chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe itching, initial injection site was swollen, hard, red,very hot and about the size of a 50 cent piece. after 1 hour was the size of a golf ball.  She complained her are, elbow and wrist was now hurting, she became very tired, and complained her neck hurt as well, I checked her glands felt swollen as well. She also has had severe diarrhea since receiving the vaccine.  2 hours later the spot had grown to around baseball size.  I was advised by clinic nurse to take her to the ER. The Dr. she saw said it was indeed an allergic reaction, and said to give her benedryl, motrin and gave her an antibiotic to treat the cellulitus it was causing, and to put ice packs on her arm to help ease the pain and swelling.  By morning the site was now the size of a softball or a bit larger, and was still very painfull.  The ER DR said to follow up with her pediatrician, and thought we should see an allergist as well to see what ingredients in the vaccine were causing her reaction.  He wondered about possible egg allergy or a possible form of penicillin in the vaccine, and suggested I get an ingredients list from the immunization clinic.  I have a follow up appt scheduled for Wednesday 08/27/2008.  She also had the very same reaction last year only in her leg, and we were not sure which vaccine had caused the reaction as she received 3 in the same area at that time, we now know it WAS indeed the varicella vaccine she is allergic to.  I gave her the second dose against my better judgement, under the advice of her doctors and pressure from her school to give it too her anyway.  Thankfully she is still here!!
Immediately after administering DTAP and IPV in same thigh and rubbing injection site, patient stopped breathing. She had not cried long. She was immediately picked up and stimulated verbally and physically. The episode lasted approx. 15 seconds. Upon coming to, she appeared lethargic for approx. 5 mins.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from a certified medical assistant on 30-AUG-2016. The nurse reported that the specified lot numbers of improperly stored vaccines administered between 19-MAY-2016 to 01-JUL-2016 were not available. This report refers to a patient of unknown age and gender. On 26-MAY-2016, the patient was vaccinated with incorrectly stored dose of ROTATEQ orally, lot#L035511 or K022993 or L029618. Additional information has been requested.
RN was doing a nurse visit and updating vaccines for child. The RN read the box of the given vaccine which states up to 7 years old and pulled the DTAP. This vaccine is only reccomended for children up to 7. Since this child is 7, the vaccine he should have got was TDAP as this one is for ages 7 and over. EMR and other system acceped this vaccine and child will not need to repeat. Spoke with RN and informed her of checking the right medication for patients age and informed her to always check as there are different recomendations for each vaccine. The vaccine box does have wording unclear but reinforced 5 rights of med admin.
No reactions occurred. Vaccine administered on 5-4-22 (2ND DOSE) and 4-15-22 (1st dose), however due to it being kept in fridge it should have expired on 4-8-22, therefore pt received expired vaccine.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001699 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional via agency (reference number: USBAV22-0690) and concerns a *46-years-old (as reported) female patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at *left deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to the Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from Bavarian Nordic on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 46-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at left deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 46-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at left deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Per patient, "possibly having a reaction to the covid vaccine, but never got a call back. I received the vaccine Saturday, I get fine the day of, and the next day I ached all over, but had no fever...itched a little, but didn?t think anything of it. Day 3 I woke up at 3 in the morning excessively itching. Rashes and small bumps all over my body. The rashes aren?t terrible, but definitely noticeable. I?d like a professional opinion on the matter. I remember when researching metoprolol back when I first started taking it, one of the medications it said not to take was Benadryl. However, I?m not sleeping because of how bad my body has itched the last 3 days."
Acute Vasculitis of lower extremities (foot/ankle/shin/calf), steroids and antibiotics, outcome uncertain.
Began with red itchy scalp approx. 9 days post vaccine and within a day or two welts/hives developed first on arms with angioedema in hands.  Welts/hives/rash spread to various parts of body with itching.  Went to ER due to "allergic reaction" type symptoms with angioedema being the most worrisome.  Was given steroids which helped with angioedema but he continues to suffer with hives/rash/dermatographia for 5 weeks now.  Has been taking antihistamine daily since onset of symptoms.  He saw our internist approx. two weeks post ER visit who acknowledged he has seen this reaction post vaccination before.
Dizziness immmediately post vaccine and continued x 31 hours, malaise,, lower than normal Blood pressure x 31 hours post vaccine, Rash on upper back 6-10 hours post Vaccine   Benadryl and increased fluid. Antivert for dizziness.
