chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: chills; fever like symptoms like sweats and hot but no fever; fever like symptoms like sweats and hot but no fever; headache; nausea; not feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 21Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced chills, fever like symptoms like sweats and hot but no fever, headache and nausea. Caller stated she is continuing on day 8 of side effects. She reported that her daughter experienced chills, fever like symptoms like sweats and hot but no fever, headache and nausea. She stated that tylenol takes the headache away for about 3 to 4 hours. Reporter stated she gave her daughter zofran in the mornings for nausea. Reporter stated ibuprofen does not help much. She stated her daughter tested negative for covid. She stated her daughter has missed some school and athletic events and reports not feeling well. Reporter stated her daughter had better days on days 2 and 3 and her worst days were yesterday and today. She reported tylenol did not help much, only for a limited time. She was concerned that the side effects are not going away and not alleviating. She asked is this common for there to be this many side effects this many days after the first dose. Reporter asked does she move forward with the second dose. She stated the pediatrician told her to ask Pfizer. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Peripheral swelling
Clinical narrative: hands are swelling; joints and muscles ache like heck; joints and muscles ache like heck; This is a spontaneous report from a Pfizer sponsored program COVAX Support consumer(patient) reported for himself that: A male 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 as single dose for COVID-19 immunization. Medical history included covid-19. Concomitant medications were not reported. It was reported that Would like to speak to someone about a reaction to covid vaccine. Said hands are swelling, joints and muscles ache like heck. also did have covid before getting 1st dose of covid vaccine. 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: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported two reports for herself and her son. This is one of the two reports. An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 2nd dose of the Pfizer covid vaccine yesterday on 28Apr2021. He had a fever in Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pyrexia
Clinical narrative: He got fever; His eye has been red since then; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Apr2021, the patient experienced he got fever, his eye has been red since then (he had like normal symptoms like he got fever but his eye has been red since then. So, is it something common that happened, I searched on web I couldn't find something for redness of eye, like after the 2nd vaccine). The outcome event was recovered for he got fever and not recovered for his eye has been red since then.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 4-5 days later she tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program (patient) reported for herself that: A female patient of unspecified age received first dose of BNT162B2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot number and expiration was not reported) via unspecified route of administration as single for COVID-19 immunization. Medical history and concomitant medication were not provided. It was reported that Caller received 1st dose of Covid vaccine 11Apr and 4-5 days later she tested positive for Covid. Her 2nd dose of the vaccine is supposed to be on Wednesday, and she was wondering if she can take it. Patient underwent lab test and procedure which included SARS-CoV-2 test positive on unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient's medical history included ventricular extrasystoles. She has had PVCs in past but no other underlying conditions. The patient's concomitant medications were not reported. The patient experienced vertigo on 25Apr2021. Event took place after use of product. On an unspecified date, the patient experienced slight dizziness, slight headache, and increased number of PVC's, although she normally does get them. The outcome of the events was unknown.   No Follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Liver function test, Liver function test increased, Rhabdomyolysis, SARS-CoV-2 test
Clinical narrative: Rhabdomyolysis (CK > 22.000); Elevated LFTs; This is a spontaneous report from a contactable physician. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 21-year-old on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was School or  Clinic. Medical history included asthma. Concomitant medication included ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported. The patient experienced rhabdomyolysis (CK > 22.000) (hospitalization) on 24Apr2021, elevated LFTs (hospitalization) on 24Apr2021.  The patient underwent lab tests and procedures which included blood creatine phosphokinase: > 22.000   on 24Apr2021, liver function test: elevated on 24Apr2021, SARS-CoV-2 test: negative on 25Apr2021 (Nasal Swab). Therapeutic measures were taken as a result of rhabdomyolysis (CK > 22.000), elevated LFTs. The outcome of events was recovering.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rhabdomyolysis and Elevated LFTs. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient sister).  A 56-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number and Dose number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The medical history and concomitant medication were not reported. On an unspecified date, patient experienced rash after developing symptoms. The outcome of the event rash was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer or other non- healthcare professional (patient's sister). A 55-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced rash. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Reporter (female, aged 57) mentioned that she received second dose on 23Apr2021, then on Monday she developed little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs. Reporter also mentioned that her sister who lived with her aged 56, also developed a similar rash after developing symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The patient's medical history and concomitant medications were not reported. Caller reporting adverse event with Pfizer Covid vaccine. She was surprised by all of this after the vaccine. Her brother had one and he was six years older than caller and it didn't phase him, only a sore arm. 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, SARS-CoV-2 antibody test
Clinical narrative: tested postive; This is a spontaneous report from contactable consumer (patient's parent) by a Pfizer sponsored program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was and concomitant medications were not reported. The patient received 1st vaccine on Friday (23Apr2021) and than tested positive for COVID-19.  Outcome of the event was unknown. The patient will have 2nd Dose on May 20th.  IInformation on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Lymphadenopathy, Nausea
Clinical narrative: Fever; Chills; kind of nauseous like with the name eating; I have been eating things stomach like things stick on stomach; it is swollen under my arm that I got the shot in; headache; Under my arm is lymph node under my arm is very swollen and got bigger; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (reported as past Monday) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, via an unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunization. After patient had a second vaccination of Pfizer shot on Monday (as reported). Patient experienced lots of problem like headache, chills, fever and kind of nauseous like with the name eating and she had been eating things stick on stomach and she had swollen under arm that she got the shot in. Under her arm was lymph node swollen and got bigger. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Fever; Chills; kind of nauseous like with the name eating; I have been eating things stomach like things stick on stomach; it is swollen under my arm that I got the shot in; headache; Under my arm is lymph node under my arm is very swollen and got bigger; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (reported as past Monday) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, via an unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunization. After patient had a second vaccination of Pfizer shot on Monday (as reported). Patient experienced lots of problem like headache, chills, fever and kind of nauseous like with the name eating and she had been eating things stick on stomach and she had swollen under arm that she got the shot in. Under her arm was lymph node swollen and got bigger. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Severe joints pain; Got fever a 100 and 101; Headache; Severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0170) via unspecified route of administration on an unknown date in left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication (Other medications: Consumer stated I am taking something for prostate and Lipitor I think) was not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8737) via unspecified route of administration on an unknown date in left arm as a single dose for COVID-19 immunization. It was reported that patient received his second shot of COVID vaccine and at around 2:00  had the adverse reaction got fever a 100 and 101, headache, severe joints pain and severe fatigue. The outcome of the events was unknown.   No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer (patient). This is a cloned case, report 2 of 2. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced fever and chills. Therapeutic measures were taken as a result of fever and chills. The patient stated that they all had certain symptoms but most people have had what they have. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Lumbar puncture, Magnetic resonance imaging head, Nervousness, Tremor
Clinical narrative: Too nervous about second dose of Covid-19 vaccine to drive to vaccination facility; A little shaky; This is a spontaneous report received from a contactable consumer (patient's wife). A 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 19Jan2021 10:20 (at 82-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol a long time ago, at least 10 or 15 years, high blood pressure a long time ago, at least 10 or 15 years, high triglycerides a long time ago, at least 10 or 15 years. Concomitant medication(s) included hydrochlorothiazide(HYDROCHLOROTHIAZIDE) taken for high blood pressure from an unspecified start date to Apr2021; eicosapentaenoic acid ethyl ester (VASCEPA) taken for high triglycerides from an unspecified start date to Apr2021; atorvastatin (ATORVASTATIN) taken for high cholesterol from an unspecified start date to Apr2021 and Multi vitamin. Patient underwent laboratory test including a CT scan and MRI, a spinal tap on the patient, and all the tests the medical staff could possibly run to try to find out what the problem was with the patient and the doctors didn't find anything on 2021. On 19Jan2021 patient experienced a little shaky following his first dose of the Covid-19 vaccine and patient was too nervous about second dose of Covid-19 vaccine to drive to vaccination facility on Feb2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Extreme diarrhea; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported. A 38-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ER8729), intramuscular, administered in Arm Left on 12Apr2021 as single dose for COVID-19 immunisation. Patient had diarrhea as well, after the first dose of the vaccine. Patient knows it came on hard, while patient was driving her car. Reporter states patient does not feel comfortable answering all of these questions for her daughter, states she is only on birth control, no further information required. The outcome of the event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhage, Heavy menstrual bleeding, Hot flush, Hypersensitivity
