chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Headache, Malaise, Ocular hyperaemia
Clinical narrative: redness of the eyes; blurred vision; headache; muscle pain; body chills; blueish discoloration in hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, the patient experienced redness of the eyes with blurred vision, headache, muscle pain, body chills & blueish discoloration in hands. Caller asked if she should receive the second Pfizer Covid vaccine The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Vision blurred
Clinical narrative: redness of the eyes; blurred vision; headache; muscle pain; body chills; blueish discoloration in hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, the patient experienced redness of the eyes with blurred vision, headache, muscle pain, body chills & blueish discoloration in hands. Caller asked if she should receive the second Pfizer Covid vaccine The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Malaise, Myalgia
Clinical narrative: headache; diarrhea; joint hurting; not feel good; sore muscles; ears ringing; This is a spontaneous report from a contactable consumer (Patient).   An unspecified age male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 08Mar2021 as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced headache, diarrhea, joint hurting, not feel good, sore muscles, ears ringing. It was reported that the patient did not take Tylenol or Aspirin to mess up the shot.  The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: headache; diarrhea; joint hurting; not feel good; sore muscles; ears ringing; This is a spontaneous report from a contactable consumer (Patient).   An unspecified age male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 08Mar2021 as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced headache, diarrhea, joint hurting, not feel good, sore muscles, ears ringing. It was reported that the patient did not take Tylenol or Aspirin to mess up the shot.  The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Thirst, Vaccination site pain
Clinical narrative: feel very tired; pain at the injection site; feel very thirsty; This is a spontaneous report from a contactable consumer (patient herself). This 27-Year-old female consumer reported for herself that received BNT162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and expiry date Unknown) via an unspecified route of administration in left arm on 08Mar2021 16:30(at the age of 27-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included depression and anxiety. Patient was allergic to zyrtec, adhesives. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol, norgestimate (ESTARYLLA), doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]), Ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines in 4 weeks. On 09Mar2021 08:15 (Timeframe between vaccine start and event onset date was 15 hrs 45 min) patient experienced feel very tired, some pain at the injection site, and feel very thirsty. Therapeutic measures were not received as a result of adverse events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia oral, Tongue disorder, Vaccination site pain
Clinical narrative: Pain in injection sight; Tingling and bumps on tongue; Tingling and bumps on tongue; Tiredness/Fatigue; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 at 11:00 (39-years age at the time of vaccination) as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive other vaccine in four weeks. No other medications was received in two weeks. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that, patient has experienced pain in injection sight, tiredness/fatigue, tingling and bumps on tongue. Patient was not received any treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible, No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever over 101 for 5 consecutive days; This is a spontaneous report from a contactable Other Health Care Professional (Patient). An adult male patient (Age: 50, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: el9263), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number=ek9231), dose 1 via intramuscular administration in Left arm on 09Jan2021 at 08:00 AM for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever over 101 for 5 consecutive days on 01Mar2021 at 09:00. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on post vaccination which included body temperature: over 101 on 01Mar2021, sars-cov-2 test: negative on 02Mar2021, sars-cov-2 test: negative on 04Mar2021. Therapeutic measures were taken as a result of the event included fever reducer. The outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Headache, Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold; hoarse voice; running nose; cough; bad headache; This is a spontaneous report from a contactable consumer (patient). A 72 (Unit: Unknown) female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via an unspecified route of administration on 06Mar2021 as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of vaccine. On an unknown date, patient experienced cold, hoarse voice, running nose ("like crazy"), cough, she also had a bad headache but it went away. The outcome of the headache was resolved and for other events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age (reported as Age: 69; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had received first dose on 08Mar2021 and he was scheduled for second dose on 31Mar2021. Caller wanted to know what to expect for his second dose of the vaccine, regarding the chills and nausea that he had experienced from the first dose injection of Pfizer-BioNTech COVID-19 Vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information on lot/batch number cannot been obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting; diarrhea; fever; chills; extreme stomach cramps; This is a spontaneous report from a non-contactable consumer or other non-hcp (Patient).   