chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an "8" year old male with asthma who on an unspecified date was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was indicated that "about 8 days after receiving the varicella virus vaccine live (Oka/Merck)" (date not specified), the patient developed a rash on his lower extremities, which moved up his body. It was reported that the rash did not look like chicken pox, but it was not ruled out. At the time of this report, the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Multiple complaints: arms turned red when going to bathroom. Went home and felt tire for next 4 days. 5 days later she had a syncipal event. AMS, BP was 70/50, slurring words. Went to ER - negative CT, MRI, EKG, given 5 bags of fluid. Went home with no dx and slept for 14 hours. woke up with facial swelling. Still has swelling of the arms and hands and a lacy rash. continued fatigue and joint pain.
pt recv vax in later summer to early fall 1994 & fainted & fully recovered w/o tx;
My daughter received 2 vaccines Tdap and HPV.  The Tdap was injected in her right arm with no complaintsor event.  Immediately after the Tdap injection she was injected with HPV vaccine in her left arm. She stated while the needle was still her arm that it hurt and she felt dizzy. As soon as she said she felt dizzy she passed out with her eyes closed.  The nurse and I grap her to prevent her from falling off the exam table. Suddenly, she jerked back at the same time she jerked backwards  her right arm jerked up over her head and her arm hit the window behind her then she  became stiff and her whole body began to jerk. This appeared to me to look like she was having a seizure.   The nusre  also stated that she was having a seizure  The nurse and I kept on calling her name and trying to stop her from banging into the window or to fall of the exam table.  She came to in amount 30 seconds startled and wided eyed with her face pale and her lips white.  The doctor came in after the entire event  examined her said she was okay she laid down for about 15 mins and she was okay but still  pale.  Went home and my dauther slept for an hour.
Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening; Chills when traveling on the plane; Felt achy; Fever of 103 degrees F for about a day and a half total of 24-36 hour; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening), CHILLS (Chills when traveling on the plane), MYALGIA (Felt achy) and PYREXIA (Fever of 103 degrees F for about a day and a half total of 24-36 hour) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 939902) for COVID-19 vaccination.     Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for HSV infection.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced MYALGIA (Felt achy) and PYREXIA (Fever of 103 degrees F for about a day and a half total of 24-36 hour). On 01-Oct-2021, the patient experienced PYREXIA (Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening) and CHILLS (Chills when traveling on the plane). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse reaction, at a dose of 1 dosage form. On 25-Sep-2021, MYALGIA (Felt achy) and PYREXIA (Fever of 103 degrees F for about a day and a half total of 24-36 hour) had resolved. At the time of the report, PYREXIA (Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening) had not resolved and CHILLS (Chills when traveling on the plane) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 103 (High) 103 degrees F. On 01-Oct-2021, Body temperature: 100 (High) 100 degrees F. On 02-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Body temperature: 99.1 to 101 (High) Fever of 99.1 ranging to 101 degrees F.         This case was linked to MOD-2021-344216 (Patient Link).
Right arm violous edema, sharply demarcated involving lateral arm, no ulcers, no deficits nerve sense or motor deficit.
Pt was given vaccine in Room. Stated she was alright left Room went to Reception. This nurse saw her in Reception asked if she was alright, she said she could use a juice. When this Nurse Returned with juice pt. had loss consciousness. Called code, called MD. MD and Nurse lifted pt to ground.
This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Got really sick like the flu) and URTICARIA (Hives after second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 038A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Got really sick like the flu) and URTICARIA (Hives after second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Got really sick like the flu) and URTICARIA (Hives after second dose) outcome was unknown. Concomitant product use was not provided by the reporter. It was reported that the hives got after second dose were better than the first time. Patient took Zyrtec before they went in, during and after vaccination. This case was linked to MOD-2022-636331 (Patient Link).
pt recvd vax 24OCT90; neurological sx began in early NOV; pt was seen in the hosp ER on 7NOV90; 14NOV90 was admitted to hosp given a dx of GBS;
Patient given booster dose of Moderna monovalent after policy changed on 9-3-22 when bivalent was not yet available.  No adverse reaction or complaints reported by patient. Will update when bivalent is in stock.
