chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm was swollen and all red; Arm was swollen and all red; A big spot and it was sore and now it is itchy; A big spot and it was sore and now it is itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date in an unspecified arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient had Pfizer Covid Vaccine, the second shot (on Saturday) and on 21Mar2021, patients arm was swollen and all red, a big spot and it was sore and now it was itchy. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Hyperhidrosis
Clinical narrative: body pain; headache; chills; sweats; fever (high 103.7); sore lower back; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Age at vaccination 45 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient not had allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9261), via an unknown route of administration at left arm on 02Feb2021 at 08:30 as dose 1, single for covid-19 immunisation. On 18Mar2021 05:45, the patient experienced body pain; headache; chills; sweats; fever (high 103.7) and sore lower back. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 103.7 df on 18Mar2021, sars-cov-2 test: negative on 18Mar2021 Negative (12 hrs after symptoms). It was reported that patient commencing on morning of 18Mar2021 thru current (21Mar2021), body pain, chills, sweats, sore lower back, fever (high 103.7), persistent tension/headache. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient did not received any other medications the patient received within 2 weeks of vaccination. The clinical outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: body pain; headache; chills; sweats; fever (high 103.7); sore lower back; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Age at vaccination 45 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient not had allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9261), via an unknown route of administration at left arm on 02Feb2021 at 08:30 as dose 1, single for covid-19 immunisation. On 18Mar2021 05:45, the patient experienced body pain; headache; chills; sweats; fever (high 103.7) and sore lower back. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 103.7 df on 18Mar2021, sars-cov-2 test: negative on 18Mar2021 Negative (12 hrs after symptoms). It was reported that patient commencing on morning of 18Mar2021 thru current (21Mar2021), body pain, chills, sweats, sore lower back, fever (high 103.7), persistent tension/headache. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient did not received any other medications the patient received within 2 weeks of vaccination. The clinical outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Influenza like illness, Lymph node pain
Clinical narrative: I had flu like symptoms; ache; ran a low grade temperature a 100; had sores in my mouth and broke out around my mouth, fever blisters around my mouth/fever blisters around my mouth/I had 3 fever blisters on the lower lip; Diarrhea; the glands in my neck was sore; I didn't really feel well; This is a spontaneous report from a contactable other hcp (Patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EN5318), via an unspecified route of administration (Age at the time of vaccination 77 years) on 09Feb2021 as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder and osteoporosis from an unknown date and unknown if ongoing. Concomitant medications included denosumab (PROLIA) taken for osteoporosis, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunization. In Feb2021 after the second vaccine the patient experienced flu like symptoms, ache, ran a low-grade temperature a 100, had sores in her mouth and broke out around her mouth, fever blisters around her mouth/fever blisters around her mouth/she had 3 fever blisters on the lower lip, diarrhea, the glands in her neck was sore, She didn't really feel well. The patient underwent lab tests and procedures which included body temperature was ran a low-grade temperature a 100 on unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Pyrexia
Clinical narrative: I had flu like symptoms; ache; ran a low grade temperature a 100; had sores in my mouth and broke out around my mouth, fever blisters around my mouth/fever blisters around my mouth/I had 3 fever blisters on the lower lip; Diarrhea; the glands in my neck was sore; I didn't really feel well; This is a spontaneous report from a contactable other hcp (Patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EN5318), via an unspecified route of administration (Age at the time of vaccination 77 years) on 09Feb2021 as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder and osteoporosis from an unknown date and unknown if ongoing. Concomitant medications included denosumab (PROLIA) taken for osteoporosis, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunization. In Feb2021 after the second vaccine the patient experienced flu like symptoms, ache, ran a low-grade temperature a 100, had sores in her mouth and broke out around her mouth, fever blisters around her mouth/fever blisters around her mouth/she had 3 fever blisters on the lower lip, diarrhea, the glands in her neck was sore, She didn't really feel well. The patient underwent lab tests and procedures which included body temperature was ran a low-grade temperature a 100 on unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Tinnitus
