chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Developed cellulitis 24 hr after the shot with expanding erythema at 48 hr. He was treated for cellulitis with cephalexin 750 mg bid x 10d. Tx started today 7-2-10.
Unsteady gait, weakness, rigidity, tremors, mild cog wheeling, mask like facies.
Had a Shingrix vaccine, 50mcg via arm injection and a Fluzone Hd Pf 2021-2022, via arm injection near simultaneously.   Today (next day) feel very run down, slightly nausious, achy.
feel like crud; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles vaccine which made him/her feel like crud for about 2 days. For tolerance of 1st dose refer case US2021AMR198037.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198037:same reporter
HEART FAILURE; This spontaneous report received from a consumer via social media concerned multiple patients of unspecified sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (vaccine dose series was 1) (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two patients died from heart failure. It was unknown an autopsy was performed. 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 20211210328 and 20211205693.; Sender's Comments: V0: 20211210341- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Heart failure (Fatal outcome). This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART FAILURE
48h after MMRV & DTaP developed swollen deltoid, red & warmth 15 x 12 cm.
No additional AE reported; improperly stored vaccine was administered; This spontaneous report was received from an office manager referring to a 5-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 28-APR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T042013, expiration date: 22-JUL-2023 (strength, dose and route of administration were not provided) for prophylaxis (product storage error). No additional adverse event (AE) reported.  The administered dose of the vaccine experienced a temperature excursion in 11.43 degrees Celsius (C) for 4 hours and 45 minutes. There was no previous temperature excursion.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA002848: US-009507513-2205USA002913: US-009507513-2205USA002951: US-009507513-2205USA002965: US-009507513-2205USA002988: US-009507513-2205USA003043: US-009507513-2205USA003118: US-009507513-2205USA003121: US-009507513-2205USA003266:
I am 30 years old and I had not had my period since I was 19. I got my 2nd dose and I got my period in July. I have now had a consistent period every month, whereas I did not have a period previously. I didn't ovulate, get discharge, or have a cycle. Now I do.  I wanted to report because I didnt think anything of it, until I saw the news article that said top universities were looking into women getting back their period, having general changes with flow, etc. It made me think it could have possibly been the vaccine that caused it, and I wanted to help science.
The symptom I am reporting is numbness on the top of my right foot-from my outer ankle bone, spreading  across and down the top of my foot to the tops of all my toes.  It covers the entire top of my foot from my ankle down.  Onset was about 52 hours after vaccination and is still occurring now (24 hours from onset).    Note:  I had Covid at the end of October.  Also both Covid vaccinations gave me chills, fever, severe body aches, fatigue, and headache.  Not allowing me to work the next day.  Onset 8 hours after both vaccinations and resolving about 36 hours later.
Information has been received from a physician's assistant concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil (yeast) (lot # not reported) IM injection. Concomitant therapy was unspecified. The patient sought unspecified medical attention. Subsequently, the patient experienced an extreme rash across her chest and up to her neck. At the time of reporting, the patient was "fine". Additional information has been requested.
sever IUGR; Tetralogy of fallot; trisomy 22; This spontaneous case was reported by a consumer and describes the occurrence of FOETAL GROWTH RESTRICTION (sever IUGR), FALLOT'S TETRALOGY (Tetralogy of fallot) and TRISOMY 22 (trisomy 22) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Allergy Pertussis Vaccine Historical Condition- DNC on 4- NOV-2020 Concomitant - Samrti Prenatals Start date : 5- FEB-2021 to  01-JUN-2021. Lab Test- Pregnancy Test On 05-FEB-2021 with Positive Result. Amniocentesis on 01-JUN-2021 For Trisomy 22.  The mother's past medical history included Maternal exposure during pregnancy since an unknown date.    No Medical History information was reported.    On 02-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 01-Jun-2021, the patient experienced TRISOMY 22 (trisomy 22) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced FOETAL GROWTH RESTRICTION (sever IUGR) (seriousness criterion medically significant) and FALLOT'S TETRALOGY (Tetralogy of fallot) (seriousness criteria medically significant and congenital anomaly). At the time of the report, FOETAL GROWTH RESTRICTION (sever IUGR), FALLOT'S TETRALOGY (Tetralogy of fallot) and TRISOMY 22 (trisomy 22) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       No Concomitant Medication Reported   No Treatment Medication Reported.  This is a spontaneous case concerning a female fetus with mother´s medical history of exposure during pregnancy, who experienced the serious (congenital and medically significant)  unexpected events Fallot´s tetralogy and Trisomy 22. Mother´s subject  received the first dose of vaccine at 4 weeks of gestation. Pregnancy outcome was elective termination at 24 weeks of gestation (reason for termination: Trisomy 22). The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-042859 (Parent-Child Link).   See case MOD-2021-042859 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: This is a spontaneous case concerning a female fetus with mother´s medical history of exposure during pregnancy, who experienced the serious (congenital and medically significant)  unexpected events Fallot´s tetralogy and Trisomy 22 . Mother´s subject  received the first dose of vaccine at 4 weeks of gestation. Pregnancy outcome was elective termination at 24 weeks of gestation (reason for termination: Trisomy 22). The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
High fever, gradually increased to as high as 102.6 F Severe body aches, muscle pain, joint pain, headache Nausea, fatigue, stomachache
1) Patient received an expired Hep A vaccine. Expired 6/17/23. Hep A was administered 7/6/23.  2) RN intended to administer Hepatitis B shot. Patient received wrong medication. She received the Meningitis B shot.  Patient c/o sore arm.  Patient came back to the public health clinic 7/18/23 and received an up to date Hep A and Hep B vaccine at no charge.
