chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Swelling
Clinical narrative: Her neck on the left side is swollen; Her neck on the left side is swollen and she is having severe pain; whole body aches; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 24Feb2021), via an unspecified route of administration on 23Feb2021 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic for 5-6 years, a heart patient and has a pacemaker - all from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient reported that her neck on the left side was swollen and she was having severe pain. The patient was having severe pain on that side, the left side and it was swollen. The pain, the severe pain was ongoing and it was severe and has stayed about the same intensity the whole time. The patient was also having whole body aches on an unspecified date in Mar2021. All of this began around the same time, and the patient confirmed around the same time as the swelling. The patient's whole body aches are off and on but the one in her neck on the left side where the swelling was, it stayed there. The patient was asking if should she go to nearest clinic or go to the doctor, her primary care. The next dosage of the patient was reported to be on 16Mar2021. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Illness, Pain in extremity, Swelling
Clinical narrative: very sick; has a temperature; Swelling; throwing up; arm is real sore; This is a spontaneous report from a non-contactable consumer (daughter). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient goes to a couple different doctors and she was fine, healthy, everything until she got her second shot. The patient experienced very sick, has a temperature, was swelling, was throwing up, her arm was real sore and she can't get up on an unspecified date. The patient was still swelling and the reporter wanted to know what to do to counteract side effects. The outcome of the events was unknown. The reporter said that she needed to know what she needed to do to try to help the patient. The reporter said that she was going to take her mother into the hospital, she didn't like these shots in the first place, she was not for them at all, she doesn't trust them, they don't have enough information to be giving them to people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very sick; has a temperature; Swelling; throwing up; arm is real sore; This is a spontaneous report from a non-contactable consumer (daughter). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient goes to a couple different doctors and she was fine, healthy, everything until she got her second shot. The patient experienced very sick, has a temperature, was swelling, was throwing up, her arm was real sore and she can't get up on an unspecified date. The patient was still swelling and the reporter wanted to know what to do to counteract side effects. The outcome of the events was unknown. The reporter said that she needed to know what she needed to do to try to help the patient. The reporter said that she was going to take her mother into the hospital, she didn't like these shots in the first place, she was not for them at all, she doesn't trust them, they don't have enough information to be giving them to people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Erythema, Flushing, Gastrooesophageal reflux disease
Clinical narrative: face felt hot/burning/on fire; face was red/chest red; chest red/flushed; numbness and tingly on face- right side of face and neck/head/right side; numbness and tingly on face-right side of face and neck/head/right side/some tingling under neck; slightly itchy face; high blood pressure 153/93 - high bp for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; heart racing; have tingly hypersensitive feeling in face 2 weeks later; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that: A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EI.9266), via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 11:30 (at the age of 48-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hashimotos thyroid, GERD (Gastroesophageal reflux disease), ana positive -connective tissue disorder, raynauds, fibromyalgia and right eye proptosis from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); liothyronine (LIOTHYRONINE); omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took benadryl and experienced drug allergy (side effect can't go to the bathroom). Patient was not received any other vaccine four weeks prior vaccination. On 18Feb2021 at 11:45 the patient experienced face felt hot/burning/on fire, face was red, chest red/flushed, numbness and tingly on face-right side of face and neck/head/right side, slightly itchy face, some tingling under neck, high blood pressure 153/93 - high bp for 4 days, extreme GERD which resulted in not being able to sleep for 4 days would wake up to heart racing, still have tingly hypersensitive feeling in face 2 weeks later. Since vaccination patient not tested for covid-19. Event resulted to visit Doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events with Pepcid, Claritin and ice packs on face. The patient underwent lab tests and procedures which included blood pressure measurement: 153/93 on 18Feb2021 High. The outcome of the event still has tingly hypersensitive feeling in face 2 weeks later was not recovered and all other events were recovered with lasting effects.    No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Insomnia, Palpitations, Paraesthesia
