chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash was all over his back, chest, arms and legs/widespread rash; This is a spontaneous report from a contactable pharmacist reported for her brother. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported and Expiry Date of Covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 24Aug2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Ibuprofen and Diazepam, both taken for an unspecified indication, start and stop date were not reported. On 26Aug2021, the patient experienced rash was all over his back, chest, arms and legs/widespread rash. The clinical details of the events as follows: She stated her brother is in (City Name) and she is in (State name) and her brother wanted to come visit her in (State name) but she told her brother he could not come unless he was vaccinated. Her brother and his wife received their first Covid 19 vaccine last Tuesday and now her brother has this rash. He was the only one she knew of who had this type of reaction. She reported she had a couple of patients faint after getting the Covid 19 vaccine. She was calling on behalf of her brother who received his first dose of the Covid 19 vaccine last Tuesday, 24Aug2021 and probably around Thursday night, 26Aug2021, her brother got a rash but not on the arm where the injection was. The rash was all over his back, chest, arms and legs. She was asking if it was safe for him to get the second dose of the Covid 19 vaccine. She stated that the reaction did not happen within the first 4 hours after the injection. Her brother sent her a picture of the rash and it was not the Covid arm at the injection site and it did not look like measles but it was widespread. She clarified from the beginning of the call when she stated the rash was not on the arm where he received the injection, she meant it was not the Covid arm associated with the injection site. Her brother asked her if he should go to the urgent care but the caller told her brother the urgent care would just suggest Benadryl and he was already taking that and Zyrtec during the day. Her brother wife did say the rash was looking better. When probing medical history and concomitant medications she stated he might just take an Ibuprofen every now and then and a Diazepam every now and then for his muscles. He was a mechanic and has been for 20 years so his body is pretty beat up. There was no investigation assessment provided. The patient outcome of the event was Resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number not available for [vaccine/BNT162B2. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Erythema, Illness, Immunisation, Pain
Clinical narrative: received coronavirus booster vaccine; sick; symptoms of arthritis flare in right arm; skin hot/ red around shoulder; skin hot/ red around shoulder; soreness; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 25Aug2021 as dose 3, (BOOSTER) single for COVID-19 immunization (at the age of 56-year-old); tofacitinib citrate (XELJANZ XR), oral from 01Oct2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included dose 1 and dose 2 of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified dates for COVID-19 immunization. The patient received coronavirus booster vaccine on 25Aug2021 and experienced sick, symptoms of arthritis flare in right arm, skin hot/ red around shoulder, soreness on an unspecified date in 2021. It was reported that, after start of therapy "rarely" missed a dose of xeljanz, took later than normal schedule (morning) over the last few weeks. Unknown if change in symptoms and received coronavirus booster vaccine on 25Aug2021 and was sick for 1 day/no fever, symptoms of arthritis flare in right arm/skin hot/red around shoulder, soreness for several days, better today. MD was unaware and encouraged to notify MD. No additional information/details provided. The outcome of the event sick and soreness was recovered on an unspecified date in 2021, and for symptoms of arthritis flare in right arm, skin hot/ red around shoulder, received coronavirus booster vaccine it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: received coronavirus booster vaccine; sick; symptoms of arthritis flare in right arm; skin hot/ red around shoulder; skin hot/ red around shoulder; soreness; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 25Aug2021 as dose 3, (BOOSTER) single for COVID-19 immunization (at the age of 56-year-old); tofacitinib citrate (XELJANZ XR), oral from 01Oct2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included dose 1 and dose 2 of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified dates for COVID-19 immunization. The patient received coronavirus booster vaccine on 25Aug2021 and experienced sick, symptoms of arthritis flare in right arm, skin hot/ red around shoulder, soreness on an unspecified date in 2021. It was reported that, after start of therapy "rarely" missed a dose of xeljanz, took later than normal schedule (morning) over the last few weeks. Unknown if change in symptoms and received coronavirus booster vaccine on 25Aug2021 and was sick for 1 day/no fever, symptoms of arthritis flare in right arm/skin hot/red around shoulder, soreness for several days, better today. MD was unaware and encouraged to notify MD. No additional information/details provided. The outcome of the event sick and soreness was recovered on an unspecified date in 2021, and for symptoms of arthritis flare in right arm, skin hot/ red around shoulder, received coronavirus booster vaccine it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, SARS-CoV-2 test, Thrombophlebitis
