chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 18 Jan 2010: This patient received a dose of H1N1 influenza virus vaccine (manufacturer and batch number unknown) on 11 Jan 2010. Almost immediately after vaccination, the patient's blood sugar levels jumped to 300 mg/dL. It was unknown whether the patient was a diabetic or had a previous history of high blood glucose levels. Outcome of the event was not reported.
very mild soreness at infection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "molds allergy" (unspecified if ongoing); "dust allergy" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "some foods allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "very mild soreness at infection site".  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives developed within 10-25 minutes.  Patient taken to the emergency department.  Patient complained of itching all over and chest tightness.  Patient medicated with 60mg of prednisone, 40mg famotidine and 50mg of diphenhydramine, and 0.3mg IM of epinephrine was ordered but the patient accidently received 1mg IM.  Medication error paperwork completed internally.   Patient complained of a sore leg at the injection site after receiving the 1mg of epinephrine.   Increased HR resolved after epinephrine metabolized.
Pt had a positive COVID test on 8/28/22 in ED; treated outpatient with Paxlovid; back to hospital on 9/4/22 with worsening cough, dyspnea; given ABX; mild fever; sputum cultures positive for Moraxella; treated with ABX; CXR showed acute PE; renal function worsening; dialysis; no improvement; opted for comfort measures and transitioned to GIP, pt passed away in the hospital
Increased heart rate this morning normal heart rate 60's. This morning 120 when waking up. Now at 80's.
Left arm pain and neck pain worsening over the 9th of August to where she did not want to move her arm.
Information was received on 06-APR-2017 from a nurse regarding 73 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 29-AUG-2016 the patient was inadvertently administered a dose of GARDASIL 9 (lot # not reported). No adverse effects were reported. No further information was provided. Action taken with GARDASIL 9 is not applicable and the outcome was unknown. The nurse did not rate the causal relationship. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and frequency were not reported) lot # K023623, expiration date 20-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 67 year old male with no relevant medical history or illness at the time of vaccination who on 05-DEC-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of Pneumovax 23 (lot 655152/0889F).  On 05-DEC-2006, the patient was concomitantly vaccinated intramuscularly in the left deltoid with a dose of FLUVAX (lot U2199AA).  On 06-DEC-2006, the patient developed redness and swelling at the injection site.  The patient presented in the office on 07-DEC-2006.  The patient's arm appeared swollen, and he was instructed to place ice on his arm.  Subsequently, the patient recovered.  The nurse requested a lot check be performed on lot 655152/0889F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  No additional information is expected.
patient reported low-grade fever, muscle aches, exhaustion, and blotchy/red arms around the injection site, she also said that there was some warmth to her arms around the spot of injection
range of motion is limited; has a hard time sleeping at night due to the pain; immediately experienced a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose and immediately experienced a sore arm.  The soreness had not resolved and his range of motion was limited.   He said he had a hard time sleeping at night due to the pain. The reporter did not consent to follow-up.
Patient stated that there was no pain on injection, but had bleeding continue when she arrived home. Called pharmacy the next day. Redness, swelling in area. Said she had a " fever" in her arm.  Told her to use ice and take Tylenol and I would check back with her, She came by the pharmacy later that day, Redness at injection site, possible allergy to bandaid adhesive, swelling extends down from injection site. Told her to continue ice packs and acetaminophen.
Pt recv vax on 2/2/99; 15 min post vax pt exp limp/pallid episode, breathing stopped for a few seconds, white color
Pt was seen in our office 5/27/14. Mother states 1 week before pt had hair loss, redness and burning. Pt was also seen in our office 6/10/14, 7/30/14, 8/3/14. Pt has also been seen at other medical facility.
Red rash over whole body; 2 types (red papular and red erythematous rash. Also redness and pain at injection site with low-grade fever X 4 days.
