chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: redness; itching in arm and leg with tiny red bumps. Also felt itchiness in left cheek but no redness.; itching in arm and leg with tiny red bumps; This is a spontaneous report received from a non-contactable consumer (reporting on herself). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. It was reported that patient never had an allergic reaction before she got second dose of BNT162B2 vaccine on left arm. 10 min after reported redness, itching in arm and leg with tiny red bumps. Also felt itchiness in left cheek but no redness. Next morning still had same symptoms. Only took Tylenol. And was asking anyone else experience this. Patient was asking any % of people who got fully vaccinated and got re infected with covid. Saying that been told she should isolate for 14 days after the dose. Asking if that true and wear a mask. The outcome of the events was un-known.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID shortly after; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A female patient of an unspecified age received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0151, Expiration Date: Jul2021) via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient experienced adverse event and diagnosed with COVID-19 shortly. The patient underwent lab tests and procedures which included covid-19: positive on 12Apr2021. The outcome of the events was unknown. The seriousness of the event COVID-19 was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: tested positive with Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On 20Apr2021 the patient tested positive with covid-19 (covid-19). The clinical outcome of the events was unknown. The patient is asking if she should get the second dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On 20Apr2021 the patient tested positive with covid-19 (covid-19). The clinical outcome of the events was unknown. The patient is asking if she should get the second dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Oral blood blister, Pyrexia
Clinical narrative: reporting that he felt feverish; had a blood blister in his mouth; he was really sweaty last night and early this morning; This is a spontaneous report from a contactable consumer.  The male consumer (patient) of an unspecified age received dose of (COMIRNATY, solution for injection, Batch/Lot Number: unknown) on an unspecified date via an unspecified route of administration at single dose for COVID-19 immunisation. The medical history and concomitant medication were not reported. Patient reported that on an unspecified date patient felt feverish, had a blood blister in his mouth, and he was really sweaty last night and early this morning. Patient was if there had been reports of a blood blister in the mouth. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She had Covid-19 after the 1st dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional via RA. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were unknown. Patient underwent lab test and procedure which tested positive for COVID-19 on unspecified date. On an specified date, patient reported that she had Covid-19 after the 1st dose. She wanted to cancel her 2nd dose scheduled on 28APR2021 and asked if it can be rescheduled. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye disorder, Palpitations
Clinical narrative: weakness; dizziness; fast heart rate; when i felt the weakness was coming my right eye got very warm and felt like it was going to be swollen shut, but it never did, but felt warm; 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), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included allergy to animal (to cats and dogs). Concomitant medications were not reported. The patient had the severe reactions that are listed in the fact sheet, it happened within minutes of getting the vaccine, she had weakness, dizziness, fast heart rate, and when she felt the weakness was coming her right eye got very warm and felt like it was going to be swollen shut, but it never did, but felt warm. The events assessed as non-serious. She wants to know if she should not get the second dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she experienced really bad hives on her face and lips.; This is a spontaneous report from a Pfizer sponsored program. The contactable female consumer of unspecified age reported for herself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection) (Lot number& expiry date not reported) via unspecified route of administration on 03, Apr 2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient mentioned that after the 1st dose, she experienced really bad hives on her face and lips. The patient wanted to know if she should continue with the 2nd dose despite what she experienced which she was scheduled on 28, Apr 2021. Outcome of event was unknown. No follow-up attempts are needed; Information about Lot/Batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The caller received his first dose on 12Apr2021. On 19Apr2012 the caller tested positive for covid; This is a spontaneous report received from a contactable consumer (patient, self-reporting). A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 19Apr2021 (7 days post vaccination), the patient tested positive for COVID-19 virus. The patient already completed his 10 days quarantine and had tested back already which shown negative for the virus on 30Apr2021. The patient was scheduled to receive second dose of the vaccine on 03May2021. There was a product complaint The patient just wanted to check if he can safely get the vaccine given that he previously tested positive with COVID19. The outcome of the event was recovered.  Follow-up #1 (30Apr2021): This is a spontaneous report received from a contactable consumer. No new significant information was updated.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: report positive COVID test and that she had one dose of the COVID Pfizer Vaccine on 17Apr2021.; This is a spontaneous report from a contactable nurse (patient). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 17Apr2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient diagnosed with COVID 19 was unknown. Since the vaccination, the patient had been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that the patient contacted (name) clinic on 30Apr2021 to report positive COVID test and that she had one dose of the COVID Pfizer Vaccine on 17Apr2021. Patient did not receive the vaccine at Pfizer where she works as a contractor. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Hypoaesthesia, Pain in extremity, Tinnitus
