chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Severe, Systemic: Weakness-Severe, Additional Details: Patient claims to have experienced in addition to all checked above, sleepiness and painful blisters in mouth/throat/butt- throughout body and muscle pains.
The pt experienced a 4cm erythema area 1 day post vax. There was mild improvement at 48 hours. No systemic symptoms.
Whole body reaction - flushed skin, hot flashes - pruritis - tried with Zyrtec.
During injection, syringe became dislodge from the needle.  More than 50% of vaccine has been injected.
This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 57 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1705USA014053:
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 03-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Myalgia, Arthralgia, Redness and swelling on lymph nodes at axillary region on injection site.
Starting 12/1/18, runny nose and cervical lymphadenopathy, 12/5 developed rash on torso, neck, and back and redness in eyes. Patient saw CNP at outside clinic, who asked patient to call us to report measles- like rxn. No labs ordered at this visit. 12/6 patient reports rash is improving but lymph nodes are same. Never took temp. 12/7 symptoms improving-slight rash only.
Patient was given Moderna Covid-19 Vaccine at age 17 in error, not approved for under 18. Patient had NO adverse outcome, this is a report of a medication error.
Day 6 raised itchy red spot on arm, nickel sized Day 7 larger , hot , pain Day 8 5cm In size, hot, painful , itching
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and genders. No medical history, current conditions and concomitant therapies were reported. On multiple unspecified dates, the patients were administered improperly stored doses of ROTATEQ orally (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom left after shot was given and within approximately 30min she saw that her son had swelling of his lips and hives on his face.  She took him to the local clinic and the PA looked at him and agreed it was a reaction and gave him Benadryl and he recovered well. Child has a peanut and egg allergy.  He was allergy tested and it was diagnosed as moderate.
large amount of swelling at injection site, redness, and heat.; large amount of swelling at injection site, redness, and heat.; large amount of swelling at injection site, redness, and heat.; large amount of swelling at injection site, redness, and heat.; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional in via Sales Representative.  This case involves a 10 years old patient who experienced large amount of swelling at injection site, redness, and heat (vaccination site inflammation), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 17-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  On an unknown date, The patient developed a non-serious large amount of swelling at injection site, redness, and heat. (vaccination site inflammation) (vaccination site swelling) (vaccination site erythema) (vaccination site warmth) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab test reported.  Final diagnosis was large amount of swelling at injection site, redness, and heat..   The patient was treated with ice the site, NAPROXEN (MOTRIN [NAPROXEN]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Unknown for the events.  Information on the batch number was 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 59-year-old female 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.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated  that because her 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. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients.
Just began methotrexate therapy 25 MG per week for arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis). The patient was treated with METHOTREXATE for Arthritis, at a dose of 25 mg,per week. At the time of the report, ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient stated that she vaccinated with both series of moderna Covid shots 6 months ago. she just began methotrexate therapy 25 MG per week for arthritis.   Reporter did not allow further contact
Initial report received from the patient on 8/4/05. It was reported that the 18 year old female patient, who had a past history of epilepsy, had received a dose of Menactra, lot number not reported, in July 2005. The route and site of administration were not reported. An unspecified amount of time later, the patient experienced seizures, nausea, vomiting, diarrhea, headache, achy joints, fever, and fatigue. it is unknown whether the patient required any medical intervention. Her recovery status is listed as unknown. (OMIC)
Moderna 8/11/21, 9/16/21. Positive on 8/5/22
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information on concurrent conditions, allergies, medical history and concomitant medications were unknown. On 25-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, (dose, frequency were not reported, lot number, expiry date were unknown) for vaccination. In July 2017, the patient experienced redness and swelling at unspecified injection site and that injection site was warm to touch. Pharmacist reported that on 26-JUL-2017, patient was seen at a clinic and was then seen in an unspecified emergency room at an unspecified hospital in an unspecified location. Pharmacist reported that patient was then evaluated for a blood clot at an unspecified site on the same day. It was unknown if this unspecified patient was admitted to unspecified hospital. The outcome of events was unknown. No further information was provided. It was unknown if any lab diagnostics were performed. No product quality compliant (PQC) was involved. Upon internal review, thrombosis was considered to be medically significant.