Clinical narrative: Tinnitus; having an inflammatory reaction; I got no reaction except the sore arm on the 27th; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown [It was hard to read, patient believe it was EN6203-not clarified]) via an unspecified route of administration on 27Feb2021 (at the age of 67-year-old) as single dose for COVID-19 immunisation. Patient had no medical history. Concomitant/other medications included Supplements, Multivitamins (unspecified). On 27Feb2021 the patient experienced sore arm. On an unspecified date patient experienced tinnitus, inflammatory reaction. Patient stated that she was still experiencing them (Adverse event), but they were not as severe at all or did not make the patient feel like she was going to die now. Patient was wondering if Pfizer was collecting information from people on any chronic adverse effects from getting the vaccine earlier this year. Patient knows of a handful of people who have experienced what she was experiencing with the tinnitus. Patient asked, how was Pfizer approving the booster doses and asked if she were to receive the Flu vaccine would, since having such a reaction to the Pfizer vaccine and having an inflammatory reaction could that make it worse? Patient stated her doctors told her that there was no data on this yet, so they do not have an answer for her, and patient needed advice on getting the flu vaccine. Outcome of the event pain in arm was not resolved, tinnitus and inflammation were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Upper lips was very swollen from left to right; This is a spontaneous report from a contactable consumer (reporter's husband). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6207), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced upper lips was very swollen from left to right. Reporter stated, we had our first vaccine (Covid Vaccine). Reporter husband, his upper lips was very swollen from left to right and he put ice on it and then Benadryl (Treatment) and that lasted for about a day and the next morning it was okay. So, reporter was wondering, is there anything related to this with the second vaccine. Therapeutic measures were taken as a result of upper lips was very swollen from left to right. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible, no further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching to face, neck, head while off Xeljanz; This is a spontaneous report from a contactable other health care professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 46-year-old), as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ) taken for an unspecified indication from 18Mar2021. The patient experienced itching to face, neck, head while off xeljanz on an unspecified date. The patient took off Xeljanz per MD request 1 day prior and 1 week after receiving COVID vaccination. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site rash
Clinical narrative: Rash on my shoulders, my arm, on my arm where the shot was given; on 16Mar, consumer stated, Yes, this red rash.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Batch/lot number: Unknown, Expiry date: 31Jul2021), via an unspecified route in the left arm by the shoulder on 16Mar2021 (age at vaccination: 78-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Batch/lot number: Unknown), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. On 16Mar2021, ever since patient received the first shot, he experienced rash on his shoulders, his arm, on his arm where the shot was given. Patient stated that this was red rash. He was wondering if that was a situation that need to be taken care of or what. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: she's having an allergy now; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer (patient) reported that, a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number and expiry date were unknown) via an unspecified route of administration on 17Mar2021 as a dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously had event (unspecified) when took Zyrtec 10 mg [cetirizine hydrochloride] for an unknown indication. The patient reported that, on an unspecified date she's having an allergy now. Patient asked if she could take again Zyrtec 10 mg which previously, she was taking daily before she had her first dose of the vaccine last 17Mar2021. She stopped taking Zyrtec 10 mg when she had the first dose of the vaccine and she wanted to take it again since she's having an allergy now. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood immunoglobulin E, Blood immunoglobulin M, Contusion
Clinical narrative: Stomach is huge; Pain in right hip; elevated CK level to 550; Pain in left shoulder and lung; Pain in left shoulder and lung; painful to take deep breath; terrible pain in R and L inner thighs; feels bruised; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration, in right arm on 20Feb2021 16:00 (at the age of 71-years-old) as dose 2, single for COVID-19 immunization. Medical history included lyme disease about 30 years ago, undiagnosed illness and recent bite from black (yellow) flies still swelling in legs/painful. Concomitant medication included ibuprofen (ADVIL 12 HOUR). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration, 29Jan2021 17:30 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced kidney pain, liver pain and shoulder blade pain. The patient experienced terrible pain in right and left inner thighs and feels bruised on 21Feb2021, pain in left shoulder and lung and painful to take deep breath on 12Mar2021, stomach is huge, pain in right hip and elevated CK level to 550 on an unspecified date. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 550, blood immunoglobulin e: problem, blood immunoglobulin m: problem, muscle tissue testing, nerve tissue testing, vein tissue testing. Therapeutic measures were taken as a result of stomach is huge and pain in right hip. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Painful respiration, Pulmonary pain
