chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  74yo male patient died on 11/23/2021 of unknown causes or circumstances. Patient did not receive medical care from the clinic. Patient did receive 2 covid vaccines from the clinic on 2/22/21 & 3/22/21. This death is likely not related to the vaccinations due to pt's advanced age, and length of time from vaccine administration.
Patient presented to local ER at approx. 18:20 with complaints of flushing, hot, short of air, feelings of "pin-needles from mid chest up". Also C/O throat being "slightly scratchy". Symptoms were reported to have begun around 16:00. Noted on Emergency Provider Record dated 11/6/19, that client had flushing to face/neck/chest with no lesions noted. No Swelling of the neck, trachea midline, no respiratory distress, heart regular rate rhythm. "Adverse Drug Reaction: - suspect Pneumonia Shot, was discharge diagnosis. Continue steroid use + Claritin daily x1 week was discharge meds. Patient discharged home on 11/6/19 @ 22:10.
Pt left the clinic and returned 5 minutes later. Wife stated she drove 1 block and her husband passed out. Pt was very diaphoretic, showing seizure-like activity. He could not answer questions. Called 911 and pt was in his automobile during this time; then went to hospital in private car per recommendation of EMT's. Follow-up call stated that pt all ok.
injection site pain, tiredness, Headache, chills, swollen lymph nodes, feels very unwell
I have developed a facial spasm/tremor/twitch on the left side of my face, on my cheek. Wearing a mask or CPAP makes it worse, but it persists even when I haven't been wearing a mask. Dr. advised taking 500 mg Naproxen twice a day and avoiding Fexofenadine ( as well as Topamax, which I was no longer taking). He has referred me to a neurologist at medical center who I will be able to see on 07/26/2021, possibly for a Botox injection. The spasms are uncomfortable and annoying and sometimes leave my cheek feeling sore.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were as unspecified.
Left Upper are red and swollen area 2"x2" AM of 6/9/05, which then extended around shoulder radius of skin. No evidence of infection.
Pt developed large localized hives at injection site, 18 days, post vax. followed by generalized fine, red, papular lesions of trunk on the 18th day, which disseminated over entire body. He was seen at the clinic and treated with Benadryl prn. Lesions are present, 2 weeks after office visit with itching.
Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling.  He had severe headache afterwards, dizzy and blurred vision.  04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to.  Wife called 911 and was talking and walking.  Was awake and talking in ambulance, oxygen level was low.  Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism
Patient was fine after vaccine. 10 days later noticed 2 bug bites at same site of injection. They were infected due to scratching. MD asked us to report.
Received the first dose on 1/15/2021 approx 10:15 am.  I noticed I had ringing in my ears that started later that evening.  The ringing is constant and has never gone away since the first vaccine.  I received the second dose on 2/5/2021 and the ringing just continued on.  It is now May 6th and I still have the constant ringing in my ears.
LIVER DISORDER; POTASSIUM HIGH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; BLOOD CLOT; This spontaneous report received from a patient concerned a 72 year old female of an unspecified race and ethnicity. 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, intramuscular, batch number: Unknow and expiry: Unknown) dose was not reported, 1 total, dose 1 (1 in 1 once) administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 8 decade old. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknow and expiry: Unknown) dose was not reported, 1 total, dose 2 (1 in 1 once) administered on AUG-2021 for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, frequency, and therapy dates were not reported for psoriatic arthritis; and metformin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 2021 (Date and month unspecified), the patient experienced blood clot. On MAR-2022, the patient experienced liver disorder, and potassium high. Laboratory data included: Potassium (NR: not provided) High (too high). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and metformin was not reported. The outcome of the liver disorder, potassium high, blood clot, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220553660- covid-19 vaccine ad26.cov2.s- blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
she can't even move; neck pain is unbearable; has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally; shoulder pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (she can't even move), NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain). On 10-Jun-2021, the patient experienced MOBILITY DECREASED (she can't even move). The patient was treated with OMEPRAZOLE ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (she can't even move), NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information received on 10-JUN-2021 contains Significant information: Events, Concomitant and Treatment medications and Vaccine Doses updated
Was scarcely even sore from shots; 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.   The patient's past medical history included shingles (Family History) (patient's cousin had shingles (on face)).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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: 27-FEB-2023 Reporter's comment: The case  was received from the patient via interactive digital media. The patient had received the Shingles vaccine and was scared even sore from shots and did not changed his/her routine. The patient reporter that his/her cousin had on his/her face, so why to take a chance. Additional supportive information: The follow-up could not be possible as no contact details were available.
