chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test, SARS-CoV-2 test positive, Vomiting
Clinical narrative: did not want to eat; flushed and hot; tested positive for covid; congestion in chest; mucus cough; vomiting and clammy; vomiting and clammy; headache; sore throad; Fever; chills; Chest tightness; coughing profusely; This is a spontaneous report from a contactable consumer or other non hcp.   A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jun2021 13:35(age at vaccination 21 years) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient got her first dose of the Pfizer Covid 19 vaccine on 14Jun2021 and is scheduled to get the second dose on 07Jul2021. On 19Jun2021 on Saturday, after they came home from an event the patient experienced coughing profusely, a lot of congestion in her chest, then she started vomiting, she was turning red and clammy and sweating and developing a fever, states initially she treated symptoms with a cold compress, headache, chills and cold sweats. yesterday afternoon she was clammy again and continued to vomit and complaining of chest tightness as well, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion. States today they decided to go to the ER, and she tested positive for Covid on 21Jun2021. she did not want to eat on an unspecified date. The patient treated with Advil and Ibuprofen/Motrin. The patient underwent lab tests which included sars-cov-2 test: positive on 21Jun2021. She Wants guidance on getting the second dose. The event outcome is Unknown for tested positive for covid, did not want to eat, flushed and hot and coughing profusely, Not recovered for Chest tightness, congestion in chest, mucus cough, sore throat and headache Recovering for vomiting and clammy, Fever and chills.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site rash
Clinical narrative: Had a localized rash at injection site; Red blotchy spot and itchy; Red blotchy spot and itchy; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jun2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included Asthma from an unknown date and unknown if ongoing Diagnosed when she was a baby, Gestational hypertension from an unknown date and unknown if ongoing Diagnosed 23 years ago, covid-19 from 2020 to 2020 Had Covid last year. The patient's concomitant medications were not reported. The patient experienced had a localized rash at injection, red blotchy spot and itchy on 21Jun2021 16:43. It was reported that, she received the dose around 3 pm and around 4:43 pm she had a localized rash at injection site that hasn't worsened. Caller wanted to know if she could use topical Benadryl after 1st dose of Pfizer Covid 19 vaccine. Consumer had no other questions during callback. Requested document to be emailed to her. The caller was calling about the covid vaccine. The caller just received the first dose today and she took the Band-Aid off and its red blotchy and itchy. The caller wants to know if she could she put benadryl on it. The caller doesn't want to take benadryl because she doesn't want to be sleepy. It was getting hivey and the caller doesn't know if it will get worse? It doesn't hurt its just a little itchy. It was not where the band aid was, it was right in the middle where the needle was, the caller's arm isn't too swollen yet. If the caller chooses not to get the second vaccine is it okay? Is it like not getting the vaccine? The caller doesn't want to go through this again. The patient had the vaccine at 3:00 pm and this event started at 4:43 pm. The spot is a little bit bigger than a quarter. When the caller took the Band-Aid off there was nothing there at all, but now the main blotch spot is about the size of a quarter and there are a couple of little pinpoint spots around it. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single, patient received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced herpes during the two doses, the patient inquired that she could take Valacyclovir without it diminishing the effect of the vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Multiple allergies, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: I started having severe allergies and they have not stopped as of today 21Jun2021; severe sinusitis; It began as a sore throat; developed into a chronic cough; sneezing; occasional weakness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL3247), at the age of 34 years old, in left arm on 20Apr2021 17:00 at single dose for covid-19 immunisation. Medical history was none. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took aspartame and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL3247), at the age of 34 years old, in left arm on 30Mar2021 09:30 at single dose for covid-19 immunisation. On 01May2021 07:00, within 2 weeks of the second vaccine, the patient started having severe allergies and they had not stopped as of 21Jun2021. It began as a sore throat and developed into a chronic cough. Within a few weeks the patient was also experiencing severe sinusitis and sneezing. The patient also experienced occasional weakness. All symptoms had been somewhat managed through doctor provided and over-the-counter (OTC) medication. The patient had never had to deal with seasonal or other allergies before. The patient had been tested for covid-19 since the vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT, PCR (covid-19) test (nasal swab) negative on 11May2021. Therapeutic measures were taken as a result of the event severe allergies and included treatment with prescription medication. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Sneezing
