chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hepatitis; sick for a long time; Second dose administered 6 months later; This spontaneous case was reported by a pharmacist and describes the occurrence of HEPATITIS (Hepatitis) and ILLNESS (sick for a long time) in a 67-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.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEPATITIS (Hepatitis) (seriousness criteria hospitalization and medically significant) and ILLNESS (sick for a long time) (seriousness criterion hospitalization). On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 6 months later). The patient was hospitalized on sometime in 2021 due to HEPATITIS and ILLNESS. At the time of the report, HEPATITIS (Hepatitis) and ILLNESS (sick for a long time) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 6 months later) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. Could not get the second dose. She received the second dose on11AUG2021 and was told due to the time difference between the first dose and the second dose, it was too long, and she would need to get another dose of the vaccine.  This case concerns a 67-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of hepatitis, and illness. The events occurred on unknown days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 67-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of hepatitis, and illness. The events occurred on unknown days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
This spontaneous report was received from Registered Nurse regarding to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regiment unknown. It was reported that the vaccine was exposed to a temperature excursion if 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Within 30 minutes of getting the flu shot, my arm got very itchy, and there appeared to be a hive, however, the shot was given near my small pox vaccine scar, so it was hard to tell if the hive was there, but a red swelling occurred around the injection site and continued to itch for 2 -3 days. The redness extended down my arm to the elbow from the injection site by the 2nd day. Only antihistamines were used to control itching.
Injection site inflamed and spreading post 72 hours. I injection site red and tender to touch. Discomfort 6/10
FEVER 101-104; CHILLS; WEAKNESS; SWEATS; DIZZINESS; HEADACHES; CONGESTION; INTERMITTENT SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fever 101-104. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced sweats. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced headaches. On MAR-2021, the subject experienced congestion. On MAR-2021, the subject experienced intermittent soreness. Laboratory data included: Body temperature (NR: not provided) 101-104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent soreness, and the outcome of fever 101-104, chills, weakness, sweats, dizziness, headaches and congestion was not reported. This report was non-serious.
Anaphylaxis onset less than 30 min-BP 160/80 pain & inflammation in joints-thickness of tongue, difficulty breathing, SOB; On 20NOV90, having problems w/blurred vision;
Shock-like sensation starting in legs and migrating up body every 3-5 minutes to head. Results in muscle spasms and head pain lasting up to 45 minutes before complete resolution.
Severe pain in pelvic area and between shoulder blades, neck and shoulder pain as well..
administered more than 30 days after 1/11/22 are not in accordance with the EUA; 82 patients administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (administered more than 30 days after 1/11/22 are not in accordance with the EUA) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (dose 3) on 26-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered more than 30 days after 1/11/22 are not in accordance with the EUA). At the time of the report, EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (administered more than 30 days after 1/11/22 are not in accordance with the EUA) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Dose administered after 30-day Use By Date or after manufacturer date of expiry Number of doses/vials: -18; Date the vial was initially stored in the refrigerator: - HCP will call back to provide the information Date(s) of administration of vaccine: 09May2022 - 9 doses; 11May2022 - 9 doses It was unknown whether this was the patients' 1st or 2nd or booster doses. I was informed that the team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 5/9/22 and 9 patients on 5/11/22 (vaccine expired 5/5/22). When investigated the above issue further, I identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 1/11/22, which means that all doses administered more than 30 days after 1/11/22 are not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge) administered between 2/16/22 and 5/11/22. Note: these 82 patients include the original 18 from the above case. The vaccine in question did NOT experience any temperature excursions. No treatment medications were reported.
I felt tired after the vaccine for that afternoon but that was all. I tested positive via a home test for COVID-19 on 08/10/2022. I had coughing, sneezing and congestion. I contacted my doctor and they prescribed an antibody (don't remember the name).  After taking it for two days, my symptoms went away.
Temp to 104, lethargy alternating with irritability, dehydration. Seen in office initially--looked toxic, tachycardic with pulse of 169 so sent to ER for evaluation. Received IVF, antipyretics.  Labs showed mild acidosis. (HCO3 of 18) otherwise normal. Also with rash (L) thigh.
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390:
Approximately 4 to 5 minutes after administered of vaccines. Patient experienced tonic/clonic seizure. Patient recovered immediately v/s stable transported to E.D.
