chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous case initially received from other non-healthcare professional on 13-Jan-2019, concerning a 38-year-old, adult, male patient. The patient's historical drug included Zantac (ranitidine; as needed) but had not used in past 5 months. The patient had no relevant medical history. On 27-Oct-2018, the patient was administered FLUCELVAX (QIVc) (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252679 and expiry date: not reported) for influenza prophylaxis. On 18-Nov-2018, 22 days after the vaccination, the patient woke up with hearing loss in right ear, followed by vertigo, dizziness, and tinnitus. The patient went to the Internist on 29-Nov-2018, who misdiagnosed as congestion in the ear. As there was no improvement, the patient then saw an ear, nose, and throat specialist who diagnosed as sudden sensorineural hearing loss (reported as Sudden sensonoral hearing loss) and gave high dose of unspecified steroids. The patient had not recovered from the events and the side effects were continuing. The reporter assessed this case as non-serious. Reporter's Comments: A 38-year-old, male patient developed sudden sensorineural hearing loss manifested by vertigo, dizziness, and tinnitus 22 days after administration of FLUCELVAX QIV. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event (Sudden Sensorineural Hearing Loss) as serious (medically significant).
Period started a few days after first dose of vaccine.  Have continued to have a heavy period for 5 weeks now.
The consumer said he thinks a couple of doses were administered after a temperature excursion but he was not sure; No other AE; This spontaneous report was received from a physician referring to an unknown number of patients whose age and gender were not specified. No information was provided regarding the patients' pertinent medical history, concurrent conditions, concomitant medication, drug reactions or allergies.  On an unknown date, a temperature excursion involving Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T033304, verified as valid for syringe formulation, with an expiration date reported and validated as 02-APR-2022) occurred. The doses of Hepatitis A Vaccine, Inactivated (VAQTA) were improperly stored at a temperature of 0.5 degrees Celsius for 20 minutes, 1.7 degrees Celsius for 50 minutes, and 1.2 degrees Celsius for 10 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger.  The reporter thought that, after experiencing the temperature excursion, a couple of doses of Hepatitis A Vaccine, Inactivated (VAQTA) were administered to the patients for prophylaxis, but he was not sure (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (product storage error). No other adverse events (AE) were reported.  This case was considered non-valid due to the lack of patients' identifiers. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
I was supposed to get a contrast MRI next week (had the 1st COVID vaccine yesterday), to wait 21 days The clinic confirmed that they are getting false positives; This is a spontaneous report from a contactable consumer. An unknown patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not provided) via unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The Patient send the below link which said that if patient had a COVID vaccine patient must wait to get a mammogram because the vaccine causes swelling in the lymph nodes and the readouts give false positives. Patient was called at hospital and confirmed this information. In patient case where patient was supposed to get a contrast MRI next week (had the 1st COVID vaccine yesterday), to wait 21 days. The patient underwent lab test and procedure which included False positive investigation result was unknown result. The outcome of the event was unknown   Information on the lot/batch number has been requested.
Influenza was mistakenly administered subdermal instead of PPD. Forearm became red, swollen, warm at site of injection. Treated with ice pack. Symptoms subsided after 2 days. Small residual red "nickel" size spot remains today.
Redness and swelling right deltoid on the evening that the vaccine was administered @ 10cm according to hand signs given by the vaccinee; Vaccinee presented to the health clinic on 6/26/17 with 3cm reddened area on right deltoid with a nodular area in center.
Contracted chicken pox. Raised sores, open sores, fever, fatigue, itching. Officially diagnosed and sent home from work until virus has ran its course. Home remedies is only treatment available, doctor stated it was too late for Valtrex.
