chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Behaviour disorder, Memory impairment
Clinical narrative: developed memory and behavioral issues; developed memory and behavioral issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02174538.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), BEHAVIOUR DISORDER (non-serious), outcome "unknown" and all described as "developed memory and behavioral issues".  Additional information: Reporter reports that after her niece received the first dose of the COVID-19 vaccine she developed memory and behavioral issues. Reporter was unable to provide any additional information for this report. No additional reported. No PQC reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing); "RRMS" (ongoing), notes: Patient's concurrent condition included: RRMS. Concomitant medication(s) included: OCREVUS; TESTOSTERONE; VITAMIN D [COLECALCIFEROL]; BACLOFEN. Past drug history included: Benzoyl peroxide, reaction(s): "Allergies: Drug allergy". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Sore throat; Back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "Sore throat"; BACK PAIN (non-serious), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Description of Event: Patient is 74-year-old male who received his primary series vaccine and both boosters. He tested Positive for COVID. His symptoms have been going on for 5 days and his symptoms are sore throat and back pain. Name of Product: Pfizer-BioNTech COVID-19 Vaccine Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she has received 4 doses of Pfizer Covid-19 Vaccine prior to diagnosis of COVID and Paxlovid start.; she has received 4 doses of Pfizer Covid-19 Vaccine prior to diagnosis of COVID and Paxlovid start.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), on 31Mar2021 as dose 2, single (Lot number: EL9264), on 08Oct2021 as dose 3 (booster), single (Lot number: 30135BA) and on 13May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing), notes: [Breast cancer Onset prior to starting Paxlovid ]. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; TRELEGY taken for asthma.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "she has received 4 doses of Pfizer Covid-19 Vaccine prior to diagnosis of COVID and Paxlovid start.". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough COVID infection".  Clinical information: The patient was fully vaccinated and boosted (1 booster) and had Breakthrough COVID infection. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: Vaccinated and boosted by Pfizer yet I still got COVID; Vaccinated and boosted by Pfizer yet I still got COVID; Vaccinated and boosted by Pfizer yet I still got COVID and have been sick for past 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccinated and boosted by Pfizer yet I still got COVID"; ILLNESS (non-serious), outcome "not recovered", described as "Vaccinated and boosted by Pfizer yet I still got COVID and have been sick for past 5 days".  Clinical course: Description of Inquiry: Patient was vaccinated and boosted by Pfizer yet patient still got COVID and had been sick for past 5 days. Doesn't inspire a lot of confidence in efficacy sorry.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough case of COVID; Breakthrough case of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Breakthrough case of COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient's symptoms began on Tuesday evening, 31May and he began taking Paxlovid in a.m., Wednesday, 01Jun. He was on day 4 of 5 (Sat, 04Jun).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "I've read and seen that covid/covid shot cause blood issues". Additional information: It was reported by reporter "I went to an urgent care they said the red bumps on my upper legs was purpura they said it will go away in 2 weeks. Went urgent Care in Jan2022. Dr Diagnosed Internal Shingles. Also had No itchy bumps end of the internal Shingles. Then got COVID Mar2022. End up with the same non itchy bump. went to an urgent Care they said it was purpura that it will go away in 2 weeks. But they came back again and gone. I got the internal shingles from the COVID shot. It messed with my DNA. I had 3 Doctors tell me they seen cases that COVID and shingles are similar. They seen patients with COVID and shingles together. Sorry for the difficulty with results. Your labs including electrolyte, liver, kidney, are all normal. Overall your blood counts are normal as well. Your lymphocytes were 0.2 less than normal which is likely transient (not caused by anything) and will improve on its own. I would like to recheck it in one month to make sure it improves. Thanks. What was wrong on my lab. I did called the office but I did not get all the information because I didn't hear her. I tried to look it up in my results and didn't see it in there. Thank you, Ever Since COVID Shot I got Internal Shingles then COVID my lymphocytes less than normal. COVID shot messed my DNA? Now I'm getting purpura it will come and go and Which is when Small blood vessels Leak blood under the Skin's Surface. which I've read and seen that COVID/ COVID Shot Cause blood issues. What is not fair all those Dr's visits and urgent care visit I'm paying for. I wish I Never got the COVID Shot. I am Not getting the 3rd Shot. This shot is not approved. If you using my Info for a steady I want to get paid. Then the purpura is from it all".