A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: En6202) via an unspecified route of administration (Age at vaccination 36-year) in Left Arm on 05Mar2021 14:15 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not received any other vaccine in four weeks. Patient does not have covid prior vaccination. On 07Mar2021 06:00 the patient experienced vomiting, diarrhea, fever, chills and extreme stomach cramps. The seriousness of all the event was reported as non-serious. Patient not covid tested post vaccination. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: feeling a bit woozy; weak; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 at 10:45 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included asthma and arthritis. The patient had known allergies to sulpha drugs, keflex, levoquin, and codeine. Concomitant medications included desloratadine (CLARINEX [DESLORATADINE]), montelukast sodium (SINGULAIR), lansoprazole (LANSOPRAZOLE), diltiazem (DILTIAZEM), and estradiol (ESTROGEN). The patient received no other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021 at 11:00 reportedly, the patient started feeling a bit woozy and weak about 5 min after the shot and that feeling continued 2 hours later. No treatment was given for the events. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye pruritus, Headache, Lymphadenopathy, Pain
Clinical narrative: fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 16:00 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other vaccines in 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 07:00, the patient experienced pain at injection site, headache, runny nose and itchy eyes, body aches, swollen glands. On 07Mar2021 at 07:00, after day 6, the patient started running a 102 fever. Adverse events resulted in doctor or other healthcare professional office or clinic visit. Post vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Fever: 102 on 07Mar2021, Nasal swab test on 09Mar2021: Result pending. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 16:00 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other vaccines in 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 07:00, the patient experienced pain at injection site, headache, runny nose and itchy eyes, body aches, swollen glands. On 07Mar2021 at 07:00, after day 6, the patient started running a 102 fever. Adverse events resulted in doctor or other healthcare professional office or clinic visit. Post vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Fever: 102 on 07Mar2021, Nasal swab test on 09Mar2021: Result pending. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: Gallbladder attack; This is a spontaneous report from a contactable Other-HCP (patient).   A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 02Mar2021 at 08:30 (at the age of 30-year-old)  as single dose for COVID-19 immunisation. Patient had no known allergies or other medical history. Patient did not receive any other vaccine in four weeks of vaccination. Other medications (concomitant) administered within two weeks of vaccination included Spironolactone and desogestrel, ethinylestradiol [Azurette] both administered on unspecified dates for unspecified indication. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. On 03Mar2021, at 13:15, patient had a gallbladder attack. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient was treated in response to the event with pain medication: unspecified. Outcome of the event was recovering.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Skin tightness
Clinical narrative: a tightness on both ankles; legs swell up, both of her legs at the ankle level; legs swell up, both of her legs at the ankle level; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported, as she does not have vaccination card handy), via an unspecified route of administration, administered in arm left on 26Feb2021 as single dose for covid-19 immunization. The patient took COVID-19 Vaccine because her husband insisted. The patient medical history and concomitant medications were not reported. No other products and no investigation assessment done. The patient had no other vaccines on the same day as her COVID vaccine. The patient was calling regarding the COVID-19 Vaccine shot. The patient was trying to find out if something she was experiencing, was a side effect of the product. The patient stated that her legs swell up, both of her legs at the ankle level on an unspecified date in 2021 and that had never happened to her before. The patient received her vaccine on 26Feb2021, and she did not know the exact day the swelling started, but she noticed it shortly after getting the shot. The patient confirmed the swelling was ongoing, she was concerned because it had not gone away. When queried regarding outcome, the patient stated that it was still about the same, it was a tightness on both ankles (start date: unspecified) and they were swollen and she thought at first that maybe it was because she walked so far from the parking lot to the facility to get the shot, but it had not receded at this point, so she did not know what was going on, because she usually did not have swollen ankles. The patient had her first dose of the Pfizer vaccine and was asking if ankle or leg swelling as a side effect of the vaccine. The outcome for tightness on both ankles was unknown and for rest both events was not recovered.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: mild itching on the left side of the body 10 minutes after receiving the injection. The itching disappeared after about three hours.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 13:45 (at 42 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin 20 mg and fluoxetine 40mg, both daily for unspecified date for unspecified indication. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient experienced mild itching on the left side of the body 10 minutes after receiving the injection. The itching disappeared after about 3 hours. The event was non-serious on 06Mar2021 at 14:00. No treatment was given due to the event. Outcome of the event was recovered on 06Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN 6199) via an unspecified route of administration administered in right arm on 09Mar2021 09:45 (at 45 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included high blood pressure, acid reflux, fatty liver, and overweight; all from unspecified date and unknown if ongoing. Concomitant medications included unspecified blood pressure and acid reflux medicines. The patient did not have COVID prior vaccination and no COVID tests done post vaccination. The patient experienced sore arm 11 hours post-vaccine and more tired than normal that evening on 09Mar2021. The patient also experienced mild headache the next morning on 10Mar2021. All were non-serious. No treatment was given due to the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headaches; Fever; This is a spontaneous report from a contactable consumer reporting for self  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/Lot Number: 6202 dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation  .  Medical history included blood pressure abnormal.  There were no concomitant medications. The patient experienced headaches and fever on 03Mar2021 02:00 with outcome of not recovered. No No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: loss of taste; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number not reported dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loss of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Slightly elevated heart rate; This is a spontaneous report from a contactable consumer (patient herself). This 38-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on the left arm on 05Mar2021 at 05:00 PM (Batch/Lot number EN6203) (at the age of 38-year old) at single dose for Covid-19 immunization. Relevant medical history was not reported. Concomitant medications were unspecified. On 05Mar2021 at 05:15 PM the patient experienced slightly elevated heart rate for 2 days, almost like a drank too much caffeine. No treatment was given for the event. The outcome was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pain
Clinical narrative: I had some slight chills and achy all around; I had some slight chills and achy all around; I had no appetite; This is a spontaneous report from a contactable consumer.  A 71-years-old male consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6204), on 09Mar2021 at 12:30 AM Left arm (at the age of 71-years-old) at single dose for COVID-19 immunization. The patient had received first dose of vaccine on  16Feb2021 lot number: EN6201 at 02:45 AM in the Left arm. Medical history included Type 2 diabetes and high BP. On 09Mar2021 by 5 on that evening, the patient had no appetite. By 7, he had some slight chills and achy all around. No treatment was received. The outcome was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder
Clinical narrative: black marks from the shoulder to the elbow; This is a spontaneous report from a contactable consumer (patient).   A 78-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose of vaccine on 06Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. On Mar2021 (reported as "at the third day after the second dose"), patient experienced black marks from the shoulder to the elbow with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Hypertension
Clinical narrative: blood pressure high; headache; fatigue; This is a spontaneous report from a contactable nurse (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had never had problems with her pressure in the past. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headache, fatigue, blood pressure high, all on an unspecified date. The events outcome was unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 165/134.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The association between the event high blood pressure with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Memory impairment, Pain in extremity, Rhinorrhoea
Clinical narrative: Short term memory less; Very strong pain the arm (could not move it or pick up any weight); Continuous runny watery nose; Excesive sweating/I sweat a lot while sleeping but I did not have a fewer.; This is a spontaneous report from a contactable consumer (patient herself). A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6200) via an unspecified route of administration in left arm on 02Mar2021 04:30PM at single dose for COVID-19 immunization. Relevant medical history was not reported. The patient had no COVID prior vaccination. Concomitant medications included iron. The patient was not administered with any vaccine in four weeks. On 02Mar2021 04:30PM the patient had very strong pain in the arm (could not move it or pick up any weight), continuous runny watery nose, excessive sweating (during the next two nights after getting vaccine, so on 02Mar2021 and 03Mar2021, the patient sweat a lot while sleeping but with no fever). In addition, about 72 hours after getting vaccine, the patient had short term memory loss (she would read something immediately forgetting was she just read (lasting for about 30-45 minutes). The patient did not receive treatment and was not tested for COVID after vaccination. Events lasted about 72 hours after getting vaccine and resolved in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Pruritus
Clinical narrative: Fast heartbeat; dizziness; itching all over; This is a spontaneous report from a contactable consumer.  A 56-years-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included hypertension from an unknown date and unknown if ongoing, Sulfonamide allergy from an unknown date and unknown if ongoing.  Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient previously took Rocephin (ceftriaxone) and experienced drug hypersensitivity, doxycycline and experienced drug hypersensitivity, ciprofloxacin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity, Oyster experienced drug hypersensitivity.  The patient experienced fast heartbeat (heart rate increased) (non-serious) on 10Mar2021 02:00 with outcome of recovering , dizziness (dizziness) (non-serious) on 10Mar2021 02:00 with outcome of recovering , itching all over (pruritus) (non-serious) on 10Mar2021 02:00 with outcome of recovering.  The patient underwent lab tests and procedures which included heart rate: fast   on 10Mar2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report from a contactable consumer (patient herself).   This 92-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on unknown date at single dose for COVID-19 immunisation. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on unknown date (at the age of 92-year-old) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After receiving the second dose everything was fine. 5 days after the shot, the patient had sinus infection. She was prescribed penicillin amoxicillin. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is swollen and sore; arm is swollen and sore; This is a spontaneous report from a contactable consumer (patient) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) on an unspecified date at single dose  in arm for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included ibuprofen. The patient stated that on an unknown date following her vaccination, her arm was swollen and sore.The outcome of the events was unknown. Patient also asked for additional information about taking ibuprofen prior to getting the covid vaccine; she took ibuprofen before having the vaccine and now worried that she may have decreased the effectiveness. Asking how much it will be affected by taking ibuprofen. No follow-up attempts are possible; information about lot/batch number cannot be obtained.No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain under left breast; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En6198), administered in left arm, on 27Feb2021 at 09:15 AM (at the age of 80-years-old) at 2nd dose, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included known allergies at bee stings, high blood pressure and high cholesterol. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced pain under left breast on 06Mar2021 at 23:00. No treatment was received for the event. The patient had not recovered from the event.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: Dizziness; A fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:00 (Lot Number: EN6202) as single dose (at age of 71-year-old) for covid-19 immunisation. Medical history included diabetes type II, asthma. Concomitant medications were not reported. The patient previously took lisinopril and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 04:00 patient experienced dizziness and a fast heartbeat a couple hours duration. The patient underwent laboratory tests and procedures which included heart rate: fast on 09Mar2021. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient recovered on unknown date from the events.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: 101.5F fever; chills; headache day after injection; This is a spontaneous report from a contactable consumer (patient).    A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), at single dose in left arm on 08Mar2021 at 12:45 pm (at 33 years) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC) and amlodipine , all  taken for an unspecified indication, start and stop date were not reported. Previously on 15Feb2021 at 12:30 PM (at 33 years) patient took the first dose of the vaccine (lot EL9267) in left arm for COVID-19 immunization. On 09Mar2021 the patient experienced 101.5F fever, chills, headache. No treatment given. Patient recovered from the events in Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Urticaria
Clinical narrative: Congestion; fatigue; cough with mild wheezing; cough with mild wheezing; 2 times severe sharp quick headache; hives at my jawline; sore arm at injection site; This is a spontaneous report from a contactable other HCP (patient).  A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 11:30 (Batch/Lot number was not reported), age at vaccination of 54-years-old, as single dose,for covid-19 immunisation.  Medical history included lyme disease from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing , psoriatic arthropathy from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing, arthropod sting from an unknown date and unknown if ongoing, dust allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included apremilast (OTEZLA) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced congestion, fatigue, cough with mild wheezing, 2 times severe sharp quick headache, hives at jawline, sore arm at injection site on 05Mar2021. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine: Workplace clinic. The patient recovered from all events on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Wheezing
