chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Supper fatigued; chills; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 28-year-old female patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at Left arm on 25Jan2021 18:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergies: Seafood. Concomitant medication included spironolactone. The patient's historic vaccine included first dose of BNT162B2 received on an unknown date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced supper fatigued and chills on 26Jan2021 10:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on Jan2021. Information on lot number/batch number requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I woke up the next day with a bad headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration at left arm on 25Jan2021 15:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food or other products. The patient's concomitant medication included Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up the next day with a bad headache. The event started on 26Jan2021 at 08:00. There was no treatment received for the adverse event. The event was non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient recovered from the event in Jan2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: I had an oral sensation like I was tasting something cold.; This is a spontaneous report from a consumer. A 65-year-old male patient received first dose bnt162b2 (COVID 19, Pfizer, EN 5318), via an unspecified route of administration, Left arm on 27Jan2021 15:15 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. On 27Jan2021 at 16:15, approx. an hour after injection, the patient had an oral sensation like he was tasting something cold. No treatment was given for the event. Outcome of event was recovered on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Dysgeusia
Clinical narrative: metallic taste in mouth; metallic taste in mouth; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration on 19Jan2021 at single dose at right arm for covid-19 immunization. Medical history included T1DM (Type I diabetes mellitus) from 1974, AVR (aortic valve replacement) from 1990 (AVR 1990 and 1992). No known allergies. Concomitant medications included insulin, simvastatin, lisinopril. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (lot number= EK5730) via an unspecified route of administration on 29Dec2020 11:00 AM at single dose at right arm for covid-19 immunization, and had metallic taste in mouth on 31Dec2020 for 3 days, chronic nausea began 07Jan2021, vomiting was explosive and unpredictable, and still occurring, splitting headaches. The patient experienced metallic taste in mouth on 19Jan (pending clarification) with outcome of not recovered. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any treatment.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test abnormal, SARS-CoV-2 antibody test
Clinical narrative: On day 19 after the vaccine was given I tested them for antibodies to the virus, they both were negative for IgM and IgG.; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is 2nd of 2 reports. A 78-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the couple was vaccinated on the same day in the same vehicle at a drive-through vaccination site. Both patients had no symptoms after the vaccination. On 17Jan2021, on day 19 after the vaccine was given, the patient was tested for antibodies to the virus, and both were negative for IgM and IgG; the control was positive. The test was negative for both IgM and IgG for both patients. The physician was asking if the first shot was not given properly and if they need a third vaccination. The physician was concerned that there may be an issue with the sensitivity of the office test. All of their friends have had at least some arm discomfort after the vaccine, they were nervous about the vaccine not working. Outcome of event was unknown.  Information on lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021063846 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report based on the information received by Pfizer from (Allergan Medical Information Request: US21-002211). A contactable consumer (patient) reported this female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ubrogepant (UBRELVY) from  13Jan2021 for headache-migraine. The patient experienced migraine on 23Jan2021 in the morning. The patient took a ubrogepant dose on 23Jan2021 and it relieved the pain. She was fine. On 25Jan2021 the patient had a severe migraine so she had to take another dose of ubrogepant. The patient stated that the migraines had been different since she received the vaccine. The patient wanted to know if there were any potential reactions between ubrogepant and BNT162B2, if it was safe to take ubrogepant in patients who have received BNT162B2, and if rebound headache was a reported side effect of ubrogepant. The outcome of migraines was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills and felt feverish; chills and felt feverish; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264) via an unspecified route of administration in left arm on 28Jan2021 at 08:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and diabetes. Patient has no allergies to medications, food, or other products. Concomitant medications included amlodipine besilate, atorvastatin calcium (CADUET) and escitalopram oxalate (LEXAPRO), both received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 29Jan2021 at 14:00, the day after the shot, which was the 1st shot, reporter's husband had chills and felt feverish. He took 2 ADVIL then he felt fine. No treatment and no seriousness criteria was reported. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on 29Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: unusual and extreme tiredness; rash on the face; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number was not reported), via an unspecified route of administration on 28Jan2021 (dose number=2) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. On 28Jan2021, the patient experienced unusual and extreme tiredness and rash on the face. The seriousness considered as non-serious. It was unknown if patient received any treatment for the adverse events. Since the vaccination, it has been unknown if the patient been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: Diarrhea; body aches; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination Yes). The patient's concomitant medications were not reported. The patient experienced diarrhea, body aches and chills on 29Jan2021. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.  No follow-up attempts needed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red rash appeared on chest. Within another 24 hours it moved over entire body...very red; red rash appeared on chest/ very red and extremely itchy; This is a spontaneous report from contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration on left arm on 23Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing non- hodgkin lymphoma. Concomitant medication included ursodiol, furosemide, spironolacton, propranolol hydrochloride (PROPRANOL). Approximately 24hours after vaccination a slight fine, red rash appeared on chest. Within another 24 hours it moved over entire body. very red and extremely itchy on 24Jan2021. visited myoncologist and was prescribed Benadryl and cortisone cream for itch. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: Made them feel weird or hurt; Made them feel weird or hurt; This is a spontaneous report received from a contactable consumer (patient) communicated to a Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown)  via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was not known if the patient was pregnant at time of vaccination. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced feel weird or hurt on an unspecified date. It was unknown if the patient received treatment in response to the event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (patient) reported that a 50-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on left arm on 22Jan2021 17:00 at single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included eletriptan hydrobromide (RELPAX), atorvastatin (LIPITOR). The patient previously took first dose of BNT162B2 on 31Dec2020 at 05:00 PM for COVID-19 immunization. On 23Jan2021, patient had fever, body aches, headache and chills. The patient received treatment with TYLENOL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Jan2021 16:15 (lot number: el3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient's concomitant medication included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC). The patient did not receive other vaccines within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm x2 days on 21Jan2021 at 07:00 AM. The patient did not received treatment. The consumer assessed the event as non-serious. The outcome of the event was recovered in 23Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product use issue
Clinical narrative: sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 01Feb2021 15:15 (lot number: EL3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history includes ulcerative colitis, shellfish allergy, sulfa allergies unknown if ongoing from an unknown date. The patients historical drug included benzthiazide (REGULON) which caused allergies. Patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 14:15 in the left arm for COVID-19 immunization. Concomitant medications included tofacitinib citrate (XELJANZ) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D). The patient was administered with other vaccine on same day i.e. 01Feb2021. However, it was also reported that the patient did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm on 02Feb2021 05:00 AM. The patient did not received treatment. The consumer assessed the events as non-serious. The outcome of the sore arm was recovered in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea
Clinical narrative: the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Hot flush, Malaise
Clinical narrative: the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pharyngeal swelling, Presyncope, Swelling face
Clinical narrative: the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: The nurse hit a vein and so the injection site started bleeding; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (mother).  A female patient (daughter) of an unspecified age (Age:24, Unit: Unknown) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse hit a vein and so the injection site started bleeding. The pharmacist on-site explained to them that the bleeding was caused by the vein and that the vaccine has been given intramuscularly so she must have received the dose. The event outcome was unknown.  Information on the Lot/Batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: right hip was very painful, it killed him/ right hip started to kill him/ couldn't walk without his hip giving way from the pain; hardly could walk on it/ couldn't walk without his hip giving way from the pain/didn't have any problem with walking around until he took the vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration (left arm), on 02Feb2021 09:00, at single dose, for covid-19 immunization. Ongoing medical history included cholesterol, GERD, heart, and prostate. Concomitant medication included carvedilol (COREG) from 2011 and ongoing for heart; lovastatin (MEVACOR) from 2011 and ongoing for cholesterol; alfuzosin hydrochloride (UROXATRAL) from 2011 and ongoing for prostate; omeprazole (OMEPRAZOL) from 2016 and ongoing for GERD; torsemide from 2001 and ongoing for water pill for his heart; and sacubitril valsartan sodium hydrate (ENTRESTO) from 2011 and ongoing for heart. The patient took the first dose of the Pfizer vaccine yesterday, 02Feb2021, at 9:00 and at 15:00 his right hip was very painful, it killed him; hardly could walk on it. His right hip started to kill him. He couldn't walk without his hip giving way from the pain. He didn't have any problem with walking around until he took the vaccine. He wanted to know if it was going to go away. The patient had not recovered from the adverse events at the time of the report. The adverse events did not require a visit to a physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was planning to receive the second dose on 23Feb2021 and mentioned that he was having a heart test later this week.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 1st of 4 reports.   A elderly patient of an unspecified gender received 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 was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021113120 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021113121 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021113122 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pruritus, Vaccination site rash
