chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's; Caller reporting a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 16-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007276: US-009507513-2104USA007270: US-009507513-2104USA007278:
Information has been received from a Nurse concerning a female patient who on 11-MAR-2008 was vaccinated IM with the first dose of GARDASIL (lot# not provided).  Thirty minutes later the patient passed out and fell on her face.  Unknown medical attention was sought.  At the time of reporting the patient was recovering.  Additional information has been requested.
Supraclavicular lymphadenopathy three days after vaccine.  Bilateral upper arm arthralgia six days after vaccine. Severe fatigue and nausea 16 days after vaccine.
pt recv vax 11MAR96 & that day was excessively sleepy & restless (denied high pitched screaming);12MAR96 congestion worsened & had episode of not breathing & turned blue;seen by MD @ ER & sent to another hosp to stay overnoc;
1-7-10 (shot day) 3 hours later ER difficulty breathing, pale, weak fast heart beat. 1-8-10 ER same things happening. 1-13-10 ER same things happening. 4 EKGS 1 chest x-ray lots lab work.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patients was vaccinated with an improperly stored dose of VARIVAX, lot number involved N021314, expiration date 07-AUG-2020 (dose, route and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot #, expiration date, dose, route and frequency were not reported). It was also reported that the temperature excursion was 12.9 Fahrenheit degrees (F) during 71 hours and 20 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported.
patient was administered improper stored dose of VARIVAX; No additional AE reported; This spontaneous report has been received from a registered nurse concerning 7-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 25-OCT-2020, there was a temperature excursion. On an unknown date (conflicting information reported as 15-SEP-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, in the left deltoid, (lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022, and upon internal validation established as the same date) administered as prophylaxis (dosage and frequency were not provided). However, this administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at an unspecified temperature, during an unspecified time frame (product storage error). No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
About 3 hrs after vaccine had tigned of legs and rash on both legs with pain. Took Benadryl but did not work. Took water pill Friday night seen PA. Had fever, nausea and pain in legs. Traveled overseas. PA give Predisone Saturday for 2 1/2 days total of 12 pills. Had trouble with vision July 1st (blurry). Seen Dr. for eyes 07/10/2006.
my throat is a little sore my throat hurts a little bit; I am having headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101211819 (Pfizer).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: EW0196) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "my throat is a little sore my throat hurts a little bit"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "I am having headache". The event "my throat is a little sore my throat hurts a little bit" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, headache.  Additional information: reporter stated, What I was trying cause I am supposed to get my second shot, Thursday, on the 16th, I was concerned cause my throat is a little sore and I am just worried about my throat being sore and I am having headache. So is this still okay to take that second shot. Scheduled Date of Second Dose: 16Sep2021. the second dose of the vaccine tomorrow. Caller reports having a sore throat off/on for 2-3 days; she suspects she scratched her throat from eating chips. Caller asked if she should receive her second dose.   No follow-up attempts are possible. No further information is expected.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 15May2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 33 years, in right arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive on an antigen test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Erythema, tenderness, mild pain and puritis, 5 days after vaccination, located at injection site.
Arthritis bone pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis bone pain) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ARTHRITIS (Arthritis bone pain). At the time of the report, ARTHRITIS (Arthritis bone pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not think the Arthritis pain is vaccine related. No treatment medication information was provided.
malfunction of syringes for ABRYSVO where the luerlock broke; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received PF-06928316 (ABRYSVO), as dose number unknown, 0.5ml single (Lot number: HF5014, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "malfunction of syringes for ABRYSVO where the luerlock broke".  Additional information: Pharmacist stated he had a malfunction of syringes for ABRYSVO where the luerlock broke. No patient was involved.
Insomnia the night of vaccine last for 4 + days at the time doing this form . started talking Temazepam 15mg that had at house. Doctor yesterday prescribe Hydroxyzine 25mg . mailed out yesterday.  note: Doctor office and pharmacy seems unaware of these type of side effects and were initially nonchalant.
Rashes at sites of injection per patient: doctor prescribed an oral medication that he took for a few days, the rashes resolved. Patient doesn't recall the name of the medication.
Patient rec'd the Covid Moderna Vaccine (Dose 1) on Friday 8/6/21 in left arm by Tech.  Tech immediately informed Pharmacist of record that pt was complaining of dizziness.  Pt was seated & looked pale, sweating. The wife is a nurse & advised nurse on duty (inpharmacy at time). Nurse called ER personnel & they arrived to assess pt. The pt's blood glucose was 100mg/dl & elevated pulse.  pharmacist  stayed w/ pt & he advised that he experiences dizziness at the site of needles & injections.  He calmed down after 10-15 minutes. Normal skin color returned; wife gave crackers & water to pt. He remained in pharmacy for a few additonal minutes & was advised to return to phar
Began to feel tired/lethargic and had a headache at around 5:30 pm, got feverish and shivery, took a nap and ibuprofen. Checked temp after waking up and had a fever of 101.3°F at 7pm, down to 99.5 at 10pm.
