chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Troponin, Ventricular tachycardia
Clinical narrative: myocarditis; NSVT episodes; chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), VENTRICULAR TACHYCARDIA (NSVT episodes) (seriousness criteria hospitalization prolonged and medically significant) and CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, MYOCARDITIS and VENTRICULAR TACHYCARDIA. At the time of the report, MYOCARDITIS (myocarditis) and VENTRICULAR TACHYCARDIA (NSVT episodes) was resolving and CHEST PAIN (chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: high (High) 4 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. In 2021, Ejection fraction: abnormal (abnormal) 53%, inferolateral hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Inferior, anterolateral STelevation. In 2021, imaging: abnormal (abnormal) Edema, delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: high (High) baseline-1327 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and high (High) Peak-1433 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) to be possibly related.    Discharged in stable condition. Treatment information not provided.  Company Comment : Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Burns second degree, Tremor
Clinical narrative: hands were shaking; second degree burns; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non Healthcare Professional (caregiver, reported for her Mother who is the patient).  A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: UNKNOWN), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer and liver cancer from an unspecified date and unknown if ongoing. The patient's concomitant medications were not reported.   Reporter stated that on an unspecified date, her mom (patient) was making hot chocolate and her hands were shaking and she spilled hot chocolate on herself. Reporter stated her mom was taken to the emergency room and she was diagnosed with second degree burns and received a tetanus shot this past Friday. Reporter stated her mother is scheduled to receive the second dose next week and her doctor told her to wait two weeks before receiving the second dose. Reporter wanted to know if her mother should receive the second dose of the vaccine after having the Tetanus shot. She was told different things by HCPs (Healthcare Professionals) and wanted to know what Pfizer says. Reporter also stated that her mom was a breast and liver cancer survivor.   Reporter clarified if her mom had breast and liver cancer prior to the 1st dose and she said yes, and stated her mom has a history of breast cancer and therefore has a compromised immune system and she was afraid of getting COVID-19. Reporter also mentioned that her mom's 2nd dose was scheduled 4 weeks between. Reporter would like to know if receiving the second dose of the vaccine outside the 3 week interval is just as effective. Reporter would like to know if the second dose can be given greater than 4 weeks after first dose. Reporter would like to know if the vaccination series will have to be repeated if given after 4 weeks. The outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: outbreak of herpes on her lips/ lip got worse/ way across the lip; outbreak of herpes on her lips/ lip got worse/ way across the lip; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200) intramuscularly, administered in Arm Left on 24Feb2021 14:45 (at the age of 72-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid condition (thyroid tests are normal and fine) and had a long history of herpes and she saw a virologist years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) 25 mcg tablet once a day by mouth taken for hypothyroidism from an unspecified start date and ongoing. No vaccination was taken 4 weeks prior to COVID-19 vaccine. The patient took the first dose about a week ago and she had an outbreak of herpes on her lips. The outbreak was kind of a low grade, she had a history of herpes and stated her outbreak was not due to the vaccine. When the patient was queried about when outbreak on her lips started, she stated that she went into the vaccine with one little spot on her lip, she has a long history of herpes and she saw a virologist years ago and was suggested that she just had to watch the foods she eats, she overloads with foods that activate it and she had to cut back. Patient called her family doctor and asked if she could take valacyclovir (VALTREX) since her lip got worse, which had to do with stress and eating poorly for a while, too much coffee and not from the vaccine. She woke up yesterday morning with more working its way across the lip. She took only one dose of Valtrex yesterday and it was 500mg, and it had helped her. She was willing to live with it for whatever period of time she should wait for taking an antiviral medication. The patient stated that she would eat very clean and when she called the doctor, the nurse told her she could take Valtrex. She wanted to know if she can take it. The patient did not visit any clinic or physician office. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based from timing of event occurrence , vaccination and patient current medical condition, the reported events were assessed as probably related and cannot e totally excluded  to suspected drug BNT162B2.  Case should be reassessed pending new drug information and patient follow-up information.  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: M
