chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in her arm) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect products included non-company products VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) for an unknown indication.    The patient's past medical history included Welts (Twenty-flve or thirty years ago she had a TB test with ppd. After that test, her entire arm "blew up" instantly with a giant welt.). Previously administered products included for Drug use for unknown indication: Flu Shots, TD and Typhoid. Past adverse reactions to the above products included No adverse event with TD and Typhoid; and Pain in extremity with Flu Shots. Concomitant products included CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) for an unknown indication.   On 09-Sep-2022, the patient received dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in her arm). At the time of the report, PAIN IN EXTREMITY (little soreness in her arm) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: Negative. On an unknown date, Tuberculin test: test was contaminated with something.         Patient dermatologist gave her a shot Of cortisone and she took antihistamines. Both her dermatologist and internist were not sure if the Fluzone HD could be the cause, especially with the 4-day delay Of onset, however the patient could not think of anything else that she might had been exposed to that would have caused the hives. When the hives began, they started in the armpit of her right arm at that same level as the injection site. She discussed her previous experience with other vaccines as to how it was so unusual for her to had hives after Fluzone HD QIV. She received Moderna Covid vaccines. The bivalent Covid booster a week ago caused her to have a little soreness in her arm. All of the  other Covid boosters did not cause problems for her. She has taken vaccines against pneumonia without problems. Twenty-five or thirty years ago she had a TB test with ppd. After that test, her entire arm blewed up instantly with a giant welt. She was told at first that she had T B. A follow-up chest x-ray was negative. It was realized that she did not have TB and that instead something was wrong with that test. She later had subsequent ppd tests without reactions. No treatment medications were provided.   This case was linked to MOD-2022-679659 (Patient Link).
About 8 days later, after covid agot started having a hard time breathing doing normal things such as talking or even going on a walk. Also had light chest pain. I normally run 3 to 4 times per week so this was not normal.  The following day after the shot I felt like I had  bad covid again (dec 2020) but I recovers after 48 hours.
Headache, Sedation, Myalgia, Arthralgia, Fever, LOSS OF TASTE AND SMELL X 3 DAYS, ANOREXIA Narrative:
He had a fever the night of the vaccination. His arms and legs were jerking involuntarily while he slept, often rotating one arm to the next, to the leg and so on. Prior to these vaccinations he was able to sit very well, and also would push himself up on his legs very easily while we were balancing him, and did it at every opportunity. After the vaccinations, he was unable to sit by himself without falling over, and refused to push himself up most of the time. When he did push up, his legs would buckle under him very quickly. He was crying with a very unusual high pitched cry. We took him to the emergency room in the middle of the night due to his high fever, where they assessed him as "normal" since his temperature went down. We were told that fevers could be caused by vaccines, but the limb flinching and muscle weakness were mostly ignored. Over the next few days we continued to monitor him, and his muscle weakness did not improve. He went from pushing himself up on his legs very easily and strongly pre-vaccination, to barely being able to hold himself up for a second, and his legs like jelly, giving way easily. The day after vaccinations, he started having long periods of staring, and not responding to anything we said or did to get his attention. We took him to the pediatrician, and on the way, we caught a video of him in one of his staring episodes, not responding to us at all. The doctor saw this video, and was concerned, so sent us to a neurologist the same day. The neurologist examined him, but he did not have any staring episodes during the examination. She considered him to be "normal", because she was not aware of his previous strength, and how much he had weakened post-vaccination. We were sent to pediatric neurology at the main Clinic campus to stay overnight, and have an EEG overnight. The doctors also considered him "normal", because they were unaware of his normal temperament and physical strength. They thought his post-vaccination weakness and temperament were simply "normal for his age". We were sent home, and he continued to be abnormal for about 2 weeks. Over the next couple of weeks: - he would wake up in the night screaming constantly - he continued to be very weak in his legs, refusing to push himself up where he used to do it constantly - his eyes would roll back in his head randomly, and often look very dazed - he continued to have abnormal twitching in his sleep, different from normal sleep movements - His urine and poop smelled like chemicals for 8 days - His poop was frothy and green for 14 days.
Arthritis worsen; Body ache; Headache; A spontaneous report was received from a consumer, concerning a   70 years-old, female patient, who received Moderna's COVID-19 vaccine and experienced body ache/Myalgia, headache,her arthritis worsen/arthritis.  The patient's medical history include arthritis. Concomitant product use was not provided by the reporter.  On 21-feb-2021, prior to the onset of events, the patient received their planned dose of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 21-feb-2021, the patient experienced body ache, headache,her arthritis worsen. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, body ache, headache, worsened arthritis, were unknown.; 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. Further information has been requested.
Patient runny fever of 103 degrees F about 14 hrs after immunizations given. Mom gave pt acetaminophen & cool bath.