I got really warm (no fever) and extremely tired for about an hour. My arm muscles were very sore around the injection site.
9/2/2022  - stated that on the first day he felt very tired after receiving the vaccine, on the second day he had a big red swollen knot on the area were he had received the MPX1. And now a week later 09/02/2022, he stated that he is experiencing on the same arm, the MPX1 was given their are a lot of pimples on his arm. And some on the other arm, and on his left upper thigh pimples/rashes that are also on his back area as well as on his biceps rashes. 9/3/2022 - 9/6/2022 had been unable to reach by clinician. Clinician was able to reach client 9/7/2022 - is being advised by his medical provider for the next steps and any care and treatment.
Patient woke up at 0700 on Sunday, 3 June 2018. Pt reported experiencing generalized muscle aches, fatigue, lightheadedness, dizziness, vision changes, and difficulty breathing. Pt did not take any medication for symptoms however, rested for the duration of the day. Symptoms persisted despite resting. Patient did not see a health care provider for the symptoms however, will see a health care provider as soon as possible since symptoms continue to affect him.
Treatment of COVID-19; Treatment of COVID-19; Dose 3 Pfizer vaccine and Dose 4 Moderna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Oct2022 as dose 4 (booster), single (Lot number: AS7162B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Oct2022, outcome "unknown", described as "Dose 3 Pfizer vaccine and Dose 4 Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Positive COVID antigen test two days after series of negative tests; (11Dec2022) Positive, notes: Positive COVID antigen test two days after series of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Initial and follow-up information has been received from a physician concerning an 18 year old female student with a penicillin allergy and no reported pertinent medical history, who on 07-AUG-2007 was vaccinated in the left arm with her first dose of Gardasil vaccine (LOT# 658100/0525U). There was no concomitant medication reported. There were no illnesses at the time of the vaccination. On 10-AUG-2007 in the evening, 72 hours after her Gardasil vaccination, the patient developed extensive urticaria (also reported as a hive-like rash) that lasted 24 hours. On 11-AUG-2007, the patient recovered. On 08-OCT-2007, the patient reported the rash at the follow-up appointment for the second HPV injection. No laboratory diagnostics were performed. No product quality complaint was involved. Additional information has been requested.
Exanthem over face, arms, chest, thighs, minimally on back and abdomen.
Patient called to schedule 2nd COVID vaccine appointment.  Patient was scheduled on 4/5 and given vaccine.  Later was discovered that patient's first dose was given on 3/31 from a vaccinator as part of the long-term care vaccine program.  Patient was in a LTC facility at time of 3/31 injection. Patient will be scheduled for correct timeframe of second dose at this facility for 28 days post 4/5 vaccine date.
Patient contacted the Vaccine Healthcare Centers Network to report possible vaccine adverse events. She was in her usual state of good health which included exercising 5x/week with running, circuit weight training and dance exercise classes. Her only chronic medication was SYNTHROID which she took for controlled hypothyroidism. On 6 Feb '13 patient received anthrax vaccine #1 and the typhoid vi vaccines. The anthrax injected arm became extremely sore and she used ice packs for 2 days to relieve pain. Within 1-3 days she developed flu-like symptoms and headache. She is unsure of how long the symptoms lasted but she had documented in text messages that on 9 and 10 Feb she was too ill to participate in family activities and 2 weeks later on 20 Feb she left work early due to a migraine. On 15 Mar '13 she received anthrax #2 and again developed an extremely sore arm- so severe she could not type or write for 3 days. She reports her arm "felt like it was broken". She again developed severe flu-like symptoms i.e. headache, chills and body aches and sought medical evaluation on 21 Mar for persisting symptoms. She missed work for several days during this period and took leave from 27-29 Mar '13 to continue her recovery. She never felt totally well again. She gradually developed episodes of dizziness, fatigue, new onset migraine headaches and exercise intolerance. In Apr and May she sought treatment several times for these symptoms and was found to have both orthostatic hypotension and orthostatic tachycardia and received IV fluid infusions multiple times. Her thyroid was evaluated and found to be normal. Echocardiogram was normal. On 29 May she was admitted to MC for observation due to her multiple clinic and ER visits for presyncope. A tilt test was performed and she was found to have POTS. INDERAL, FLORINEF and midodrine were prescribed. In June '13 she was referred to Cardiology and salt tablets were added. In August '13 she was referred to Neurology where she continues to be treated for an autonomic nervous system disorder, which is characterized by both postural orthostatic tachycardia syndrome (neuropathic type) and neurally mediated hypotension. In Oct '13 she underwent additional autonomic testing at Neurology specialist. Results again confirmed postural orthostatic tachycardia syndrome. Her QSART testing was abnormal and was consistent with a postganglionic sympathetic sudomotor abnormality like that seen in small fiber neuropathy. Her current medications are INDERAL 20mg bid, midodrine 2.5 mg bid, salt supplements and SYNTHROID 88 mcg/day. Recently pyridostigmine 30mg bid was added. Patient also drinks 2-3 liters of fluids/day and uses liberal table salt. She attempts to report for work 40 hours/week but frequently requires sick days or needs to work from home. She is unable to exercise and continues to have headaches and episodes of lightheadedness and nausea upon standing. Her condition has progressed to include symptoms in multiple body systems which is consistent with dysautonomia.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13; (lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. No concomitant medications, medical history, or relevant testing or investigations to report. The pharmacist stated that the area around the injection was more red than normal, there was more of a bump, and the top layer of skin peeled off like a sunburn. The outcome of the events was unknown. Information regarding lot/batch number has been requested.