This spontaneous report as received from a 74 year old female consumer reporting on herself with no drug reactions or allergies. The patient's medical history included mini stroke. The patient was vaccinated with ZOSTAVAX in September 2012 (dose, route and lot # not provided). No other co-suspects were reported. Concomitant medications included folic acid, fexofenadine hydrochloride, ALLEGRA-D, NEXIUM, CELEBREX, alprazolam, chloroquine, furosemide (manufacturer unknown), sertraline hydrochloride, naproxen, verapamil, tramadol hydrochloride, phytonadione, omega-3 marine triglycerides, calcium (unspecified), iron (unspecified), CENTRUM SILVER. The consumer stated that in September 2012 about a week after receiving ZOSTAVAX she developed shingles. The patient stated that her physician was not available so she was diagnosed by clinic. After that her physician was made aware. She reported that it was a mild case but was directed to call by an unspecified pharmacist. Unspecified cream was given as a treatment. A blood work was performed (no results provided). The outcome of shingles was reported as recovering. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
I got a positive pregnancy test the previous week (October 21st). On October 25, I was bleeding and went to the hospital and they told me I was miscarrying. And I didn't need to have a DNC or anything and I went home.
Large, lemon-size lump in left armpit area.  Painful and uncomfortable.  Large lymph nodes in left  neck.
Member was given the Flumist on 09/22/2011.  On 09/25/2011, member was feeling chest pain and not feeling well after dinner and going to the Club.  Mamber was found down face in vomit by his friends.  CPR was started and 911 activated.  Paramedics arrived and continued CPR en route to Hospital where CPR was continued unsuccesfully.  Member was pronounced dead at 0215 by Dr.
-Soreness around injection site  ( Started right after and the severity is the same as the flu shot) - Warm feeling around injection site for the first 15-30 minutes after receiving the injection - 6 hours later around 8:00/30 I began having bloating, stomach cramps and diarrhea
Initial misuse report received from a healthcare professional on 11 April 2013. A dose of ADACEL that had expired on 02 September 2012 was administered to a patient (No information was provided regarding the patient) on 09 April 2013. No adverse event was reported. List of documents held by sender: none.
This is a 67Y/O MALE who was seen for a routine primary appt on  Jan 27th and was given immunizations with shingles, flu as well as pneumococcal vaccine and subsequently noted significant soreness on his left arm that started that same night, now he states that the areas is spreading beyond the site of the injections on his left deltoid, also having fevers and chills headaches as well as sinus congestion. No BM in 4 days.
After HPV injection pt amb with mother out of exam room and was at check out desk and pt started to feel "whoosie" and fell to the floor and hit back of head on wall on way to floor. Passed out for 1-2 minutes, aroused and vs taken feet elevated until conscious and assisted to w/c and given juice and wheeled back to exam room for monitoring.
experienced only mild arm soreness with the vaccinations; experienced only mild arm soreness with the vaccinations as well as minimal fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "experienced only mild arm soreness with the vaccinations"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "experienced only mild arm soreness with the vaccinations as well as minimal fatigue".
pt recv vax 12JAN96 & 2FEB96 devel a red bumpy rash on face;mom reported that one of the bumps almost formed a vesicle, but not quite;
Approximately 48 hours after administration of Tdap + MCV4, Pt. had fever & didn't feel well.  Could not pin point.  16 hours later cried uncontrollably X1 home, vomit X1.  On 3/20/09, fever & general malaise @ 1700 til bedtime.  Better next morning after sleep.
My back of head left side bottom started aching within about 1hr later that day around noon. I started feeling flush 10:00 am and my throat felt like it was getting tight, hard to breathe, by 6:00pm I was having a panic attack. By midnight, terrible anxiety attack had set in. Called paramedics in early AM taken to ER on Sat. Went back to ER at clinic  Sunday. Dr took a blood sample about 4 days later after injection.
This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of GARDASIL, intramuscular injection, (Lot # K010215 with an expiration date of 05-MAY-2017), (strength and dose were not provided). On 08-FEB-2016, the patient was vaccinated with a dose of GARDASIL, intramuscular injection, (Lot #, expiration date, strength and dose were not provided). The reporter stated that the patient received GARDASIL 9 (Lot # L001312 with an expiration date of 24-FEB-2017) inadvertently on 15-MAR-2016. No side effect were reported. Additional information has been requested.
Fever to 104.1 rectal prior to Tylenol administration, and vomit x2 when picked up to soothe moaning. Child hungry after fever began to subside, and no more vomiting despite feeding immediately.
01/05/2022: : Patient presents with shortness of breath.  States she was diagnosed with Covid on 12/23, has had progressive shortness of breath since then, had a single J&J vaccination last April, went to facility on 1 January which was 4 days ago and was apparently stayed for 3 days, was sent home on home oxygen, does not know how much she was on at home, acutely became more short of breath today and came to the ED.   known Covid positive given Decadron, 01/10/2022: remains in hospital
Vaccine drawn from expired vial by mistake. Vial had been opened the day prior to administration. Maximum time opened vial should be used is 12 hours.