Clinical narrative: face felt hot/burning/on fire; face was red/chest red; chest red/flushed; numbness and tingly on face- right side of face and neck/head/right side; numbness and tingly on face-right side of face and neck/head/right side/some tingling under neck; slightly itchy face; high blood pressure 153/93 - high bp for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; heart racing; have tingly hypersensitive feeling in face 2 weeks later; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that: A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EI.9266), via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 11:30 (at the age of 48-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hashimotos thyroid, GERD (Gastroesophageal reflux disease), ana positive -connective tissue disorder, raynauds, fibromyalgia and right eye proptosis from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); liothyronine (LIOTHYRONINE); omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took benadryl and experienced drug allergy (side effect can't go to the bathroom). Patient was not received any other vaccine four weeks prior vaccination. On 18Feb2021 at 11:45 the patient experienced face felt hot/burning/on fire, face was red, chest red/flushed, numbness and tingly on face-right side of face and neck/head/right side, slightly itchy face, some tingling under neck, high blood pressure 153/93 - high bp for 4 days, extreme GERD which resulted in not being able to sleep for 4 days would wake up to heart racing, still have tingly hypersensitive feeling in face 2 weeks later. Since vaccination patient not tested for covid-19. Event resulted to visit Doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events with Pepcid, Claritin and ice packs on face. The patient underwent lab tests and procedures which included blood pressure measurement: 153/93 on 18Feb2021 High. The outcome of the event still has tingly hypersensitive feeling in face 2 weeks later was not recovered and all other events were recovered with lasting effects.    No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensitive skin
Clinical narrative: face felt hot/burning/on fire; face was red/chest red; chest red/flushed; numbness and tingly on face- right side of face and neck/head/right side; numbness and tingly on face-right side of face and neck/head/right side/some tingling under neck; slightly itchy face; high blood pressure 153/93 - high bp for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; heart racing; have tingly hypersensitive feeling in face 2 weeks later; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that: A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EI.9266), via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 11:30 (at the age of 48-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hashimotos thyroid, GERD (Gastroesophageal reflux disease), ana positive -connective tissue disorder, raynauds, fibromyalgia and right eye proptosis from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); liothyronine (LIOTHYRONINE); omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took benadryl and experienced drug allergy (side effect can't go to the bathroom). Patient was not received any other vaccine four weeks prior vaccination. On 18Feb2021 at 11:45 the patient experienced face felt hot/burning/on fire, face was red, chest red/flushed, numbness and tingly on face-right side of face and neck/head/right side, slightly itchy face, some tingling under neck, high blood pressure 153/93 - high bp for 4 days, extreme GERD which resulted in not being able to sleep for 4 days would wake up to heart racing, still have tingly hypersensitive feeling in face 2 weeks later. Since vaccination patient not tested for covid-19. Event resulted to visit Doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events with Pepcid, Claritin and ice packs on face. The patient underwent lab tests and procedures which included blood pressure measurement: 153/93 on 18Feb2021 High. The outcome of the event still has tingly hypersensitive feeling in face 2 weeks later was not recovered and all other events were recovered with lasting effects.    No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling, Rash maculo-papular
Clinical narrative: There are red spots, about 4 of them on her leg/4 more on the opposite leg/they are slightly raised but they don't itch/red dots under the skin/She started breaking out/breaking out on her legs; She had an allergy before and it is acting like that; Her arm swelled up got real red and sore; Her arm swelled up got real red and sore; Her arm swelled up got real red and sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Lot number: EL9266, Expiration Date: Not Reported) via unspecified route of administration on 25Feb2021 (at the age of 74-years-old), as dose 1, single for COVID-19 immunisation. Medical history included had an allergy before and allergic reaction to a drug, Penicillin (reported as She didn't think much about it but she had one allergic reaction to a drug, Penicillin and she had taken it for 2 months before). There were no concomitant