chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: colonoscopy; This case has been considered invalid since there is no indication that the patient experienced an event under Product PFIZER-BIONTECH COVID-19 VACCINE.   This is a spontaneous report.This male consumer (patient) reported for himself that:  Reporter Subtype: Patient PQC Present: No AE Present: Yes CEP/PSP: 159558(Pfizer COVID-19 Vaccine Call Center)  PQC Details:   Request Name: REQ-383452 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: CEP: 159558.  Consumer said that he already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. The 1st dose on  19Feb2021, and the 2nd dose on 12Mar2021. Right now, he said he is filling up a sheet of paper for his colonoscopy, and is given three choices for what vaccine he has received. The choices were the following: 1.) Covid-19 mrna 100mcg/0.5 ml  2.) Covid-19 mrna 30mcg/0.3 ml 3.) Covid-19 vaccine vector-nr,rs-ad26,pf,0.5ml However, he does not know what to pick so he is seeking Pfizer's help.  The call got disconnected while the consumer was on hold. Placed a callback on 1JUL2021 at 4:25PM EST. Provided outbound call disclaimer.  DSU: E-transmitting; Potential AE. I noticed after the call. Response: Responded from the attached PI, "FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0)." "The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart." LAB-1451-6.0; Revised: 25 June 2021.  Request Name: REQ-383495 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: "You've been helpful." Response: I thanked the consumer for his feedback.  Follow-up ( 01Jul2021) This is a follow-up spontaneous report. This male consumer (patient) reported for himself that:  Is the Reporter a Healthcare Professional (HCP)? UNKNOWN  Occupation/Specialty: UNKNOWN  Is the reporter the prescribing HCP? UNKNOWN  Occupation/Specialty: UNKNOWN  Suspect Product(s):  Pfizer Covid-19 Vaccine  Start Date:   Stop Date:   Verbatim and Event Description Caller is filling out a sheet of paper for his colonoscopy. On the immunization part on the form, there are multiple choices for Covid 19 Vaccine and he doesn't know what to choose from those 3 choices, Pt is already done with both doses of the Pfizer Covid 19 Vaccine (1st dose - 19Feb2021 and 2nd dose - 12Mar2021) Resolution: - Read Privacy Statement - Gathered info  Medical Information Were any medical questions addressed by this program forwarded/referred to Medical Information? (Live Operators Only) :No Information About Lot/Batch number were requested  Amendment: This follow up is being submitted to amend previously reported information: To route the case to appropriate work flow.
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: He has three blood disorders; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EN5318) via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL1283) via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient who had received his Pfizer-Biontech Covid19 vaccine series but had also received chemotherapy. The patient stated he was calling with a question he cannot get answered anywhere about the Pfizer COVID vaccine effectiveness on a chemo patient and asked if his chemotherapy just finished up would it get flushed out or deemed ineffective at this point. Stated he asked different oncology people and no one can give a definite answer whether he needs another set of Pfizer COVID Vaccines or a booster of the Pfizer COVID Vaccine since he just finished up chemotherapy treatment. The patient asked if there are any studies going on about this or any information at all, any clinical trials underway and there plans to study the vaccine response in this population. The patient was asked for the name of his chemotherapy and stated the chemotherapy treatment was the tricky part and began on 27Feb2021 and he just finished it up on 18Jun2021 and he had three blood disorders and for that they gave him like five different combinations of chemotherapy drip which was pretty complex and stated he had no names of the chemotherapy treatments with him and no lots, expiry dates or NDC numbers to provide because they were all hand mixed by the pharmacy. The patient stated the chemotherapy was an eight hour drip with 5-6 different bags hung during that period and it was very complex and there are not a lot of cases of what he had; caller was asked if the blood disorders were diagnosed prior to him receiving the Pfizer COVID vaccine and stated it took them three months to figure out what was wrong and to come up with a diagnosis but he would say they did not have the diagnosis when it started in January, no further details provided by the caller. Outcome of the events was unknown.  Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Feb2021 as a dose 1, single for COVID-19 immunization. No medical history and concomitant medications were reported. It was reported that the patient was not able to get the 2nd dose because he got hospitalized due to Pneumonia on an unspecified date in 2021. The event was Serious (Medically Significant and Hospitalization). The reporter stated that a patient was interested to receive his second dose of the Pfizer BioNtech Covid-19 vaccine today (01Jul2021), however his first dose was last 01Feb2021 and wanted to know if there was a need to start over the Pfizer BioNTech Covid-19 Vaccine series from the first dose if a patient had exceeded the allowable second dose schedule. The outcome of the event was unknown.  Information on batch/lot number had been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pneumonia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Laboratory test, Night sweats