Clinical narrative: swelling lead to a superficial clot and later a DVT; left leg started to swell on occasion and go back down; swelling lead to a superficial clot and later a DVT; This is a spontaneous report from a contactable consumer or other non-healthcare professional reporting for himself (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EWO158, expiry date unknown) via an unspecified route of administration in left arm on 06Apr2021 (at the age of 49-year-old) as dose 2, single for covid-19 immunization at a Public Health Clinic/Military Administration facility. The patient medical history included severe case of COVID in Jan2021 on an unknown date and was allergic to sulfa. Patient's concomitant medications included carvedilol and levothyroxine sodium (SYNTHROID). The patient previously took first dose of BNT162B2, formulation: solution for injection, Lot Number: ENG208, expiration date: unknown) via unknown route of administration in left arm on 16Mar2021 (at the age of 49-year-old) as dose 1, single for covid-19 immunization. No other vaccines were administered within four weeks. On 20Apr2021, patient stated after second dose in Apr2021 his left leg started to swell on occasion and go back down (Thrombophlebitis leg). He started going to the doctor in Jun2021. This swelling lead to a superficial clot and later a Deep vein thrombosis (DVT). The patient hospitalized due to the events and AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR; Nasal swab) negative on 09Sep2021. Therapeutic measures were taken as a result of events and treatment included Advil then Xarelto. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Due to an administration error patient received the second dose of Moderna instead of Pfizer today; This is a spontaneous report from a contactable contactable Nurse. A 61-years-old female patient received first dose ofNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; (Batch/Lot Number: FD8448; Expiration Date: Oct2021)) via intramuscular, administered in Deltoid Right on 27Aug2021 at (at the age of 61 years old)  as, 0.3 mL, Single dose for COVID-19 immunisation; Patient received Second dose of covid-19 vaccine (mrna 1273) (MODERNA COVID-19 VACCINE, Solution for injection,(Batch/Lot Number: 006D21A; Expiration Date: 21Apr2022)),via intramuscular administered in Deltoid Right on 17Sep2021at (at the age of 61 years old), 0.5 mL Single dose for COVID-19 immunisation. Patient had no medical history. Patient had no allergies There were no concomitant medications. he patient experienced due to an administration error patient received the second dose of moderna instead of pfizer today. The patient did not receive any treatment for the events.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Biopsy, Blood test, Electromyogram, Magnetic resonance imaging
Clinical narrative: I have had months of horrible neuropathy that is spreading very quickly. I was diagnosed with small fiber neuropathy via biopsy; I also nowhave vision and balance issues; I also nowhave vision and balance issues; This is a spontaneous report from a contactable consumer or other non-health care professional.   A adult female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for covid-19 immunisation. It was unknown whether the patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was unknown that whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown that whether the patient has been tested for COVID-19 since the vaccination. It was unknown if covid prior vaccination. It was unknown if covid tested post vaccination. It was unknown if patient had any known allergies. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient reported that the patient had an adverse reaction to the second Pfizer shot. The patient had months of horrible neuropathy (medically significant) on 14May2021 that is spreading very quickly on. The patient was diagnosed with small fiber neuropathy via biopsy, but all blood tests/MRI/EMG are normal. The patient had been to so many doctors and no one knows how to treat this or help. The patient had trying to get to a specialist. There are many others that are suffering with similar or worse symptoms. The patient also had vision issues on an unspecified date in 2021 and balance issues on 14May2021. Symptoms started 12 hours after the second shot on 14May. Vision issues began 5 weeks after second shot. Patient said she had been dealing with medical issues prior to the shot. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: small fiber neuropathy on unspecified date in 2021, blood test: normal on unspecified date in 2021, electromyogram: normal on unspecified date in 2021, and magnetic resonance imaging: normal on an unspecified date in 2021. It was unknown whether the patient received any treatment for the adverse event. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Visual impairment
