chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Paraesthesia, Vision blurred
Clinical narrative: Bad headache; Blurred vision; Tingling in the arm where the vaccine was administered (not at injection site but down the arm).; felt dizzy; This is a spontaneous report from a contactable pharmacist. An adult male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 19Jan2021, within 15 minutes of vaccination, the patient experienced a bad headache, blurred vision, and tingling in the arm where the vaccine was administered (not at injection site but down the arm). The patient was asked to sit and rest for continued monitoring. After 20-30 minutes, the patient attempted to stand but felt dizzy. The events resulted in emergency room/department or urgent care for further evaluation. The clinical outcome of the events bad headache, blurred vision, tingling in the arm where the vaccine was administered (not at injection site but down the arm) and felt dizzy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Dizziness; nausea; low grade fever; low grade feverlow grade fever; achy muscles; This is a spontaneous report from a contactable consumer or other non hcp.   A 27-years-old female Non Pregnant  patient received bnt162b2 (BNT162B2(Batch/Lot Number: EM9810), dose 2 intramuscularly, administered in Arm Left on 16Feb2021 08:30 as single dose for covid-19 immunisation. Medical history included hormone level abnormal from 2011 and ongoing, anxiety from 2010 and ongoing, depression, blood iron decreased from 2020 and ongoing, diabetes mellitus, cataract, blood cholesterol increased, iron deficiency. Concomitant medication(s) included metformin (METFORMIN) taken for polycystic ovaries from 2011 and ongoing; bupropion hydrochloride (WELLBUTRIN XL) taken for anxiety from 2019 and ongoing; duloxetine hydrochloride (CYMBALTA) taken for anxiety from Sep2020 to Mar2021; ferrous sulphate (FERROUS SULFATE) taken for iron deficiency from Oct2020 and ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced dizziness, myalgia on 16Feb2021 13:00 with outcome of recovered, nausea, low grade fever, headache on 16Feb2021 13:00 with outcome of recovered with sequelae. No treatment was received.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Fatigue; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm  on 26Feb2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD) and postural orthostatic tachycardia syndrome (POTS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexlansoprazole (DEXILANT), budesonide; formoterol fumarate (SYMBICORT) and salbutamol (ALBUTEROL); all for unknown indications from an unknown date and unknown if ongoing. The patient previously took sulfamethoxazole; trimethoprim (SEPTRA) for an unspecified indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 at 15:00, the patient experienced fatigue, chills and headache. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills and headache was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Frequent bowel movements, Headache, Hypoaesthesia, Pain
Clinical narrative: Tingling sensation across my back and down arms. But then became much more intense like pin pricks.; Numb hands. The sensation became really intense and spread into hips and thighs.; Felt similar to restless leg syndrome but then became much more intense like pin pricks; Upset stomach (frequent BMs all morning); Upset stomach (frequent BMs all morning); Headache in the afternoon; Very uncomfortable feeling of restlessness; Somewhat achy as well; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 25Feb2021 at 18:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included a similar reaction to whooping cough vaccine as the COVID-19 vaccine. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) and experienced tingling, numbness, restless leg syndrome, upset stomach (frequent Bowel Movements (BMs)), restlessness, headache and ache (also reported in medical history). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 05Feb2021 at 18:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation.  On 26Feb2021 at 04:00, the patient experienced a tingling sensation across her back and down her arms and numb hands. The sensation became really intense and spread into her hips and thighs. It felt similar to restless leg syndrome but then it became much more intense like pin pricks and upset stomach (frequent Bowel Movements (BMs) all morning); then a headache in the afternoon. The tingling sensation had been persistent all day. The patient had a very uncomfortable feeling of restlessness and felt somewhat achy as well. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling, numbness, restless leg syndrome, upset stomach (frequent BMs), headache, restlessness and achy were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Restless legs syndrome, Restlessness
Clinical narrative: Tingling sensation across my back and down arms. But then became much more intense like pin pricks.; Numb hands. The sensation became really intense and spread into hips and thighs.; Felt similar to restless leg syndrome but then became much more intense like pin pricks; Upset stomach (frequent BMs all morning); Upset stomach (frequent BMs all morning); Headache in the afternoon; Very uncomfortable feeling of restlessness; Somewhat achy as well; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 25Feb2021 at 18:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included a similar reaction to whooping cough vaccine as the COVID-19 vaccine. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) and experienced tingling, numbness, restless leg syndrome, upset stomach (frequent Bowel Movements (BMs)), restlessness, headache and ache (also reported in medical history). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 05Feb2021 at 18:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation.  On 26Feb2021 at 04:00, the patient experienced a tingling sensation across her back and down her arms and numb hands. The sensation became really intense and spread into her hips and thighs. It felt similar to restless leg syndrome but then it became much more intense like pin pricks and upset stomach (frequent Bowel Movements (BMs) all morning); then a headache in the afternoon. The tingling sensation had been persistent all day. The patient had a very uncomfortable feeling of restlessness and felt somewhat achy as well. