chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a female patient of unknown age with no drug reactions or allergies and no concomitant medication. In January 2013 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, injection, intramuscularly, lot number #H010649. expiration date: 20-FEB-2015. In 2013 reported as after receiving of GARDASIL, the patient experienced hives. The patient did not seek medical attention. The patient's mother, of her own accord, gave the patient over-the-counter BENADRYL. No lab diagnostics studies were performed. No additional adverse events were reported. The outcome of hives was unknown. Relatedness between vaccination and GARDASIL and hives was not reported. Additional information has been requested.
At the time of my second shot, I immediately experienced pain in the joints of my wrist and in the knuckle of a previously injured trigger finger as well as in my ankles. Beginning on the night of my second vaccine dose, I began to have extreme chills, fever, and nausea that lasted 48 hours. By Wednesday, it set off my asthma that was fully and previously  well-managed causing me to go to an urgent care for my  first ever Covid test to rule it out. Since then I have had ringing in my right ear, and a sense of being off balance but the most alarming side effect was the fluttering in my heart that lasted well over two to three weeks that I had never experienced the shot.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017 at 09:26, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
24 hours post vax, the pt developed nausea and vomiting. He also had myalgias. No fever, no URI, no diarrhea. Self treated after 24 hours. Bood in emesis. He will undergo endoscopy next week.
Shingrix was administered after being exposed to -21.7 degree C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix was administered after being exposed to -21.7 degree C).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The reporter was clinical office manager. The reporter called to report that Shingrix was administered after being exposed to -21.7 degree C, which led to incorrect storage of vaccine. The reporter did not consent to follow-up.
Information has been received from a nurse practitioner concerning a 28 year old male patient with no known drug allergies who in 2000 was vaccinated with a complete series of varicella virus vaccine live (site unknown). There was no concominant medication. On 07 AUG 2001 it was reported that a recent titer did not detect seroconversion. The patient sought unspecified medical attention. Additional information has been requested.
suspected vaccination failure; shingles; 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.   The patient's past medical history included shingles (had several times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. On an unknown date, the patient received Covid 19 vaccine. After receiving Shingles vaccine, the patient got shingles. The patient stated that, Shingles vaccine did not help, but the unbelievable vaccines that had helped was the vaccine for the COVID-19. The patient suggested anyone who was having the shingles was, to get vaccinated because it protected against other problems to amen for the vaccine for the COVID-19. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Cellulitis; Dermatitis; A reddish rash at the same spot of the vaccine; A reddish rash at the same spot of the vaccine; Itchy at the same spot of the vaccine; A lot of pain in the arm; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lot of pain in the arm, itchy at the same spot of the vaccine, a reddish rash at the same spot of the vaccine, dermatitis and cellulitis.  The patient's medical history was not provided. Concomitant medications reported were Hydrochlorothiazide, Pepcid (Famotidine)  drug used for unknown indication.  On 13-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced a lot of pain in the arm . On 21-Jan-2021, the patient experienced itchy at the same spot of the vaccine . On an unknown date, the patient experienced the events a reddish rash at the same spot of the vaccine, dermatitis and cellulitis.  The patient received antibiotics and prednisone for dermatitis and cellulitis. No treatment information was other events.  Action taken with mRNA-1273 in response to the events were not reported.   On 18-Jan-2021 the outcome for a lot of pain in the arm was resolved. The outcome of other events were recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever started approximately 55 hours after vaccination. Initially low grade, has become increasing and around 102.5-103.1 for the past 48 hours (72-96 hours) post vaccination. Fever continues this morning.
From telephone contact with PT's mother it was stated that a 20 y.o. female PT received Imovax Rabies, a Typhim VI and a Hep A (mnft'r not specified) vaccination on 7/26/01. Reportedly w/in 24 hrs the PT developed a headache, chills, fever of 104F and muscle aches.
