chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: The reporter (patient's wife) stated that her husband who had two shots and had nothing. He was tired.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; diarrhea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (chills), PYREXIA (fever), DIARRHOEA (diarrhea) and the second episode of CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced the first episode of CHILLS (chills), PYREXIA (fever) and DIARRHOEA (diarrhea). On 23-Mar-2021, the patient experienced the second episode of CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 23-Mar-2021, PYREXIA (fever) and DIARRHOEA (diarrhea) outcome was unknown. At the time of the report, last episode of CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.
This is a spontaneous report from a contactable nurse (Internal medicine). A 64-year-old female patient received the 1st dose of PREVNAR 13, (Lot # R28322, Expiry Date 01Mar2018) IM at 0.5ml, single in deltoid on 09Jan2017 14:30 for immunization, in the physician office. Medical history included ongoing depression, ongoing osteopenia, ongoing vitamin D deficiency, ongoing hyperthyroidism, ongoing type 2 diabetes mellitus, ongoing gastrooesophageal reflux disease (GERD), ongoing blood cholesterol increased, hypertension, drug hypersensitivity to Codeine, Penicillin and Sulfa Anti-biotic. Concomitant medication included BABY ASPIRIN 81 mg, 1x/day, BENAZEPRIL 1 DF, 1x/day for hypertension, BUPROPION 150 mg, 1x/day for depression, CALCIUM W/VITAMIN D NOS 400 IU, 2x/day for osteopenia and vitamin D deficiency, LEVOTHYROXINE 50 ug, 1x/day for hyperthyroidism, LEXAPRO 20 mg, 1x/day for depression, METFORMIN 500 mg, 1x/day at bed time for Type 2 diabetes mellitus for Diabetes Type 2, NEXIUM 20 mg, 1x/day for GERD, SIMVASTATIN 40 mg, 1x/day for high cholesterol, VENTOLIN for shortness of breath, RELAFEN 500 mg, 1x/day, ONDANSETRON for nausea. The patient previously took codeine experiencing drug hypersensitivity. Last vaccine that she received was her Flu vaccine but that was in October (year not mentioned). No other vaccine was given on the same day of the suspect. On 12Jan2017 (as believed by the reporter who did not know the specific date) the patient experienced rash on her chest, her upper extremities and in her thighs; multiple two to three centimetre area lesions and the doctor made the diagnosis of Erythema Multiforme. The outcome of the event was not recovered. Erythema multiforme was reported as worsened. The reporter stated the doctor considered there was not a reasonable possibility that the event was related to the suspect vaccine. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported event cannot be excluded based on the known adverse event profile and on the temporal relationship. The Company however considers the administration of concomitant medications an important confounder in the independent assessment of the causal relationship.
Vaccine was administered 8/10/06, patient was subsequently admitted to MC 8/13/06-8/16/06 with cellulitis requiring IV antibiotics. 9/25/06 Received medical records from hospital which revealed patient admitted 8/13/06-8/16/06 w/final Dx: left shoulder cellulitis, diet controlled diabetes, dyslipisemia.  Left shoulder pain, swelling & erythema began day after tetanus injection with fever & chills.  Exam on admit revealed LUE & shoulder erythema, induration & tenderness w/increased warmth.  WBC 6900.  LUE/shoulder X-ray was WNL.  Blood cultures were neg.  Improved significantly & was d/c to home on oral antibiotics./ss
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE details; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP, also reported as office manager) and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-APR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot number: U022819, expiration date: 14-JAN-2023, administered for prophylaxis (dose, strength, and route of administration were not provided). Vaccine was improperly stored in temperature of 70 F for 96 hours (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Patient recieved her first dose of the Pfizer Pediatric Covid-19 vaccine (for ages 5-11) at approximately 1:20pm. Following vaccine she was sitting in the waiting area for observation and at approximately 1:27pm her mother notified us that she felt hot and was sweating. The patient was sitting on Mom's lap and not standing following the vaccine and during the reaction and not standing. The patient removed her face mask to cool off, and was given cold water to sip on. Her radial pulse was checked about within normal limits. Patient reporting feeling tired, patient and mom denied any difficulty breathing, lightheadedness, or other symptoms. Pt remained awake and alert during the reaction. She remined seated for another 10 minutes approximately for further observation. Mom requested vaccine record card and permission to leave at approximately 1:40pm stating that Eve felt much better.
Weakness throughout body for 3 and a half days, swelling at injection site and reddened area at injection site, Left arm very weak and sore.  To raise left arm I had to use the right arm.  Slight dizziness.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-SEP-2013, the patient was inoculated with ZOSTAVAX at community health center for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated at the Emergency Room for a blistering outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed famciclovir and Calamine lotion for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages.
Information has been received from a registered nurse concerning "multiple" pt's who were vaccinated with varicella virus vaccine and subsequently developed varicella. Unspecified medical attention was sought. Additional information has been requested.
Diagnosed with premature heart beat in upper atrium after 2nd shot; Felt Nauseous after 2nd dose; Dizziness after 2nd dose; Exhausted after 2nd dose; Diarrhea on & off after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of EXTRASYSTOLES (Diagnosed with premature heart beat in upper atrium after 2nd shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NAUSEA (Felt Nauseous after 2nd dose), DIZZINESS (Dizziness after 2nd dose), FATIGUE (Exhausted after 2nd dose) and DIARRHOEA (Diarrhea on & off after 2nd dose). In October 2021, the patient experienced EXTRASYSTOLES (Diagnosed with premature heart beat in upper atrium after 2nd shot) (seriousness criterion medically significant). On 20-Mar-2021, NAUSEA (Felt Nauseous after 2nd dose), DIZZINESS (Dizziness after 2nd dose), FATIGUE (Exhausted after 2nd dose) and DIARRHOEA (Diarrhea on & off after 2nd dose) had resolved. At the time of the report, EXTRASYSTOLES (Diagnosed with premature heart beat in upper atrium after 2nd shot) outcome was unknown.            No concomitant medications reported. No treatment details provided.  She reports that she had a reaction with the second shot: 2 hours after second shot, she felt Nauseous, Dizziness, exhausted and had Diarrhea on & off.  In OCT2021, She visited the doctor and she was diagnosed with upper Atrium in the heart premature beat. She declined providing the doctor's name or what type of test was done. She states after vaccination, she never had chest pain, nor Shortness of breath. She never had heart fluttering either. She did not feel anything after vaccination that would give her a clue as to having atrium problems. She has never had a positive COVID test.   Reporter did not allow further contact; Sender's Comments: This case concerns a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious unexpected event of extra systoles approximately 7 months after the second dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
Had chills with no fever 9/1-3, nausea 9/1 -3 and 1 vomiting event 9/3 (5am). Warm, blistered rash appeared on left arm at site of vaccination on 9/3 12:30pm (Covid Arm)
Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month after 1st dose of vaccine
Pfizer was given as second dose of which patient received moderna for the first one.  Patient experienced a warm feeling in the arm.  It continued but by the afternoon 3 o'clock he was feeling better
Product storage error; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Product storage error) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2022 at 10:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Feb-2022 at 10:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  A Series of patients approx. 540 patients received lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.   Treatment information was not provided.
Arthralgia, Nausea, limb mobility decreased, paresthesia, chills.
having mental status changes; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of mental status changes in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 34MK3, expiry date 08-JUL-2024) for prophylaxis.   Concurrent medical conditions included hypertension and penicillin allergy.   On 02-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 03-SEP-2023, 1 days after receiving Shingrix, the patient experienced mental status changes (Verbatim: having mental status changes).  The outcome of the mental status changes was not resolved.   It was unknown if the reporter considered the mental status changes to be related to Shingrix.     It was unknown if the company considered the mental status changes to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 The patient received concomitant drug included blood pressure medication. The patient's husband stated on 3rd September 2023 she started having mental status changes. The husband stated that she was talking about the things which did not exist, or which were untrue. This remains ongoing and the patient had not been medically evaluated for this. Pharmacist reviewed patient's chart in their system and did not note any relevant concomitant medications or medical history. She did stated the patient was on blood pressure medication and had a penicillin allergy, neither of which pharmacist believed to be relevant to this issue.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Pt vaccinated with MMR developed extreme sleepiness. Father took child to ER facility. Exam negative. Rechecked in Dr.'s office late afternoon. Exam negative.
Information has been received from a physician concerning a 4 year old female who on approximately 19-FEB-2008 was vaccinated with "one dose" of PROQUAD. Concomitant therapy included poliovirus vaccine inactivated unspecified and PEDIARIX given in the other leg. On approximately 19-FEB-2008 the patient developed "one localized big hive in the injection area' after receiving the vaccine. No further information was provided. Unspecified medical attention was sought, the patient called the physician. The outcome was reported as recovered approximately 21-FEB-2008, "within a couple of days after receiving the vaccine. There were no lab diagnostic studies performed. there was no product quality complaint. Additional information has been requested.