Clinical narrative: Stomach is huge; Pain in right hip; elevated CK level to 550; Pain in left shoulder and lung; Pain in left shoulder and lung; painful to take deep breath; terrible pain in R and L inner thighs; feels bruised; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration, in right arm on 20Feb2021 16:00 (at the age of 71-years-old) as dose 2, single for COVID-19 immunization. Medical history included lyme disease about 30 years ago, undiagnosed illness and recent bite from black (yellow) flies still swelling in legs/painful. Concomitant medication included ibuprofen (ADVIL 12 HOUR). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration, 29Jan2021 17:30 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced kidney pain, liver pain and shoulder blade pain. The patient experienced terrible pain in right and left inner thighs and feels bruised on 21Feb2021, pain in left shoulder and lung and painful to take deep breath on 12Mar2021, stomach is huge, pain in right hip and elevated CK level to 550 on an unspecified date. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 550, blood immunoglobulin e: problem, blood immunoglobulin m: problem, muscle tissue testing, nerve tissue testing, vein tissue testing. Therapeutic measures were taken as a result of stomach is huge and pain in right hip. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; malaise; fever (38.5ºC); chills; multiple arthralgia; This is a spontaneous report from a contactable Physician (patient). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via intramuscularly in arm left on 22Mar2021 14:00 (age at vaccination 44 years) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies to pollen, dust and GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (CETRIZINE). No other vaccine in four weeks, no COVID prior vaccination and no COVID tested post vaccination. The patient historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via intramuscularly in arm left on 01Mar2021 14:00 (age at vaccination 44 years) as dose 1, single for COVID-19 immunization. On 23Mar2021 13:00, the patient experienced injection site pain, malaise, fever (38.5 degree centigrade), chills and multiple arthralgia. On 23Mar2021, the patient underwent lab tests and procedures which included fever: 38.5 degree centigrade. Paracetamol, 650 mg every 6 hrs was received due to events. Therapeutic measures were taken as a result of injection site pain, malaise, fever (38.5 degree centigrade), chills and multiple arthralgia. On an unspecified date in 2021, the outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Diarrhoea, Dizziness, Erythema
Clinical narrative: toes on right foot became itchy, red and swollen/Swelling went down in foot; toes on right foot became itchy, red and swollen; toes on right foot became itchy, red and swollen; rashes are lightening up a bit; diarrhea; woke up with swollen; I am having what I am believing is an allergic reaction to it; I had a red swelling itchy face and then spread up all over my body; I had a red swelling itchy face and then spread up all over my body/really red; I had a red swelling itchy face and then spread up all over my body/itching foot/the whole body is itching; Stomach pains/stomach pain; nauseous; dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on an unspecified date in Feb2021 (age at vaccination: 39-years-old) as dose 1, single for COVID-19 immunization (Pharmacy or Drug Store). It was reported that patient did not receive other vaccine in four weeks. Patient not tested COVID post vaccination. Medical history included ventricular extrasystoles Verbatim: PVC in Heart. Concomitant medication included flecainide taken for an unspecified indication, start and stop date were not reported. On 12Feb2021, the patient experienced stomach pains/stomach pain, nauseous and dizzy. On an unspecified date, patient toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit, diarrhea, woke up with swollen, i am having what i am believing is an allergic reaction to it, i had a red swelling itchy face and then spread up all over my body, i had a red swelling itchy face and then spread up all over my body/ really red and i had a red swelling itchy face and then spread up all over my body/ itching foot/the whole body is itching. On 23Mar2021, the patient underwent Blood test which showed everything was normal, there was nothing abnormal. On May2020 haematocrit was normal, there was nothing abnormal. On Jul2020, haematocrit was normal, there was nothing abnormal. Patient received methylprednisolone for the treatment of stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, toes on right foot became itchy, red and swollen, rashes are lightening up a bit. The outcome of the events Stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/Swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit was reported as not recovered and rest of the events outcome was unknown.  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Hypersensitivity, Nausea, Peripheral swelling, Pruritus
