chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered a dose of the Moderna Covid-19 Vaccine to a patient in the 6 months to 5 years range from a vial that was initially punctured more than 12 hours prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Covid-19 Vaccine to a patient in the 6 months to 5 years range from a vial that was initially punctured more than 12 hours prior) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 8:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022 at 8:00 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Covid-19 Vaccine to a patient in the 6 months to 5 years range from a vial that was initially punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Covid-19 Vaccine to a patient in the 6 months to 5 years range from a vial that was initially punctured more than 12 hours prior) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient belongs to age group of 6 months to 5 years. No concomitant medications were reported. On 22 Jun 2022 the vial was initially stored in the refrigerator, on 22 Jun 2022 at 05:00 PM vial was initially punctured and refrigerated, vial did not undergo any temperature excursion, total amount of time the vial was exposed to room temperature range (8 degrees to 25 degrees C equal to 46 degrees  to 77 degrees F) was unknown, but only a couple of doses had been removed previously & room temperature exposure was minimal and the vial did not exposed to room temperature for greater than 24 hours. No treatment medications were reported.
Tingling under arm and breast; Discomfort under breast; It hurts; Discomfort under arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling under arm and breast), BREAST DISCOMFORT (Discomfort under breast), PAIN (It hurts) and DISCOMFORT (Discomfort under arm) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling under arm and breast), BREAST DISCOMFORT (Discomfort under breast), PAIN (It hurts) and DISCOMFORT (Discomfort under arm). At the time of the report, PARAESTHESIA (Tingling under arm and breast), BREAST DISCOMFORT (Discomfort under breast), PAIN (It hurts) and DISCOMFORT (Discomfort under arm) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Information has been received from a nurse practitioner concerning a 24 year old female who on 10-JUL-2008 was vaccinated with the second dose of GARDASIL (lot# not reported).  Concomitant therapy included LEXAPRO and ampicillin.  The patient experienced cellulitis at the injection site.  The patient had a sore arm for about 5 days.  The patient recovered from cellulitis at the injection site.  The patient sought medical attention.  Additional information has been requested.
Developed severe sinus infection with yellow mucus, runny nose, and sinus congestion within 2 days after receiving the vaccine. Symptoms lasted 2-3 days and resolved without medication.
Extreme itchiness through out the evening of the first day of shot. Nausea and fatigue for two days after event.
expired dose of Fluzone Quadrivalent was administered with no reported adverse event; a pregnant patient received an expired dose of Fluzone Quadrivalent with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a consumer or other nonprofessional via Global Media information (under the reference 00852655).  This case involves a 25-year-old female patient receiving expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and a pregnant patient received an expired dose of fluzone quadrivalent (maternal exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  At unknown gestation period and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 27-Aug-2021.  The estimated due date was not reported.  The actual date of delivery was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [Once, lot UT700CA, expiry date: 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  This case is medication error due to expired vaccine used (latency same day).  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received FLUZONE QUADRIVALENT.  Additionally, at time of reporting, the outcome of the pregnancy is 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 by the regulatory authority. 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.
Kawasaki disease with probable coronary aneurysms.  9/10/2007 MR received for DOS 5/29-6/02/2007 for admission for DX of Kawasaki's Disease.  Seen in ER at another facility for fever and discharged.  Infant continued with fevers and developed red, cracked lips, red conjunctiva, and a diffuse macular rash. Emesis and diarrhea also present, now resolved.  PE significant for tachycardia, (+) murmur, and erythematous macular rash.  Txd with IVIG, ASA, and propranalol. D/C PE WNL except 1/6 systolic ejection murmur.  9/11/2007 Reviewed ER medical records of 5/21/07 which reveal patient experienced fever, nasal congestion, runny nose.  Patient's 3 siblings have vupper respiratory viral syndromes.  Tx w/IM antibiotics x 1.  Released to home. FINAL DX: Fever. 5/12/10 Follow up: unknown-coronary arter aneurysms have resolved, but longterm effects of this unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Runny nose, Diarrhea, Headache. I contacted my Doctor and was prescribed with Paxlovid for 5 days. I took it for 3 days but my stomach got really upset and I went to the ER to have some tests and it was determined that I had Idiopathic Pulmonary Pancreatitis and was advised to go on a soft diet. As of today 07/06/2022 I feel completely fine and back to normal.
10 minutes after injections, PPD left forearm, flu vaccine left deltoid, #1 Hep A right deltoid, developed red cheeks with small hives, spread to forearms and upper arms. Left worse than right.
I got sweaty & nauseous. Then my body started to ache, I had the chills, & was drenched in sweat throughout the night.