On 6/9/99, the pt experienced a lack of response. Additional information has been requested.
patient stated she felt tingling,numbing in her left arm. She felt dizzy and stated she felt like she wanted to pass out.
Had immunizations on 1/2/01 and noticed swelling of lymph nodes under left arm on 1/4/01 and tenderness under left arm although enlarged nodes were not painful. States no increase in lump or other symptoms. Referred to MD.
Severe pain from my buttocks down to my toes; body aches and pains particularly in the knees; cough with yellow phlegm; severe diarrhea; tiredness.
Uncontrollable shaking began 4 hours after shot and lasted 6 hours, fever onset 5 hours after vaccine, fever spiked to 104.3 by 8 hours after vaccine then held at around 102.5-103 after taking Motrin, fever broke about 20 hours, headache for 24+ hours
Patient received vaccine 9/27/14 as IM on right shoulder. Patient stated she started experiencing pain to her right elbow. She states the pain is similar to tennis elbow. She stated that if occurred after the soreness in her shoulder had subsided.
Patient was found resting or slumped over steering wheel. He experience some ithing after 1st shot. He reported dizzy, itchy, woozy, spinnige sensations. Onsite EMS was called and took he to the hospital.
PT'S MOM CALLED TODAY TO REPORT THAT PT HAD RXN TO TDAP VACCINE RECIEVED YESTERDAY. REPORTS HEADACHE, NECK/JAW ACHE, WEAKNESS/FAITGUE. DENIES ANY REDNESS OR SWELLING AT INJECTION SITE. DENIES SOB OR DIFFICULTY BREATHING. PT'S MOM REPORTS THAT PT "BLEACHED TEETH OVERNIGHT" AND HAS ALSO BEEN "TRYING TO FIGHT OFF SINUS INFECTION". RECOMMENDED OTC MEDS (TYLENOL, MOTRIN, BENEDRYL) FOR S/S. INSTRUCTED TO F/U WITH PRIMARY MD IF S/S PERSIST AND TO GO TO ER IF S/S WORSEN. AGREED WITH POC. WILL F/U WITH PT ON MONDAY.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included SHINGRIX. On 6th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX and an unknown time after starting MOTRIN, the patient experienced pain in arm, headache, general body pain, fever, injection site swelling, injection site wheal and drug dose administration interval too short. The patient was treated with MORTIN and TYLENOL. On an unknown date, the outcome of the pain in arm, headache, general body pain and injection site swelling were not recovered/not resolve and the outcome of the fever was recovering/resolving and the outcome of the injection site wheal and drug dose administration interval too short were unknown. The reporter considered the pain in arm, headache, general body pain, fever and injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were provided as follows: On 7th March 2018, the patient received 1st dose of SHINGRIX. One month after receiving 1st dose the patient received 2nd dose of SHINGRIX in an unknown arm, which led to shortening of vaccination schedule. The patient experienced adverse events same night of vaccination, unknown how may hours after injection. It was reported that the arm in which the vaccination was received was described as really sore and site of injection swollen the size of a fist. Injection site was also welting up. The patient described her fever as high. Achiness was described as being full body. On 7th April 2018, the patient's body temperature was recorded as 102.1 degree F and on 9th April 2018, it was recorded as 99 degree F. The patient was managing issues by alternation TYLENOL and MOTRIN.
This case was reported by a nurse and described a 24 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three doses of Engerix-B (lot number not specified). Subsequently on 08 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Called to patient's side after receiving COVID vaccine, he became diaphoretic  and dizzy. He states he was feeling dizzy prior to receiving the vaccine, but  felt much worse immediately after. He denies n/v/chest pain/SOB. He denies any  palpitations.   On intial exam HR 120, patient diaphoretic, appeared weak, fatigued.  He was placed in wheelchair, declined stretcher, and brought to recovery area.  He had not eaten or had anything to drink. He tolerated juice without  difficulty. He reports feeling really nervous.   On exam he was found to be diaphoretic.  Heart was found to have irregular rhythm with pauses on auscultation.  Lungs mild wheezing throughout.   He is alert in oriented, but seems somewhat slow to respond. He is answering  questions appropriately overall.   He denies fever, chills, cough.   EMS activated.  Transferred to EMS stretcher upon EMS arrival with plan to go to
15-20 hours after the yearly vaccine, I passed out.  This is the second year in a row that this occurred.  I had all three initial shots and had minimal adverse reactions, however, the yearly vaccine in 2022 and 2023 saw a significant reaction many hours after the injection.