Clinical narrative: toes on right foot became itchy, red and swollen/Swelling went down in foot; toes on right foot became itchy, red and swollen; toes on right foot became itchy, red and swollen; rashes are lightening up a bit; diarrhea; woke up with swollen; I am having what I am believing is an allergic reaction to it; I had a red swelling itchy face and then spread up all over my body; I had a red swelling itchy face and then spread up all over my body/really red; I had a red swelling itchy face and then spread up all over my body/itching foot/the whole body is itching; Stomach pains/stomach pain; nauseous; dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on an unspecified date in Feb2021 (age at vaccination: 39-years-old) as dose 1, single for COVID-19 immunization (Pharmacy or Drug Store). It was reported that patient did not receive other vaccine in four weeks. Patient not tested COVID post vaccination. Medical history included ventricular extrasystoles Verbatim: PVC in Heart. Concomitant medication included flecainide taken for an unspecified indication, start and stop date were not reported. On 12Feb2021, the patient experienced stomach pains/stomach pain, nauseous and dizzy. On an unspecified date, patient toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit, diarrhea, woke up with swollen, i am having what i am believing is an allergic reaction to it, i had a red swelling itchy face and then spread up all over my body, i had a red swelling itchy face and then spread up all over my body/ really red and i had a red swelling itchy face and then spread up all over my body/ itching foot/the whole body is itching. On 23Mar2021, the patient underwent Blood test which showed everything was normal, there was nothing abnormal. On May2020 haematocrit was normal, there was nothing abnormal. On Jul2020, haematocrit was normal, there was nothing abnormal. Patient received methylprednisolone for the treatment of stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, toes on right foot became itchy, red and swollen, rashes are lightening up a bit. The outcome of the events Stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/Swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit was reported as not recovered and rest of the events outcome was unknown.  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: toes on right foot became itchy, red and swollen/Swelling went down in foot; toes on right foot became itchy, red and swollen; toes on right foot became itchy, red and swollen; rashes are lightening up a bit; diarrhea; woke up with swollen; I am having what I am believing is an allergic reaction to it; I had a red swelling itchy face and then spread up all over my body; I had a red swelling itchy face and then spread up all over my body/really red; I had a red swelling itchy face and then spread up all over my body/itching foot/the whole body is itching; Stomach pains/stomach pain; nauseous; dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on an unspecified date in Feb2021 (age at vaccination: 39-years-old) as dose 1, single for COVID-19 immunization (Pharmacy or Drug Store). It was reported that patient did not receive other vaccine in four weeks. Patient not tested COVID post vaccination. Medical history included ventricular extrasystoles Verbatim: PVC in Heart. Concomitant medication included flecainide taken for an unspecified indication, start and stop date were not reported. On 12Feb2021, the patient experienced stomach pains/stomach pain, nauseous and dizzy. On an unspecified date, patient toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit, diarrhea, woke up with swollen, i am having what i am believing is an allergic reaction to it, i had a red swelling itchy face and then spread up all over my body, i had a red swelling itchy face and then spread up all over my body/ really red and i had a red swelling itchy face and then spread up all over my body/ itching foot/the whole body is itching. On 23Mar2021, the patient underwent Blood test which showed everything was normal, there was nothing abnormal. On May2020 haematocrit was normal, there was nothing abnormal. On Jul2020, haematocrit was normal, there was nothing abnormal. Patient received methylprednisolone for the treatment of stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, toes on right foot became itchy, red and swollen, rashes are lightening up a bit. The outcome of the events Stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/Swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit was reported as not recovered and rest of the events outcome was unknown.  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; 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 and expiration date were not reported), via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. Patient asked is it okay to have the knee injection for arthritis before the second dose appointment. Outcome of event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise
Clinical narrative: Caller stated she pressed so hard it gave her a bruise.; Caller stated she pressed so hard it gave her a bruise.; This is a spontaneous report from a contactable consumer (patient). A female patient of age 58 (units: unknown) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm on 15Mar2021 (at the age of 58 (units: unknown)) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included a biologic called kevzara for rheumatoid arthritis. The patient received the first dose of the pfizer covid 19 vaccine on 15Mar2021 and her second dose was scheduled on 05Apr2021. The patient stated that when the administrator gave her the vaccine, she squeezed her arm and she pressed her arm when she put on the bandaid. She stated the administrator wriggled her finger around the injection site after injection and after putting on the bandaid. She pressed so hard it gave the patient a bruise. The patient asked if she should ask not to squeeze her arm so hard. She stated she heard on the news not to squeeze that area because the vaccine needs to be given IM and not in the fatty tissue. She wanted to know if pressing or squeezing will damage the vaccine/ does pfizer say yes or no to this damaging the vaccine. The patient stated that she takes a biologic called kevzara for rheumatoid arthritis and it weakened her immune system. Caller stated she waited an extra week before getting the vaccine because she did not know if this would affect her vaccine. Caller wanted to know if this was something that she needs to do and will the kevzara affect the vaccine. Outcome of the event bruise was unknown.  No follow-up attempt are possible. Information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Pyrexia
Clinical narrative: fever; flu-like symptoms; cough; This is a spontaneous report from a contactable consumer (patient) reported herself. A 76-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on 11Mar2021 (at the age of 76-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 18Mar2021, the patient experienced fever for two days, has had flu-like symptoms and a cough, ask if those symptoms may be associated to the vaccine. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Rash, Rash macular
Clinical narrative: red spots developed over my chest, stomach, back, abdomen and legs.; red spots developed over my chest, stomach, back, abdomen and legs.; red spots developed over my chest, stomach, back, abdomen and legs.; This is a spontaneous report from database. A contactable consumer (patient) or other non HCP.    A 46-years-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number EN206, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 04Mar2021, at 03:30 (age at vaccination: 46-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia and Perimenopause from an unknown date and unknown if ongoing. Concomitant medication included lisinopril 10mg; ezetimibe (ZETIA) 10mg; and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) all taken for an unspecified indication, start and stop date were not reported. patient previously took Amoxycillin and experienced Drug hypersensitivity. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. On 06Mar2021, 2 days after vaccination the patient experienced red spots developed over my chest, stomach, back, abdomen and legs, then a spot on left wrist the next day, then over the next two weeks red spots developed over chest, stomach, back, abdomen and legs. The spots are dime sized or smaller, and don't really itch, but continue to spread over the last 2 and a half weeks. Patient visited Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Hydroxyzine 10 mg, it hasnt helped at the time of reporting. The outcome of the events were not recovered.  No follow-up attempts are needed, no further information is expected
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Feeling hot
Clinical narrative: Does feel warmth where there is redness; Red square, now around arm; Little bit low on breathing, is more out of breath; Red square, now around arm; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:30 (76-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (probably about 7 years), oxygen therapy (Confirmed COPD and requiring oxygen occurred prior to both COVID shots). The patient's concomitant medications were not reported. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6198, Exp: 30Jun2021) on 25Feb2021  as dose 1, single for covid-19 immunisation and reported had no reaction at all and received flu vaccine; never had a "reaction for immunization. The patient experienced red square, now around arm on Mar2021, red square, now around arm on 23Mar2021, little bit low on breathing, is more out of breath on 20Mar2021, does feel warmth where there is redness on an unspecified date. Husband noticed redness first. Initially, redness was more circular than square about 1.5 inches in diameter. Clarified Little bit low on breathing, is more out of breath began four days ago. If she is just sitting her oxygen level is at 95 to 96. When she gets up to walk to the bathroom, her level drops to low eighties, which normally would not happen with her. Usually can walk with no troubles. The patient underwent lab tests and procedures which included oxygen: if she is just sitting her oxygen level is at 95 (If she is just sitting her oxygen level is at 95 to 96. When she gets up to walk to the bathroom, her level drops to low eighties, which normally would not happen with her). The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pigmentation disorder