Clinical narrative: night sweats; has a lot of allergies /sensitivities; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient got the first Pfizer Covid vaccine and started having night sweats and thinks he is past the time allowed for the second dose. It was believed he was 5 weeks out from the first dose. Wanted to know how much protection he has by the first dose and how that looked to protect him. Had a lot of allergies and does not want this to be another one. Caller stated she spoke with a nurse who said the 1st dose had an 85 percent protection. Due to the night sweats, caller got nervous to get the 2nd shot of the vaccine. Caller had taken her son to the doctor who ran tests wherein the results were fine. Caller had delayed the 2nd shot for her son due to the adverse event and because her son also had allergies and sensitivities. Wanted to know where they can get more information on how much antibodies he had because he had a lot of allergies and does not want this to be another one. This was a concern and knew it was a part of the side effects, but she really wanted to know if it was protecting him and not knowing makes her feel really concerned. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Drug ineffective, Nausea
Clinical narrative: Lack of drug effect; Diarrhea; Nausea; Constipation; This is a solicited report from the marketing program facilitated collect received from a contactable physician.     A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as single dose for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from Aug2020 and from May2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult crohn's disease. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced lack of effect, diarrhea and nausea. In 2021, the patient experienced constipation. Covid-19 Vaccine was also considered suspect. The action taken in response to the events for adalimumab was unknown. Outcome of all events was unknown.   Causality assessment of the reporter for constipation was possibly related with bnt162b2.   The reporter's assessment of the causal relationship of the events lack of effect, diarrhea and nausea with suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: The events are all assessed as related to the suspect product,  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  This case will be updated when new information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headaches daily; This is a spontaneous report from a contactable physician who is the patient.   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on an unknown date in May2021 as a single dose for COVID-19 immunisation. Medical history included migraines. The patient's concomitant medications were not reported. The patient stated that since receiving the vaccine in May2021, he had severe headaches daily. The patient stated that he was a chronic migraine sufferer, but had it controlled with medicine. Since the vaccinations, the patient stated that he did not get relief from his migraines. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Has not stopped shaking since; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as single dose for COVID-19 immunization. The caller declined all further demographics, stated the patient was older. Stated the patient received second dose about a week ago and has not stopped shaking since. The patient stated that he had read the entire EUA and it states that he is part of the Phase 3 clinical trial. The patient asked why no one indicated it was experimental. The patient stated that he would not have taken it.  The patient indicated his brother was a doctor and had conveyed to him it was experimental and per VAERs this was reported adverse event. The patient asked how it was being given to kids and he knows two children that have experienced myocarditis. The patient stated was sitting there like a vegetable. He patient stated that he eats healthy, a vegan and runs. The patient stated that he would complete a VAERs report and encourages those not to receive mRNA vaccines. The patient asked if the patient was aware that mRNA vaccines do not meet the definition of vaccine. On an unknown date, the patient received the second dose of Pfizer BioNTech COVID 19 Vaccine and said about a week ago and the patient had been shaking for a week. Further probing could not be done as the consumer hung up the call before call could be connected to Pfizer Drug Safety. Call back could not be done as no information was provided over the call to the transferring agent. Hence limited information available over the call. The patient was not recovered from the event.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: twitching under her right eye on and off/twitching muscles underneath the eye; This is a spontaneous report from a contactable health care professional (pharmacist). A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration on 24May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On May2021, the patient experienced twitching under her right eye on and off/twitching muscles underneath the eye. Pharmacist calling on behalf of his 31 year old female patient at the pharmacy to receive her second dose of the Pfizer Covid-19 Vaccine. Patient received her first dose on 24May2021. She experienced twitching under her right eye on and off after the vaccine. She was back for her second shot and she was worried that the second dose may cause a more severe reaction. She had not reached out to her HCP about her experience. Caller was asking has there been any reports of muscle twitching after the first dose, wanted to make sure it was not worse with the second shot. Within half hour after getting the dose, the patient experienced twitching muscles underneath the eye which lasted for 24 hrs. The patient has come back already today and was about to get her second dose after 38 days. She got the first dose last 24May2021. It was their first time hearing this side effect and wanted to know what they should