chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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.   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 and shingles were unknown.   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 age at vaccination was not reported. The reporter thought the shot gave you shingles. The reporter know someone who took the shingle shot and came down with Shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case has been linked with the case US2021AMR190886 reported by same reporter.
The patient reports that after the vaccine was administered, her right arm itched a lot, which was the one that administered the vaccine. She was evaluated and the medical control was called, who indicated that 50mg of intramuscular BENADRYL be administered. The patient begins to respond beneficially to it and is evaluated every 15 minutes. The patient reports feeling well and leaves the place.
Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 922YF, expiry date 07-MAY-2025) for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 97MR2, expiry date 11-OCT-2025) for prophylaxis.   In AUG-2023, the patient received Twinrix, Shingrix and Boostrix. In AUG-2023, an unknown time after receiving Twinrix, Shingrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion).The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2023 The reporter called to inform that on the month of August, Twinrix, Boostrix, and Shingrix were in an excursion where they were exposed to a temperature of 59.0 degree F that lasted 240 hours and all three products had been inadvertently administered to an unknown number of patients during the month , which led to incorrect storage of vaccine. The reporter was informed that GlaxoSmithKline had no data to support the stability of such products  Since in the facility they did not know that the products were not supported. The Vaccine Administration Facility was the same as primary reporter. The reporter did not have any details since the number of patients that received doses from the lot numbers that were in the excursion was unknown. The reporter consented to follow up.
This is a spontaneous report from a contactable other health care professional (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported),via an unspecified route of administration, administered on left leg on 31Jan2021 at 13:00 (reported as 01:00 PM) (at the age of 61 years old) as first dose, single for COVID-19 immunization. The facility where the vaccine was administered was reported to be "other". The patient medical history was not reported. Patient has known allergies with Bupivacaine on an unspecified date. The patient was not pregnant at the time of vaccination and did not receive any other vaccines in 4 weeks. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced ringing in ear on 21Feb2021 at 04:00 (reported as 04:00 AM). No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of event was not recovered. The patient received the second dose of BNT162B2 (lot number: not reported) via an unspecified route of administration, administered in left arm on 21Feb2021 at 01:15PM, at the age of 61 years old as second dose, single for COVID-19 immunization. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
(Note: these may be related to underlying insomnia, but felt it important to report in case needed). Strong tension headache occurred around 12:00am 10/25 until 4am. Felt more sick and tired than previous 2 days. Lethargic, fatigued, lesser headache. Had sensation of metallic taste on tongue around 2:20pm. Around 3:00pm felt a slight numbness/tingling on my left side cheek area. 3:20pm minimal acute pain between lower neck and collarbone left side body. Potential (hard to tell) numbness in arm. Lastly around 4:00pm tinnitus left ear lasting about 10pm. All symptoms subsided within an hour or less, aside from cheek sensation lasting about 2+ hours, and headaches on and off. No fever throughout the events (checked +3 times)
Started acting irritable and unhappy. Started to feel a little warm and weak. It is now 12/07/2014 at 10:15 AM, and patient has been up all night with varying degrees of fever (from 100- 104 degrees).
C/o fever (100.5), (R) para cervical neck pain. > onset 10/24/10 VAERS report requested by treating physician.
Developed tender mildly pruritic erythematous papules over bilateral hands, dorsal > palmar surfaces, onset approximately 18 days following receipt of SPV administered left deltoid on 4/3/2009; no mucosal surfaces involved; no systemic symptoms; seen first in ED w/diagnosis contact dermatitis; started on steroid burst by PCM 2 days later for dx possible HS reaction to SPV; skin biopsy taken (results pending); all symptoms resolved within 4 days (by 4/27/2009).  + hx sick contact exposure prior to vaccination, but he was well prior & day of vaccination; + hx orolabial HSV several mos ago (2008), fungal derm during teen years, &  childhood VARICELLA.  No new drug exposures except receipt of AVA #1, TYPHOID vaccine 3/23/2009; started MVI 2 mos prior; no prior vaccine, drug, latex, insect, or food allergies.  Received AVA #2 4/29/2009.  Symptoms: Lesions, papule, Pruritus, Tenderness.