Clinical narrative: right after her arm was sore for a little bit; pain in her back.; hears thumping and heart pounding  in her head/ears; hears thumping and heart pounding  in her head/ears; she did feel numb in her arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, administered in arm right on Sunday 25Apr2021 at 1:00 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer reported that right after her arm was sore for a little bit and she felt out of it. She reported that she did feel numb in her arm and this went away. She reported the next day something happened in her lower back. She stated she was outside weeding for about 10 minutes and had to take three advil that day because of the pain in her back. She stated she was nervous about the shots and does not want to take the second dose. Consumer also reported that when sleeping she hears thumping and heart pounding in her head/ears that wakes her up. She did not know if that was a heartbeat or blood pressure. She stated she did not want to call her HCP until she talked to someone and asked about myocarditis. On an unspecified date, the patient experienced right after her arm was sore for a little bit, pain in her back, hears thumping and heart pounding in her head/ears, she did feel numb in her arm. Therapeutic measures were taken as a result of event pain in her back and included treatment with take three advil. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: On 20Mar2021 he had dots form on his body so he went to Urgent Care and he was diagnosed with Shingle; This is a spontaneous report from a contactable reporter (patient). A 68-years-old male patient received bnt162b2 first dose of (Formulation: solution for injection) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 20Mar2021, the patient had dots form on his body so he went to urgent care and he was diagnosed with shingle, patient was told by doctor that not to receive the second dose and to wait for the shingles to clear up. The patient said that, the shingles were gone. The patient was scheduled to receive the second dose on 23Mar2021. The events were considered as non serious. The outcome of the event dots form on his body so he went to urgent care and he was diagnosed with shingle was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: he had a COVID-19 test done but the results came back positive for COVID-19 three days later; runny nose; He got the shot without knowing that he had the virus; This is a spontaneous report from a contactable consumer (Caregiver). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Medical history included rhinorrhoea (Verbatim: Runny nose), nasal congestion (Verbatim: Congestion). The patient's concomitant medications were not reported. The patient reported he had a covid-19 test done but the results came back positive for covid-19 three days later, runny nose, he got the shot without knowing that he had the virus on an unspecified date. Patient didn't go to the hospital, had no severe symptoms, only a runny nose, didn't even have a fever or cough". Patient received first dose of Pfizer Covid vaccine on 18Apr2021, that same day in the morning he had a COVID-19 test done but the results came back positive for COVID-19 three days later. patient was originally scheduled to get second dose on 09May2021, however due to the positive COVID-19 test result he was now told he should wait 3 months to receive 2nd dose. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: sore arm; bad headache; felt that bad; This is a spontaneous report from a contactable nurse, other hcp. (Patient mother). A 28-year-06-months old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unknown), via unspecified route on an unspecified date (this past Saturday in Apr 2021) for COVID-19 immunisation. The patient previously received first dose of BNT162b2 vaccine on an unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced a sore arm. Reporter then stated that her son was now complaining of a bad headache and would like to know if it was unusual to experience this side effect 4 days after the vaccine dose. The patient took 2 extra strength Tylenol on morning that did not help, and reporter stated that her son had to ask his professor for an extension on his homework because he felt that bad. Reporter stated that the patient normally do not have headaches but did for a while a couple of months ago, but he cut back on his caffeine consumption which helped. She stated that she has heard on TV and from friends and relatives that this was a common side effect with the vaccine. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: her right arm started feeling heavy with sharp pains in it; her right arm started feeling heavy with sharp pains in it/ her right thumb is "killing me"; her right arm has a tingling sensation and numbness to it; her right arm has a tingling sensation and numbness to it; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in left arm, on 26Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in left arm, on Friday, 26Mar2021, as a single dose for COVID-19 immunization. The patient reported that on Saturday, the patient woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them. She went to her chiropractor for an adjustment, and it appeared to feel a little better, but she reported that her right thumb "was off" feeling numb and with pain. She missed her second dose because her son tested positive for COVID and so she got her second dose on Monday, 26Apr2021. The patient also reported that she was fine but then on Tuesday, her right arm started feeling heavy with sharp pains in it and today she reports that her right thumb was "killing me" and her right arm has a tingling sensation and numbness to it. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Atrial fibrillation, Extra dose administered, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: afib; 104.7 fever; tired; Third dose on 21Apr,  (second dose did not meet requirements of CDC guidelines).; Third dose on 21Apr; This is a spontaneous report from a Pfizer sponsored Program.  