Patient is a 78 y.o. male patient of DO with history of COPD, chronic hypoxemic respiratory failure, paroxysmal atrial fibrillation, HTN, cardiomyopathy, Essential tremors who presented on 1/18/2023 with a fall. Consulted by MD for medical management.      Covid-19 Virus Infection Date of onset of symptoms: 1/20 Symptoms present on admission: s/p fall, cough and fever Date of covid positive test: 1/20 Vaccination status: vaccinated Imaging: Chest Xray  Oxygen requirements on admission: 3L NC  Current oxygen requirements: 3L NC  Medical therapy: Remdesivir and Solu-Medrol Consultants following: ID Anticipated special isolation end date: 1/30      Acute on chronic hypoxemic respiratory failure Acute COPD exacerbation - end stage COPD Pulmonary Hypertension Wears 3L per NC at HS only Goal SpO2 >88% - 92% - Avoid hyper-oxygenation.  Give Duoneb treatments x2 now Check ABG Increase frequency of scheduled bronchodilators to q4h/2h PRN Change Symbicort to Pulmicort BID while in acute exacerbation Add IV steroids (uses chronic prednisone therapy) Add Singulair, Mucinex BID.  Was on  Azithromycin IV daily Continue Spiriva Cautious use of benzodiazepines in acute exacerbation.  NIPPV PRN Treatment of COVID as above Discontinue IV ceftriaxone azithromycin   Fall Thoracic/Lumbar Compression Fracture Left orbital hematoma/abrasion Management per trauma services and neurosurgery. PT/OT.   Urinary Retention UTI with E. coli History of chronic self catheterizations. Urology consulted. Antibiotic discontinued by infectious disease team Cardiomyopathy Chronic diastolic heart failure History of EF 10-15% with recovery Last TTE 7/2021: Normal LV size and systolic function. LVEF 60%; RV dilation with reduced RV function; pulmonary hypertension.  Monitor fluid balances closely.  Strict I/O   Paroxysmal atrial fibrillation Not on AC due to bleeding issues  Continue amiodarone and digoxin
Outbreak of shingles, the same day she got vaccine.  She was treated at Urgent care center with Valtrex and improved.
sore left arm after first dose; drowsiness after first dose; dizziness after first dose; headaches for four days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after first dose), SOMNOLENCE (drowsiness after first dose), DIZZINESS (dizziness after first dose) and HEADACHE (headaches for four days after first dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, OMEPRAZOLE, GABAPENTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, VIT D [VITAMIN D NOS] and ASCORBIC ACID (VIT C) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm after first dose), SOMNOLENCE (drowsiness after first dose), DIZZINESS (dizziness after first dose) and HEADACHE (headaches for four days after first dose). On 06-Mar-2021, HEADACHE (headaches for four days after first dose) had resolved. On 06-Apr-2021, PAIN IN EXTREMITY (sore left arm after first dose), SOMNOLENCE (drowsiness after first dose) and DIZZINESS (dizziness after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information  was provided by the reporter.   This case was linked to MOD-2021-089507 (Patient Link).
Tues. night 8/28/07 c/o headache. Child woke up 8/29/07 at 6am with headache, fever 100.9 and dizziness. Advil given x 2 during the day. Child missed 1 day of school. Mom stated fine on 8/30/07. Mom called physician when symptoms occurred.
localized cellulitis at site. site marked, Benadryl dose amount provided to mom oral steroid x 1 day, topical antibiotic
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-JAN-2015 the patient was administered an improperly stored dose of VARIVAX (Merck) (lot#, expiry date, dose, route unspecified). No adverse events were reported. No PQC involved. Additional information has been requested.
DIED; This spontaneous report received from a consumer via a company representative via media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported and expiry: unknown) 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. 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 from an unknown cause of death. It was unspecified if an autopsy was performed or not. The reporter stated that, "Unfortunately, my cousin took your Covid vaccine and died right after". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220520946-covid-19 vaccine ad26.cov2.s - died. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt started with vomiting on 9/5/13.  Had decrease wet diapers and lethargy on 9/6/13.  Pt then was taken to ER for evaluation.  Pt was transferred to hospital for intussusception.  Pt had barium enema x 2 without success.  Pt then underwent laparoscopic eval with spontaneous reduction and appendecomty.  Pt released from hospital on 9/8/13.
Pt vaccinated with Pneumococcal/FLU noted heat at injection site- rt arm extending to elbow w/fluid accumulation at elbow, making elbow "sagy" looking. No other symptoms, pain, or irritation.
Initial redness, warmth, and tight at injection site that resolved after a few days, but since then having progressive inability to use that arm - unable to flex/extend shoulder or elbow, biceps & triceps very tight, possible dystonia.
This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 02-JUN-2016, unspecified dose of improperly stored PROQUAD (lot # L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
redness at injection site,sore and swelling on same day of injection still red. 7 days after injection developed hives all over  body. the rash moved all over body including hand feet and scap. I am now taking now taking prednisone.I  have marks all over that have not yet gone away I hope by the time  I finish course of predisone they will go away . I have 4 days left on these pills
Severe chills 3/30 @ 10pm - 3/31 @ 12am resolved on own  Fatigue 3/30 @ 9pm - 3/31 @ 11pm resolved on own Body aches 3/31 @ 7am - 11pm resolved on own
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: El3302), in left arm, on 02Feb2021 as dose 2, single (Lot number: 6200), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: 7485) at the age of 78 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: MOBIC; ACTONEL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: It was reported that the patient had no known allergies.