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling, numbness, restless leg syndrome, upset stomach (frequent BMs), headache, restlessness and achy were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Terrible taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 26Feb2021 at 16:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic sleep disorder (Trazadone) and known allergy to aspartame. 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. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) taken for chronic sleep disorder from an unknown date and unknown if ongoing, colecalciferol (VITAMIN D3), fish oil (OMEGA 3), magnesium (MANUFACTURER UNKNOWN) and naproxen sodium (NAPROSYN); all from unknown dates for unknown indications and unknown if ongoing. On 26Feb2021 at 17:15, the patient experienced terrible taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event terrible taste in mouth was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 22Feb2021 at 21:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as none. 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. The concomitant medications included daily vitamins (unspecified) and red yeast rice (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the arm left on 29Jan2021 at 16:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 22Feb2021 at 17:00, the patient experienced fatigue. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue was resolved on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Injection site pain; Muscle pain; Nausea; Vomiting; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 26Feb2021 at 10:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medications for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Feb2021, the patient experienced injection site pain, muscle pain, nausea, vomiting and headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, muscle pain. nausea, vomiting and headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Lower back and neck pain; Lower back and neck pain; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient had unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Feb2021, the patient experienced lower back and neck pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events lower back and neck pain was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Fatigue
Clinical narrative: 24 hours later very fatigued and weak; 24 hours later very fatigued and weak; 10 minutes after being vaccinated got a bad taste in mouth.; This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 26Feb2021 at 16:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, anxiety, Meniere's disease, asthma, migraine and allergies to sulpha and opiates. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included estradiol (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), celecoxib (CELEBREX), losartan (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing.  The patient previously received povidone-iodine (BETADINE) on unknown date for unknown indication and experienced drug allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 16:40, 10 minutes after vaccination, the patient experienced a bad taste in her mouth. On 27Feb2021, 24 hours later, the patient experienced very fatigued and weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bad taste in mouth, very fatigued and weak was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Screaming
Clinical narrative: Severe pain and leg cramping in both legs from foot to upper thigh; Severe pain and leg cramping in both legs from foot to upper thigh; I was screaming in pain; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, depression, attention deficit hyperactivity disorder (ADD), hernia, low thyroid and high cholesterol. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 at 02:00, in the early morning, the patient experienced severe pain and leg cramping in both legs from foot to upper thigh. The patient had not experienced anything like this and the pain lasted over an hour. The patient was screaming in pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain (in both legs from foot to upper thigh) and screaming in pain was recovered on 26Feb2021 whereas the event leg cramping in both legs from foot to upper thigh was recovered an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Restless legs syndrome
Clinical narrative: 10 days after second vaccine began to experience right sided, below the knee a pins and needles feeling on the inside of the leg to the top of the big toe.; Both legs felt tired as well.; Four days after second vaccine began to experience restless legs.; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 28Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was 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. Concomitant medications included salbutamol (ALBUTEROL), testosterone (MANUFACTURER UNKNOWN), anastrozole (ARIMIDEX) and chorionic gonadotrophin (HCG) ); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9231) via an unspecified route of administration in the left arm on 07Jan2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 01Feb2021, 4 days after the second vaccine, the patient began to experience restless legs and both legs felt tired as well. On 07Feb2021,10 days after the second vaccine, the patient began to experience right sided, below the knee a pins and needles feeling on the inside of the leg to the top of the big toe. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event restless legs, both legs felt tired as well and right sided, below the knee a pins and needles feeling on the inside of the leg to the top of the big toe was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Pain
