chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AE for Supported TE for VARIVAX; This spontaneous report was received from a nurse referring to 15-month-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On unknown day, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot #X007373, expiration date 12-MAR-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown dates, the suspect vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-13C) for 18 minutes. Previous temperature excursion of -14 C to -10 C (-13.8C) for 26 minutes was reported.
Pt autistic. After receiving FLUMIST in 2012, 2013, 2014 mom noted pt behavior became more aggressive and out of control from his normal baseline scales. Sx lasted x several weeks - could not attend school. Note as baseline, pls advise if other reports of similar sx.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.     On 26-Jan-2022 at 3:28 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 26-Jan-2022 at 3:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient's ethnicity was reported   No concomitant drug information was provided.  The30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg exp date of 04-Apr-2022  No treatment drug information was received.   This case was linked to MOD-2022-542869 (Patient Link).
Patient presented to the clinic, 12 days after immunization, stating patient had bruises on the left face after falling down, the day before. This morning noticed more bruises on legs, arms, trunk & came to MD office, who noticed petechiae & sent pt to hospital.
Recurrent spontaneous pneumothorax - Procedures performed:  Left thorascopic bleb resection and pleurodesis.  She was admitted back to the floor with a chest tube in place.  She was kept to suction for 2 days after surgery and then transitioned to waterseal.  On waterseal she had a slight increase in her apical pneumothorax. The chest tube was placed back to suction for 24 hours and follow up cxr was stable.  She was transitioned to waterseal the following morning and as her follow up cxr was stable her chest tube was removed later in the afternoon.  Post chest tube removal cxr showed her lung was stable after removal and she was discharged home in stable condition. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
COUGH AND FEVER SINCE MONDAY 5/3/21, DISCHARGED WITH MEDICATION AND FOLLOWED BY VIRTUAL HOSPITAL
Patient developed an abscess at the vaccination site, ultimately requiring hospitalization and surgical I&D.  Abscess subsequently grew out MSSA, and patient had MSSA bacteremia requiring outpatient antibiotic therapy. Of interest, her husband reports receiving the vaccination at the same time from the same vial, and did not have any negative sequelae.
TDAP admin (R) deltoid 8/11/16, during evening arm achy and injection site Red, tenderness with nodule present. Had fevers with DTAP as infant. TX w/ Clindamycin for possible cellulitis.
Patient with longstanding history of bilateral exostosis. Noted to have left sudden hearing loss, unsure about timing ~ 1-2 weeks after. Treated with oral and intertympanic steroids
This spontaneous report as received from a 71 year old female consumer refers to herself as a patient with asthma, borderline type 2 diabetic, ampicillin and CAFERGOT allergy. On 28-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot, dose and route were not reported). Concomitant medication included astatine and cataract medication. On an unknown date in 2014 (reported as a couple of days after receiving the vaccine), the patient experienced nerve pain and inflamed muscle pain all over her body. The patient was unable to walk and now had to use a walker. When the patient tried to lie down she was unable to rest because of the severity of the pain. The patient sought for medical attention (called physician). The patient received unspecified pain shot as treatment for the events. No lab diagnostics performed. The outcome of nerve pain and inflamed muscle pain all over her body, unable to walk and unable to rest were reported as not recovered. The events were considered serious due to disability by the reporter. Additional information has been requested.
Later that day I began having hot flashes, vomited, was nauseaed and just didnt feel well.  I hydrated  with alot of cold water and began feeling better.  About 3-4 days  later on 4/19 I began having severe diarrah and not feeling well and on 4/20 I was prescribed metrodonazole and vomited again.  To date I am still experiencing the severe diarreah but no vomiting. EDD 6/24/2021
Shortly after receiving the vaccine I began experiencing symptoms.  I first noticed abdominal cramping.  Then I began to get itchy eyes, then tingling in my lips.  After that my throat , tongue and the inside of my nose felt swollen and numb.  I had a fast heartbeat and I began to get hoarse.  My husband drove me to the emergency room.  I was treated with a steroid injection and pepcid. Within fifteen minutes of receiving the treatment my symptoms began to subside.
