chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow Up Appended (Second reporter Information)
Patient was administered the pediatric dose (0.2 mL) of Pfizer COVID vaccine but he is 12 years old and should have received the adult 12+ (0.3) dose.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 14-OCT-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sore arm; Chills; Nausea; Low grade fever; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old female (non-pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration on the left arm on 19Mar2021 at 12:00 (at the age of 51 years), as a single dose for COVID-19 immunisation. Patient medical history included COVID-19. Patient concomitant medication included vitamin D (MANUFACTURER UNKNOWN) and armour/thyroid (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The Patient did not have any allergies to medications, food, or other products. No known allergies ware reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccintion. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient experienced sore arm, chills, nausea, low grade fever and headache on on Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of sore arm, chills, nausea, low grade fever and headache was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information.
Swelling from elbow to top of shoulder with warmth and low grade fever high of 100F. Patient states that it lasted 36 hours and swelling has since dissipated. Patient also complains on her arm being sore.
NO ADVERSE EVENT OF SYMPTOMS & SIGNS IDENTIFIED. THE BOOSTER VACCINE (0.25ML) WAS ADMINISTERED BEFORE THE 6MO WAITING PERIOD OF THE 2ND DOSE OF THE COVID19 VACCINE.
Patient presented to office 7/13/06 with erythematous papulovesicular rash on torso, extremeties, and head; approximately 50 lesions. Diagnosed as Varicella and discussed typical symptomatic treatment with family.
26JAN93 & 4MAR93 pt recvd Hep B vax & on 10FEB93 recvd hive like reaction to vax; & on 8APR93 hive like reaction, fatigue, hive reaction over trunk, face, legs & arms; referred to pvt MD for treatment;
Patient had 2 doses of Pfizer COVID vaccine on 2/23/21, and 3/16/21 and patient was hospitalized with COVID on 12/12/21.
Sever muscle and body aches within the hour of getting it.. Burning at injection sight immediately and a very sore arm. All of which is still severe 2 days later.
11/9/06 10:32 First time flu vaccine observation, c/o dizzy; 10:45 c/o SOB SaO2 96%, HR 88; 10:55 c/o itchy & HA Benadryl 25mg po, acetominophen 325 mg po, Temp 99.0, SaO2 95%, HR 98, RR 24; 12:35 Released to school.
evening after first vaccine developed loud ear ringing left side and vertigo triggered by changes in head position and constant imbalance  the vertigo got better but was triggered again after second vaccination 3/5/2021
This spontaneous report was received from an unspecified source, concerning to an unknown number of female patients of unreported ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that vaccination with GARDASIL, was associated with a "very rare but serious condition of premature ovarian failure POF (premature menopause)". No further information was cited. The reporter considered the premature menopause to be possibly associated with GARDASIL. The premature menopause was considered by the reporter as serious. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002408: US-009507513-1705USA002407: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830.
Around 4 hours after the shot I had intense pain at the injection site and a migraine. Arm pain lasted 4 days. The migraine lasted the rest of the day of the injections but had a headache for the following 3 days. I am also now almost 2 weeks late for my period. Usually I am early and if I am late it is only by a day or two. No chance of being pregnant.
A few minutes after vaccines administered, client started to say that her "stomach hurts" when walking out to the lobby to head home. Client started to look pale and wanted to sit down. Assisted client onto chair out in lobby. Mom beside client at the time. Staff member from health department brought in wheelchair over for client. Client started to puke up a little bit of clear liquid. Mom states that client had breakfast and was nervous during shots. Wheeled client into immunization room with ice pack applied to back and forehead, water, and snacks. Client laid in bed for few minutes.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in 2014, the patient received a dose of ZOSTAVAX and on 08-JUN-2017, the patient received another dose of ZOSTAVAX reconstituted with sterile diluent (dose, route, lot numbers and expiration dates for both doses were not provided) for prophylaxis. There were no adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose in September 2018, for tolerance of 1st dose refer case US2019GSK023600.). In January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was one of the 6 cases reported by the same reporter.
