chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with VAQTA, lot # M022924 with expiry date 24-JAN-2018 (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius(C) for 6 hours. No adverse effects were reported in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
24 hrs later of vaccination on 1/14/2021 my right eye got swollen until 1/16/2021 I went to the doctor on 1/15/2021 & I got steroid.
CHIEF COMPLAINT/REASON FOR VISIT Shortness of Breath   HISTORY OF PRESENT ILLNESS     85-year-old female past medical history significant for multiple chronic conditions.  She is presenting to the emergency department today due to worsening shortness of breath over the past couple of days.  It was initially exertional but now she is short of breath at rest and requiring 2 L nasal cannula.  She does not normally require 2 L nasal cannula.  She reports that she does normally take her Breo and albuterol inhalers.  She has not been using these over the past few days.  Note she is also on warfarin.  She denies fevers, chills, chest pain, nausea, vomiting.
Patient began with muscle/body aches and chills on 12/24. Highest temperature recorded was 99.8, took ibuprofen. On 12/25, lymph nodes near right clavicle and right axilla swollen and stiffness in neck and shoulder. Right foot also became swollen. On 12/27, developed pain behind eyes, swelling began decreasing on 12/27. Began having headache on 12/28.
Son was unresponsive 01/30/2015 and was very disoriented. After numerous tests administered by hospital, neurologist attributed mental status to adverse reaction to MMR vaccine.
On 9/20/01, the vaccinee received her 1st IM 20mcg dose of Engerix-B. On 9/25/01, 5 days, post vax, she was admitted to the hospital with abdominal pain, nausea and vomiting. Her liver enzymes (NOS) were "over 1000". A dx of acute hepatitis B was made. The Engerix-B immunization series was discontinued. As of 9/26/01, 1 day after onset, the adverse events had not resolved.
Fever 100.2, Chills, Malaise, Myalgias, Fatigue, HA, nausea
Hearing loss in left ear a few days after first vaccine   Right ear was affect after second vaccine on 2/18/2021 which was profound.  My physician ordered prednisone ear drops and ordered a CT scan.   Then referred me to ENT. Was placed on Prednisone for 2 weeks for sudden profound hearing loss.
Headache, fever, heavy chest, racing heart rate, muscle spasms throughout entire body, muscle cramping, random uncontrollable burping, chills
Itchiness in both ears. Given diphenhydramine 50 mg here at the pharmacy.
2/3/2023 Affected Vestibular system first, I got up and felt dizzy and I fell into the wall upon waking form a nap.  This could seem like Orthopedic Hypotension but did not feel like that.  I was unable to balance enough to stand for a few moments.  After that I developed a low-grade fever with fatigue, cough, runny nose, and gradually lost sense of smell and taste.  Tested positive on an At Home COVID-19 Test.  This test result was confirmed via an app that the manufacturer of the test.  Taste and smell returned after about a month.  Day 7, 8, or 9 I had another day of balance loss, lasting several hours worse when moving from sitting to lying.
A report has been received from a physician concerning subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 08-Dec-2013. It was reported that patient was administered an expired FLUMIST QUADRIVALENT which started on 08-Dec-2013. The outcome of the event administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This spontaneous report as received from a consumer refers to a 80 year old female patient. No medical history or current conditions were reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dosing information and route not reported) (lot # and exp date not reported). No concomitant medications were reported. On an unknown date, after vaccination the patient thought she was going to die from it. The outcome and action taken of adverse event was unknown. This is one of several reports from the same source. Additional information is not expected.
pt recvd vax 16AUG95 & @ site of DTP blister devel p/3 days; MD states area now has scab, no swollen lymph nodes, no reddness or inflammatory sxs @ site; referral to MD for eval
Medical examiner verbally stated child died from SIDS. Mother is blaming on immunizations that child received.Mother states child was very tired & slept until next am,at time of death child's rectal temp was 106.
I had a very bad headache that caused dizziness one day after the shot. I had to take multiple migraine medications in order to get relief. I normally never suffer from headaches or migraines. Two days after receiving the shot I suffered from weakness, paleness, and nausea which caused me to vomit multiple times and made eating difficult as I would throw up what I would try to eat. This lasted the entire day.
migraine for the past few days; Headache is going away but she wants to make sure that it is safe for her to take the vaccine; This is a spontaneous report received from a contactable consumer (patient reported herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "patient would get the second dose of the PFIZER-BIONTECH COVID-19 VACCINE today 23Mar2021 and asked if she could get the vaccine even if she had been experiencing migraine for the past few days. Headache was going away but she wanted to make sure that it was safe for her to take the vaccine. She mentioned that she already spoke to another agency to report the symptoms". Outcome of the event migraine was unknown whereas another event was recovering. No present.  Information on the lot/batch number has been requested.
