chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the Shingles after the shot/Suspected vaccination failure; received the Shingles after the shot on the face; left with nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated he/she experienced the shingles after the shot on the face and was left with nerve damage. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Pt was sitting for observation, after 8min, pt suddenly fell to lateral side, pt denies head trauma. IM Rx and Technician responded immediately.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Vomiting-Mild, Additional Details: Five minutes after administration of vaccine, patient who was sitting, began feeling dizzy and faint. The pharmacist on duty was notified who rushed to observe the patient. The patient's temperature and blood pressure (found low) where checked and EMTs were called. Patient experienced an episode of vomiting, but no difficulty breathing at any time. After being evaluated by emergency services, the patient was deem well enough to not go to the hospital. No other occurence.
Bad headache day after shot. Then headache came and went, not too bad until 4.21.21. Sharp pain behind right eye. Dr ran labs, and all look ok. But today, 2 weeks to the day of shot, my headache came roaring back ad bad as day 1. Most pain is behind forehead and eyes. Finally took advil...But pain is not gone. Worst pain is behind right eye. I've never had migraines before. I'm tired of the pain.
This spontaneous report as received from a healthcare worker regarding to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-MAY-2015, the patient was vaccinated with expired dose of RECOMBIVAX HB (lot # H017800, expiry date 01-JUN-2014) (dose and route were not reported). No adverse effects were reported. The outcome of the events was unknown. Additional information is not expected as the reporter did not wish further contact.
his wife is bedridden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:   A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: MOBILITY DECREASED (non-serious), outcome "unknown", described as "his wife is bedridden".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
outbreak of shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but it was selected as an adult as per the vaccine indication. After receiving 1st dose Shingrix, the patient had a new outbreak of shingles. The reporter consented to follow up.
Injection given too high in arm resulting in pain, soreness & loss of range of motion in the shoulder. For example, unable to lift arm higher than shoulder level because of extreme pain. Unable to sleep on left side. These symptoms still persist as of this submission.
isn't immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (isn't immunocompromised) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Penicillin allergy.    On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (isn't immunocompromised). At the time of the report, OFF LABEL USE (isn't immunocompromised) outcome was unknown.            Caller reported that her husband takes lot of medications , but she doesn't know the names of them.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles/ blistering vesicular outbreak, which was diagnosed as herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 07-APR-2008, he was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at county health department, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-FEB-2017, he was treated by the physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The pt was prescribed hydrocodone and valacyclovir hydrochloride (VALTREX) for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
tested positive for Covid-19; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On 11-Jul-2021, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-257895 (Patient Link).
A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine). On 23-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
started feeling soreness on the second day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (started feeling soreness on the second day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (started feeling soreness on the second day). At the time of the report, PAIN (started feeling soreness on the second day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-134044 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-134044:wife's case
DID NOT GIVE BIVALENT AS 3RD DOSE gave regular as 3rd Dose. NO REACTIONS
nausea - seven hours after injection general malaise - day 2 arm and shoulder swelling and pain - day 2-3  after injection, some residual swelling on day 4 very strong tinnitus - day 3-4 after injection
Filling sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just received dose of Shingles vaccine last night of reporting and felt sore but better than he/she would, if he/she got shingles. Additional supportive information: The follow-up would not possible, as no contact details were available.
This spontaneous report as received from a researcher via market research agency refers to a 30 year old male patient. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and frequency not reported). Other co-suspects and concomitant medication was not reported. It was reported that the patient was sick for a month (dates unspecified). The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Patient states about one day after vaccine she had an itchy neck with some redness. On 9/15, she woke up with very red neck "like she just got radiation", itching and lip tingling.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-MAR-2014 (also reported as today) the patient was vaccinated with second dose of PROQUAD (Merck), 0.5 ml subcutaneously (lot number unknown, expiry date 23-FEB-2014) (dosing regimen and frequency unknown) which had expired on 23-FEB-2014. No adverse event was reported. The action taken with the therapy with PROQUAD (Merck) was unknown. No product quality issue was reported. Additional information has been requested.
Fatigue; Feeling like "I" will throw up; Unable to get out of bed; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, the patient experienced fatigue, was unable to get out of bed and felt like she would throw up. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, unable to get out of bed and felt like she would throw up were unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pain in left upper arm since day 3 after injection.  It hurts to raise left arm or move it into certain positions.
Pfizer BioNTech COVID 19 Vaccine EUA - After waiting the 15 minute observation time in our clinic, patient proceeded to car.  Patient became dizzy, got out of car and returned to clinic.  Provider assessed patient as a vasovagal reaction. AFter 30 min additional observation time, symptoms resolved and patient was discharged to home.
