chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fracture, Hypoaesthesia, Meniscus injury, Muscle strain
Clinical narrative: chipped her bone; right foot numbness; fell; right torn meniscus; tore a muscle; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single and dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that on an unspecified date in 2021 she fell a month ago and has a right torn meniscus, chipped her bone, tore a muscle, and has complaints of right foot numbness, and that her right leg was "killing her".  Caller was asking for information on how to obtain her vaccination card for the Pfizer Covid-19 vaccine. The outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: He had a mild skin rash after the first dose; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient claims he had a mild skin rash after the first dose. He states this rash has still not resolved over two weeks later. He went to see his doctor and all of his blood tests are clean and he's not allergic to something. His doctor told him to drink benadryl every day, and he has been for two weeks but its not helping. His PCP suggested he call Pfizer for treatment. The patient underwent lab tests and procedures which included blood test: clean (he's not allergic to something) on an unspecified date of 2021. Therapeutic measures were taken as a result of he had a mild skin rash after the first dose. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: felt some pain higher up in the shoulder area; This is a spontaneous report from a contactable other health care professional received via sponsored program Support. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, on 22Jul2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 22Jul2021, the patient believed that vaccine was administered too high and into the shoulder joint instead of the deltoid muscle because she felt some pain higher up in the shoulder area. It was reported that pharmacy intern would be calling to see how to proceed and if the second dose needs to be repeated or not. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms, Thrombosis
Clinical narrative: I have been on my period for 84 days, 2nd vaccine 08May2021, period started 27May2021, still bleeding; Horrible cramps; It's has clots; This is a spontaneous report from a contactable consumer. This 48-Year-Old female consumer(patient) reported. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 12:30 (age at the time of vaccination was 48-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , meniere's disease from an unknown date and unknown if ongoing , facet joint syndrome from an unknown date and unknown if ongoing , spinal deformity from an unknown date and unknown if ongoing , fibromyalgia from an unknown date and unknown if ongoing , balance disorder from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing, Migraine from an unknown date and unknown if ongoing, Gastrooesophageal reflux disease from an unknown date and unknown if ongoing, Impaired gastric emptying from an unknown date and unknown if ongoing, Irritable bowel syndrome from an unknown date and unknown if ongoing, experienced drug hypersensitivity to Sulfa Antibiotics. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm right on 17Apr2021 03:00PM (age at the time of vaccination was 48-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient had been on her period for 84 days, period started on 27May2021, and was still bleeding. The patient had been checked for cancer; it was clear. Horrible cramps on27May2021, worst the patient ever had and the patient had gone through boxes and boxes of feminine products. It's has clots on 27May2021, the patient had gone to urgent care, gynecology, general doctor. They even gave the patient medication to try and stop it and it did not work. The patient had biopsy, ultrasounds and it just kept bleeding. Treatment medication included Norethindrone Acetate (AYGESTIN) 5 mg Oral Tab. Outcome of all the events was reported as not recovered at this time of the report. Device Date reported as 18Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Mechanical ventilation
Clinical narrative: two of her patients are breakthrough cases; two of her patients are breakthrough cases; these two are in critical conditions and they had to be put on ventilator.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for an unknown patient (one of 2 patients). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history included Blood pressure and diabetes mellitus. The concomitant medications for patient were not reported. It was reported that the caller mentioned his daughter (Physician) working in ICU and she told the caller that "two of her patients are breakthrough cases" where they had conditions such as blood pressure and diabetes, and "these two are in critical conditions and they had to be put on ventilator". The caller declined to complete a report on these 2 patients and stated he did not know any information. His daughter told him as she was working in the ICU unit. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunodeficiency
Clinical narrative: immunocompromised; has recently developed Shingles; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer (patient herself). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration on 12Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 19Feb2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. In 2021 the patient experienced immunocompromised and has recently developed shingles (medically significant). Therapeutic measures were taken because of immunocompromised and has recently developed shingles. It was reported that the patient called with questions about booster COVID vaccines. Also mentioned that she received her second COVID vaccine in March but has recently developed Shingles. The outcome of the events was unknown.  Follow up(18Aug2021): The new information received, and it includes: In a call, patient asked also asked if the booster dose will be different for the general public in September or will it be the same as the booster dose that is authorized now for immunocompromised individuals. She asked if antivirals (acyclovir, valacyclovir) would have an effect on getting the vaccine. Caller reports she now has shingles and is immunocompromised. Caller wants to know what's the reasoning behind waiting until her shingles cleared before getting a booster dose and also if she were to get the booster dose would it make the shingles worse.  Follow up(18Aug2021): The new information received, and it includes: date, dose and lot number about the first vaccine and treatment given for the shingles. It was reported that the patient was immunocompromised, and she is a teacher that teaches children that have behavioral issues and she have both of her Pfizer Covid-19 vaccine, the second one was back in March, and the teacher has cases shingles right now and she was enquiring that she did some reading, even her doctor said that after the shingles have resolved she should wait at least 2 weeks before receiving the booster. She wants to know if that's true because she goes back to work on Monday. And she wants more information on booster after having shingles. And also, she was on the medication for her shingles, and she received Valaciclovir, she said that she was taking 1 gram 3 times daily. And she was also wanting to know if this medication will affect the efficacy if she has would have the booster as well.  No follow-up attempts possible. No further information expected
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Vaccination failure
Clinical narrative: Positive diagnosis of Covid-19; Positive diagnosis of Covid-19; Mild cold-like systems; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose, and received first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced positive diagnosis of COVID-19 associated with mild cold-like systems. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received the Pfizer COVID-19 Vaccine, first dose; Tested positive for Covid before getting the second dose; Received the Pfizer COVID-19 Vaccine, first dose; Tested positive for Covid before getting the second dose; This is a spontaneous report from a contactable consumer or other non hcp via pfizer sponsored program regulatory authority. A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 30Jul2021 as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received pfizer covid-19 vaccine, first dose; tested positive for covid before getting the second dose on an unspecified date in 2021. Patient was asking how long would it take for him to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID on 8/18/21; Tested positive for COVID on 8/18/21; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 43-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: En6198) via an intramuscular route of administration in Arm Right on 20Feb2021 07:00 (age at vaccination 43-year-old) as single dose, and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: En6208) via an unspecified route of administration in Arm Right on 11Mar2021 (age at vaccination 43-year-old) as single dose for COVID-19 immunisation. Medical history included Rare autoimmune disease called Isaacs syndrome from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, coeliac disease from an unknown date and unknown if ongoing, gluten sensitivity from an unknown date and unknown if ongoing, contrast media allergy from an unknown date and unknown if ongoing. 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. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Concomitant medication(s) included immunoglobulin human normal (IVIGLOB-EX) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had been tested positive for COVID-19. The patient tested positive for covid on 18Aug2021. Date of start of reaction/event was reported as 17Aug2021 16:00. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed after the second dose/paralyzed from the waist down; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient was paralyzed after the second dose/paralyzed from the waist down on an unspecified date. It was reported that, Caller stated nothing against Pfizer, but he knew someone who was paralyzed after the second dose. The outcome of the event was unknown.    Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Positive; COVID-19 Positive; This is a spontaneous report from a contactable consumer. It was reported that a 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 (Lot unknown) as single dose for COVID-19 immunisation. No Known allergies. No covid prior vaccination. Medical hsitory was not reported. No other vaccine in four weeks. There was other medications in two weeks. The patient experienced COVID-19 Positive started from 11Aug2021. No treatment for AE. If covid tested post vaccination on 15Aug2021 with Positive result. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: has blood clots throughout his body; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated that after three of her family members received the Pfizer Covid-19 vaccine that they all developed blood clots. The patient has blood clots throughout his body and didn't have long to live and was sent home with morphine. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076809 same reporter/product, similar event, different patient.;US-PFIZER INC-202101076810 same reporter/product, similar event, different patient.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Hypersomnia, Loss of consciousness
