chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 02-APR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Yesterday I took part 1 of 2 of the Shingles Vaccine and got a reaction that was only relieved by taking some Benadryl. Shortly after receiving the shot at the Drug Store I got dizzy, then shaky, my heart rate increased and my vision got funny. After that I became nauseous, got a headache and I found it difficult to stand and breath.  Yes, my arm is sore where injected, but I expected that.  I reported what happened to the pharmacist and she wondered if my doctor would want me to avoid the second shot due in two months.
Is itching a normal side effect; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Is itching a normal side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Is itching a normal side effect). At the time of the report, PRURITUS (Is itching a normal side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Pt received adolescent dose of TDAP instead of PENTACEL. No adverse reaction noted.
Swelling, bump was hard on (R) thigh Advised to use ice and Tylenol and to swaddle baby.
herpez zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Allergic to pumpkins" (unspecified if ongoing), notes: Known allergies: Allergic to pumpkins. Not allergic to any medications. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Joint pain, weight gain, blood pressure spiking, black and blue bruises without prior injury, extreme fatigue
Chest tightness, palpitations, dizziness, headache, generalized itchiness, lip numbness, throat tightness - symptoms improved after Benadryl 25mg though headache persists today.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea for two days and couldn't sleep. The clinical outcome of the event, nausea for two days and couldn't sleep, was unknown.
pt recvd flu vax on 27OCT92; On 11NOV92 presented to MD w/ c/o h/a, back pain, arm numbness & disequilibirum; pt was hospitalized; pt dx GBS on 13NOV92;
Itchy at site, red, swollen at shot site, warm came to office 5/18/13. Treatment: cephalexin x 3 days. Localized reaction calmed down and resolved.
Acne-like blisters on upper left arm (injection site) spreading to shoulder, neck, back and forearm; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 22-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03May2021 at 11:00 (at the age of 22-year-old) both as a single dose for COVID-19 immunisation. The patient had no relevant medical history and had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced acne-like blisters on the upper left arm (injection site) which was spreading to the shoulder, neck, back and forearm and some soreness after a week. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events acne-like blisters on the upper left arm (vaccination site) and soreness were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt rcvd vax; pt devel arthritic symptoms; MD felt exp not related to vax;
Patient reported pain at site of injection (thigh), and started limping a few hours after injection. On the day after injection, patient had substantial swelling and hives/redness throughout site of injection (thigh, through to knee), and the site of injection was tender and warm to the touch.
Similar to 2nd dose, joint/muscle aches (especially hips/lower back, but also general muscle aches), headache, extreme fatigue, chills New: initiation of period, though I'm on week 1 of my cycle, and take birth control to control menses (skip active weeks)
Had it twice after shots/Suspected vaccination failure; Had it many times, twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had it twice after shots/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had it many times, twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 10-MAR-2023 The case was received from the patient via interactive digital media. The patient had it many times and twice so far after the 2 Shingles shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression.  On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. This report was non-serious.
Patient noticed an itchy rash beginning the evening after the IMZ was given. She said it was on her back, stomach, arms, and legs. She began taking Benadryl and said it helped some. She called to report the reaction on 3/16/16 and said that it had cleared up some but was still itchy. I told her to continue taking the Benadryl and to inform her doctor if it didn't clear up or if the rash seemed to get worse.
migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 15:00 as dose 2, single (Lot number: EN5318) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HSV2" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "herniated discs" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing); "known allergies: lactose" (unspecified if ongoing); "known allergies: Hazelnuts" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; OMEPRAZOLE; LIVALO; VALACYCLOVIR [VALACICLOVIR]; D3; B12 [CYANOCOBALAMIN]. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Ibuprofen, reaction(s): "known allergies: Ibuprofen". Vaccination history included: BNT162b2 (dose 1, is bivalent: False, lot number: EP7534, administration time: 03:00 PM, vaccine location: Left arm), administration date: 20Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "severe lightheadedness/dizziness", "I had burning tongue syndrome beforehand", "it has gotten much worse", "tinnitus", "weakness in my left arm", "severe headache", "nausea". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraines".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253096 same reporter/patient/product, different dose/event;US-PFIZER INC-2021367791 same reporter/patient/product, different dose/event;US-PFIZER INC-202300253122 same reporter/patient/product, different dose/event;
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients received doses of improperly stored PROQUAD lot # M044718, expiration date 07-MAY-2018 (dose and route of administration not reported) on the following dates: 23-MAY-2017, 01-JUN-2017, 02-JUN-2017, 05-JUN-2017, 06-JUN-2017 and 07-JUN-2017. Between 18-MAY-2017 and 22-MAY-2017, the vaccines underwent a temperature excursion between 47 and 77 degrees Fahrenheit for 47 hours and 15 to 46 degrees Fahrenheit for 90 hours. There were no previous excursions reported. Digital data logger was used to record the excursion. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000669: US-009507513-1707USA000670: US-009507513-1706USA004880:
5 days after the vaccine, I had very severe gland swelling in my neck. In the front of my neck, back of my neck and under my arms for about 3 to 4 days. It was very painful. I called my doctor, they said to keep an eye on it and give them a call if anything changes. I had no fever but it was very, very painful.