No additional AE; patient received the vaccine six days before his first birthday; This spontaneous report was received from Physician and refers to an 11-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUL-2013, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection,  dose: 0.5 milliliter as prophylaxis (strength, lot #, expiry date, dose number, and route of administration), six days before his first birthday (Product administered to patient of inappropriate age).
No adverse event-- Patient received J&J vaccine 5-14-2021. She presented today for booster vaccine and was given 0.5ml Moderna vaccine instead of typical 0.25ml booster. Patient did not answer the immunocompromised question on her form-- if immunocompromised the 0.5ml dose would be correct. We called patient to clarify but had to leave a message. Submitting as incident until we hear from patient.
My heart rate has increased as high as 153, my blood pressure has nearly dounled and I've been extremely nauseous
After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse practitioner concerning a 70-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.   On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70-year-old, male patient, who experienced an unexpected event of vaccine administered after they lost temperature.  This report refers to a case of out of specification product use for mRNA-1273 (Lot number: 027L20A). There were no reported AEs associated with this case of out of specification product use.
Diarhea, loose stools, hemoroids, stomach issuesRash on Right upper liner Leg. Flatulence anal seepage
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose refer case, US2018GSK216414). Concurrent medical conditions included diabetes. On 16th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th September 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The caller reported that her brother did not feel good (unknown symptoms) after the SHINGRIX. Limited information was provided by the caller. The caller reported that her brother experienced side effects after taking SHINGRIX.
This is a sample VAERS submission for a group of patients who received potentially ineffective vaccine due to a batch being stored under inappropriate storage conditions. Per consultation with CDC a single form will be submitted and a spreadsheet containing pertinent information for all affected patients will be submitted. These were not Adverse Events, but potential administration errors.
it hurt a little, not much; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 10Jan2021 at single dose for COVID-19 immunization. Concomitant medications and past drug/medical history were not reported. Patient was wondering how long to keep this band aid on this. Patient had done (receiving the Covid-19 vaccine at the hospital) earlier today (10Jan2021) and it was fine and now patient was trying to exercise because it was a problem, it hurt a little, not much on 10Jan2021. Outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/12/21 and 4/09/21. Covid + 1/20/22. Patient was admitted to ED on 1/20/22 with acute hypoxic respiratory failure secondary to COVID PNA. C/o SOB that worsened over the past 3-4 days and O2 at 70%. CXR showed atypical PNA. Placed on 12L NC and O2 sat improved to 85-86%. Continued to deteriorated requiring Airvo then intubation on 1/30/21. Admission c/b shock, renal failure, & hyperkalemia. Patient was transitioned to comfort care/DNAR.  Treated with baricitinib, steroids, rocephin, cefepime. Expired 2/03/22.
swelling & red whelps on face-looks like had measles or small red rash on inside of arms, chest, back & thighs;eyes were swollen & nose was swollen;
left arm pain; Fatigue; fever; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 13-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0173, expiry date: not reported), via an unspecified route of administration in the left arm on 06Jun2021 08:00 (at the age of 13-years old) as dose 2, single for covid-19 immunisation. Medical history included juvenille arthritis and the patient previously received morphine and experienced allergies. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Post vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0179, expiry date: not reported), via an unspecified route of administration in the left arm on 29May2021 9:30 as DOSE 1, SINGLE for covid-19 immunisation. On 16Jun2021 21:00, the patient experienced fatigue, left arm pain, fever, headache. No treatment was received for the events. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected
This spontaneous report was received from a other register nurse reporting an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (oka-merck) PROQUAD (dose, dose number, lot number, expiration date and route were not reported. Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unknown number of patients were administered (oka-merck) PROQUAD that had been  improperly stored. No adverse effects were reported. This is one (1) of three (3) reports from the same source (MARRS 1408USA017042, 1409USA006413 and 1409USA006413). Additional information has been requested.
Patient  started  complaining  of  Dizziness  and  Rapid  heartbeat , Vital  signs  were  checked BP 136/90,Pulse  71,02 96% patient had  some  redness on her  neck which then  spread up the  face and  head rash on  arms and   Diphenhydramine 25mg Im  given  per  verbal order  from the doctor. patient  continue to be observed  for  additional  20 minutes Vital signs  recheck BP 132/80, pulse  78, 02 96% room air
Cellulitis at injection site with fever & swelling KEFLEX 500mg 1 po BID x 10d.
