chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 86 but did not have a lot of history of receiving medical care in the system. There is note mentioned his death in the chart. His possible contributing comorbidities are advanced age, HTN, HLD, DM, mitral valve insufficiency.
no additional adverse event; Caller reports that an expired dose of MMR II was administered to a patient today. Caller confirmed that dose was properly stored up through time of administration. No additional adverse events reported. No product quality complaints. No further info; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #T031437, expiration date: 15-SEP-2022, administered as prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that the dose was properly stored up through time of administration. No additional adverse events were reported.
administered an expired dose of Menveo to a patient yesterday; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA467A, expiry date 31st March 2022) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Menveo. On 6th April 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022061853   Additional Information: GSK receipt date: 08-Apr-2022 Reporter's comment: Certified medical assistant administered an expired dose of Menveo to a patient a day before of reporting day (yesterday). Lot number did not identify as a GlaxoSmithKline vaccine, but it was confirmed with health care professional by repeating back twice. Consented to follow-up via postal. Additional Supportive Information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Severe allergy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Severe allergy) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Severe allergy). At the time of the report, ALLERGY TO VACCINE (Severe allergy) 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.   Reporter did not allow further contact
Injection site pain hardly noticeable; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch no: not reported/ Lot Number: EN5318; expiration date: unknown) via unknown route administered in left arm on 13Feb2021 01:30 PM (at the age of 30-year-old) as dose 2, single and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283, expiration date: unknown) administered via unknown route in left arm on 23Jan2021 01:00 PM as dose 1, single both for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not take other vaccinations within 4 weeks prior to vaccination. Patient had no COVID-19 prior to vaccination was not tested post vaccination. On an unknown date in 2021, the patient reported injection site pain hardly noticeable. Other than that patient experienced zero symptoms from either injection. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Admitted for COVID pneumonia, bacterial pneumonia, acute encephalopathy, hypoxic respiratory failure and hypercalcemia due to malignancy; tx w/abx, steroids, O2 (required intubation); PEG tube placed for failed ST; Dc'd to rehab.
By the end of the evening, joints ached, arm was swollen to the size of her hand, and area was warm to touch.
The boy was lethargic and very tired; The boy was lethargic and very tired; This spontaneous report has been received from a physician, through a field employee, concerning a male patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant medications were unknown.    On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not provided) as prophylaxis.   On the same date of vaccination (reported as "all the way through the day and the following day"), the patient was lethargic and very tired.   At the reporting time, the patient had recovered with no incidence from lethargy and tiredness, and it was reported that the employee had "nothing beyond that". It was unknown by the reporter if there was treatment given for the adverse events.   The causal assessment between the patient's lethargy, tiredness, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
PT REPORTED TODAY THAT AREA OF INJECTION SITE IS RED WITH A LUMP APPROXIMATELY 1" X 1" UNDER THE SKIN, AREA IS SLIGHTLY PAINFUL AND IS ITCHY JUST AT THE SITE. DENIES ANY RESPIRATORY SYMPTOMS. ALSO C/O SORENESS IN RIGHT ARMPIT NEAR AREA OF LYMPH NODES. NO OTHER SYMPTOMS. ADVISED HER TO CONTACT HER PRIMARY DOCTOR FOR INSTRUCTIONS, THEY ADVISED SHE GET EVALUATED TODAY AND IS CURRENTLY BEING SEEN.
Local Swelling and redness at site. Warm to touch and painful. approx size 15 cm
At the 4th shot (2nd booster) on April 14, 2022 I developed a rash at the site of the vaccine. One day later, it began to spread to the upper right arm and itched. I used over the counter Cortizone 10 for a week to help with the itch. On Saturday, April 23, I visited the urgent care and was given triamcinolone acetonide ointment. Today, April 25 I visited the family medical facility and saw a Dr. to get a refill or something more to control the itch. He prescribed the same but in cream form that I will begin using tonight. He told me it will go away but it may take a couple of weeks. It might scab over and then flake off as it heals.
Redness (10 x 10 cm) swelling and pain at injection site which persisted for >4 days. Would liike to attach picture.
He had chicken pox right before MMR, Hib, DTP, TD, DT were given. He was sleepy, 1 put him down for nap. I heard the crib hitting wall, I ran in room, he was sweaty and very hot. I could not wake him up. I called neighbor over. We called clinic and they said use cold wash clothes to wake him and if I witness another seizure or fever doesn't go down take him to ER. He also had a knot the size of gold ball at injection site for about a month after. He regressed. Stopped walking and talking and began repetitive movements and noises. I found out that even though it is mandatory to report any adverse reaction the doctor or the clinic never did. I am so upset about this. I am included shot record and pediatric clinic's record.  10/30/06 Received medical records from PCP office. Birth Hx: Term NSVD, 6 lbs 7.5 oz.  Mom w/toxemia during preg so was induced. PMH: extreme hyperactivity & speech difficulty.  Food allergies (significant for milk & corn)  Frequent OM w/tubes 5/96. Constipation.  Current dx: ADHD w/developmental delay & possible autism.  Family hx:  Mom recently dx w/ ADD.  Patients sister with ADHD. In 1998, began receiving IVIG 1x/mo which continued thru last office notes of 6/02 for autism symptoms & allergies which was helping somewhat.  Physical growth was WNL.  Delayed development in several areas: fine motor, language, & gross motor components./ss. 60 day Follow-up Information 04-OCT-2006: Hypogammaglobulinemia; Seizure disorder; heavy metal toxicity; wheat/dairy severe allergy; severe allergies/food & environmental; Learning disabled; many Gastrointestinal pblms; Enzymes w/oall major meals; Severe constipation; Inflamation; Colitis; Leaky gut; Many sensory problems; Language and socially delay. My child is now autistic. He had language, eye contact he was social and was walking. He regressed after his seizure just hours after his shots and lost all of these things.