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Magnesium low; Potassium low; Bowel resection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4417628-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159928) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTESTINAL RESECTION (medically significant) with onset 22Jan2022, outcome "unknown", described as "Bowel resection"; BLOOD MAGNESIUM DECREASED (medically significant), outcome "unknown", described as "Magnesium low"; BLOOD POTASSIUM DECREASED (medically significant), outcome "unknown", described as "Potassium low". The patient underwent the following laboratory tests and procedures: Blood magnesium: (07May2022) Low; Blood potassium: (07May2022) Low; Weight: (unspecified date) Losing. The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced weight loss/losing weight, low on magnesium, body was not absorbing nutrients and low on potassium. on 22Jan2022, the patient experienced bowel resection surgery. On 07May2022 the patient ended up in the emergency room, she was low on potassium and magnesium.  Causality For Humira (Adalimumab): The reporter's causality for the event(s) of bowel resection surgery, was no reasonable possibility. The reporter's causality for the event(s) of low on magnesium and low on potassium was not provided Agency opinion is that the events of bowel resection surgery, low on magnesium and low on potassium are not assessable.  The reporter's assessment of the causal relationship of "bowel resection", "magnesium low" and "potassium low" with the suspect product(s) BNT162b2 was not reported 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 possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event bowel resection, magnesium low, potassium low and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested POSITIVE for COVID-19; She tested POSITIVE for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 86-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Congestive Heart Failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested POSITIVE for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: She tested POSITIVE for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: altered taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Lot number: EW0179) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Lot#ER8733), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "COVID". The following information was reported: TASTE DISORDER (non-serious) with onset Jun2021, outcome "unknown", described as "altered taste".  Additional information: Caller was patient who has had 2 doses of Pfizer COVID 19. She stated since the second dose that she had an altered taste and was asking if this was a known side effect. Patient stated that she waited so long to get her 2nd vaccine because she got COVID between the first and second vaccine doses. She asked if maybe having COVID gave her the altered dose and not the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Headache" (unspecified if ongoing), notes: Headache; "Migraine" (unspecified if ongoing), notes: Migraine. Concomitant medication(s) included: AIMOVIG taken for migraine. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "Body aches through out the night"; CHILLS (non-serious) with onset 04Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 04Jun2022, outcome "unknown" and all described as "He had a migraine, headache which he normally gets". Therapeutic measures were taken as a result of migraine. Additional information: NDC number and UPC number of COVID-19 vaccine: Unknown. Prior vaccinations (4 weeks) reporter was not aware. They got the 4th booster shot of Pfizer yesterday morning and by evening time they had typical symptoms. The patient had a migraine, headache which he normally gets and takes Amovig for. He had chills, fever and body aches through out the night." Other medication the only one they know was for migraines Aimovig, it's a monthly injection. Not aware about Lab test. Treatment: just migraine medicine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Sneezing, Vaccination failure
Clinical narrative: Tested Covid-19 positive after vaccination; Tested Covid-19 positive after vaccination; sneezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9264), on 09Mar2021 as dose 2, single (Lot number: EN6207) and in 2021 as dose 3, booster (single) (Lot number: FF8841) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "brain surgery" (unspecified if ongoing), notes: many years ago when she had her brain surgery; "Asthma Has had it all her life" (unspecified if ongoing), notes: Asthma Has had it all her life. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested Covid-19 positive after vaccination"; SNEEZING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: unknown results, notes: She is under the care of a neurologist who does blood test periodically to make sure the levels of the medication are correct; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, sneezing.  Clinical course: Gave primary care physician the message this morning that she was stopping the medication. Caller was an asthmatic and has been all her life. She developed a horrid cough from the COVID. Almost like she was choking. She was choking from coughing. It was not fun. It was a deep cough. It was awful. It was hard to catch her breath. The patient was treated with paxlovid for the events on 31May2022 or 01June2022. She was reading the material from Pfizer last night, then went to bed. She had been taking the Paxlovid for 2.5 days. Her temples started squeezing and it was reminiscent of many years ago when she had the brain surgery. Vaccination facility type was pharmacy. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room nor physician office. No prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). Always get the flu shot in Oct. She has had the pneumonia and shingles vaccines and others. She has bene having vaccines and shots since she was 10 years old for allergies. There were no predisposing factors.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 7-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 7 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Jun2022, outcome "unknown", described as "Diarrhea"; VOMITING (non-serious) with onset Jun2022, outcome "unknown". Additional information: Reporter stated, "I am calling to report side effects of my son who received third COVID vaccine on Thursday." Reporter was informed about the role of Pfizer drug safety. Lot# and expiration date: Reporter stated, "I am sorry that one I do not have." The patient did not receive any other vaccines or medicine within four weeks prior to the vaccination. Reporter further stated, "I have a quick question, I wasn't aware that a third dose of the COVID vaccine was being recommended, is that correct?" You are taking about booster dose: Reporter stated "Yes." Reporter was informed about Pfizer information department for the question and offered the number. The information on the batch/lot number for [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Procedural pain, Spinal fusion surgery, Vitamin B12 decreased
Clinical narrative: Back pain because of fusion; Back pain because of fusion; Low B12; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4421179-00.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1161756) at cf, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL FUSION SURGERY (medically significant), PROCEDURAL PAIN (non-serious), outcome "unknown" and all described as "Back pain because of fusion"; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "Low B12". The patient underwent the following laboratory tests and procedures: Blood test: Low, notes: Low B12. The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event (s) of back pain because of fusion unknown onset, back pain because of fusion unknown onset and low B12 was not provided. Agency' s opinion is that there is no reasonable possibility that the events of back pain because of fusion unknown onset, back pain because of fusion unknown onset and low B12 are related to Humira (Adalimumab).   The reporter considered "back pain because of fusion" and "low b12" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 81-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: EW0150) at the age of 81 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient has no history of COVID-19 infection. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovered" (Jan2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (PCR test): (04Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "recovered" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not have covid prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood lactic acid, Blood urea normal, COVID-19, Cardiomegaly
Clinical narrative: Patient presented to the ED after a fall.  Denied any shortness of breath but reported chronic cough.  Has intermittent urinary difficulty.  In the ED noted to be hypotensive with blood pressure 73/36, heart rate 120, temperature 97.1°.  BUN was 11, creatinine 1.2.  Lactate was 3.2.  Procalcitonin was 0.08.   Chest x-ray showed stable cardiomegaly and mild pulmonary venous congestion.  No lobar infiltrates.  COVID-19 test was positive.  Patient was given starter dose of IV antibiotics and admitted.  Patient did not require any supplemental oxygen and therefore was not started on any Decadron.  He was afebrile during his hospital stay.  His blood pressures normalized.  Antibiotics discontinued as procalcitonin was not elevated and cultures were negative.  Patient did have inflammatory markers elevated from underlying COVID-19.  Because of COVID-19, patient will not be able to go to any facility for a few more days until he finishes with isolation.  Patient vehemently refused to go to rehab and was discharged home in stable condition. his discharge diagnosis were: Sepsis present on admission secondary to COVID-19 infection-resolved COVID-19 infection without hypoxia Hypotension on admission secondary to above-resolved
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Culture negative, Dysuria, Fall
Clinical narrative: Patient presented to the ED after a fall.  Denied any shortness of breath but reported chronic cough.  Has intermittent urinary difficulty.  In the ED noted to be hypotensive with blood pressure 73/36, heart rate 120, temperature 97.1°.  BUN was 11, creatinine 1.2.  Lactate was 3.2.  Procalcitonin was 0.08.   Chest x-ray showed stable cardiomegaly and mild pulmonary venous congestion.  No lobar infiltrates.  COVID-19 test was positive.  Patient was given starter dose of IV antibiotics and admitted.  Patient did not require any supplemental oxygen and therefore was not started on any Decadron.  He was afebrile during his hospital stay.  His blood pressures normalized.  Antibiotics discontinued as procalcitonin was not elevated and cultures were negative.  Patient did have inflammatory markers elevated from underlying COVID-19.  Because of COVID-19, patient will not be able to go to any facility for a few more days until he finishes with isolation.  Patient vehemently refused to go to rehab and was discharged home in stable condition. his discharge diagnosis were: Sepsis present on admission secondary to COVID-19 infection-resolved COVID-19 infection without hypoxia Hypotension on admission secondary to above-resolved