Patient stayed in store after shot because it had been multiple years since receiving the last one, about 15 mins after the shot was administered she became lightheaded, dizzy, and flushed in the cheeks. She described it as "feeling drunk". She sat down for about 5 mins and the feeling did not subside. She then took 25 mg BENADRYL (diphenhydramine) in case it was an allergic reaction. About 10 mins after taking the BENADRYL, she got up to walk around and felt better. No swelling or redness at the injection site.
Body aches, fatigue,  chill  (pain reliever acetaminophen 500mg/5ml), feeling warm, nauseau(ondansetron 4mg ODT): Saturday evening 02/20/21--no fever   Body aches, fatigue continue (heating pad, rest): Called Doctor on Thursday 02/25/2021, she says to push fluids, rest and take ibuprofen and to call her back on 03/01/2020 if symptoms continue and to come in to do a blood test  Nauseau and vomiting: Friday night (02/26/2021).  Saturday 02/27/2021: Fatigue, body aches took ibuprofen 400 mg  tab  (total)
and unable to get up off of the bed or couch; panic attacks; heart palpitations; higher anxiety amped up and worry; shaking; drenched in pool of sweating; headache became worse, day symptoms got worse and worse; low grade fever; slight headache; feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (higher anxiety amped up and worry), HYPERHIDROSIS (drenched in pool of sweating), CONDITION AGGRAVATED (headache became worse, day symptoms got worse and worse), GAIT DISTURBANCE (and unable to get up off of the bed or couch) and PANIC ATTACK (panic attacks) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety (Anxiety). Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced PAIN (feeling achy). 11-Mar-2021, the patient experienced PYREXIA (low grade fever) and HEADACHE (slight headache). On 12-Mar-2021, the patient experienced CONDITION AGGRAVATED (headache became worse, day symptoms got worse and worse). On 13-Mar-2021, the patient experienced HYPERHIDROSIS (drenched in pool of sweating). On an unknown date, the patient experienced ANXIETY (higher anxiety amped up and worry), GAIT DISTURBANCE (and unable to get up off of the bed or couch), PANIC ATTACK (panic attacks), PALPITATIONS (heart palpitations) and TREMOR (shaking). The patient was treated with ALPRAZOLAM for Symptomatic treatment, at an unspecified dose and frequency and SERTRALINE ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ANXIETY (higher anxiety amped up and worry), HYPERHIDROSIS (drenched in pool of sweating), CONDITION AGGRAVATED (headache became worse, day symptoms got worse and worse), GAIT DISTURBANCE (and unable to get up off of the bed or couch), PANIC ATTACK (panic attacks), PALPITATIONS (heart palpitations), PAIN (feeling achy), TREMOR (shaking), PYREXIA (low grade fever) and HEADACHE (slight headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  This is a case of expired product administered for this 64-year, male patient with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 64-year, male patient with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of the vaccine is not affected by this report.
Extreme Fatigue; Chills; Fever - Temperature of 101.2F; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Extreme Fatigue), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.2F) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Extreme Fatigue), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.2F) and HEADACHE (Headache). On 06-Mar-2021, FATIGUE (Extreme Fatigue), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.2F) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided self treated with Tylenol   Reporter did not allow further contact
This spontaneous report as received from a healthcare worker, an immunization coordinator refers to an unspecified patients of unknown age and unknown gender. Since 30-MAR-2015, the unspecified patients were vaccinated with MMR II (lot # K007107 and expiry date: 16-MAY-2016), which was exposed to a temperature outside of the recommended range on 30-MAR-2015. No adverse effect was reported. No product quality complaint (PQC) was reported for MMR II. Additional information has been requested.
received booster (jansen) on November 5, 2021, at approx 3:30, While in my car driving, the right side of my face became hot and I felt like it was sagging and felt hot,  I drove myself to the fire department while they took my blood pressure (a little high), and other vitals, I waited for about 1/2 hour  and did not get worse so I went home,  I woke the next morning with more numbness and sagging on left side of my face and extreme pain in my stomach. My right arm began to tremor and clinch in to my side. Soon after my leg did the same.  It looked as if I had bells palsy or parkinstons.  I called my mother, who took me to emergency room., who after seeing me said I had a severe allergic reaction and treated for such.
