chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt started to see blurry spots, then finished. Pt was caught by her father and helped to a chair. Vitals were taken. Pt was brought to an exam room to rest BS was checked. Juice was provided as well as cold packs to the head until pt. recovered.
strong pain in his abdomen and right side of his body; strong pain in his abdomen and right side of his body; took his body temperature and it was at 99.14 Farenheit (F); He checked his temperature which was recorded as 101.66 F; he recorded his temperature to be at 101.67 F; patient was feeling bad; he felt bad all Friday and was in bed for the whole day; This is a spontaneous report received. A contactable consumer (patient) reported a non-pregnant 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration, administered on left arm on 02Mar2021 16:00 (Batch/Lot number: EL9262) as 1st dose, single dose (at the age of 59 years old) for COVID-19 immunisation. Patient's medical history included Barrett's esophagitis (Barret esophagus) on an unspecified date and penicillin allergy. Concomitant medications included pantoprazole via an unspecified route of administration from an unspecified date at 40mg daily for an unspecified indication. On 11Mar2021 01:30, the patient reported waking up in the middle of the night with a strong pain in his abdomen and right side of his body. He thought it was because of his gallbladder and claimed that he had the vaccine last week so he wasn't sure. The next morning (yesterday (reported)), the patient was feeling bad so he took his body temperature and it was at 99.14 Fahrenheit (F). He stated that he felt bad all Friday and was in bed for the whole day. He checked his temperature which was recorded as 101.66 F (pyrexia) and took one ibuprofen (ADVIL LIQUID GEL) at 07:15. At 09:20, he recorded his temperature to be at 101.67 F. The patient was asking for advice. The patient did not receive treatment for the other events other than pyrexia. The outcome of the reported events were not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On unspecified dates, in 2016, the patients were vaccinated with PROQUAD Lot # M002053 with expiration date of 11-JUL-2017, M004895 with expiration date of 26-JUL-2017 and Lot # L026723 with expiration date of 15-JAN-2017 (Lot number L026723 is an invalid lot number for the vaccine) (dose and route were not reported), which were stored at 10.7 F for 1 hour. The temperature excursion occurred on 09-MAY-2016, so the doses had been administered since that time to 09-JUN-2016. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, chills Narrative:  Myalgia, arthralgia, headache, chills, fever to 100.9; taking tylenol and motrin.
Havrix expired 8/1/21 and was given to the patient on 8/9/21.  The provider, NP, immediately notified Mom, patient, and writer about the incident. NP will be diligent about verifying expiration dates prior to administering medications/vaccines. Mom and patient agreeable to obtaining Havrix again with a valid expiration date. Interim director notified of the incident. PH aide was notified and the medication/vaccine was immediately removed from the fridge and placed into the dirty utility room. NYSIIS inventory sheet was re-printed and the PH aide was re-educated about where to find expired vaccines in NYSIIS, as well as when to pull the inventory sheets to prevent this from happening again in the future.
Initial report was received on 25 February 2011 from a health care professional. A 41-year-old male patient who had no illness at the time of vaccination had received a first dose subcutaneous left deltoid injection of YF VAX, lot number UF803AB on 25 February 2011 and two hours later, developed nasal congestion. The patient had no known allergies. Concomitant medications and medical conditions were listed as none. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information received from a health care professional on 19 April 2011 reported that the patient had no illness at the time of vaccination. He received on 25 February 2011 a left arm intramuscular injection of DECAVAC, sanofi pasteur Inc. lot number U2861BA. The patient had no diagnostic or laboratory testing performed. The patient was treated with ZYRTEC 10 (units not reported) with good results. The patient's outcome remained not recovered. Documents held by sender: none.
Arm sore for 24 hours after first dose. Approximately 12 hours after second dose began to run fever.  Went to bed and woke in the morning with fever, general body aches, typical mild flu-like symptoms.  Symptoms last approx. 24 and feeling better.