Clinical narrative: When I try to push through it I feel like I'm going pass out and weak; When I try to push through it I feel like I'm going pass out and weak; I have been feeling off; I slept the whole time. I will sleep 18 hours at a time.; My fatigue is out of control.; Every week 2-3 days a week I'll have various colored vaginal spotting; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EN6204) dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (at the age of 32-years) as dose 2, single dose for covid-19 immunisation. The patient medical history included HIV, bipolar, anxiety, PCOS, fibromyalgia, liver disease, asthma, obesity, periodic limb movement disorder, hepatic adenomas, fatty liver disease on an unspecified date. The patient past drug therapy included BNT162B2 (Dose: 1, Lot no: EM9809, Time: 02:15 PM, Vaccine location: Left arm) for COVID-19 immunization on 08Mar2021. The patient had allergies with penicillin, cefuroxime adhesive tapes. The patient's concomitant medications included duloxetine, topiramate, lithium, lamotrigine, bikta for unknown indication on an unknown date. The patient had tested covid post vaccination. The patient has been feeling off and feeling like I did before I was put on medicine for HIV since I received my second shot. I was put down for 4 days after the 2nd vax shot, I slept the whole time. I will sleep 18 hours at a time. My fatigue is out of control. When I try to push through it, I feel like I am going pass out and weak. I have also had continuous spotting since May. Every week 2-3 days a week I will have various colored vaginal spotting on 29Mar2021 07:00 PM. The patient underwent lab tests and procedures which included nasal Swab (SARS-CoV-2 test) was negative on 02Aug2021. The outcome of the events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: When I try to push through it I feel like I'm going pass out and weak; When I try to push through it I feel like I'm going pass out and weak; I have been feeling off; I slept the whole time. I will sleep 18 hours at a time.; My fatigue is out of control.; Every week 2-3 days a week I'll have various colored vaginal spotting; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EN6204) dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (at the age of 32-years) as dose 2, single dose for covid-19 immunisation. The patient medical history included HIV, bipolar, anxiety, PCOS, fibromyalgia, liver disease, asthma, obesity, periodic limb movement disorder, hepatic adenomas, fatty liver disease on an unspecified date. The patient past drug therapy included BNT162B2 (Dose: 1, Lot no: EM9809, Time: 02:15 PM, Vaccine location: Left arm) for COVID-19 immunization on 08Mar2021. The patient had allergies with penicillin, cefuroxime adhesive tapes. The patient's concomitant medications included duloxetine, topiramate, lithium, lamotrigine, bikta for unknown indication on an unknown date. The patient had tested covid post vaccination. The patient has been feeling off and feeling like I did before I was put on medicine for HIV since I received my second shot. I was put down for 4 days after the 2nd vax shot, I slept the whole time. I will sleep 18 hours at a time. My fatigue is out of control. When I try to push through it, I feel like I am going pass out and weak. I have also had continuous spotting since May. Every week 2-3 days a week I will have various colored vaginal spotting on 29Mar2021 07:00 PM. The patient underwent lab tests and procedures which included nasal Swab (SARS-CoV-2 test) was negative on 02Aug2021. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp.  This case is for 2nd patient of 37 patients. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318) as dose 2, single and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686) as dose 1, single both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Mar2021, the caller that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. The patient underwent lab tests and procedures which included NAAT Covid test positive on 14Mar2021. Outcome of events was unknown.   Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/AE, different patiens
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; first dose on 26jan2021 second dose on 12feb2021; This is a spontaneous report from a contactable consumer. This is a report 3 of 37, reports on a 57-years-old female. The report is cross referenced to report ID: E4LNU061. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 as dose 1, single, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9266) via an unspecified route of administration on 12Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing fibromyalgia. The patient's concomitant medications were not reported. Unknown other Products. Unknown height and weight. Assistant Director of Health (non-HC) calling today from a withheld Health Department. She stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide to DSU upon transfer. Caller stated, reclarified later in report, she had 37 patients with partial identifiers. Caller stated she could not provide some identifying details and that she would need to check with her legal department first. On 10Mar2021, caller stated that covid positive was defined as having both vaccines first dose on 26jan2021, second dose on 12feb2021 (inappropriate schedule of vaccine administration) and testing positive for Covid longer than two weeks after both doses (drug ineffective). Caller stated unknown or could not provide to other questions. Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Mar2021. The consumer reported seriousness as no. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer. This case is for 8th patient of 37 patients. A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318), via an unspecified route of administration on 31Jan2021 (age at vaccination 51-year-old) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EH9899), via an unspecified route of administration on 10Jan2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes. The patient's concomitant medications were not reported. The patient experienced tested positive for covid virus, after being fully vaccinated on 22Jul2021. It was reported that, they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller confirms she is calling about the Pfizer Covid 19 vaccine.Caller reclarifies later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller states, reclarified later in report, she has 37 patients with partial identifiers. The patient underwent lab test which included Covid test was positive on 22Jul2021. The outcome of the event COVID-19 was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Testing positive for Covid longer than two weeks after both doses/Tested positive for Covid virus, after being fully vaccinated; testing positive for Covid longer than two weeks after both doses/Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. This report is 12th of 37, reports.   A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 06Feb2021 as single dose, and received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EJ1686) via an unspecified route of administration on 16Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing asthma and ongoing hypertension. The patient's concomitant medications were not reported.  The patient tested positive for covid longer than two weeks after both doses/tested positive for covid virus, after being fully vaccinated on 27Jul2021.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Jul2021. Caller stated that, they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller called because she had some concerns, and the health department was tracking breakthrough cases in that area. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reporting same event(s) under the same suspect product(s) for 37 patients. This is for 14th (69-year-old-male) of the 37people. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318) as dose 2, single and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes, ongoing Parkinson's disease, ongoing rheumatoid arthritis.  The patient's concomitant medications were not reported. Caller was an Assistant Director of Health and works at a local health department called because she had some concerns, and the health department was tracking breakthrough cases in her area. Stated 15% of breakthrough cases were from one Pfizer Covid 19 Lot number: EN5318. On 30Jul2021, patient tested positive for covid virus, longer than two weeks after both doses. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Jul2021. Product Complaint description included Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The clinical outcome of the events was unknown at the time of report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This is 15 of 37, reports on a 59-years-old female. A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 31Jan2021 as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EH9899) via an unspecified route of administration on 10Jan2021 as dose 1, single for covid-19 immunization at pharmacy. Medical history included ongoing high blood pressure, atrial fibrillation and diabetes. The patient's concomitant medications were not reported. unknown other products. The patient tested positive for Covid virus, after being fully vaccinated on 31Jul2021. The clinical course reported as follows, she stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Caller reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller stated, reclarified later in report, she has 37 patients with partial identifiers. Caller stated she cannot provide some identifying details and that she would need to check with her legal department first. Caller provides the details she was allowed to identify. Caller stated unknown or could not provide to other questions. On 31Jul2021, caller stated that covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included body mass index: 34.9 on an unspecified date, sars-cov-2 test: positive on 31Jul2021. The outcome of events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/AE, different patient
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reporting same event(s) under the same suspect product(s) for 37 patients. This is 1 of 37 reports. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 23Jan2021 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunisation at health department. Medical history included ongoing chronic obstructive pulmonary disease (COPD) AND ongoing congestive heart failure (CHF). The patient's concomitant medications were not reported. After being fully vaccinated, on 29Jul2021, patient tested positive for COVID virus. The patient underwent lab tests and procedures which included body mass index (BMI): 28.7 and NAAT COVID test: positive on 29Jul2021. Outcome of the event was unknown.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nucleic acid test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated event; covid positive; This is a spontaneous report from Pfizer a contactable pharmacist, the patient.  A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in the left arm on Friday 05Feb2021(at the age of 34 years) as dose 1, single, for COVID-19 immunization, by a technician. Reason for not providing lot number was mentioned as patient was unwilling to complete the report. The patient's medical history and concomitant medications were not reported. On 05Feb2021, they injected the vaccine pretty low about 4.5-5 inches from the top of her shoulder (injected low in the arm and not in the muscle) and she believed that the vaccine was administered incorrectly, because it was not administered in the deltoid muscle (Vaccine administered at inappropriate site). She stated that, on unspecified date in 2021, her arm was pretty sore to lay on and the fatty tissue was sore, and she experienced pain at the injection site but did not experience any muscle soreness in her triceps or deltoid muscle. She states they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Agent states the Caller was an assistant director