Contracted Covid 6 month after vaccine. One day after vaccine I woke up weak with body ache; develop fever cough continue into the second day when breathing deep caused me to cough and body ache continued. On the fourth day symptoms subsided, the fifth day I began to feel better. I was prescribed PAXLOVID. Negative Covid results 12/27/2022.
Initial report received from a health care professional on 16 Aug 2010: This patient was vaccinated with MENVEO (batch unknown), intramuscularly on an unspecified date. The reporter stated that the patient received only liquid portion of the MENVEO. No associated illness occurred. CDC advised to repeat both vaccinations with complete product. The outcome of the event was not reported. Follow-up report received on 19 Aug 2010: The patient's demographics, treating physician's information and vaccine lot number (090701) were provided.
My child received the only shot she's had since her birth which is the mandatory vitamin k shot in the state. Her symptoms began at birth with jaundice and 7 to 8 months later when she began to walk, the same leg where she received her vaccination was is now suffering from nerve damage. Her foot and ankle is affected and is not functioning properly for a child her age, as if something neurological is blocking her from using her foot properly.
Child had significant balance issues starting the day after the vaccine was administered. He will walk a few steps and then loses his balance out, which was not happening prior to vaccine. Pt. continues to have these symptoms as of today.
2 days after immunization had seizure episode. partial seizure. Lasted 3 to 5 seconds and has been eating normal ever since with normal exam today 12/11/06.
itchiness at the injection site; swelling at injection site; redness at injection site; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at injection site), MYALGIA (muscle soreness) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MYALGIA (muscle soreness). On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at injection site), MYALGIA (muscle soreness) and VACCINATION SITE ERYTHEMA (redness at injection site) had not 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 relevant concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccines administered on 02/07/2002 am. Pt's mother states "no problems" until 02/08/2002 pm. Infant had elevated temp of 103 deg. F. Tylenol given through the night. On 02/09/2002 am, child seized one time and was taken to emergency room. Motrin/Tylenol given in ER.
sore arm; some aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Family history included shingles (grandmother had shingles).   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced pain in arm (Verbatim: sore arm) and pain (Verbatim: some aches). The outcome of the pain in arm and pain were resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Flu vaccine.     It was unknown if the company considered the pain in arm and pain to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023AMR049524   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 after hearing the horror stories about the shingles and he or she pray for anyone who had or has the shingles. The patient stated that his or her grandmother had shingles and it took 3 months to fully recover from it and the pain was unbearable. The patient stated that go and get the shingles vaccine it was just like getting a flu vaccine sore arm and some aches for a day we shall worth from the vaccine. Follow-up would not possible as no contact details were available. This case is linked with US2023AMR049524, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR049524:Same reporter
Narrative:  90 YOM with family history of VTE and personal history of lymphoma (followed every 6 months by oncology in 2021, no current therapy in October 2021) developed idiopathic DVT and Saddle PE, diagnosed 11 days after his first Moderna COVID-19 vaccine booster given on 9/17/2021, but wife notes that symptoms started within 2-3 days after booster. Patient was admitted to MICU after he presented to ED with leg pain, chest pain and dyspnea. He was treated with enoxaparin and was switched to Eliquis for discharge. Date of discharge summary 10/18/2021. Patient continues Eliquis 5mg PO BID. Sonogram 9/1/22 shows improved clot burden.
Patient fainted post-vaccination.  Observed patient beginning to lean forward and RN was able to prevent her from falling.  Patient's eyes observed to roll upward while patient became unresponsive to stimuli and diaphoretic. No incontinence.  EMS called while patient assisted simultaneously to gurney by multiple staff.  Upon lying down, patient awoke and become alert and oriented to person, place, time, and situation, though stayed pale and diaphoretic for several minutes.   VS @ 12:55: BP 120/80, P 59, SAO2 99%, resp unlabored. VS @ 13:00:  BP 138/83, P 62, R 20, SAO2 99% VS @ 13:04:  BP 123/73, P 54, SAO2 99% VS @ 13:10: BP 100/69, P 78, SAO2 98%  Sitting at edge of bed without symptoms at 13:05, alert and conversing with staff and mother. EMS arrived at 13:07 - their monitor showed NSR, random blood sugar = 93. Ate a snack and drank juice, symptoms completely resolved.  Mother declined transport to ED. Discharged home with mother with post-vaccination instructions, will receive 2nd dose while lying down.