medications. The patient experienced there are red spots, about 4 of them on her leg/4 more on the opposite leg/they are slightly raised but they don't itch/red dots under the skin/she started breaking out/breaking out on her legs, She had an allergy before and it is acting like that, and her arm swelled up got real red and sore on an unspecified date. It was reported that patient noticed, on the first week on an unspecified date, that there were red spots, about 4 of them on her leg and she didn't think that much about it then later on she noticed like 4 more on the opposite leg then last night there was one more on that leg and she got up this morning and there are 3 on the original leg it started on. They were in a cluster of 3-4, they were slightly raised but they don't itch. It was also reported that patient noticed that her arm swelled up got real red and sore and she said that was not a bad reaction but that was the first thing she noticed and the other thing gradually she started breaking out. Patient also reported that she has been taking the same medicine for years so that makes her think the reason why she would be breaking out on her legs was probably related to the vaccine. Patient was also inquiring if she can take diphenhydramine (BENADRYL) because of the events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to the first time around and it wasn't serious. The outcome of the event was unknown. The patient was querying if the second shot that they were getting is a little bit lighter or a heavier one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on whole entire body, front and back and all over the place; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Lot number: EN6205, Expiration Date: Not Reported) via an unspecified route of administration on 27Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on whole entire body, front and back and all over the place on the morning of 05Mar2021, 6 days after the vaccination. Reporter was asking if this was a side effect of the vaccine. The outcome of event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: body rash; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6198, Expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and acid reflux both from an unknown date. Concomitant medications included simvastatin; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), and benzonatate all taken for an unspecified indication and potassium bicarbonate , sodium alginate (GAVISCON ADVANCED) taken for acid reflux; start and stop date were not reported. On an unspecified date in Mar2021 about 8 o'clock, the patient had a body rash, no other reactions, and felt fine. She went to bed and the body rash was gone. She just wanted to make sure she can go ahead and get her second dose scheduled on 25Mar2021. No treatment was received for the event. The outcome of the event was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inappropriate schedule of product administration, Rash erythematous, Vaccination site swelling
Clinical narrative: Bad headache; Joint ache; Left arm swelling; Red rash; first dose given on 17Feb2021, second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03Mar2021 at 10:30 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. Medical history included multiple sclerosis and penicillin allergy both from an unknown date. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 17Feb2021 at 10:30 (at the age of 67-years-old) for COVID-19 immunisation. On 03Mar2021 at 21:00, the patient experienced bad headache, joint ache, left arm swelling, and red rash. The patient was administered with first dose of BNT162B2 on 17Feb2021 and second dose of BNT162B2 on 03Mar2021 which was an inappropriate schedule of vaccine administered. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EM9809) via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:45 (age at vaccination was 32-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included some SVT (supraventricular tachycardia) in heart. The patient's concomitant medications (within 2 weeks) were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The facility type where the vaccine was administered was reported as doctor's office/urgent care. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: PAA156051) via an unspecified route of administration, administered in left arm on 10Feb2021 at 13:30 (age at vaccination was 32-year-old), as dose 1, single for COVID-19 immunization and experienced slight metallic taste and became energetic over the next two days. On 04Mar2021, the patient experienced super hot / increased heat / extremely hot, back pain, increased heat and sweating, headache, chills / strong waves of chills / cold chills, left side of face feeling weird, fever/ 99.3 fever with shakes / from 99.5 to 101.6 in exactly 20 minutes / 101.6 to about 103 in 34 minutes / fever fluctuated between 101.3 to 102.7, muscle aches, joint aches, and increased heart rate (120 bpm resting). It was reported that the patient experienced super hot for 10 minutes on 11:30 (hour 1) and hour 4; major back pain, hot but no fever on hour 8; back pain with increased heat and sweating on hour 9; trace headache, chills and left side of face feeling weird but nothing physically noticeable on hour 10; patient was the same (but not as much), with