Symptoms starting 12/9/21: fatigue, sinus congestion, nasal drainage, cough, sore throat; reports frequent sinus infections and last two antibiotics only seem to take the edge off and it comes right back; also needing her inhaler more often essentially 2-3 times per day, dating back to September and questions if needs to try something else.
Approximately 10 minutes after receiving the vaccine I began to notice generalized redness/flushing and an increase in temperature of my face, ears and neck. Started on the left side and spread to the right as well. Took 1000mg acetaminophen orally and the redness/flushing resolved after about 2.5-3 hours.
10 to 24 hrs p/vax recvd pt devel labored breathing w/temp elevation pt screamed high pitched for 2-3 hrs; labored breathing lasted for period of 8 hrs;
approximately six hours after receiving the shot she felt ill, swollen lymph nodes on the right side, excessive sweating, confusion, muscle stiffness, palpitations, tinnitus, became disoriented, aphasic, profuse sweating,  swelling from upper right arm up to ear which took three days to begin to improve.
This is a spontaneous report from a contactable consumer reporting for her son. This is the 2nd of 2 reports and regards the 1st vaccination dose. An 18-year-old male patient received the 1st dose of TRUMENBA, via an unspecified route of administration at 1 DF, single on an unspecified date in 2016 3 months before this report (because he was going to college and he would be on campus). The patient medical history was not reported. There were no concomitant medications. On an unspecified date in 2016 the patient experienced chills, low grade fever, it was chills like flu, he was cold. The outcome of the events was recovered in 2016. Therapeutic measures were taken as a result of stiff neck and TYLENOL and ADVIL were received. The patient had undergone lab work for his physical.
Developed Cellulitis of left upper extremity at location of injection within 24 hours. Patient evaluated at urgent care and discharged with Rx for  Bactrim. Followed up with resolution of cellulitis.
Narrative: Pt is a 90y.o. male who died on 03/21/2021 w/ h/o HLD, HTN, AFib, past aortic valve replacement, macrocytic anemia, COPD. Pt received Moderna Covid-19 Vacciantion 2/2 on 02/24/2021. Pt was found on the floor of his bedroom by his wife last PM around 1900 3/21/21, 911 was initiated, pt was taken to hospital and resuscitation was not successful. Per wife, pt had a good day with family and had gone to the restroom and then to his bedroom. Pt wife did request an autopsy. Unlikely that Moderna Covid-19 Vaccine Caused/Contributed to pt death.
On the afternoon of the immunizations (4/14/11) mom noted "egg" at injection site on (R) thigh - was red, swollen, and firm. Fussy baby with 100.2 fever. Had office visit next day (4/15/11) Dx with localized reaction to PENTACEL vaccine.
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection.  Rapid Response called @1721, patient monitored.
Swollen lymph nodes near collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes near collar bone".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states the last time she was in she had the pneumonia shot and states, "it about did me in".  Pt states she was extremely sick afterwards, lost use of R hand and unable to raise it since injection.  Pt states she lost feeling in 3 fingers in R hand and unable to hold utensils anymore.  Inj was in L arm.  Pt states she has been sluggish since and has weight loss.
Patient was under the age of 18 at time of administration.  Followed up with her Mother and  she is doing okay.
arm pain Narrative:  Patient took 2nd dose of moderna covid vaccine on 19feb. He co headache and arm pain starting on 21feb. He states he took advil and symptoms have improved. no sob, no cp. no fever.
Patient w/HSP - clear of rash for 3-4 weeks prior to giving immunizations. Rash recurred within 10 days of administration.
weakness; hot and cold sweats; very odd dreams; fogginess; Upset stomach; Cold sweats; joint achiness; Fatigue; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COLD SWEAT (Cold sweats) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), COLD SWEAT (Cold sweats) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown and COLD SWEAT (Cold sweats) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Updated the Contact information.
I have always been regular (24-26 days) with my menstrual cycle & after the second round of the shot (on Feb  21 @ 4 PM) my menstrual cycle completely stopped & has not returned since.  It's been almost 8 full months without any evidence of a menstrual cycle or ovulation cycle.