Clinical narrative: I have had months of horrible neuropathy that is spreading very quickly. I was diagnosed with small fiber neuropathy via biopsy; I also nowhave vision and balance issues; I also nowhave vision and balance issues; This is a spontaneous report from a contactable consumer or other non-health care professional.   A adult female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for covid-19 immunisation. It was unknown whether the patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was unknown that whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown that whether the patient has been tested for COVID-19 since the vaccination. It was unknown if covid prior vaccination. It was unknown if covid tested post vaccination. It was unknown if patient had any known allergies. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient reported that the patient had an adverse reaction to the second Pfizer shot. The patient had months of horrible neuropathy (medically significant) on 14May2021 that is spreading very quickly on. The patient was diagnosed with small fiber neuropathy via biopsy, but all blood tests/MRI/EMG are normal. The patient had been to so many doctors and no one knows how to treat this or help. The patient had trying to get to a specialist. There are many others that are suffering with similar or worse symptoms. The patient also had vision issues on an unspecified date in 2021 and balance issues on 14May2021. Symptoms started 12 hours after the second shot on 14May. Vision issues began 5 weeks after second shot. Patient said she had been dealing with medical issues prior to the shot. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: small fiber neuropathy on unspecified date in 2021, blood test: normal on unspecified date in 2021, electromyogram: normal on unspecified date in 2021, and magnetic resonance imaging: normal on an unspecified date in 2021. It was unknown whether the patient received any treatment for the adverse event. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Nervous system disorder, Peripheral coldness, Peripheral swelling
Clinical narrative: his feet feel like they are 4 times their size, and it was not like that before; ringing in his ears; numbness in his feet; coldness in his feet; her feet getting more nerve; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), via an unspecified route of administration, administered in Right Arm in 2021 (at the age of 66-years-old) at dose 1, single and via an unspecified route of administration, administered in Arm Left in 2021 at dose 2, single for covid-19 immunization. Medical history included allergies, hay fever, allergic to sodium nitrate in all meats, allergic to gin. There were no concomitant medications. The patient previously took statins and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He got the vaccines six months ago. After first dose, patient reported that he had ringing in his ears and his feet were numb and cold, he felt his feet were 4 times the size they really were, and these got worsened after the second dose of the vaccine. He described that he has extreme numbness and coldness in his feet and his doctor has not been able to do anything to help it. He was asking if there was any information on those side effects and if there was anything that could help. He also stated that his feet felt like they were 4 times their size and was not like that before. He also experienced a worsening of his feet getting more nerve. He already had the issue, but it got worse. It was a nerve thing just like his ears. His feet were numb and cold. It was getting worse. It is about the same feeling. He didn't realize it was related. With the numbness and coldness in feet, his feet felt 4 times the size they really were. They were getting worse instead of better. He has received acupuncture and went to a chiropractor, and nothing has made it better. He went to a neurological doctor who couldn't get anything better either. The vaccine was not administered at military facility. The events resulted in physician office visit. Patient underwent lab tests and procedures included brain MRI with unknown results. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: his feet feel like they are 4 times their size, and it was not like that before; ringing in his ears; numbness in his feet; coldness in his feet; her feet getting more nerve; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), via an unspecified route of administration, administered in Right Arm in 2021 (at the age of 66-years-old) at dose 1, single and via an unspecified route of administration, administered in Arm Left in 2021 at dose 2, single for covid-19 immunization. Medical history included allergies, hay fever, allergic to sodium nitrate in all meats, allergic to gin. There were no concomitant medications. The patient previously took statins and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He got the vaccines six months ago. After first dose, patient reported that he had ringing in his ears and his feet were numb and cold, he felt his feet were 4 times the size they really were, and these got worsened after the second dose of the vaccine. He described that he has extreme numbness and coldness