do. The clinical outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer (Patient) or other non HCP  A 52-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6207, Expiration Date: not reported) via an unspecified route of administration in right arm on 22Mar2021 (at the age of 52-year-old) as dose 1, single for COVID-19 immunization. Medical history included sleep apnoea syndrome, type 2 diabetes mellitus, high blood pressure, depression, high cholesterol.The patient's concomitant medications were not reported. Patient did not received any other vaccine in four weeks. Patient received other unspecified medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. There were no known allergies. The patient experienced tiredness on 22Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) negative COVID-19 NAT on 01Jun2021. The outcome of the event was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tourette's disorder
Clinical narrative: Have had Tourette's Syndrome all my life. It was showing up at 5%, all of the sudden at 100%+. right at the time of the COVID shot; Have had Tourette's Syndrome all my life. It was showing up at 5%, all of the sudden at 100%+. right at the time of the COVID shot; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for Injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in left arm on 30Apr2021 at 04:00 PM (vaccinated at the age of 61 years) as a single dose for covid-19 immunization. Medical history included heart issues and ongoing tourette's syndrome. No known allergies. Concomitant medications included clopidogrel bisulfate (PLAVIX), metoprolol, atorvastatin (LIPITOR), carbamazepine and lisinopril dihydrate (LISINO); all taken for an unspecified indication from an unknown date, the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 04:00 PM, the patient reported that he had Tourette's Syndrome all his life which shows 5%, all of the sudden at 100%+ right at the time of the COVID shot. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The outcome of the event was not recovered.  Additional information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Hypersensitivity, Pain in extremity
Clinical narrative: a little shaky tummy; He suffered from allergies; He had experienced Fatigue; Soreness in his arm; This is a spontaneous report from a contactable consumer or other non-Health Care Professional (Patient's wife). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on Nov2020 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on Oct2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for Covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date 2020 the patient experienced a little shaky tummy, suffered from allergies, had experienced fatigue, soreness in his arm in his arm after his injections. The outcome of events was unknown.  Information on Lot/Batch information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Hot flush, Malaise, Myalgia
Clinical narrative: Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; This is a spontaneous report from a non-contactable consumer (patient) reported for herself that: A 36-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jun2021 11:15(Age at vaccination: 36-years) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past Medical history included, food allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication and iron (IRON) taken for an unspecified indication. The patient previously took pcn 200 and experienced drug hypersensitivity, diflucan and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 25Jun2021, at 23:00 the patient experienced Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at times of vaccine. No treatment was received. The event outcome was Recovered on unspecified date.  Device Date: 01Jul2021  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021823853 same reporter/drug, different patient and event
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Seizure
Clinical narrative: patient had significant seizures resulting from the Covid infection; two weeks later tested positive for Covid; two weeks later tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient that a 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that a pharmacy technician (21-year-old, female) who received her first dose of the Pfizer Covid- 19 vaccine in Jan2021. Caller states 3 weeks later she tested positive for the Covid infection and has never received the second dose. Caller was asking if she should administer the second dose or if she needs to restart the series. It was answered that the vaccine did not contain Sars-Cov-2 and cannot give you the Covid infection, addressed that each patient can react differently and it would be up to the providers discretion on whether a specific patient should receive a vaccine. On an unspecified date, the patient experienced patient had significant seizures resulting from the covid infection, two weeks later tested positive for covid. It was asked by the reporter that if the Pfizer Covid-19 vaccine would trigger these seizures as well. No Serious was reported. Reporter seriousness for Received first dose of Pfizer COVID-19 vaccine in January later she tested positive; never received the second dose was unspecified. The patient underwent lab tests and procedures which included covid resulted as positive as first dose of Pfizer COVID-19 vaccine in January and '3' weeks later she tested positive. The outcomes of events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events seizure, drug ineffective and covid-19 and the suspect drug BNT162B2. 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.,Linked Report(s) : US-PFIZER INC-2021822840 Same reporter/ drug/ AE, different patient