This spontaneous report was received from a licensed practical nurse and refers to a patient unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot #L038132, expiration date 27-APR-2016 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of -3 degrees Celsius for 6 months. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 56-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Patient came to pharmacy for flu vaccine  and  was given COVID vaccination by mistake  without her consent.  Approximately 2 weeks later patient states that she does not fill well . Patient does not mention any specific symptoms
Headache, red hard area around injection site with two blister like eruptions and hives at site.
PT WAS ADMINISTERED INCORRECT VACCINE...SHE REQUESTED SHINGRIX .   MODERNA WAS ADMINISTERED.   PT HAD PREVIOUSLY RECEIVED 2 DOSES OF COVID 19 PFIZER IN MARCH 2021 AT ANOTHER INSTITUTION.
Woke up two days after injection to a red butterfly rash on my forehead(between my eyes), cheeks and nose. It feels like a chemical burn and skin is peeling. I had done nothing different except I had received my second moderna shot.  My face seems to be swollen as well.
Pt. received vaccine Fri 6/17 and presented to the pharmacy Sun. 6/19 with local reaction: 2 inch diameter area at injection site raised, red area warm to the touch and somewhat itchy.
This case was reported by a healthcare professional and described the occurrence of fever in a 6-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), PCV 13 (non-gsk). Concurrent vaccination included Hib (non-gsk); Sanofi; unknown; unknown given on 10 September 2012; ENGERIX B; GlaxoSmithKline; unknown; unknown given on 10 September 2012. On 10 September 2012 the subject received 2nd dose of KINRIX (.25 ml, unknown, unknown thigh) and 2nd dose of PCV 13 (Non-GSK) (unknown). On 10 September 2012, at the time of vaccination with KINRIX, the subject experienced inappropriate age at vaccine administration and vaccine underdose. KINRIX was administered on 10 September 2012. The subject was meant to have received DTaP and IPV. On 10 September 2012, less than one day after vaccination with KINRIX and Pneumococcal vaccines (Non-GSK), the subject experienced fever. At an unspecified time after vaccination with KINRIX and PCV 13, the subject experienced shortness of breath. The subject was hospitalized on 16 September for shortness of breath. The healthcare professional stated the fever had improved but at that time of the report the subject's status was unknown. At the time of reporting the outcome of the fever and shortness of breath were unspecified.
Client was given a Moderna booster per parent request, even though they received Pfizer for their primary series. No complaints of any reactions.
Hyporesponsive-hypotonic event within 12 hours of aDPT, IPV, Hep B-HIB, and PCV7 immunizations. Afebrile. Medical Records received on 1/20/2004 states loose stools, lethargy and gastroenteritis.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 18-SEP-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two 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: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
I slept 12-14 hours/day for nine days following the injection and was very groggy when awake. This is likely a mast cell activation flare, but I am reporting it as an adverse reaction just in case). People with MCAD receive no information about potential flares, whether one dose vaccines are safer, the excipients in the injection (which can cause flares), etc. There are enough of us that you may want to track this. I received no information about excipients....
This spontaneous report was received from a registered nurse who refers to an unknown number of patients of unknown age and gender. The nurse reported that patients might have been vaccinated with a doses of RECOMBIVAX (dose, route and lot# not reported) which were improperly stored (vaccines were exposure to 31 F for 1 and 1/2 hours). No adverse event reported. This is one of several reports from the same source. Additional information has been requested.
12/28 sx of runny nose and body aches. Missed work 12/29, set up for testing 1/3 (Negative test 1/6/21 - SC)
Patient passed out and looked like they went into a seizure about 3-5min after getting the vaccine. The patient was sitting in the chair waiting the 15min and I heard a crash and the patient fell off the chair. I attended the patient and his eyes were rolled in the back of his head and he is making muttering noises. Pt was like this for under a monitor then became conscious and didn?t know where he was at.  I called 911 and we all accessed the patient and determined he was okay and he assisted to leave with his life.
Hospitalized 12/30/21 -1/12/22 cough, runny nose, poor appetite, altered mental status; COVID positive, PNA, hypoxia, fatigue, weakness, lost taste and smell, sepsis Had antibody infusion 12/28/21
Patient reports dizzy spell that lasted about 5-10 min aproximately one hour after immunization.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # K011801, expiry date: 21-AUG-2016) (Incorrect product storage). No adverse events reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
vaccinated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HBV (Engerix B) (batch number 2L2B9, expiry date 9th May 2021) for prophylaxis.   On 28th October 2021, the patient received Engerix B. On 28th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was vaccinated with an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up.
