chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 14-year-old male. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 28-Dec-2010, 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. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Patient sitting in chair after administration of Hepatitis A (dose 1) and HPV (dose #3) vaccines when her eyes fluttered and rolled to the back of her head and she started to slide of out of her chair. Responsive to voice and touch within 3 seconds, nurse able to catch patient and lowered her head to the floor. Rested in supine position for several minutes with ice pack to neck then sitting position for several minutes. No other adverse reactions. Patient had juice and crackers as well.
Missed miscarriage. Due date was 7/13/2022. I had a Moderna booster and tetanus shot the same date.
soreness at sight of injection, muscle pain throughout body for about 24 hours (enough to require reduction in normal daily activity)
Whole body hives, runny nose and watery eyes, throat constricted, flushed face, racing heart rate, itchiness.
feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm; a lot of mucus/excessive spitting; feeling like she would faint; fatigue; muscle pain; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067h21a, 012m20a and 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, 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 experienced FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE SWELLING (swelling in the injection site). At the time of the report, FEELING ABNORMAL (feeling like she couldn't walk/different feeling/thinking that she can´t walk/a feeling in her right arm), SECRETION DISCHARGE (a lot of mucus/excessive spitting), PRESYNCOPE (feeling like she would faint), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE SWELLING (swelling in the injection site) outcome was unknown.            Treatment medication contains medication for congestion.
it was rpt pt recv 1dose of varivax 2/21/97 & in 5/98 pt was seen in MD ofc w/blisters, rash & itching. pt treated w/oatmeal baths & calamine lotion
Patient was meeting all of his milestones perfectly. Notably, after the MMR & Hep A vaccine my son didn't recognize certain animals anymore, wasn't responding to his name, became extremely sensory, started developing eye tics and blinking extremely hard with the mouth smiling or open. Crying most of the time & locking up of limbs at certain times.  This all continued for around 1 year. He is now in Speech Therapy and OT and is not where he should be developmentally for the age of 3.  I also noticed in pictures that his eye was going inward after his 4  month vaccine cluster shots, which I have learned is also a reaction. He was given Tylenol after vaccines which DR told to give.
This spontaneous report as received from a 66 year old registered nurse referring to herself. The patient had no drug reactions/allergies. Pertinent medical history was none. Concurrent conditions were not reported. On 11-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J013135, expiry date: 17-JAN-2015) 0.65 ml, subcutaneous. Concomitant therapy included SYNTHROID. On 11-JUL-2014, the patient experienced redness, swelling and pain around injection site. No laboratory tests were performed. The patient sought medical attention, had called up to the physician's office. The patient was treated with ibuprofen. The outcome of redness, swelling and pain around injection site was reported as not recovered. Additional information has been requested.
Hives on face and stomach, Pain in left arm and neck (Deltoid and Trapezoid).
2 days after 4 mo immunization, broke out, whole body red spots.  No other problems.  Taken to PCP, told hives and may want to give shots one at a time.
approx 12 hours after admin I began having chills, soreness, fatigue.  Sx mimicked the flu, but no fever or nausea.  Much better at 24-36 hours after admin.  I did not call doctor or visit ER/clinic.
Left upper arm redness, soreness, swelling, and warm to touch. Symptoms worsened with redness and swelling extending beyond elbow into left forearm. Pt went to ER and was diagnosed with cellulitis.
Vertigo immediately following shot. One week letter nerve shakes in upper body. Unable to fall into a deep sleep. Still experiencing vertigo daily. Nerves feel extremely shaky during REM sleep.
This spontaneous report as received from a pharmacist refers to a 70 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number: H011049, expiration date: 05-SEP-2013) on 10-OCT-2012. There were no concomitant medications. The patient developed rash behind both knees and on the left shoulder following vaccination with ZOSTAVAX. The rashes were described as dime size on 15-OCT-2012. The patient did not remember exactly when the rash developed. The patient had contacted pharmacist for medical attention. No treatment or laboratory diagnostics studies were given. The outcome of rash was reported as not recovered/not resolved.  Additional information is not expected.