No adverse event; The patient was administered the 1st dose of GARDASIL 9 on 18-JUN-2018. the 2nd dose on 03-JAN-2019 and the 3rd dose on 27-JUN-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported.  On 18-JUN-2018, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N028092, expiration date: 28-MAY-2020; on 03-JAN-2019, with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R008163 expiration date: 18-NOV-2020; and on 27-JUN-2019, with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602283, expiration date: 18-AUG-2021 (reported as 16-AUG-2021) (route of administration and anatomical location not provided for any dose) all for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
RLE swelling starting ankle then progressed to knee.  Associated with pain in the Achilles tendon with ambulation.  Severe enough to prevent sleep.  Went to the ER and was evaluated.  Given dose of lovenox and had formal doppler on 4/19/21 which showed no DVT.  The pain and edema have improved but not resolved yet.   There were no injuries around this time to explain the edema or pain.
When I got home I felt a sharp pain in my right shoulder. Also, that night my right side arm was tingling and felt like needles. Later in the week I had a sudden pain in my chest. By Wednesday I had called the doctor for advice. On that Thursday saw the doctor and had EKG and it came back normal. Take Tylenol and drink plenty.  Pain and tingling subsided but still feel it in both hands fingers.
Accidently given First dose to 17 year old; A spontaneous report , was received from a pharmacist, concerning a 17 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The pharmacist called in to ask and confirm if he should give the second dose to a 17-year-old patient, who had been accidently given her first dose at the same pharmacy on 18 Jan 2021. The pharmacist did not have any additional patient identifier, or any other information related to this event.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, accidently given first dose to 17-year-old, was recovered on 18 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
20MAY92 informed consent obtained pt was vaxed & approx 1 hrs later pt was taken to hosp mom stated pt fainted became pale, cold & lips turned purple; denied any convulsions; pt loss consciousness approx 5 sec & vomited;
Approximately two weeks after the vaccination, the patient developed a Dupuytren's contraction on his left palm. A few weeks later, he also developed similar nodularity on the right palm concerning for early Dupuytren's contracture.
12/13/21: This is a 76-year-old female with a history of coronary artery disease, hypertension and DVT.  She has been vaccinated against COVID-19 (completed 1st 2 doses).  She had a booster dose on 12/10/2021.  Soon afterwards, she began having generalized weakness, dizziness and coughing.  Symptoms progressed, and so she presented to the ER tonight.  COVID-19 PCR positive.  She had a fever in the ER.  She was given vancomycin and Zosyn, in addition to IV fluids.
quick onset flu like symptoms; high fever with chills; sensitive skin; body aches; still foggy; headache; Colleague reported not feeling well; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in left arm on 09Mar2021 at 07:00 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history included pregnancy and C-section on 01Apr202, the patient did have a baby within the past year via C-section. No longer breastfeeding though. She was born on 01Apr2021. The patient's concomitant medications were not reported. It was not reported whether prior to vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient has been tested for COVID-19. On 10Mar2021, the patient experienced quick onset flu like symptoms, high fever with chills, sensitive skin, body aches, still foggy, headache and colleague reported not feeling well. After first dose of COVID vaccine the patient experienced quick onset flu like symptoms on 10Mar2021. The symptoms started approximately 24 hours after receiving the vaccine. The patient on 10Mar2021, felt like had a very high fever with chills, sensitive skin, and body aches. The patient took the temperature, and it was normal. The more severe symptoms lasted about 12 hours. When the patient woke up the next morning, felt much better but still foggy with headache. The patient had no underlying conditions besides weight. The patient also reported of not feeling well, was not being able to work in the morning on the day after the shot. By early afternoon the patient was feeling ok. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 10Mar2021. The patient was not recovered from the events still foggy and headache, colleague reported not feeling well was recovered on an unspecified date in Mar2021 and the patient was recovered from all the other events on 11Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client reported that about 40 minutes after the dose she developed, ?slight throat closing.? The client stated the symptoms lasted one hour. The client denied any other signs or symptoms of anaphylaxis. The client didn't take any medications for the symptoms.