Inappropriate diluent/non-approved diluent to reconstitute the powder; Inappropriate diluent/non-approved diluent to reconstitute the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA910A, expiry date 20-MAR-2024) for prophylaxis.   On 15-JUN-2023, the patient received Menveo. On 15-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate diluent/non-approved diluent to reconstitute the powder) and inappropriate dose of vaccine administered (Verbatim: Inappropriate diluent/non-approved diluent to reconstitute the powder). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter informed that earlier that day there was a vial of the liquid component of Menveo left without the powder component.  According to the healthcare professional that indicated that the product had probably been administered using a non-approved diluent to reconstitute the powder. The vaccine administration facility was the same as primary reporter. The reporter did not have details on the patients as it was unknown who it was. However, healthcare professional stated that only two doses had been administered that day, so it could be one or the other. The reporter consented to follow up. The patient had probably been administered with Menveo using a non-approved diluent to reconstitute the powder, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR085388:same reporter
We had a dose of Moderna Covid-19 that was given after it expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a dose of Moderna Covid-19 that was given after it expired) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a dose of Moderna Covid-19 that was given after it expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a dose of Moderna Covid-19 that was given after it expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. It was reported that vial was initially stored in the refrigerator on 27 Jun 2022 and vial did not undergo any temperature excursions. It was unknown whether patient had Allergies and ever had COVID positive test or diagnosis. It was unknown whether patient was given other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown AE cause patient to seek medical care. It was unknown whether the patient experienced a similar event in the past. No treatment medications were provided.
felt terribly sick; migraine; fever; severe spine and neck pain; severe spine and neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt terribly sick), MIGRAINE (migraine), PYREXIA (fever), SPINAL PAIN (severe spine and neck pain) and NECK PAIN (severe spine and neck pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced MALAISE (felt terribly sick), MIGRAINE (migraine), PYREXIA (fever), SPINAL PAIN (severe spine and neck pain) and NECK PAIN (severe spine and neck pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (felt terribly sick), MIGRAINE (migraine), PYREXIA (fever), SPINAL PAIN (severe spine and neck pain) and NECK PAIN (severe spine and neck pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient took muscle relaxant as treatment medications.No concomitant medications were reported.This case was linked to MOD-2021-385695 (Patient Link).
COVID arm.  About a 3 inch rash at injection sight, hot, red and itchy
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning an 36-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 13-Feb-2012. The patient inadvertently received expired product on 16-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 26-Mar-2012: The reporter stated that the patient did not experience any adverse events and the patient received FLUMIST very soon after it expired.
older sibling recv vax & pt (younger sibling) was exposed to varicella in daycare 6 days prior to vax;pt devel an extensive case of chickenpox w/lesions everywhere;
The day after child received rotavirus vaccine, she developed bloody diarrhea. Initial blood culture was positive but repeat neg. Even several days later, frequent BMS continued (13 times) with occ blood specks.  7/30/09 Hospital records received DOS 7/9/09 to 7/10/09. Assessment: Bloody diarrhea, likely infectious.  Patient presented with bloody stools. Twin sister and mother also have bloody stools. Loud systolic murmur. 9/9/09-ICD-9 codes received 558.3.
pt recv vax 15NOV95 & LMP 15OCT95;pt became pregnant;estimated date of delivery 1AUG96;pt consumed alcohol & LSD, crack cocaine a/9wk gestation;26JUL96 failed to progress & underwent C-section;nl male delivered;exp tachypnea;
I started smelling smoke around 8:30 pm on the night of the 16th, but I assumed it was from local fields being burnt. Then I started smelling cigarette smoke, sometimes strongly, sometimes faint. Even when I am work, inside the office, and there is nobody around. Even now as I write this, it smells like I am in the same room as someone with a lit cigarette.
Blood clot a few weeks after first dose; Unable to get second dose of the vaccine, outside recommended schedule; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot a few weeks after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot a few weeks after first dose) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Unable to get second dose of the vaccine, outside recommended schedule). At the time of the report, THROMBOSIS (Blood clot a few weeks after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Unable to get second dose of the vaccine, outside recommended schedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   The reporter stated that the patient had received first dose of the Moderna COVID-19 vaccine in March 2021 and couple of weeks later, the patient reportedly had a blood clot and was unable to get the second dose of the vaccine.  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.; 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.
uncomfortable; heart stinging/dull stinging sensation; Now a few hours later it feels like I have heart burn; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0169 and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:30 (at the age of 23-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0158 and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:30 (at the age of 23-years-old) as dose 1, single dose for covid-19 immunization. The patient had known allergies with augmentin. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination, has the patient has not been tested for COVID-19. On 28Apr2021 13:30, on the day of vaccination, when injected patient started to feel heart stinging for around a minute after shot. It was a dull stinging sensation so she wasn't in severe pain, it felt more uncomfortable but it went away shortly after. Now a few hours later it feels like she has heart burn. She wasn't sure if it was related to something she ate with first shot and being anxious, but realize these side effect were definitely caused from shot after receiving second dose. AE not resulted in Physician visit/ER visit. No treatment taken for reported events. The outcome of all the events was recovering.   No follow-up attempts are needed. No further information is expected.
started w/fever Saturday PM;broke out in rash Wednesday 19JUN96 on upper trunk, face, neck, & upper arms;
Myocardial infarction leading to a Stent followed by clotting the Stent within 3 hours and second Stent needed.  Also right arm still has considerable pain in right arm leading to limited mobility and use
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 07-NOV-2013 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # J000783, expiration date: 30-APR-2014), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided. Time from first puncture-14 days   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up document document contains non significant information; Sender's Comments: This report refers to a case of Expired vaccine used for mRNA-1273, Lot# 006C21A with no associated AEs. Causality for this medication error is not applicable.
Headache, neck, back pain, nausea, fever, starting 12 hours after vaccine.
FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, from the same reporter.