Clinical narrative: I started having severe allergies and they have not stopped as of today 21Jun2021; severe sinusitis; It began as a sore throat; developed into a chronic cough; sneezing; occasional weakness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL3247), at the age of 34 years old, in left arm on 20Apr2021 17:00 at single dose for covid-19 immunisation. Medical history was none. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took aspartame and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL3247), at the age of 34 years old, in left arm on 30Mar2021 09:30 at single dose for covid-19 immunisation. On 01May2021 07:00, within 2 weeks of the second vaccine, the patient started having severe allergies and they had not stopped as of 21Jun2021. It began as a sore throat and developed into a chronic cough. Within a few weeks the patient was also experiencing severe sinusitis and sneezing. The patient also experienced occasional weakness. All symptoms had been somewhat managed through doctor provided and over-the-counter (OTC) medication. The patient had never had to deal with seasonal or other allergies before. The patient had been tested for covid-19 since the vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT, PCR (covid-19) test (nasal swab) negative on 11May2021. Therapeutic measures were taken as a result of the event severe allergies and included treatment with prescription medication. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Restlessness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 37-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient had patient reported she had chills, body aches and restlessness, she stated symptoms were similar to her covid-19 injections on an unspecified date. The outcome of the events were unknown. Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Lab confirmed covid; Lab confirmed covid; This is a spontaneous report from a contactable other health care professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ocrelizumab (OCREVUS). On an unspecified date, the patient experienced lab confirmed COVID. Caller stated, I can add that one of these patient's was a male, around 50, and obese. Quoted by HCP was OK- two ms patient now>1 month post second vaccine (both Pfizer) with lab confirmed covid. Both with medically significant illness, neither required hospitalization (one went to ER for shortness of breath and lowO2). On an unspecified date, the patient underwent lab tests and procedures which included COVID-19: lab confirmed COVID. The outcome of the event was unknown.  No further information was reported. Information about batch/Lot number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid 19 . The case will be reassessed once new information is available
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling of her tongue; This is a spontaneous report from a contactable pharmacist via a sales representative. A female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling of her tongue begin within 15 minutes after administration. Swelling was described as mild and did not inhibit breathing. Therapeutic measures were taken as a result of swelling of her tongue was given diphenhydramine. The outcome of event was recovering.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Oxygen saturation decreased, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Lab confirmed covid; Lab confirmed covid; shortness of breath; low O2; This is a spontaneous report from a contactable Other Health Care Professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ocrelizumab (OCREVUS) taken for unspecified indication start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, it was reported that patient experienced COVID after 1 month of second  vaccine (both Pfizer) which was Lab confirmed covid. Both with medically significant illness, neither required hospitalization one went to ER for shortness of breath and low O2. The patient underwent lab tests and procedures which included sars-cov-2 test positive: confirmed on an unspecified date. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: As per the information provided in the narrative, the causal association between the suspect drug and 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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104  , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number.  Information on the lot/ batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear pain, Fatigue, Headache, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104  , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number.  Information on the lot/ batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104  , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number.  Information on the lot/ batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104  , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Malaise, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A consumer (patient) of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 18Jun2021 at approximately 13:00 in afternoon as dose number unknown, single for COVID-19 immunization. Medical history included high blood pressure which was diagnosed a year ago and the patient had nausea, vomiting and all same symptoms which occurred after vaccination. The patient concomitant medications were not reported. On 19Jun2021 the patient was not feeling too good and on 20Jun2021 it was even worse as the patient experienced vomiting all day and it seemed to become worse. It was not subsiding as the patient thought it would. The patient asked was this a typical side effect of blood pressure and checked blood pressure which was normal. The patient was wondering if whole nausea thing was picked up since morning and had gotten worse during the day. The patient also experienced some soreness and stuff on an unspecified date in Jun2021. The patient underwent lab tests and procedures which included blood pressure measurement as normal. The outcome of all the events was not resolved. Follow-up attempts are possible. Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site mass