Large red welt the size of a tennis ball, hot to the touch, itchy, swollen
syringe failure with first dose, no vax administered, second dose adminstered with no failer
Approx 24 hours after vaccine mother states LD became warm to touch, red, slightly swollen. No other effects seen.
PT GIVEN JANSSEN VACCINE FOR COVID INSTEAD OF PFIZER AS APPROVED BY CDC/FDA FOR 12 YEAR OLDS.
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, (strength and dose were not reported) administered orally (lot # M029252, expiration date 14-MAR-2018) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperatures excursions: 1 hour and 50 minutes between >0 degrees Celsius (C) and <2C, and 3 hours and 49 minutes between >0C and <2C. No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1702USA005707: US-009507513-1702USA005576.
Chest pain; Pain (side pain, in their arm); Nausea; Headaches; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)), NAUSEA (Nausea) and HEADACHE (Headaches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Myeloma (Patient has cancer (myeloma) for the last 5 years. Patient go to chemotherapy once a month.) since 2016 and Hypertension.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headaches). On an unknown date, the patient experienced CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)) and NAUSEA (Nausea). At the time of the report, CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)), NAUSEA (Nausea) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant therapy included blood pressure medicine and chemotherapy.  Patient experienced headaches that seems to go and come back so patient does not know if it's side effect of the vaccine or the chemotherapy. Patient never had headache like that.  Treatment information was not provided.
took both shots and come down shingles/ suspected vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was reporter's son. The age at vaccination was not reported. The patient received both Shingles shots and has now came down with shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Upon administering 1st dose of Moderna, patient had adverse reaction. After about 1 minute post administration, patients eyes rolled back, begin to shake and slumped back into his chair. I tapped him on his shoulder numerous times and yelled his name as appeared unresponsive. At this point I notices his lips were turning blue so I administered an epipen in his right thigh and yelled to Technician to call 911. Within 2 seconds of the epipen administered, patient was responsive. I asked him his name, birthday, and where he was. Patient was able to provide all correct answers. He stated he felt a little warm and dizzy. I continued to watch patient and ask questions until EMS arrived. I also provided him with a cup of water. Patient stated he did not have any allergies prior to the administration of the vaccine. After this incident he said he felt lightheaded before when giving blood. When EMS arrived his vitals were within normal limits and declined being checked out at the Hospital.
57 yo male with history of cardiomyopathy of unknown etiology received the smallpox vaccine on 3/13/03.  Experienced pruritis at the vaccination site and low-grade fever one week after vaccination which lasted 2 days.  Was called on 5/23 by health department representative for active surveillance follow-up.  At that time vaccinee reported that on 5/14/2003, in the setting of a febrile URI, he had been seen for follow-up at the heart failure clinic.  He reported no changes in cardiac symptomatology (no DOE, SOB, increased fatigue).  No new c/o at the time other than the URI. Cardiologist heard rales on auscultation of the lungs.  Performed an echocardiogram which revealed an ejection fraction of 30% (decreased from prior EF of 60% (by echo) done 2-3 years ago).  He was brought back to clinic on 5/19 for a MUGA scan which revealed an EF of 48%.  The patient is currently doing well, functioning at baseline, and back to work.  Will follow-up again with cardiologist next week.  We are awaiting medical records from the above described work-up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Experiencing itchiness,  wheezing, cough and chest tightness following 1st dose of Moderna Covid19 vaccine. Currently taking Benadryl every 6 hours to ease symptoms. Still experiencing chest tightness and itchiness.
presented to the ER for evaluation of shortness of breath that started 1 day ago. Patient reported fever, generalized muscle ache, and shortness of breath.  She denied nausea or vomiting.  She denied chest pain.  She does have urinary symptoms including burning and frequency.
