chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT IN THE LEG; PASSED OUT; BLOOD CLOT IN LUNGS; This spontaneous report received from a consumer (parent) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on an unspecified date in 2022 for covid-19 prophylaxis. 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 in JAN-2023, the patient experienced blood clot in the leg that went to his lungs (blood clot in lungs) and later, he had passed out and was taken to the hospital. In the hospital they performed laboratory tests and found blood clot in lungs for which they had done emergency surgery within a couple of hours and later many more laboratory tests were performed and found blood clot had started in his leg. The patient had taken thinners as treatment medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the leg, passed out and blood clot in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230200683 -blood clot in the leg. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230200683- passed out. 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.  20230200683 -blood clot in lungs. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Raised red rash with 4-5 quarter size hives, itchy and hot, was sore to touch. BENADRYL prescribed.
ERYTHEMA TO LEFT INNER ASPECT OF THIGH 68MM, WARM COMPRESS.
Slight Fever; Body aches; Lymph node on clavicle on the side where i got my injection is tender; Lymph node swollen feels like there is a rock above my clavicle; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Slight Fever), PAIN (Body aches), LYMPH NODE PAIN (Lymph node on clavicle on the side where i got my injection is tender) and LYMPHADENOPATHY (Lymph node swollen feels like there is a rock above my clavicle) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight Fever), PAIN (Body aches), LYMPH NODE PAIN (Lymph node on clavicle on the side where i got my injection is tender) and LYMPHADENOPATHY (Lymph node swollen feels like there is a rock above my clavicle). At the time of the report, PYREXIA (Slight Fever), PAIN (Body aches), LYMPH NODE PAIN (Lymph node on clavicle on the side where i got my injection is tender) and LYMPHADENOPATHY (Lymph node swollen feels like there is a rock above my clavicle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Vomited x1 and c/o not feeling well and came to nurse/medical room and vomited twice. Also said she have no lunch and w/stomach ache, w/c per nurse student. Had sev. titers. Had CAT planned of. T=97.8. Given H2O to drink and to sx levitated.
first vaccine 1/7/21, hard time finding the 2nd dose; A spontaneous report was received from a consumer concerning a patient of unspecified age and gender, who received Moderna COVID-19 vaccine (mRNA-1273) and reported had first vaccine, hard time finding the second dose missing dose/product dose omission issue .  The patient's medical history is unknown. Concomitant medication were not reported.  On 07 Jan 2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (Batch no: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that, hard time finding the second dose. No Laboratory details provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Post vax pt developed an injection site reaction characterized by swelling and blotchy redness. The patient recovered. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Acel-Immune lot 469-396.
Pt developed (R) leg swelling 1 day after his inj - He responded to Benadryl. no fever. pt did have limping also improved after Benadryl.
Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (Little tired). On 11-Feb-2021, FATIGUE (Little tired) had resolved. Not Provided          Action taken with mRNA 1273 in response to drug is not applicable . No Concomitant  information was  provided. No Treatment information was  provided. Patient donate blood regularly and on 16MAR2021 before his blood donation, he received a false positive Hep C test. He mainly wanted to report this AE.
6/17/02 mother calls stating child given varicella 6/6/02, child now has red spot on leg, did not have last week. Advised child to be seen in office today. Child not brought in . 6/19/02 mother calls and child still with spot on leg. Mother insists report be filed. Speaks with MD and advised mom use Benadryl it if spot still present in AM child to be seen.
Sunday night fever 102.3  nausea chills.   Fever all day Monday,  Monday night, n=experienced night sweats.   Tuesday morning still had fever.  Left arm sore, large red rash and swollen muscle.  Muscle is hard and warm to the touch.    Tuesday afternoon fever breaks Wednesday status of left arm remains the same
No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.    On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not provided; lot# was S038700 and expiration date was 12-JAN-2021) 0.5 milliliter after temperature excursion for prophylaxis (product storage error). No additional adverse event (AE) was reported.         The administered doses experienced a temperature excursion at -13.8 degree Celsius and time frame for temperature excursion was 41 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger.
