chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel really sick; Couldn't talk for a week; Can barely move; Diarrhea; Pain in arm and legs; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel really sick), DYSARTHRIA (Couldn't talk for a week), HYPOKINESIA (Can barely move), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm and legs) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (Feel really sick), DYSARTHRIA (Couldn't talk for a week), HYPOKINESIA (Can barely move), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm and legs). On 20-Mar-2021, DYSARTHRIA (Couldn't talk for a week) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, MALAISE (Feel really sick), HYPOKINESIA (Can barely move) and PAIN IN EXTREMITY (Pain in arm and legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included as Cold medicine.
< 4 hours after - numbness in tongue. 48 hours after - paralyzed in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. Headaches. Treated at office and ER, CAT scan, MRI and placed on steroids for testing of GBS or Bell's Palsy.
This case was reported by a physician via call center representative and described the occurrence of muscle pain in a adult patient who received 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 muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced muscle pain after receiving a dose of SHINGRIX. The health care professional had no information regarding patient and vaccine. This case is linked to case US2019000441, reported by same reporter.
client accidently received Pfizer vaccine for COVID vaccine #2 dose. Received Moderna for #1 vaccine dose.
7 pm 102.5 temp-103-104 temp during NOC Despite Ibuprofen- Vomited this AM Fussy-cranky-restless.
acute onset of high pitched unconsolable crying w/in 1 hr of immun crying persisted x 4 hrs became intermittent for another 2 hrs then ceased; no fever (sx pat appeared nl late in day (nl feeding, etc);
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 21-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 29-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown). The nurse reported the patient developed a headache and a fever one week (05-FEB-2013) after receiving a first dose of GARDASIL. The outcome of fever and headache was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information is not expected.
Cardiac Arrest Death Sepsis due to methicillin susceptible Staphylococcus aureus
Patient received her 2nd dose of Pfizer covid vaccine.  Approximately 5 minutes later, pt developed a severe headache and "hot streak" in her left posterior neck. She also reported blurry vision and pain and weakness in her left arm. EMS was called and pt was transported to Medical Center.
This case was reported by a consumer via Social Media and described the occurrence of vaccination failure in an unspecified number of patients who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be related to DTaP vaccine. Additional details were provided as follows: The age at the time of vaccination was not reported. The reporter stated that, actually, suspect vaccine was not working. The patients who are vaccinated against pertussis (DTaP) were becoming asymptomatic and were spreading whooping cough. This case was considered as suspected vaccination failure because the primary vaccination schedule and laboratory confirmation was unknown. The reporter had not given consent to contact them further.
no additional AE reported; a consumer received their 1st dose of VARIVAX on 10-MAR-2021 / they are receiving their 2nd dose of VARIVAX today, 10-DEC-2021; This spontaneous report was received from a pharmacist and refers to a 30 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2021, the patient was vaccinated with the first dose od varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # T006347, expiration date 20-FEB-2022 (formulation, concentration, site and route of administration not provided) for prophylaxis. The pharmacist reported that the patient was receiving their second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)(dose, route and site of administration, lot # and expiration date not provided) on 10-DEC-2021 (reported also as "today") (inappropriate schedule of vaccine administered). No additional adverse event was reported (no adverse event).
Shot received on 4/5 at 9:30am.  On 4/6 at 7:45am (approximately 22 hours later), I fainted, injuring myself.  I also vomited and experienced chills, fever, and fatigue.
I am in menopause and haven't had a period for over 6 months and started spotting on 4/7/2021 and still am. I have not seen my doctor about it yet but wanted to report it just in case it is related to the vaccine.
My reaction still hadn't subsided after my 1st vaccine, I was nervous, but knew I needed the 2nd one. I decided to get this one in my right arm instead. The same thing happened. My right arm started hurting really bad at my inner elbow, and I got another bumpy mass on my inner elbow. This mass wasn't as big as the left one had been. I haven't gone back to my Dr. because it was the same as before with no and a diagnosis.
SOB, FEVER, NAUSEA, LOSS OF APETITE, FATIGUE, PRODUCTIVE COUGH
Pin hole size itchy clear fluid filled blisters on hands, palms, fingers, wrists,  arms, legs, bottom of feet. Raised red spots and extremely itchy. Red raised itchy  rash clusters on left arm site of vaccination.