Pt was a regular hard working person at work and doing work around the house and outside of his house. Approximately three weeks (06/20/2021) after he received the first dose of the Pfizer vaccine he started having complications walking. From June 20 through June 23rd he used a cane to get around to help him but was still struggling to walk. After those three days and it getting worse he went in to an urgent care where his Primary works at. They referred him to the Emergency room . He went to the emergency room on June 23rd where he was receiving treatment and was moved to inpatient on the morning of June 24th. The Hospital has run multiple tests including three MRIs, provided physical therapy, and none of the tests they have performed have all come back normal. This is not normal for the Pt not to be able to walk, he has always been very self sufficient even with having a hurt back.
12/28/2020 received covid vaccine Pfizer #1--12/29/2020 1am--nausea, then hot and cold flashes, no temperature.  Stabbing pains  bilateral arms, shaking due to being cold--difficulty walking-- difficulty sleeping--called into work due illness 12/29/2020.  during hydrated and starting feeling  better around noon time.  Today 12/30/2020--patient is feeling fine and working normal work schedule.
I was sick in bed for four days unable to get up except to occasionally use the rest room. I had no fever, but I did have a runny nose, cough, and sore throat which disappeared after I was able to get up on the fifth day. This was far worse than the one day of tiredness listed as a normal reaction.
Information has been received from a consumer, for the Pregnancy Registry for VARIVAX (Merck), concerning herself, a 33 year old female with latex allergy and no pertinent medical history reported who on 11-MAY-2009 was vaccinated with first dose of VARIVAX (Merck) (dose, route and lot number not reported). There was no concomitant medication. The patient reported that she had her last menstrual cycle on 23-MAY-2009. The patient was not about  five weeks pregnant. No adverse event was reported. Lab test performed included "pregnancy test and blood work", results not provided. The patient sought unspecified medical attention. Follow up information indicated that in July 2009 the patient had a miscarriage. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
Itchy and redness to left lower extremity and neck.  Benadryl 25 mg IM given
Began on the 8th on Rt. wrist as an itchy spot.  Put otc cortisone later that day.  Thought it was a mosquito bite.  The next day Hives had spread to both arms and Friday night spread to Torso.  Took Benadryl that evening. Seen a physician on 8-10-13 with no prescriptions. Took 2 Benadryl and have taken one every night until the 20th. Seen my Dr. on the 15th and prescribed Pepcid and Zoloft for itching. Had to go to ER on the 20th for Lt. side throat swelling with hives on torso, arms and legs. Nausea.  Treated with Zofran. Prescribed Z-Pack, Prednisone, generic Claritin.
Ringing in the left ear began off and on after the 1st shot, it was not constant, and didn't think much of it.  After the 2nd shot the rining become constant and steady around May 4th, but wasn't too bad.  Then over time, my left ear hurt and felt full as well as pain from that radiated into my jaw.  I went to my primary Dr. on 6/28/21  and he felt there my eardrum was a little cloudy so I prescribed antibiotics and steroids.  I took them and over a period of 10 days, there was little improvement.  I went back, and he sent me to an ENT - over the course of the next 3 months or so, we investigated TMJ, vascular migraines, and more.  Ultimately I did an MRI on 9/7/21 and the result showed that there were no abnormalities.  We did a steroid back and that eventually seemed to calm down the Tinnitus for a period of time.
Passed out, blacked out, landed flat on her face, hospitalized due to the events; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Nerve pain in July 2020, Carpal tunnel syndrome, Broken foot (40 years prior to reporting time.), Lung operation NOS in July 2020, Hip replacement in 2017, Hip replacement in December 2020, Bladder operation NOS in November 2020, Foot surgery, Knee surgery NOS, Shoulder operation NOS and Tubal ligation. Concurrent medical conditions included Allergy to antibiotic and Allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], SERTRALINE, GABAPENTIN and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) (seriousness criterion hospitalization). The patient was hospitalized from 17-Apr-2021 to 19-Apr-2021 due to LOSS OF CONSCIOUSNESS. On 19-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Cardiac function test: normal (normal) normal. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal, normal (normal) normal and normal (normal) CT Scan Head/Brain with Contrast. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Primary Care Physician scheduled an MRI and Carotid Artery Ultrasound after a week from the reporting time. She was also placed on a heart monitor for 30 days. This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness.  Event latency 5 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness.  Event latency 5 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Post vax, the patient experienced a sore throat, rhinitis, a fever, and muscle and joint pain for 5 days. The injection site became sore, red and elevated for 24 hours once the cold symptoms were treated 6 days post vax.