I have gotten an ear infections hours after both shots; This is a spontaneous report received from a contactable consumer (Patient himself) via Pfizer sponsored program.  A patient of unspecified age and gender received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: UNKNOWN), via unspecified route on 12Feb2021 as a SINGLE DOSE for COVID-19 immunisation and on 12Mar2021, the patient received second dose of BNT162B2 (COMIRNATY, Lot number: unknown), via unspecified route as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient gotten an ear infections hours after both shots and reported that just interesting data and would take busters but really hate having the infection. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Employee experienced prolonged right arm pain lasting over 2 weeks limiting range of motion. Saw PCP.
ACUTE NON ST ELEVATION MI 2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Tingling sensation on the same arm as she got vaccinated; This spontaneous case was received on 21-Oct-2020 from pharmacist via Health Authority (reference number: SEQW20-04023) and concerned a 47-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 04-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: right arm) for flu prevention. The batch number reported was 276566 and expiration date: 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed tingling sensation on the same arm as she got vaccine. The patient did not receive any corrective treatment.  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from event.  The reporter did not provide causality assessment.  The reporter assessed this case as non-serious.  Company comment: Event 'tingling of extremity' is assessed as related to Flucelvax QIV.; Sender's Comments: Event 'tingling of extremity' is assessed as related to Flucelvax QIV.
Red itchy, warm to the touch, rash 5.5cm in length near injection site. Also tiredness to the level of having mononucleosis. Itching started the day after rash appeared. Rash appeared 6/13 and itching started morning of 6/14. Monitoring the site to see if it gets any bigger, if so then will have to seek medical. I do take a high level oral otc allergy medication everyday ( Allegra 24hr) so I cannot take anymore allergy medication for the day.
Covid diagnosis; Covid diagnosis; This is a spontaneous report from a non-contactable Nurse. The nurse reported the same event for three patients. This is the 1st of three reports.    A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had a Covid diagnosis and died. It was unknown if autopsy was performed. The reporter mentioned that she knew 3 people who were vaccinated that went into the hospital that came out with a Covid diagnosis; one of whom died. She did not say which vaccine they had gotten. Outcome of the event Covid diagnosis was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101468108 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101468109 Same Reporter/Drug/AE, Different Patient; Reported Cause(s) of Death: Covid diagnosis; Covid diagnosis
Fever x2 days, presented 7 days after vaccine, generalized Varicella  rash presented 9 days after vaccine. Vaccine given 10/14/08 to right upper arm.
Pt had negative pregnancy test 1/3/07, given smallpox vaccine and HPV. Had positive pregnancy test 1/27/07.
Approximately 10 minutes after patient received her Pfizer vaccine she stated that "she need to move her bowels."  Then she started to become nauseous and turned pale.  EMS assessed her.  Patient's  heart rate dropped.  Patient was lying down.  Patient was then taken to the hospital in stable condition.
Patient presented to the pharmacy on 01/11/2021. Stated that post vaccination on 01/07/2021 he experienced severe headache, shaking, severe stomach upset, and diarrhea. He asked the pharmacist to follow-up and report his symptoms with the appropriate agency. Stated that he had no issue with dose 1 of the Shigrix except for a sore arm for a few days
Patient was fully vaccinated in February, admitted to acute care hospital, positive for COVID19 in July. Patient diagnosed with COVID pneumonia, completed treatment, was considered recovered from COVID. Patient while still in acute care expired on 7/26/2021
Patient states she initially had swelling at the injection site, however over the course of the two weeks following the vaccination,  a swelling occurred in the form of a band that wraps around her injection arm directly below the deltoid muscle.   (not at the site of injection)
death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No Treatment Medication reported.  Reporter mentioned her best friend died. Caller mentioned patient called before. Company comment This spontaneous fatal case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious fatal event of DEATH. Onset date of the events were not provided nor vaccination date or schedule; hence, latency cannot be assessed. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Reporter mentioned her best friend died. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received on 25 Feb 2022 contains No New Information.; Sender's Comments: This spontaneous fatal case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious fatal event of DEATH. Onset date of the events were not provided nor vaccination date or schedule; hence, latency cannot be assessed. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Reporter mentioned her best friend died. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Received vaccine 3:30 pm. At 10:00 p.m. severe headache, pain in left arm. Couldn't lift arm. Ached all over. Pain in joints. Couldn't sleep. Lethargic next day. Took ADVIL for pain and headache.
Deltoid area is red with pain in the shoulder. Should is inflamed. At two days, the area of the injection with has edema is red and very hot on the side and painful. Treatment antibiotics IM anti-inflammatory IM.