Information has been received from a consumer father concerning a 20 year old female (his daughter) who was vaccinated with one of two vaccinations of MMR II (dose, route and lot number not reported). The father reported the patient had a recent titer was "low" and the patient was revaccinated with a dose of MMR II on approximately 23-JUN-2009 (dose, route and lot number not reported). It was reported the patient did not received other vaccinations at the same time. The father stated her daughter developed an itchy rash on her body and face a week later of vaccination (on 30-JUN-2009). The rash on her face was like a mask. The patient saw her doctor and was prescribed an unknown cream and oral medication. The rash was not getting worse at this time. The outcome of the patient was not recovered. The patient sought medical attention by visiting her dermatologist. Additional information has been requested.
Left eye swollen shut, right eye slightly swollen within 15 minutes after vaccines administered. No respiratory symptoms. BENADRYL given.
Small welt between breast /hives across pelvis area/ Hives and  back red spots on back /    Dr advised take 25 mg Benadryl  immediately as long as breathing was ok...In 4hrs take an additional benadryl 25mg   All hives went away approximately bedtime at 1030 pm..................2 days later some hives appeared took 1  benadryl 25mg   (   NO other symtoms in the 30 min wait at the premises where shot was given )
Missed 5th dose of DTaP vaccine at 4 y/o; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTap vaccine  (received 4 doses of DTaP on an unknown date (unknown manufacturer/brand)).   On an unknown date, the patient did not receive the 5th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-Oct2022 Reporter's comment: The patient never receive the 5th dose at 4 years of age. No additional information was available regarding brand/manufacturer of previous DTaP doses. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 5th dose of DTaP, which led to incomplete course of vaccination.
Assessment and Plan Patient is a 79 y.o. male patient of CNP with history of T2DM, HTN, h/o stroke, presented with multiple falls most likely related to COVID infection.  Pt presented to the ED on 8/1322 and was discharged on 8/25/2022   Generalized weakness w multiple mechanical falls COVID-19 infection.   Presented w URI and symptoms, weakness and multiple falls started on 8/10/22 COVID: positive, no hypoxia, need for treatment, out of isolation Generalized weakness possibly due to COVID-19 infection.   PT/OT recommending up to 5 days/week, daughter wants patient to go to SNF SNF will accept pt on 8/24, transport set  Primary HTN CKD stage III B SBP is on lower side 130-97, will hold losartan/hydrochlorothiazide, give 1L bolus SBP continues to stable 120's, will cont to hold lasix, losartan/hydrochlorothiazide for now   DM2 w hyperglycmia  A1c 8.6, restart oral medications   History of CVA.   No residual weakness, stable, continue aspirin, statin.
Headache, nausea and " a lot of myalgias" stayed home from work times 1 day improved that day.
one patient was administered a 6-month expired YF VAX with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves patient with unknown demographics who was administered a 6-month expired yellow fever vaccine [YF-VAX] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Yellow Fever Vaccine solution for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On an unknown date the patient developed a non-serious one patient was administered a 6-month expired yf vax with no reported adverse event (expired product administered) on the same day following the administration of Yellow Fever Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event one patient was administered a 6-month expired yf vax with no reported adverse event.  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 the 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.
10:30AM Arm pain and body aches, 2:00 PM Body aches and bad headache, 6:00PM Body aches, throbbing headache, sharp pains shooting up left side of neck, chest pains on right side.  Symptoms lasted until layed down to go to bed approximately 9:00PM; was too weak to nurse her baby.  After 9:00PM chills set in and ran fever of 99.9.  Took some type of flu medication at this time. 10:00PM fever 100.4.  10-12-11 at 12 midnight got extremely hot fever was 100.6, started sweating but fever did not go down.  2:00am fever still 100.6, 5:30am fever at 100.8, couldn't hardly move; call in to worked will not be in. 6:00AM fever broke.  Achy all day fever back 99.9 at 2:00PM.  4:00PM fever finally gone felt better.  Returned to work 10/13/11 still a little weak but feeling much better.
Rapid development of blisters on both legs from toes to groin.  Severe pain.  Admitted to the hospital by 08/27/2011.