I tested positive for COVID-19 on 11/26/22.  I had a sore throat, chills, fatigue, runny nose, and a low-grade fever.  I contacted my doctor and was prescribed 5 days' worth of Paxlovid. A week after testing positive, I ended up getting Shingles. I am still dealing with Shingles at this time.
p/vax pt exp jaundice;ER or MD visit was required;no tx was given;lab studies were negative for hep A, B, & C;outcome of pt is unk;
One swollen itchy eye after received immunization no other symptoms reported. Mother denies child having difficulty breathing, hoarseness, wheezing, hive, paleness, weakness, fast heartbeat, dizziness, redness at shot site or fever.
I started to feel congested in the head and throat. I also had a headache. The next day I had a lot of mucus develop as well. I spoke to my doctor and was prescribed an antibiotic.
No additional adverse events reported; patient received a partial dose of PEDVAX HIB and a repeat dose was administered; patient received a partial dose of PEDVAX HIB and a repeat dose was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 17-JUN-2021, a nurse had a malfunction with a non-Merck syringe, so the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T026067, expiration date 01-APR-2023; strength, dose and anatomical location were not reported) intramuscularly for prophylaxis which was not given in its entirety (incorrect dose administered by device). It could not confirm exact issue with syringe and reports it could have been user error. On the same day, the patient was vaccinated with a repeat dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (0.5 ml, lot# T026067, expiration date 01-APR-2023; strength and anatomical location were not reported) intramuscularly for prophylaxis (extra dose administered). Agent confirmed no product quality complaint with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). No further information provided. No additional adverse events reported (no adverse event).
pt recvd vax 15JUL94 & 15JUL94 exp stiff neck, 17JUL94 fever 102, pain in legs, & numbness; MD dx pt had a arthritic react to medication; pt still has back, shoulder & neck pain; also post immun arthralgia;
My arm was sore; My body started to get achy/ body aches; I continued to have abdominal pain all night; Back of neck pain; I projectile vomited four times; stooled myself following diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 27May2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis and abdominal pain. The patient was unknown about known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 18:30, a few hours after getting 1st vaccine, the patient experienced body started to get achy and the patient had abdominal pain that got worst. She projectile vomited four times and stooled herself following diarrhea. She was able to make it to the bathroom but it was a mess and she had to shower. Then she continued to have abdominal pain all night. She used ice packs on her stomach and back of neck to help with the pain. She had never experienced anything like this before. Also, before getting her vaccine she was hydrated, had no alcohol for a week, ate well, did not eat anything that she had not eaten before, was well rested, and even had a nice non stressful day before the injection. 16 hours later her arm was sore and body aches. She was hoping to have no more symptoms and she was very hesitant to get the second shot. She was never diagnosed with COVID but if she did have it her body did not make her sick and the shot did. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of body started to get achy/ body aches, abdominal pain, back of neck pain, vomited four times, diarrhea and sore were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
PCR Covid-19 positive 08/16/21 with onset 08/15/21
1/22/10 c/o head congestion/nasal congestion. 1/25/10 c/o facial swelling & rash; went to M.D. on Naval Base referred to Dermatologist on 1/20/10; rash resolved after treatment but eczema remain to face but c/o rash spreading from neck to chest pt remains under Dermatologist care.
The pt developed redness, swelling and soreness reaction. Went to ER on 12/30/01.
Information has been received from a health professional for the pregnancy registry for VARIVAX (Merck) concerning male baby whose mother on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the mother was 10 weeks pregnant. It was reported that on 10-MAY-2011, the mother started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth to the baby boy via C-section with a birth weight of 8 pound and 1 ounce. The baby had neonatal jaundice. The total bilirubin was 12.2 mg/dl on 27-NOV-2011 and 7.3 on 06-DEC-2011. On 06-DEC-2011, review of neurological revealed swelling of the scalp. Physical exam revealed 2 cephalohematoma on each parietal region. CARDIOVASCULAR exam found systolic murmur on left sternal border. The assessment of the routine infant health check revealed neonatal jaundice, contusion of scalp and cardiac murmur. On 23-DEC-2011, the baby was seen in audiology for an evaluation at the request of a doctor. The baby failed his initial newborn hearing screening on his right ear. The baby's father did indicate he did seem to respond well to sounds and they had no significant family history of hearing loss. Audiological findings reveal normal distortion product otacoustic emissions at 2000 through 8000 Hz bilaterally. This was a good indicator normal outer hair-cell cochlear function, which was a good indicator of normal peripheral hearing mechanism. A diagnosis of abnormal auditory perception was made. The patient would see the doctor for any medical needs and had now passed his newborn hearing screening bilaterally. On 28-DEC-2011 a congenital transthoracic echocardiogram revealed normal echocardiogram. There was physiologic acceleration of flow in the branch pulmonary arteries with no evidence of narrowing. There was a left to right shunt through a patent foramen ovale. Thymic tissue was prominent. At the time of the report, the outcome of the events was unknown. The mother's experience has been captured in MARRS# 1104USA01360. Follow up information has been received from the health care worker refers to the approximately 35 days old infant. The health worker stated the patient's mother vaccinated with the first dose VARIVAX (Merck) (lot #668455/1310Z) subcutaneous on 06-APR-2011 morning in the patient's right arm. Other suspect was the patient's mother vaccinated with the first dose of MMR II (lot #669017/1250Z) on 06-APR-2011 morning in the patient's left arm and the first dose of DECAVAC (lot#U3815CA, reported as TD) intramuscular in right deltoid. Additional information is not expected.
