chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RASH (SHE HAD CONSTANT ITCHING AND SHE STARTED SCRATCHING), IT WAS HIVEY AND RED; HEADACHE; BODY ACHES; VERY LISTLESS AND DID NOT WANT TO DO ANYTHING; SORE ARM; SEVERE HEARTBURN AT NIGHT, WHILE IN BED; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: allergy problems, and concurrent conditions included: colon cancer, and problem with kidney function. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for colon cancer. On 14-SEP-2021, the patient experienced severe heartburn at night, while in bed. On 14-SEP-2021, the patient experienced sore arm. Treatment medications included: calcium carbonate, omeprazole, and paracetamol. On 15-SEP-2021, the patient experienced body aches. On 15-SEP-2021, the patient experienced very listless and did not want to do anything. On 15-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced rash (she had constant itching and she started scratching), it was hivey and red. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heartburn at night, while in bed on 14-SEP-2021, body aches, very listless and did not want to do anything, and headache on 16-SEP-2021, and sore arm on 15-SEP-2021, and had not recovered from rash (she had constant itching and she started scratching), it was hivey and red. This report was non-serious.
Patient reported tongue numbness following vaccination. No other complaints. Vital signs stable. Patient drank water and sat down,  Patient felt well and went home.
Left v1 distribution shingles; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Eh9899) intramuscular on the left arm on 18Dec2020 11:00 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) and zolpidem tartrate (AMBIEN). On 21Dec2020 10: 00 AM, the patient experienced left v1 distribution shingles. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and dexamethasone (DECADRON). Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date.   No follow up attempts are possible. No further information is expected.
Unconsolable after receiving vaccines. Returned home, took a nap and awoke crying. Called health unit, which is when she was referred to MD or ER for concerns. 5/16/14 attempted phone f/u. 5/17/14.
This spontaneous report as received from a physician and from a support service director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported. There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified) lasting for 1488 hours, with the lowest recorded temperature of 27 degrees Fahrenheit (-2.77 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 4 year old female who was vaccinated with a dose of PNEUMOVAX 23 in her thigh. Later in the vaccination evening, the patient had experienced swelling of the thigh, redness, hot to touch, cellulites and pain that went from the injection site down the leg. The physician reported that the experience got progressively worse over the next couple of days, and a hot pad and anti inflammatory medication was provided. At the time of this report, the patient has seen the physician and was recovered on therapy. The physician reported that he gave this same vial to two other patients who had a similar experience (reported in 0902YUSA01696 and 0902USA01697). Additional information has been requested.
2 year and 8 month old was given 0.5mL of Afluria instead of 0.25mL. No known symptoms as pt left the facility.
Patient experienced headaches, weakness, body aches, and was extremely fatigued. This lasted approximately 12 hours and started 24 hours after vaccination. She took Tylenol which seemed to help her headache and body aches.
devel fever followed by generalized shaking of bdoy & rolling back of eyes w/unresponsiveness around 5AM on 18FEB94; this was followed by persistent crying; another episode occurred around 9AM on 18FEB94; t106.3 u/a abn;
Facial Droop rig ht-sided facial weakness.  Noticed some tingling on the right side of the face last evening, woke this morning with significant weakness.  Unable to close right eye.  Difficulty chewing and swallowing due to the facial droop.
Tickling in Left Ear off and on throughout day. Minor Fever & Chills (9pm-3am) Minor Head Congestion (9pm-6am)
Presents to the ED via EMS from independent living facility c/o 2 week worsening weakness, worsened over the last 3 days; dx w/COVID pna;  tx w/ abx; supportive tx w/zinc, VitC, melatonin; no O2 required; pt discharged home
pain in her lower back; pain in her buttocks; pain in her knees; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, expiry date, RX number: unknown) via an unspecified route of administration on 26Jun2021 at 08:20 (at the age of 61-years-old) in left upper arm as a single dose for covid-19 immunization. The patient's medical history (including any illness at time of vaccination) and investigation assessment were not reported. She started a new prescription (unknown concomitant medication). Additional vaccines administered on same date of the Pfizer suspect was reported as none. Family medical history relevant to adverse events was not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Batch/lot number, NDC number, expiry date, RX number: unknown, route, anatomical location: not provided) on 05Jun2021 (at the age of 61-years-old) for covid-19 immunization and did not had any problem. Prior vaccinations within 4 weeks included Tetanus shot (manufacturer, lot number, route, anatomical location: not provided) on an unknown date. The patient experienced pain in her lower back, buttocks, and knees on 27Jun2021. She did not require emergency room and physician office visit. She couldn't think of anything that may had caused the events, but she didn't saw the list of side effects on the EUA fact sheet. Relevant tests were reported as none. The outcome of the events was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Tinnitus became extremely loud approximately 1 month after 2nd shot and has not quieted down since.
an expired Daptacel vaccine (vaccine expired 3 days ago) was given to patient; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 year old female patient who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2019, the patient received a single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C526AA (expiry date: 15-May-2019)  via unknown route.  It was of actual medication error due to expired vaccine used.  It was not reported whether adverse event was experienced...  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
p/ pt recv 1 dose of vax in 1996 then pt in 1998 devel chickenpox.