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Inflammatory marker increased, Procalcitonin, Pulmonary congestion, SARS-CoV-2 test positive
Clinical narrative: Patient presented to the ED after a fall.  Denied any shortness of breath but reported chronic cough.  Has intermittent urinary difficulty.  In the ED noted to be hypotensive with blood pressure 73/36, heart rate 120, temperature 97.1°.  BUN was 11, creatinine 1.2.  Lactate was 3.2.  Procalcitonin was 0.08.   Chest x-ray showed stable cardiomegaly and mild pulmonary venous congestion.  No lobar infiltrates.  COVID-19 test was positive.  Patient was given starter dose of IV antibiotics and admitted.  Patient did not require any supplemental oxygen and therefore was not started on any Decadron.  He was afebrile during his hospital stay.  His blood pressures normalized.  Antibiotics discontinued as procalcitonin was not elevated and cultures were negative.  Patient did have inflammatory markers elevated from underlying COVID-19.  Because of COVID-19, patient will not be able to go to any facility for a few more days until he finishes with isolation.  Patient vehemently refused to go to rehab and was discharged home in stable condition. his discharge diagnosis were: Sepsis present on admission secondary to COVID-19 infection-resolved COVID-19 infection without hypoxia Hypotension on admission secondary to above-resolved
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Patient presented to the ED after a fall.  Denied any shortness of breath but reported chronic cough.  Has intermittent urinary difficulty.  In the ED noted to be hypotensive with blood pressure 73/36, heart rate 120, temperature 97.1°.  BUN was 11, creatinine 1.2.  Lactate was 3.2.  Procalcitonin was 0.08.   Chest x-ray showed stable cardiomegaly and mild pulmonary venous congestion.  No lobar infiltrates.  COVID-19 test was positive.  Patient was given starter dose of IV antibiotics and admitted.  Patient did not require any supplemental oxygen and therefore was not started on any Decadron.  He was afebrile during his hospital stay.  His blood pressures normalized.  Antibiotics discontinued as procalcitonin was not elevated and cultures were negative.  Patient did have inflammatory markers elevated from underlying COVID-19.  Because of COVID-19, patient will not be able to go to any facility for a few more days until he finishes with isolation.  Patient vehemently refused to go to rehab and was discharged home in stable condition. his discharge diagnosis were: Sepsis present on admission secondary to COVID-19 infection-resolved COVID-19 infection without hypoxia Hypotension on admission secondary to above-resolved
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid positive on 5/15/2022
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID positive
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Chills, Cough, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Soreness at site, chills, fever, sore throat, coughing, congestion still occurring 2 days after injection
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Respiratory tract congestion
Clinical narrative: Soreness at site, chills, fever, sore throat, coughing, congestion still occurring 2 days after injection
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Death, Dyspnoea
Clinical narrative: Presented to ED, Hospital, with c/o cough and hypoxia.  Patient was diagnosed with Covid-19 on 04/10/2022.  Since then he has had SOB and nonproductive cough.  Chest Xray revealed some bilateral pulmnary infiltrates.  Patient was also found to have a UTI and started on Macrobid for 7 days.  Patient was discharged home with home health.  Patient expired on  05/13/2022.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Lung infiltration, Urinary tract infection
Clinical narrative: Presented to ED, Hospital, with c/o cough and hypoxia.  Patient was diagnosed with Covid-19 on 04/10/2022.  Since then he has had SOB and nonproductive cough.  Chest Xray revealed some bilateral pulmnary infiltrates.  Patient was also found to have a UTI and started on Macrobid for 7 days.  Patient was discharged home with home health.  Patient expired on  05/13/2022.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Hypophagia, Mental status changes, Pneumonia
Clinical narrative: Patient admitted 03/08/2022 after he stopped eating and drinking after having contracted Covid-19 at home.  He was admitted to the hospitalist service and he was in renal failure as well as having an AMS and PNA.  His renal function worsened and he was not responding to therapy, family decided to make him DNR/Comfort care.  Patient expired on 03/11/2022.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, Therapy non-responder
Clinical narrative: Patient admitted 03/08/2022 after he stopped eating and drinking after having contracted Covid-19 at home.  He was admitted to the hospitalist service and he was in renal failure as well as having an AMS and PNA.  His renal function worsened and he was not responding to therapy, family decided to make him DNR/Comfort care.  Patient expired on 03/11/2022.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 7/20/21, 8/11/21. Positive on 6/8/22
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Akinesia, COVID-19, Cardiac arrest, Death, Endotracheal intubation complication
Clinical narrative: Patient arrived to ED on 03/08/2022 in cardiac arrest.   By the time the patient arrived to ED patient without a pulse for approximately 1 hour or more.  ET tube was beginning to fill with blood.  Patient had no reactivity to her pupils and was making no spontaneous movements.  Rapid covid-19 antigen returned positive.  Patient expired on 03/08/2022.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Inappropriate schedule of product administration, Pulse absent, Pupillary reflex impaired, SARS-CoV-2 test positive
Clinical narrative: Patient arrived to ED on 03/08/2022 in cardiac arrest.   By the time the patient arrived to ED patient without a pulse for approximately 1 hour or more.  ET tube was beginning to fill with blood.  Patient had no reactivity to her pupils and was making no spontaneous movements.  Rapid covid-19 antigen returned positive.  Patient expired on 03/08/2022.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: , Additional Details: three days after vaccination, patient came back into the pharmacy and her left arm was clearly very red and swollen. Patient stated that her upper arm was very sore to the touch. She had not taken anything for it at this time. I advised her to try Benadryl and to contact her doctor if the swelling and pain does not subside.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19, Cardiac failure congestive, Chest X-ray abnormal
Clinical narrative: Patient is fully vaccinated and boosted.  COVID positive on 5/6/2022 at admision to hospital.90-year-old female who presented to the hospital for evaluation of hyponatremia/difficulty swallowing.According to her daughter, in December she was diagnosed with pneumonia for which she initially presented to the urgent care, was prescribed Levaquin and prednisone however she became much worse therefore she presented to a local Hospital, she was diagnosed with new onset myocarditis and atrial fibrillation and new onset congestive heart failure with low ejection fraction,dx: acute hypoxic respiratory failure.  Chest X ray with pleural effusion.  Medications: oxygen, decadron, antibiotics. WBC 31.8, elevated inflammatory markers. Thrombocytopenia. + hyponatremia. Pt transferred to Beaumont in house rehab from 5/17 to 6/4. Discharged
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Ejection fraction decreased, Hyponatraemia, Inflammatory marker increased, Myocarditis
Clinical narrative: Patient is fully vaccinated and boosted.  COVID positive on 5/6/2022 at admision to hospital.90-year-old female who presented to the hospital for evaluation of hyponatremia/difficulty swallowing.According to her daughter, in December she was diagnosed with pneumonia for which she initially presented to the urgent care, was prescribed Levaquin and prednisone however she became much worse therefore she presented to a local Hospital, she was diagnosed with new onset myocarditis and atrial fibrillation and new onset congestive heart failure with low ejection fraction,dx: acute hypoxic respiratory failure.  Chest X ray with pleural effusion.  Medications: oxygen, decadron, antibiotics. WBC 31.8, elevated inflammatory markers. Thrombocytopenia. + hyponatremia. Pt transferred to Beaumont in house rehab from 5/17 to 6/4. Discharged
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pneumonia, SARS-CoV-2 test positive, Thrombocytopenia, White blood cell count increased
Clinical narrative: Patient is fully vaccinated and boosted.  COVID positive on 5/6/2022 at admision to hospital.90-year-old female who presented to the hospital for evaluation of hyponatremia/difficulty swallowing.According to her daughter, in December she was diagnosed with pneumonia for which she initially presented to the urgent care, was prescribed Levaquin and prednisone however she became much worse therefore she presented to a local Hospital, she was diagnosed with new onset myocarditis and atrial fibrillation and new onset congestive heart failure with low ejection fraction,dx: acute hypoxic respiratory failure.  Chest X ray with pleural effusion.  Medications: oxygen, decadron, antibiotics. WBC 31.8, elevated inflammatory markers. Thrombocytopenia. + hyponatremia. Pt transferred to Beaumont in house rehab from 5/17 to 6/4. Discharged
Age: 103.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles to face and neck
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Approximately 2 months and a half after my 4th dose I contracted COVID-19 and have the following symptoms: Fatigue and minor nasal congestion. I have not been taking any medications for treatment but I called my doctor's office to request a prescription of PAXLOVID but have not heard from them yet. As of today 06/09/2022, I am still experiencing the same symptoms.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Expired product administered
Clinical narrative: After administration, realized the expiration date was 5/28/22. No adverse signs or symptoms noted.
