chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse regarding unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored. No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
On January 22,2021 @2:30a i woke up with burning sensation on my chest, back and flushed face, January 24, 25 and 26, the same feeling, i saw my primary doctor January 26, that day @. 2:30 burning sensation on my chest, back and flushed face. I had an ekg that day and my doctor said it?s fine, today @6a, same reactions, episodes last for 10 minutes.
Arm reported by mom to be size of baseball, red & hot. Afebrile. Symptoms first appeared about 24 hours after vaccine. Mom giving Tylenol putting ice packs on arm. To see Dr today.
needle error, did not receive full dose of vaccine, received less than half- re-vaccinated with full dose per Agency guidance
fever to 103 max off & on over 2 wks; past from 8OCT93; 8OCT93 t101.5 ax while mom holding pt; started jerking arms & legs for about 5 mins;
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
The patient reported that she did not feel well 10-15 minutes after receiving the vaccine, generalized not feeling well.  She thought it was because she hadn't eaten, She got lunch and left the store.  After getting home she felt worse, disoriented, difficulty breathing, hives, and increased blood pressure one hour after the shot and went to the ER for treatment.
Right upper arm swollen with skin redness at immunization site - cellulitis tx with Keflex 250mg/5ml suspension. 1 Tsp PO q hours.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Apr-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 57.27.  Concomitant product use was not provided by the reporter.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
felt sicker; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves female patient (unknown age) who felt sicker (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious felt sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, this is not true for everyone because the reporter also knows people who had gotten the flu shot that haven't got sick sense and have no side effects. There are even people, even on comments on here that say it had severe side effects for people they know, but say you cannot compensated if a vaccination screws up you or your loved ones. Don't know what the factors are why it works for some and not others. Maybe immune system, maybe allergies who knows.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
I had a fever of 103 and was unable to work.  I had blurred vision and could not find the wrung on my beds ladder to get out of bed, I was working at the time.  I had weakness for months afterwards and lost almost a minute on my mile and a half PT run.
@ 7 days p/MMR pt devel a fever rash & sores in mouth on 10th day; also had swollen glands, sore throat, loss of appetite; MD called but pt not seen; did have pain in joints & fussy;
38 year old male presented to the ED with weakness to the left side of the face beginning 45 minutes prior to arrival.  He stated that he had his COVID vaccine 2 days prior.  He states the day after he began to lose his sense of taste and he has a weird feeling in his right arm as well.   Diagnosed with Bell's Palsy.  Started on valacyclovir as well as a prednisone taper.
No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 1-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 07-NOV-2022 at 11:10, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter intramuscular injection, 0.5 milliliter, lot #U038841, expiration date: 06-MAR-2023, administered intramuscularly for prophylaxis in left thigh after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the hepatitis a vaccine, inactivated (VAQTA) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038:
Patient presented to ED after sensation of tongue enlargement and strachiness in the throat. Symptoms improved with oral diphenhydramine
Patient was to have Moderna Bivalent booster, patient received Moderna Monovalent.
Rare side effect of loss of smell beginning pm on Wednesday, December1, 2021.  Continuing as of Monday, December 6, 2021.  Tongue can taste salt, sugar, bitterness, savory, etc., but loss of smell leaves recipient of vaccination unable to enjoy full range/embodiment of taste.  Called doctor's office to ask about this.  Doctor informed patient that anosmia is rare side effect of the Moderna booster, and to monitor situation/get back with him.  Informed patient that loss of smell would "last a while".
Received 2nd dose one month after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30th May 2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 20th February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 20-Feb-2023. Reporter's Comment: Reporter did not provide full patient demographics or lot number and expiration date of dose one. The reporter did not consent to follow-up. Additional Supportive Information: Patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to drug dose administration interval too short.