in his feet and his doctor has not been able to do anything to help it. He was asking if there was any information on those side effects and if there was anything that could help. He also stated that his feet felt like they were 4 times their size and was not like that before. He also experienced a worsening of his feet getting more nerve. He already had the issue, but it got worse. It was a nerve thing just like his ears. His feet were numb and cold. It was getting worse. It is about the same feeling. He didn't realize it was related. With the numbness and coldness in feet, his feet felt 4 times the size they really were. They were getting worse instead of better. He has received acupuncture and went to a chiropractor, and nothing has made it better. He went to a neurological doctor who couldn't get anything better either. The vaccine was not administered at military facility. The events resulted in physician office visit. Patient underwent lab tests and procedures included brain MRI with unknown results. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: This is a spontaneous report from a contactable consumer (patient, cardiovascular technologist). A 46-year-old female patient received second dose of bnt162b2 (COMIRNATY (COVID 19 Vaccine, Mrna), Solution for injection, Lot Number: EW0185; Expiration Date: 01Oct2021), via unspecified route of administration on 09Sep2021 (at the age of 46-year-old), in right arm as single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (COMIRNATY (COVID 19 Vaccine, Mrna), Solution for injection, Lot Number: EW0164, expiration date Aug-2021), in right arm on 19Aug2021, at single dose for COVID-19 immunization. The patient's medical history included anemia from heavy periods and takes iron supplements for this. On 11Sep2021, patient had heavy menstrual bleeding. The patient reported that on an unspecified date in 2021, her period became very irregular and had been very heavy with lots of big clots coming out of her. Usually it lasts for 5 days. She says the first three days it was very heavy, the fourth it slowed and stopped and on day five. she was done but still she was spotting, with heavy bleeding and spotting that was not going away. She reported that she is anemic to begin with, and she cannot afford to bleed like this. She says her job had her get the vaccine because she is in the medical field, so now she is calling to find out if this was a side effect. The patient was taking Pfizer COVID-19 vaccine as her job demanded it. The patient reporter that she does not have one yet since she moved. The patient reported that she did not receive treatment. Her period was doing what it does for those days and the problem was not stopping and continued with the heavy clotting. She had never seen clots like this. The patient wanted to be sure, her situation was not to be ignored. The patient wanted to know if this could be a side effect of the vaccine. The patient stated that she had not seen a health care professional because she had no insurance. The patient stated that she has been having cycle for years and this was something different. Her heavy bleeding always stops on the fifth day. The patient was asking if this ever going to stop. The clinical outcome of events heavy clots coming out of her and irregular menstruation was reported as unknown and remaining events as not recovered. Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Headache, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: Severe headache/Headaches still persist on today's date 6 weeks later; Stiff neck; Intestinal cramps; This is a spontaneous report from a contactable other hcp (patient). A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered in right arm on 09Aug2021 13:00 (at the age of 52 years) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. Patient did not have covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); and sertraline (SERTRALINE), both taken for an unspecified indication, start and stop date were not reported. On 10Aug2021 13:00, the patient experienced severe headache, stiff neck and intestinal cramps. It was reported that, headaches still persist on today's date 6 weeks later. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient underwent lab tests and procedures which included nasal swab test for covid: negative on 10Sep2021. The outcome of all the events was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Immune system disorder, Joint swelling
