chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported lightheadedness within 15 minutes s/p vaccination. Instructed pt to lay supine in car seat with lower extremities elevated. Pt reported resolution of sx within a few minutes. Consistent with mild vasovagal reaction.
Pregnant medical assistant splashed Shingrix into her eye; splashed Shingrix into her eye; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of occupational exposure to product via eye in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2022, the patient received Shingrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Shingrix at an unknown time during the pregnancy. On 8th April 2022, unknown after receiving Shingrix, the patient experienced occupational exposure to product via eye. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the occupational exposure to product via eye and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up.       Additional Information: GSK Receipt Date:   08-APR-2022 Reporter's Comments: The pregnant medical assistant splashed Shingrix into her eye. The health care professional disconnected from chat after providing information. Additional Supportive Information: As the pregnant medical assistant splashed Shingrix into her eye, which led to occupational exposure to product via eye and vaccine exposure during pregnancy.
Swelling of Face, Neck, Chest, Back, and leg on left side. Headache, confusion, mild chest pain with in 10 minutes after receiving the vaccine. Benadryl, steroid.
Red and swollen at injection sight. This occurred over 24 hours after the shot. It was sore the day of the shot but then started swelling the next day. It?s warm to the touch, swollen and red 3 days after the vaccine. Will be interesting to see how long it lasts
RECEIVED SHINGLES SHOT ON 4/9/08. HAD A RASH TO (LT) HIP/THIGH. CLIENT CAN'T REMEMBER IF SHE DEVELOPED RASH BEFORE OR W SHOT. REALLY NOTICED IT TO BE PAINFUL ON 4/12/08. WENT TO ER ON 4/14 - NO DIAGNOSTIC TEST DONE.
Body/muscle aches. Headache. Fever. Hands trembling. Body trembling. Nausea
6-8 hours after injection, localized swelling and pain at injection site, heightened elbow and back pain(sore prior to shot), headache. The headache and joint pain subsided in a day, the localized swelling and pain at injection site lasted 4 days. At day #8, inflammation at injection site-itchiness and swelling which increased on day 9.
pt recvd 2 doses of vax & lab eval 6-7wks post vax revealed 11 neg titers & 6 equivocal titers;
injection site soreness; headache.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Program. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 30-years, on 13Apr2021 at 9:00 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included headache that usually from dehydration, stress, and/or hormone-related fluctuations during menstrual cycle. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient's concomitant medications were not reported. The patient experienced injection site soreness and a bad headache after the 2nd dose of the COVID-19 vaccine. The headache developed overnight after receiving the vaccine and she woke up with a headache on 14Apr2021. Events outcome was unknown.  Information on the lot/ batch number has been requested.
Initially large sore swelling on deltoid area. Then extreme malaise starting in 6 hrs, then severe sinus issues for 2 days, then dry chest cough starting 3rd day.
severe neck pain along the side; Pinched nerve feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 15:45 (Lot number: EM9809) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. The following information was reported: NECK PAIN (non-serious) with onset Feb2021, outcome "not recovered", described as "severe neck pain along the side"; NERVE COMPRESSION (non-serious) with onset Feb2021, outcome "not recovered", described as "Pinched nerve feeling". Therapeutic measures were not taken as a result of neck pain, nerve compression.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
Redness, hardness; red hard lump by injection site also on face & possibly back. Went to clinic 8/22/11; vomiting, chills. Possibly fever (very warm) sweating.
Initial misuse report received from a healthcare professional on 10 July 2013. A child patient of unspecified age had received only DTAP-IPV component from PENTACEL. The ACTHIB component of PENTACEL was not given. No adverse event was reported. List of documents held by sender: none.
This case was reported by a physician via sales rep and described the occurrence of neurologic reaction in a adult male patient who received FLUARIX QUADRIVALENT. In October 2015, the patient received FLUARIX QUADRIVALENT. In 2015, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced neurologic reaction. On an unknown date, the outcome of the neurologic reaction was unknown. It was unknown if the reporter considered the neurologic reaction to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: In 2015, on an unknown date, 1 day after vaccination, the patient experienced sciatic nerve reaction.
Pain at shot location after vaccine; swelling in upper left arm at shot location after vaccine; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 08:45 (Batch/Lot number was not reported) at the age of 62 years old as 1st dose, single dose for COVID-19 immunization. Medical history included glaucoma from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included celecoxib (CELEXA); latanoprost; escitalopram oxalate (LEXAPRO); atorvastatin calcium, ezetimibe (STATIN EZ); taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021 23:30, the patient experienced pain & swelling in upper left arm at shot location 7.5 days (as reported) after vaccine dose 1. No treatment was received for the adverse event. Outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient was nauseated 10 minutes after dose, proceeded to have tingling in feet first, then legs and arms that moved into abdomen as well.  Pain and extreme heaviness in arm shot was administered in. Ice packs were placed on arm and back of neck. Patient then stated after another 10-15 minutes that breathing was becoming labored and then both hands drew in and locked unable to move them. EMS was called at this time and EPIPEN was readied but not administered. Patient continued to communicate tingling was coming and going and after another 10 to 15 minutes breathing eased up and tingling in lip and body was fading along with able to move fingers but not thumbs. EMS arrived and took all vitals and cleared patient. About 15 minutes after patient was able to leave on own accord.