Pain; Allergic reaction/ allergy to Thimerosal; It burned going in; left arm was swollen, fevered, and red; left arm was swollen, fevered, and red; Swollen arms/the left arm was swollen; her arm was really swollen and blistered and the blisters popped immediately; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) intramuscularly on left arm on 11Jun2020 at a single dose for immunization, and also received unspecified products with thimerosal via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history was none. Concomitant medications were not reported. The patient ran a fever in Jun2020 and her arm was really swollen and blistered and the blisters popped immediately on 11Jun2020. The patient was wondering if this was one of the common side effects or adverse reactions and if so, does Pfizer know what ingredients were in it that she would be allergic to. Not uncommon for her, she had allergy to thimerosal and stays away from things/vaccines that contain it. They were not worse and just now clearing up, but she had a few blisters to completely resolve. They started from the shoulder half way down to the forearm. Could tell right away that she was going to have a problem with the vaccine when it went it because it burned on 11Jun2020 and the fever also started right away. Right afterwards the left arm was swollen, fevered, and red right away (on 11Jun2020). The next day it was twice as big, it was huge and she looked like she had Popeye's arm. It was really, really swollen and so she went to the pharmacist to talk about it and was encouraged to contact her doctor. First found out about allergy to thimerosal as a teenager and trying out contact lenses. The solution contained this product. Used paracetamol (TYLENOL) to treat the fever, pain, and swelling and used it for 3 days. For the blistering it stung, but after they popped they didn't sting anymore. Had blisters that started right after vaccine administration and popped immediately, it burned, caused swollen shoulder halfway down to forearm. The outcome of event fever was resolving, of blistered and the blisters popped immediately was not resolved, and of other events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
2-3 hours after receiving vaccine reported having a tingling sensation in face, head and arms, shoulders to fingertips. This has continued as of date and is intermittent lasting an hour and is not consistent in area.
I developed Bells? Palsy. I did not have any prior symptoms. I went to the doctor on 02/17/2023. I tested negative for COVID-19 twice and Lyme?s disease so we do not know why I got it. They also did an MRI to rule out anything else but everything was fine. I am still recovering from it.
lump on collar bone; This spontaneous case was reported by a consumer and describes the occurrence of lump on collar bone in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced lump on collar bone. At the time of the report, lump on collar bone outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.
Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient  Patient received COVID vaccine on December 31.
Fever 24 hours after the first injection. Took Tylenol and temperature has gone down.
Felt sick; Aches / Pains; Fever; Chills; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick), PAIN (Aches / Pains), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt sick), PAIN (Aches / Pains), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle aches). At the time of the report, ILLNESS (Felt sick), PAIN (Aches / Pains), PYREXIA (Fever) and CHILLS (Chills) had resolved and MYALGIA (Muscle aches) outcome was unknown.            No concomitant product reported by reporter.  Patient got the first and second shot for Moderna but not it was not clear if patient mentioned his first and second booster shot is from Pfizer or Moderna. It was reported that patient experienced muscle aches and normal side effects of the vaccine.   It was reported that patient received 4 moderna COVID-19 vaccine and experienced aches, pains, fever, chills, and he felt sick for a day or two afterwards.  No treatment medication reported by reporter.
got the vaccine. Then I had shingles AGAIN/ suspected vaccination failure; lost some hearing; 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 and shingles.   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), hearing loss (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, hearing loss and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the hearing loss to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles twice.  The patient stated he/she got the Shingles vaccine and had shingles again and lost some hearing from Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
administered a dose of Adacel that expired on 04Mar2023 with no adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years and 9 months old female patient who was administered a dose of diphtheria-2/ tetanus/ 5 AC pertussis vaccine [Adacel] that expired on 04mar2023 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W (with either Menactra or Menveo) for Immunisation.  On 19-Jul-2023, the patient received 0.5 mL dose of expired suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U6969AB; expiry date: 04-Mar-2023) via intramuscular route in the right deltoid for Immunization with no adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered a dose of adacel that expired on 04mar2023 with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Onset of severe fatigue and weakness of bilateral forearm extensor muscles and swelling/weakness of 1st interdigital webspace of both hands.
