chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 17-year-old male patient. The patient's concurrent conditions pertinent, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date in July 2017, the patient was vaccinated with the first dose of VAQTA (dose, route of administration, #lot and expiration date were unspecified). On an unknown date in February 2018, the patient was vaccinated with the second dose of VAQTA (dose, route of administration, #lot and expiration date were unspecified). The pharmacist reported that the second dose was given only 5 and half months after the first dose. No adverse effect was reported.
A few months after the vaccine on 10/11, I woke up with congestion, a postnasal drip, a sore throat and extreme fatigue. I went to Inova Urgent Care and was swabbed for COVID, Flu, Strep all of which was negative. It had growth but all normal flora was present. A week later because I still wasn't feeling well so I reached out to my PCP who then performed all the same test. I had a little more growth but still all normal flora. And was then put on an antibiotic Sulfamethoxazole for 10 days but no improvement. A F/U a week later again the same test was performed and was still negative and it was declared at that time it was Allergies. Allergy blood work was taken but according to the bloodwork I have no additional allergies. Total IGE was 27 and for everything I was tested for was less than 0.1 showing what I am experiencing is not allergies. The following week I visited my PCP who now has referred me to see an ENT, but that appointment has not yet been made. On 9/11, bloodwork taken showed my liver enzymes were elevate where my Alkaline Phosphate was 160 and on 9/21 it was retested again and was 145 at that time, ALT-53 on 9/11 and 48 n 9/21. Glucose 110 9/11 and on 9/21 it was 106. My hemoglobin A1C was 6 and my GGT was 101 on the 9/21. The fatigue is so severe sometimes I can sleep 10-15 hours a day easily and I am still experiencing all these symptoms to date.
This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On 14-AUG-2016 ((two days too soon from the first dose), the patient was vaccinated with dose 2 of RECOMBIVAX HB) (dosing details not provided). Pharmacist reported that the patient received their first dose on 19-JUL-2016. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 20-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
acute dementia improved in an unbelievable way; acute dementia; This is a spontaneous report from a contactable consumer (patient's daughter) from a Pfizer-sponsored program. A 96-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced acute dementia (medically significant), and acute dementia improved in an unbelievable way (medically significant). The clinical course was reported as follows: The patient's daughter wanted to report that after receiving two doses of the COVID vaccine, the patient's "acute dementia improved in an unbelievable way." The patient went from being nonverbal and inarticulate, to becoming articulate and reading short words; something the patient's daughter had not seen in two years at least. The patient's daughter reported that there was only one change in her environment, which was the vaccine. The patient's daughter wanted to share her story and hoped this could help others. The patient's daughter stated: "I've seen anecdotal evidence and am amazed." The clinical outcome of the event, acute dementia, was recovering. The clinical outcome of the event, unexpected beneficial therapeutic response, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
40 hrs post immunization emesis then pallor, limp. Improved 15 minutes.
Autopsy report received on 12/19/2002 indicates gastrointestinal hemorrhage and intussusception. Additional info was received on 12/11/02 from an investigator provided medical history, revised event info and coroner's report. Info has been received from an investigator regarding a 5 month old male with a hisory of asthma and a recent history of ear infection and pneumonia. On 6/6/02, he was found unresponsive and was not breathing. Subsequently, he was taken to the hospital. On 6/8/02, he expired as a result of gastrointestinal hemorrhage due to small bowel intussusception. This was confirmed by the coroner's report. The investigator considers the intussusception and gastrointestinal hemorrhage to be "not related" to the study product or concomitant vaccine administration. The medical monitor's assessment is unknown. This case has been expedited per agreement with the FDA.
I had a rash appear and it was very itchy.  Discoloration on my skin at site of the injection. I called doctor, they said I should put a hot towel on it and keep the area clean and it should go away. My arm was sore.
Syringe leaked- less than 1/2 of the  vaccine was lost. Dose not repeated.
8th day skin reaction at injection site 1 inch in diameter - red, warm to touch, itchy 9th day redness increased to 3 inches in diameter, bulls eye appearance, applied steroid cream 10th day faded away
patient describes total body aches/ pains, diarrhea, upset stomach, nausea the night/early morning the vaccine was given
our fridge being out of range on 02Dec2022 for one hour; No adverse event; 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour).    No concomitant medications were provided by the reporter.  HCP  reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on 16-Dec-2022. Excursion happened on 02-Dec-2022 during 1 hour and minimum temperature reached was 1.2 A degree C.  No adverse events were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-695843, US-MODERNATX, INC.-MOD-2023-695862 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Non-significant follow-up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695843:Same reporter US-MODERNATX, INC.-MOD-2023-695862:Same reporter
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient with 1 siblings, birth weight of 8.3 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and influenza virus split virion 4v vaccine inactivated (FLULAVAL). The patient's concurrent conditions and medical history were not provided.   Since 12-FEB-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 08-DEC-2020, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot# T017686, expiration date 20-NOV-2021  subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
I lost consciousness, had a seizure and stopped breathing.  My husband had to administer rescue breathing to get me to start breathing again.
Runny nose 24 hours later cough 48 hours later - azithromycin feverish (hot/sweating) 5 days later but afebrile "erratic" sugar levels at home during next week.
Her toes ankle and feet were becoming discolored; Bottom of feet feel like ice; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Her toes ankle and feet were becoming discolored), PERIPHERAL COLDNESS (Bottom of feet feel like ice) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (Chills). On 23-Apr-2021, the patient experienced SKIN DISCOLOURATION (Her toes ankle and feet were becoming discolored) and PERIPHERAL COLDNESS (Bottom of feet feel like ice). At the time of the report, SKIN DISCOLOURATION (Her toes ankle and feet were becoming discolored), PERIPHERAL COLDNESS (Bottom of feet feel like ice) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) body temperature was increased.         Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.   This case was linked to MOD-2022-690879 (Patient Link).