Vaccine: COVID19, UNK
Symptoms: Blood triglycerides, Blood triglycerides increased, COVID-19, Drug ineffective, Pain in extremity
Clinical narrative: elevation in triglycerides; sore arm after vaccine; weight loss, improved energy; COVID infection jan2021; COVID infection jan2021; This is a spontaneous report from a non-contactable consumer, based on information received by Pfizer, for BNT162B2.   A male patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIOEH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as an unspecified dose for covid-19 immunization and lenvatinib mesilate (LENVIMA), oral from 19Aug2020 (Batch/Lot number was not reported) to an unspecified date, at 12 mg for renal cancer. The patient medical history and concomitant medications were not reported. It was reported that Patient feeling better since COVID infection jan2021 as previously reported. Was able to restart Lenvima 08Feb2021 after MD hold approximately 2 weeks while positive for virus. Patient reports last labs still show some elevation in triglycerides, lowered red blood count and some change in thyroid level, has weight loss, but energy improving since COVID symptoms Jan2021. Had 1st Covid vaccine and had sore arm for a bit but improved. MD aware of all symptoms. No additional issues due to medication being on hold noted at this time. The patient underwent lab tests and procedures which included blood triglycerides: some elevation in triglycerides, red blood cell count: lowered, sars-cov-2 test: positive for virus on Jan2021, thyroid function test: some change in thyroid level, weight: loss on Jan2021. Treatment drug include EVEROLMUS 5mg/QC ,PO for renal cancer .The outcome for the events sore arm after vaccine, weight loss, improved energy was resolving and for remaining all events outcome was unknown.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Red blood cell count, SARS-CoV-2 test, Thyroid function test, Weight, Weight decreased
Clinical narrative: elevation in triglycerides; sore arm after vaccine; weight loss, improved energy; COVID infection jan2021; COVID infection jan2021; This is a spontaneous report from a non-contactable consumer, based on information received by Pfizer, for BNT162B2.   A male patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIOEH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as an unspecified dose for covid-19 immunization and lenvatinib mesilate (LENVIMA), oral from 19Aug2020 (Batch/Lot number was not reported) to an unspecified date, at 12 mg for renal cancer. The patient medical history and concomitant medications were not reported. It was reported that Patient feeling better since COVID infection jan2021 as previously reported. Was able to restart Lenvima 08Feb2021 after MD hold approximately 2 weeks while positive for virus. Patient reports last labs still show some elevation in triglycerides, lowered red blood count and some change in thyroid level, has weight loss, but energy improving since COVID symptoms Jan2021. Had 1st Covid vaccine and had sore arm for a bit but improved. MD aware of all symptoms. No additional issues due to medication being on hold noted at this time. The patient underwent lab tests and procedures which included blood triglycerides: some elevation in triglycerides, red blood cell count: lowered, sars-cov-2 test: positive for virus on Jan2021, thyroid function test: some change in thyroid level, weight: loss on Jan2021. Treatment drug include EVEROLMUS 5mg/QC ,PO for renal cancer .The outcome for the events sore arm after vaccine, weight loss, improved energy was resolving and for remaining all events outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: he records his blood pressure every day, it had been 160-170 /90 since Friday (12Mar2021); This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on 11Mar2021 as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and autoimmune disease. The patient reported that he records his blood pressure every day, and it had been 160-170 /90 since Friday (12Mar2021). Therapeutic measures were taken as a result of the event. The patient stated that he had been increasing his blood pressure medication from 25 mg to 40 mg, and that his HCP instructed him to call if his blood pressure goes up to 180 in 2 days in a row. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate increased, Pain in extremity
Clinical narrative: Heart pain; Rapid heart beat; Arm pain shooting through arm; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 12Mar2021 15:15 (Batch/Lot number was not reported) (at the age of 23 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included allergies to sulfa from an unknown date. The patient's concomitant medications were not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 at 20:45, the patient experienced rapid heart beat, heart pain, arm pain shooting through arm. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain, Pain in extremity, Swelling, Wrist fracture