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: received undiluted doses of the vaccine; received undiluted doses of the vaccine; This is a spontaneous report from a contactable physician reported same events under the same suspect product for 4 patients. This is three of 4 reports.  A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EW0179; expiration date: Aug2021), dose 2 via an unspecified route of administration, administered in left arm on 01Jul2021 (at the age of 12 years), as 0.3 ml single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), administered on an unknown date, as single dose for COVID-19 immunisation. On 01Jul2021, patient received undiluted 0.3 ml dose of the vaccine. The physician reported as serious. Outcome of an events was unknown. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the serious event "overdose"and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021822170 Same reporter/product/event, different patient
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Herpes zoster, Nasal congestion, Pyrexia
Clinical narrative: Under my right arm pit by my ribs I have broken out in Shingles. It's also on my back and on my chest.; had a high fever, along with chills; had a high fever, along with chills; back pain; congestion; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: Ew0181), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jun2021 at 12:00 (at the age of 35-year-old) as dose 2, single for COVID-19 immunization at Pharmacy/drug store. Medical history included Severe anxiety. Concomitant medication(s) included alprazolam (XANAX). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Ew0217), dose 1 via an unspecified route of administration in Left arm on 29May2021 (at the age of 35-year-old) for COVID-19 immunization. Patient had no known allergies. 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 had not been tested for COVID-19. On 28Jun2021 at 14:00, patient experienced under my right arm pit by my ribs patient have broken out in Shingles. It's also on my back and on my chest. Patient also had a high fever, along with chills, back pain and congestion. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient received Anti viral as a treatment for the adverse events. The outcome of events was not resolved at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Disease recurrence
Clinical narrative: Asthma; My asthma symptoms reappeared; This is a spontaneous report received from a contactable consumer.   This 60-year-old male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 21Apr2021 at 15:30 (at the age of 60 years) as dose 2, single for covid-19 immunization. Patient had known allergies to Plaquenil. Other medical history included asthma which he had since childhood and it was well managed with albuterol and Advair. He only needed it occasionally, generally in early spring and autumn. When he started taking prednisone/Medrol and Xeljanz for his rheumatoid arthritis in 2015, his asthma symptoms disappeared completely. He had been asthma free for the past 5-6 years. The patient received the medication within 2 weeks of vaccination tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2015. Historical vaccine included he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 31Mar2021 at 15:45 (at the age of 60-year-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at pharmacy or drug store facility. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021, at 12:00 Am, the patient asthma symptoms reappeared. The Patient reported that a couple of months ago, his asthma symptoms reappeared, coincident with his COVID-19 vaccination in April. He took his first dose of the Pfizer vaccine at the end of March and stopped taking Xeljanz for one week, on advice of his doctor. He also stopped taking Xeljanz for 1 week after the second dose on April 21st. On 01May2021 at 12:00 AM, he started experiencing asthma again and he now needed to take Advair and albuterol daily to keep it in check. The treatment received for the adverse event included Advair and albuterol daily to control asthma. The events were reported as non-serious. The outcome of the events not resolved.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Nausea, Peroneal nerve palsy
Clinical narrative: Loss of feeling in left leg and foot; Foot drags when walking.; Nausea; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 16-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection: Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Right on 18Jun2021 09:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Jun2021 13:00 Hour, the patient experienced loss of feeling in left leg and foot. Foot dragged when walking. Leg shook when still. Nausea and shortness of breath. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. The outcome of the events was not recovered.   Additional information has been requested and will be provided as it becomes available. ; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient with young age, unrelated to Bnt162b2. Relevant medical history, concurrent disease, trauma history are missing for a medically meaningful assessment.   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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Pain in extremity
