severe chills, severe bone and joint pain,dizziness, headache, nausea and vomiting and major fatigue from 4 hours after vaccine until Friday Feb 5th for 9 days.  I was in the bed so sick for 9 days could not even sit up in bed without being extremely sick.  Tylenol 1000mg every 8 hours for 9 days. Prescribed Phenergan 25mg and written out of work until 2/6 by physician due to vaccine reaction to first dose of pfeizer covid vaccine. Instructed to not take second dose or any subsequent dose of vaccine. And listed as adverse vaccine reaction in EMR. Was followed by Physician at clinic and health nurse. They also reported this vaccine reaction to hospital.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Has been feeling sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in left deltoid on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient stated that he has been feeling sick. The event outcome was unknown at the time of the report.  Information on lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported a 42-years-old female patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686  ) , via an unspecified route of administration on 19Jan2021 at SINGLE DOSE right Arm for covid-19 immunisation.  The first dose bnt162b2 was received on 28Dec2020 for covid-19 immunisation. Medical history included severe allergies, hypothyroidism.  There were no concomitant medications.  The patient experienced swollen lymph nodes on 20Jan2021. The patient has done no treatment for the swollen lymph node, not even applying heat. The outcome of event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose  for COVID-19 vaccination. Medical history and concomitant medication were not reported. On an unspecified date, the reporter stated that she heard 2 other people tested positive after receiving the vaccine. The clinical outcome of she heard 2 other people tested positive after receiving the vaccine was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082667 same reporter/drug/event, different patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain-5, swollen, red,itchy, raised skin margin, initially- 1.5? by 2.5? then tripled in area within 4 hrs.  Nurse noted injection given I low and in back edge of arm (subcutaneous  Dr  prescribed ZPack Arithromycin 6 tabs and Benydril
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills; Tired/ tiredness/exhausted; achy; This is a spontaneous report from a contactable consumer (patient). This 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 20Jan2021 at 10:30 at the age of 81-year-old at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history was none. There were no concomitant medications. On 20Jan2021, the patient experienced chills and in Jan2021 he experienced tired/ tiredness/exhausted and achy. The patient specified that he was not panicked. He got the first dose on 20Jan2021 and he was really tired. He had the chills in the night. He was just exhausted. He did not have a fever. Corrective treatment taken as a result of the events included acetylsalicylic acid (ASPIRIN). The patient was recovering from chills and he had not recovered from fatigue and pain.  Information about lot/batch number has been requested.