A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Jan-2013. The patient experienced abdominal pain which started 06-Feb-2013 and stomach aches which started on 18-Jan-2013. The outcome of the event of stomach aches and abdominal pain is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 09-Apr-2013 from Health Professional: new event of abdominal pain added, new reporter of health professional added, therefore case was medically confirmed, narrative updated.
Pt developed cellulitis morning after injection.  Redness and swelling at injection site.
Patient got the vaccine in the left deltoid. Within a few hours, while mom ran errands after the office visit, said "my eye(lid) hurts". The next day (yesterday), she woke up and right upper eyelid was slightly puffy. Went to camp that day and came home and right upper eyelid was more swollen. She tried putting cold compresses at our suggestion but the skin is very sensitive. No trouble breathing, swallowing, lip or tongue or mouth symptoms. No cough.  Left eyelids and lower right eyelid are completely normal.  Has normal binocular vision.
Mother, presented with patient to be vaccinated at this health clinic. She documented the patient's birthday on her intake form over some other numbers which are scribbled out. The same DOB was entered into the electronic database. This would make the patient 5 years old. However, the local Immunization Registry lists patient's correct DOB as different date. She has other immunizations accredited to this entry and DOB. If local record is correct, then this child was only 4 years old when she was vaccinated. The error was discovered while reconciling the records with local record after vaccine administration.
Patient was inadvertently given the second dose in the series 11 days after the first vaccination. The scheduled date of the second dose was 2/16/21.
Pt. has a patient facing role as ED registration at Hospital.  Pt. received 2nd dose of Pfizer vaccine on 2/17/21.  Pt. had a high risk community exposure on 4/10/21.  Pt. tested per hospital policy 2x after exposure.  1st test was negative but 2nd asymptomatic test taken on 4/21/21 was COVID positive despite being fully vaccinated.
10-13-15, PM - sudden onset of seizures clonazepam 0.125 mg PO, for seizures lasting greater than 3 minutes.
Headache and chills on the 2nd day. Felt fine on the 3rd day.
Swelling, redness 2"x2" noted on right shoulder 24 hrs post immunization. Ice/Motrin recommended.
Viral URI with cough,  Dry Cough, Myalgia and Covid-19
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medication was not reported. On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25 U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reports as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Laid down at 6pm and fell asleep.  Woke at 11pm, went upstairs, and suddenly felt very nauseous.  Went into the bathroom in case anything came up then broke into a cold sweat kneeling in front of the toilet.  Laid down on bathroom floor, pulled towel down from the rack to put under my head.  Called for husband to bring me a blanket.  Cold sweat and extreme nausea for approximately 40-minutes.  Very weak, joints hurting, cold sweat, nausea, wimpering out loud as I do when I'm unsure and physically feeling quite awful.  Pulled self up using side of bathtub and went downstairs and climbed into bed.  Chills and cold sweat abated.  Remained still to keep nausea quiet.  Slept.  Weak again and foggy-headed in the morning.
This spontaneous report as received from a pharmacist via company representative, refers to an immunocompromised patient of unknown age and gender. On an unspecified date, approximately 5 years ago (estimated as in 2009) the patient was vaccinated with a dose of ZOSTAVAX (dose, indication, lot # and expiration date were not reported). On an unknown date, the patient had been experiencing recurrent shingles flare ups. Outcome of event was not reported. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Janssen COVID-19 Vaccine EUA  Persistent/Chronic feeling of "pressure" or "numbness" in left shoulder injection site
Severe itching all over my body (scalp, behind ears, neck, chest, arms, stomach, back, & legs). Started roughly 12 hours after receiving the vaccine on 9/25 and still hasn't fully gone away, though it has improved some (today is 9/30). Rash like bumps on chest, stomach, and back that weren't there before - also some hives. Not sure if it is directly related to the vaccine, but I have not changed anything else about my routine - using the same laundry detergent, soaps, hair products, makeup, deodorant, lotion, perfume, etc. Haven't eaten any new foods that may have caused it either. Husband was also vaccinated and did not have this reaction. I have been taking Benadryl to help with the itching.
Pt states after she received her 2nd Moderna, she went home and later that afternoon started developing hives.  She took a benadryl and woke up this morning with worsening hives. NP instructed pt to go to hospital for additional medications.
Initially fever and tylenol given for pain and fever.  It wasn't until about a month or 2  later she started having asthma symptoms and allergies.
Initial and follow up information has been received from a registered nurse concerning a Caucasian 24 year old female student with sulfonamide allergy, drug hypersensitivity and surgical tape allergy who on 08-MAY-2007 at PM was vaccinated IM in the right deltoid with her second dose of Gardasil (Lot #657617/0384U).  On 10-MAY-2007 at AM the patient experienced pain and developed swelling at the injection site, patient also had a fever and felt nauseous after receiving Gardasil.  The nurse recommended TYLENOL and BENADRYL and to use an ice pack at the injection site.  In follow up it was reported that on 10-MAY-2007 at AM the patient also developed redness at the injection site and took BENADRYL and TYLENOL and ice to the injection site.  On 11-MAY-2007 it was reported that the patient's condition improved.  Additional information is not expected.
A week later, almost to the hour of the injection,  the area around the location of the shot started to itch.  Within 8 hours it was red and bumpy and about the area of a goose egg around the original injection site.  The bumps went away a day later, but the itching and redness continued for an additional 48 hours.
At the time only slight headache and sore arm at site. Developed chronic hives as of July 2021 (on going to date) Rec'd 3 more of same vaccines since 1st one as recommended by CDC Got Covid 19 July 23, 2022 anyway! And hives
This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date in third trimester of her pregnancy the patient was vaccinated with GARDASIL (therapy dates, dose, route not reported). The last menstrual pregnancy (LMP) and estimated date of delivery (EDD) is not known. The outcome of event reported is unknown. No product quality complaint was involved. Additional information is not expected.
dizzy spells/lightheaded; head pressure; vomiting; felt nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells/lightheaded), HEAD DISCOMFORT (head pressure), VOMITING (vomiting) and NAUSEA (felt nauseas) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Two knee replacements). Concurrent medical conditions included Penicillin allergy, Drug allergy (Narcotics), Pollen allergy, Dust allergy and Allergy to molds (Mold and mildewallergy).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (dizzy spells/lightheaded), HEAD DISCOMFORT (head pressure), VOMITING (vomiting) and NAUSEA (felt nauseas). At the time of the report, DIZZINESS (dizzy spells/lightheaded), HEAD DISCOMFORT (head pressure), VOMITING (vomiting) and NAUSEA (felt nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
BLURRED VISION, HEADACHE, CHILLES, SEVERE PAIN IN RIGHT ARM, SHOULDER AND BACK FOR DAYS. STILL HAVING BLURRED VISION AND LITTLE HEADACHES
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 83 years old female patient who was vaccinated once with an 0.5 ml expired dose of FLUZONE HIGH DOSE (lot UI890AB; expiry date: 05-Jun-2018 via intramuscular route in the left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Arm was immediately tight and sore at injection but no shooting pain. Stiffness developed in arm and then shoulder. In the next few days, the shoulder on the right side became sore with acute pain. Neck on right side also became painful and tender. Then the shoulder improved slightly after one more week but shooting pain continued in right arm.
Severe upper left quadrant tooth pain. Biting on meat or any hard food sent jabbing, radiating pain. Also accompanying head and neck pain. Pain duration 3 days