chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states that on 29Apr2022, he tested positive for Covid; Caller states that on 29Apr2022, he tested positive for Covid; 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 79-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021), on 12Feb2021 as dose 2, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 29Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "skipped heartbeats" (unspecified if ongoing); "prostate" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for arrhythmia; GABAPENTIN; AVODART taken for prostate infection. Vaccination history included: Flu vaccine (AE(s) following prior vaccinations: Yes, in terms of the flu vaccine, they give him adverse reactions. His airways start shutting down and it is not very pleasant.), reaction(s): "His airways start shutting down".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "Caller states that on 29Apr2022, he tested positive for Covid". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results, notes: he has had blood tests but clarified there are no relevant details to provide; SARS-CoV-2 test: (09May2022) Positive; (29Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. Prior Vaccinations (within 4 weeks) was reported as no. AE(s) following prior vaccinations was reported as yes, in terms of the flu vaccine, they give him adverse reactions. His airways start shutting down and it is not very pleasant. Caller states that it was a few years ago. He had a reaction when he took the flu vaccine one year. He had trouble breathing and the next year he took it and ended up with the paramedics. Patient's Medical History (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to AE(s): Not that he is aware of. His mother had cancer of the liver.
We received the following information from a literature article on 02 SEP 2009: A female adult patient with ulcerative colitis had been managed with 6-MP, sulfasalazine, and intermittent steroids and she had been in remission without steroids for 9 months. After 9 months on 6-MP and while in remission, she received a subcutaneous injection of influenza vaccine (manufacturer and batch no. unknown) and that night she developed abdominal pain and bloody diarrhea. On examination she had very active ulcerative colitis with friability, ulceration, and exudate. She also had recurrence of bilateral uveitis. She was hospitalised and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of ulcerative colitis was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal ulcerative colitis and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. The patient suffered from earlier exacerbation of ulcerative colitis after a previous influenza vaccination (please refer to case MA2009-2378). (Requests were sent on 03 SEP 2009, 09 SEP 2009 and 17 NOV 2009, no follow-up information received.)
half of the dose was administered with no reported adverse event; Initial information  on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom half of the dose was administered with no reported adverse event for vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE standard strength (dose, formulation: unknown) (lot UT7723KA , exp date: 30-Jun-2023) via unknown route in unknown administration site for immunization. Pharmacist states that approximately half of the dose was administered with no reported adverse event (incorrect dose administered) (latency: same day)) and half of the dose spilled on the patient's arm.  Pharmacist called to get some guidance whether they need to revaccinate a patient that was given FLUZONE QUADRIVALENT.   Upon further question the pharmacist states that the person who administered the vaccine advised her that the spill is due to broken vial but does not have any other information.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6021), on 25Mar2021 as dose 2, single (Lot number: FR2613), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 3C1308A), in left arm and on 10Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Degenerative Disc Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies : penicillin" (unspecified if ongoing), notes: Known allergies : penicillin; Sulfa; "Known allergies : Sulfa" (unspecified if ongoing), notes: Known allergies : penicillin; Sulfa. Concomitant medication(s) included: LIPITOR; NYQUIL; SUDAFED 12 HOUR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2weeks reported as Lipitor, Nyquill and Sudafed. Patient received Paxlovid treatment from 23Sep2022 to 28Sep2022.
Fever 102 F developed 24 hours later lasted 1-2 days - also nasal congestion and sore throat (URI vs. vaccine adverse event), also erythema at site of injection appeared at 48 hours later - still evident after 5 days but fading.
Suspected vaccination failure; He got shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Hives  and intense  itching at injection site (plus pain, redness, swelling) . Minor stomach pain.  Took Benadryl approx 5 hours after injection which relieved itching - temporarily.  Hives and itching persist today.  Asthma exacerbation noted now as well.
3 X 6 INCH ERYTHEMA RASH ON UPPER LEFT ARM, STARTING ABOUT AN INCH OR MORE AWAY FROM CENTER OF ARM (INJECTION SITE).
At first I was feeling dizzy after the vaccine, Fatigues, no fever. I got severe muscles aches and pains, vertigo, stabisvus ( eye muscles problems) 6 -16. My hands duprincans ( Tendons /hand problems  soft muscle issue). I cant walk far and garden, trouble climbing the stairs. Did virtual doctor's appointment. Oncologist .
My eye (above my eye) starting swallow and turn red, got bumpy, in both edges. I went to the urgent care and prescribed steroids medicine plus the cream, and I used that for 5 days, it mostly cleared up after a few days. .
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vaccine dose number=2 pfizer, Vaccine dose number=1 Moderna" (unspecified if ongoing), notes: Vaccine dose number=2 pfizer, Vaccine dose number=1 Moderna. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that the patient received the treatment. The patient did no received any other medication within 2 weeks. It was reported that the adverse event Rebound COVID-19 symptoms within 2 days of stopping Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
GENERALIZED FEVER AND MALAISE ESCALATED RAPIDLY TO 104.5-104.9 FEVER. PROFUSE SHAKING, SHORTNESS OF BREATH, DIZZINESS. ATTEMPTED HOSPITALIZATION BY VISITING ER THAT COULD NOT SEE ME FOR HOURS. I RETURNED HOME WITHOUT SEEING ANY MD. I  SUBMERGED MY HEAD IN COLD WATER IN ATTEMPT TO PREVENT NEUROLOGICAL AND TISSUE DAMAGE DUE TO DANGEROUSLY HIGH TEMPERATURE.  1000MG OF TYLENOL & 800MG IBUPROFEN TAKEN Q6-8H.
Hashimoto's thyroiditis; This is a spontaneous report from a contactable physician. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Hashimoto's thyroiditis on an unspecified date. The outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: The event Hashimoto's thyroiditis is most likely an underlying/ intercurrent condition and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
received the 1st dose in June 2022 and has not yet returned to get the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in June 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the 1st dose in June 2022 and has not yet returned to get the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter asked if received one dose of Shingrix and did not go back/ not yet returned to get the 2nd dose of Shingrix, how did you proceed. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after post-vaccination 15 minute observation period patient experienced loss of conscioussness and a fall from standing. Patient transported by ambulance to emergency department alert and oriented with stable vital signs reporting headache. Patient found to have moderate right subarachnoid hemorrhage, extensive facial and mandibular fractures, bilateral nasal fractures, and right ribs six and seven fractures. Patient determined not to be a candidate for surgery and admitted for pain control, antibiotics, and monitoring. Discharged medically stable on antibiotics with neurology and oral maxillofacial surgery follow-up in place.
A week and a half approximately after the initial vaccination of the J+J covid vaccine I started having a course of strange symptoms. Insomnia, inability to focus on things directly in front of me (a hand in front of my face would go out of focus automatically after a second), blurred vision, short term/long term memory loss, severe emotional issues, difficulty breathing, anxiety. Shortness of breath at a certain point was so bad I thought I was not going to make it. One very troublesome symptom that culminated after weeks of 4 hours of sleep was that my brain started feeling "funny". The best way to describe it was a brain "orgasm" which I have never experienced before. At the same time I experienced dry heaving for several minutes, and severe shortness of breath. After this experience my symptoms gradually improved over the next week or two. Prior to this it felt like my brain was not getting enough oxygen/blood, which could have been feeding my insomnia. When I would try to sleep, I would wake up at 4 am gasping for air, as I felt like my breathing was labored when sleeping. I could not focus on my computer screen to do my job at home. Large amounts of melatonin seemed to help my brain feel better and get some rest. I took hydroxyzine for unrelated reasons prior to the vaccine injection as needed, however not too often. During  March I did not take it, as I had experienced disruptions in circadian rhythm due to the medication. I feel it is possible I had a blood clot that has been described in the news, although now there may be no way to know for sure. I talked with  my primary care physician about this, and he did not think this was the case because I was male. However I have a BMI of 18.7 and some issues females have such as TMJ and inability gain weight/anorexia diagnosis when younger. I also was recently diagnosed with an only recently described actual medical issue called R-CPD, which is the complete inability to burp or belch. I felt like during the time when I experienced the side effects, that this condition was heightened (bloating/loss of appetite). I lost quite a bit of weight during March, I usually weigh 135-140, and was down to 115 at a certain point. I am now back up to 130.   I now take sertraline at 1/4 pill dosage to treat the anxiety I experienced as a result of these symptoms as well as some other personal issues. I experienced severe side effects from the sertraline taking it at full dosage, and still experience some at 1/4 pill dosage.
arm is sore; This is a Spontaneous report from a Pfizer sponsored program via a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient's arm was sore on an unspecified date on Jan2021 and she was asking if they can take cold or warm to get rid of the sore. Outcome of the event was unknown.  information on the LOT/Batch number has been requested.
Immediately after vax the patient experienced paleness and slight dizziness. Ten minutes later the patient felt like crying, a deep aching pain began to spread throughout her body and experienced an intense feeling of heaviness. 30 minutes post-vax the patient developed joint stiffness. 60 minutes post-vax the patient experienced difficulty breathing, a frantic feeling, nausea, and numbness in her hands. 90 minutes post-vax the patient experienced slight delirium and flailing arms. 2 and 1/2 hours post-vax she experienced a high fever and weakness. Treated with Vitamin C.
After Tdap developed large local reaction than 2-3 days later developed total body raised, pruritic rash.
Normal reaction I had fever and chills for 24 hrs. July 1, 2021 started develop blisters on my hand. I went to a dermatologist. They said it could be eczema (Atopic Dermatitis). I have to topical steroids. It keeps getting worst and still have it.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (soreness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (soreness) outcome was unknown.            Treatment of the events included ibuprofen.
Day 1: Fatigue, headache, feeling hot and then cold,  fever, fast and shallow respirations, muscle pain, cold extremities, difficulty sleeping for more than a few hours.  Day 2: nausea, fatigue, fever
8 patients given vaccine dose from vial that was in refrigeration for 40-41 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients given vaccine dose from vial that was in refrigeration for 40-41 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients given vaccine dose from vial that was in refrigeration for 40-41 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients given vaccine dose from vial that was in refrigeration for 40-41 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
pt recvd vax & slept 8PM-230AM was awakened @ 230AM extremely pale, unresponsive; recovered in approx 15 mins; PMD advised DT for future immun, per MD hypotensive/hyporesponsive react;
Had 2 doses: 4/27/18 & 10/19/18 - Experienced severe vomiting within about 12 hours of receiving the vaccines on both occasions. Could not stop vomiting for 9 - 12 hours after both doses. Never had a reaction to any other vaccines in the past.
It was determined there was a preparation error at vaccine administration location on 1/19/23. Between 4-5 individuals received Moderna 6 month to 5 years monovalent formulation. Preppers unintentionally prepared 1 vial of the 6 months to 5-year monovalent formulation (with volume of 0.5 ml per dose) and labeled it as a Moderna 12+ years bivalent formulation. There was a total of 14 patients scheduled to receive the Moderna 12+ years bivalent on 1/19/23. Vaccine administration location Clinic is unable to determine if patient received the correct bivalent dose versus the Moderna 6 month-5 years monovalent formulation.   Information about other Moderna formulation: Moderna 6 months to 5 years monovalent dose, Lot AS1414B, manuf. exp 2/13/23.  Patient/her mother have been notified of vaccine error that may have potential impacted her. Patient is feeling well and has no signs/symptoms of adverse reaction.
This spontaneous report was received from a registered nurse concerning a currently 14 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of (Oka/Merck) VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513 1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505.
Pt had previous reaction to Moderna first dose on 7/8.  Pt received Janssen dose to complete primary series. 40mins post vaccination, pt c/o Nausea, Vomiting, itching of the neck and arms, cough, throat tightness. Vitals:@18:30 BP 137/79, HR 68, RR 18 Pt had gradually worsening symptoms.  no visible rash.  Lungs CTAB, good air movement. @18:30 Pt was administered 25mg IM Benadryl to Right Deltoid Recommended pt go straight to urgent care for further observation as a precaution, accompanied by daughter.  Recommended pt also f/u w/ PCP.  It is unclear if the patient went to Urgent Care.  Next visit known to this writer was 10/28 for dental concerns.  No mention of continued symptoms at that visit.