Red itchy circular rash around site of injection. 1-2 inches diameter. Resolved on own after ~2 days
He presented to the ED after having a syncopal episode with altered mental status. Also reports having some loose stools earlier in the day. Denies nausea, vomiting, chest pain or shortness of breath.  No prior positive COVID-19 infections.
patient developed severe pain in right arm at injection site of pneumovax. pain severe enough that not improved wth vicodin and unable to move arm d/t severe pain. pt states had some pain in right arm after injection. required ER visit
2 months after my Booster vaccine, I started notice symptoms of shingles. At first I felt funny and nothing was showing up on my skins surface. After getting checked by a P.A. they stated that I seemed to have shingles. I was then given an anti-viral prescription and started it right away. I took this prescription for the week long course and then also received prednisone for 5 days and then after a break for about 4 weeks and Gabapentin for the entire duration. These symptoms lasted from January to March. I still have red spots that are there however there is no more discomfort or pain.
headache; lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left); opposing arm also has swollen lymph nodes; lymph nodes by breast were swollen (left); soreness; dizzy; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness), DIZZINESS (dizzy), ASTHENIA (felt weak), HEADACHE (headache) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007521A and 015A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizzy) and ASTHENIA (felt weak). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness), HEADACHE (headache), VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)), LYMPHADENOPATHY (opposing arm also has swollen lymph nodes) and LYMPHADENOPATHY (lymph nodes by breast were swollen (left)). On 06-Mar-2021, DIZZINESS (dizzy) and ASTHENIA (felt weak) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (soreness), HEADACHE (headache), VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)), LYMPHADENOPATHY (opposing arm also has swollen lymph nodes) and LYMPHADENOPATHY (lymph nodes by breast were swollen (left)) outcome was unknown.            There was no concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-071037 (Patient Link).
This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a physician concerning a 17 year old female patient who on 27-JUN-2008 was vaccinated with first dose of GARDASIL (Lot # 660555/0279X) and on 13-OCT-2008 she received second dose of GARDASIL (Lot # 660555/0279X).  At an unspecified interval after her second dose she developed "allergies".  The patient went to an immunologist and allergist for these "allergies".  Both specialists diagnosed her with "psoriasis due GARDASIL".  Patient was currently beginning treatment for this condition but no specifics known.  At the time on the report on 21-JAN-2009 patient was not recovered.  Patient sought medical attention at the office.  Additional information has been received from a physician who reported on 12-JUN-2008 the patient was vaccinated with of GARDASIL (Lot # 660555/0279X) 0.5ml at 12:00 PM. The patient's outcome was unknown. Additional information is not expected.
Patient called today and stated she had rash, heat, and discomfort at site and around site of injection.  She will monitor it.  If it continues and does not resolve, she will follow up with prescriber.  She may use benadryl and an ice pack to decrease swelling and discomfort.
Case number PHEH2016US022997, is a spontaneous report initially received from a consumer on 07 Sep 2016. This report refers to a 55 years old female patient. Past medical history was not reported. Her current condition included common variable immune deficiency (CVID). Concomitant medications included prednisone and RITUXAN. The patient was vaccinated with single dose of FLUAD (batch number: not reported) at a dose of 0.5 ml intramuscularly on 06 Sep 2016. After vaccination, on 07 Sep 2016, she noticed that her arm was very sore (like a bad bruise) and the injection site was warm. It was reported that she was on high doses of prednisone and had a high dose RITUXAN on a day before this report. It was reported that the adverse reaction was not resolved as of 07 Sep 2016. Final outcome of the events was not reported. The seriousness of the event sore arm was reported as non serious by the consumer and for other events was not reported. The causality of the events was not reported. Follow up information received from a consumer on 07 Sep 2016: Updated events outcome.