Clinical narrative: Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Allergies; Hot flashes; Nausea waves for two weeks; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0151) as 2ND DOSE, SINGLE for covid-19 immunization, at the Age at Vaccination of 36 years old.  The patient medical history was not reported. Patient was not Pregnancy at time of Vaccination. Historical vaccine included first dose of BNT162B2 on 20Mar2021 (Lot number: EP6955; Dose number=1; Vaccine location=Left arm) for covid-19 immunization, reported the first shot she had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Concomitant medications (medications the patient received within 2 weeks of vaccination) included Implanon, Straterra, adderall, multivitamin, ashwa (as reported), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bleeding (medically significant), along with a week and a half of heavy fatigue (non-serious), sneexzing (non-serious), allergies, hot flashes, nausea waves for two weeks (non-serious), heavier menstrual bleeding (non-serious), all on 25Apr2021 with outcome of unknown. Reported as she never have period due to her birth control methods. She got heavier bleeding a few days after her second dose that lasted about a week, along with a week and a half of heavy fatigue, Sneexzing and feeling like she had allergies, with occasional hot flashes and nausea waves for two weeks. And even heavier menstrual bleeding starting 15 days after second shot. No treatment received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sneezing
Clinical narrative: Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Allergies; Hot flashes; Nausea waves for two weeks; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0151) as 2ND DOSE, SINGLE for covid-19 immunization, at the Age at Vaccination of 36 years old.  The patient medical history was not reported. Patient was not Pregnancy at time of Vaccination. Historical vaccine included first dose of BNT162B2 on 20Mar2021 (Lot number: EP6955; Dose number=1; Vaccine location=Left arm) for covid-19 immunization, reported the first shot she had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Concomitant medications (medications the patient received within 2 weeks of vaccination) included Implanon, Straterra, adderall, multivitamin, ashwa (as reported), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bleeding (medically significant), along with a week and a half of heavy fatigue (non-serious), sneexzing (non-serious), allergies, hot flashes, nausea waves for two weeks (non-serious), heavier menstrual bleeding (non-serious), all on 25Apr2021 with outcome of unknown. Reported as she never have period due to her birth control methods. She got heavier bleeding a few days after her second dose that lasted about a week, along with a week and a half of heavy fatigue, Sneexzing and feeling like she had allergies, with occasional hot flashes and nausea waves for two weeks. And even heavier menstrual bleeding starting 15 days after second shot. No treatment received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Influenza, Pyrexia, Rhinorrhoea
Clinical narrative: Mild flu; Runny nose; Cough; Fever; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for her 70 years mother-in-law.   A 70 years old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 23Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 2 weeks after the vaccination, the patient experienced symptoms of a mild flu with runny nose, cough, fever and headache. Patient was tested for COVID-19 because of her symptoms but the result was negative. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Mild flu; Runny nose; Cough; Fever; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for her 70 years mother-in-law.   A 70 years old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 23Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 2 weeks after the vaccination, the patient experienced symptoms of a mild flu with runny nose, cough, fever and headache. Patient was tested for COVID-19 because of her symptoms but the result was negative. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sepsis
Clinical narrative: sepsis; A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO ASSESS THE EFFICACY AND SAFETY OF AD26.COV2.S FOR THE PREVENTION OF SARS-COV-2-MEDIATED COVID-19 IN ADULTS AGED 18 YEARS AND OLDER  This is a Non-Pfizer sponsored interventional study report, based on information received by Pfizer from Janssen Vaccines & Prevention B.V. (manufacturer report number USA-U38-US10051-2021-VAC31518COV3009000010 (0)).   