Dose administered 15-20 minutes after the 6 hour vial puncture expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 15-20 minutes after the 6 hour vial puncture expiration) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 15-20 minutes after the 6 hour vial puncture expiration). On 23-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 15-20 minutes after the 6 hour vial puncture expiration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.   This case was linked to MOD21-061626, MOD21-061629, MOD21-061632, MOD21-063388 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Contact Information for reporter was updated; Reporter's Comments: This report refers to a case of Expired product administration, for mRNA-1273, lot #: 041L20A,  with no associated AEs.; Sender's Comments:  MOD21-061626: MOD21-061629: MOD21-061632: MOD21-063388:
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a first dose of ROTATEQ (lot number and expiry date were not reported) 2 milliliter (ml) orally at 14 weeks of age, which was other-than-indicated. No adverse effect was reported. Additional information has been requested.
Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022; No adverse event; Received expired first primary dose beyond 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date), PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date), PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022).    No concomitant information was reported. Pediatric patient was of age 8-10 years. The unbroken carton vial size was 2.5ml. Received Thawed on 13OCT2022 with a note that it expired on 13OCT2022. The vial did not underwent any temperature excursions.   This case was linked to US-MODERNATX, INC.-MOD-2022-673530 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673530:same reporter
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored ROTATEQ (route oral, dose, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
diagnosed with cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with cancer after receipt of her first dose of Shingrix. The follow up consent was granted.
Received immunization at clinic around 2:00 pm. By the evening on that same day noticed scattered raised pink rash over left arm and dorsum of hand, mild amount on dorsum of right hand and forearm. Rash also developed onto her torso and bilateral thighs.
Neck glands began swelling and she felt like she could not breathe. Mother called pmd and he advised to give Benadryl. Mother called me 5/18 and pmd advised her to give Zyrtec in am and Benadryl in pm and gave Epi Pen just in case. Doing better now, glands still swollen.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (dose, route of administration, lot # and expiration dates were not reported) at intervals outside of the labeled dosing regimen of 0, 2 and 6 months. There was no adverse effect reported. Additional information has been requested.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 29-NOV-2010, patient received improperly stored VARIVAX dose 1, from batch/lot # 666869/0469Z (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
tenderness at needle site location two days post vaccine, lymph node swelling on left side between breast and underarm
Dizziness, Myalgia, Arthralgia, Rash, pain, redness, swelling, itching and lump in site of vaccination RUE; chills, arthralgia, myalgia, fatigue. Narrative:  Pain, redness, swelling, itching and lump in site of vaccination RUE; chills, arthralgia, myalgia, fatigue, about 3 hours after COVID-19 vaccination.
Arm rash for approx. 72 hours, circular, red, itchy on Left arm;Fever for 12 hours beginning around 11am;Sore throat for approx. 72 hours;Body aches for 12 hours; Congestions for approx. 72 hours.
Administered pt's 2nd dose of shingrix and realized that entire dose ran down outside of pt's arm. Pt was OK with coming back so we can wait for proper procedure from our clinical specialist. Clinical specialist recommended that pt can come back the same day to get a full dose or 4 weeks after from today's date for a full dose. Pt will come back in 4 weeks to complete final series.
He received his vaccine in the right arm and the next day it was very sore, could feed himself but that was eat.  That morning he had a temp of 99+ fever, and then went up to 101.4 which lasted for the 2nd day.   He had fatigue like the flu, which he just rested and slept.  He had chills 5/10, headache as well 7/10 that was with him the entire day and on the 3rd day he had minimal headache.  Had minimal muscle pain and joint pain 5/10.  Just surprised that he was affected by it, and is concerned if he's going to have the same symptoms with the 2nd vaccine.  He had COVID in October 23rd and that his symptoms were severe and he was going to have a bad time of it.  He remained severely sick for 16 hours and went to see his doctor who told him to go home and wait it out.  These symptoms were similar to but not as intense as the symptoms he had with the COVID virus.  He did not take anything for the symptoms that he had from the vaccine.  He did take some CBD oil one day and he did not take it again.  He has resolved now from the symptoms.
Pt had rash, red bumps, all over x 1 day, itching, no fever. Tx with Acyclovir 8ml qid x 5 days.
