chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Left arm very swollen, became erythmatous and warm. Large patch of erythema and swelling over the left arm. DX swelling or mass of limb and Aseptic inflammation from vaccine shot. No treatment. Was told it was rare (1 out of every 1,000 children this would happen to) by pediatrician. My child started stuttering two days after the vaccine, lost his balance and has had brain shrinkage and developmental delays sense the vaccines. Was recently diagnosed with partial focal epilepsy. Problems with muscle tone and stiffness, he cannot speak clearly now and had a full vocabulary and no issues with speaking before the vaccine. So the outcome has been severe developmental regression and balance issues due to muscle tone and neurological issues. Has to wear AFO's and needs to use a wheelchair most of the time do to loss of muscle tone and sensory/balance issues. He had no problems with balance or walking before the vaccine.
A FEW HOURS AFTER THE VACCINE WAS GIVEN (~6PM 10-19-17), PT STARTED TO FEEL TIRED AND HAD A SLIGHT FEVER. AT 6AM THE NEXT MORNING, SHE COMPLAINED OF TROUBLE BREATHING, LEFT ARM SWELLING AROUND SITE OF INJECTION, RASH ON LEFT ARM AT SITE OF INJECTION. SHE WENT TO THE ER LATER THAT MORNING WHERE THEY GAVE HER BENADRYL. A WEEK LATER, PT COMPLAINED OF SWOLLEN, HOT TO THE TOUCH, LYMPH NODES. WENT TO SEE DR ABOUT THESE, MD SAID THEY WERE INFECTED AND PRESCRIBED ABX (AUGMENTIN 875 BID X10DAYS). PT SAYS SHE IS BETTER NOW, LYMPH NODES ARE STILL A LITTLE SWOLLEN AND IS HAVING TO USE RESCUE INHALER MORE THAN NORMAL TO HELP WITH BREATHING.
No adverse effect; the patient was inadvertently administered a dose of MMR II that was expired; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-AUG-2019, the patient was inadvertently vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N020922, expiration date: 01-AUG-2019 for prophylaxis (dose and route of administration were not reported). No adverse effect was reported.
Right after shot patient feeling faint, intructed head to knee position while seated in chair in exam room. Water given. 5 minutes ambulated to traement room when she stated began to "black out". LOC approxiamtely 5 seconds. Diaphoretic .With assiatance from my coworker aided student to the floor. Lying down elevated legs with pillows. Dr. was made aware. P: 60R: 18 cool cloth to forehead.Within 5 minutes:  color back to face feeling better. 10 minutes later sitting up , gatorade given and crackers. Amulated without difficulty to infirmary to lie down in bed. P: 60 B/P 100/70 R: 18 Additional 40 minutes rested in infirmary feeling better Before discharge: P: 72 R 18 B/P 100/70 Stable, Alert and oriented.
My left arm has hurt ever since that first shot.  Not at the site of injection, but kind of in the bicep.  It hurts to try to put it behind my back, hurts to pull up my pants in the back.  Hurts to stretch that arm to the left.  Hurts to try to lift things in a certain way.
Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022; doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-Jun-2022, the patient received booster dose (batch no. 058A22-2A) of Moderna COVID-19 Vaccine.  Vial was initially stored in the refrigerator on 09-Jun-2022 and was first punctured on 10-Jun-2022 at 1:05 PM. Post puncture vial was stored in a container to protect from the light and kept in the fridge. All 4 doses administered on 13Jun2022 at 11:24 AM, 12:30 PM, 1:30 PM, 3:00 PM. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was Approximately 5 times, but did not reported a exact amount of time. Vial was not exposed to room temperature for more than 24 hours. It was unknown that Patient was experiencing any symptoms.  No treatment medications were reported.
Fever x five days, dyspena, headach, vomiting. To PMD on 3/14/03- dx with strep throat, gave med exemption to further HBV
Administered FLUMIST to patient under 2 yrs of ago. Wrong age (patient not correct age for vaccine given).