The same day post vax, this pt became nauseated and lightheaded. No syncope. The pt also experienced myalgia of bilateral lower extremities, cephalgia, and visual disturbances - blurred, unable to focus. It is reported that she recovered.
9/21/2015- left eye was slightly crossed. 9/22/2015 left eye straightened out, right eye started crossing. 9/23 - right eye completely crossed. 9/24 - loss of some movement in right eye, he couldnt turn his eye well. 9/25 - vision impairment in right eye, loss of most movement in right eye.
This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Case number PHHY2011US64492 is an initial spontaneous report received from a health care professional (medical assistant) on 15 Jul 2011: This report refers to a 18 year old male patient. He was vaccinated with MENVEO (batch number: A10053) intramuscularly on 13 Jul 2011. But, the patient received only Men CYW-135 liquid conjugate without reconstituting it with Men A lyophilized powder conjugate. No adverse event was reported following this drug administration error.
Sore arm for 48 hours, and mild chills and slight fever for 24 hours
Caregiver reported patient felt hot and started shaking.  The child shook for about 1 minute and resolved when the mother called the baby's name.   Then the baby started crying.  Dx febrile seizure, first episode.  Referred to pediatric neurology
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 01-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. 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: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002850: US-009507513-2104USA002851:
Stopped having menstrual cycles.  Hot flashes x few weeks.  Now has fragmented sleep, mood lability, weight gain (8 pounds in 1 month).  Labs suggest mesopause.
had been sick with allergies; with allergies; fluid on the eardrum; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient had been sick with allergies, and there were fluid on the eardrum. The physician prescribed antibiotics and steroid shots. At the time of report, she started taking 2 pills on 23Mar2021 (last night) and 2 on 24Mar2021 (this morning), continuously up to 7 days as per advised and a shot of Steroid 23Mar2021, afternoon. Her second dose of the vaccine was scheduled on 23Mar2021, where she wanted to reschedule it on 01Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Monday - Evening of the vaccine, developed headaches, then was up all night with chills, fever, very sore arm, stomach issues. Slept all day on Tuesday (at least 12 hours - my husband checked to see if I was breathing at one point). Chills and fever gone by Tuesday evening. Headaches continued until Thursday. It is now Friday and my arm is still sore and very hot. It became itchy during the night, so I lightly scratched it. A small amount of oozing occurred. I am getting better daily. My main concern is that my first two vaccines were Moderna, and the booster was Pfizer. I was allowed to register for the booster online, even though I checked off "Moderna" as my initial vaccines. To further verify that it was okay, I told the nurse upon arrival that I had taken the Moderna vaccines, and she said it was fine to get the Pfizer, that it was approved by the CDC. Now every news segment is saying that the CDC says you should not mix vaccines, and that it will be two weeks before the Modern booster is out. My husband is waiting for that one.
large red square noted around the injection site on 1/14/21. Diagnosed with cellulitis on 1/15/21 and started on Keflex 500mg 3x/day x7days
BONES HURT; HEADACHE; This spontaneous report received from a patient concerned a 23 year old female. 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 not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bones hurt. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and bones hurt was not reported. This report was non-serious. This case, from the same reporter is linked.
suspect pregnancy at time of vaccine d/t cycle not starting as it was due to start weekend prior to vaccine.  Vaccine on 2/21/2022 - Positive Pregnant test on 2/22/2022 and bleeding also started that day.  after HCG labs were done, again determined to have a non-viable pregnancy.