Information has been received from a physician concerning a 16 or 17 year old female who on an unspecified date was vaccinated with Gardasil (lot# unknown). On an unspecified date the patient had a seizure at home. Medical attention was sought. The patient went to the emergency room and her pediatrician ordered unspecified tests. The patient may have received an IUD (intrauterine device) at the same office visit as the Gardasil vaccination. At the time of reporting it was unknown if the patient had recovered; "there has been no determination on the seizures". No other details were available. upon internal review, seizures is considered to be an other medical event (OME). Additional information has been requested.
Instant wave from head to toe of dizziness.  Headache began within a few minutes of injection as a dull but constant headache with pressure of entire head.  Headache worsened off and on the next 3-4 days but the pressure headache has always remained constant.  OTC did not work.   High blood pressure started with the headache following initial injection.  Blood pressure has been high since 11/3/2021.   Arm soreness for about a week, very painful and difficult to raise above shoulder but only limited to right bicep.  Dizziness and fatigue was very strong for first 2 weeks, both continue now.   Major fatigue, chills, body/muscle/joint aches continue.  Chills continue along with feeling hot and flushed (fever-like but not high temperature). Menstrual cycle changes:  cycle began 11/3/21, and one week after cycle, on 11/15/21 I get another cycle (on 3rd day now).  This began one month prior, when my husband received his first dose of Covid-19 mandated vaccine21 days +/- previous to my first dose.  Menstrual cycle changes have changed the last two months.
This spontaneous report received from a patient via a company representative via a social media concerned a patient of an unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, after 10 days of vaccination, the patient experienced clot. It was reported that "JNJ contact me if you'd like to discuss the clot I developed 10 days after your vaccine". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: vaccine ad26.cov2.s-Clot. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I got extremely itchy, and at the clinic they kept me for 30 mins and gave me Benadryl and gave me a Epi pen if I needed to use it.  I stayed itchy all day, it wasn't until the next morning I was ok and not itchy, I just had a headache for about 12 hours. I took Tylenol to help with the  headache.
Case number PHEH2015US020217 is an initial spontaneous report from a pharmacist received on 08 Oct 2015. This report refers to a 18-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 06 Oct 2015. On 08 Oct 2015, the patient was inadvertently vaccinated with FLUCELVAX (batch number: 173253) intramuscularly. No adverse event reported following this medication error (inappropriate schedule of vaccine administered).
needle malfunctioned retracting and an underdermined amount of vaccine was released from syringe after giving dose. followed cdc guidelines and adminstered anohter full dose the same day in the opposite arm
tested positive for COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-AUG-2023, the patient received Arexvy (intramuscular). On 21-AUG-2023, 3 days after receiving Arexvy, the patient experienced covid-19 (Verbatim: tested positive for COVID).The outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Arexvy.   It was unknown if the company considered the covid-19 to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-SEP-2023 The patient reported that she received the Arexvy vaccines at a local pharmacy.  The lot and expiration date were unknown.  The patient reported that she tested positive for Covid. No additional information was provided. Not all information was available.  The customer did not provide consent to follow up with healthcare professional.
pt recv vax; staring w/ dec responsiveness for 1 hr;no sz, no loss of consciousness; dec ?; tone
My 19 month old daughter had the Hep A Vaccine on Wednesday and about 5 hours later she had no appetite, vomiting, diarrhea, lethargy, disrupted sleep, irritability, fever and green discharge from one eye. She has had these symptoms for 2 1/2 days now.
Red spots (looked like ring worm) all over, my neck, back and chest. Occurred three weeks after vaccination, scab still present. Fifth week and spots appear larger and more abundant, scab still present, no treatment.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 28-JAN-2015, the patient was vaccinated with first dose of VAQTA (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. On 23-JUL-2015, the patient was vaccinated with second dose of VAQTA (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. The reporter stated that the second dose was administered too early. No adverse effects were reported.
Mother called our clinic to report rash (chickenpox in nature). Pt not ill appearing. Treat with calamine lotion.
within a week of injection,  I noticed a linear rash on my hand up to my mid forearm. this rash continues to come and go as of today (10/8).  No new soaps or lotions had been used.  Diagnosis is perivascular dermatitis.
