chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little sore on the injection spot; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "only felt little sore on the injection spot, no other symptoms and feeling great, so far." The outcome of the event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
pt recv vax 10AM & by 6PM t103, vomiting to ER because of inc fever dx mild OM; s/s during noc vomiting, h/a, pale; improved by 4Pm 7JUN95 eating, no further vomiting, no fever; 12JUN95 pt has had no further problems;
Immun given AM 2AUG91 "about MN" had t103.2 & sz; MD called not seen; Seen by MD 5AUG91 & had EEG 6AUG91; results not back; seized in April or May of 91 w/high fever illness related; Brother also seized once w/high temp;
Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt 3/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt 1/6
Post injection day 1-4 fatigue, body aches, fever, headache, and nausea. Received COVID-19 PCR test on post-injection day 4 which was negative. Symptoms persisted and on post-injection day 6 presented to MD with systolic BP in 80's and admitted to local hospital. On admission temp 101.4, Serum sodium 120. Received IV hydration with Normal Saline. TSH was elevated to 23 and anti-TPO antibodies 157. Over next 3 days sodium improved to 130 with sodium supplementaion by mouth, oral levothyroxine therapy initiated, fever resolved, and became normotensive with improved energy level.  Discharged with diagnosis Hashimoto's thyroiditis (US thyroid hypervascular no mass). At discharge sodium remained low at 127 and a spot AM cortisol level was noted to be low but was not appropriately timed. Labs repeated as outpatient and spot serum AM cortisol was low (0.7) ans sodium remained low 129.  On follow up with MD was noted to be hypotensive with systolic pressures in th 70's and severe weakness. Referred back to hospital for readmit on post-injection day 15. Fluid resuscitation in ER and subsequent AM cosyntropin stimulation test confirmed new onset Addisonian adrenal insufficiency. Hydrocortisol initiate and serum sodium and blood pressure normalized over next 3 days before discharge home on 1-29-2022.
10/08/19 Employee noted redness, warmth and swelling to injection site (left deltoid). After she arrived home she noted hives to her lower abdomen and left thigh which itched and burned. 10/09/2019 hives improved, injection site red, swollen and warm to touch. Employee denied difficulty breathing or swallowing on 10/08/19 and 10/09/19.
This spontaneous report was received from a Nurse refers to 3 unspecified patients of an unknown age and gender. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On 17-FEB-2016, 2 unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030587 (10-FEB-2017) (dosage not reported). It was stored at 20F temperature and time frame was 599 hours. There was no previous temperature excursion. No product quality complaint reported. No adverse events reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Severe depression - improved, still present. Patient has Major depressive disorder and states that this severe depression he experienced after the vaccine administration was his worst since a year ago.  Patient was stable prior to vaccine.  fatigue -lasted 5 days anhedonia - improved, still present bodyaches- 5 days  Took Tylenol only for arm soreness
Pain in lower back; BLISTERS ON HAND AND FEET; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in lower back) and BLISTER (BLISTERS ON HAND AND FEET) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No known allergies.  Concurrent medical conditions included Psoriatic arthritis.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In April 2022, the patient experienced BACK PAIN (Pain in lower back) and BLISTER (BLISTERS ON HAND AND FEET). At the time of the report, BACK PAIN (Pain in lower back) outcome was unknown and BLISTER (BLISTERS ON HAND AND FEET) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: Heart levels were a little elevated.         Concomitant product use was not provided by the reporter.  On an unknown date, the patient experienced heart test results/ heart levels were a little elevated. In Apr-2022, the patient ended up with blisters on hand and feet and pain in lower back after taking booster dose of Moderna covid-19 vaccine. No treatment information was provided. The reporter's causality of Humira for the event(s) took covid booster vaccine/ended up with blisters on hand and feet, took covid booster vaccine/ended up with pain in lower back was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2022: Live follow up added and it contains lab data added, event outcome updated, causality updated for the reporter and narrative updated.
exceeded six-month for their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter inquired how to proceed if the patient had exceeded the six month window for their second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up via postal channel. The reporter had no further details on patient or product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227440:Same reporter
6:00PM - 10:00PM MUSCLE SORENESS, FATIGUE, CHILLS, HEADACHE. 10:00PM - 3:00AM SORENESS, FEVER, HEADACHE, AND INCREASED HEART RATE. 3:00AM - 11:00AM SORENESS, HEADACHE, FATIGUE.
Needle leaked, unsure how much product patient received; Part of the vaccine run down patient's arm; Part of the vaccine run down patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 7th September 2022, the patient received the 1st dose of Havrix. On 7th September 2022, unknown after receiving Havrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK receipt date: 7-Sept-2022 Reporter's comment: The reporter was unsure how much of the product the patient actually received.  This was the first dose in the series for this patient.  The reporter consented to follow-up. Additional supportive information: The pharmacist reported that she was administering a dose of Havrix to patient on the day of reporting, when the needle leaked causing part of the vaccine to run down the patient's arm, which led incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Patient states that he woke up the next day extremely fatigued. About 3pm, he could not move his arm/right hand and had trouble walking. He called his doctor's office who told him to call 911. At the hospital, he was given emergency medication for a blood clot. He states the ER told him his stoke was from the covid vaccine.
Patient turned red and was unable to speak right after receiving. Speech came back immediately but patient complained of being hot and slightly short of breath. After 5 minutes complained of sharp pain in the hip/back region. These symptoms subsided after about 20 minutes. Paramedics did workup and patient went home.