Stomach ulcer came back; Had been throwing up and was throwing up again; Back spasms; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC ULCER (Stomach ulcer came back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach ulcer (he had been diagnosed with a stomach ulcer in March 2021) in 2021.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced MUSCLE SPASMS (Back spasms). On 13-Sep-2021, the patient experienced GASTRIC ULCER (Stomach ulcer came back) (seriousness criterion medically significant) and VOMITING (Had been throwing up and was throwing up again). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Stomach ulcer, at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM HYDROXIDE, SIMETICONE (MYLANTA [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM HYDROXIDE;SIMETICONE]) for Stomach ulcer, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach ulcer, at an unspecified dose and frequency. At the time of the report, GASTRIC ULCER (Stomach ulcer came back), MUSCLE SPASMS (Back spasms) and VOMITING (Had been throwing up and was throwing up again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drug details not provided.  Company Comment: This case concerns a 59-year-old, male patient with relevant medical history of stomach ulcer, who experienced the unexpected event of stomach ulcer The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. However, the patient's medical history and concomitant use of Advil, remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 59-year-old, male patient with relevant medical history of stomach ulcer, who experienced the unexpected event of stomach ulcer The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. However, the patient's medical history and concomitant use of Advil, remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.
p/vax pt c/o numbness & tingling in limbs progressing to muscle spasms;mom called poison control & MD who prescribed meds; MD felt rxn w/Wellbutrin; pt symptoms gone except fatigue.
Had DTAP on 10/22/2003.  Right arm redness in 24 hours as shown in picture.
Irritable bowel syndrome, joint and muscle pain, fatigue, tingling in fingers, memory loss, new onset headaches. See clinical summary.
Took my son to get his routine 15 month vaccinations. after he received his vaccinations he immediately started feeling tired and wanted to go to bed. Son had high fever later in the night and started having seizures and convulsions.  Called the on call Nurse for sons PCP 4 times in the night and they stated that all was normal and advised he did not need to be seen at Er. Thought we were talking to the Ped group on call but found out that they were speaking to a sub contracted ped group after hour center and does not know if the enter was professionally staffed. Group will not release the call information.  Convulsions/ tremors lasted for about a month and son started not being himself. 2015 Dr. Dr. diagnosed with sleep seizures (febral seizure activity). temp throughout the night was up to 103. After spoke with on call nurse 4th time. next day started having tremors throughout the day. Spoke with several family members who are MDs and they told me to let him sleep it off. Went in to  MD (Dr.) and he started getting weird with me.Did not preform any tests or report to the VAERS program. few months later he diagnosed him autism. Son was on track with every milestone before the admin of vaccine. Have seen 3 different types of neuro MD psychologists. Placed him in a study at the treatment center. Study.  ( showed remarkable results). to this day he is still nonverbal. still lacking some Muscular control.
Tender lymph node; Swollen lymph nodes; Fever; chills; Tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 13Apr2021 at 09:15(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression and food allergy(honey).The patient previously took nickel(MANUFACTURER UNKNOWN) on an unknown date and for unknown indication and experienced drug allergy. The patient previously took povidone-iodine(BETADINE) on an unknown date and for unknown indication and experienced drug allergy. The patient previously took neomycin sulfate; polymyxin b sulfate; gramicidin(NEOSPORIN) on an unknown date and for unknown indication  and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), meloxicam (MOBIC) and montelukast sodium (SINGULAIR) all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 the patient experienced swollen, tender lymph node, fever, chills and tired. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events swollen, tender lymph node, fever, chills and tired were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
hearing loss; neuropathy; postherpetic neuralgia; severe outbreak of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.      On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe outbreak of herpes zoster, postherpetic neuralgia, neuropathy and hearing loss. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, the events of neuropathy and hearing loss were considered to be medically significant.
Patient developed a rash distal to the injection site - with erythematous small raised patches and papules that were burning and very tender this rash then spread to other parts of his body over a month's time.