N/V? 48 hours Loss of appetite?48hours Chills?-2 hours Fatigue?-72 hours Headache?48 hours Brain fog/forgetfulness?1 week Sweating - 4 hours Metallic taste - 48 hours Severe body aches - 24 hours Reflux - 24 hours Burning/hurting/sensitive skin- 12 hours
PATIENT FAINTED A COUPLE OF MINUTES  AFTER THE SHOT AND WAS BACK TO HER CONSICOUESNESS AFTER 2-3 SECONDS.
broke out in hives; I started feeling really bad ;not feeling well; she was sick; brain fog/like foggy head; headache; sore throat; completely without energy; little bit of sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via unspecified route of administration on 06Mar2021 (at the age of 88-year-old) in dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications not reported. Patient queried for and like to know if it was possible to experience side effects 2 weeks after receiving the vaccine. Reporter stated that her symptoms did not start until last Friday in the afternoon. She reports that for 2-3 days on 19Mar2021 she was sick and experienced brain fog, headache, sore throat, and was completely without energy. She reports that these symptoms got better but then completely broke out in hives on 22Mar2021. She states that she was covered in hives. She reports that she has not done anything different in her life since receiving the vaccine, which was why she was attributing these side effects to the vaccine. She said she already spoke with her doctor who was recommending she wait on receiving the second dose, which was due 27Mar2021. Reporter would like to know how long she can wait before receiving her second dose of the vaccine. Patient went on 06Mar2021, got her first vaccine and she was fine except the little bit of sore arm and it was okay about till the last Friday. Friday on 19Mar2021 she started feeling really bad, like foggy head, sore throat, headache and just basically not feeling well and then that subsided. On Wednesday that was subsided. Monday morning on 22Mar2021 and then she dropped out into bunch of hives so now she was dealing with hives. So she had an appointment with her doctor and she was just wondering that if she should take her second shot because she will due to take it on 27th which was this coming Saturday. She was a kind of leery right now because she so full of hives. It was like crazy. Anyway she just thought she report these side effects. Reporter queried for was it possible to get a reaction 2 weeks later. Almost It was, almost 2 weeks before she got the reaction. she need to know if she need if she can take If that safe to take second vaccine, the second dose. Reporter stated that she was surprise after for almost 2 weeks that she would reaction. Outcome of event little bit of sore arm was unknown and broke out in hives was not recovered and recovered for all events on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nausea until 11/5/09 in AM. Rash on trunk and back that looks like little red dots with minor itching, no pattern.
It started out with a headache and then a cough. After a couple days of a headache, that's when I developed the cough. After the cough, I tested for COVID-19 and it came back positive. That day, I started a five day course of molnupiravir and by the next day, I was feeling better. It took maybe 3-4 days before the cough completely went away. I tested negative a week later.
06/26/03- Patient's boyfriend received primary smallpox and anthrax #1 vaccines- he did not cover his vaccinated site with a dressing- patient had a prolonged contact with the boyfriend during this time. 06/25/03- Patient noticed a "blister" on gum line under her left upper lip- patient's mother reported this event to the DoD Hotline. 07/03/03- 07/04/03- "Fever= 99.6" (max) 07/05/03- Went to ER- by the time of the visit, her fever had dissipated and her "blister" got "popped accidentally."- was examined and was told that her "ulcer" was benign. 07/09/03- Patient noticed a cluster of "five blisters" on her right shoulder- lesions were itchy but did not scratch- went to ER again for evaluation- seen by the hospital's "infectious disease team" and was told that those lesions could "possibly be smallpox vaccine related."- no instruction to cover the site was given and patient received no meds or treatments for those lesions. 07/16/03- Patient's "ulcer" in the mouth has now completely healed- "five blisters" on her right shoulder "almost gone."- patient has no complaints at this time.  Attachment: SUMMARY
Pain / Aches; Shivering; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering, fever and fatigue. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the shivering, fever and fatigue were unknown.   It was unknown if the reporter considered the pain, shivering, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms the day he received the injection. The reporter refused to answer any additional questions. The reporter denied permission to follow up. In the XML document outcome of event pain was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system. Also in XML document age group was mentioned as infant, but as per Shingrix indication age group was captured as adult.
The patient became lightheaded and dizzy soon after the injection was administered. The patient was instructed to lay back on the exam table and a cold towel was placed on her head. The patient then had jerking movements. She was also confused. A code blue was called; three physicians and other nursing staff responded. An ammonia capsule was wafted to the patient's nares. She was still confused an pale for about one more minute, but then she became alert and oriented to name and location. Her blood pressure was checked every five minutes - 52/40 and 80/50. The patient was taken to the ER where she was monitored for about two hours. The patient did vomit; Zofran ODT was administered. Oral fluids were provided. EKG revealed normal sinus rhythm. Blood pressure returned to baseline. The patient was stable during her ED stay; she was discharged with instructions to warn her nurse when receiving future shots.