of health and works at a local health department. Agent states the Caller called because she had some concerns, and the health department is tracking breakthrough cases in her area. Agent reports that Caller states 15% of breakthrough cases are from one Pfizer Covid 19 Lot number: EN5318. Agent confirms Caller is calling about the Pfizer Covid 19 vaccine. Caller confirms she was calling about the Pfizer Covid 19 vaccine. Caller reclarifies later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller states, reclarified later in report, she had 37 patients with partial identifiers. Caller states she cannot provide some identifying details and that she would need to check with her legal department first. Caller states that Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. Patient was hospitalized with Covid, but no other information can be provided by Caller. The outcome for the events was unknown at the time of report.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid virus, after being fully vaccinated; tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This is 18 of 37 reports. This consumer reported for a 78-year-old male patient. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot Number: EN5318)), dose 1 via an unspecified route of administration on 28Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EN6202) as dose 2, single for COVID-19 immunisation. The patient's medical history included ongoing cardiac failure congestive. The patient's concomitant medications were not reported. Caller was an healthcare supervisor and works at a public health provider called because she had some concerns, and the regulatory health authority was tracking breakthrough cases in her area. Stated 15% of breakthrough cases were from one Pfizer COVID-19. On 04Aug2021, 78-years-old male patient tested positive for covid virus, longer than two weeks after both doses. The seriousness of the reported was hospitalization. The patient underwent lab tests and procedures which included body mass index: 25.1 on an unspecified date, sars-cov-2 test: positive on 04Aug2021. Product Complaint description included Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer.    A 37-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 as single dose and received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid virus, after being fully vaccinated (vaccination failure) on 01Aug2021. The patient underwent lab tests and procedures which included NAAT COVID test which was positive on 01Aug2021. Outcome of the events was unknown.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/eevnt, differnt patients
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer reported for 37 patients. This case is for 24th patient of 37 patients. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266), via an unspecified route of administration on 25Feb2021 as dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration on 04Feb2021 as dose1, single for Covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Assistant Director of Health (non-health Care) called on 19Aug2021 from a Health Department. She stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however was going to work on pulling patient information so that she would be able to have this information available. She stated that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Aug2021, body mass index: 30.6. The outcome of events was Unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) dose 1 via an unspecified route of administration on 26Jan2021 (Lot Number: EN5318) as dose 1, single and with lot number (EL9266), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for COVID virus, after being fully vaccinated (after two doses) on 10Aug2021. The patient underwent lab tests and procedures which included Covid test (sars-cov-2 test:) positive on 10Aug2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Vaccination failure
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 32nd patient of 37 patients.  A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9266, expiry date was unknown), via an unspecified route of administration on 22Feb2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration, at an unknown administration site on 27Jan2021 as dose 1, single for COVID-19 immunization, at physician's office. The patient's medical history and concomitant medications were not reported. On 09Aug2021, the patient was tested positive for Covid virus, after being fully vaccinated (covid-19 confirmed by positive covid-19 test). Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included Antigen COVID-19 test on 09Aug2021, with positive results. Also, the patient had body mass index: 27.5 (calculated on an unknown date). On an unknown date, it was reported that the reporter had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided EN5318 and there was an investigation assessment, and a product complaint was initiated. The outcome of the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Body mass index increased, COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or non-healthcare professional from medical information team. This consumer reported similar events for 37 patients. This report is for 33rd patient of 37 patients. A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 19Jan2021 (Lot Number: EL3249) and dose 2 via an unspecified route of administration on 09Feb2021 (Lot Number: EN5318); both as single dose for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. On 10Aug2021 (longer than two weeks after both doses), patient was tested positive for covid virus, after being fully vaccinated. On an unknown date, patient underwent body mass index test which showed 28.7. On 10Aug2021, NAAT Covid test resulted positive. Caller stated 15% of breakthrough cases were from one Pfizer Covid 19 Lot number: EN5318. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients