chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLEPT THE MAJORITY OF THE DAY; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced slept the majority of the day. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and slept the majority of the day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210403741.
Relentless Hives.  They come and go with no rhyme or reason. All areas of the body except face. Itchy. Wheels. Streaks. Have not stopped and only subside with allergy medication.
There was a temperature excursion for Adacel and the range got down to 27 C, 2 vials were administered to 2 patients before it was known there was a temperature excursion/ no AE; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 54 years old male patient who was vaccinated with a 0.5ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5602AA via unknown route in the left deltoid on 08-May-2019 which had temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  case details: It was reported that there was a temperature excursion for Adacel and the range got down to 27 C. Caller said she is not sure how long the refrigerator was out. Caller stated 2 vials were administered to 2 patients before she knew there was a temperature excursion. Adacel injection that had been frozen in a prior temperature excursion where the temperature reached 27 F making the doses not suitable for use.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
given at 9:47 and started with itching  on neck and lip swelling/tingling, @ 10:02 had previous similar reaction after 1st vaccine
Two weeks post the booster shot I started getting hives over body, starting on back of neck and back then moved to stomach arms and legs as well. Started out very itchy but that improved but going on 3 months with hives and no history of hives either myself or immediate family.
This case was reported by a nurse and described the occurrence of vaccine underdose in a 16-year-old female patient who received INFANRIX (batch number 75H53, expiry date 22nd September 2016). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced vaccine underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine underdose and inappropriate age at vaccine administration were unknown. Additional information: The nurse reports administration of INFANRIX to a 16 year old patient that was supposed to take Tdap.
Swollen injection site reaction (egg-sized) Nausea Gastric symptoms Headache
Patient returned to clinic after approx 10minutes after leaving.  Just prior to entering the building, she vasovagaled.  She was immediately placed in a wheelchair and taken to a stretcher.  BP was low 88/54 and diaphoretic.  Stated she started to feel better once lay  down.  After approx 10min of stretcher, pt began to get the chills and stated she had tingling in her mouth and left side of face and neck.  Transferred patient to ED for further evaluation.
Pt received MMR for college requirements on 4-14-08. Also rcvd PPD test (administered on this date). Returned to clinic 4-16-08 for PPD read and stated to this nurse that a blister had formed at injection site (left upper arm SC) blister was noted to be 1 cm long and 4 mm wide. Blister intact. No s/sx infection. Advised to cover with bandage to protect.
1/4/22 pt admitted to hosp with 4 days of SOB and cough; positive COVID test; hypoxic; on BiPAP; chest x-ray showed pneumonia; transferred to ICU; pt decompensated when off BiPAP x 20mins; alternating Vapotherm during the day and BiPAP at night; given dexamethasone, baricitinib, remdesivir; A Fib with RVR; pt continued to decline; respiratory distress requiring intubation followed by profound shock; condition worsened and pt passed away in the hospital
Tested positive for COVID-19 disease; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Oct-2021 and was forwarded to Moderna on 03-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 disease) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced COVID-19 (Tested positive for COVID-19 disease). At the time of the report, COVID-19 (Tested positive for COVID-19 disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications are provided.  No treatment medications are provided.; Sender's Comments: This case concerns a 69-year-old male patient with no relevant medical history reported, who experienced non serious unexpected event of special interest  COVID-19. The event occurred approximately 5 months after the second dose of Spikevax however, the exact time to onset was unknown. Rechallenge was not applicable since the event occurred after the second dose.  The benefit-risk relationship of drug is not affected by this report. Although the time between the second dose and the event was more than15 days, Lack of efficacy not captured since there are no exact vaccination dates and time between doses.
pt recv vax & 5 days later pt exp mild fever, severe migraine, n/v, joint pain, fatigue, & diarrhea;tx w/APAP;sx lasted approx 4 days & have resolved;
headaches; fatigue; bruising all over body; undetectable platelets; Immune thrombocytopenia; petechiae; Arm pain at site; This is a spontaneous report received from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: ER8735) at the age of 19 years old, at single dose for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced arm pain at site in 2021, headaches in May2021, fatigue in May2021, bruising all over body in May2021, undetectable platelets in 2021, immune thrombocytopenia in 2021, petechiae in 2021. Arm pain at site, mid-May: headaches, fatigue, bruising all over body. Hospitalized with undetectable platelets and Immune thrombocytopenia and petechiae. The patient was hospitalized for all events for 3 days. All events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Jun2021. The outcome of the all events was recovering. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Prior to April 2021, I was a 5', 104 pound healthy 58 year old female. In early April I fell on my right kneethere was no swelling and little pain. By late April/May, the knee started to swell, ache, stiff. By late June 2021, I had all-over body stiffness, inflammation, and limited flexibility and weakness. Stiffness increased over time along with agonizing pain. 08/10/2021 blood test=my C-Reactive Prot 44.2. I started Prednisone (Medrol dose pack) on 08/21/2021, was pain free. Pain returned when Prednisone stopped. August to present on tapering dosage. ER visit on 09/28/2022 (allergic reaction/EPI pen). 12/02/21 Spine MRI and 02/22/2022 Brain MRI, but this form will not allow me to continue nor use bottom section
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 15-JUN-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration an anatomical location were not provided, which was stored at -1.11 Celsius Degrees for 80 hours, 8.33 Celsius Degrees for 416 hours, 8.88 Celsius Degrees for 24 hours, 9.44 Celsius Degrees for 168 hours, 15 Celsius Degrees for 56 hours, -3.0 Celsius Degrees for 1172 hours, and -3.0 Celsius Degrees for 1172. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
APPROXIMATELY 2 HOURS AFTER VACCINATION PATIENT REPORTED START OF RASH WHICH BECAME FULL BODY. SHE ALSO REPORTED A PERIOD OF HEART PALPITATIONS, HEADACHE, AND FEVER. SHE ALSO STATED SHE FELT LIKE SHE WAS IN A FOG YESTERDAY (DAY AFTER VACCINATION).
Fever of 103 with rigors and severe myalgias- Treatment NSAIDS with resolution after 24 hours Headache with sharp pains bilateral ears Nausea Mild dyspnea and cough started 01/27/21 assumed to be asthma exacerbation- treatment Albuterol Inh - improvement 01/29/2021 but ongoing  -- No significant desaturation
Severe Fatigue, teeth chattering chills, muscle weakness. I could hardly walk,  felt as my legs and feet were paralyzed. Vomiting and headache. Went to ER was given a IV for fluids.
Pt developed fever of 101 the day after the vaccination. Fever went up to 102 but controlled well with TYLENOL. No other symptoms.
This information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 25-APR-2017, the patient was vaccinated with a dose of VARIVAX with lot number M041080 and expiration date on 06-OCT-2018 (dose, dose number and route of administration were not provided), administered 45 minutes after reconstitution with sterile diluent (manufacturer unknown) (lot number and expiration date were not provided) in the left arm for prophylaxis. The next day, on 26-APR-2016, the patient experienced a rash or insect bite on his calf, not at the injection site and visited the physician's office. The reporter also stated that she would call back with additional adverse event information. At the time of the report, the patient had no recovered from rash and arthropod bite and the causal relationship between VARIVAX, the sterile diluent (manufacturer unknown) and the events was unknown. Lot number M041080 has been verified to be a valid lot number for VARIVAX. Additional information has been requested.
Patient received vaccination of TDAP on 04/02/2018 and was kept in clinic after vaccination to be monitored per policy for 15-20 minutes and did not report a reaction and was released. Patient had started getting flu-like symptoms six hours later with fever/chills, nausea, headache, and dizziness. The left deltoid was given the immunization, and the area was hot and tender to the touch with mild edema.
Bruised and screamed all over; Bruised and screamed all over; This case was reported by a pharmacist via call center representative and described the occurrence of screaming in an unspecified number of  adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced screaming and contusion. On an unknown date, the outcome of the screaming and contusion were unknown.   It was unknown if the reporter considered the screaming and contusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The received Shingrix and bruised and screamed all over. The reporter did not consent to follow up.
pt diagnosed positive for COVID, received antibody infusion day before admittance into hospital; presented to ED with worsening SOB, dyspnea, incoherent; HX:  SVT, was on metoprolol but quit taking it on her own; pt's O2 requirement worsened; intubation; started on remdesivir, antibiotics, mucinex; pt was septic; transferred to ICU; eventually transferred back to the floor where she shortly passed away
VARIVAX breakthrough.  Had VARIVAX on 1-16-96 and 5-4-07.  Diagnosed with varicella in our office on 11-5-2008.  Had about 17 lesions. No fever.
