chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 13-NOV-2016, the patients were vaccinated with improperly stored doses of M-M-R II lot # L043704, expiration date 04-NOV-2017 and lot# L032182, expiration date: 25-AUG-2017 for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014190: US-009507513-1612USA014191: US-009507513-1612USA003501:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 24-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K022992, expiration date 30-JUN-2016, orally, dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient due for first dose monovalent pfizer peds vaccine. Was give bivalent pfizer peds dose in error.
-vomiting; fevers; chills, fatigue starting 9 hours after vaccine administration -hives on arms; chest and bilateral legs 24 hours after vaccine administration -night sweats for 3 days
I had very minimal symptoms after my shot, within 48 hours my slight arm pain had gone away   About a week later in the early morning of 4/2/21 I woke up feeling very fatigued and feverish. My symptoms continue to be a low grade fever, fatigue, headache, and sore throat.
Patient's whole arm in pain. Shoulders to below elbow. She had to see MD and get pain medication and be put on sling.
presented some side effects that are listed, such as aches; Chills; a rash like patches here and there; the injection site is warm; the injection site is warm and sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose number unknown at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID-19 vaccine and presented with some side effects that are listed, such as aches, chills and a rash like patches here and there and the injection site is warm and sore. She would like to know if there is anything she could take before the second vaccine such as Benadryl to prevent side effects from happening. The clinical outcome of events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain, swelling, edema, rapid heartbeat, fever. A very large red welt from injection site to elbow. The vaccine was given on 9/2/2019 and today's date is 9/4/2019 and the site is still red and swollen. When I had my first vaccine over a year ago all I had was a sore arm.
Did not feel well, felt dizzy x 1-2 days after the 2nd Gardasil shot. Nauseous , abd pain, local pain at site.
shot was given IM instead of SQ.  patient has not reported any adverse events related to injection.  merck reports no need to repeat the dose.
Itchiness of the ear.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced itchiness of the ear. She asked if she could take Nasacort. She also mentioned that she took Omeprazole the day after the first dose. The outcome of event was unknown.  Information on the Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information was expected.
Information has been received from a Hair Dresser concerning an approximately 14 or 15 year old female customer who was "recently" vaccinated with GARDASIL. The Hair dresser reported that she tried to dye the patient's hair blond, she noticed the color bubbled and got hot and started turning blond very quickly and she had to wash it off immediately. At the time of the report the patient's outcome was unknown. Additional information is not expected.
By 7:30, I felt drunk. My brain was not functioning normally and had a fever all night. By 7:15 I felt fine, with the exception for random joint pain. The following Friday, April 9th, I had bloodwork done. It felt like I had hit my funny bone. I had shooting pain up my arm and into my neck and down my spine. I thought it was just the blood draw, so I suffered all weekend. My husband made me go to the doctor on Monday. My doctor said I had the same symptoms of a blood clot. They sent me to the hospital for an ultrasound and blood tests recommended, but everything was negative. She told me to just watch out for any changes and it went away after a few days.
Hives reported by aunt on face approx 2:00 pm this afternoon. Received DTAP this a.m.
I spoke with pt, who had her second Moderna COVID-19 vaccine on 05/04/21. She called 05/07/21 to inform me that on 05/06/21 she had developed a pinkish, red, swollen, sore grapefruit sized lunch surrounding the injection site. She called an on-call nurse who advised her to take APAP and use cool compresses. I recommended IBU for swelling ,pain, and inflammation (unless her MD does not want her taking IBU), cool compresses, and diphenhydramine. She said the swelling has subsided some and is down to a baseball sized lump (from grapefruit sized yesterday). I advised her to contact her MD or go to urgent care if this does not subside or if it worsens. Pt is and has been afebrile.
After my first dose (Jan 12, 2021) I had no reaction other than fatigue. After my second dose (2/5/2021) I had a headache, body aches, and an upset stomach. I also developed a large, red lump at the injection site, that has grown larger over the past 3 days and now almost covers my entire upper right arm.