Tingling in face, mouth; stiff neck; fatigue; joint pain; sore arm; swollen lymph nodes in armpits, more so in left armpit; slight wheezing
Possible reaction to VARIVAX.  Right arm red and warm to touch and knot on arm.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 9:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 9:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 74.60.  No concomitant medications were reported.  Batch number 031L20A administered on 12-Feb-2021 had  temperature 35 from 10:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 at 11:00 as dose 3 (booster), single (Lot number: EW0219) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure,; "osteoarthritis" (unspecified if ongoing), notes: Other medical history: osteoarthritis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid orally (Lot number: GF1750) from 20Sep2022 to 25Sep2022 as treatment for Covid-19.
PATIENT'S ARM BEGAN TO BLEED AND CADBURY SIZED BUMP FORMED ALMOST IMMEDIATELY AFTER NEEDLE WAS WITHDRAWN. APPROXIMATELY 4 INCH DIAMETER REDNESS OCCURED AROUND THE INJECTION SITE. PATIENT DENIED SHORTNESS OF BREATH, NO HIVES APPARENT. PATIENT WAS ASKED TO STAY IN THE PHARMACY FOR OBSERVATION. PATIENT WAS OFFERED AND ACCEPTED 25MG BENADRYL. SHE REMAINED UNDER PHARMACIST OBSERVATION FOR 30 MINUTES AFTER INJECTION. PATIENT WAS GIVEN 2 ADDITIONAL DOSES OF BENADRYL TO TAKE HOME AND COUNSELED ON 4 HOUR INTERVAL DOSING. WAS ALSO COUNSELED ON USE OF ICE AND IBUPROFEN AS NEEDED TO HELP WITH SWELLING, PAIN, AND IRRITATION. PATIENT WAS GIVEN PHARMCY PHONE NUMBER AND HOURS TO CONTACT WITH QUESTIONS OR IF CONCERNS ARISE. COUNSELED TO SEEK EMERGENCY ROOM CARE, GIVEN LOCATION AND ACCESS TO LOCAL HOSPITAL IF REACTION BEGAN TO WORSEN OR PHARMACIST WAS UNAVAILABLE FOR CONSULT. RECOMMENDED HAVING A SECONDARY DRIVER IF SHE SOUGHT EMERGENCY ROOM CARE. CALLED PATIENT 2.5 HOURS AFTER INJECTION. SHE DENIED USING ADDITIONAL DOSES OF BENADRYAL AND DENIED ANY TROUBLE BREATHING. STATED REDNESS HAD DISSIPATED AND SWELLING WAS ALMOST ENTIRELY GONE. PHARMACIST REINFORCED COUNSELING ON ICE AND IBUPROFEN, REMINDED ABOUT SEEKING CARE IF REACTION WORSENS AT ANY TIME. RECOMMNENDED REPORTING THIS REACTION ON FUTURE HEALTH HISTORY/VACCINE QUESTIONAIRES.
Starting July 15 with fatigue, achiness & rash of face & chest. July 16 noted fever & erythema at injection site. July 17 more rash. July 18 improvement. July 19 continued improvement but still some rash.
Rash with blisters, spreading on right butt cheek, down the top part of the right leg, right groin.  Painful, itchy.  Prescribed Valtrex for 7 days
A serious, spontaneous report of medication error, bronchospasm and exacerbation of asthma has been received from a physician concerning a two-year-old male patient subsequent to FLUMIST administration.  Medical history included asthma.  The patient was not taking concomitant medications.  On 10-Aug-2009, the patient received FLUMIST.  On 11-Aug-2009, the patient developed bronchospasm and was admitted to the hospital.  The diagnosis was exacerbation of asthma.  On 12-Aug-2009, the patient was discharged from the hospital.  The outcome of the events, bronchospasm and asthma exacerbation was resolved.
Patient slept a lot after vaccine for 24 hours & only ate 5 times instead of her normal 8-9 times.
26sep89 pt vax hepta B.  1 -2 days later pt devel. severe h/a, fever, dizziness, stiff neck and right shoulder, and joint and muscle soreness.  pt recovered and elected not to complete series.