Information has been received from a nurse concerning a 4-year-old male who on approximately 05-JUL-2007 was vaccinated with a 0.5 milliliter dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 657188/0431U).  On approximately 06-JUL-2007, the patient experienced redness and swelling at injection site.  Unspecified medical attention was sought.  The outcome is reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
Symptoms of TMJ, including extreme bouts of jaw pain and difficulty opening the mouth fully. Patient has never before had TMJ. Symptoms have this far continued for 8 days and persist even after a 5-day course of 400mg ibuprofen (Motrin) thrice daily.
Headache, queasy stomach, fatigue, started date of vaccine, Tues. 12/29/2020, a few hours after I received the vaccine, and lasted until  Sat., 1/2/2021 (5 days)
Had 2 injections for COVID Pifzer vaccines given on 14/01/2021 and 1.4.21 mainly possible myocardictis due to vaccines -New cardiac murmur
pt recv vax & exp intermittent heart block on 13OCT97;pacemaker inserted;
Began with systemic symptoms of headache, nausea, tingling/numbness of left arm. Then developed difficulty with walking describing that his legs "felt heavy".
Hives/rash on chest/lower abdomen, itching palms, resolved in 2 hours with 50 mgs of Benadryl.
Pt's left thigh became red, warm and swollen on 4/5/06 when pt awakened in AM. Gradually worsened. On 04/06/06 10x6cm red warm, swollen area. Pt came back to our office for exam. Zyrtec 1 tsp q/2 if size increases ABTS.
sick feeling; shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAR-2023, the patient received Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: sick feeling) and shivering (Verbatim: shivering).  The outcome of the feeling unwell and shivering were unknown.   It was unknown if the reporter considered the feeling unwell and shivering to be related to Shingrix.     It was unknown if the company considered the feeling unwell and shivering to be related to Shingrix.   Additional Information: GSK Receipt date: 03-Mar-2023 The reporter stated she was visiting her register pharmacist (RPH) for medical guidance.  The reporter states her the RPH reported to her that he had gotten a dose of Shingrix and was experiencing shivering and a sick feeling. Did not consent to follow-up.; Sender's Comments:  US-GSK-US2023034610:same reporter
Seen in Uniontown Hospital ER for pain, swelling and redness posterior left arm.  Started on Keflex.
RAPID ONSET OF NAUSEA, DIZZINESS, MALAISE, FATIGUE
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N003997, expiry date: 20-OCT-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  Vaccine expiration date was reported as 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included reporter details.
received Pfizer COVID-19 vaccine and tested positive for COVID; received Pfizer COVID-19 vaccine and tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. 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 "unknown" and all described as "received Pfizer COVID-19 vaccine and tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive for COVID. Clinical course: Patient was updated with vaccines and stuff but just tested positive. Patient works in a nursing home (further clarification unknown) but tested positive for COVID. Patient's aunt advised to call the number for medication for COVID (unspecified medication; unspecified if taken).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms began with scratchy throat and hoarseness, dry itchy eyes, after about 1 hour chills and fever began, fever maxed out at 102 degrees and continued through the night. Upon awaking at 7 am hives began and continued until about 1 hour after administration of t capsule  25 mg Benadryl, fatigue and muscle aches continued throughout the day 09/07/2014.
Immediately felt like her skin was on fire.  She then felt light headed following and still feels light headed and dizzy, her skin is tingly and she has had fainting spells where she blacks out and doesn't remember what happened along with shaking uncontrollably.  She has been seen in the emergency room and has had numerous tests done and is about to undergo even more tests.  She was a very healthy athlete upon getting this immunization she is not.
49 y.o. healthy female received Typhim-Vi 12/16/11 c/o fatigue 12/19/11, vertigo 12/20/11 and diarrhea 12/20/11. Reported symptoms 12/22/11 - vertigo persists, improved with meclizine.
I felt ok after injection all the first day.  During nigh had chills.   Woke with right arm soreness, great fatigue and headache pain (6-9/10) not constant, nausea, vomited once.   In bed all day w/ HA pain and fatigue.  Next day felt much better without symptoms, just a bit of tiredness.
This spontaneous report as received from a 61 year old female registered dental hygienist (R.D.H) refers to herself. The patient had no pertinent medical history and no drug reactions/allergies. On 19-FEB-2014 the patient was vaccinated with ZOSTAVAX vial (dose, route and lot# unspecified). No concomitant medication. On approximately 02-APR-2014 (reported as "6 weeks" after receiving ZOSTAVAX), the patient experienced neuropathy mainly in her toes that was very painful. The patient did not seek medical attention. No lab diagnostics studies were performed. No treatment was given for the event. The registered dental hygienist stated the neuropathy came and went and if it affected her walking she would consider it a significant disability. Additional information has been requested.