A contactable other HCP and clinician (as reported) reported that a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown),via an unspecified route of administration on 01Mar2021 as single dose, second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 10Apr2021 to 22Apr2021, at 1 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced afib, 104.7 fever, tired, third dose on 21Apr. Verbatim and Event Description received as, fever, Atrial fibrillation (AFib), hospitalization, tired, and takes the medication as directed. Patient states Vaccination 01Mar2021, 31Mar2021. Called 4/1 wanted me to take the third dose (second dose did not meet requirements of CDC guidelines). Third dose on 21Apr2021, 22Apr2021 had 104.7 fever, AFib, in hospital four days. Stopped 22Apr2021 Inlyta. See oncologist 28Apr2021.  Felt good when I was on it. Little bit tired, doing okay. The patient underwent lab tests and procedures which included pyrexia: 104.7 on 22Apr2021. Therapeutic measures were taken as a result of afib, 104.7 fever and tired with the medication as directed. Outcome of the events afib, 104.7 fever and tired was recovered for on an unknown date and remaining events were unknown.  Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events of atrial fibrillation and fever cannot be excluded, due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Atrial fibrillation, Blood calcium, Blood creatine, Blood test, Body temperature
Clinical narrative: afib; 104.7 fever; tired; Third dose on 21Apr,  (second dose did not meet requirements of CDC guidelines).; Third dose on 21Apr; This is a spontaneous report from a Pfizer sponsored Program.  A contactable other HCP and clinician (as reported) reported that a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown),via an unspecified route of administration on 01Mar2021 as single dose, second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 10Apr2021 to 22Apr2021, at 1 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced afib, 104.7 fever, tired, third dose on 21Apr. Verbatim and Event Description received as, fever, Atrial fibrillation (AFib), hospitalization, tired, and takes the medication as directed. Patient states Vaccination 01Mar2021, 31Mar2021. Called 4/1 wanted me to take the third dose (second dose did not meet requirements of CDC guidelines). Third dose on 21Apr2021, 22Apr2021 had 104.7 fever, AFib, in hospital four days. Stopped 22Apr2021 Inlyta. See oncologist 28Apr2021.  Felt good when I was on it. Little bit tired, doing okay. The patient underwent lab tests and procedures which included pyrexia: 104.7 on 22Apr2021. Therapeutic measures were taken as a result of afib, 104.7 fever and tired with the medication as directed. Outcome of the events afib, 104.7 fever and tired was recovered for on an unknown date and remaining events were unknown.  Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events of atrial fibrillation and fever cannot be excluded, due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: afib; 104.7 fever; tired; Third dose on 21Apr,  (second dose did not meet requirements of CDC guidelines).; Third dose on 21Apr; This is a spontaneous report from a Pfizer sponsored Program.  A contactable other HCP and clinician (as reported) reported that a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown),via an unspecified route of administration on 01Mar2021 as single dose, second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 10Apr2021 to 22Apr2021, at 1 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced afib, 104.7 fever, tired, third dose on 21Apr. Verbatim and Event Description received as, fever, Atrial fibrillation (AFib), hospitalization, tired, and takes the medication as directed. Patient states Vaccination 01Mar2021, 31Mar2021. Called 4/1 wanted me to take the third dose (second dose did not meet requirements of CDC guidelines). Third dose on 21Apr2021, 22Apr2021 had 104.7 fever, AFib, in hospital four days. Stopped 22Apr2021 Inlyta. See oncologist 28Apr2021.  Felt good when I was on it. Little bit tired, doing okay. The patient underwent lab tests and procedures which included pyrexia: 104.7 on 22Apr2021. Therapeutic measures were taken as a result of afib, 104.7 fever and tired with the medication as directed. Outcome of the events afib, 104.7 fever and tired was recovered for on an unknown date and remaining events were unknown.  Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events of atrial fibrillation and fever cannot be excluded, due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Heart rate irregular, Lymph node pain
Clinical narrative: swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Syncope, Tremor
Clinical narrative: swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Myocardial infarction, SARS-CoV-1 test
Clinical narrative: Heart Attack; Didn't feel good; Tested and I had Covid; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had the first vaccine, 5 days later, patient didn't feel good and then 6 days later patient went to ER (not clarified) and had heart attack, patient wasn't came home and next day got tested and had Covid. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. The event outcome was unknown. Reporter seriousness was unspecified.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Electromyogram, Heavy menstrual bleeding, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Extremely heavy and painful menstrual cycle; Extremely heavy and painful menstrual cycle; Pins and needles/numbness in left leg through foot; numbness in left leg through foot/ Hands and feet "fall asleep"/go numb very frequently; Extreme muscle tightness in left calf; muscle weakness; muscle weakness/fatigue; muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) via an unspecified route of administration at left arm on 02Mar2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications that the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration at left arm on 09Feb2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pins and needles/numbness in left leg through foot began about 3 hours after 2nd dose (from 02Mar2021 12:00). Extreme muscle tightness in left calf. Ultrasound done on calf came back negative. Full brain/spinal cord scan done to detect demyelination of nerves - MRI came back normal. EMG done on left leg to check for peripheral nerve damage - EMG came back normal. Almost 8 weeks post 2nd dose and still experiencing muscle weakness/fatigue and muscle spasms, specifically in legs through feet. Hands and feet "fall asleep"/go numb very frequently, even when the extremities are not restricted in any way. No medication or other treatment given for symptoms. Extremely heavy and painful menstrual cycle this month (1 month after 2nd vaccine, Apr2021), which is extremely abnormal for patient. Events were assessed as serious with criteria of Disabling/Incapacitating. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of muscle weakness/fatigue and muscle spasms was not recovered; outcome of other events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Muscle fatigue, Muscle spasms, Muscle tightness, Muscular weakness
Clinical narrative: Extremely heavy and painful menstrual cycle; Extremely heavy and painful menstrual cycle; Pins and needles/numbness in left leg through foot; numbness in left leg through foot/ Hands and feet "fall asleep"/go numb very frequently; Extreme muscle tightness in left calf; muscle weakness; muscle weakness/fatigue; muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) via an unspecified route of administration at left arm on 02Mar2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications that the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration at left arm on 09Feb2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pins and needles/numbness in left leg through foot began about 3 hours after 2nd dose (from 02Mar2021 12:00). Extreme muscle tightness in left calf. Ultrasound done on calf came back negative. Full brain/spinal cord scan done to detect demyelination of nerves - MRI came back normal. EMG done on left leg to check for peripheral nerve damage - EMG came back normal. Almost 8 weeks post 2nd dose and still experiencing muscle weakness/fatigue and muscle spasms, specifically in legs through feet. Hands and feet "fall asleep"/go numb very frequently, even when the extremities are not restricted in any way. No medication or other treatment given for symptoms. Extremely heavy and painful menstrual cycle this month (1 month after 2nd vaccine, Apr2021), which is extremely abnormal for patient. Events were assessed as serious with criteria of Disabling/Incapacitating. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of muscle weakness/fatigue and muscle spasms was not recovered; outcome of other events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Ultrasound scan
Clinical narrative: Extremely heavy and painful menstrual cycle; Extremely heavy and painful menstrual cycle; Pins and needles/numbness in left leg through foot; numbness in left leg through foot/ Hands and feet "fall asleep"/go numb very frequently; Extreme muscle tightness in left calf; muscle weakness; muscle weakness/fatigue; muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) via an unspecified route of administration at left arm on 02Mar2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications that the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration at left arm on 09Feb2021 08:30 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pins and needles/numbness in left leg through foot began about 3 hours after 2nd dose (from 02Mar2021 12:00). Extreme muscle tightness in left calf. Ultrasound done on calf came back negative. Full brain/spinal cord scan done to detect demyelination of nerves - MRI came back normal. EMG done on left leg to check for peripheral nerve damage - EMG came back normal. Almost 8 weeks post 2nd dose and still experiencing muscle weakness/fatigue and muscle spasms, specifically in legs through feet. Hands and feet "fall asleep"/go numb very frequently, even when the extremities are not restricted in any way. No medication or other treatment given for symptoms. Extremely heavy and painful menstrual cycle this month (1 month after 2nd vaccine, Apr2021), which is extremely abnormal for patient. Events were assessed as serious with criteria of Disabling/Incapacitating. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of muscle weakness/fatigue and muscle spasms was not recovered; outcome of other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dyskinesia, Lip swelling, Moaning, Muscle rigidity
Clinical narrative: Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering.   Follow-up information requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering.   Follow-up information requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Fever; Real bad sweat; throwing up and it lasted for 9 hours; This is a spontaneous report received from a contactable consumer (patient) reported for himself.  A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiry date: unknown) intramuscular, administered in left arm on 22Apr2021 at 11:00 am (age at vaccination was 62 years) at a single dose for COVID-19 immunisation. The patient's medical history included blood pressure high, heart disease, kidney disease and COPD for which the patient had taken lot of medication (Further clarification unknown). Concomitant medication was not reported. The consumer stated that he had his first Pfizer shot on the 22 which was last Thursday at 11 clock in the morning and at 6 'o' clock that night he started running the fever, having real bad sweats and throwing up and it lasted for 9 hours and but the next morning he was okay and his concern was, whether he should take the next shot or not. The consumer stated that he didn't have any computer, so he didn't have smartphone so he didn't have any email, they could text message him at the phone number he had given them. Reporter seriousness for events was unspecified. The consumer stated that the scheduled date of second shot was 13May2021. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Deep vein thrombosis, Muscle spasms, Pyrexia
Clinical narrative: DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis and suspect drug bnt162b2 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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate