chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 13-APR-2017, the patient was vaccinated with improperly stored ZOSTAVAX (dose and route of administration were not provided) lot # M035692, expiration date: 07-NOV-2017) for prophylaxis. A sterile diluent (STERILE DILUENT) (lot# and expiration date were not reported) was used to reconstitute the vaccine. No adverse effects were reported. The ZOSTAVAX was stored for 2 months in 70 degrees Fahrenheit. There was no previous temperature excursions. It was not a case of a "data logger". Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was an employee. This case had been linked to the case US2018GSK048935 and US2018GSK053449 reported by the same reporter.
The patient developed severe left sided abdominal pain, followed by frank bloody diarrhea.  Current provisional diagnosis is ischemic colitis.
Child had vaccine and 5 hours later had a temperature of 103 and a febrile seizure. He was seen in the emergency room and treated with Ativan and sent home.
patient was immunocompromised/ unknown if the patient was immunocompromised before or after the Prevnar 13 shot was given; This is a spontaneous report from a Pfizer-sponsored Program. A contactable physician reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date in 2011 (batch/lot number was not provided) as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient's medical history and concomitant medications were not reported. The physician had a patient that was administered with Prevnar 13 product 10 years ago (2011). It was explained the patient was immunocompromised and the physician would like to know if the patient should be given the Prevnar 20 shot. Agent responded that caller needs to go to specified entity for this information since it could not be clarified if the patient was immunocompromised before or after the Prevnar 13 shot was given. The outcome of the event was unknown.   The batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not provided and will be requested during follow-up.; Sender's Comments: The association between the event immunocompromised with PREVENAR 13 can not 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.
Had shingles after Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Had shingles after Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Had shingles after Moderna vaccine). At the time of the report, HERPES ZOSTER (Had shingles after Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J007060, expiration date 28-AUG-2014, 0.5 ml, subcutaneous. Secondary and concomitant therapies were not reported. On 12-SEP-2014, the patient was inadvertently administered PNEUMOVAX 23 that had expired in 28-AUG-2014. No adverse effects reported. Additional information is not expected because the reported do not want to be contacted.
Ringing in both ears, 1 week after 1st shot. It's been over 6 months and I still have constant Ringing.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. On an unknown date an unspecified number of patients received improperly stored ROTATEQ. No adverse symptoms reported. Follow up information was received on 21-AUG-2014. The reported stated that had heard nothing concerning any incorrect storage of vaccines at the facility. This is one of several reports from the same source. Additional information is not expected (cancelled all scheduled correspondence).
High pitch crying rt p/receiving shots; 2 episodes of limpness 3 day & 7 days taken to ER both times afterwards.
Heart palpitations, and early heavy period with severe cramps an bloating, water and weight gain
Fever of 101 for 24 hours then terrible really bad (couldn't hardly get out of bed) headache for 3 more days
Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Client received 3 immunizations and a TST on Friday, 7/18/14 and returned on Monday for TST read.  Mentioned at that time that she had a bruise and pain on the back of her left arm.  Bruise evident.  It was recommended to her that she take ibuprofen or acetaminophen for pain as needed.
stored outside of recommended temperature range; This case was reported by a consumer and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Fluarix, 2021-2022 formulation at her local pharmacy. The pharmacy called the patient after the administration of the dose at the pharmacy, and informed her that the dose she was administered may be a part of a recall due to the vaccine being stored outside of recommended temperature range which led to incorrect storage of drug. The patient did not mention that she has had any adverse reactions from the dose administered. The date of the vaccine administration was not reported. The reporter gave consent to contact her health care professional.
It occurred on 03/07/2021, I did not feel like I had any symptoms, but I noticed whenever I picked up anything with my left hand I would drop it quickly. I drove to my sister's. They said my face was droopy. They suggested we go to the hospital. We went and they did a heart test. It showed I had a stroke. I was there overnight and then they dismissed me. From then, I have been going to doctors because I developed tachycardia and I had to have a procedure for that. Then I developed atrial fibrillation. They put on a chip recorder in my chest because they were not sure how the stroke occurred. That has been there since March. They also did a platelets test which was negative, they also did a biopsy, but I do not know the results.
fatigue, confusion, slurred speech, heart fluttering, shortness of breath.  The concerning side effect, which has continued, is the shortness of breath. It feels like when I had pericarditis years ago.