Clinical narrative: Have a bump in the area where she got the injected; Tingling in her nerves, like weird stimulations in her nerves/tingling from arm to the neck; numbness in arm; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, and expiry date: not reported)dose 1, via an unspecified route of administration, administered in arm on Jun2021 (at the age of 58years) as single dose for covid-19 immunisation. Medical history included arthritis, gastrooesophageal reflux disease (GERD), allergy. The patient's concomitant medications were taking medications for GERD and for allergies (she had allergies and arthritis). No investigation assessment done. The patient had received her first dose in the beginning of Jun2021 and she was experiencing side effects as like tingling in her nerves, like weird stimulations in her nerves (start date: Jun2021) and she also had like still have a bump in the area where she got the injected (start date: Jun2021) with the COVID 19 vaccine, and she told the tingling all the way from the injection site into her full arm into like a finger and then all the way back into her neck. The patient was experiencing some side effects such as tingling in the nerves, bump at injection area, numbness in arm (start date: Jun2021), and tingling from arm to the neck. Events were being still experienced and, it was actually seemed to be getting worst. It was still the same, like she said it seemed to be getting a little bit worse, the more she used her arm like it seemed to be more persistent and was not 'intermittent' anymore. No treatment was done for events. The outcome of events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: had prior anaphylactic reaction, seen at ED; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 17Jun2021 12:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient age at vaccination was 52-year-old. The patient medical history included sulfa allergy. Patient was not pregnant. Historical vaccine included 1st dose of BNT162B2 on 27May2021 at 12:00 pm via intramuscular in left arm for COVID-19 Immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), duloxetine and fexofenadine hydrochloride (ALLEGRA), all taken for an unspecified indication, start and stop date were not reported.  The patient had prior anaphylactic reaction on 17Jun2021.  Event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (Immediate risk of death from Event). Therapeutic measures were taken as a result of event included epi x 2, steroids, Benadryl. Outcome of the event was not resolved.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Pruritus, Throat tightness, Urticaria
Clinical narrative: Full body itchiness; Red face; Hives on left arm; Tightness in throat; coughing; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient (no pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 21Jun2021 at 10:00 AM at 43-year-old as single dose for COVID-19 immunization. Medical history was reported as: known allergies included: Sulfa, seaonal allergy, milk, allergy shots, and penicillin shot. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication included Clarithromycin (CLARITIN) within 2 weeks of vaccination. On 21Jun2021 at 11:15 AM, the patient experienced full body itchiness, red face, hives on left arm and tightness in throat and coughing. High dose of Benadryl and antihistamine were received as treatment. The outcome of events was recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea; Headache; Very Tired; Soreness; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jun2021 (Lot Number: EW0191) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nausea, headache, very tired, and soreness on an unspecified date and wanted to know how long side effects lasts. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Protein urine present
Clinical narrative: high protein in urine; This is a spontaneous report from a contactable consumer (patient's father). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the PFIZER COVID VACCINE less than 2 weeks ago in Jun2021 and went to his doctor for a regular annual check-up and for the first time, he had high protein in his urine on an unspecified date in Jun2021. The outcome of event was unknown.  Follow up attempts are needed; Information on lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got covid after it; he got covid after it; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non-health care professional (patient's wife) reported for male patient (reporter's husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had vaccine but got covid after it. On an unspecified date the patient underwent lab tests and procedures which included Covid-19 positive.  Information on the batch/lot number has been requested. Additional information is expected
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Increased heart rate; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced increased heart rate after COVID vaccine on 21Jun2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report received from a contactable consumer (patient). A 12-year-old male patient received second dose of BNT162B2 (lot number: EW0202) on 06Jun2021 (at age of 12-year-old) at single dose for COVID-19 immunisation. Medical history included known allergies: Penicillins. Concomitant medications were none. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 on unspecified date for COVID-19 Immunization. Patient experienced Appendicitis and appendectomy starting 5 days after 2nd shot (11Jun2021). The evet result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 1 day. Treatment Appendectomy received. The outcome of the event was recovered in Jun2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had Covid test post vaccination: Nasal Swab on 12Jun2021 with result of negative. The seriousness criteria was reported as Life threatening and Caused/prolonged hospitalization.   Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and headache on an unspecified date. The outcome for the events were unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She got allergic reactions; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jun2021 (Batch/Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergic reactions on 21Jun2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms, Urine analysis abnormal