Wrong vaccine administeredI´m not sure if both shots were Moderna...I think 1 was Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administeredI´m not sure if both shots were Moderna...I think 1 was Pfizer) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administeredI´m not sure if both shots were Moderna...I think 1 was Pfizer). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administeredI´m not sure if both shots were Moderna..I think 1 was Pfizer) outcome was unknown.            no concomitant drugs included no treatment drugs included
Unconsolable high pitched crying for approx 3 hrs which began 4 hrs p/shots were given; lt leg redness & swelling of thigh from hip to knee;
No adverse effects; the administration of one dose of an improperly stored vaccine VAQTA; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-NOV-2019, the patient received one dose of improperly stored vaccine, Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml (strength and route were not reported, lot # S009943, expiration date: 26-JUL-2020) for prophylaxis (product storage error). The vaccine was exposed to 58.5 degrees Fahrenheit for 10 minutes. No previous temperature excursion was reported. The data logger was involved. No adverse effects were reported.
fever; muscle pain at the vaccination side; experienced a temperature of 99.9 that lasted through Saturday and was gone by Monday; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for 2 patients (Reporter self and Daughter). This is for reporter self.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family history included pemphigus vulgaris. The patient did not have any autoimmune disease. Historical Vaccine included bnt162b2 for covid-19 immunisation. On an unspecified date, the patient experienced fever, muscle pain at the vaccination side, experienced a temperature of 99.9 that lasted through saturday and was gone by monday.  The patient underwent lab tests and procedures which included body temperature: 99.9 experienced a temperature of 99.9 that lasted through Saturday and was gone by Monday. The patient reported she felt like doing nothing. She did not take Tylenol for it. She wanted to know about taking Tylenol for the side effects. She wanted to know if that would compromise the efficacy of the vaccine. She herself did not have any lasting side effects. she reported that she really was disappointed in Pfizer because she informed that the clinical trials for the Pfizer BioNTech COVID-19 vaccine excluded people with autoimmune disease but now people with autoimmune disease are being given the vaccine. She said that sounds malpractice. She also stated that she spoke with a friend who has an autoimmune disease and received Moderna as her vaccine was told that one of the side effects they experienced, which was stomach diarrhea, does last longer than expected. Outcome of the events were recovered.   Follow-up (26Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported information included new event and outcome of the events.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
a 2 inch round, red area on her arm; This is a spontaneous report from a non-contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose one, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a 2 inch round, red area on her arm. The caller has stated the red spot went away went away in a couple days and also she checked with my HCP and got the 2nd dose anyway. The outcome of the event was considered as recovered..  Patient states the vaccinator "told to take Benedryl or Claritan. Patient was asking whether is it ok to take after receiving Pfizer vaccine. Patient states that she had read that taking Ibuprofen or Tylenol post vaccination will affect vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was given an undiluted dose of Pediatric Pfizer vaccine.  Discussed situation with local Health Department's medical director - determination was that no medical intervention was necessary.  PHN supervisor contact the parent via phone call ( translation used), guardian advised of administration of undiluted Pfizer pediatric vaccine.  Guardian advised that no medical intervention was needed, reviewed when to contact emergency care if needed.  Guardian reported that pt. was experiencing no adverse events after vaccination.  Provided PHN's name and phone number if questions/concerns arose.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.83 on 31-Mar-2021.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recv vax 4 hr p/vax & c/o double vision, numbness, inc heart rate, dizziness, h/a & hearing trouble;ER or MD visit was necessary; MD exam did not show double vision, numbness or inc heart rate;MD stated that pt had a lot of anxiety;
Pt had a 3 inch in diameter red, raised area at site of vaccine. Negative itching. No other signs, symptoms.
Information has been received from a pharmacist concerning a "mid to late seventies" female patient, who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported that the patient developed a case of shingles after receiving the ZOSTAVAX vaccine. The patient sought unspecified medical attention. Additional information has been requested.
My partner and I were getting our FLUZONE HD this past Saturday October 12-2013. After a few hours we became extremely sick with all the symptoms describe as side effects. For older people (that we are) 74 and 71 weight just a little above 150 pounds, that dosage was much too strong.
Mother states the child has an approximately (5 1/2cm) lump on his left arm which was ntoed the evening of the day the child received his shots. She says the lump itself felt hot to the touch and was red. The child had no other signs/symptoms.
Patient received vaccines on 5-3-18 and returned to the office on 5-4-18 with a rash on the left upper arm non-specific to Band-Aid.