Age: 1.25
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: On 6/8/2022 patient received two doses of Varicella, mistakenly. No adverse reaction has been reported at this time. Doctor has informed mother of event and informed to call office or go to ER with any site reaction, fever, HA, excessive fussiness, or seizure. Again at this time mother reports no adverse reaction.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss, excessive shedding. Observable, all over loss, thinning
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram head normal, Death, Echocardiogram normal, Electroencephalogram normal
Clinical narrative: Patient reported to hospital on 01/18/2022  with inability to walk and right extremity weakness.  Acute stroke was not seen on CT of brain.  Patient underwent CT MRI EEG and echo, no evidence of acute stroke.  Patient did test positive for Covid-19.  Patient was placed on oxygen for comfort.  Patient was discharged back to long term care facility.  Patient expired on 04/05/2022.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Hemiparesis, Interchange of vaccine products, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: Patient reported to hospital on 01/18/2022  with inability to walk and right extremity weakness.  Acute stroke was not seen on CT of brain.  Patient underwent CT MRI EEG and echo, no evidence of acute stroke.  Patient did test positive for Covid-19.  Patient was placed on oxygen for comfort.  Patient was discharged back to long term care facility.  Patient expired on 04/05/2022.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient reported to hospital on 01/18/2022  with inability to walk and right extremity weakness.  Acute stroke was not seen on CT of brain.  Patient underwent CT MRI EEG and echo, no evidence of acute stroke.  Patient did test positive for Covid-19.  Patient was placed on oxygen for comfort.  Patient was discharged back to long term care facility.  Patient expired on 04/05/2022.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Blood gases abnormal, COVID-19, Chest X-ray normal, Exposure to SARS-CoV-2
Clinical narrative: Patient presented from home, she is mentally retarded.  She could not provide any history.  She is sitting in a motorized wheelchair.  She was seen here yesterday for respiratory distress, she was COVID-positive.  She was discharged with instructions to provide trach suctioning, oxygen and breathing treatment.  She returned this morning with respiratory distress, she was not given oxygen at the home.  The accompanying staff could not provide any meaningful history.  Patient O2 sat was about 76% on room air.  She was suctioned and supported.  As mentioned above patient cannot provide any history, she is nonverbal.  I reviewed her medical records.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoxia, Oxygen saturation decreased, Rales, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Patient presented from home, she is mentally retarded.  She could not provide any history.  She is sitting in a motorized wheelchair.  She was seen here yesterday for respiratory distress, she was COVID-positive.  She was discharged with instructions to provide trach suctioning, oxygen and breathing treatment.  She returned this morning with respiratory distress, she was not given oxygen at the home.  The accompanying staff could not provide any meaningful history.  Patient O2 sat was about 76% on room air.  She was suctioned and supported.  As mentioned above patient cannot provide any history, she is nonverbal.  I reviewed her medical records.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Stoma site discharge, Wheezing
Clinical narrative: Patient presented from home, she is mentally retarded.  She could not provide any history.  She is sitting in a motorized wheelchair.  She was seen here yesterday for respiratory distress, she was COVID-positive.  She was discharged with instructions to provide trach suctioning, oxygen and breathing treatment.  She returned this morning with respiratory distress, she was not given oxygen at the home.  The accompanying staff could not provide any meaningful history.  Patient O2 sat was about 76% on room air.  She was suctioned and supported.  As mentioned above patient cannot provide any history, she is nonverbal.  I reviewed her medical records.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Chest pain, SARS-CoV-2 test positive
Clinical narrative: Approximately 4 months after my 3rd dose vaccination I contracted COVID-19 and experienced the following symptoms: (Tightness of chest) Unusual pressure on my left side (Heart to rib cage) and I contacted my Doctor because I wanted them to do an X-Ray and see what's happening but they advised me to do a COVID-19 test first before they see me and the result was positive. I did not take anything for treatment and just let my symptom run its course. Overall it was 7 days until I have fully recovered from my chest pain.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 16 yo patient received Moderna instead of Pfizer for first dose