NOV 12 DIZZINESS,SORENESS NOV 15 WENT TO CHOC HOSPITAL W/CHEST PAIN NOV 18 RECHECK W/PCP DEC 2 2ND COVID-19 GIVEN JAN 18 2022 STILL W/CHEST PAIN PCP DC W/COSTOCHONDRITIS
Chills, fever, sweats and body aches.  Symptoms started at 2.am. and are still present.
Suspected vaccination failure; expereinced  shingles now on right side under chin, usually on left side (herpes infection ); This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer. Concurrent medical conditions included white blood cell decreased.   On 7th December 2020, the patient received the 2nd dose of Shingrix. On 5th October 2020, the patient received the 1st dose of Shingrix. On 7th December 2020, the dose was an unknown dose. On 12th April 2021, 126 days after receiving Shingrix, 189 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had cancer 11 years before reporting date. The patient had ongoing low WBC (white blood cells). Past week before reporting date, the patient had shingles (herpes infection) on right side under chin. The patient used Valtrex for treatment of herpes, which patient's oncologist always wanted. The patient asked about what happened and asked if she need a booster dose. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. No lot information available. The reporter consented to follow up.
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 16-SEP-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-AUG-2013, the patient was treated by a physician at a clinic for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Pt was administered FLUZONE High Dose on Left arm (Bicep) claims that it's all black & blue.
pt recv vax & 1wk post vax exp a macular rash on arms & legs;ER or MD visit was required;tx periactin & pred;
Information has been received from a physician concerning an 8 year (reported as 14 year) old male who on 18-OCT-2004 and 20-SEP-2005 was vaccinated with the first and the second doses of MMR II respectively. On 29-NOV-2009 the patient experienced onset of symptoms. On 30-NOV-2009, the patient was diagnosed with mumps. The patient was afebrile and had bilateral parotitis. The other symptoms included pain under ears. On 03-DEC-2009, the patient was vaccinated with a third dose of MMR II (lot # 664363/05547). On 04-DEC-2009, the first blood work was performed (no results were reported). At the time of this report, the outcome of the patient was unknown. This is one of several reports from the same source. No further information is available.
Rash on stomach night of the vaccine as well as welts on my ankles. Several flare up of rashes and welts since and still happening. Have several pictures.
starting to get a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Apr2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. 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.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 03Apr2022, outcome "unknown", described as "starting to get a sore throat".  Additional information: Patient just had booster with the Pfizer vaccine (Further clarified as Pfizer COVID-19 vaccine) and patent was starting to get a sore throat. Patient was wondering could take any Ibuprofen."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Lump in neck and shoulder area; Lump in neck and shoulder area; Soreness around the lumpin neck/shoulder; Soreness around the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 8th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 9th September 2020, the patient experienced neck mass, mass and pain. On an unknown date, the outcome of the injection site pain, neck mass, mass and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix. The reporter considered the neck mass and mass to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. After receiving Shingrix, in evening the patient had soreness around the injection site, and this lasted a couple of days and then resolved. About 28 to 29 hours after receiving the Shngrix, the patient also had a lump in her neck and shoulder area and soreness around the lump.  The patient reported she went to her doctor about the lump and the doctor thought it was from the vaccine.  The reporter did not consent to follow-up.
Next day, swole to size of golf ball and left bruise. 1 week later, still slightly swollen and small bruise. Patient thinks vaccine maybe administered too high in arm?!
On 9/14/01 the pt began with low-grade fever, headache, and myalgias. On 9/15/01 the pt had a fever to at least 101.8 orally, eye pain, anorexia, abdominal cramps, myalgias and diarrhea and a white coating on tongue with peripheral erythema with loss of papillae. Fever abated by 9/16/01 and other symptoms resolved gradually by 9/19/01.
This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 65-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. On 22nd May 2018, 5 days after receiving SHINGRIX, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called to ask if a patient could get the chicken pox virus from receiving SHINGRIX. The health care professional stated that, a patient received SHINGRIX on 17th May 2018 and went to her physician on the day of reporting and was diagnosed with the Chicken pox virus. The pharmacist said the patient's physician told the patient that 1 to 2 percent of patients get the chicken pox virus from SHINGRIX. No further information was provided.
6 weeks after my secondshot while sitting at my desk t home I heard a very high tone sound that lasted for about a minute and then the sound volume went down and changed to a high pitch ringing in both my ears that has not gone away or stopped since
passed out; stiff; Initial information received  on 09-Feb-2021 regarding an unsolicited non-valid  serious case received from a other health professional.This is a courtesy case received from MERCK.  This case involves a 11 years old female patient who experienced passed out and stiff after receiving vaccines HPV VACCINE VLP RL1 9V (YEAST)[GARDASIL 9]and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE( lot number not reported) and a  dose of suspect HPV VACCINE VLP RL1 9V (YEAST) not produced by Sanofi Pasteur (lot number not reported) at an unknown dose via unknown route in unknown administration site for immunization.  On an unknown date, it was reported that after receiving the vaccine doses the patient became stiff (musculoskeletal stiffness) (latency: same day) and passed out (Loss of consciousness )(latency: same day).The patient was monitored in the office for about 30 minutes and then released home .   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events (passed out, stiff).  Outcome: Unknown for both events  Seriousness criteria: medically significant for Loss of consciousness