Severe fatigue, dizziness, nausea, headache, backache, pain in arms, pain in hips
minor rib pain; This is a spontaneous report from a contactable consumer (patient himself). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that with the first dose, he felt fine. Then on an unspecified date, patient reported having received his second Pfizer Covid vaccine dose. When he went to get the dose he had some minor rib pain. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
74 years old female (09/04/1946) got her moderna vaccine on 03/03/2021 @1300. patient reported that on 03/06/2021 @0400 she woke up with cloudy vision on both eyes. patient reported on 03/06/2021 she went to the eye doctor to check on her eyes.  Patient reported 03/07/2021 she developed a black plaque on her left eye lead to vision loss in the left eye. patient was send to the hospital stayed there for 3 days she was diagnosed with stroke in the eye. patient reported penicillin allergies. patient reported  no medical history. patient reported no current medications. patient called, because she wants help to get all her paperwork and the labs she have done during her stay at the hospital, to provide it to her ophthalmologist during her appointment on Monday. patient was instructed to call the hospital or to call the department of health to get the lab results.
A 68-year-old patient was inadvertently given his second booster prior to the recommended interval of 4 months.  Dates of doses:  2/19/21, 3/12821, 12/10/21.  The fourth dose was given 7 days early.
While walking around store child broke out in rash and hives, face and arm began swelling. Difficulty breathing.
Redness and swollen at injection site. Redness is down from injection site to elbow and warm to touch. 1 pt, he only experienced soreness and redness on day of injection, and worst starting 3 days ago.
This spontaneous report was received from a licensed practical nurse regarding a 12 months old patient of an unknown gender. On 27-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion") (Incorrect product storage). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000128: US-009507513-1708USA010196: US-009507513-1710USA011199: US-009507513-1710USA011203: US-009507513-1710USA011201:
Client reported feeling warm/flushed. Swelling and tenderness along with heat assessed at injection site in L deltoid. Stated that he had tingling in R arm and up neck with first dose for approx. 2 hours.
Blurry vision, near syncope after receiving vaccine. Onset of symptoms was 3-4mins after vaccine administration. Did not eat breakfast this morning Given juice and crackers Exam was normal Discharged to home
expired dose of MENACTRA was inadvertently administered to a patient today with no adverse events; Initial information was received on 28-MAR-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.   This case involves a 16 years old female patient who experienced expired dose of menactra was inadvertently administered to a patient today with no adverse events while receiving vaccine 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 28-Mar-2022, the patient received  0.5 ml of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (formulation and strength: unknown) ) (lot U6874AB, expiry date- 21-FEB-2022) via intramuscular route in the right arm for Immunization.  On 28-MAR-2022 the patient developed a non-serious expired dose of menactra was inadvertently administered to a patient today with no adverse events (expired product administered) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of menactra was inadvertently administered to a patient today with no adverse events.  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.
Information has been received from a consumer who posted her granddaughter's experience on internet on 13-NOV-2009. It was reported that the patient received one dose of GARDASIL (lot# not reported) and hadn't been right since. She had been in doctor's office 3 times since shot and diagnosed with flu, virus...-yet 6 weeks later she was still ill. She had stomach upset, headache, very tired (she even looked tired...dark circles under her eyes, pale, listless). She broke out in shingles 3 weeks after shot. Her joints/muscles ached. But, most alarming was the partial paralysis in fingers and toes (worse in toes). Her toes literally cramp up and curl under towards her foot. Most recently she has a vaginal infection and possible urinary tract infections (UTI) (going to get that checked tomorrow).  At the time of this report, the patient's outcome was not reported for the patient's shingles. Upon internal review, partial paralysis in fingers and toes was considered to be an other important medical event. Additional information has been requested.
Pt was described as extremely irritable, unable to sleep x 36 hrs p/inject, then for next 36 hrs was very lethargic, sleeping continuously;