Aug. 4th, 2021 diagnosed with late gestational hypertension at week 37 and 6 days. Hospitalized and induced with delivery of  well developed, well formed, healthy male. 1 Min. APGAR 7.  Wt. 6 lbs., 12 oz.  Infnt remains in excellent health and developing normally. Reporting mother is also in usual state of good health.
9 year old male inadvertently received adult 12+ pfizer bivalent booster instead of correct 5 to 11 year old bivalent booster dose.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L014878, expiry date 17-JAN-2018 (strength, dose, route and site of administration were not reported). No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
At around 40 minutes he had a foreign body sensation in the pharynx and mild dysphonia. The sensation of a pharyngeal foreign body did NOT prevent breathing and it decreased as the hours passed, but it persisted for 48hrs slightly. He did not require an emergency consultation. Days later we consulted in the office of an ENT and immunology.
Participant felt numbness and tingling in left arm, both legs and right side by waist after receiving flu vaccination. Symptoms did not subside, 911 was called and participant was taken to the local hospital.
Lightheaded, head spinning effect like vertigo (4th day) , site pain, chills, skin sensitivity like pinching with needles, fever for two days, super heavy headache.
Patient was given a Pfizer bivalent as his first dose instead of the monovalent.  No reaction of any kind of the patient
Right after 2nd shot for 4 hours after I had tachycardia up and down. Then almost 2 weeks later I got an uti, that within 3 days turned into a severe kidney infection into sepsis. My liver enzymes were in the 500?s.  My right kidney was swollen and I spent 4 days in the hospital and it took a month to return to normal. Then 3 weeks later I get diagnosed with pancreatitis on June 21.  Symptoms subsided now they are back again. Fever, abdominal tenderness, flank pain, aches, and diarrhea and nausea.   Took covid test always comes back negative.
Case number PHEH2015US0228892 is a spontaneous report initially received from a nurse on 02 Nov 2015. This report refers to a 28 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) intramuscularly into left deltoid on 05-Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34F overnight. No adverse event was reported. Follow-up received from a nurse on 22 Dec 2015: Patient details (date of birth) and vaccine details (Batch number, site and date) were updated. Report type was changed to "spontaneous report" from other".
I volunteered at a clinic to help old people get their swine flu vaccine.  At the end the doctor announced that the people who helped out could get a free shot.  I knew that my son who had a heart condition would need one so I wanted to get it first  to see if it would be  safe for him.   Within a half hour after getting the shot  my fingers on my left hand started to get numb and turn white - one at at time.  Then, the right hand the same thing.  It went away after a while.  I do not remember how long it took but every time my hand got very cold they would again get white and numb.  That lasted many for years later.
In Mar2022 he had surgery for an insulinoma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN. Vaccination history included: BNT162b2 (Dose: 01, LOT: EN6198), administration date: 26Feb2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (Dose: 02, LOT: EP7534), administration date: 19Mar2021, when the patient was 85-year-old, for COVID-19 immunization. The following information was reported: INSULINOMA (medically significant), outcome "unknown", described as "In Mar2022 he had surgery for an insulinoma". The patient underwent the following laboratory tests and procedures: Biopsy: Everything was clear and the biopsy was good., notes: Everything was clear and the biopsy was good. Therapeutic measures were taken as a result of insulinoma.  Follow up information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 8-week-old male patient who received HIBERIX (batch number 2S27K, expiry date 17th September 2017). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018), HIBERIX (batch number 5FC3Z, expiry date 20th January 2017), HIBERIX (batch number 4B745, expiry date 23rd February 2018) and MENVEO. On 2nd February 2017, the patient received the 1st dose of HIBERIX. On 12th April 2017, the patient received the 2nd dose of HIBERIX. On 7th June 2017, the patient received the 3rd dose of HIBERIX. On an unknown date, the patient received HIBERIX and MENVEO at an unknown dose. On 2nd February 2017, immediately after receiving HIBERIX and not applicable after receiving HIBERIX, HIBERIX, HIBERIX and MENVEO, the patient experienced injection site hyperpigmentation. On 12th April 2017, the patient experienced injection site hyperpigmentation. On 7th June 2017, the patient experienced injection site hyperpigmentation. On an unknown date, the patient experienced injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. After the administration of HIBERIX a black dot was left on the patient, may be MENVEO as well. The black dot had not gone away from the patients after months of administration. The health care professional said that it may be up to six patients and 4 different lots. Only two patients information was given. When probing a little more the health care professional felt it could be MENVEO as well. The spots appear immediately, at the time of vaccination, after vaccination. The reported lot number (2527K) for HIBERIX did not exist and was updated to 2S27K, according to sales database. This is 1 of the 2 reports reported by same reporter.