Clinical narrative: she wasn't feeling well/it is like getting worse/She is feeling not great; Headache; Her lymph nodes are really swollen and there is pain everywhere; Her lymph nodes are really swollen and there is pain everywhere; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/lot number: EL3302), dose 2 via an unspecified route of administration on 18Feb2021 as dose 2, single for covid-19 immunization. Medical history included Hashimoto's disease (she got immuno Hashimoto's but nothing that she was suffering from). Concomitant medication included levothyroxine sodium (SYNTHROID). Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/lot number: not reported) via an unspecified route of administration, on an unknown date as dose 1, single for covid-19 immunization. Reporter stated that his wife and he got the second dose of Pfizer Vaccine. He was fine but her wife was going through long reaction. So, she got it on Thursday morning on 18Feb2021 and that night she started just like a slight headache and the Friday 19Feb2021 she wasn't feeling well. Saturday on 20Feb2021, started to feel little better, but still didn't feel well and then on 21Feb2021 it was like getting worse. Patient lymph nodes are really swollen and there was pain everywhere, on an unknown date in Feb2021. She was feeling not great. Therapeutic measures were taken as a result of headache and pain included treatment with Tylenol. Outcome of the events was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the left arm; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EN9581), via an unspecified route of administration, administered in left arm on 30Jan2021 at 15:00 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications not reported. No other vaccine in four weeks and no other medication in two weeks of vaccination. The patient did not have covid prior vaccination. The patient not tested for covid post vaccination. On an unspecified date in 2021, after first vaccination, the patient experienced soreness in the left arm. The patient not received treatment for event. The outcome of events recovering at the time of report.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via a Pfizer sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced headache on an unspecified date. Patient is asking if she can take pain reliever. The outcome of event was unknown.  Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Somnolence
Clinical narrative: Sleepy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 74-years-old male patient received BNT162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL9262; Expiration Date: May2021 and NDC number was unknown) via an unspecified route of administration, administered in left arm on 26Jan2021 as dose 1, single (at the age of 74-years-old) for COVID-19 immunization. Medical history included lung transplant on an unspecified date (both lungs, exactly 11 months ago, patient was in that medical fragile category) and slightly anaemic from an unknown date and unknown if ongoing. Concomitant medication included iron taken for slightly anemic, start and stop date were not reported. Patient had no other vaccines on the same days as COVID-19 shot. On 27Jan2021, the next day after the first dose, patient had no problem, but he was just sleepy, he got up for coffee and then went to bed for 5 hours. Patient asked if this was common side effects and for how long will they usually last. Patient had blood work done this week, within the last week, as he gets it done twice, once for his annual physical and the other was because he gets blood tested every three weeks for his transplant team. Patient had not received the results from his bloodwork from this past week yet. On the whole, patient stated that most of his tests, there were 52 tests he had done regularly, he was in the green on 48 of those tests, but he was just slightly anemic, but he was taking iron to bring that up. Patient stated that there was nothing else remarkable on his usually blood work. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient (husband). A 92-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Feb2021 the patient experienced diarrhea. The reporter reported that they got the first dose yesterday together with elderly couple. She helped them to get the vaccine since they were of old age (both 92 years old). The elderly couple, the husband got diarrhea after the same dose. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 COVID vaccine. The patient received unspecified medications within two weeks prior to the vaccination.  On 24Feb2021 at 22:00, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was recovered on an unknown date in Feb2021.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Overwhelming nausea; Pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 19:15 (at the age of 26-years old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension and generalized anxiety disorder. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 at 19:45, the patient experienced overwhelming nausea about 45 minutes after injection, which continued in the night and dissipated by morning and pain at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event overwhelming nausea which continued in the night and dissipated by morning was recovered on an unknown date in Feb2021 and the event pain at the injection site was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Odynophagia
Clinical narrative: Pain swallowing fells like something is obstructing the windpipe; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm on 26Feb2021 at 14:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. 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 COVID vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), potassium chloride (KLOR-CON), quinapril (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and ezetimibe (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. On 27Feb2021 at 21:00, within 36 hours of vaccination, the patient experienced pain swallowing felt like something was obstructing the windpipe. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain swallowing was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Nausea; Muscle pain; Feeling unwell the evening of the injection which was February 25, 2021; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: Jun2021) via an unspecified route of administration in the left arm on 25Feb2021 at 11:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and COVID-19. The patient had confirmed case on 03Jan2021. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had unknown allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021 at 21:00, the patient experienced injection site pain, tiredness, headache, chills, nausea, muscle pain and feeling unwell the evening of the injection. The same symptoms persisted the next day, then again alleviated on 27Feb2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, chills, nausea, muscle pain, feeling unwell was recovered on an unknown date in Feb2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Nausea; Muscle pain; Feeling unwell the evening of the injection which was February 25, 2021; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: Jun2021) via an unspecified route of administration in the left arm on 25Feb2021 at 11:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and COVID-19. The patient had confirmed case on 03Jan2021. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had unknown allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021 at 21:00, the patient experienced injection site pain, tiredness, headache, chills, nausea, muscle pain and feeling unwell the evening of the injection. The same symptoms persisted the next day, then again alleviated on 27Feb2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, chills, nausea, muscle pain, feeling unwell was recovered on an unknown date in Feb2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program Support.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: Unknown) via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included cancer. The patient concomitant medication was PEMBROLIZUMAB for cancer and last dose was on 09Feb2021. On an unspecified date in Feb2021, the patient experienced arm pain and not feeling well after the administration of first dose. It was reported that the patient received first dose on 04Feb2021 and was scheduled for second 18Feb2021. She missed the second dose due to weather and not feeling well. Potentially scheduled for this Thursday. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state
Clinical narrative: Momentary confusion; Memory loss; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Feb2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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. Concomitant medications were not reported. On 23Feb2021 at 12:15, next day of vaccination, the patient experienced momentary confusion and memory loss. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events momentary confusion and memory loss was resolved on an unknown date in Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, SARS-CoV-2 test
Clinical narrative: wet cough; This is a spontaneous report from contactable consumer Pfizer-sponsored program. A contactable consumer reported for an 88-year-old male patient (her father).  An 88-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 20Feb2021 (at the age 88-years-old) as dose 1, single for covid-19 immunisation. Medical history included cough from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Before the first dose patient already had a cough but for reporter it appeared that after the first dose the cough seems more like wet cough. Reporter was asking if that was something they need to be concerned about or does her father need to consult the HCP. Patient tested negative for the COVID-19 test. The patient underwent lab tests and procedures which included sars-cov-2 test negative. The outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Extreme stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 02Feb2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccine. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) and experienced drug allergy. On 27Feb2021 at 10:00, the patient experienced extreme stomach pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme stomach pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: A lot of pain; bad headache; tiredness; Arm soreness; achy; This is a spontaneous report from a Pfizer-sponsored program. A female contactable consumer reported for herself.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number: Not reported Expiration Date: Unknown) via an unspecified route of administration on 21Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number: Not reported Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On 21Feb2021 after the second dose of vaccination, the patient experienced a lot of pain, bad headache, tiredness, arm soreness, achy.  Patient took Excedrin Migraine and Tramadol after she went home. The outcome of events was unknown.  Follow-up attempts have been completed and no further information is expected. information about batch/lot number is not available despite the follow-up attempts made.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Intermittent chills; Sweating; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. 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 COVID-19 vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); both for an unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jan2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 05:00, the patient experienced intermittent chills, sweating and fatigue. The effect lasted from 18 hours after vaccine to approximately 66 hours after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events intermittent chills, sweating and fatigue were recovered on an unknown date in Feb2021.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat; Fatigue; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history included fibrosis pulmonary. 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. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore throat and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat and fatigue was resolved on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees F for ~ 24 hours prior to receiving it.; Temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees F for ~ 24 hours prior to receiving it.; This is a spontaneous report from a contactable healthcare professional. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9810) via intramuscular route of administration in the left arm on 24Feb2021 at 07:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 07:45, the patient experienced Temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees Fahrenheit for approximately 24 hours prior to receiving it and it was unsure for how long refrigerator temperature was out of range but it appeared it was approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees Fahrenheit for approximately 24 hours prior to receiving it, was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.