Lateral left upper thigh swelling, warmth noticed at daycare, patient crying for 30 min, non tender today. At 1400, site is slightly edematous, 6cm x 9cm, diffuse, assynomical, location of PROQUAD vaccination. Ice was applied. Decreased swelling.
pt recv vax 14AUG97 & 17AUG97 pt exp urticaria secondary to allergic rxn that started on lower extremities & is now generalized;pt then took DPH went to sleep, woke up & urticaria worse;seen by MD;given atarax for itching;
Several bouts of illness and cold symptoms, Difficulty breathing, Wheezing, Coughing, Tiredness. I was prescribed asthma medication and an albuterol inhaler by my doctor.  I also started using a nebulizer. I was diagnosed with allergy induced asthma.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 27-OCT-2014 (yesterday) the patient was inadvertently administered an expired dose of ZOSTAVAX (lot J008530, expiration date 12-OCT-2014) (dose, route unspecified). No adverse effect reported. Additional information has been requested.
vaccine expired 10/13 and administered to pt on 10/15.  after investigation, moderna confirmed the lot should give full coverage.  no adverse event reported
The pt experienced fluid filled blisters on left deltoid one inch from injection site, noticed two days post vax after removing bandaid.
Intense itching, puffiness, redness surround injection site began exactly two weeks after taking shot. Applied hydrocortisone cream 2.5% and took Benadryl which lessened itch. Much better on third day with only slight itch. Still have some redness and puffiness.
Pulsatile tinnitus on date of 2nd dose: 3/28/21 Continuous/Constant tinnitus the day after the 2nd dose: 3/29/21 Tinnitus still present
fever, circular rash (red spots on back) and diffuse erythematous rash on trunk, clear drainage from eyes and nose, projectile vomiting and copious amounts of diarrhea for 48 hrs
Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19). At the time of the report, COVID-19 (Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment medications provided.
Patient moved his arm while given a dose of GARDASIL-9, which resulted in administration of a partial dose; This initial spontaneous report was received from a medical assistant, regarding a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported. This case concerns one patient and one combination product.  On 11-MAR-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), pre-filled syringe (dose, route of administration, site of administration and vaccination scheme were not reported; lot number 1614897, expiration date 20-SEP-2021) as prophylaxis. During the administration, the patient moved his arm, which resulted in administration of a partial dose (incorrect dose administered). 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: 1614897; expirationdate: 20-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
SHE GOT SHINGLES A WEEK AFTER THE IMZ AFTER SHE GOT THE VACCINE, SHE WAS VERY ILL, HAD TO LAY IN BED FOR TWO DAYS AND COULDN'T MOVE.
Patient got vaccinated at 4:03 p.m. At 4:10 p.m., patient had involuntary muscle movements and lost consciousness. Per parent, patient has history of panic attacks presenting like same symptoms observed., vital signs taken: BP 154/89 and 120/77, PR: 138; blood glucose: 124, EKG: sinus tachycardia; oxygen given at 4:26 p.m. and discontinued at 4:37p.m.; patient transported to hospital at 4:45 p.m.
Headaches, dizziness, nausea, neck stiffness, tingling in hands
A report has been received from a Physician concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Inadvertent inoculation in eye was reported. The outcome of the event of inadvertent inoculation in eye is unknown. The report was considered to be non-serious by the reporter.
complaints of sore arm on July 28 and July 29, 2007.  Hive like itchy rash behind ears, neck, lower trunk and under one arm on 8-1-07. denies fever, headache.  No known allergies.  Mother gave benadryl tabs and used calamine lotion.
Moderna COVID-19 Vaccine EUA on 1/21 I had fever of 101+, body aches, headache, fatigue, which lasted until 1/23. On 1/26 started to get rash behind ears, neck and throat, not sure if related or not to vaccine
delayed allergic response of hives that won't fully clear, currently taking different allergy medications and using steroid cream with little relief
Rash on left arm and right arm, face, and chest. Blisters within 2 hrs of shot-broke out in rash-I got a PREDNISONE shot and rx for loratadine and PREDNISONE.