Approximately 1 month following the vaccinations he started losing hair rapidly. He was diagnosed with Telogen Effluvium. No treatment at present time.
17NOV95 severe h/a lessening on 18NOV95 & 19NOV95 & 19NOV95-20NOV95 dizziness;sxs gone 20NOV95;
my son passed on 20Oct2020 after getting the men B vaccine; This case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In October 2020, the patient received Meningococcal B vaccine. On 20th October 2020, 4 days after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 20th October 2020. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by a patient's parent via interactive digital media. The reporter's son passed 4 days after getting the Meningococcal B vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
did not feel good; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel good) and FATIGUE (tired) in a 69-year-old patient of an unknown gender 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 FEELING ABNORMAL (did not feel good) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL A) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel good) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes Thyroid Medication.   This case was linked to MOD-2021-404024, MOD-2021-404070 (Patient Link).
she got a hugh swollen arm and it was tender and painful and had to go to hospital and it got infected and she got chicken pox out of the vaccine had to be in the hospital for a day or two
Chills, aches, and pains began at approximately 10 p.m. the day of the vaccine.  Headache began at approximately 2 a.m. the following day, progressing to migraine-level headache with mild nausea and mild diarrhea.  Chills subsided quickly but headache persisted until approximately 4 p.m. the following day. Patient was unable to do regular activities such as work, prepare meals, etc.  Additionally, injection site arm pain appeared at approximately 3 p.m. the day of the vaccine but subsided approximately 15 minutes later to a mildly tender arm at site. Arm is still tender at time of reporting (9/17/2022, 11:00 a.m.)
Because of my previous hospitalization due to an allergic reaction with anyphylaxis (due to food allergies) they observed me for 30 minutes instead of 15. About one hour after the vaccine my entire face started tingling. The tingling continued for 6-7 hours. I then had a sharp headache located on the right forefront of my head that lasted for 24 hours.
horribly sick; Fever; chills; can't stay awake; dehydrared; can't eat; can't eat (nausea); headache; dizziness; cannot get out of bed; This is a spontaneous report from a contactable consumer or other non-health-care professional (Patient herself).  A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 15May2021 12:00 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Vaccination facility type was Pharmacy or Drug Store. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown Expiration Date: Unknown) on 24Apr2021 12:30 as DOSE 1, SINGLE for COVID-19 immunization. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Patients Medical history included iron deficiency anaemia and asthma. The patient's concomitant medications were not reported. Patient stated she had diarrhea since her first dose. and treatment received with diarrhea medication, ibuprofen. She had COVID so expected to be ill after the first vaccine. Patient was horribly sick after the second dose too on an unspecified date in May2021. She experienced Fever, chills, can't stay awake, dehydrared, can't eat (nausea) headache, dizziness unable to go into work on an unspecified date in May2021. That was the 2nd day she could not get out of bed on an unspecified date in May2021. Patient received no treatment for reported events. Outcome of all events was resolving.   Additional information about batch/lot number has been requested.
About 4 minutes after the patient received the vaccination, they began to show signs of unconsciousness and rigid body motions. This lasted about 1 minute and the patient regained consciousness. Her vitals were checked and her BP was 96/51.We placed a cold pack on her head and elevated her feet for approximately 30 minutes. Patient was stable, BP was stable and she was able to leave on her own.
Two weeks after the first dose of Pfizer COVID19 vaccine the patient developed generalized rash all over body; This is a spontaneous report form an other HCP, he reported for 70's-year-old patient. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. No medical history and concomitant medications were reported. The patient previously took steroids. It was unknown if any other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19. Known allergies were none. It was reported that a licensed acupuncturist and herbalist informed that he had a patient who was in his/her 70's received first dose of Pfizer COVID19 vaccine and other demographics are unknown. On an unspecified date, two weeks after the first dose of Pfizer COVID19 vaccine the patient developed generalized rash all over body. The patient sought medical attention and received steroid injection, however the rash even worsened after the steroids. The patient sought help from this reporting acupuncturist/herbalist and received chinese herbal medication as alternative treatment which was effective, and the rash improved after receiving herbal medication. The clinical outcome of the event was resolved.  Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "Rash" 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.
suspected flu symptoms such as cough, congestion, nausea. nausea has continued for 3 months since sickness has gone away.