Chills; Headache; Diarrhea; not feeling too well right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2023, 3 days after the suspect product(s) administration, outcome "unknown"; DIARRHOEA (non-serious) with onset 2023, 3 days after the suspect product(s) administration, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 2023, 3 days after the suspect product(s) administration, outcome "unknown"; MALAISE (non-serious) with onset 2023, outcome "not recovered", described as "not feeling too well right now".  Additional information: She was 80-year-old and had the COVID-19 Vaccine. Three days later she got sick: Got the chills, headache, and now had diarrhea. She was not feeling too well right now. Alternative phone number provided was her husbands number. Provides her husbands name as (Name: Withheld).   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
BLOOD CLOT; This spontaneous report received from a physician via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, 1 total, 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.  On an unspecified date, the patient died from blood clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211009193 and 20211010279.; Sender's Comments: V0:20211010045- covid-19 vaccine ad26.cov2.s -blood clot. This event(s) is considered unassessable. 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).; Reported Cause(s) of Death: BLOOD CLOT
Patient felt nauseous, shaky, flushed on 6/27/07 in the afternoon, no vomiting, no diarrhea, sxs passed after about 1 hour. At time of exam on 6/28 <3mm area of erythema around injection site felt fine.
There were no adverse events from this encounter .  Patient was inadvertently given the Janssen COVID vaccine, which is not approved for children under 18 years old.  Patient was seen 2 days later and no ill effects reported.
Patient reported very  hot and red arm at administration site with streaking. She works at emergency room and said the physician there looked at it and said it was cellulitis and started her on doxycyline which did start to improve her arm.
One day after getting the second shot of the vaccine, my left eye lid started burning. then the next day i had a shingles outbreak in the area.
Low grade fever Tmax 100.7F, fatigue, myalgia, recurrent UTI approximately 1 month after second dose of vaccine and persistent
Woke up with pounding and searing headache, extremely cold with chills, got a blanket, had to decide between being extremely cold and shaking or being super hot and sweating it out. Decided to sweat it out. Would get very light headed upon standing and was continuously nauseous. Woke my mom up at around 4am after fighting the illness all night and she made me tea to rehydrate and eventually I was able to keep down advil and the headache subsided. Felt ALOT like the side effects I had after getting a lumbar puncture.
This spontaneous report was received from a nurse and refers to a 2 male patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB injection, lot number N002202, expiration date: 04-NOV-2019 (exact dose, route of administration were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001646: US-009507513-1805USA001647: US-009507513-1710USA011550.
reaction around the site where I had the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction around the site where I had the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction around the site where I had the shot). At the time of the report, VACCINATION SITE REACTION (reaction around the site where I had the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Vaccine administered  after it was stored beyond 12 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered  after it was stored beyond 12 hours at room temperature) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered  after it was stored beyond 12 hours at room temperature). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered  after it was stored beyond 12 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Diarrhea; stomach hurting; abdominal issues; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), MYALGIA (arm is sore) and ABDOMINAL DISCOMFORT (abdominal issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Vitamins and FISH OIL for an unknown indication.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), MYALGIA (arm is sore) and ABDOMINAL DISCOMFORT (abdominal issues). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), MYALGIA (arm is sore) and ABDOMINAL DISCOMFORT (abdominal issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On Tuesday after receiving the vaccine Lowell fell out of bed and was unable to get up. I called 911 and the EMTs helped him up into his wheelchair. Since he has Parkinson's and has balance problems he is unable to stand on his own for very long. All day Tuesday he was incoherent and fell twice in the bathroom where on the floor he was incontinent of his bowels. Later in the day he was incontinent of urine while sitting in his chair and was unaware of it. Two days later he says he doesn't recall any of that but his cognition seems to be better now. I think this should be a warning for Parkinson's patients.
Warmth, redness and swelling at site of injection. Swelling measures 55mm in width and 65mm in height. Redness is larger in diameter than the swelling.
Information has been received from a registered nurse concerning a 6 year old female pt with no known drug allergies and no past medical history who on 06/05/1996 was vaccinated with varicella vaccine. There was no concomitant medication. On 11/22/2001, the pt developed mild to moderate chicken pox. It was reported that the rash was found on the pt's back, chest, face and upper shoulders. Some of the lesions were noted to be crusty, however, the rash was not itchy. Unspecified medical attention was sought. The pt subsequently recovered from the event. Additional info has been requested. The nurse also reported that the 11 year old sister of this pt had a similar experience following vaccination with varicella vaccine. (WAES01120807).
No additional adverse effects; Expired vaccine used; This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 09-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot# R018777 and expiration date 01-JUL-2020 (dose, strength, frequency, and route of administration were not reported). The vaccine was reconstituted with sterile diluent(MERCK STERILE DILUENT) invalid lot# reported as 000494.  The patient experienced no adverse events.