NOT FEELING HUNGRY; FELT SCARED WORSENED/ANXIOUS WORSENED; OFF LABEL USE; TEMPERATURE OF 101; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included felt muscle aches in legs, and concurrent conditions included multiple sclerosis, numbness, tingling, visual disturbances, swollen ankles, trouble sleeping, crohns disease, not able to do things which friends could do, nausea, vomiting, felt anxious/scared, sometimes pain in stomach or abdomen, and eight watery stools/loose stools.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, The batch number was not reported. The company was unable to perform follow up to request batch number. expiry: unknown) dose was not reported, administered on 22-MAR-2021, and dose was not reported, administered on 22-FEB-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 22-JAN-2021 to 22-JAN-2021, and dose was not reported, 1 time every 14 days from 05-FEB-2021 to 05-FEB-2021 for crohns disease; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 19-FEB-2021 to 19-FEB-2021 for crohn's disease. No concomitant medications were reported.  On 2021, the subject experienced fatigue. On 2021, the subject experienced headache. On 23-MAR-2021, the subject experienced temperature of 101. Laboratory data included: Body temperature (NR: not provided) 101.01 F. On an unspecified date, the subject experienced not feeling hungry, felt scared worsened/anxious worsened, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 2021, had not recovered from not feeling hungry, and the outcome of temperature of 101, felt scared worsened/anxious worsened and off label use was not reported. This report was non-serious.
Fever, chills, headache, body aches, joint pain, light headed Treated with Tylenol and Advil
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use by Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxicillin allergy). Concomitant products included SALBUTAMOL SULFATE (VENTOLIN HFA) for an unknown indication.    On 06-Apr-2022 at 11:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 11:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested COVID positive within last month. The expiration date was 25 Mar 2022. Date and time the vial was initially stored in the refrigerator on 25 Feb 2022. Vial didn't undergo any temperature excursions. It was reported that the patient did not experienced any side effects yet. No treatment medication information provided
Seconds after vaccination patient showed signs of irritation (hives) on chest, neck, and upper extremities. No issues with airway. Treatment by provider included 0.3 mg of Epinephrine and 10mg or Zyrtec post medication patient visibly improved. Patient was held for observation for and hour.
Got shot, have it right now/ Suspected vaccination failure; Shingles in eye; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, have it right now/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in eye) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or She received Shingles vaccine and right now have wonder of shingles and even in his or her eye. The patient stated that he or she nothing like it and good luck. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
DIED; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 84 year old male. 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 not reported, batch number: 1821286, expiry: unknown) dose was not reported, 1 total administered on 16-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, the patient contracted Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). On 09-JAN-2022, the patient died. On 09-JAN-2022, the patient died from unknown cause of death. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 09-JAN-2022, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint number 90000213926.; Sender's Comments: V0: 20220150815 -COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. 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).  V0: 20220150815-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
24 hrs post/vax, pt had a brief tonic/clonic seizure; not associated with fever. No medication required.
No issues at injection site, no adverse reaction until 11/25@11 pm.  Rapid onset of severe chest pain after walking dog before bed.  Couldn't sleep.  Called 911 and took ambulance to ER at 3:30 am 11/26/2021.  Got EKG before leaving house and I believe it showed problem w/ rt atrium.  Upon arrival another EKG showed no issue w/ rt atrium, but a blockage (secondary?).  Received 81 mg * (3 or 4) aspirin, 100 units nitro, fentanyl and something for nausea in ambulance, and antibiotics when I arrived in the ER. Began feeling better, then admitted to hospital. WBC count was high.  After leaving hospital w/ antibiotics, WBC count was normal, but I developed a persistent cough, which got progressively worse as the day went on, and also worse each day.  Currently I have a persistent cough and shortness of breath.  I'm taking various day & night cough medicines, 200 units ibuprofen and 100 mg benzonatate, both 3 x/d, and my prescription meds for blood pressure and cholesterol. Note that I am supportive of the vaccines, think the m-RNA technology is a major positive breakthrough in medicine, and believe the staff are managing my care in a competent manner. I got the over 65 yrs old seasonal flu vaccine.  I have no idea which one or the exact date, but it was more than 2 weeks earlier than the pfizer booster.
12 seizures so far after getting 1st dose of coronavirus vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (12 seizures so far after getting 1st dose of coronavirus vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Seizures. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE SPRINKLE), CLONAZEPAM, LEVETIRACETAM, PYRIDOXINE HYDROCHLORIDE (VITAMINE) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (12 seizures so far after getting 1st dose of coronavirus vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (12 seizures so far after getting 1st dose of coronavirus vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event/s has been provided at this time.  Further information has been requested   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Headache, muscle aches, nausea, back pain, sore arm, chills, fever - began approx 20 hrs after injection, persisting into evening of day two.