Clinical narrative: broke her my wrist; swelling; Pain; Sore arm; Inflammation in her wrist; This is a spontaneous report from a consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 15Mar2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received her first dose of the Pfizer vaccine and then then broke her wrist the following day (unspecified date in Mar2021) and got her stitches removed on 16Mar2021. The doctor told her to take Aleve 3 of them three times a day for swelling and pain and to start physical therapy. She was also instructed to take Aleve three times a day for inflammation in her wrist. Patient stated she heard Aleve and the vaccine were not supposed to be taken. My second dose was on 5Apr2021. She questioned that, are we not allowed to have Mammograms, magnetic resonance imaging (MRI) and X-rays. She had no reaction only a sore arm for a day but nothing else happened. She only took 2 Aleve because she did not want it to interfere with the vaccine. Patient visited Physician office due to events broke her wrist and inflammation in her wrist. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid ten days later; Sick; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 05Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient stated that he received the first dose of the Pfizer vaccine on 05Feb2021. He became sick and tested positive for Covid ten days later (on an unspecified date in Feb2021). He was prescribed Bamlanivimab infusion the next day and was told by nurses not to get the second dose of the vaccine until ninety days later. He reached his principal doctor from the assistant and was told he should wait only forty-five days to get the second shot. He was calling to get an opinion on the matter, whether he should wait forty-five or ninety days before getting the second dose. 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: Myocarditis
Clinical narrative: Myocarditis; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 18Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (Patient).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and had abnormal side effects. On an unspecified date the patient experienced myocarditis. She mentioned that she was 76-year-old woman not a teenager or 30-year-old man. She stated that she had to run around and spend like 20minutes going through all these menus and was not helpful. Patient doctor wants to call and report that they think patient have Myocarditis. Patient wanted to connect to the medical department so that she can talk to the nurse to know if her problem was the result of the vaccine. The outcome of the event myocarditis is unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Herpes zoster, Illness, Rash, SARS-CoV-2 antibody test
Clinical narrative: Bell's Palsy Type Sensory Reaction; 4 day she developed the shingles; She was so sick; she developed Spots on her chin and cheek leftover from the shingles; This is a spontaneous report from a contactable consumer (patients mother) or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, the patient underwent quantitative antibody lab tests included sars-cov-2 antibody after the first shot and the count results were 77.74 milliliters. Patient mother wanted to know how safe her daughter was because she could not get a second one as her doctors had told her she could not take the second dose. Patient never had Covid which reporter thanked God. Reporter stated that somebody had to have some data. 132 needed to donate convalescent plasma. On 23Jan2021, the patient experienced Bell's Palsy Type Sensory Reaction (always serious event) and 4 day she developed Spots on her chin and cheek leftover from the shingles. The events were considered as medically significant events. Reporter stated that she had an appt today with the dermatologist. They gave her almost like a bleaching thing and something for the itch. Patient mother stated that she had such a horrible, horrible reaction. The shingles and the way she reacted reporter thought she should have good antibodies. She was so sick the first 3 days and the 4 day she developed the shingles, bells palsy type reaction. Reporter got a table of all the companies that do the IGG testing and had gone to 7 doctors, 3 MRIs, 2 neurologists, her brain, cervical trigeminal nerve infectious disease and ophthalmologist. She further stated that there were other people getting these bells palsy type reactions. It was reported that they are all 27 (Patient) came out of it and patient left with spots on her face and her mother was grateful that she did not had nerve paralysis. Further reported that patient never had chickenpox. She was the first age group that got Varicella before kindergarten. She never got chicken pox so to get shingles and never had chicken pox, only 22% of the population gets that. 78% of the people that get the vaccine did not get shingles. But yet her antibodies for the varicella zoster was off the roof after the vaccine. IT was over 3000 and her face was proof of it. The outcome of Bell's Palsy Type Sensory Reaction was recovered on unspecified date and rest events was reported as unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Haematochezia