Clinical narrative: Mild vasovagal reaction; Itching; Rash at injection site; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had a mild vasovagal reaction and rash at injection site. She stayed an hour for observation and said she felt fine but by the time she left, had complained of itching all over. The outcome of the event itching all over was unknown while recovered on unspecified dates for the other events.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Cough, Eyelid pain, Headache
Clinical narrative: my results came back stating I was positive; feel ill with a severe back pain on my left side. The same side where I was given the shot; cough; runny nose; headaches; a lot of pain in my bones; a lot of pain in my bones, and eye lids; Feel ill; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 11:00 at the age of 65 years old at a single dose for COVID-19 immunisation at the school/student Health Clinic. Medical history was none. The patient has no allergies to medications, food and other products. The patient is not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 07:00, patient began to feel ill with a severe back pain on her left side. The same side where she was given the shot. In addition, patient also experienced a cough, runny nose, headaches, a lot of pain in my bones, and eye lids. At first, she believed it was due to the vaccine but as she got worse, she decided to take a COVID test (nasal swab) on 31Jan2021 and the results came back stating she was positive. Since then the patient has been in quarantine. No treatment was received in response to the events. The patient was recovering from the events. The patient has a second vaccination appointment scheduled on 13Feb2021 and would like to know if she will still go as scheduled or will she need to go in a later date.    Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: my results came back stating I was positive; feel ill with a severe back pain on my left side. The same side where I was given the shot; cough; runny nose; headaches; a lot of pain in my bones; a lot of pain in my bones, and eye lids; Feel ill; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 11:00 at the age of 65 years old at a single dose for COVID-19 immunisation at the school/student Health Clinic. Medical history was none. The patient has no allergies to medications, food and other products. The patient is not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 07:00, patient began to feel ill with a severe back pain on her left side. The same side where she was given the shot. In addition, patient also experienced a cough, runny nose, headaches, a lot of pain in my bones, and eye lids. At first, she believed it was due to the vaccine but as she got worse, she decided to take a COVID test (nasal swab) on 31Jan2021 and the results came back stating she was positive. Since then the patient has been in quarantine. No treatment was received in response to the events. The patient was recovering from the events. The patient has a second vaccination appointment scheduled on 13Feb2021 and would like to know if she will still go as scheduled or will she need to go in a later date.    Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a sngle dose for covid-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. She mentioned that she received the vaccine on Sunday (unknown date) and reported that for the last 4 days she had been pretty sick with fever, chills, headache and body aches. She had been alternating acetaminophen (TYLENOL) and ibuprofen (ADVIL). She did have COVID in Nov2020. The patient inquired if the symptoms after dose 2 would be worse if she's had COVID in the past. She also inquired if she will have the same symptoms for the second dose and if how long side effects will last. She add that she did have some vomiting on Sunday later after she got the vaccine. She was wondering because she is to get the second dose on the 21st, the pharmacist did say that sometimes people who have had the Covid virus already can sometimes experience strong side effects from the vaccine. She does not want to feel or get sick. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm/arm pain; "felt the fire"/felt the burning of it going in; chills and heat/little chills; chills and heat/little heat; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as 85, unit not provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date unknown), 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. Historical vaccine included flu vaccine received on an unspecified date and the patient got really sick, got really sick with the flu, was like got the flu but in 2 hours. The patient received BNT162B2 vaccine and experienced sore arm on an unspecified date. He "felt the fire", experienced chills and heat on an unspecified date and then the next day he was fine. He stated that after the first shot, he had arm pain for a couple of days, felt the burning of it going in and a little heat and little chills but the next day he was on the way to being good. The patient recovered from the event sore arm/arm pain and was recovering from the events "felt the fire"/felt the burning of it going in, chills and heat/little chills and chills and heat/little heat. The reporter assessed the events as non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Myalgia