Vaccine Underdose; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine Underdose).    No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non follow up added.
Night after receiving nasal spray vaccine, high fever 103 degrees, fatigue, paleness, palpitations.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # M029681 with expiry date 08-NOV-2018 and lot # M029681 with expiry date 22-JAN-2018 (dose, route of administration and vaccination site were not specified) for prophylaxis. Administered doses of PNEUMOVAX 23 underwent a temperature excursion between 32 Fahrenheit degrees and Fahrenheit degrees for 10 days. There was no previous temperature excursion. Data Logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA013078: US-009507513-1709USA007903: US-009507513-1709USA013075: US-009507513-1709USA013076.
No additional AE details; Expired vaccine used; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 11-JAN-2021 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S030587, expiration date was 06-JAN-2021, route and strength were not reported) 0.5 milliliter for prophylaxis (expired vaccine used). No additional adverse event details was reported.
Swelling and pain at injection site, felt hot to the touch, bruising, weak feeling, aches over the whole body.
Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen  currently at day 9)
Injection precipitated a Lyme's Disease episode:  fatigue, confusion, dizziness, low grade fever, ringing in the ears. Treatment: Amoxicillin. 1000mg twice a day. Continued anti-biotics for 30 days. Symptoms receded after 30 day treatment ended
When I went for my annual physical my blood pressure was elevated. I monitored for 4 weeks and returned to the doctor. It was still elevated. I started medication Losartan Pot 25 mg. Will return for a recheck.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Nov2021 at 18:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other medication in 2 weeks. No known allergies were reported The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I also tested negative on days 6-8 on at home Covid tests; (24May2022) Positive, notes: started paxlovid same day I tested positive for Covid; (01Jun2022) Positive, notes: 4 days after completing my paxlovid treatment, I began having Covid symptoms again, and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient started paxlovid same day she tested positive for Covid and had symptoms. She completed the 5 day course of paxlovid, and her symptoms went away by day 5. She also tested negative on days 6-8 on at home Covid tests.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
This non serious case was received on 27 March 2009 from a health care professional.  A 21 year old male patient received IPOL (lot number B0476-2), TYPHIM VI (lot number B0347-2), and YF VAX (lot number UF427A) all intramuscularly on 16 March 2009.  One week post vaccination the patient developed stomach tightness and diarrhea.  No other symptoms were reported.  Recovery status was not reported.  List of Documents held by Sender:  None.
This case was reported by a healthcare professional via a sales representative and described the occurrence of projectile vomiting in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On the morning of 12 May 2011 the subject received 1st dose of ROTARIX (oral) and experienced projectile vomiting after the dose was given. At the time of the reporting the outcome of the event was unspecified. No further information was known at the time of reporting.
Patient friend called out the nurse, upon the   nurse arrival patient was already unconscious. Ammonia placed under the nose by the nurse and patient regained consciousness.  Paramedic is assessing patient at this time.  Patient is now alert and oriented.
patient has drooping/paralysis on right side of the face presenting that it looks like temporary Bells Palsy
Itchy throat, hives, swollen lips, tightness in chest  Symptoms improved with multiple doses of Benadryl
Medication error. The patient was not supposed to receive MMRV but only MMR. The patient received both in the same visit.
administered Boostrix subcutaneously; redness around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XF3RY, expiry date 4th February 2022) for prophylaxis.   On 22nd May 2020, the patient received Boostrix (subcutaneous). In May 2020, less than a week after receiving Boostrix, the patient experienced injection site erythema. On 22nd May 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Boostrix.  Additional case details were reported as follows: The age at vaccination was not reported. The nurse administered Boostrix in right arm by subcutaneous route to the patient, which led to intramuscular formulation administered by other route.  The patient was experiencing redness around the injection site and it was being monitored by a physician. No other details were provided.
Tiredness/Exhaustion at first.  I was unable to stand or get out of bed.  Ambulance called and was hospitalized for 2 weeks.  Was out of work for 4 months recuperating.  I was diagnosed with rheumatoid arthritis.
I had a sore arm. I had a fever for a few days. I also had chills and a headache. My taste has been off. When I eat it does not taste right. I went to get tested for Covid-19, I am waiting on the result.
Took second dose of Vivotif which was left unrefrigerated for 48 hours; Spontaneous report received on 16DEC2019.  A female consumer reported that she "took second dose of Vivotif which was left unrefrigerated for 48 hours" (PT: Product storage error), while being on oral Vivotif (lot number: 3003304) for typhoid fever prophylaxis. On 14DEC2019, the consumer took the first dose and then left the Vivotif unrefrigerated for 48 hours before taking the second dose on 16DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif, which was left unrefrigerated for 48 hours (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A consumer took second dose of Vivotif, which was left unrefrigerated for 48 hours (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
grandmother died from half flu shot; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a consumer or non-healthcare professional.  This case involves a female patient (age was not reported) who died (death), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, family history and concomitant medication were not reported.   On an unknown date, the patient received a dose (reported as half dose) of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Also, this event was assessed as medically significant.  Details of laboratory data were no reported.  It was not reported if the patient received any corrective treatment before death.  At the time of reporting, it was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient of unknown age who died (death) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant therapy, allergic history, previous vaccination and tolerance, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: grandmother died from half flu shot