Clinical narrative: spots; eczema is getting bad; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of 78 (age units was not reported) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient stated when she got her first Pfizer vaccine dose they asked if she had taken any steroids. The patient stated she have a topical cream 5 percent steroid. The patient stated her eczema is getting bad (on unspecified date) and she need to use it. The patient asked will it have some effect with the Pfizer vaccine, it has been bothering her, but she have not been using it. The patient stated she have new spots stared (on unspecified date) which occurred after getting the vaccine. The patient stated she know the vaccine raises the immune system and her eczema is like an auto immune condition. The patient asked will you have more information regarding drug interactions with the vaccine in the future. The outcome of the events was unknown.   Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash pruritic, Urticaria
Clinical narrative: hives on wrists and hands/hive is on her foot; hands are swollen, the bottom of her feet are swollen in different places; itchy rash with hives; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced rash, hives on wrists and hands/hive is on her foot, hands are swollen, the bottom of her feet are swollen in different places, hands were swollen and itching, itchy rash with hives. Reporter stated that it went away and came back and left inside of her forearm was hivey, bumpy, and itchy and had a rash. She stated that Benadryl helped to calm it down. Caller wanted to know is this a reaction that people have reported. Caller wanted to know if she should keep taking Benadryl. Reporter is wondering if this could be from the vaccine. The rash keeps coming and going and she has not eaten anything different or done anything so she does not know what this could be from besides the vaccine. 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pruritus, Urticaria
Clinical narrative: flu-like symptoms; hives/ welts; itching; chills; This is a spontaneous report from a contactable other HCP (nurse). A 65-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration on 17Mar2021 (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced welts, hives, itching a day after receiving the vaccine, chills, and flu-like symptoms on 17Mar2021 a few hours after receiving the vaccine. The outcome of the events was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis got my back hurting; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number/Expiry date: Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis got her back hurting bad on an unspecified date. The patient received XELJANZ XR 11mg for the treatment of event. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint lock, Pain, Pain in extremity
Clinical narrative: Both knees feel locked; Burning pain coming from the inside from both knees down both legs; Burning pain coming from the inside from both knees down both legs; Burning pain coming from the inside from both knees down both legs/Burning from inside from knees down to her feet; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 13:30 (at the age of 81 years) as dose 2, single for COVID-19 immunisation. The patients medical history included diabetes, obesity and allergies to aspirin. The patients concomitant medications included metformin (METFORMIN); losartan potassium (LOSARTIN); gabapentin (GABAPENTIN); ibuprofen (IBUPROFEN); simvastatin (SIMVASTATIN). The Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 16Feb2021 11:00 (at the age of 81 years) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 12:00 the patient stated both knees felt locked, burning pain coming from the inside from both knees down both legs. Sitting, standing walking with a walker was awful pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The outcome of all the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hypersensitivity, Immune system disorder
Clinical narrative: allergic reaction; difficulty breathing; dizziness; fast heartbeat; weak immune system due to the medications that she is taking.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced allergic reaction, difficulty breathing, dizziness, fast heartbeat, weak immune system due to the medications that she is taking. The patient underwent lab tests and procedures which included heartbeat: fast on 24Mar2021. It was reported that 30 seconds after receiving the 1st dose had an allergic reaction. She wants to know if there is a duration of time for the reaction to be considered as severe. The outcomes of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: allergic reaction; difficulty breathing; dizziness; fast heartbeat; weak immune system due to the medications that she is taking.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced allergic reaction, difficulty breathing, dizziness, fast heartbeat, weak immune system due to the medications that she is taking. The patient underwent lab tests and procedures which included heartbeat: fast on 24Mar2021. It was reported that 30 seconds after receiving the 1st dose had an allergic reaction. She wants to know if there is a duration of time for the reaction to be considered as severe. The outcomes of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.