Patient arrives to observation at 14:15 following feeling lightheaded, having tunnel vision, feeling tingly, and sweaty after receiving the vaccination.  BP 111/64 HR 61 oxygen sat 99% on room air. She was given some graham crackers and water.  14:25 BP 127/73 HR 75 Pulse oxygen 97% on room air.   patient stated he feels better and was escorted to the exit in a wheelchair
Chills; Fever; Soreness in my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Soreness in my shoulder) and CHILLS (Chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (Fever) and ARTHRALGIA (Soreness in my shoulder). On 13-Jan-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Shoulder pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and ARTHRALGIA (Soreness in my shoulder) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Severe arm pain. Unable to open and close fingers. Back hurts Chills Cough
Pt had a generalized grand mal sz; eval in ER, transfer to another hosp treated w/Phenobarb p/ER; had fever @ the time;
Pfizer was mistakenly given as a second dose in the mRNA series of COVID19 vaccine. Patient waited 30 minutes post injection to ensure no immediate reactions.
Suspected Vaccination failure/ Had shingles; Had shingles; shingles again this time on both lower legs; Very painful.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles, shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine years ago from reporting date and experienced Shingles. The patient experienced shingles again this time on both lower legs, which was very painful. The patient mentioned that the shingles started on back then moved to legs. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates between the year 2008 and January 2016, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, injection site, lot# and expiration date were not provided). Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
The evening after vaccine given pt experienced chills & shivering, the got very hot. The next day she did not feel good & stayed in bed all day.
Immediate pain in arm that got worse first 12 hours.  About 15 hours post vaccine and an unrestful night, woke up around 5-6am and almost fainted or passed out.  I was very nauseaus, had a fast all over body drenching sweat, dizzy and numbing in fingers/toes (can't remember which but had tingling and was dizzy).  Rest of day was low fever, headache and tired.  Right arm was sore where couldn't lift it but that subsided after 2-3 days. Just wanted to report the fainting that almost occured the next early AM.
Fever, shivers, muscle weakness in legs, tired, indigestion, and arm soreness.
Injection site hot/red, headache, low grade temp 98.4; 1 1/2 inches in diameter.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the GARDASIL 9 (lot number L019297, expiration date 18-AUG-2017, lot number M023169, expiration date 13-JUN-2018) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients.  From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported.   Additional information has been requested.; Sender's Comments:  US-009507513-1703USA001520: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA007372:
After receiving both vaccines patient was walking around the store with his mom and told her he didn't feel good.  Patient proceeded to pass out and hit his head.  Patient peed his pants and felt light-headed until the ambulance arrived and they checked him out.
Dx; Varicella. Stomach, chest, red bumps vesicle. Vaccine breakthrough per doctor.
I had the vaccine at 11:30am and at 9:00PM is when I do  my kick count and she wasn't moving.  I contacted my OB and was told to do another set of kick counts.  At 11:00PM I did another kick count and she still wasn't moving. I went into my  OB's office for tests and observation. I had a fever, body aches and chills. I was given Tylenol and fluids and was observed. After the initial dose, her heart rate was back to normal. I was sent home and continued Tylenol and fluids and eventually my heart rate and blood pressure returned to normal. My estimated date of delivery is 05/02/2021 but I'm having an induction on 04/28/2021.
Localized reaction - red irritation around injection site with minor swelling. Care Giver put hydrocortisone on area and gave BENADRYL - minor swelling went down - then took to the physician.
This spontaneous report as received from health care worker/medical assistant refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On 15-MAY-2014 the patient was vaccinated with M-M-R II (dose, route, lot# not reported) was improperly stored. No information provided regarding concomitant medication. No adverse effect reported and PQC was not involved. This is one of two report received from same reporter link (1405USA010435). Additional information has been requested.
Fever 102(+), Seizure, Given Tylenol every 4 hours, (?), Had 2 seizures in less than 6 hours after vaccine, Next day, No seizures, 99 degrees - Temp, Eating well
Breakthrough case admission after 4 vaccines Pfizer 2/2/21 Lot# EL9261;  Pfizer 10/2/21 Lot# FF2589;  Pfizer 4/8/22 Lot# FK9893;  Pfizer 10/11/22 Lot# GJ6665
The symptoms started 2 days after my 2nd dose. I had shortness of breath and just minor activities had me easily winded. I started having chest pain. It was being wined made me call the doctor for an examination. The doctor said I had Hypertension stage 2 and she advised me to start taking medicine Valsartan and Hydrochlorothiazide and avoid salt. I had a EKG and ECO Cardiogram. The just pain was daily just until the beginning of April this year. I did get the Pfizer booster instead of the Moderna. I did not have any noticeable reactions.