Clinical narrative: Bloody stool; Diarrhea; Dehydration; This is a spontaneous report from a contactable consumer. An 80-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Deltoid Left on 01Feb2021 12:40 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from 01Jan1990 and ongoing, PE from Jan2001, Hypocholesteremia from 01Jan2000 and ongoing, cardiac disorder Cardiac health, GERD. Concomitant medications included asa (ASA) taken for Cardiac health; atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for hypocholesterolaemia; losartan (LOSARTAN) taken for HTN; famotidine (PEPCID [FAMOTIDINE]) taken for GERD. The patient previously took bnt162b2 for covid-19 immunisation. On 01Feb2021 18:40, the patient experienced bloody stool, diarrhea, and Dehydration. The outcome of the event bloody stool, and dehydration was unknown, for the event diarrhea was recovered on 04Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller received both covid vaccines. She is still covid positive; Caller received both covid vaccines. She is still covid positive; This is a spontaneous report from a contactable consumer or other non hcp (patient) via 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 2nd dose, single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient received first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunization. The patient reported that she had received both covid vaccines. She was still covid positive. The patient underwent lab test and procedures which included Sars-cov-2 test which showed covid Positive. The case was assessed as medically significant. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the virus; tested positive for the virus; This is a spontaneous report from a Pfizer sponsored program. A non-contactable Male consumer reported for himself that or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The patient tested positive for the virus (sars-cov-2 test positive) on an unspecified date. INT-# Swap from (Name)- first time caller received his first covid vaccine and then tested positive for the virus. He was suppose to get his second covid vaccine and was now wondering if he should still get it. Upon collecting his information (only got his name) for transfer he stated his work was calling for conference call and he had to get off the phone. Provided him medical information to call later.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive to COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 09Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got tested positive for Sars-CoV-2 and the patient is scheduled to have second dose and is just completing her isolation. The patient's doctor has recommended her to wait 2 weeks before getting the second dose, but she also heard opposite recommendations. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive for covid after the first dose; he tested positive for covid after the first dose; This is spontaneous report from a contactable pharmacist. A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported) via an unspecified route of administration on unspecified date as a 1st dose single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient was due to take the second shot of the covid vaccine today but he tested positive for covid after the first dose. Reporter wanted to know should she still give the second dose to patient.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture
Clinical narrative: broke her ankle; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: not reported) dose 1 via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant was not reported.  It was reported that patient broke her ankle, and she could not make it on 02Apr2021 for her second dose schedule. She wanted to reschedule. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; dizziness; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9264), dose 1 intramuscular, administered in right arm on 30Jan2021 as single dose for COVID-19 immunisation. Medical history included COPD. The patient's concomitant medications were not reported. The patient was tested negative for COVID-19 several times before getting the first dose of the vaccine. On an unspecified date he tested positive and went to rehab centre in Feb2021, prior to received his second dose of the product. In Feb2021, patient had dizziness had been ongoing for might be about 2 to 3 weeks. The patient underwent lab tests and procedures which included COVID-19 test: positive in Feb2021. On an unspecified date, the patient was discharged from rehab centre. he outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Swollen tongue, Tremor
Clinical narrative: Do not take the second dose; I will not be able to be fully covered; Started shaking specially my hands; I started to feel very giddy; My tongue started to swell up badly; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 76-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. She had many vaccines in her lifetime. The Pox vaccine to live in abroad when she was young. Then vaccine to live abroad to work. Then another country and then in another country. She had so many but she never had any reaction to anything. On 22Mar2021, the patient had started shaking specially her hands and then within the first 15 minutes then it was okay and then she started to feel very giddy like she had several glasses of champagne and then her tongue started to swell up badly. The events were considered serious as medically significant events. Patient received Benadryl as treatment for the events. On an unknown date, patient stated that she definitely do not take the second dose. So, she will not be able to be fully covered. It was reported that patients doctor send her to an allergist to see if she should take the second dose. She told that she had even get a the green pass and who knows if she could take anymore vaccine that are created for the mutant strains of this virus. Further, this was a very severe reaction, and she was on the first one not even the second one and its not acceptable. Patient stated that there are people that did not have allergic reaction to anything before in their life. These things nothing, scorpion bite nothing and this was a huge surprise. They need to know this kind of things all this other stuff. It was reported that patient was not experiencing the problem or symptoms.  