fever, headache (feeling), muscle aches and joint aches on hour 11; more and more strong waves of chills, increased heart rate (120bpm resting), no headache while back pain and aches continue on hour 12; extremely hot with super cold chills, and 99.3 fever with shakes on hour 13; and on hour 14, the patient went from 99.5 to 101.6 in exactly 20 minutes and in the same hour the patient went from 101.6 to about 103 in 34 minutes. It was reported that between hour 15 and 18, the patient's fever fluctuated between 101.3 to 102.7. The patient underwent lab tests and procedures which included body temperature of 99.3 (fever; hour 13), 99.5 (hour 14), 101.6 (hour 14; changed in exactly in 20 minutes), 103 (hour 14; changed in 34 minutes), 101.3 (between hour 15 and 18 fever fluctuated), and 102.7 (between hour 15 and 18 fever fluctuated); all on 04Mar2021; and heart rate of 105 bpm (normal rest rate) on an unspecified date and 120 bpm (resting; increased; hour 12) on 04Mar2021. There was no therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EM9809) via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:45 (age at vaccination was 32-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included some SVT (supraventricular tachycardia) in heart. The patient's concomitant medications (within 2 weeks) were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The facility type where the vaccine was administered was reported as doctor's office/urgent care. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: PAA156051) via an unspecified route of administration, administered in left arm on 10Feb2021 at 13:30 (age at vaccination was 32-year-old), as dose 1, single for COVID-19 immunization and experienced slight metallic taste and became energetic over the next two days. On 04Mar2021, the patient experienced super hot / increased heat / extremely hot, back pain, increased heat and sweating, headache, chills / strong waves of chills / cold chills, left side of face feeling weird, fever/ 99.3 fever with shakes / from 99.5 to 101.6 in exactly 20 minutes / 101.6 to about 103 in 34 minutes / fever fluctuated between 101.3 to 102.7, muscle aches, joint aches, and increased heart rate (120 bpm resting). It was reported that the patient experienced super hot for 10 minutes on 11:30 (hour 1) and hour 4; major back pain, hot but no fever on hour 8; back pain with increased heat and sweating on hour 9; trace headache, chills and left side of face feeling weird but nothing physically noticeable on hour 10; patient was the same (but not as much), with fever, headache (feeling), muscle aches and joint aches on hour 11; more and more strong waves of chills, increased heart rate (120bpm resting), no headache while back pain and aches continue on hour 12; extremely hot with super cold chills, and 99.3 fever with shakes on hour 13; and on hour 14, the patient went from 99.5 to 101.6 in exactly 20 minutes and in the same hour the patient went from 101.6 to about 103 in 34 minutes. It was reported that between hour 15 and 18, the patient's fever fluctuated between 101.3 to 102.7. The patient underwent lab tests and procedures which included body temperature of 99.3 (fever; hour 13), 99.5 (hour 14), 101.6 (hour 14; changed in exactly in 20 minutes), 103 (hour 14; changed in 34 minutes), 101.3 (between hour 15 and 18 fever fluctuated), and 102.7 (between hour 15 and 18 fever fluctuated); all on 04Mar2021; and heart rate of 105 bpm (normal rest rate) on an unspecified date and 120 bpm (resting; increased; hour 12) on 04Mar2021. There was no therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash came again but worse, covering more of the tops of her hands; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:45 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. No medical history was reported. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included zinc; elderberry [sambucus nigra], vitamin c [ascorbic acid] and turmeric - all 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 previously received the first dose of BNT162B2 (lot number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 at 04:45PM  (at the age of 47 years old) as dose 1, single for COVID-19 immunisation and experienced rash on top of both hands, extending to a couple fingers and itchy rash. On 26Feb2021, the patient reported that the rash came again but worse, covering more of the tops of her hands. It was same as before, but it didn't show up until about 2 days after the second shot. At 9 days after the shot, it was still here and was not any better. The patient was using hydricortizone cream as treatment. The patient haven't seen a doctor about it, but have taken pictures. Since vaccination, the patient has not been tested for COVID-19. The patient did not recover from the event.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: Weakness; Arm is still very sore; Extremely tired/Fatigue; Headache; Muscle pain; Chills; Joint pain; Fever never got over 99.9; unwell; Nausea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified dates in 2021, the patient experienced weakness, arm is still very sore, extremely tired/fatigue, headache, muscle pain, chills, joint pain, fever never got over 99.9, unwell, and nausea. The patient still had weakness, arm was still very sore, extremely tired and fatigued, feels very unwell and weak. The patient's headache, muscle pain, chills, joint pain, fever, and nausea went away. The outcome of headache, nausea, muscle pain, chills, joint pain, and fever never got over 99.9 were recovered on unspecified dates in 2021 while the remaining events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Weakness; Arm is still very sore; Extremely tired/Fatigue; Headache; Muscle pain; Chills; Joint pain; Fever never got over 99.9; unwell; Nausea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified dates in 2021, the patient experienced weakness, arm is still very sore, extremely tired/fatigue, headache, muscle pain, chills, joint pain, fever never got over 99.9, unwell, and nausea. The patient still had weakness, arm was still very sore, extremely tired and fatigued, feels very unwell and weak. The patient's headache, muscle pain, chills, joint pain, fever, and nausea went away. The outcome of headache, nausea, muscle pain, chills, joint pain, and fever never got over 99.9 were recovered on unspecified dates in 2021 while the remaining events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weakness; Arm is still very sore; Extremely tired/Fatigue; Headache; Muscle pain; Chills; Joint pain; Fever never got over 99.9; unwell; Nausea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified dates in 2021, the patient experienced weakness, arm is still very sore, extremely tired/fatigue, headache, muscle pain, chills, joint pain, fever never got over 99.9, unwell, and nausea. The patient still had weakness, arm was still very sore, extremely tired and fatigued, feels very unwell and weak. The patient's headache, muscle pain, chills, joint pain, fever, and nausea went away. The outcome of headache, nausea, muscle pain, chills, joint pain, and fever never got over 99.9 were recovered on unspecified dates in 2021 while the remaining events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: half of lower lip was swollen to about twice normal size; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via unspecified route of administration on 01Mar2021 (reported as Monday) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced half of lower lip was swollen to about twice normal size (about half of the lower lip) on 05Mar2021. The patient does not know if this was a possible side effect. It does not hurt but it's swollen up as if it was a huge blister and the patient have never had anything like this before. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a horrible rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number, and Expiration Date: Not Reported) via unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had a horrible rash on an unspecified date. Patient took diphenhydramine (BENADRYL) as a result of the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchiness at the shot site; This is a spontaneous report from a contactable consumer (patient reported for himself). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, strength 0.3ml (reported as 30mcg/0.3 ml), Lot Number: EL9262, expiry date not reported), via an unspecified route of administration on 05Feb2021 (at the age of 76 years old) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported.  There were no concomitant medications.  Patient had no problems with the first shot, she had the first shot 05Feb2021 and she had no problems other than the band aid left some glue behind, she left it on for 10 minutes then she yanked it off, that was because she had a coat on and could not get to it but the glue on the band aid was enough that she had itchiness at the shot site (05Feb2021) but that was not because of the shot other than that she had no problem with the first shot. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and reporter assessment, there is no possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Vaccination site pruritus which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: aches; fever of 101.8 degrees F; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program regulatory authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced aches and fever of 101.8 degrees F. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: light headedness; sore arm; chills; headache; nausea; fever; This is a spontaneous report from a Regulatory Authority via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she experienced side effects after the vaccination. On an unspecified date, the patient experienced light headedness on the next day of vaccination, sore arm on the second day of vaccination and the events chills, headache, nausea and fever on the third day. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: light headedness; sore arm; chills; headache; nausea; fever; This is a spontaneous report from a Regulatory Authority via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she experienced side effects after the vaccination. On an unspecified date, the patient experienced light headedness on the next day of vaccination, sore arm on the second day of vaccination and the events chills, headache, nausea and fever on the third day. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 at 12:00 pm (at the age of-29 year) as a single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm on 10Mar2021 at 16:00 pm. No treatment was received for the adverse event. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program COVAX US support via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced chilling and little fever in Mar2021. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Blood pressure increased, Blood pressure measurement, Chills