Clinical narrative: evidently attacked my immune system and sent my RA into overload; taking out my ability to walk or stand; pain in my knees and legs.; RA into overload; I felt excruciating pain below my knees/ Knees were swollen and very painful; My knees were swollen and very painful; I couldn't walk/ very unstable walking as my legs give out; couldn't move my legs; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via unspecified route of administration on 17May2021 (at the age of 62-year-old) and non-pregnant at the time of vaccination, as dose 2 in left arm, single for COVID-19 immunization. The patient medical history included hypertension, fibromyalgia, rheumatoid arthritis, epstein-barr virus infection. The Concomitant medication(s) included Amlodipine, Methotrexate. The patient previously took Bactrim and experienced drug hypersensitivity, Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175), via an unspecified route of administration on 26Apr2021 at 10:30 as dose 1, single in left arm for covid-19 immunisation. On 17May2021 at 23:15 patient experienced couldn't move my leg, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. Seriousness criteria (hospitalization, disability). The patient was hospitalized from 18May2021 to 20May2021. Therapeutic measures were taken as a result of couldn't move my legs, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. AE treatment included Pain medications, tests, drained fluid off right knee. The patient had no covid prior vaccination, nor tested post vaccination. The clinical outcome of the events were recovering.  Follow-up attempts are completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Rheumatoid arthritis
Clinical narrative: evidently attacked my immune system and sent my RA into overload; taking out my ability to walk or stand; pain in my knees and legs.; RA into overload; I felt excruciating pain below my knees/ Knees were swollen and very painful; My knees were swollen and very painful; I couldn't walk/ very unstable walking as my legs give out; couldn't move my legs; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via unspecified route of administration on 17May2021 (at the age of 62-year-old) and non-pregnant at the time of vaccination, as dose 2 in left arm, single for COVID-19 immunization. The patient medical history included hypertension, fibromyalgia, rheumatoid arthritis, epstein-barr virus infection. The Concomitant medication(s) included Amlodipine, Methotrexate. The patient previously took Bactrim and experienced drug hypersensitivity, Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175), via an unspecified route of administration on 26Apr2021 at 10:30 as dose 1, single in left arm for covid-19 immunisation. On 17May2021 at 23:15 patient experienced couldn't move my leg, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. Seriousness criteria (hospitalization, disability). The patient was hospitalized from 18May2021 to 20May2021. Therapeutic measures were taken as a result of couldn't move my legs, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. AE treatment included Pain medications, tests, drained fluid off right knee. The patient had no covid prior vaccination, nor tested post vaccination. The clinical outcome of the events were recovering.  Follow-up attempts are completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Internal itching on extremities mainly arms hands and face. Sometimes feet and legs.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Sep2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Factor V, PCOS, Type 2 Diabetes. Concomitant medication included clonazepam (KLONOPIN) and metformin taken for an unspecified indication. Patient had no known allergies and no past drug event. 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. On 05Sep2021 the patient experienced internal itching on extremities mainly arms hands and face, sometimes feet and legs. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for the event with Zyrtec (once a day). Since the vaccination the patient was not tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: heart rate averaging 15 to 20bpm; left arm extremely painful hot; whole upper arm is itchy going under my armpit up my neck; stiff neck; insomnia; diarrhea; red rash on left arm; migraine; headaches; extremely hot; chills; fever up to 101.7; body aches; nausea; difficulty breathing /issues with breathing; stuffy nose; pain in injection site; feeling exhausted; This is a spontaneous report from a contactable consumer (patient). A 35-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301458a) via an unspecified route of administration, administered in arm left on 14Sep2021 05:30 PM (age at vaccination was 35 years and she was not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation at pharmacy/ drug store. The patient's medical history included asthma and known Allergies of citalopram, CT dye. There was no other vaccine administered in four weeks. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol sulfate (VENTOLIN HFA), ranitidine hydrochloride (ZANTAC), Ibuprofen, soolantra. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Fd8448) via an unspecified route of administration, administered in arm left on 24Aug2021 06:30 PM (age at vaccination was 34 years) as dose 1, single for covid-19 immunisation. On 15Sep2021 (at 05:15 PM), 24 hours after second dose out of no where she got chills and a fever up to 101.7, body aches, nausea, difficulty breathing, stuffy nose, pain in injection site, feeling exhausted, on 16Sep2021, fever through morning with headaches, body aches, nausea afternoon arm was more sore at injection site and firm and extremely hot, issues with breathing and on 17Sep2021, insomnia, diarrhea, red rash on left arm, migraine and on 18Sep2021, left arm extremely painful hot where red rash was, whole upper arm was itchy going under her armpit up her neck, stiff neck and body aches, heart rate averaging 15 to 20bpm recorded on Apple Watch. The patient did not receive treatment for adverse events. Information of covid prior vaccination and covid tested post vaccination were unknown. The patient underwent lab test and procedure included body temperature and resulted into fever upto 101.7 on 15Sep2021. The outcome of all adverse events was recovering.  Follow-up attempts were completed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate decreased, Insomnia, Migraine