STOMACH ACHE; DIARRHEA; GROUCHY; SORE THROAT; FEELS MUSCLY; LEGS HURT; MUSCLE SORENESS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mitochondrial disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on right arm on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stomach ache. On 17-MAR-2021, the subject experienced diarrhea. On 17-MAR-2021, the subject experienced grouchy. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced feels muscly. On 17-MAR-2021, the subject experienced legs hurt. On 17-MAR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, diarrhea, grouchy, muscle soreness, legs hurt, sore throat, and feels muscly. This report was non-serious.
Facial numbness, right side uncontrollable movements, cant walk, cant feed himself, severe pressure on right side of head(migraine like) Vertigo,
Patient states initially had a small bump at injection site then reports 8 days later noticed redness at injection site that has continued to grow larger in diameter. Patient denies any nausea, vomiting, diarrhea, itchy throat or difficulty breathing. Patient advised to report reaction to the Vaccine Hotline and also to her family doctor. Patient verbalizes understanding.
I woke up on April 22 and could not feel or move my entire body. This lasted from the time I woke up (5:15am) until I was discharged from the hospital later that night. I was weak and in a brain fog the entire weekend (Thursday, Friday, and Saturday). I slept all weekend and have no memory of the entire weekend.
Rotavirus given at 4 mos of age and contraindicated to start first dose after 14 weeks and 6 days of age. Provider notified.  Parent notified and instructed per provider to call office if patient experiences any abdominal pain, increased fussiness or other symtpoms.
patient was treated with Paxlovid for COVID-19; patient was treated with Paxlovid for COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history. The patient has no known allergies. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient was treated with Paxlovid for COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spontaneous report from a contactable consumer, the patient.  A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 12:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation.  The patient's medical history included hashimoto's thyroiditis. Patient had allergies to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication.  On 05Mar2021 at 13:30, patient experienced very hot, flushed face and weak and feeling like legs were made of jello. This lasted for approximately 3 hours. On 05Mar2021, patient experienced merely nauseated. On 17Mar2021, patient underwent lab tests nasal swab (PCR) and result was negative. No therapeutic measures were taken for the reported events. The clinical outcome of the events very hot, flushed face and weak, feeling like legs were made of jello and merely nauseated was recovered/ resolved on 05Mar2021.    No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 6 year old male student who on 2/24/99 was vaccinated with a dose of varicella virus vaccine live. It was noted, the patient's mother reported that on 3/30/04 in the PM the patient developed a chicken pox breakout and by 3/31/04 he had 35-40 lesions. Additional information has been requested. The registered nurse also reported that the patient's brother developed a chicken pox breakout following vaccination with varicella virus vaccine live (WAES0404USA00505).
On February 3, I suffered a severe headache.  I have never had such a headache prior.  The next morning my eyes were spinning rapidly.  Contacted Dr., and she called in medication for vertigo.  Approximately 5 days later, I suffered both double and blurred vision.  I immediately visited with an Optometrist followed by an ophthalmologist.  Both did not see any problems.  Eventually, I was able to contact a neuro-opthalmologist.  She diagnosed me with Cranial Nerve Palsy 6.  As we awaited the MRI results, a week later my eyelid shut.  Visited an Eye Hospital.  There I was diagnosed with Myasthenia Gravis based on an ice cube test.  A week later, blood work for this disease was negative.  However, results associated with Thyroid Peroxidase were questionable (numbers were high).    I then visited with a neurologist.  Although she had nothing else to go on, she concluded with treatment for Myasthenia Gravis.  Further testing for this disease proved negative.   I have been taking prednisone since June 2022.  Clearly, the disorder is associated with my autoimmune system being completely out of control.   This condition has resulted in loss of clear vision in the right eye only.
night of shot and following 2 days: moderate tenderness and noticeable swelling in right deltoid but no redness.and slight increase in sinus mucus.   Up to current day, 1/15/2021, I have developed dull pain right shoulder joint and also noticed area of redness on right deltoid with continued visible swelling in the area/s of redness.  (three visible areas of swelling/redness in triangular pattern with top of triangle being the actual injection location)
Patient received Pneumovax 23 and Shingrix on 2-26-20 at approximately 2:47 pm.  Patient's wife called around 6:00pm to let us know that he had been having tinnitus for about an hour.  I called patient back around 6:30 after speaking with Merck and patient's wife stated that it had gotten better but not resolved completely.  I advised patient to seek medical attention if symptoms got worse or if he felt he needed to see a provider.  I called the patient in the morning and he stated that they symptoms had completely resolved and he did not have to seek medical attention overnight.