24 hours after vaccine experienced acute pain on both sides where the jaw meets the ear. Unable to fully open mouth in order to eat and drink.   Pain in Jaw. Unable to open jaw fully in order to eat/drink. Limited range of motion in Jaw.   Symptoms continued for over 24 hours and then began to fade. Symptoms subsided completely within 72 hours.
Pt received ZOSTAVAX at pharmacy on 3/10/2016. He got diagnosed "shingles" about 3-4 days later. Currently he is being treated for shingles.
Patient presented to the ED and was subsequently hospitalized for STEMI within 6 weeks of receiving COVID vaccination.
My injection site felt very hot and itchy, I got very shaky and sweaty. I had to sit down and I felt ill due to this
Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Aug2023 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Aug2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 as the patient took Paxlovid on 07Aug2023 to 12Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
PT RECEIVED THE TDAP, PPV23, AND INFLUENZA VACCINES AT THE CLINIC ON FRIDAY AM  (09/30/2011).  PT DEVELOPED FRONTAL HEADACHE THE EVENING OF THE VACCINATIONS (9/30/2011).  HEADACHE WORSENED OVER THE NEXT TWO DAYS AND MIGRATED TO THE BACK OF HIS HEAD. PT ALSO HAD BODY ACHES AND CHILLS ON SATURDAY AND SUNDAY.  PT COMPLAINED OF A SEVERE CRUSHING HEADACHE ON EARLY MONDAY MORNING.  HE ALSO HAD A SYNCOPE EPISODE AT 2:00 AM THAT MORNING (10/3/2011).  HE WAS ALSO EXPERIENCING SEVERE CHILLS, BUT WAS UNSURE IF HE HAD A FEVER BECAUSE HE HAD NO THERMOMETER AT HOME.  PT WENT TO THE ER ON MONDAY 10/3/2011 AM.  HE HAD CT OF HEAD, LABWORK AND CARDIOLOGY WORKUP AND SPINAL TAP.  THEY KEPT HIM OVERNIGHT AT THE HOSPITAL AND DISCHARGED HIM ON TUESDAY.  ALL TESTING WAS NEGATIVE.  THE DOCTORS WERE UNSURE OF WHAT THE CAUSE OF PT'S SYMPTOMS WERE.  PT HAD NEVER RECEIVED THE TDAP VACCINE BEFORE, BUT HAD PREVIOUSLY RECEIVED PPV23 AND INFLUENZA VACCINES, SO QUESTIONS ARISE IF PT HAD A REACTION TO THE TDAP VACCINE.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with ROTATEQ (orally, dose frequency and indication were not provided). In July 2014 the patient completed series of ROTATEQ. The nurse provided lot numbers: reported as J010928; J004944 (expiration date: 12-NOV-2014); J001815 (expiration date: 06-JUL-2014); J001257 (expiration date: 27-AUG-2014); H016249 (expiration date: 27-MAR-2014); H012981 (expiration date: unknown); H011458 (expiration date: 04-DEC-2013). On an unknown date the patient was diagnosed with rotavirus and was hospitalized approximately in March 2015 (reported as "in the last two weeks") (at the time of report, 20-MAR-2015 the patient was discharged). The outcome of rotavirus infection was unknown. The relatedness between rotavirus infection and vaccination with ROTATEQ was not reported. This is one of several report received from the same source. Additional information has been requested.
On 11/04/2022 around 06:00PM my daughter had a fever of 100.06, headaches, body aches and fatigue. On 11/13/2022  she had a sore throat, cough and fever. I took her to the urgent care on the same day. She was tested for COVID-19 test which was negative. She was also tested for flu which was positive. I gave her ADVIL for 8 hours from 11/11/2022. Her last dose of ADVIL was on Sunday 11/13/2022 at 01:00PM.
2cm swelling and redness at injection site persisting at least 1 week. Left thigh. Still present 9 days after injection.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.