Clinical narrative: right arm is visibly pulsating and twitching; Arm is throbbing; right arm was getting sore; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0217 and Expiration Date: 30Sep2021), via an unknown route of administration, administered in right arm on 30Jun2021 at 11:00 (at the age of 44-years-old) as dose 2, single for covid-19 immunisation. The patient has no medical history. Patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 via an unknown route of administration in right arm on 06Jun2021 (at the age of 44-years-old) (Lot number: EW0177 and Expiration date: 31Aug2021) and got period again and arm was a little sore. Prior vaccination, patient has not received any other vaccine within 4 weeks. Patient has no family history relevant to adverse event. On 30Jun2021, the patient reported that within 4-5 hours after vaccination the right arm was getting sore, later in the evening there was minor soreness. She was knowing that the second shot would be worse. She reported that with the soreness, it kind of hurts to move her arm but it's nothing excruciating. She cannot really lift her arm up high or anything, but its getting better. She was able to deal with the discomfort through the night. On 01Jul2021, she reported that her arm was throbbing. At time of call on 01Jul2021, she had her arm and its totally relaxed. She reported that her arm was pulsing and it just started happening. She said that her right arm was visibly pulsating and twitching even her child can see it. She had never seen anything like that. Her daughter stated that her arm was pulsating almost as fast as she is blinking. She explained that she can move her arm halfway up "freely", otherwise if she moves it up any further the pulsating was worse. She said that pain really was not an issue. Emergency room visit was not required for adverse event. Outcome of event right arm was getting sore was recovering and outcome of other events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation, Psoriasis, Psoriatic arthropathy
Clinical narrative: flare of psoriasis; her legs where the psoriasis was is still inflamed; flare of psoriatic arthritis; worse after getting the vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional.   A 50-year-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EN6205), via an unspecified route of administration on 25Feb2021 (at the age of 49-year-old), as DOSE 1, SINGLE, and received second dose bnt162b2 (BNT162B2, Batch/Lot Number: EP7534), via an unspecified route of administration on 16Mar2021 (at the age of 49-year-old), as DOSE 2, SIN-GLE both for Covid-19 immunization. Medical history included psoriatic arthropathy from an un-known date and unknown if ongoing, She just has been diagnosed with it but has had probably 4 years. It was diagnosed 3 or 4 months ago, psoriasis from an unknown date and unknown if ongoing Had psoriasis prior to getting the vaccine and has had for around 47 years, asthma from an un-known date and unknown if ongoing. Concomitant medications included over the counter cetiriz-ine hydrochloride (ZYRTEC, CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported, and she just takes an inhaler (unspecified) for asthma. She states within a week or two of taking the vaccine, it started after the first vaccine, and if she could re-member correctly when but it also got increasingly worse since. On an unspecified date, the patient experienced flare of psoriasis, her legs where the psoriasis was still inflamed, flare of psoriatic arthritis, worse after getting the vaccine as the condition aggravated. Therapeutic measures were taken as a result of flare of psoriasis with Cimzia 400mg twice a month, she said normally the bio-logic would work relatively quickly for her and it had worked in some areas but there is some areas where it has been untouched, and areas seem untouched. Duobrii 100 gram tube for 30 days. she got her prescription for 3100 g tubes for 30 days. She states that her legs where the psoriasis was still inflamed after over a month of being on this medication. The other areas did clear up completely. She adds that she was not sure the timeline of when she started these two medications as mentioned for treatment. She started them before the vaccine if she remembers correctly and then at the same time as the vaccine, she dropped down to a maintenance dose of the medication and it flared up. Then, it was boosted back up to the initial dose and now she was on the initial dose and it was not helping. They have cleared up a lot, just not completely gone. The outcome of the events of flare of psoriasis, flare of psoriatic arthritis and worse after getting the vaccine was unknown. The outcome of the event of her legs where the psoriasis was is still inflamed was re-ported as not resolved.    Follow-up attempts were completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a non-contactable consumer (patient) reported for another patient (1st case of two children reports). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He states he would not have taken it. He indicates his brother is a doctor and has conveyed to him it is experimental and per VAERs this is a reported adverse event. Asks how it is being given to kids and he knows two children that have experienced myocarditis. He states is sitting there like a vegetable. States he eats healthy, a vegan and runs. The patient experienced myocarditis on an unspecified date. The outcome of the event was unknown.  The response to consumer question was provided as Approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of for up to 24 months, for assessments of safety and efficacy against COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on 11Dec2020. On 7May2021, Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the FDA for approval of the vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency. A submission for the 12 to 15 years group will occur once the required data six months after the second vaccine dose are available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021823458 as same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported reporter knows two children who experienced myocarditis. On an unknown date, patient experienced myocarditis. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021823457 as same reporter/drug/AE, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Hyperhidrosis, Menstrual disorder, Vaginal haemorrhage