At the time of report, patient was recovering from the events shaking specially my hands, started to feel very giddy and tongue started to swell up badly without hospitalization. The outcome of the event Do not take the second dose; I will not be able to be fully covered was unknown and for other events was recovering.   Information about batch/ lot number has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Mouth and face shingles; This is a spontaneous report from a contactable physician. A 89-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection) intramuscularly in right deltoid on 27Jan2021 as single dose for COVID-19 immunization. Medical history reported was hyperlipidemia, osteoporosis, chronic ischemic cardiovascular disease (CICD III), stroke prevent, all ongoing. Concomitant medications reported was atorvastatin (LIPITOR) for hyperlipidemia, acetylsalicylic acid (ASPIRIN) for stroke prevent, all ongoing and via orally route. Patient previously received first dose of BNT162B2 (lot: EH9899) in right deltoid on 06Jan2021 for covid-19 immunization. The patient experienced mouth and face shingles on 25Feb2021. Patient was hospitalized from 28Feb2021 to 03Mar2021. Treatment was received as tramadol for and Gabapentin for shingles. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Herpes zoster cannot be totally 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Lymphadenopathy, Monoplegia, SARS-CoV-2 test
Clinical narrative: When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; My lymph nodes swelled up and that lasted a few days; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:15 (Age at time of vaccination 38-years-old ) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history, concomitant medications was not reported. The patient previously taken historic vaccine first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: ER8730) administered in Arm Left on 24Mar2021 01:45 pm for covid-19 immunization. The patient did not administer other vaccine in four week and no other medication in two week. The patient was not covid vaccination prior and post vaccination. On 04Apr2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative Covid test type: Nasal swab  Covid test name: PCR  Covid test result: Negative. On an unspecified date the patient experienced when i got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed, my lymph nodes swelled up and that lasted a few days. The outcome of events was recovered with sequelae.  Information about the Lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Paraesthesia, Throat tightness
Clinical narrative: Tightness in throat; Coughing; Dizziness; Legs tingling; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and hypertension, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included losartan potassium 100 mg, and diltiazem hydrochloride 240 mg, both from unknown dates for unknown indications. The patient previously received sodium benzoate from an unknown date for an unknown indication and experienced drug allergy, hydrochlorothiazide from an unknown date for an unknown indication and experienced drug allergy, unspecified angiotensin converting enzyme (ACE) inhibitors from unknown dates for unknown indications and experienced drug allergy; cefazolin from an unknown date for an unknown indication and experienced drug allergy; and hydrocodone-acetaminophen from an unknown date for an unknown indication and experienced drug allergy. On 03Mar2021 at 10:45, the patient experienced tightness in throat, coughing, dizziness, and leg tingling. The events required a physician office visit and emergency department visit. The patient was treated with intravenous diphenhydramine hydrochloride (BENADRYL) and steroids. The clinical outcomes of tightness in throat, coughing, dizziness, and leg tingling were recovered on unspecified dates in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: he is still feeling very very tired; This is the spontaneous report from a contactable consumer (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24May2021, the patient was still feeling very very tired. He wanted to know if this was normal. The outcome of very very tired was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Burning sensation, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: could not talk because of her swollen tonsils/tonsillitis; fatigue; burning legs and toes; arm pain; swollen lymph nodes; could not talk because of her swollen tonsils; This is a spontaneous report from a contactable consumer (patient's father). A 20-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Three to four days after receiving the vaccine, the patient experienced fatigue, burning legs and toes, arm pain, swollen lymph nodes, and swollen tonsils. She could not talk because of her swollen tonsils and was diagnosed with tonsillitis. The patient received treatment with steroids and antibiotics. The outcomes of fatigue, burning legs and toes, arm pain, swollen lymph nodes, swollen tonsils, could not talk, and tonsillitis were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: could not talk because of her swollen tonsils/tonsillitis; fatigue; burning legs and toes; arm pain; swollen lymph nodes; could not talk because of her swollen tonsils; This is a spontaneous report from a contactable consumer (patient's father). A 20-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Three to four days after receiving the vaccine, the patient experienced fatigue, burning legs and toes, arm pain, swollen lymph nodes, and swollen tonsils. She could not talk because of her swollen tonsils and was diagnosed with tonsillitis. The patient received treatment with steroids and antibiotics. The outcomes of fatigue, burning legs and toes, arm pain, swollen lymph nodes, swollen tonsils, could not talk, and tonsillitis were unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Hypokinesia, Pain in extremity
