chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; patient received improperly stored vaccine on 11/4/2021; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 04-NOV-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)dose reported as 1 dose, lot #U010399, expiration date: 01-APR-2023 (dose number, site and route of administration were not provided) for prophylaxis (product storage error). The vaccine was stored at temperature 10 degrees Fahrenheit (F) for 350 hours. There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4503591-00 (AbbVie).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till 10Jul2022 at cf, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: the patient experienced COVID. The action taken for adalimumab was dosage permanently withdrawn on 10Jul2022. Additional information It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The reporter's causality for the event(s) of COVID with Humira was not provided. Causality as per reporter (Vaccine): Possible.   The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
injection site tender; injection site swollen; joint achiness; dull headache; a little bit of chills; a little bit of nausea; feels so crappy; funny metallic taste in her mouth; little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), DIZZINESS (little dizzy), VACCINATION SITE PAIN (injection site tender) and VACCINATION SITE SWELLING (injection site swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced DIZZINESS (little dizzy). On 20-Jan-2022, the patient experienced FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), VACCINATION SITE PAIN (injection site tender), VACCINATION SITE SWELLING (injection site swollen), ARTHRALGIA (joint achiness), HEADACHE (dull headache), CHILLS (a little bit of chills) and NAUSEA (a little bit of nausea). At the time of the report, FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), DIZZINESS (little dizzy), VACCINATION SITE PAIN (injection site tender), VACCINATION SITE SWELLING (injection site swollen), ARTHRALGIA (joint achiness), HEADACHE (dull headache), CHILLS (a little bit of chills) and NAUSEA (a little bit of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
No initial reactions or side effects from the first dose on April 12, 2021.  Three weeks later on May 3, 2021 if felt fatigued by evening time and had chills and sweats all night.  No energy on May 4, 2021 and slept all day with bouts of chills and sweats but never had a temperature over 98F.  Woke up the morning of May 5, 2021 and discovered a large red patch centered over my left hip THR incision scar.  The incision scar was very sore and a dark purple.  I had a dull dehydration type of headache and had to urinate about every 20 minutes on May 4th.  Went to the emergency room and was diagnosed to have cellulitis and given a 7 day dose of antibiotics and 10 day dose of antiviral medication.  The rash never was very itch and started to subside immediately after taking the first dosage of these two medications.   Went to see my primary physician on May 10, 2021 and he believes I had vasculitis and not cellulitis.  No signs of any insect bites or cuts to have started the infection/inflammation. He noticed that blood vessels in and around the red patch which was about the size of a dinner plate were elevated to the surface.  Followed up with Dr on May 25th via telemedicine visit and he ordered another series of blood lab and urine tests on June 10, 2021, to make sure my ESR, CRP, and urinalysis results were continuing to decline.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of an unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of ZOSTAVAX (lot # M017294 and expiration date 28-JUN-2017) (dose and route of administration were not reported). There were no adverse effects reported. The doses of ZOSTAVAX were stored in -1.9 degree Celsius for 7 hours and 30 minutes, on an unknown date. The previous temperature excursions were reported as -14 degree Celsius for 2 hours and -13.7 degree Celsius for 7 hours and 30 minutes, both on unknown dates. This is one of two reports from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Day1 after injection - soreness & slight swelling at injection site on right arm Day 2 - ? Day 3  - Right shoulder became sore & had twinges of pain Day 4 - ? + hard to raise right arm - very painful every time it was moved. Unable to undress without help. Extremely painful. Took Tylenol & used heating pad.  Day 5 - unable to move right arm at all without extreme pain.  Taking Tylenol.  Right rotator cuff was previously repaired surgically in 2005.  No issues in 15 years until now.
At around 9:15 PM I started to feel nauseous and got out of bed to go to the bathroom. While using the bathroom I felt a very strong chill come over my whole body and started shivering and got directly back into bed and wrapped myself up in a thick blanket. For 45 minutes I laid wrapped up and was shivering constantly. At 10 pm I was brought extra blankets and a heating pad but moving to get situated caused dizziness. It was about 10:30 when the shivering stopped. I was able to sleep but got up to go got the bathroom around midnight and my entire body was drained of energy and I felt that I could barely stand and walk on my own. I was dizzy and my head hurt as well. I could barely hold my arms up to look at my phone briefly. Between 11 PM and 2 AM I had 5 or 6 high heart rate alerts (over 120) according to my Apple Watch but I did not wake up to them. In the morning (Sunday 4/4/21) around 9-10 am my head still hurt and my body was very achy and I felt very hungover. All day I continued to feel achy almost with a bad cold or a minor flu. Today has been better but I have still felt pretty drained. I?ve had continuous arm soreness in the arm I got the injection - but nothing too severe.   15 minutes after my vaccine on Saturday 4/3/21 I took 600 mg of ibuprofen and around midnight of that night I took 2 of pain relief PM acetaminophen (1000 mg of acetaminophen total snd 50 mg of diphenhydramine HCI total)
Case number PHEH2014US021350, is an initial spontaneous report from a nurse received on 21 Oct 2014. This report refers to a 56-year-old male patient. His medical history included  neurological issues and left side weakness. Concomitant medications were not reported. He was vaccinated with intramuscular dose of FLUVIRIN (batch number: unknown) on an unknown date. Post vaccination, since 09 Oct 2014, the patient experienced left side of his face drooping for one week and visited nurse. The nurse treated the patient as if he had Bell's palsy. The outcome, seriousness and causality assessment of the event was not reported.
p/vax pt exp redness & swelling of the arm;the swelling was noted to be 1 to 1 1/2time the nl size;1 day later pt recovered;
This spontaneous report as received from a physician via company representative refers to a female patient reported to be in her late 60's to early 70's. The patient's medical history included naturally occurring shingles. On an unknown date (4 or 5 months after recovering from the original case of shingles) the patient was vaccinated with ZOSTAVAX injection (route, dosage and lot number not reported). Upon follow-up at her Physician's office, the patient was found to have developed a painless rash in unspecified locations of the body. The patient sought medical attention (doctor visit) but received no treatment. The outcome of the event was reported as recovered (unspecified date).  Additional information is not expected.
Patient developed fatigue, sore throat, nausea, chills and fever within 4 hrs of receiving vaccination.  Symptoms caused patient to seek treatment in the Emergency Department.
MOM DESCRIBED IT AS RASHES FROM HIS SHOULDER TO HIS ELBOW, LEFT SIDED.  MOM OFFERED BENADRYL, RASHES SUBSIDED NEXT DAY.
pt recvd vax & 2 hrs p/receiving vax exp a recurrence of tingling in lips, cheek & tongue; presented to ER for treatment; No further details were provided;
RN DID NOT CREATE A WHEAL ON THE FIRST ATTEMPT SO SHE SWITCHED ARMS TO DELIVER A SECOND DOSE AND CREATED A WHEAL.
Syncopal episode, patient hit lip on desk, splitting it open.  Did arouse after about 10 seconds.
The vaccine had a very noticeable effect in DIMINISHING the symptoms of my guttate psoriasis!  I WANT MORE!  LOL.
Pediatric dose of HepA was given to adult. Pt and Dr. notified.
2/23/21 about 5pm started having heart palpitations that would not clear up  with coughing, and also had mild shortness of breath with this irregular heart.  And mild chest & left neck pain.  Symptoms  finally started to ease up near 10 pm and I went to bed and was quite tired.  I woke up the next morning 2/24/21 around 7 am with reddening, hard swelling, and itching at injection site in my upper left arm. Arm symptoms slowly improving.
10 AM vacc. (ADACEL) admin. Lt thigh. Pt's only comment was feeling tingly, but OK. 1330 Mom, called ->principal called --> pt. short of breath, arms numb/tingly, pupils very small. Pt's family picked up & took to ER on advice of Dr. Few hours later Mom updated us. States ER phys determined pt hit on/at injection site in P.E., causing allergic response by body. ER MD told Mom not 1st time he had seen this. (of note: pt could not walk at school & at doctor). Also: Twin sister got same vacc w/o problems yesterday.
Muscle pain continuing to 3rd day after injection; sharp intermittent stabbing pains in the back; fatigue; headache; chills; right arm soreness and itchiness ongoing third day post injection; right arm soreness and itchiness ongoing third day post injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; Batch/lot number: EN6204) administered in right arm via an unspecified route of administration on 08Mar2021 at 12:15 PM (at the age of 66 years) as dose 1, single for covid-19 immunisation. The patient's medical history included diabetes. The patient had known allergies to Statins, Amlodipine, and blood pressure medications. Prior to vaccination, the patient did not have COVID. The patient did not test for COVID post vaccination. No other vaccines were administered in four weeks. Other concomitant medications in two weeks included LIVALO, ZINC, ESTER C, FISH OIL, 81 mg ASPIRIN taken for an unspecified indication, start and stop date were not reported. On 08Mar2021 at 14:30 PM, the patient experienced muscle pain continuing to 3rd day after injection, sharp intermittent stabbing pains in the back, fatigue, headache, chills during the first 24 hours, right arm soreness, and itchiness ongoing third day post injection. No covid prior vaccination and not tested for covid post vaccination. No treatment was received for all the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Ulcerative colitis flare ups after COVID vaccine; Neck pain; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis flare ups after COVID vaccine) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis flare ups after COVID vaccine) (seriousness criterion medically significant), NECK PAIN (Neck pain) and DISCOMFORT (Discomfort). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis flare ups after COVID vaccine), NECK PAIN (Neck pain) and DISCOMFORT (Discomfort) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication provided. No treatment information mentioned. Patient experienced ulcerative colitis flare ups, discomfort and neck pain after COVID vaccine. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in Company comment. This spontaneous case concerns an adult male patient with concurrent medical condition of ulcerative colitis that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, serious (medically significant) AESI of Colitis ulcerative (Ulcerative colitis flare ups after COVID vaccine) and other non-serious events. The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The concurrent medical condition of Ulcerative colitis remains a confounder to the event's Ulcerative colitis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns an adult male patient with concurrent medical condition of ulcerative colitis that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, serious (medically significant) AESI of Colitis ulcerative (Ulcerative colitis flare ups after COVID vaccine) and other non-serious events. The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The concurrent medical condition  of Ulcerative colitis remains a confounder to the event's Ulcerative colitis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Arm where injection was, right arm, hurt and felt heavy. Red blotchy skin on right arm, stomach, and back. Next day red blotchy skin also on breast and itchy.
Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) 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 was a confusion between the expiration date printed in the carton the expiration date when the code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 04-Oct-2021.  No treatment medications were reported.
Pt recvd HIB/DTP/OPV vax on 23APR91 & on 25APR91 pt was found to have a "knot @ inject site"; There was no redness or tenderness noted; the "knot" subsided; No further details were provided;
COVID arm - red, hard lump at injection site, warm to the touch, swelling in the injection arm; fatigue; headache; chills; aches
This was the first time I had ever seen one of my children turn completely yellow. (I have had three sons prior to this who were at this time 20, 15 and 10 years old.) I was so freaked out I brought him back to the doctor who told me it must be something I was eating and that it couldn't have been his vaccines.  I told him what a difficult time my boy was having, the screaming, the lack of sleep--he told me to stop nursing him and give him Formula.  I did not.  I continued to nurse him and he regained his normal color after several months.  His second very bad reaction, which we believed changed his whole personality, was on to his vaccinations came when he got his MMR ON 12/3/2010.  Patient had an extremely high fever that night, (106), which we brought down with advised Tylenol and Motrin alternated every four hours and wet cloths to cool him down.  He shook like seizures, screamed, started pooping his pants with watery poop that ended up last five years to date.  He started waving his hands, refusing to wear shoes or clothes, screamed and hit himself, could not look at me anymore and kept spinning in circles and banging his head.  He also started repeating odd things he would hear and lined up all kinds of bizzare objects.  He was not the same little boy anymore.  We knew he was seriously damaged since the day he took that shot.  We subsequently brought him back to his doctor to tell him what had happened to Patient.  He, Dr. said he suspected autism and sent us to a specialist.
No additional AEs filed.; the possibility of the caller experiencing an exposure to the live virus vaccine; when retracted the needle 2-3 drops of MMR II went to the air; he was a physician and administered the MMR II vaccine to his wife in their home/ possibility of the caller experiencing an exposure to the live virus vaccine; This spontaneous report was received from a male patient of unknown age, who was a physician and was reporting on himself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 21-APR-2022, the physician administered Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, injection site, lot number, expiration date and albumin status were not reported) as prophylaxis to his wife in their home. The reporter stated, that after he administered the vaccine, he retracted the needle, and 2-3 drops of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) "went into the air" (accidental exposure to product, occupational exposure while administering product). The physician wore gloves when he administered the virus. No additional adverse events were reported. It was unknown if the physician sought medical attention. The caller was very concerned about this possible exposure and was requesting an urgent call back.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007531:
Shots here 11/9/09, (monday) The next day (afternoon) was crying and not standing.  By that next night Addison was more hysterical and would not stand up. Mom gave her milk and yogurt and then she calmed down. Mom held her and she fell asleep. Mom did not give any motrin or tylenol  Mom gave her natural sniffles and sneezes homeopathic dissolving meds. (cold meds),  By the next day she was coughing and sneezing.  Mom gave her umcka cherry flavored syrup for cough or sore throat (1/4/ of tsp). (weds and thurs pm) No temperature.   Then still mostly crying alot (weds and thurs), did not want to do much, was listless. Not jumping and playing, wanted to be held Mostly was sitting down. Only would stand for a little while.  Then eased up. Didn't cry all day, just less active. Mostly dealing with coughing and runny nose.   By thurs was walking and stand up.  Now is fine.   ? Reaction to shots (possibley was just pain related and might have warranted pain meds).  Is it related to the intercurrent illness?
The patient states her "arm very swollen the whole upper part, very warm to touch, and a little red". She applied ice and took Ibuprofen with relief. The arm was swollen the next evening when ice was not used. The swelling lasted until Monday, 05/21/01. At the present 05/24/01, the patient has only itching at the site.