Clinical narrative: Gushing blood from her vagina; Extreme fatigue; Started cramping really badly; Stated that she has been having the worst period of her life; Cramps are so intense they make you sweat; This is a spontaneous report from a contactable consumer, the patient. This case is created for second dose. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), dose 2 via an unspecified route of administration, administered in arm on 01Jun2021 (at the age of 32-years-old) as a single dose for covid-19 immunization. There were no medical history and concomitant medications. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8735), dose 1 via an unspecified route of administration, administered in arm on 11May2021 (at the age of 32-years-old) as a single dose for covid-19 immunization. There were no medical history and concomitant medications. No other products, patient history, investigation assessment were reported. The patient ever since she got the vaccine that she has been having the worst period of her life and was reported as worsened. Stated that if she knew this would happen she would have never got it. Is for the Pfizer Covid vaccine. A few days after the shot on the 01Jun2021 that it started and she was cramping really badly and gushing blood. Stated the cramps are so intense they make you sweat. She just started her period again and was experiencing the same thing. She had extreme fatigue. She stopped gushing blood two days ago when her menstrual cycle ended. Stated that she noticed the gushing blood during her period. She started spotting on 03Jun2021 and gushing blood on 04Jun2021. Stated that she recovered completely because her menstrual cycle stopped. The cramps feel like contractions and are so bad that they make her sweat. Later clarified that she was having these issues with the first dose but she wanted to document the start date as being after the second shot because she was not keeping track of all of this. None treatment was reported. Outcome of the event vaginal haemorrhage and sweaty was unknown; while that for others was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Hot flush, Malaise, Myalgia
Clinical narrative: Headache for 5 days starting 12 hours after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient (non-pregnant) received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number: EW0196) via an unspecified route of administration, in the left arm on 25Jun2021 (at the age of 36-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was non-pregnant at the time of vaccination. The vaccination facility type was pharmacy or drug store. The patient medical history includes food allergy, (allergy: shrimp), drug hypersensitivity (Allergy: Sulfa). Concomitant medications included (received within 2 weeks of vaccination) Prenatal vitamin, Sertraline Hydrochloride (ZOLOFT) and Iron. Past drugs included PCN, Diflucan and there allergy. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since the vaccination. The patient previously received BNT162B2 (BNT162B2, Solution for injection, Batch number: EW0180) via an unspecified route of administration, in the left arm on 04Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 25Jun2021 23:00, 12 hours after vaccine, the patient experienced headache for 5 days. She also experienced hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine. She was currently breastfeeding and 5/8 weeks postpartum at times of vaccine. The patient did not receive treatment for events. Outcome of the event was recovered on an unspecified date in Jun2021 while rest events recovered on 28Jun2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021822395 same reporter/drug, different patient and event
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain, Peripheral swelling, Restlessness
Clinical narrative: Vaccine wasn't good on my body, I am not feeling fine at all; My left hand was swollen and was black in color, I have been going through a series of pain; My whole body is being disorganized; It is making me restless; My left hand was swollen and was black in color, I have been going through a series of pain; My left hand was swollen and was black in color, I have been going through a series of pain; This is a spontaneous report from a contactable consumer or other Non-health care professional (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 704AZ1A), via an unspecified route of administration, administered in left arm on 12May2021 (age at vaccination was 63 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after taking the vaccination the patient experienced that vaccine wasn't good on her body, as she did not feel fine at all and it even' bought her to the hospital, and medication was given to side effect. She was not feeling fine at all. She reported that since I got it, I have not been myself, my skin on the left hand, and her left hand was swollen and was black in color, she did not know, it seemed to black. Had been going through a series of pain, she was not getting any 'relief' at all, went to the hospital and they gave her 'Naproxen'. She inquired about the when the medicine gets off her body her whole system as her body was being disorganized. She did not feel okay with this. So, she was inquired to reduce the effect on my body, it was making her restless. The event wasn't good on her body, as she did not feel fine was serious hospitalization and other events were Unspecified. The patient received treatment for the event pain. It was reported that patient don't want to get another injection, just the medication that will reduce the pain, that remove the one that she already have one in her body already, that's what she am looking for. The outcome of the events was peripheral swelling, skin discoloration was unknown and other events was not recovered.  Follow-up attempts are completed. No further information is expected.