This spontaneous prospective pregnancy report as received from a pharmacist refers to a female patient of unknown age. The patient had none concomitant medication, none pertinent medical history and none drug reactions or allergies. The LMP and EDD was not known. On 05-NOV-2018, the pregnant patient was inadvertently vaccinated with GARDASIL 9, 1 dosage form, intramuscularly (exact dose, lot number and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified). Trimester of exposure was unknown. The patient experienced no adverse event. The pregnancy outcome was pending. No treatment was given for the adverse event. None lab diagnostics/studies were performed. The patient did not seek medical attention. No intervention was made to prevent serious criteria. The patient did not die, was not hospitalized. The event was not life threatening. There was no PQC present.
Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches; There are bumps in the rash, it has a dead border and, in the middle, a live pustule.; it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle; Itchy rash which is almost a scar because of scratching; This spontaneous case was reported by a patient and describes the occurrence of PUSTULE (There are bumps in the rash, it has a dead border and, in the middle, a live pustule.), SCAR (it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle), RASH PRURITIC (Itchy rash which is almost a scar because of scratching) and RASH (Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no allergies. Patient was never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: J & J vaccine (Previous dose was J&J). Past adverse reactions to the above products included No adverse event with J & J vaccine. Concurrent medical conditions included Clot blood (Blood coagulation). Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.    In March 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced RASH (Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches). In 2022, the patient experienced PUSTULE (There are bumps in the rash, it has a dead border and, in the middle, a live pustule.), SCAR (it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle) and RASH PRURITIC (Itchy rash which is almost a scar because of scratching). At the time of the report, PUSTULE (There are bumps in the rash, it has a dead border and, in the middle, a live pustule.), SCAR (it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle), RASH PRURITIC (Itchy rash which is almost a scar because of scratching) and RASH (Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches) outcome was unknown.            Concomitant medication also included blood coagulation medication. It was reported that there were bumps in the rash. Patient had visited the Doctor. Treatment included Antibiotics, Corticoids.
Pt developed a severe headache within a few hours of vaccination.  She experienced a sore arm, numbness, bluish discoloration and swelling of the arm.  This began the evening of injection and lasted for 2 days.
Her throat hurt a lot to point of her crying. It lasted an hour or so. Has had a 100 degree fever all weekend. 02/07/2016 7:00 AM She woke up and couldn't hear me at all she said she didn't know what was wrong with her ears and kept rubbing them and cried. Deafness lasted about 2 hours. Mild deafness has lingered with soft and low sounds. Will go to doc tomorrow if symptom persists.
With 10 min of vaccination, Heaviness and numbness in arm, cool tingling going from top of both legs down to toes, warm rush and tingling starting at lower back and going up back and chest, nausea. The feeling in chest and back would last about 10 seconds, subside for a little while and then start again. This happened off and on for about an hour. The tingling in legs continued for about 2 hours. About 1 hour after I received vaccine I started having vision problems, blurriness, strange spots /lights , had trouble focusingnmyneyes. Then a terrible headache set in. I have had similar vision problems with a migraine headache in the past. Felt like it triggered a migraine. Vitals were normal. Checked out by EMS and went to local ER.
18APR96 5PM fatigue;7PM fever, chills, diarrhea, h/a lasted for approx 12 hr, stayed in bed; 19APR 12:00 finally able to get out of bed slowly started to feel better
No adverse event; Extradose administered; This spontaneous report as received from a consumer referring to her son of an unknown age. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were not reported. On 23-DEC-2019, the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose/frequency, lot#, expire date and route were unknown) (extra dose administered) for prophylaxis. No adverse effects were reported. The outcome of extra dose administered and no adverse event was unknown.
Information has been received from a nurse via a company representative concerning to a 64 year old patient (gender not reported). In September 2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). In September 2014, the patient was diagnosed with shingles of an unspecified eye. The patient was treated with an unspecified antiviral for the shingles and the patient recovered on an unknown date. On 23-SEP-2016, the patient was diagnosed with shingles that was located on the "back of the patient's right shoulder, neck, hairline, and across her face". The patient was treated with an unspecified antiviral and recovered on an unknown date. No hospitalization nor cancer were reported. No product quality complaint was involved. The relationship between shingles and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Patient had non-stop crying for 3 hours the evening of 2/17/04. (She would only stop crying for a short time to catch breath). Had 104.7 temperature on 2/18/04 and was taken to ER. Medical record from 05/06/04 states: Urinary Tract Infection.