Clinical narrative: heart rate averaging 15 to 20bpm; left arm extremely painful hot; whole upper arm is itchy going under my armpit up my neck; stiff neck; insomnia; diarrhea; red rash on left arm; migraine; headaches; extremely hot; chills; fever up to 101.7; body aches; nausea; difficulty breathing /issues with breathing; stuffy nose; pain in injection site; feeling exhausted; This is a spontaneous report from a contactable consumer (patient). A 35-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301458a) via an unspecified route of administration, administered in arm left on 14Sep2021 05:30 PM (age at vaccination was 35 years and she was not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation at pharmacy/ drug store. The patient's medical history included asthma and known Allergies of citalopram, CT dye. There was no other vaccine administered in four weeks. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol sulfate (VENTOLIN HFA), ranitidine hydrochloride (ZANTAC), Ibuprofen, soolantra. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Fd8448) via an unspecified route of administration, administered in arm left on 24Aug2021 06:30 PM (age at vaccination was 34 years) as dose 1, single for covid-19 immunisation. On 15Sep2021 (at 05:15 PM), 24 hours after second dose out of no where she got chills and a fever up to 101.7, body aches, nausea, difficulty breathing, stuffy nose, pain in injection site, feeling exhausted, on 16Sep2021, fever through morning with headaches, body aches, nausea afternoon arm was more sore at injection site and firm and extremely hot, issues with breathing and on 17Sep2021, insomnia, diarrhea, red rash on left arm, migraine and on 18Sep2021, left arm extremely painful hot where red rash was, whole upper arm was itchy going under her armpit up her neck, stiff neck and body aches, heart rate averaging 15 to 20bpm recorded on Apple Watch. The patient did not receive treatment for adverse events. Information of covid prior vaccination and covid tested post vaccination were unknown. The patient underwent lab test and procedure included body temperature and resulted into fever upto 101.7 on 15Sep2021. The outcome of all adverse events was recovering.  Follow-up attempts were completed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nasal congestion, Nausea, Pain, Pain in extremity
Clinical narrative: heart rate averaging 15 to 20bpm; left arm extremely painful hot; whole upper arm is itchy going under my armpit up my neck; stiff neck; insomnia; diarrhea; red rash on left arm; migraine; headaches; extremely hot; chills; fever up to 101.7; body aches; nausea; difficulty breathing /issues with breathing; stuffy nose; pain in injection site; feeling exhausted; This is a spontaneous report from a contactable consumer (patient). A 35-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301458a) via an unspecified route of administration, administered in arm left on 14Sep2021 05:30 PM (age at vaccination was 35 years and she was not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation at pharmacy/ drug store. The patient's medical history included asthma and known Allergies of citalopram, CT dye. There was no other vaccine administered in four weeks. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol sulfate (VENTOLIN HFA), ranitidine hydrochloride (ZANTAC), Ibuprofen, soolantra. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Fd8448) via an unspecified route of administration, administered in arm left on 24Aug2021 06:30 PM (age at vaccination was 34 years) as dose 1, single for covid-19 immunisation. On 15Sep2021 (at 05:15 PM), 24 hours after second dose out of no where she got chills and a fever up to 101.7, body aches, nausea, difficulty breathing, stuffy nose, pain in injection site, feeling exhausted, on 16Sep2021, fever through morning with headaches, body aches, nausea afternoon arm was more sore at injection site and firm and extremely hot, issues with breathing and on 17Sep2021, insomnia, diarrhea, red rash on left arm, migraine and on 18Sep2021, left arm extremely painful hot where red rash was, whole upper arm was itchy going under her armpit up her neck, stiff neck and body aches, heart rate averaging 15 to 20bpm recorded on Apple Watch. The patient did not receive treatment for adverse events. Information of covid prior vaccination and covid tested post vaccination were unknown. The patient underwent lab test and procedure included body temperature and resulted into fever upto 101.7 on 15Sep2021. The outcome of all adverse events was recovering.  Follow-up attempts were completed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous, Vaccination site pain