Patient reports "such bad heart palpitations I thought I was going to die". She called her "anxiety doctor" because she said that she had no primary care doctor. The palpitations were so bad she thought she might go to the ER. Then they stopped.
Has a red welt on his left leg, is 2 3/4' when mom measured it is warm to the touch, no fever. Tylenol, is not tender, isn't itchy. Portax 3ml 256 x 5/8" for DTaP B-D 1ml 276 1/2 for MMR.
CONFIRMED COVID-19 INFECTION; SUSPECTED VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity unknown. 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: Unknown) dose not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that on an unspecified date, the patient experienced confirmed covid-19 infection, suspected Vaccination Failure. On an unspecified date in Jul-2021, the patient died from confirmed covid-19 infection. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Suspected Vaccination Failure was not reported. This report was serious (Death).; Sender's Comments: V0-20210808115-covid-19 vaccine ad26.cov2.s-Confirmed COVID-19 infection. 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). 20210808115-covid-19 vaccine ad26.cov2.s-Suspected Vaccine 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: CONFIRMED COVID-19 INFECTION
patient was 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported. Pharmacist realized that she vaccinated a patient that was 17, but turning 18 before the patients second dose.   This case was linked to MOD-2021-283794 (Patient Link).
Starting about one month after the bivalent booster, I started having heart palpitations, mostly at night. The palpitations would wake me up, and usually would subside on their own after 3-5 mins. However, after about a week the palpitations were lasting longer, so I lowered my thyroid medicine dose from 30 mg/day to 22.5 mg/day.  After lowering my thyroid dose, the heart palpitations happened less frequently, but are still happening one to two times per week. I stopped taking the multi-vitamin and the digestive enzymes in case there was something in there that was making my heart sensitive.  But, that did not seem to improve the issue. My estrogen and progesterone levels are monitored regularly with lab tests, so figure that's unlikely to be the problem. My thyroid levels are also monitored regularly, and if anything, showed that my levels were a little low when tested in September. So, should not be experiencing HYPER-thyroid symptoms now.  Was looking at everything else I was ingesting in my life, wondering if something accidentally had iodine in it that was making me hyperthyroid, but didn't find anything. Then, yesterday, I read that the covid vaccines have been reported to occasionally cause irregular heart beats. So, I decided to report this in case it is related to the vaccination.  One other thing that might be relevant, when I got this booster, it had only been 3 months since my 4th booster, which was also a Moderna booster. I had some foreign travel coming up, so I got the bivalent booster even though it hadn't been the recommended six months in between.
Patient received one dose of Moderna vaccine on 4/22/21. Today 4/23/21 facility where the patient resides discovered the patient had already been fully vaccinated with 2 doses of Pfizer vaccine in February 2021. Patient is asymptomatic at this point in time, facility will continue to monitor.
Approximately 10 minutes after the client received his first dose of Pfizer COVID-19 he became dizzy in observation.  Client was placed in supine position on the ground and his legs were elevated.  Vital signs were taken and patient was monitored by clinical staff.  When asked, patient stated that his last meal was at 10:30AM.  Client was recovered quickly and was given Gatorade.  He was able to sit in a chair under his own power.  He was monitored for an additional 30 minutes and assessed by our on-site doctor once again before he left with accompanying girlfriend.
52 year old female patient received a dose of GARDASIL 9; No adverse effects reported; This spontaneous report as received from a pharmacist refers to a 52-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical site, lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Last dose was on 10/25/21 booster dose was due 3/25/22 . was given on 1/23/22
Redness and swelling, gave antihistamines was not see at our clinic for reaction.
I developed itching initially at the site of the injection only that was persistent with some fatigue.   By the next day I was itching all over.  I took cetirizine 10mg and it resolved completely after about 1 hour.  No other symptoms after the 1st shot.
Disorientation; Chills / Teeth chatter; Fever; Body ache; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (Disorientation), CHILLS (Chills / Teeth chatter), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DISORIENTATION (Disorientation), CHILLS (Chills / Teeth chatter), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Disorientation, Chills, Fever, Fatigue and Myalgia, at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disorientation), CHILLS (Chills / Teeth chatter), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-056490 (Patient Link).
Administered after FDA removed the emergency use authorization for monovalent boosters. Submitting as directed via CDC meeting on 9/1/22.
25APR96 approx 15-20mins p/vax pt began vomiting, itching & runny fever;tx w/APAP, tepid baths;26APR96 low grade fever, itching, red rash on neck, back, armpits;activity level-nl;tx APAP, fluids;
Persistent hypotension since second vaccine.  Multiple near syncopal episodes and one syncopal episode.  11 lb weight loss.  BP used to always be in the 115/80 range.  Now it is persistently in the 90s systolic.  increased dietary salt intake without benefit.