Tennis ball- sized painful lump underarm.; Tennis ball- sized painful lump underarm.; Stiff neck; Pain in shoulders; Pain in upper back; Insomnia; Sore arm at injection area; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ELV0171) via an unspecified route of administration in the left arm on 23Apr2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cyproterone acetate / ethinylestradiol (DIANE) for birth control, fluoxetine (MANUFACTURER UNKNOWN), bromazepam (MANUFACTURER UNKNOWN) and methocarbamol (ROBAXIN); for an unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the right arm on 26Mar2021 at 11:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 22:00, the patient experienced sore arm at injection area. On 24Apr2021 at 22:00, 24 hours after the vaccination, the patient experienced tennis ball- sized painful lump underarm. Then on 23Apr2021 at 22:00, the patient experienced stiff neck, pain in shoulders and upper back, and insomnia the following 3 days. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ice packs, ibuprofen (MANUFACTURER UNKNOWN) and ketorolac (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm at injection area, tennis ball- sized painful lump underarm, stiff neck, pain in shoulders and upper back and insomnia was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a female with a history of chickenpox who in December 2007, was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse reactions reported. Additional information has been requested.
mom states pt had been fussy all evening;p/bath mom laid pt down & said noticed seemed limp;stated went back to check pt few mins later & was pale & seemed like wasn't breathing;mom shook pt & woke her up; seemed hyper;had not temp;to MD
Painful, swollen, itchy eye; mild facial swelling, tight chest, lethargy and fatigue; mild nausea. Eye pain and swelling 2-3 hours after vaccine.
Swollen red hard painful lump that itches. Chills and extreme body aches.
Patient believes that she started Gardasil 9 series but did not complete it; No other adverse event reported; This spontaneous report was received from a pharmacist referring to a 32-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The pharmacist reported that the patient believes that she started hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series but did not complete it (inappropriate schedule of product administration ).
Janssen COVID-19 Vaccine EUA Injection site pain; muscle stiffness; joint pain in shoulders, elbows, knuckles, hips, knees; severe headache; nasua; fatigue; low grade fever
Erythema, Cellulitis of LUA- Keflex 500mg ordered
patient reports to pharmacy that post Shingrix vaccine, he experienced a hyperanesthesia at the bottom of his skull, unilaterally on the same side as the vaccine injection. He felt it was reportable, as it is not listed in the package insert.
Local redness to injection site on right upper arm, measuring 9 1/2 cm x 12 cm.
vaccine was administered after the expiration date of 4/28/21.  pt reports no adverse events.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 07-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
pt recv vax 14JUL98 & 23JUL98 pt devel elevated BP 145/100, diff breathing, extreme fatigue, dizziness, tingling lt arm & foot, palpitations, loss of coordination, insomnia & the inability to walk;seen in ER;dx peripheral neuropathy;
Severe headache that lasted 12 days.  Tachycardia that lasted 8 days. Resting heart rate would jump  from 70 to 115 while sitting and would feel pounding heart and that I couldn?t catch my breath.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 14:00 as dose 1, single (Lot number: FJ4989), in right arm and on 12Sep2022 at 14:00 as dose 2, single (Lot number: NCD #59267-0304-02) at the age of 75 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Mild kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment".  Clinical course: COVID 19 was treated with Paxlovid. Paxlovid treatment start date: 03Mar2023 and stop date: 07Mar2023. It was reported that there was no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118739 Same patient, different product/event;US-PFIZER INC-202300118838 Same patient, different dose/ event;
Several hours later I felt like my heart was pounding way too hard and fast.  I felt very out of breath and dizzy.  My voice gets hoarse and I feel weak and sick.  I did not have these problems before the shot and do not have a family history.  I specifically asked for and wrote down a request for the 'fresh' shot without the preservatives as discussed with my doctor, but the nurse gave me the wrong shot by mistake.
Head to toe maculopapular rash appeared on day 6 after first dose of moderna vaccine. No other symptoms. seen in clinic only.
One day post vax, the pt developed paresthesia. Four to five months later, he developed joint symptoms. Twelve to thirteen months later, he developed dysequilibrium and a numb sensation. Fourteen to fifteen months later, he developed eye blurring and sleep disturbance. Pt had continued symptoms at evaluation on 7/16/01. Pt recvd first Anthrax vax on 1/5/00, manufacturer Bioport, lot # FAV024, administered in left arm.
Extreme body pain, fever, nausea, headache all began the morning after my shot.  I also had terrible injection site soreness; it was a large welt that was hot as well.  None of my symptoms were alleviated with any medications.   These extreme reactions lasted for 30-ish hours.  When I woke up after the next day I only had a mild headache.
After vaccine injection my fatigue began about and hour later then progressed as the day went on. It was difficult to keep awake. My arm at injection site was swollen and tender to the touch, no redness.  Day after injection began very fatigued and very achy and progressed throughout the day.  Took 900mg ibuprofen over the course of the day to manage aches. Spent the whole day in bed or laying on the couch with no energy, no drive and no real appetite. The aches get less as the days go by.  I have been managing by resting often through out the day.
Chills x 6 hours. Sore arm at site of IM (L) arm.