EPISTAXIS/NOSEBLEED. A nurse reported that a male child received a dose of flumist influenza virus vaccine, live intranasal 2003-2004 formula nasal solution frozen on 07-jan-2004 and experienced a nosebleed. The reporter described the nosebleed as "just a few drops of blood". The night before Flumist vaccination, the patient experienced a nosebleed in the same nostril; the reporter indicated that "the Flumist probably loosened a clot" from the previous night's nosebleed. It is unknown if Flumist was administered into the second nostril. No additional information was available at the time of this report.
Developed extreme vertigo lasted 3 months. Vertigo would be off/on started using vertigo wrist support bracelets for balance. Was prescribed medication but didn't take.
Oliguria and decreased oral intake with associated rash and intermittent fever over a one week period. 8/13/08-records received for DOS 7/25-7/26/08-admitted for observation after having decreased urine output over past 2-3 days. Fever to 102 and mild decreased intake over past five days. Rash. Loose stool.  Assessment:Post varicella vaccine reaction of fever and rash.
pt recv vax 20MAY96 & on 16JUN96 pt devel black & blue lesions/petechiae & broken blood vessels primarily on feet, legs & back;
This spontaneous report was received from registered nurse refers to an unspecified number of patients (no demographics provided). No medical history or concurrent conditions were reported. On an unspecified date, the patients were vaccinated with GARDASIL (dose, rout, strength and lot number were not provided). No co-suspect or concomitant therapies were reported. On an unspecified date, GARDASIL was administered to an unspecified number of patients after being exposed to 34F for a cumulative time of 18 hours over two excursions, and then to 47F for 9 hours. The reported did not have any patient information. No adverse effects reported. This is one of two reports from the same source. Additional information is not expected.
DTap given 8/30/06. 9/1/06 marked swelling, warmth and erythema at injection site-13 cm x 10 cm swelling-treated as bad reaction with Benadryl and Motrin. Started on Keflex 9/2/06
Scheduled for cataract surgery; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT OPERATION (Scheduled for cataract surgery) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 CATARACT OPERATION (Scheduled for cataract surgery). At the time of the report, CATARACT OPERATION (Scheduled for cataract surgery) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   It was reported that patient was scheduled to have cataract surgery next week. Caller stated that her husband has had three Moderna shots. The booster shot was in January.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow-up included no new information
A non-serious spontaneous report of administration to 54 year-old female was received from a health professional. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Covid-19 infection; SOA, weakness. O2 stats dropped below 90% currently requiring 2 L O2
Shingles; Information has been received from a lawyer regarding a case in litigation, concerning a 55-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-OCT-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). Subsequently on 25-OCT-2017, the patient suffered shingles, including any and all of its sequelae.  As a result of the receipt of the vaccination, the patient experienced sustained severe and permanent personal injuries, as well as significant pain, suffering, and emotional distress. The reporter considered the event of shingles to be related to suspect therapy. At the time of the report, the patient's outcome was not recovered.  Upon internal review, shingles was considered a disabling event.
tested positive for COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Shingles on left side of head, exterior layer and around eye,  face to nose.  Intense headaches began on morning of 4 th day after 2 nd vaccine dose, leading to intense stabbing headaches 3 minutes apart on 8th day after dose...initially misdiagnosed/ treated as cluster headache.  Shingles  Rash presented 9 th day after dose.  This has involved 1 Visit to urgent care; 3 ER visits and repeated ophthalmologic care.  Still not resolved, with ongoing eye and  nerve pain
Case number PHEH2014US025002, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 42 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the administration.
Nausea, body aches, chills, swollen glands, sore arm.
48 hours post vax, broke out with red, fine rash on face and body and swelling around eyes. No fever. Rash fading on 5/22/00.