A 52-year-old male subject received blinded therapy (Ad26.COV2.S /Placebo) on unspecified date. The subject also received Pfizer COVID-19 vaccine (BNT162B2), intramuscularly, first dose on unspecified date and second dose on 17Apr2021. The subject's medical history was not reported. Concomitant medications included alprazolam from 01Jan2015 for anxiety, rosuvastatin from 01Jan2018 for high cholesterol, and lisinopril from 01Jan2018 for high blood pressure. The subject experienced sepsis on 18Apr2021, which was considered as life-threatening event and required hospitalization. Clinical course was as follows: subject's wife called site on 26Apr2021 to report that subject had not been feeling well since 18Apr2021, one day after receiving second dose of Pfizer COVID-19 vaccine. He was having body aches and fatigue. Since symptoms were getting worst, subject decided to go to hospital on 22Apr2021. He was admitted and informed he had sepsis. Subject continued being in the hospital. Sepsis adverse event toxicity was grade 4. Relevant tests were not reported. The action taken in response to the event for blinded therapy and for BNT162B2 was not applicable. The outcome of the event was recovering.  The investigator considered there was not a reasonable possibility that the event sepsis was related to blinded therapy; however, the investigator assessment of the causal relationship of the event sepsis with the product BNT162B2 was not provided at the time of this report. Efforts are being made to obtain such final determination. Since no determination has been received, the case is managed as if the investigator's assessment was that a reasonable possibility exists that the event was related to BNT162B2, as a cautionary measure and for reporting purposes.; Sender's Comments: Based on the information currently provided, the company considers there is not a reasonable possibility that the event sepsis is related to Pfizer COVID-19 vaccine (BNT162B2) and Non Pfizer blinded therapy due to the lack of a plausible pathophysiological mechanism.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Calling for her daughter who took 1st dose of Covid vaccine a few weeks ago and developed an intermittent, fine, itchy rash and still had it as of last weekend; This is a spontaneous report from a contactable consumer. A contactable mother reported for her daughter (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving 1st dose of Covid vaccine patient developed an intermittent, fine, itchy rash and still had it as of last weekend. 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: Dyspnoea, Illness, Skin erosion, Skin warm
Clinical narrative: Daughter took 2nd dose yesterday and got very sick and skin was hot to the touch; Daughter took 2nd dose yesterday and got very sick and skin was hot to the touch; At 1am the daughter called and was having trouble breathing; Today her rash is gone but now the skin feels raw; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for her daughter (patient) of an unspecified age that she received the second dose of 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 in 2021 (reported as yesterday) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization a few weeks ago after which the patient developed an intermittent, fine, itchy rash and still had it as of last weekend. The reporter stated that the patient took 2nd dose yesterday and got very sick and skin was hot to the touch. At 1am, the patient called and was having trouble breathing. Today the rash was gone but now the skin feels raw. The patient would like to talk about the side effects with someone. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash after the first dose; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on an unknown date for COVID-19 immunisation. The patient medical history included Polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS). Concomitant medications were not reported. It was reported that the patient experienced rash after the first dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: throbbing of my left arm; 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 mRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration, in left arm on 24Mar2021 10:30 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced throbbing of left arm for approximately 24 hours. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Soreness at the puncture site; slight fever lasting 1 hour; This is a spontaneous report from a contactable consumer (patient).   An unspecified age and gender of patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0161) via an unspecified route of administration on 14Apr2021 at 10:30 as a single dose for COVID-19 immunization. Past vaccination includes first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via unspecified route of administration on 24Mar2021 at 10:30 AM as a single dose for COVID-19 immunization and side effect was a throbbing of left arm for approx.24 hours. The patient medical history was not reported. Concomitant medication included arnica montana (ARNICA (PLANTA TOTA) "WELEDA") (MANUFACTURER UNKNOWN).  Patient chose to take Arnica on tues prior (with the ok from patient's primary care and RN at the vaccination clinic (withheld). On an unspecified date, that time, patient's symptoms were soreness at the puncture site (only when the patient accidentally touched) and a slight fever lasting 1 hour. On Friday, patient was feeling fine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of (Pfizer/BioNTech COVID-19 Vaccine, Solution for injection, and expiry date: not reported) via an unspecified route of administration in the region of left arm on 09APR2021 at single dose for Covid19 immunisation. Medical history of the patient was reported as cataract, which the patient had for over a year and Left eye surgery for cataracts. The patient's concomitant medication was not reported. The patient had cataract surgery in the left eye on 20Apr2021, the outcome of which at the time of observation was reported as recovered. On an unspecified date after the vaccination the patient experienced soreness in the left arm that went away in 4-5 days. The outcome of the event soreness in the left arm was unknown.  No follow-up attempts are needed. No further information is expected. .