Clinical narrative: First Covid-19 Vaccine: flu-like symptoms; First Covid-19 Vaccine: whole left arm muscle was sore; First Covid-19 Vaccine: joint in his elbow was like somebody had a knife sticking in it; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EH9899, first dose) solution for injection intramuscular in the left arm on 28Dec2020 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing severe COPD (chronic obstructive pulmonary disease) from 2014 and ongoing idiopathic pulmonary fibrosis from 2020. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, after the first Covid-19 vaccine, the patient experienced flu-like symptoms, whole left arm muscle was sore and joint in his elbow was like somebody had a knife sticking in it. There was no emergency room or physician office for the events flu-like symptoms, muscle soreness and joint pain. Treatment for the events muscle soreness and joint pain included acetaminophen (TYLENOL). The outcome of the event flu-like symptoms was recovered in Jan2021, after about 3 days. The outcome of the events muscle soreness and joint pain was recovered in Dec2020, after about 24 hours.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 2nd of 4 reports.   A elderly patient of an unspecified gender received 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 was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 3rd of 4 reports.   A elderly patient of an unspecified gender received 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 was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 4th of 4 reports.   A elderly patient of an unspecified gender received 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 was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Illness, Loss of personal independence in daily activities
Clinical narrative: chest is hurting; ill/sick; trouble breathing; wasn't able to function; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 30Jan2021 (Saturday morning), the patient woke up and was ill, she had trouble breathing, wasn't able to function and has been sick since. As of 03Feb2021, the patient's chest was hurting a bit less (onset date unspecified) and it was reported that the patient needed to go to the emergency room to know what was going on. The reporter told the patient she should be tested for the virus. The outcome of the events ill/sick, trouble breathing and wasn't able to function was not recovered; and the outcome of chest is hurting was recovering.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gingivitis
Clinical narrative: infection in the gum of a tooth that she had pulled; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had an infection in the gum of a tooth that she had pulled. She was placed on Clindamycin which she has not taken yet. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: extreme pain at the injection site; extreme pain at the injection site/could barely lift her arm without having a sharp pain/could barely move it, it felt very heavy; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included asthma and anaemia. The patient previously took amoxicillin, advil [ibuprofen], ibuprofen and experienced Allergies to medications. Patient received the vaccine on Thursday, 28Jan2021. That night she had extreme pain at the injection site. She could barely lift her arm without having a sharp pain. It felt like she could barely move it, it felt very heavy. Even when not moving my arm, there was a dull burning pain that was present. This pain continued into the next day, Friday, 29Jan2021. On Friday night, the pain was slowly subsiding. On Saturday, 30Jan2021, there was still a dull pain but she was able to move her arm and do daily activities again and she felt a lot better. On Sunday, 31Jan2021 her arm was completely normal again and there was no more pain. The patient received no treatment.  Outcome of the events was recovered on 31Jan2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and sore arm on 27Jan2021. The outcome of the events was reported as unknown.   Information about Lot/ Batch has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) intramuscularly in the left upper arm on 13Jan2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 13Jan2021, the patient was dizzy to the point of needing to lay down. The patient queried whether she should take the second dose. The patient did not receive treatment for this event, nor did the event require a visit to the emergency room or doctor's office. The clinical outcome of "dizzy" was resolved on 24Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID virus; tested positive for COVID virus; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer Sponsored Program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 25Jan2021 at a single dose for COVID immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of COVID vaccine on 25Jan2021, just after that, the patient tested positive for COVID virus on unspecified date in 2021. The patient's caregiver also tested positive, the caregiver has been quarantined and has been symptom free. The patient was in hospital for observation while having COVID. The reporter is wondering if the patient or caregiver (not sure if the caregiver received the first dose of COVID vaccine; pending clarification) is able to get the second dose of vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: I started having intense chills; developed a fever of 102.5; I had a big headache as well; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3248), via an unspecified route of administration right arm on 04Feb2021 06:45 at single dose for covid-19 immunization. Age at vaccination was 25 Years. Patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products included Penicillin allergy. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included Ovasitol. Historical vaccine included first dose of bnt162b2(COVID19, Pfizer, Lot number: EL3248) via an unspecified route of administration on right arm on 13Jan2021 06:45 at single dose for covid-19 immunization. On 04Feb2021 at 18:00, the night after she received the vaccine (12 hours afterward) she started having intense chills and developed a fever of 102.5. She had a big headache as well. Tylenol was received as treatment for the events. Outcome was recovering.  No follow-up attempts are possible. No further information is expected.