Clinical narrative: heart rate averaging 15 to 20bpm; left arm extremely painful hot; whole upper arm is itchy going under my armpit up my neck; stiff neck; insomnia; diarrhea; red rash on left arm; migraine; headaches; extremely hot; chills; fever up to 101.7; body aches; nausea; difficulty breathing /issues with breathing; stuffy nose; pain in injection site; feeling exhausted; This is a spontaneous report from a contactable consumer (patient). A 35-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301458a) via an unspecified route of administration, administered in arm left on 14Sep2021 05:30 PM (age at vaccination was 35 years and she was not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation at pharmacy/ drug store. The patient's medical history included asthma and known Allergies of citalopram, CT dye. There was no other vaccine administered in four weeks. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol sulfate (VENTOLIN HFA), ranitidine hydrochloride (ZANTAC), Ibuprofen, soolantra. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Fd8448) via an unspecified route of administration, administered in arm left on 24Aug2021 06:30 PM (age at vaccination was 34 years) as dose 1, single for covid-19 immunisation. On 15Sep2021 (at 05:15 PM), 24 hours after second dose out of no where she got chills and a fever up to 101.7, body aches, nausea, difficulty breathing, stuffy nose, pain in injection site, feeling exhausted, on 16Sep2021, fever through morning with headaches, body aches, nausea afternoon arm was more sore at injection site and firm and extremely hot, issues with breathing and on 17Sep2021, insomnia, diarrhea, red rash on left arm, migraine and on 18Sep2021, left arm extremely painful hot where red rash was, whole upper arm was itchy going under her armpit up her neck, stiff neck and body aches, heart rate averaging 15 to 20bpm recorded on Apple Watch. The patient did not receive treatment for adverse events. Information of covid prior vaccination and covid tested post vaccination were unknown. The patient underwent lab test and procedure included body temperature and resulted into fever upto 101.7 on 15Sep2021. The outcome of all adverse events was recovering.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Confusional state, Echocardiogram, Full blood count, Headache
Clinical narrative: Headache; Confusion; Bilateral lower extremity weakness; Shaking; This is a spontaneous report from a contactable nurse (patient sister).   A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Left on Sep2021 as dose 3, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia, anxiety and sleep disorder from an unknown date and unknown if ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE via an unspecified route of administration, on unspecified dates as dose 1 and dose2 , single for covid-19 immunisation. Concomitant medication included gabapentin, Trizedon, paracetamol (TYLENOL,) all taken for trigeminal neuralgia, bupropion taken for anxiety, all start and stop date were not reported. The patient had confusion, bilateral lower extremity weakness and like she gonna 'eat them pretty much' (Not clarified), shaking and a headache was admitted in the hospital on Tuesday (14Sep2021), she was still in the hospital. It was reported that patient was in hospital because of possibly related to booster vaccine. Patient was treated with IV steroid, she is going physiotherapy and for headache they gave her tore ball. The patient underwent lab tests and procedures which included on Sep2021 computerised tomogram, echocardiogram, full blood count, x-ray, magnetic resonance imaging: unknown results and on 14Sep2021  Complete blood count (CBC), comprehensive metabolic panel (CMP): unknown results. The outcome of the event was recovering.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Muscular weakness, Tremor, X-ray
Clinical narrative: Headache; Confusion; Bilateral lower extremity weakness; Shaking; This is a spontaneous report from a contactable nurse (patient sister).   A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Left on Sep2021 as dose 3, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia, anxiety and sleep disorder from an unknown date and unknown if ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE via an unspecified route of administration, on unspecified dates as dose 1 and dose2 , single for covid-19 immunisation. Concomitant medication included gabapentin, Trizedon, paracetamol (TYLENOL,) all taken for trigeminal neuralgia, bupropion taken for anxiety, all start and stop date were not reported. The patient had confusion, bilateral lower extremity weakness and like she gonna 'eat them pretty much' (Not clarified), shaking and a headache was admitted in the hospital on Tuesday (14Sep2021), she was still in the hospital. It was reported that patient was in hospital because of possibly related to booster vaccine. Patient was treated with IV steroid, she is going physiotherapy and for headache they gave her tore ball. The patient underwent lab tests and procedures which included on Sep2021 computerised tomogram, echocardiogram, full blood count, x-ray, magnetic resonance imaging: unknown results and on 14Sep2021  Complete blood count (CBC), comprehensive metabolic panel (CMP): unknown results. The outcome of the event was recovering.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.