Fatigue,  102 temp, headache, swelling at the injection site, pain behind my eyes, skin painful to the touch. sore body aches, cold and hot chills, appetite suppressed, lower abdominal pain and cramps, diarrhea,     All events lasted 24 hours except: Headaches, skin pain, and body aches, and appetite suppression, which lasted another 24 hours. After 48 hours just appetite suppression.
PT. LOST CONSCIOUSNESS AFTER RECEIVING COVID -PFIZER VACCINE.  PT SEEMS HAD A SEIZURE FOR FEW SECONDS. AFTER A MINUTE OR TWO, PT. GAINED CONCIUSNESS AND ASKED, "WHAT HAPPENED?" PT. WAS ALERT AND LOOKED PALE. PT'S MOM DECLINE VITALS CHECK FROM RESCUE. MOM SAID THAT HER DAUGHTER IS OKAY AND DOES NOT NEED TO SEEN IN ER. RESCUE ACCOMPANIED THE PT. ON THEIR WAY OUT.
Information was received from a pharmacist who reported that two unknown patients (demographics not provided) were administered M-M-R II (albumin status unknown; lot number, dosage and route of administration not reported) that had been reconstituted with sterile diluent MRK on an unknown date that was improperly stored. No adverse effects reported. Temperature range/time frame reported as: > 32F but < 36F for 2 hours, and 1 cycle below 32F for 30 to 45 minutes. No further information provided. The is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006765.
Around 12:15 pm, 15 minutes after first vaccine, patient started having repeated itchiness. Gave Benadryl 25 mg around 12:30 with some improvements. At 1:10 gave another dose of Benadryl since itchiness was not fully resolved. She then developed a rash/hives under her left upper arm.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 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.
Covid vaccine in pre-drawn up bag. Nurse took one out and gave to patient, vial was empty but looked like it had the .02 ml needed for pediatric patient.
inadvertent administration of an expired product to a patient with no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 5-month-old female patient who had inadvertent administration of an expired product diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine 13V (Pneumococcal 13 Valent Vaccine) for Prophylactic vaccination; and rotavirus vaccine for Prophylactic vaccination.  On 19-Sep-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) (lot: UJ737AAA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for Immunization and inadvertent administration of an expired product to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel (VERO)) was not applicable.  Outcome: unknown.   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.
Right Upper arm redness, swelling, tenderness, warmth around flu vaccine injection site. Denies fevers or chills. Started the day after vaccine administration.
Dizziness Narrative: lightheaded; dizzy; felt like passing out within 15 of vaccine
The day after the booster I started having vertigo again and it has continued to this day. When I look up the room spins to some degree. It is much milder than after the first shot but I am still experiencing it and it is annoying. I want to add the word dizziness so the CDC will recognize this as a more common affect. I contacted my doctor and he offered to give me vertigo medication but I did not accept it. I also went to an ENT to check my inner ear and that doctor said everything looked normal.
A report has been received from a Health Professional concerning a male patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. HCP reported that patient took Nasal FLUMIST (intranasal), 0.2 milliliter, started last week in Mar-2016 on an unknown date. HCP reported patient experienced wheezing same day they got the dose in Mar-2016 on an unknown date. The outcome of wheezing was unknown. Company physician assessed the wheezing as non serious.
Rash, itching on face, neck, back with small papules oozing yellow fluid. Rash was elevated, red and scaly.  Rash has lasted 4 days and is still present despite treatment. Also fatigue., joint pain the day after the vaccination, lasting only 1 day
Breakthrough case admission after 2 vaccines  Moderna 1/5/21 LOt# 026L20A;  Moderna 2/1/21 Lot# 007M20A