7/9/13 Healthy 6 month baby receives vaccinations 9/20/13 Mother calls health center stating a lump noted on baby's leg 1 week after vaccinations. No infection, not warm to touch, not bothering baby. 8/25/13 To urgent care for lump (R) thigh. DX cellulitis and abscess unspecified. Treatment: Keflex.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hasimoto's thyroid disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROENDOCRINE CARCINOMA (death, hospitalization, medically significant), outcome "fatal", described as "She was diagnosed with neuroendocrine cancer"; AUTOIMMUNE THYROIDITIS (death, hospitalization, medically significant), outcome "fatal", described as "She did have Hasimoto's thyroid disease"; PERIPHERAL SWELLING (non-serious), BREAST SWELLING (non-serious), outcome "unknown" and all described as "right arm and breast swelled". The patient underwent the following laboratory tests and procedures: biopsy: negative, notes: 2 biopsies were neg; investigation: neuroendocrine cancer. The patient date of death was unknown. The reported cause of death was neuroendocrine carcinoma, autoimmune thyroiditis. It was not reported if an autopsy was performed. It was reported that patient received both doses and two weeks after the second dose her right arm and breast swelled. She was diagnosed with neuroendocrine cancer, spent close to 60 days in the ICU (17 days on a ventilator) and died 4 months and 1 day after her first symptoms. Reporter reported this to Pfizer before she was diagnosed with cancer. She did have Hasimoto's thyroid disease. 2 biopsies were negative. The lot number for bnt162b2 was not provided and will be requested during follow up. Reported Cause(s) of Death: he was diagnosed with neuroendocrine cancer. She did have Hasimoto's thyroid disease.
This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 8 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had no further information for the patient. No batch number and expiration date of product was given. The healthcare professional might be able to provide further detail once safety follows up with healthcare professional.
No AE; Use of a pediatric dose in an adult; The caller said the patient was supposed to received Engerix B and not VAQTA; The patient received two doses of VAQTA.; This spontaneous report has been received from a consumer and refers to a 48-years-old male patient. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies and reactions were not reported.   On an unknown date, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) (Lot #, expiration date, Strength, route of administration and anatomical location of vaccine) 1 mL, for prophylaxis. On 27-SEP-2021, the patient received a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) (Lot #, expiration date, Strength, route of administration and anatomical location of vaccine) 0.5 mL; the patient supposed to received to Hepatitis b vaccine rhbsag (YEAST) (ENGERIX B). The patient did not present any adverse event.
Nausea, vomiting, trouble breathing, angina (chest pain), muscle aches, dizziness, high fever, weakness, excessive ear aches, neck stiffness, diarrhea, blurred vision, weight loss, hives, hoarse voice, rapid heart beat, behavior changes as far as aggressiveness and suicidal thoughts, fatigue. Frequent doctor/hospital visits, but no results. Has been healthy majority of lifespan prior to shot being given.
A couple of months after vaccination, I had chills, hot flashes, extreme fatigue, and body aches. It transformed into extreme body pains and diarrhea and vomiting. I took an at-home COVID-19 test that came back negative. So then I went to the doctor who conducted a CT scan and blood samples and tests to try to diagnose me. The doctor assumed I had a urinary tract infection. He prescribed me antibiotics and medicine for the abdominal pain (nitrofurantoin-mono NCR and hyoscyamine). As of now, I feel recovered and better.
ear infection; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (recurrent ear infections).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (ear infection). At the time of the report, EAR INFECTION (ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
According to report the client presented in the Emergency Room with respiratory distress on 11/17/2021 from home where he has had 1 week of Covid symptoms. His symptoms included minor upper and more major lower respiratory symptoms of cough, shortness of breath, fatigue, and fevers. He was hypoxic in triage, he denied any chest pain. Other symptoms included fairly profound diarrhea; there is no abdominal pain nausea or vomiting.
Fever; Chills; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Slight headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021. It contains No New Information.
Fainted; Had a seizure; A spontaneous report  was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and had a seizure.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, after vaccine administration, the patient fainted and had a seizure. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, fainted and seizure, were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of fainted and seizure. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Immediately after administering the MMR, notice redness.  Within 10-15 min. the redness was 40mm with a 2mm wheal.  Clt. reported pain at site but denied all other s/s such as SOB, itching etc.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 18-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
p/pt vax exp swelling under rt eye; mom noticed about 15min p/vax;no resp distress-child smiling & in no distress;pt sent to ER for check; tx DPH; dx: allergic react localized under rt eye;disch in good condition;
7/7/08: Pt reports sudden onset of rash across abdominal area.  1 cm papulo squamous lesions, red, four total scattered on abdomen.