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Peripheral swelling, Pyrexia, Vaccination site mass
Clinical narrative: lump under his armpit on same arm that he got the shot in; lump under his armpit on same arm that he got the shot in; swollen lymph nodes (lymphadenopathy); Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0157), via an unspecified route of administration, on 21Apr2021 at 10:30, administered in Arm Right as single dose for covid-19 immunisation. Patient's first dose of bnt163b2 (BNT162B2, Batch/lot number: ER8733) was administered on 31Mar2021 at 10:30 in left arm. The patient's concomitant medications were not reported.  On 21Apr2021 the patient experienced fever (08:00), chills (thinks around 21:00 or 22:00). She says on 21Apr2021, the same day as his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. She does not know the NDC number, lot number, or expiration date of the ibuprofen he took. On 23Apr2021 lump under his armpit on same arm that he got the shot in. On 23Apr2021 swollen lymph nodes. Prior Vaccinations within 4 weeks were none. The patient was not sick at the time of either vaccination. There was no family history. The outcome for events fever and chills were recovered on 22Apr2021 but for event lump under his armpit on same arm that he got the shot in was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site mass
Clinical narrative: Chills; lump under the arm that got injected; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 at 10:30 (Batch/Lot number: EW0157, expiration date: unknown) as single dose for covid-19 immunisation. This is a clone master case, report 1 of 2. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 31Mar2021 at around 10:30 as single dose for covid-19 immunisation. No Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. On 21Apr2021, the patient experienced fever around 21:00 or 22:00 PM, chills around 22:00 PM and lump under his armpit on same arm that he got the shot in injected around on 23Apr2021 08:00 AM. The lump was noticed in morning when he woke up, and thinks it was 8 in the morning. The reported said, that she thought it was about the same. The caller stated that her whole family got vaccine on 21Apr2021. The caller stated that her whole family got vaccine on 21Apr2021. They all had a little bit of symptoms here and one of her oldest son who is 19 has a lump under the arm that got injected She was wondering if this was common, if it'll go away and if she should consult his doctor. The reported said that, patient goes to the clinic and that the doctor there that is their primary care provider is no longer there, so they see whoever is available. The fever started around 9 or 10 at night on 21APR2021, that it must have ended last night on 22Apr2021, because patient was running fever during the day and chills started at 10pm that night, 21Apr2021. On 21Apr2021, the same day of his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. There was no additional vaccines administered on same date of the Pfizer suspect. The patient had not yet visited Emergency Room or physician office, but he probably will. The was not sick at the time of either vaccination. The event fever and chills recovered and outcome of evet lump under the arm that got injected was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid after receiving first dose of vaccine; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with COVID-19 after receiving first dose of vaccine. The patient wanted to know if patient should receive second dose of vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: he tested Positive for Covid; chills; tiredness; This is a Spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that last Monday, he had symptoms; chills and tiredness and it became worse yesterday. He took the COVID Rapid test and he tested positive for COVID. Also took the PCR test but he was still waiting for the results. Asked if this has anything to do with the vaccine. There were unaddressed medical questions referred or forwarded to Medical Information. 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: Tinnitus, Vaccination site pain
Clinical narrative: ringing in his ears; Arm left arm is sore. injection site; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date in Apr2021 as a single dose on for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot# EW0158, Expiration date: 31Jul2021) on 08Apr2021 as a single dose for COVID-19 immunization. On an unknown date at 2:45pm the patient got his 2nd shot of Pfizer, 6 am woke up with ringing in his ears, and his arm left arm is sore. injection site. 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: Malaise
Clinical narrative: not feeling good; This is a spontaneous report from a contactable consumer, the patient, from Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: UNKNOWN), dose 1 via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient missed his 2nd dose on 14Ap2021 because he has been not feeling good that day. The clinical outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) reported for herself that the patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiry date: Unknown) through an unspecified route (age at vaccination:62-year-old) on 26Apr2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medication was not reported. On 28Apr2021, Wednesday, the patient tested positive for Covid-19. The patient enquired what to do about the second dose of the vaccine and did they need to take it or wait. Caller mentioned that she didn't think she got COVID from the vaccine but wasn't sure. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) reported for herself that the patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiry date: Unknown) through an unspecified route (age at vaccination:62-year-old) on 26Apr2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medication was not reported. On 28Apr2021, Wednesday, the patient tested positive for Covid-19. The patient enquired what to do about the second dose of the vaccine and did they need to take it or wait. Caller mentioned that she didn't think she got COVID from the vaccine but wasn't sure. 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: Lymphadenopathy, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: body and muscle aches; body and muscle aches; fever; swelling in the lymph nodes under her left arm; not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient experienced body and muscle aches, fever, and swelling in the lymph nodes under her left arm, which was the same side as the vaccination. She's not feeling well and wanted to know how long the symptoms may last. She had been running a low fever, since her second dose, and wanted to make sure she can't spread it to anyone. She indicated that she was not ill before being vaccinated. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tension headache
Clinical narrative: I am feeling nauseated; slight tension headaches; This is a spontaneous report from a contactable consumer (Patient, Self-reported).  A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: not provided), via an unspecified route of administration, on 27Apr2021, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received the second dose on the 27th of the month and then the patient felt nauseated and slight tension headaches, patient ask the question response was given, spoke from attached documents and referred to HCP. The outcome of the events was unknown.  Repot received date 30Apr2021  follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness on the right side of her face; numbness on the right side of her face; This is a spontaneous report from contactable consumer (patient) via medical information team. 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 as a single dose at left arm on 21Apr2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient experienced numbness on the right side of her face and the back of her tongue (towards the throat) on 21Apr2021, maybe one hour after the 1st vaccine dose. Patients 2nd Pfizer vaccine dose is scheduled for 12May2021. The outcome of the events was unknown.   No follow-up attempts are needed :information about lot/batch number cannot be obtained.