Clinical narrative: I believe it triggered a pretty bad case of arthritis in both knees, and it is still a daily struggle; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; This is a spontaneous report from a contactable consumer (patient herself).  A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 14:00 (Batch/Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included obesity from an unknown date and while the knees were not in perfect health prior to the shot, patient was able to walk and hike, that patient had not been able to do at the time of report. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine and fluoxetine hydrochloride (PROZAC); both taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received first dose of BNT162B2 (Lot number: EL9264) via unspecified route on the left arm at age 37 years on 02Mar2021 at 08:30 AM for COVID-19 immunisation. On 24Mar2021 19:00, the patient experienced significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving. The doctor recommended Advil and electrolytes. It got a little bit better for a short time, but the pain is still there- I believe it triggered a pretty bad case of arthritis in both knees, and it is still a daily struggle. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the adverse event included cortisone shots so far, physical therapy, naproxen. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a Public Health Clinic. The outcome of the event was not recovered.   Further information has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: I suffered from acute Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 10:00 (Batch/Lot Number: EW0177) (at age of 34 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was none. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other concomitant medications the patient received within 2 weeks of vaccination included vitamin C gummies. The patient suffered from acute idiopathic thrombocytopenic purpura on 18May2021 19:00. At the end of the 18th, patient noticed spots on arms and legs, about the size of the average mole. Later, gums bled and patient had blood blisters in mouth, from 1 to 3 after rinsing with listerine. The next day, he noticed more spots on feet and lower legs, similar to freckles. By the end of the day, his gums were bleeding unprovoked and he had hematuria. The bleeding continued and he went to the ER the following day and was informed that his platelet count dropped to 0. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Number of days of hospitalization was 3 days. Treatment received for the adverse events included Intravenous Immunoglobulin and steroids. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information on Lot/Batch number is available; Further information has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Diplopia, Feeling abnormal, Nervousness, Visual impairment
Clinical narrative: double vision whenever he moved his head; vision was disrupted when he would move his head; equilibrium was totally off; Head felt wobbly, head was in a fog type haze; The felling was scary; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 54-year-old via an unspecified route of administration in the left arm on 22May2021 16:00 (Lot Number: EWO179) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Nov2020 to Nov2020 prior to vaccination. The patient has no known allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both indications, start and stop date were not reported. The patient received the most recent COVID-19 vaccine in a public health clinic or facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days after the vaccination (24May2021 08:00), the patient's vision was disrupted when he would move his head. He saw almost what you would call double vision whenever he moved his head, like while driving or looking from one side to the other. He couldn't drive for about 3 days because the movement of one car would look like 2 cars. This didn't happen when head was still and looking straight. His equilibrium was totally off, his head felt wobbly, his head was in a fog type haze for about 2 weeks. The feeling was scary. He mentioned that he did have covid Nov2020. He added that he made phone call to his doctor and they said to give it 2 weeks before coming in which is exactly when symptoms started to subside but still feel a little off. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Syncope
Clinical narrative: tummy was weird; fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: En6203), dose 2 via an unspecified route of administration, administered in arm right on 07Jun2021 15:30 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 17May2021 15:45 (lot number: En203) for COVID-19 immunization. On 08Jun2021 05:15, patent experienced fainted morning after vaccine, and was lightheaded, tummy was weird too. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.