Mid to low grade fever (99.5-101) from 3 days to 2 weeks following vaccine, nausea from 3 days to ~12 days after vaccine
Pt L arm reddened, swollen, warm approximately 1 1/2 - 2" around injection site (full diameter 1 1/2 - 2").
hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 39-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 39D2G, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received FluLaval Quadrivalent (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2021, 1 days after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. The patient was treated with doxylamine, famotidine (Pepcid), cetirizine hydrochloride (Zyrtec), benadryl (nos) (Benadryl Spray), benadryl (nos) (Benadryl Cream) and benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows:  The patient self-reported this case. A day after vaccination in the morning, the patient had hives all over her body. The hives were treated with Benadryl by mouth, Benadryl spray, Benadryl cream, Zyrtec, Pepcid and doxylamine.   The patient's hives were not recovered till the time of reporting. The patient consented to follow up with the physician. The reporter consented to follow-up.
I have tracked my period for decades.  My period is very regular on cycles that run every 23-27 days averaging 25 days. My periods last 5-7 days. I never spot between cycles. I was given my second dose of COVID on day 10 of my cycle and my period started 4 days later on day 14. It lasted 5 days.  Other symptoms I experienced after my second dose included: (1) tired - took a nap starting 5 hours after dose was administered, (2) chills - started 10 hours after dose, lasted for 7 hours, and required multiple folded king-sized comforters to get warm (3) all over body aches - lasted until about 36 hours after dose.
The syringe separated from the needle when injecting the flu vaccine. About half or more of the vaccine came out from the syringe. The needle was in patient's arm when syringe popped off. Nurse on site took out the needle and placed a gauze over the injection site. Patient left without getting another dose.
The patient began to break out with a rash starting on her back approximately 1 hour after being vaccinated. This spread around her waist and up to her trunk. The rash subsided approximately 3 to 4 days later. The patient used cetirizine on her own to treat the rash and did not seek out further medical care. Of note, all materials used including gloves and bandages were latex free.
Vaccine was administrated after the beyond use date after the thawprocess; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thawprocess) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether the patient had chronic or long lasting health conditions. It was unknown whether the patient had ever been diagnosed or tested with positive for COVID-19.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thawprocess). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thawprocess) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.
Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medium
Later in the day of recving vax, pt was exercising on a treadmill which was a new activity for her. About 9-9:30 PM she noticed a fine, red rash on back, across shoulders and a little on chest. It was a little itchy. Rash remained as of 3/28/01. Pt had no other complaints. On 4/4/01, PMD recommended Benadryl with next dose and to continue series.
Bad chills - from 11 pm - 8am next day skin felt like burning  couldn't stand very dizzy - felt like head explode called doctor next day for advise chivered for 5 hrs. Couldn't get warm enough.  very bad chills - very dizzy couldn't stand felt like head was going to explode skin felt like it was on fire - burning. Couldn't get warm enough -  didn't go to er that cost money.  Doctor advise not to get #2 shot.  Called Doctor on 4/3/19 for advise. Was able to eat on 4/4/19
This spontaneous report as received from a nurse via company representative refers to a 11 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. On 16-SEP-2014, the patient was vaccinated with her first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prevention of HPV. Concomitant therapies included DTaP, TDAP vaccine and MENVEO. On 16-SEP-2014, the patient experienced a stomach ache. There was none treatment given for the adverse event and none lab diagnostic studies performed. The outcome of the stomach ache was unknown. The relatedness between the event and GARDASIL was unknown. The patient sought medical attention. Additional information has been requested.
11 year old presents for follow up from urgent care center seen 8/2/17 at 21:43 for concern of allergic reaction potentially to vaccines which were given one day earlier. According to documentation from visit and report from patient and his father, they noted new onset swelling are erythema on face, cheeks, below eyes. There was no rash/swelling at injection sites on arm. There was no chest pain, SOB, nausea, vomiting, nor fevers, however throat was reported to feel "a little scratchy". As for potential exposures there is the potential for outdoor contact dermatitis for such as poison ivy, there was no other recent changes in soap/detergent/shampoo. There was no significant changes in food but he did attend a fair and ate some "junk food" there such at cotton candy. The urgent care administered Epinephrine x 2, prednisone and discharged on MEDROL DOSEPAK. Since that time the rash around face has improved. There was subsequently rash noted on right forearm/anecubital region and upper medial thighs. There has been no prior history of allergic reaction.