Information has been received from a physician concerning a 4 year old male patient with Epstein Barr syndrome, natural killer cell deficiency and allergy to egg white and milk who on 18-Mar-2006 was vaccinated with first dose of MMRII (lot No. not reported). Concomitant therapy included VALTREX. In approximately July 2009 the patient was restless, running around trees and "did not come when called". A rubella titer done in July 2009 showed a rubella titer of 407. The patient was placed on therapy with Amantadine, Ribavirin and TAMIFLU for 21 days. Subsequently the behavioral symptoms resolved and a rubella titer performed which was 4.7. When the children's behavioral symptoms returned a rubella titer performed on 11-Nov-2009 was 259. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. The physician also reported that during the patient's lifetime, the patient had been hospitalized five times for dehydration because he had refused to eat or drink when he has had a cold. Additional information has been requested.
Pt c/o anxiousness, trembling, chills, HA 1-1 1/2 hrs after vaccination.  Mother gave her TYLENOL - symptoms resolve within 1 hour.
9/21/2022. I have a history of an auto immune disease. That day my body became more achy. I contacted my doctor. I was placed on meloxicam about a month ago. I am doing physical therapy. It is getting better now.
Mom reported on 8/21/08 patient feeling dizzy, having difficulty breathing, muscle weakness and fever; temperature 103.7 approximately 12 hours after vaccines given lasting for 24 hours.
Very sore at injection site later in day/Monday 15th-used ice that night and it calmed down by morning.  Minor tenderness on Tuesday. Body aches and slight pain throughout my body on Tuesday 16th,   Seem to subside on Wednesday.  Today,  Wednesday felt a little dizzy.   Will observe.
COVID Vaccine Breakthrough CAse  Pfizer Dose 1 2/6/21 (lot NA) Pfizer Dose 2 3/6/21 (lot NA) COVID Positive 11/27/2021  12/5/21: 66-year-old man who was brought into the emergency department with worsening shortness of breath, hypoxia following COVID diagnosis 9 days ago.  He reports feeling unwell approximately 2 weeks ago with generalized myalgias, low-grade fevers, shortness of breath.  He subsequently had COVID-19 PCR testing 10 days ago which was positive.  He has had COVID vaccines x2, scheduled for booster dose prior to onset of illness.  His status post monoclonal antibody infusion as outpatient despite which he has had worsening symptoms.  He has noted desaturation particularly with activity with oxygen saturation down to 88-89% on room air.   he continues to have low-grade fevers, poor appetite with poor oral intake, shortness of breath aggravated by exertion.  Presented to the emergency department where he was hypoxic on room air to 88%, laboratories  Revealed lactic acidosis, elevated D-dimer.  He has a contrast dye allergy precluding stat CT pulmonary angiogram, ventilation perfusion scan pending.  He will be admitted to the hospitalist service for further treatment and evaluation.  12/7/21: 66-year-old man who presented worsening shortness of breath, cough and myalgias following COVID-19 infection diagnosis 9 days ago.  On evaluation in the emergency department he was found to be hypoxic down to 88% on room air.  Chest x-ray demonstrated bilateral infiltrates in keeping with viral pneumonitis, elevated D-dimer was noted however ventilation perfusion scan done on account of contrast dye allergy was low probability for pulmonary embolism.  He was admitted to the hospitalist service and started on IV remdesivir, Decadron, empiric antibiotic therapy with good effect.  Significant improvement in oxygen requirements were noted during hospital course.  Oxygen walk for home determination done prior to discharge revealed that he did not meet criteria for home oxygen.  Has been discharged in stable medical condition to continue outpatient follow-up.
diagnosis of diabetes.; having a heart murmur; right knee replacement; aortic valve stopped working, the valve was replaced with a bovine valve; having stents put in in 2000; This spontaneous report was received from a currently 91 years old female patient referring to herself. The patient's pertinent medical history included rheumatic fever as a child. The patient's concomitant medication and drug reactions/allergies was not reported.     On an unknown date (reported as long ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient was having a heart murmur, having stents put in in 2000, as well as right knee replacement, during which her aortic valve stopped working, the valve was replaced with a bovine valve; diagnosed of diabetes. The outcome of the events was unknown. The causality assessment was not reported.     Upon internal review, diabetes was determined to be medically significant.