Extreme fatigue; dehydration; chest pain; lump in armpit (golf ball size); pounding headache; muscle spasms; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced extreme fatigue, dehydration, chest pain, lump in armpit (golf ball size), pounding headache and muscle spasms on 07May2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Allergy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy".  Additional Information: Unable to obtain patient age and gender.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm was painful, slightly swollen, feverish and had a reddish color and lasted for four days.  There was some relief when the patient took a Benadryl on the third day.
Info has been received from a physician concerning a 5 year old white female who on 3/5/01 was vaccinated with a 1st 0.5ml, SC, dose of varicella virus vaccine live. On 10/10/05, the pt presented with breakthrough chickenpox involving over 50 lesions and a fever on the 1st day. The pt was treated with Benadryl. It was noted that, at the time of the report, the pt was still recovering. No product quality complaint was involved. No other info was provided. Follow-up info from a physician indicated that on 10/10/05, the pt had in excess of 50 lesions on the 1st day of breakthrough. Additional info has been requested.
12 hours after vaccine started to feel achy. Had chills starting at midnight. Woke up in the morning with headache, two hours later had a fever of 103.4. Fever lasted for two hours. Took Tylenol and ibuprofen
Tingling and pins and needles effect in lower extremities.  Spread to hands and fingers.  Neuropathy was accompanied by paresthesia.  Nerve Twitches, complications breathing, falling when walking or getting up from sitting or laying down.
For about 3 wks after shots she had fevers, rashes, loss of appetite, vomiting, muscle pains.
6-year-old received a dose of PENTACEL last week with no reported adverse event; Initial information was received from on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who received a dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] last week with no reported adverse event.  The patient's past vaccination(s) included measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine, hepatitis a vaccine, hepatitis b vaccine, Prevnar 13 and Pentacel. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination (immunisation); measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine (measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine) for prophylactic vaccination (immunisation); hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination (immunisation); and hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination (immunisation).  Last week on 28-Jul-2023, a 6-year-old patient received dose 2 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml  once (lot number: UJ877AA, expiration date: 22-Mar-2024) via intramuscular route in the right deltoid for prophylactic vaccintation (immunisation) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 6-year-old received a dose of pentacel last week with no reported adverse event.  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.
She got her vaccine, had a fever of 101.7 for 24 hours and everything that comes with it, chills, no appetite and a sore arm.  She just felt horrible the day after the shot.    With the second vaccine she got the shot at 4:00 PM, by the next day she felt like something was ricocheting in her torso, like a metal ping pong ball, which then disappeared when the fever got really high.   She also had a fever of almost 103.  Thought she was going to pass out at one point, but did not.  She did not go to the ER.  The next day she had a fever of 99.9, and was OK after that.  She felt it was pretty severe.  Also had a sore arm.
I had episodes 3 times of running an elevated fever. Head colds are not uncommon for me but running a fever is. The first time I ran a fever, it was 101.8 along with body aches and a headache. I called the doctor at this point. Each time, I was sent to have a covid test done. I?ve had 3 covid tests done since receiving the vaccine. Each time was negative. The second testing did result positive for strep. Due to the strep I was put on antibiotics for 10 days. This last time, I didn?t have the same head cold but I did run a fever again which got up to 100.8. for me that is elevated because my normal temperature is 97.6
This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown ages. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot #s M025867, expiry date 24-MAY-2018 and N002204, expiry date 19-JAN-2019).  Other suspect therapies included sterile diluent (manufacturer unknown). It was reported that the vaccines were improperly stored with a temperature excursions between -14°c to -10°c during 2.5 hours. It was reported because a data logger (yes). The sterile diluent (manufacturer unknown) used to reconstituted all vaccines were properly stored. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports from the same reporter source, (linked to MARRS # 1707USA011181). Additional information has been requested. Sender's Comments: US-009507513-1707USA011181.
BLOOD CLOTS IN CORONARY ARTERY RESULTING IN MYOCARDIAL INFARACTION
Participant fainted after receiving vaccine/ participant stated has history of fainting when seeing needles/ per company policy 911 called/ EMS assessed participant, participant stated felt fine.