Woke up in middle of the night with chills and intense sweating that lasted for approximately one hour.
No adverse event; Vaccine administered past the expired date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 (Vaccine administered past the expired date).    This case was created for the 12th patient of the 13 patients involved.  Concomitant medication was not provided. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case(Patient 1)
THE PATIENT CALLED THE PHARMACY ON 5/5/21 REPORTING A RASH THAT HAS DEVELOPED ON HER CHEST ABOVE THE BRA LINE AND NECK. AT FIRST SHE ASSUMED IT WAS FROM THE BEING IN THE SUN DURING THE WEEKEND (5/1/21-5/2/21), BUT REALIZED TODAY IT MIGHT BE FROM THE VACCINE. SHE HAS BEEN TREATING WITH OTC DIPHENHYDRAMINE CREAM AND TAKES A DAILY ORAL ANTIHISTAMINE. THE RASH IS NOT SPREADING AND SHE IS NOT HAVING ANY SORT OF DIFFICULTY BREATHING OR HIVES.
Did not receive full dose; Fell drops on their arms; A spontaneous report was received from a Healthcare Professional concerning a patient who was administered Moderna's COVID-19 vaccine and did not receive full dose.  The patient medical history was not included. Patient concomitant was not included  On 07-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) prophylaxis of COVID-19 infection.  Caller states there were 2 patients that received the vaccine on 07-feb-2021. The needles were not attached completely and they did not receive the full dose. The patients fell drops on their arms. She reported this through VAERS. She wants to know if she should repeat the shot or continue.   Treatment of these event (s) were not provided.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact with no associated AEs reported.
patient had been given three doses of Menactra instead of two dose; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site.  The patients past medical history, medical treatments, vaccinations and family history and concomitant therapies were not provided.  It was as actual medication error case due extra dose administered. The patient was administered three doses of Menactra instead of two dose.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Information on the batch number was requested.  List of documents held by sender: none.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health, Centers for Disease Control and Prevention, and Pfizer have determined that the dose of vaccine that you received is valid.
Metal taste in mouth within 3 minutes of receiving the vaccine. Metal taste lingered in mouth for several hours after receiving the vaccine. Metal taste had disappeared completely after approximately 6 hours post vaccine administration.   No anaphylaxis or allergic effects. Patient did not need medical treatment.   Patient intends to receive the second dose on schedule.
Diarrhea; headache; sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 32-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EN6206), via an unspecified route of administration in his right arm on 12Mar2021 at 14:15 (at the age of 32-years-old) for COVID-19 immunisation. Medical history included anemia, blood pressure high, obesity and heart murmur. The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN)), amlodipine Besylate (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) for an unknown indication. On 12Mar2021, the patient experienced diarrhoea, headache and sore arm. Therapeutic measures were not taken for events experienced. The clinical outcome of the diarrhoea, headache and sore arm was recovered.    No follow-up attempts are needed. No further information is expected.
Dizziness; BP 137/66 (pulse 63), O2 sat 100%. Orange juice and graham crackers provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years 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 included: "Chronic migraine" (unspecified if ongoing), notes: Other medical history: Chronic Migraine. Concomitant medication(s) included: DULOXETINE; MEMANTINE. Past drug history included: Galcanezumab, reaction(s): "Known allergies: Galcanezumab", notes: Known allergies: Galcanezumab.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective. Additional information: Other medication in 2weeks product: Duloxetine 60mg and Memantine 10mg. Anti-viral details: Product = COVID 19 Treatment. Brand = Paxlovid. Treatment start date = 10Aug2022. Treatment stop date = 04Sep2022. Adverse event: Paxlovid rebound. Started course of Paxlovid on day 1 on symptoms onset (aches, chilles, fever, sore throat). By Day 5 He felt normal and started returning to routine activities. By Day 10 covid symptoms returned (congestion, fever, fatigue, aches). By day 15 He was starting to recover from the second bout but he was still experiencing sore throat, congestion and periodic fever. His partner was away during the initial symptoms and appears to have caught covid from him during the rebound. Adverse event start date: 30Aug2022. AE resulted in: [None of the above]. If treatment AE: No. The patient was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.