STROKE; FLU LIKE SYMPTOMS (FEVER FOR 4 HOURS AND ACHINESS); FELT A LITTLE OFF (NOT FEELING GOOD); This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known dug or food allergies and no any history drug abuse / illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: Unknown) dose was not reported, 1 total, administered on 23-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAY-2021, the day of the vaccine the patient was fine and he went out to dinner and around 9 pm he started not feeling good and felt like he had the flu (flu like symptoms). He had a fever for about four hours and took some Tylenol (paracetamol) for it along with this he had achiness like someone had pounded his back with a hammer. The day after the vaccine he still felt a little off so he took the day off from work and was fine after that until he had the stroke was reported. On 01-JUN-2021 (eight days later), the patient developed stroke, and was hospitalized for around 30 hours and on 02-JUN-2021 he was discharged from hospital was also reported. The treatment medications included: Aspirin 81 mg (acetylsalicylic acid) and Lipitor (atorvastatin calcium) were reported The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke, and was recovering from felt a little off (not feeling good), and flu like symptoms (fever for 4 hours and achiness). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211061443-covid-19 vaccine ad26.cov2.s-stroke.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Extreme body aches, chills, joint pain, fatigue.  800mg ibuprofen taken which somewhat relieved symptoms, but not completely.
Anaphylactic shock, patient passed out couldn?t breathe, talk, impaired speech, and epinephrine was administered
ALLERGIC TO ONE OF THE COMPONENTS IN THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced allergic to one of the components in the vaccine. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to one of the components in the vaccine was not reported. This report was non-serious.
A pharmacist reported a pt received a vaccine on 4/20/2000. The next day pt developed a fever of 103 deg F, reaction characterized by redness and swelling. The fever ad injection site reaction resolved after 3 days.
This spontaneous report was received from a company representative who is also a patient's parent and refers to a 11-year-old male patient. The patient had no pertinent medical history, concomitant medications, drug reactions and allergies. On 22-AUG-2018, the patient was vaccinated with GARDASIL 9 0.5 ml suspension for injection, intramuscularly (site of administration, lot# and expiration date were not reported) for prophylaxis. On the same day, the patient experienced pain at the vaccination (reported as injection) site. No treatment was given for the event, the patient did not seek medical attention. No lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL 9 was not reported.
Case previously recorded as MA2009-4580. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m on 13 NOV 2009. Reference no: NA09008308.
Fully vaccinated EE, COVID positive tested on 9/8/2021 PCR
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient with no prior heparin exposure. Started on prophylactic heparin (5000U TID SQ) following lobectomy. Developed severe HIT with optic density 2.8. Placed on argatroban after diagnosis, which was prompted by PE. Please note, patient immediately on heparin ppx following surgery and ambulatory. No history of coagulopathy in family or personally. Platelets never rose despite a week of therapeutic argatroban without any pauses in drip or sub therapeutic ranges. At 7 days after initiation of drip, the patient had a second PE and expired.   I know it's a long time out from his vaccine but wondering if prior vaccination and subsequent heparin may be a trigger for HIT.
Dizziness; Sore arm; Nausea; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Mother arrived w/ 3 children, asked for flu vaccines for all three. PSR gave her forms to fill out (in Spanish). Each form had child's name and birth date at the top to identify them. Mom incorrectly filled out brother's info on baby's form and baby's info on brother's form. She did not fill in birth date or age on baby's form. (Should be noted that baby is fairly large size for age- 13# 6oz). Nurse checked to establish VFC status, did not review baby age. Flu vaccine given. Mom then asked if baby could still have reg vaccines at appt on the next Monday. This caused nurse to look at chart and discover baby only 4 months old.
After taking Moderna Booster shot the injection site is terribly  aching and throbbing in the muscle.  No relief.  I tried cold hot compresses exercises, message etc More specific information to relieve Covid Arm should be available to public .  This pain is horrible!    I am planning to go to my Doctor if this horrible pain continues. We need more information on side effects and how to treat them.
The evening of the vaccine started with fast heart beat, was unable to get to sleep as her heart was beating fast and she was breathing fast.  She has a sore arm with a slight redness.  They lasted over night and then resolved.  All these symptoms have resolved.
He spent week with mother W/ COVID, Told grandfather that his body reacted terribly, felt like he was getting punched and could not sleep, Feeling fever, chills. Grandfather told him to contact us, he told him that honestly he felt that was seeing visions, slipping in and out of consciousness . Headaches as well, said he feels better now.
Moderna booster- constant itchiness with raised, red skin in streaks matching scratching. First occurred in evening, marks would take about 30min to away if stop scratching.  Itchiness persists and hard to entirely stop scratching.  I have no known allergies, never had event like this before.