Severe kidney infection. Pain in lower back; unable to work or function due to extreme toxic reaction. Bed ridden for 3 weeks.
Pt passed out within 1 min of vaccine and he also experienced "seizure like" activity for 5-10 secs.
Six month baby came in for scheduled Rotavirus vaccine.  Patient identified by full name and DOB. Patient was administered COVID-19, Influenza, PCV13, Rotavirus and Pentacel (Dtap, IPV, Hib) vaccines per MD order and with consent.  Rotavirus oral vaccine was administered prior to the remainder vaccines ordered per MD. Covid Moderna, Influenza, PCV13, and Pentacel vaccines were administered half hour later after careful monitoring of baby and were well-tolerated by baby.  This is the third scheduled Rotavirus vaccine baby has received in total in immunization history. Baby consumed Rotavirus vaccine by mouth without fussiness. Immediately became flushed with rashes appearing on both cheeks radiating to upper back. Dr. assessed baby head to toe with recommendations to first monitor baby for 20 minutes in room for any further adverse reactions, then to resume remainder vaccines administration, and for mom to follow up with PCP if any concerns.
School nurse notified of 4 X 4" red, indurated and blistered area of right arm.  Temp = 98.4.  Referred to family practice MD of choice.
1. Sharp Pain in left leg behind knee. Felt similar to nerve pain when leg cramps. Pain occurred randomly off and on throughout the day. 2. Nausea. Occurred 2-3 times throughout the day. 3. Nose bleed. Occurred 2x on 5/2 and again on 5/4.
REPORT REDNESS, PAIN SWELLING, ITCHINESS AT THE SITE OF INJECTION AND JOINT PAIN
Fever awakened at midnight after dose, sweating on head Then 30 minutes shaking with chills Then aches in practically every joint in body for several hours, including awareness between each disk in spine! Toes felt like each were exploding for several hours Fatigue  Ache around brain At 6:00 a. m. I took one acetaminophen 500 mg At noon on that Saturday, April 3, I took one more acetaminophen 500 mg   Remained in bed all day except small meals  Tired with some aches on Sunday, April 4. Interesting: during late Saturday and some on Sunday a random, joint ached suddenly fired then ceased: example right elbow, left ankle, single disk in spine.  About 4:00 p.m. April 4, Easter Sunday my energy was back and I felt better and resumed a couple of activities spraying pollen off my porches, off car, and off the garage floor.   Monday: awakened with slight headache, disappeared after breakfast.
(+) blood culture-Strep Pneumonia after 3 Prevnar. First given on 10/17/01 (lot 478322) and 2nd given on 12/13/01 (lot 484140).
4 1/2 hours after receiving flu vaccine, patient called to say she had all over flushing, intense itching and that a friend had taken her BP and it was lower than normal, she had also taken 50mg BENADRYL, she was instructed to go to ER if her symptoms continued or worsened.
Severe shortness of breath, administered inhaler, hydralazine  with no improvement. Dr. notified. Sent to ER
This case was reported by a physician and described the occurrence of influenza in a 54-year-old female subject who was vaccinated with Influenza vaccine, manufacturer unspecified. In October 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced influenza and vaccination failure. A physician reported that his wife, the subject, received a flu vaccine from an unknown manufacturer approximately two months ago, in October 2008. On 24 December 2008, the physician inquired about using RELENZA in the subject and noted the subject was immunized and still got the flu. The physician did say that the subject's throat was swabbed and it was identified as a B strain. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.