Dizziness, itching of entire arm for days, migraine and nausea, sore muscles and fatigue for days, sinus pressure and pain, small rash at site
devel hives all over except for trunk;works in allergists office so called MD on call;pt was given DPH for 48hr although the hives lasted only 24hr;
Patient complains of black and blue bruise mark on the site of injection which has progressively gotten worse since she first noticed it on the day of injection. She measured the size to be approximately 2 inches around. She is worried since she assumed the bruise would disappear in few days but only appeared to get worse since the bruise mark got much bigger in size. She has applied ice around the site of injection but has not used any medication to treat it. She does not report of any pain, burning, or itchiness, rash or any other side effect from the site of injection.
glaucoma; This is spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot and was scheduled to receive the second dose on 27Jan2021 however, she has an eye surgery for glaucoma scheduled on 22Jan2021 and 25Jan2021. The patient wanted to know if she re-schedule the eye surgery. The outcome of the event glaucoma was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Information has been received from a health professional concerning a 30 year old female who was vaccinated with the first and second doses of varicella virus vaccine live. Subsequently, the patient showed a negative titer 4-6 weeks after the second dose. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional info has been requested.
This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # and expiration date were not provided). The doses were exposed to temperatures of -9.5 degrees C for 1 hour and 43 minutes, and then were administered. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.  The case was reported by patient's a friend The age at vaccination was not reported. The patient was vaccinated with Shingrix. The patient had flu-like symptoms begin within 12 hours after the shot and resolved after 1-2 days. The reporter did not feel comfortable giving her friends' initials or their ages. The reporter provided limited information. This was 1 of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245582:same reporter US-GLAXOSMITHKLINE-US2020245591:same reporter US-GLAXOSMITHKLINE-US2020245580:same reporter US-GLAXOSMITHKLINE-US2020AMR246337:same reporter US-GLAXOSMITHKLINE-US2020AMR246110:same reporter
I got very sick from my second Pfizer Covid shot.  (Chills, Low grade fever, nausea, vomiting on and off for a few hours, and extreme fatigue the next day) The next day I noticed a buzzing in my ear.  It continued on and off for the next few months.  On Nov. 08, 2021, I got my booster.  I got sick again.  The buzzing in my ear returned and at times is worse than ever.  The lot number of that shot is FH8028.  That shot was given at pharmacy at 10:00 am.  I am seeing Dr. an ENT.  He prescribed two nasal sprays and ear drops. I do have some sinus issues.  He also removed ear wax from my ears.  However, after using the nasal sprays and ear drops for a few weeks the buzzing continues.  Some days the sound is softer, but is constantly there.  I am scheduled for a hearing test in a few weeks.
expired vaccine given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Hepatitis A vaccine (batch number unknown, expiry date 12th December 2021) for prophylaxis.   On 1st July 2022, the patient received Hepatitis A vaccine. On 1st July 2022, unknown after receiving Hepatitis A vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment: The reporter stated that an expired Hepatitis A vaccine was accidentally given to one of their patients. The reporter asked did they need to re-administer a non-expired Hepatitis A vaccine. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Hepatitis A vaccine which was already expired, which led to expired vaccine used.
Child fussy evening post vaccine adm. On about 7-10 days later he had jerking of right cheek for few seconds occurring several times a day. Lasted 1-2 weeks with increased intervals and symptoms lasting for longer times. Saw neurologist who diagnosed Focal Seizures and ordered Trileptal medication Bid. In late Sept, one month later, childs hands and arms jerked along with facial symptoms. Referred to  Hospital Neurologist who diagnosed Infantile Spasms and prescribed Vigabatrin 5mg Bid along with the Trileptal.  Child has had no seizures for 2 months and so on 12/5 Neurologist stated he could continue all shots and sent along a Rx.
pt recv vax & 24hr later the devel an inj site rxn characterized by: redness, warmth, swelling & pain; rxn resolved on it's own w/in 2-3 days;this is one of three pt, from the same site, reporting a similar rxn;
Dizziness, lightheaded, struggling to find everyday words when speaking.  This occurred an hour or so after the vaccine.  Right arm was very sore for 24 hours.  The following day (Wed, April 7) while I was putting gas in my car, I had a strange experience.  I was in the car, which was in park.  I felt as though the car was moving as I was sitting in it at the pump.  I kept holding down the break, but then realized I was still in the same spot.  Very disturbing sensation.  Since that day I have experienced periods of faster heart rate, dizziness, lightheadedness, and vertigo.
NURSE INJECTED 2 FLUARIX SHOTS INTO MUSCLE AND DID NOT INJECT THE COVID 5-11 YEAR OLD VACCINE ON 11/18/2021
Presented to EC c/o nausea & vomiting on 04/24/21; discharged back to Facility on 04/29/21.