Generalized paresthesia of arms, hands, legs; sensation of skin irritation; resolved spontaneously p/2-3 wks of observation;  MD felt poss sensory neuritis;
Patient stated she developed muscle spasms  in her right arm on 9/1/2021.  On 9/8/2021, the muscle spasms had increased in frequency approximately every 10-15 minutes.  She denied having Covid-19 virus at any time.  History of muscle spasms before.  She stated the spasms occurred after a fall four years prior to 9/1/2021.  Checked on 9/9/2021 and the spasms had decreased, small twitch noted.  She was advised and did contact her MD, but had not received a return call back.  9?10/2021 - no muscle spasms. 9/29/2021, patient stated she had been having muscle spasms off and on in both right and left arm in past few weeks. She will make an appointment to see Dr. for follow up.
STERILE WATER FOR INJECTION MIXED IN AS DILUENT NO ADVERSE REACTION REPORTED AT TIME OF THIS REPORT
Immediate dizziness, nausea, and complete loss of hearing (subsided after 10-20 seconds), vomiting water. Dizziness remained for a few days along with other more common symptoms such as headache and arm soreness and pain and heavy fatigue.
p/returning home p/vax pt became pale & listless;remained that way most of the day;
I had slight soreness on my left arm for 2 days after being vaccinated then a week later on May 1 the injection site became red and hot.  The red patch was initially about 2 inches in diameter but has now become about 4 inches long and still 2 inches across.  I also have slight discomfort under my arm but can't feel any swollen lymph glands.
20-30 minutes after injection, Intense itching, hives on arms and stomach. Was given Benadryl immediately. Later that night serve nausea, fever. 4/2/21 was awaken with severe migraine, still had fever and nausea. 4/3/21 left hand began to burn and 3 fingers turned snow white and redline on under sude of palm appeared last for about 5 minutes. Became itchy all over later that day. 4/3 headache and leg cramps. Leg cramps daily, cramps start and subside. 4/6 intense hives on arms side of leg and stomach. 4/7, 4/8,4/9 my arms would begin to burn and would become one huge hive would take Benadryl and wrap arms in cold towels. Hives now appear daily when I scratch my skin it bruises. Strange headache appears as a burning sensation across forehead. Doctor has me taking Benadryl daily two time a day. Still experiences leg cramping.
HEADACHE; Information was received from a Consumer/other non health professional concerning a 58 Year(s) old Female patient, who received Suspect product APIXABAN for pulmonary embolism, Tablet, Oral (from 01-Feb-2022 2 every 1 Day), lot number:1856965; Suspect product COVID-19 VACCINE for product used for unknown indication (from 20-Mar-2022), lot number:Unknown. On 21-Mar-2022, the patient experienced headache(headache) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter did not provide a causal assessment for event headache to product APIXABAN. The reporter considered event headache related to product COVID-19 VACCINE. Tracking of Changes: 21-Mar-2022: Initial information was received. Eliquis is under agreement with Bristol-Myers Squibb. Causality Assessment for drug Eliquis for event headache as per reporter no Information and as per company (BMS related. And Causality Assessment for COVID-19 VACCINE for headache as per reported related and as per company (BMS) not related.
parotitis occuring 8 days p/vax w/moderate swelling of lt parotid & swollen stenson's duct; tx w/ATB & warm compresses;
stuffy; rash on neck; Rash on arms; Rash on side; Rash on groin; Fatigue; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy), RASH (rash on neck), RASH (Rash on arms), RASH (Rash on side) and RASH (Rash on groin) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Benedryl, PARACETAMOL (TYLENOL), Zonagram, VERAPAMIL, DESVENLAFAXINE SUCCINATE (PRISTIQ), Trazadone, Adavan and Marpax for an unknown indication, levathyroxine.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (fever). On 05-Mar-2021, the patient experienced NASAL CONGESTION (stuffy), RASH (rash on neck), RASH (Rash on arms), RASH (Rash on side) and RASH (Rash on groin). At the time of the report, NASAL CONGESTION (stuffy), RASH (rash on neck), RASH (Rash on arms), RASH (Rash on side), RASH (Rash on groin), FATIGUE (Fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine administered to pt's left arm on 7/17/14. Had panic attack night of 7/17/14. Shaky with low-grade fever (99.9) on 7/18/14 - developed rash/hives on (L) arm and (L) thigh 7/23/14.
no additional adverse event; the patinet received the first dose of MMR II at age 5 months; This spontaneous report as received from a other health professional refers to a 4 month (also reported as 5 month) old patient.    On 16-JUN-2009 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT).   On 16-JUN-2009, 1 day after onset of therapy the patient experienced product administered to patient of inappropriate age.  On an unknown date the patient experienced no adverse event.      This report was voided incorrectly as case # 2003USA004717. The root cause for the error was misunderstood of guidelines. The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) cannot be administered to 4-month-old patient.
Patient got dizzy the morning after second dose of Pfizer Vaccine while in the shower, fell and chipped her tooth, no further complications, no hospitalization, no loss of consciousness
SUBJECT: second dose of COVID-19 was administered on 10 April 2021, using the manufacturer Moderna with lot number 031A21A. Injection site was upper left arm, intramuscular. The  developed unusual reactions: persistent headaches with photophobia that started on Sunday Night, that had worsen today with anorexia, fatigue and joints pains. He was evaluate by medical provider who recommended a Treatment and recommended to go home rest, takes plenty of fluids and VAERS report. He will return to work when he becomes asymptomatic (7-10 days). This note documenst this unusual reaction to COVID-19 vaccine on the medical records and follow any procedures set forth to follow-up on this case and to report it to the VAERS program. This is to document the injury in case he requires  medical treatment.
DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified (middle) age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. The cause of death was unknown. The date of death was not reported. It was unknown whether an autopsy was performed. Reporter stated that, "I knew healthy people, one middle aged who died shortly after the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221152669, 20221152749 and 20221152742.; Sender's Comments: V0: 20221152816-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fell and hit her head after moderna vaccine dose 1. Pt said she didnt eat or drink anything after working out this morning. We gave patient two options: we offered to call ambulance to take pt to hopsital or we offered to take her over to the ER on our lot in a wheelchair. Pt wanted to wait for her boyfriend and wanted to go to ER with him. We gave patient cholcolate and water. Pt was feeling much better- no dizziness or feeling faint. Highly recommended her to go to ER for evaluation.
Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) second dose via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 was unknown. The patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise on same day of second shot. It was reported that No treatment was given to patient. The outcome of events was unknown.   Information on the lot/batch number has been requested.
20mins post vax initial soreness @ inj site progressed through the day exp nausea w/pain-deep achy feeling in arm if used;
itchiness, flushing, inc R-24, inc P100, shakiness, apprehension, weakness in legs;epi given;
general malaise; tiredness; soreness in the left arm at the injection site; left arm was warm to the touch with heat that lasted a full five days.; This non-serious case was reported by a consumer via call center representative and described the occurrence of general malaise in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced general malaise (Verbatim: general malaise), tiredness (Verbatim: tiredness), injection site pain (Verbatim: soreness in the left arm at the injection site) and hot feeling in hand (Verbatim: left arm was warm to the touch with heat that lasted a full five days.). The outcome of the general malaise, tiredness, injection site pain and hot feeling in hand were resolved (duration 5 days).   It was unknown if the reporter considered the general malaise, tiredness, injection site pain and hot feeling in hand to be related to Shingrix.     It was unknown if the company considered the general malaise, tiredness, injection site pain and hot feeling in hand to be related to Shingrix.   Additional Information: GSK receipt date: 23-JUN-2023 The reporter reported that after the injection she experienced general malaise, tiredness, soreness in the left arm at the injection site and her left arm was warm to the touch with heat that lasted a full five days. The reporter consented to follow up.
Received expired dose of boostrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 374lb, expiry date 28-JUN-2022) for prophylaxis.   On 01-JUL-2023, the patient received Boostrix. On 01-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Received expired dose of boostrix vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter was the patient's father. The reporter did consent to follow up. The patient received a Boostrix vaccine which was already expired, which led to expired vaccine used.
Pfizer covid-19 vaccine was inadvertently mixed with 0.9 mL of 0.9% NaCl instead of the required 1.8 mL of 0.9% NaCl
CHRONIC HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Patient developed significant bruising on arm around injection site and surrounding axila area first seen the morning after the injection. Patient also reported pain in injection site at time of injection and myalgia which had fully resolved upon follow up call 6/26/2020.  Bruising was still present according to patient upon follow up call 6/26/2020 but was continuing to go away. Patient also reported feeling like her axillary lymph nodes were swollen prompting us to refer her to her physician. Upon follow up questioning she reported that her doctor believed it was a blood clot and not lymph node swelling.
Nausea, vomiting, severe dizziness, diarrhea. Arrived at work but had to leave. Contacted Family Care for medication. Prescribed Zofran. 2nd day slight headache, tiredness. Took Pepcid and Tylenol. 3rd day worse headache than 2nd day of side effects. Took Pepcid and Tylenol. Tylenol has not lessened headache in 2 hours.