Clinical narrative: Throat swelling; chills; muscle tremors; weak; dizzy; high resting heart rate 135 to 145; elevated BP 168/58; BP fluctuated; heart and BP fluctuated; head ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 10:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history of the patient included GERD, allergy from Oxy family which causes significant respiratory depression. Concomitant/other medications in two weeks included Omeprazole 20 mg, famotidine [PEPCID AC], cannabidiol [CBD oil] taken for unspecified indication. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if patient had COVID prior vaccination. On 11Mar2021, at 10:45 patient experienced Throat swelling, chills, muscle tremors, weak, dizzy, high resting heart rate 135 to 145, elevated BP 168/58. Both heart and BP fluctuated, headache. AE resulted in: Emergency room/department or urgent care. Patient was not for COVID tested post vaccination. Treatment in response to the events were unknown. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: Throat swelling; chills; muscle tremors; weak; dizzy; high resting heart rate 135 to 145; elevated BP 168/58; BP fluctuated; heart and BP fluctuated; head ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 10:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history of the patient included GERD, allergy from Oxy family which causes significant respiratory depression. Concomitant/other medications in two weeks included Omeprazole 20 mg, famotidine [PEPCID AC], cannabidiol [CBD oil] taken for unspecified indication. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if patient had COVID prior vaccination. On 11Mar2021, at 10:45 patient experienced Throat swelling, chills, muscle tremors, weak, dizzy, high resting heart rate 135 to 145, elevated BP 168/58. Both heart and BP fluctuated, headache. AE resulted in: Emergency room/department or urgent care. Patient was not for COVID tested post vaccination. Treatment in response to the events were unknown. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Tremor
Clinical narrative: Throat swelling; chills; muscle tremors; weak; dizzy; high resting heart rate 135 to 145; elevated BP 168/58; BP fluctuated; heart and BP fluctuated; head ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 10:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history of the patient included GERD, allergy from Oxy family which causes significant respiratory depression. Concomitant/other medications in two weeks included Omeprazole 20 mg, famotidine [PEPCID AC], cannabidiol [CBD oil] taken for unspecified indication. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if patient had COVID prior vaccination. On 11Mar2021, at 10:45 patient experienced Throat swelling, chills, muscle tremors, weak, dizzy, high resting heart rate 135 to 145, elevated BP 168/58. Both heart and BP fluctuated, headache. AE resulted in: Emergency room/department or urgent care. Patient was not for COVID tested post vaccination. Treatment in response to the events were unknown. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Diarrhoea, Dyspnoea
Clinical narrative: 14 days after vaccine I started severe diarrhea; severe joint aches; Coughing; 4 Days after I had a strange headache for 2 days; then felt fatigue; fever of 99 for an afternoon; noticed lungs seemed different as breathless, which progressed to a little pressure which I have never had before; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6203) via an unspecified route of administration (age at vaccination 76-year) in right arm on 28Feb2021 at 01:15 PM as dose 1, single for COVID-19 immunization. Medical history included diverticulitis; SOD; emphysema; Known allergies: several drugs, bee/wasp stings, msg, most preservatives; all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); tiotropium bromide (SPIRIVA RESPIMAT); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d nos (VITAMIN D NOS); all taken in two weeks of COVID vaccination, for an unspecified indication, start and stop date were not reported. The patient received no COVID prior vaccination. The patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Reported facility type vaccine was Doctor's office/urgent care. The patient experienced 4 days after she had a strange headache on 04Mar2021 for 2 days; then felt fatigue, fever of 99 for an afternoon, noticed lungs seemed different as breathless, which progressed to a little pressure which she never had before, on an unspecified date in Mar2021; 14 days after vaccine she started severe diarrhea, severe joint aches, coughing, on 14Mar2021. It was reported that "She never had before though, she had emphysema. Called her physician and she said to not take scheduled second shot when scheduled on 14Mar2021. Then she was concerned of what's next." AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 99 (fever of 99). The patient received no treatment for the adverse events. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.