The day after the vaccination the patient developed an itchy red patch at the injection site.  Two days after, small blisters appeared and it was oozing a little fluid.  The patient came in to inquire if this was normal after vaccination on the third day.  She had not tried any treatments at that time.  I advised her of a couple creams that she could try for the itch.  I also told her that if it seemed to be spreading or appearing elsewhere, or if the redness or itching was getting worse, it might be a good idea to have it checked.
had lung cancer diagnosed after receiving the vaccine first dose; This is a spontaneous report from Pfizer-sponsored program . A contactable other health profession (patient's friend) reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lung cancer diagnosed after receiving the vaccine first dose on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on known pathophysiology of lung malignancies, reported lung cancer is considered intercurrent and unrelated to suspect BNT162B2. Carcinogenesis takes years. 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.
Pt stated she has severe needle phobia.      Syncopal event after shot,  BP 160/110,  5 minutes. later, BP 122/74. P70. R22 then R 18 Monitored by EMTs 10:45 am.  Feeling better 10:56 am. Home with husband
Headache developed 18hr post vaccination; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 30Mar2021 at 09:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 31Mar2021 at 12:00, 18 hours post vaccination, the patient experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
developed the flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who developed the flu after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (developed the flu).  At time of reporting, the outcome was Unknown for the event developed the flu.
This spontaneous report as received from a female patient of unknown age with penicillin allergy refers to herself. The patient did not remember what else she was allergic to. About 3 years ago, in approximately October 2010 the patient was vaccinated with a dose of ZOSTAVAX to help with prior case of shingles (dosage and route was not reported). Concomitant therapy included nabumetone. The patient reported that she had a prior case of shingles was not sure of exact date it started but it was about 3 years ago and she took the vaccine as advised. She stated that her shingles symptoms did not get better she still had itching. The side where she had been diagnosed was her left shoulder and she advised it was spreading. She stated that her muscle tissues were inflamed and she was taking medication for that. The patient sought medical attention. At the time of the report, the outcome of events was reported as not recovered. Additional information is not expected.
Chills, fever, full body muscle pain, vomiting, nausea  for 18 hours
Rash all over body, appeared 1 hour after vaccine was given. No fever. A little itchy.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received Havrix. On 31st January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comments: The reporter reported that the patient received an expired dose of Havrix. The vaccine expired on 30th January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Information has been received from an 81 year old female with type 2 diabetes mellitus, chronic obstructive pulmonary disease and carpal tunnel syndrome in both hands and no drug reactions or allergies who on 18-DEC-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included glyburide and metformin. "Approximately two months after receiving ZOSTAVAX," in February 2008, the patient began to experience both muscle pain and nerve pain in various parts of her body. The pain began in her right arm and then she had a Charlie horse type of pain in her right calf. She also had pain and soreness on her hip and in both arms. At the time of the report, the patient's muscle pain and nerve pain persisted. Unspecified medical attention was sought. No further information is available.
fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Bell's Palsy  June 12th   Numbness of my left side of face  Medication prescribed   Famciclovir 500mg Prednisone 20m Azithromycin 250mg
4X6 Erythematous, Warm, Tender and Swollen area left arm. Prescription: Keflex and Benadryl   Px : Cellulitis
Hives on hands and feet triggered when she went outside in cold 24 hours later. Continued on and off for several days, not severe but noticeable for a child who hadn't been sick for 3 years straight. Would go away on own. Into third week and she developed a cough and got hives again and also fevers.
one week to the day I developed a small rash spot at the site of the injection and it was warm and periodically became itchy.  This is 3 days after the rash appeared and it occasionally is still itchy and red.
This spontaneous report was received from Registered Nurse regarding to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to precious temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
excursion on shipping Tenivac; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a female patient of unknown age who was vaccinated with a dose of  vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which had excursion on shipping, (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. It was reported that Time 7/9/19 received 7/11/2019 (2 days).  It was unknown whether the patient experienced any adverse event post vaccination.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
All over itching. Red rash on feet, legs, hands, arms, chest, neck, back, and scalp. Skin very warm to the touch. Puffy lips. fever. Used cold compress to alleviate itching. Took 10mg loratadine at 11pm.