Clinical narrative: Cramps; Started her period again after being post menopausal; Dark urine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female 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 22May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the 1st dose of the Pfizer COVID19 vaccine 22May2021 and since then she has had dark urine, cramps, and has started her period again after being post-menopausal on an unspecified date. Her 2nd dose was scheduled to be had 28Jun2021 and she was asking if there was any guidance for her regarding getting the 2nd dose or not. She stated she was terrified. She continued to have intermittent cramping this week with dark urine. She remembered hearing something and unsure if there was possible blood in her urine. Caller stated this was infuriating to people like her after advises no information available for consumers regarding post-menopausal bleeding and referring to HCP. She states that she has done some of her own research and felt it was 100 percent associated with the vaccine. Millions of women were experiencing this. She would like this concern to be forwarded to whomever needs to know this was happening. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell Palsy symptoms/left facial nerve palsy; This is a spontaneous report from a contactable physician reported for a female patient.  A 30-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) solution for injection, intramuscular, administered in arm left on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 30-year-old, not pregnant) for COVID-19 immunization.  The patient medical history was not reported. Concomitant medication included clindamycin.  The patient previously took amoxicillin and azithromycin and experienced allergy both.  The patient previously received BNT162B2 for Covid-19 Immunization as 1st dose.  There was no other vaccine in four weeks.  The patient did not have COVID-19 prior vaccination, no COVID tested post vaccination.  The most recent COVID-19 vaccine was administered in pharmacy or drug store.  Since the vaccination, the patient had not been tested for COVID-19.  Patient started developing left facial weakness 3 days after the vaccination on 18Jun2021 and had progressed to significant left facial nerve palsy on 18Jun2021. Seen today (22Jun2021) in ER by the physician, 4 days of progressing bell Palsy symptoms from 18Jun2021. These events resulted in emergency room/department or urgent care.  These events did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  The patient received treatment of steroids and antiviral medications.  Outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event Bell's palsy was related to BNt162b2 based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Productive cough
Clinical narrative: coughing; phlegm for more than 15 days; she has mucus when she blows her nose and her mucus has blood in it as well; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 55-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 24May2021 (age at vaccination: 55 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 55 year), as a single dose for COVID-19 immunization. The patient reported that she received the second dose of the Pfizer COVID vaccine on 24May2021 and on an unspecified date, she has been coughing with a lot of phlegm for more than 15 days now. She also stated she had mucus when she blows her nose, and her mucus had blood in it as well. The patient was wondering if anybody had reported this. She also stated she took antibiotics for the mucus because the doctor said it's not a side effect of the vaccine and is just sinus. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: have been throwing up for 6 hours non-stop and that is just horrible.; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has been throwing up for 6 hours non-stop and that was just horrible on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Lymphadenopathy
Clinical narrative: She is asking if it's okay to take it further than her scheduled 2nd dose; she has lymphadenopathy; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date: not reported), via an unspecified route of administration on 09Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in Jun2021, the patient experienced lymphadenopathy. The clinical course of the events was reported as she received the 1st dose of our COVID-19 vaccine last 09Jun2021 and scheduled for the 2nd dose on 08Jul2021 (29 days apart). She claimed that her daughter just read about the new update that it was okay to take the 2nd dose within a maximum of 42 days. If this was so, she was asking if it was okay to take it further than her scheduled 2nd dose because she had lymphadenopathy (as long as it would not exceed 42 days). She was also asking if there would be side effects when she did take the 1st dose and not knowing that it might affect people with swelling of the lymph nodes. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 03Jun2021, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) DOSE 1, SINGLE  for covid-19 immunization (no reaction experienced).On 03Jun2021, the day patient received the 2nd shot of COVID vaccine, patient experienced fever. The outcome of event was unknown.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pallor, Vomiting
Clinical narrative: throwing up; white as a ghost; wasn't feeling good; This is a spontaneous report from a contactable consumer (Mother of patient).  A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0196 and expiration date: not reported), via an unspecified route of administration, on Right Arm, on 12Jun2021 in the afternoon (at the age of 12-year-old), as DOSE 1, SINGLE for covid-19 immunization at . The patient had no medical history and there were no concomitant medications. There were no other previous immunizations. No other vaccines administered on same date. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. There were no adverse events following prior vaccinations. Reporter stated that, the patient has an elderly grandmother and patient wanted to go see her and every time they go see her, they have to get tested for COVID. On 22Jun2021 patient experienced, throwing up. The patient went and got the milk and came back and wasn't feeling good, she was as a ghost on 22Jun2021. The reporter stated that patient is okay now, at the time of reporting, and wanted to know if it was normal after taking the shot, if it was a side effect from the shot or not. No test was taken. The outcome of the events was recovered on 22Jun2021.