Pain at injection site, high fever seizure, brain damage, stopped eating, stopped talking, stop potting and went back to diaper's and went back to bottle. Pt still does not speak and still is not potty trained. He has and will always have problems his entire life time.  4/17/07 Received medical records 10/99-10/06 from hospital/clinics which reveal patient received monthly IVIG w/steady but slow improvement. Followed in Rheumatology clinic, ortho.  Had an episode of urticarial rash & LOC 8/05 requiring overnight hospital stay, no dx provided & no further episodes.  Had 1 bout of right otitis media.  Occasional episodes of agitation & rarely aggressive. FINAL DX: static encephalopathy, developmental delay, autism, eating disorder, speech delay, arthralgias, spondyloarthropathy, difficulty walking, sleep disturbance, fatigue & IgG deficiency.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Tested and positive; (29Jun2022) negative, notes: I was previously negative 29Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical information: Vaccine has been received and other medication in 2weeks too. Paxlovid has been taken on 22Jun2022 and stopped on 26Jun2022 for COVID 19 Treatment. Other medication details includes Armor Thyroid (brand=Armor). Patient was tested for COVID-19 and is positive. She was previously negative on 29Jun2022.  No follow-up attempts are possible. No further information is expected.
IMMEDIATELY AFTER RECEIVING THE BOOSTER THAT WAS REQUIRED BY MY JOB TO GET I WAS DIZZY, LETHARGIC AND ACHY, SO MUCH SO THAT I HAD TO CALL OUT OF WORK FOR THE REST OF THE WEEK. I HAVE NEVER CALLED OUT OF WORK MORE THAN FIVE TIMES IN THE 35 YRS. I HAVE WORKED AS A NURSE.  AT THE END  OF MARCH BEGINNING OF APR. I NOTICED MORE HAIR IN MY BRUSH THAN USUAL.  WHEN I WENT TO THE HAIRDRESSER FOR MY SUMMER CUT IN JUNE SHE NOTICED SEVERAL BALD PATCHES. AND BY THE MIDDLE OF JULY I WAS COMPLETELY BALD AND HAD NO BODY HAIR ANYWHERE.
pain in arm; tiredness; achy; mild headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, tiredness, general body pain and headache. On an unknown date, the outcome of the pain in arm, tiredness, general body pain and headache were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in arm, tiredness, achy and mild headache. The patient asked how long do some of side effects generally last.
Please see above.  On both first and second Moderna vaccine administrations, approx 2 days after the shot I had a swollen left axillary lymph node followed by an intensely itchy rash.
Throat swollen, and neck swollen, hard to swallow Thyroiditis, sore throat, could not lift neck due to severe pain,  heart palpitations, achy flu symptoms, chills, fever and nervousness and shacking. Feels like something stuck in throat and  muscle. Started  29 to current as I type this today Nov 11, 2021
Symptoms first started 3 weeks after the first injection. Symptoms are best described as mild-moderate and constant lightheadedness/vertigo/dizziness. They came on slowly the first week and escalated that by the end of the second week to the point where I went to the emergency room. EKG and all bloodwork came back normal, I have prescribed meclizine which had no effect. Symptoms vary slowly improved over the course of the next 2 months, at which point progress stagnated. Still feel light-headed constantly, have difficulty focusing, and have felt nauseous in the past, but that has improved. Made worse by caffeine and alcohol. Benadryl and Sudafed seem to have helped in the past, but only for a few days before their effects wear off.
Patient had Pertussis-Like syndrome with paroxysms of coughing starting 1 week after injection and lasting for 4 weeks.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of PEDVAX HIB (route, dose and frequency not reported, lot # L014429, expiration date 15-MAR-2018, lot # reported as L042386, expiration date 24-AUG-2016, lot # M014925, expiration date 16-FEB-2019). The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit) and 225 minutes in low temperature (34.1 Fahrenheit) (the total cumulative time in high and low temperature was reported as 342 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited case received from other non-health care professional on 10 Aug 2017. This case involves around 4-5 patients (age, and gender not reported) who were vaccinated with a dose of PENTACEL (Batch number, expiry date, dose, dose in series, route, and site of administration were not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, around 4-5 patients developed Pertussis over the last 12 months. The patients' relevant lab tests and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review the company decided to consider the case as serious due to important medical event Pertussis. List of documents held by sender: none.; Sender's Comments: The patients experienced pertussis post vaccination with Pentacel. The time to onset was not known and the event is listed with the vaccine. This case was not considered to be a case of vaccination failure as no information regarding dosing or lab confirmation via PCR or serology was provided. Based upon reported information the role of the vaccine can not be assessed.
Was reconstituting it and the syringe where the lurer lock placed on the adaptor broke off; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF7708, Expiration Date: Feb2025) for immunisation, Device Lot Number: GY5692, Device Expiration Date: Feb2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Was reconstituting it and the syringe where the lurer lock placed on the adaptor broke off".  Causality for "was reconstituting it and the syringe where the lurer lock placed on the adaptor broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for "She was reconstituting it and the syringe where the lurer lock placed on the adaptor broke off and she was unable to use it." for ABRYSVO INJECTABLE (VACCINE) is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury.
Patient said she experienced atrial flutter later that evening. She reported that it went back into normal rhythm in a day and a half. She stated she would contact her cardiologist to discuss.
Within 3 hours of vaccination developed dry cough, scratchy dry throat, blurred vision, bloodshot eyes with mucous formation; severe headache developed & stayed all night with ringing ears (tinnitus). Blurred vision & cough subsided in 4 hours from onset but headache continued until next day.