Deceased Narrative: This was a 77 yo F with h/o HFpEF, afib (warfarin), COPD, obesity hypoventilation syndrome, OSA on BiPAP, T2DM, RA, L-sided follicular bronchitis and newly diagnosed probably malignant pulmonary process. Patient was admitted to facility 9/26-10/15 for acute on chronic hypercarbic respiratory failure with persistent O2 requirement despite treatment for CAP, COPD and CHF exacerbation. Patient then underwent high dose steroid taper per Rheum. Patient presented an overall poor state of health and was at high risk of complications with any procedures and was not a candidate for systemic therapy for a malignancy based on functional status. Patient was accepting of terminal diagnosis and transitioned to comfort measures at home.
pt to hospital, found to have a positive COVID test; O2 needs continued to increase, pt placed on BiPAP; given remdesivir, decadron, ABX; COVID pneumonitis; hospital course complicated by hemoptysis; pt developed SVT; became unresponsive and a code was called; pt was unable to be revived and passed away in the hospital
I had my vaccination on 10/05/2022. I was driving on 01/16/2023 and I started to experience severe dizziness and I wanted to pass out. I pulled my car over and hoped someone would find me. A volunteer paramedic found me in the parking lot and called 911. I was very scared when it happened but I did not hurt. I had a MRI and CAT scan done at the emergency room. I was told I had cerebellar stroke syndrome. I am given different medication to make the plaque slimy in my body so it will help me if this happens again. I am being followed up with neurology and medical team.
Sore arm, very tired on the day after vaccine. Two days after vaccine: appearance of blotchy redness near injection site, nausea and vomiting.
Upset stomach/diarrhea.; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: En6204), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. The patient was sensitive to some anti-inflammatory drugs and pseudoephedrine. Concomitant medications included metformin (MANUFACTURE UNKNOWN) and Tylenol (MANUFACTURE UNKNOWN), reported for diabetes. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 19:30, the patient experienced upset stomach/diarrhea. The patient was diabetic and on metformin and also took Tylenol prior to getting the injection. No therapeutic measures were taken as a result of event. The clinical outcome of diarrhea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal.  On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.
No additional AE reported; Nurse reported a patient was administered an expired dose of MMR II.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, lot # T020655, expiration date 16-JUN-2022 (dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The reporter confirmed that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) had no temperature excursions and was provided the supported disclaimer based on the information in the Post Expiry Memo. No additional adverse events were reported (no adverse event).
Four days after immunization given, rash and hives appeared. Given Rx for Benadryl. Returned to doctor 12 days after immunizations; hives remain. Rx given for Atarax. 14 days after immunization, hives and rash have resolved.
Red, itchy Hives started to appear on my left arm on 05/10 around 10:00 AM.   (4 days after the shot was administered).  They hives are itchy and red and then "spread" to my right arm and my legs.  Since then, I've noticed red/itchy spots on my torso and in my hair.   I'm taking a benadryl  - antihistamine to relieve the itchness.
In the summer of 1994, the pt experienced weakness in her legs. In July 1995, the pt experienced tingling in her legs and burning of thighs. In March 1996, the pt experienced sharp pain in her left cheek and pain in her eyes for 2 days. The pt sought unspecified medical treatment and is going to be tested for multiple sclerosis.
Tested positive for string B of the flu after receiving the vaccine; This is a spontaneous case, initially received from other health professional (nurse) via agency (reference number: SEQ20-00724) on 25-Feb-2020, concerning a 56-year-old, male patient.   The patient's relevant medical history and concomitant medications were not reported.   On 10-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, batch number: 261204, expiration date: 26-Jun-2020, anatomical location: not reported] as prevention of seasonal influenza.  On the same day, after receiving the vaccine, the patient was tested positive for string B of the flu. The patient was prescribed anti influenza medicine Zona flu, as reported, however, it was unknown if the patient started treatment.  At the time of initial reporting, the patient was recovered from the event of influenza B virus infection'.   The event of influenza B virus infection' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 56-year-old male patient experienced influenza after vaccination with the suspect product Flucelvax QIV. Reportedly, on the same day after receiving the vaccine, the patient was tested positive for string B of the flu. Chronology seeems plausible. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as possibly related to the event.; Sender's Comments: A 56-year-old male patient experienced influenza after vaccination with the suspect product Flucelvax QIV. Reportedly, on the same day after receiving the vaccine, the patient was tested positive for string B of the flu. Chronology seeems plausible. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as possibly related to the event.
This spontaneous report was received from a nurse practitioner, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The nurse informed that on an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). It was also reported that on 29-JAN-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported) as a second dose (inappropriate schedule of drug administration). The nurse also informed that the patient was scheduled for the third dose of (strength, dose, frequency, lot number and expiration date were not reported). No adverse effects were reported.
The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that theDepartment of Health recommends being revaccinated at their earliest convenience.
Follow up to initial VAERS on 9/1/99/follow up VAERS on 6/17/02.  Continues to have mild bilateral tinnitus, but does not interfere with activities of daily living or work duties. Has now received Anthrax #5 and #6 without worsening of tinnitus, and without return of other symptoms (fatigue, paresthesias, arthralgias, etc.) Anthrax follow up questionnaire received on 08/21/2003: "The vaccine recipient did recover from the adverse event.  The vaccine recipient's current employment status is full duty.  No workdays were missed as a result of this event.  The vaccine recipient did receive further Anthrax shots since the reported event, and there were no more adverse events." Follow up: Since her last VAERS report, patient continues to experience mild bilateral tinnitus, which does not interfere with her work duties or limit activities of daily living. She has not received any additioinal anthrax vaccines since her last follow up VAERS was filed. She has not had any recurrence of original sxs of fatigue, insomnia, hearing loss, paresthesias of the foremarm, arthralgias, or cognitive dysfunction.
This case was reported by a healthcare professional and described the occurrence of forearm erythema in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent vaccination included Fluarix, GlaxoSmithKline, correct dosage administered on 2 November 2007.  Concurrent medications included Tuberculin (tuberculosis skin test).  On 2 November 2007 at 09:00 the subject inadvertently received a dose of Fluarix at 0.1 ml, subcutaneously in an unknown forearm.  The subject was supposed to have received a Tuberculin skin test and the nurse noted that she inadvertently administered an incorrect dose of Fluarix via the wrong route of administration instead.  That same day, on 2 November 2007, the nurse repeated the Tuberculin skin test appropriately in the other forearm and also administered a correct dose of 0.5 ml Fluarix in an unknown deltoid.  On 3 November 2007, 24 hours after vaccination with Fluarix, the subject experienced mild forearm erythema and slight swelling where the Fluarix was administered subcutaneously.  At the time of reporting, the events were improving with a mild pink area and decreased swelling by 5 November 2007.  The healthcare professional considered the forearm swelling and redness were probably related to vaccination with Fluarix.  Follow-up information was received on 29 November 2007.  The healthcare professional reported she inadvertently administered 0.1 ml of Fluarix as a Tuberculin skin test (PPD).  The healthcare professional stated, "no PPD was placed ever in either forearm".  The full dose 0.5 ml of Fluarix was then administered to the left deltoid.  On 05 November 2007, the subject reported her forearm was a "mild shade of pink and the swelling was very minimal".  The subject was concerned about receiving more than 0.5 ml of Fluarix and if she would experience an adverse reaction.  The healthcare professional explained to the subject she was experiencing symptoms that were expected from the vaccine administered in the wrong location.  As of 22 November 2007, no further complaints were noted by the subject.
Muscle aches, fever, chills. Onset 1/8/21 - employee unable to work next shift due to muscle ache pains
Severe chronic diarrhea up to 20 times a day; potassium level at 2; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe chronic diarrhea up to 20 times a day) and BLOOD POTASSIUM DECREASED (potassium level at 2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe chronic diarrhea up to 20 times a day) (seriousness criterion hospitalization) and BLOOD POTASSIUM DECREASED (potassium level at 2) (seriousness criterion hospitalization). The patient was hospitalized from 16-Mar-2021 to 24-Mar-2021 due to BLOOD POTASSIUM DECREASED and DIARRHOEA. At the time of the report, DIARRHOEA (Severe chronic diarrhea up to 20 times a day) and BLOOD POTASSIUM DECREASED (potassium level at 2) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt had vax on 4AUG92; a couple of weeks later started having spells of shaking head up & down vigorously; also started hitting self in the mouth; also noticed that didn't respond to sound; dx hearing impaired;