Fever, chills, extreme headache, soreness, and fatigue for about 24 hours
Pruritus; Severe Edema; Erythema at injection site extending to elbow; Fatigue; Temp; Generalized myalgia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue) and PYREXIA (Temp) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Mild hypertension-Treated). Concomitant products included SIMVASTATIN (ZOCOR), LANSOPRAZOLE (PREVACID), MELOXICAM and METOPROLOL for an unknown indication.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Sep-2021, PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took bed rest and was observed and treated at home. The vaccine was taken on 21-Sep-2021 at 08:45 a.m.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received on 18-oct-2021, case contains No new information.
Pt seen on 11/2/01 with an 8 day history of rash and 6 day history of URI symptoms. On exam, her rash was consistent with erythema multiforme. Pt also noted to have right otitis media. Follow-up exam on 11/6/01 showed possible mucous membrane involvement, questionable erythema multiforme minor. Follow-up exam on 11/14/01 showed no new erythema multiforme lesions but new fever and bilateral otitis media. It is unknown if erythema multiforme time course was consistent with vax as cause. Pt also had infection as possible etiology.
Student was given Tdap, Varicella and then Meningococcal immunization.  As soon as shots given, student was sitting in chair and head fell forward onto chest and student was unresponsive for approx. 15-20 seconds.  Came to on his own but was very pale and diaphoretic.  Didn't realize what had happened.  Mother stated afterwards that this had happened to student last time he had a Tdap immunization.
10 minutes after receiving vaccine, he stepped out into the sun and felt "like he had been drugged" he felt dizzy and lightheaded, 2 hours after receiving vaccine and after eating and resting he felt better from dizziness but then felt "tingly" all over, 5 hours after receiving vaccine, he felt almost completely back to normal.
Left arm red, swollen prescribed with  BENADRYL prn and BACTRIM PO twice daily for 5 days
Patient called Monday 3-15-21 to report on Saturday 3-13-2021 She developed a few hives on 1 finger, on thumb near ribcage & on both elbows. Patches were itchy & cortisone cream helped relieve symptoms.
Initial report received from a reporter on 07-Oct-2013.  A unknown-year-old patient (gender unknown) had received FLUZONE (batch number: unknown, dose number and site of administration not reported) on an unknown date. The patient's medical history was unknown. The patient had no illness at the time of vaccination and concomitant medications. Expired FLUZONE vaccine was administered to patient and patient did not have any adverse event. No laboratory tests were performed and corrective treatments were not reported. List of documents held by sender: none.
Severe muscle aches- particularly in neck and shoulders.  Slight fever, sore throat and diahrea.
Extraordinarily painful upon injection, large amount of bleeding from the injection site, immediate throat tightness.  By noon the next day, overall body pain comparable to my episode of covid 3 months before. No fever. Became bedfast with illness for 3 days then still remained ill with covid-like symptoms for 10 days. One full month for full recovery. My right deltoid injection site still has occasional shooting pains one year later.
Approximately 6 minutes after vaccination, patient experienced a syncopal event and passed out. He became nauseated after the event then vomited. Pt was seen in the emergency department, patient admitted to hospital for overnight observation.
fever; dizziness; head hurts feeling like it is going to split/headache; medicine taste in her mouth; aches all over; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. This consumer reported same events for different patients. This is the first of two reports.  A female patient of unspecified age (reported as 56 [units unspecified]) received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unknown route of administration on unknown date at a single dose for COVID-19 immunization. The patient reported that she got her second vaccine and her friend got the vaccine same day and her friend was feeling the same way as the reporter was feeling: had fever, dizziness, headache (also reported as head hurts feeling like it is going to split), aches all over, medicine taste in her mouth, and has been in bed all day; all on unspecified dates. The patient reported that she has taken acetaminophen (TYLENOL) but no diphenhydramine (BENADRYL). The outcome of the events was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021031286 same reporter/drug/events, different patient