All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my mouth, headache, sore arm, itchiness on legs and back, rash on inner thigh
Arm was itching. Warm to the touch, rash across the upper arm, raised, itchy, rough rash. Today, much less, not bothering as much.
Hospitalized with worsening dyspnea and O2 sats of 65% in ED. Acute respiratory failure, volume overload (missed dialysis appt),  COVID + on 1/6/2022.  COVID probably not as contributory to illness as missed dialysis session.
Information has been received from a 65 year old female patient with allergic reaction to LEVAQUIN and no other pertinent medical history who in April 2010, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). There was no concomitant medication. About a week after receiving ZOSTAVAX (Merck), the patient developed a fever blister on her lip. Then about three to four weeks ago the patient had itching, tingling, burning, or painful feeling starting from the corner of her right eye down to her chin. Then about two or three days after that, the patient developed one big bump in the middle of her cheek along with a few small bumps. The patient went to see her physician and from what she was describing, they thought the patient had the shingles so they give her acyclovir (manufacturer unknown) and prednisone (manufacturer unknown). The patient reported that she still had a numbing feeling that went from her pupil to the corner of her eye. The patient reported that she was going to see her eye doctor. The patient also reported while taking acyclovir (manufacturer unspecified), she had a burning sensation in the upper part of her stomach. No laboratory diagnostics studies were performed. At the time of the report, the patient was not recovered. No further information is available.
Administered vaccine to patient. Patient older than eligible age. Product guidelines say age less than 65 yrs old is eligible. Client is 65 yrs old.
Received 1st dose of Pfizer COVID vaccine on 1/6/2021.   On 1/11/2021 developed body aches, loss of taste/smell, rhinorrhea, and pharyngitis.  Positive COVID test.
Initial case received from a nurse practitioner on 29 October 2010. It involves inappropriate schedule of vaccine administration. A 5-year-old female patient received the following vaccines on 18 August 2010: a first right thigh injection of IPOL (lot number D0532); a third left thigh injection of DTaP (manufacturer and lot number not reported); and a first left thigh injection of MMR (manufacturer and lot number not reported). On 19 August 2010, the patient's parents reported that the IPOL injection site was red, swollen, slightly raised, and warm to the touch. On 25 August 2010 the family again called to report that the reaction had increased to a 3.5 inch area which was red, swollen, warm, and purplish in appearance. Per the parent report, the area eventually extended to a 5 x 6 inch area which lasted 5 days. The patient had no known allergies, no medical conditions, and had not experienced any reactions following previous DTaP vaccinations. Follow-up information was received from the health care professional on 18 January 2011. In addition to IPOL, the patient also received DTaP (GlaxoSmithKline, lot number AC14B091AA) and MMR II (Merck, lot number 0253Z) on 18 August 2010. Per the patient's medical record, the patient's mother called the physician on 19 August 2010 to report that the injection site was red and swollen and "the size of a peach". The area was slightly raised, but was not warm to the touch; the patient had no fever, and was acting normally. The mother was advised to give the patient TYLENOL or MOTRIN and to apply cool packs to the site 10-15 minutes at a time every 1 to 1.5 hours. She was instructed to call back if the patient did not improve. The patient received another dose of IPOL on 10 December 2010 with no associated adverse events. Per the reporter, the patient had received IPOL off schedule due to "parent choice".
15MAR98 pt had sz (grand mal) w/ fever to 104.3;PE nl for presumed viral exanthem;
Patient received PCV 13 vaccine on 4/5/2018 and reported that she started having fever 102 F on 4/6/2018 morning. It has decreased to 100.8 F in the afternoon of 4/6/2018. Patient also had sore arm but has decreased. Patient denied allergic symptoms, headache, dizziness chills, SOB, hives or any other discomfort on 4/6/2018 afternoon.
pt recvd vax & exp inject site pain, edema & induration 4-6 hrs later; pt was treated w/warm compresses & APAP;
Severe pain at site for 1 week 2 days, headache for 1 week 2 days, joint pain all over day 2-day 6, all over body aches day 2- day 4, fatigue & tiredness 1 week 2 days, nausea day 1- day 3
A non-serious spontaneous report of swollen neck on both sides and abdominal pain has been received from a health professional concerning a 14-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 30-Nov-2011. On 07-Dec-2011, the patient experienced abdominal pain which persisted on 13-Dec-2011. Both sides of the patient's neck was swollen. The outcome of the events swollen neck on both sides and abdominal pain was not recovered.