Clinical narrative: Congestion; fatigue; cough with mild wheezing; cough with mild wheezing; 2 times severe sharp quick headache; hives at my jawline; sore arm at injection site; This is a spontaneous report from a contactable other HCP (patient).  A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 11:30 (Batch/Lot number was not reported), age at vaccination of 54-years-old, as single dose,for covid-19 immunisation.  Medical history included lyme disease from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing , psoriatic arthropathy from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing, arthropod sting from an unknown date and unknown if ongoing, dust allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included apremilast (OTEZLA) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced congestion, fatigue, cough with mild wheezing, 2 times severe sharp quick headache, hives at jawline, sore arm at injection site on 05Mar2021. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine: Workplace clinic. The patient recovered from all events on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: very hard time breathing; pulse ox went down to 94%; This is follow-up spontaneous report from Pfizer-sponsored program. A contactable 66-year-old female consumer reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified routed of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history included ongoing seasonal allergy (in fall time). Concomitant medications were not reported. The patient had a reaction from her first dose. Five hours after she received her shot, she had a very hard time breathing and her pulse oxygen went down to 94%. Then, five days later it happened again. She had Benadryl, breathing treatment, and Albuterol because of her seasonal asthma. Her Family Doctor told her to call the Allergist, someone else told her to call the drug store. The events were not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Disturbance in attention, Dysuria, Fatigue
Clinical narrative: Balance issues; nauseau; alterations to sense of smell; inability to focus; constant feeling needing to urinate/ inability to feel when I need to urinate; headache; joint pain; exhaustion; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 13:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation.  Relevant medical history was not reported. Concomitant medications included probiotics and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]).  The patient previously took gluten and experienced drug hypersensitivity.  On 24Feb2021 the patient experienced balance issues  nausea, alterations to sense of smell, inability to focus, constant feeling needing to urinate/ inability to feel when I need to urinate, headache, joint pain, exhaustion, muscle aches, all with outcome of not recovered.  Therapeutic measures were taken as a result of events.   No follow-up attempts are possible; no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Parosmia
Clinical narrative: Balance issues; nauseau; alterations to sense of smell; inability to focus; constant feeling needing to urinate/ inability to feel when I need to urinate; headache; joint pain; exhaustion; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 13:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation.  Relevant medical history was not reported. Concomitant medications included probiotics and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]).  The patient previously took gluten and experienced drug hypersensitivity.  On 24Feb2021 the patient experienced balance issues  nausea, alterations to sense of smell, inability to focus, constant feeling needing to urinate/ inability to feel when I need to urinate, headache, joint pain, exhaustion, muscle aches, all with outcome of not recovered.  Therapeutic measures were taken as a result of events.   No follow-up attempts are possible; no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm is sore near the injection site; This is a spontaneous report from a contactable consumer (the patient herself). A 44-year-olf female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247) intramuscularly in right arm on 09Mar2021 14:30 (at the age of 44-year-old) at single dose for COVID-19 immunisation. Relevant medical history was none. The patient did not have vaccine in four weeks nor COVID prior vaccination. Concomitant medications included esomeprazole sodium (NEXIUM), fexofenadine hydrochloride (ALLEGRA), cyanocobalamin (B12), bifidobacterium lactis (PROBIOTIC) and glucosamine. On 10Mar2021 09:00 the patient had right arm sore near the injection site. No treatment was received. The patient was not tested for COVID post vaccination. The event was non-serious and resolving.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have pain in my left arm since 2nd shot.; This is a spontaneous report from a contactable consumer (patient).   A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Feb2021 10:45 (Batch/Lot Number: EL8982)  at the age of 76-year-old, as single dose for covid-19 immunisation.  Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number : EK9231) on 11Feb2021.  Medical history included   from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported.   The patient experienced pain in left arm since 2nd shot (pain in extremity) (non-serious) on 01Feb2021 11:00 with outcome of not recovered.  Therapeutic measures were taken as a result of the event pain in extremity.    No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured, Nausea
Clinical narrative: Nausea; loose stools different color than usual; loose stools different color than usual; This is a spontaneous report from a contactable consumer (patient herself).  This 69-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route in the right arm, on 03Mar2021 (at the age of 69-year-old) at single dose for COVID-19 immunisation, administered at hospital. No other vaccine was received in four weeks. Relevant medical history included allergy to sulfa, allergy to kiwi fruit and latex. Relevant concomitant medications included paracetamol (TYLENOL), levothyroxine, progesterone, and propranolol. On 04Mar2021 at 16:00, the patient developed nausea, loose stools different color than usual. The events were reported as non-serious. The patient was not treated for the events. Pre and Post-vaccination COVID tests were not done. The patient had not recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.