chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 3 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 22-AUG-2018, the patient was vaccinated outside the recommended dosing schedule with PROQUAD for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). There was no adverse event involved.
Info. has been received from an MD concerning a 6-mt old female who was vax'd w/the 2nd dose of Hep B vax recombinant. Subsequently, the PT experienced screaming and would not eat for 3 days. Unspec'd medical attention was sought. Add'l info has been requested.
Received vaccine on 8/13/2019; arm very sore starting at 4:00pm that day.  On 8/14/2019, at 5:08 am, a severe headache woke me up, so I took three 200 mg ibuprofen tablets. This took the edge off, but headache remained.  1:00 pm same day, developing chills and body aches.
Pt w/ chills, fevver, SOB x1 week, tested + for COVID 1 day PTA. Missed dialysis x1 week, was hypotensive on arrival and with metabolic acidosis. CT c/w findings for COVID pna, non-hypoxic. Remained on RA. Discharged home.
Fever 102.1; chills, aches, c/o (R) arm hurting.
Woke up with fever, body aches, sweating around 3am. This continued all night, body hurt so bad, cold and hot flashes, shivering, SEVERE headache, sweating, fever above 100, went to dr. Told to rest and take aspirin for 3 weeks to prevent clot. Fever remained, exhausted, facial hives started around 5 pm slept from 9 am-2pm then slept again off and on until the next day on 11/17 woke up with no fever. Still sweating but almost all symptoms resolved aside from arm pain.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of MMR II (albumin status of recombinant human albumin (rHA), dose and route were not reported, lot # K000174, expiry date 08-JAN-2016; lot # K011188, expiry date 12-AUG-2016; lot # K020189, expiry date 11-SEP-2016). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe respiratory issues, couldn't breath, broke out in hives from head to toe, severely ill for 2 weeks with fever, chills,diaherra, headaches, muscle aches.
Fever 102, n/v/d, headache continuous, fatigue, decrease appetite,  lethargic, body aches, and liver enzymes over 300. still sick after 6 days
Temporary loss of vision and loss of feeling in the arms and legs. Also experienced extreme sweating and chills over night and chest tightness, stomach upset, headache, numbness.  Did not have to get medical care - Symptoms resolved after 72 hours
PUT IN ICU; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, Expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, after vaccination the patient was kept in intensive care unit (ICU) for an unspecified adverse event. The hospitalization date was unknown. It was also reported that the patient cried that she had to get the vaccine because she did not want to get the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of put in ICU was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210958237-COVID-19 VACCINE AD26.COV2.S Put in ICU. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received VARIVAX (Merck) which was improperly exposed to temperature above 5F. No known adverse effects reported. No product complaint was reported for VARIVAX (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
08/11/08, adolescent received 5 recommended vaccines (HepA, HPV, MCV4, Tdap, Varicella), client lost consciousness for 5-10 seconds; fell to floor in exam room landing on left side hitting left temporal. Nauseated immediately afterward.
3-4 days after vaccine, developed asymmetric, localized edema in both ankles along with neuropathic-type pain in both lower extremities.  Flare-up of epididymitis also with headaches.  Nausea, malaise, which continues now, two weeks later.  Started spiking high-grade temps every night up to 102.8 degrees.  Weakness, fatigue.  These symptoms are atypical for me!
9-29 felt bad, 9-30 went to ER with increased heart rate and blood pressure. ER found her having low magnesium levels, administerer magnesium and HR and BP lowered. Stayed in hospital for 1 day then released
Lymphadenopathy persisting at least 11+ weeks  post vaccination-supraclavicular LN >4 cm on long axis; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 13Jan2021 at 10:00 (at the age of 39-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on an unknown date in 2021  (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sunscreen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naltrexone hydrochloride, bupropion hydrochloride (CONTRAVE) from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 the patient experienced Lymphadenopathy persisting at least 11 plus weeks post vaccination-supraclavicular Lymph Node greater than 4 cm on long axis and bloodwork normal. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Lymphadenopathy was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
presumed pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "No adverse event, patient was presumed healthy prior to Covid booster". The following information was reported: PULMONARY EMBOLISM (death), outcome "fatal", described as "presumed pulmonary embolism". The patient date of death was unknown. Reported cause of death: "presumed pulmonary embolism". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported event Pulmonary Embolism and the suspect drug BNT162B2 cannot be excluded. 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; Reported Cause(s) of Death: presumed pulmonary embolism
Ache in the lower left rib cage and left side; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL32Y6), via an unspecified route of administration on left arm on 16Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included congenital heart defect and dairy sensitivity. The patient's concomitant medications were not reported. The patient experienced ache in the lower left rib cage and left side on 31Jan2021 12:00. The adverse event result in doctor or other healthcare professional office/ clinic visit. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The event was assessed as non-serious by the reporter. The outcome of the event was reported as not recovered.
the day following vax pt exp redness at the inject site which spread even larger the day p/ & 4/29 is an area of 10x14cm w/an orange peel appearance and induration
rash on the right side of the abdomen and was diagnosed with herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 26-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a rash on the right side of the abdomen and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), his symptoms resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
This spontaneous case, initially received on 12-Sep-2018, reported by other health professional (nurse), concerning a 16-year-old, female patient adolescent patient. The patient's historical condition included irritable bowel syndrome (IBS) and the current conditions included anxiety and depressive disorder (reported as medical history). The patient's concomitant medications included sertraline and PROAIR inhaler for unknown indications. On 10-Sep-2018, the patient (under age of 65 years) was inadvertently administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250789 and expiry date: 30-Apr-2019]. It was reported that, the patient did not experience any adverse events after vaccination. The reporter assessed the case as non-serious. Non-significant follow up report received on 08-Oct-2018: The nurse confirmed that, the patient did not experience any adverse events after vaccination.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2016, the patient was vaccinated with incorrectly stored doses of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
MD rpt pt recv vax in 6/96 & on 5/13/98 pt exp chickenpox. MD treated w/acyclovir
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Crohn's" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06Oct2022) Positive, notes: COVID rebound, tested positive again 06Oct. It was reported that the patient experienced covid-19 on an unspecified date and received Paxlovid as treatment from 23Sep2022 to 27Sep2022. The patient tested positive again on 06Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
administered past the 30 day refrigeration time; Improper storage of unused product; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.  Third shot info of patient includes  Date administered: 18AUG2021, Lot number: 008C21A , Expiration date: 31OCT2021 , Date refrigerated: 20APR2021, Temperature changes (in F): 41
Pt received Comvax #3 on 2/13/03 and developed a fever within 24 hours. It spiked to 103F on 2/16/03 and the pt had an apparent seizure. Taken by ambulance to hospital where he had another seizure. Temperature was 99.5F at the time. He was admitted to wait for observation overnight. Mother said while eating lunch, he went limp, eyes rolled back in his head and he had shaking of all his extremities. She reports that while they were en route, he seemed to be quite sleepy but then did seem to come around. She denies any history of seizures nor is there any family history. She reports that he has been ill with a cough and URI symptoms. She has been giving him Robitussin prn for his cough.  On exam: temperature is 99.5F (rectally), pulse is 122, respirations are 24 and room air pulse oximetry is 95%. While the pt was here in ER, he was noted to have a tonic-clonic seizure activity lasting approx. 60 seconds, with a post-ictal period afterwards. Prior to this, his temperature had been rechecked and noted to be 100.2F (rectally). During the seizure, he was given a blow by O2, a saline lock was inserted. Afterwards, he was given a Feverall suppository. MD consulted another MD and ordered a CT scan of the head and was noted to be negative. Dx: seizure and right lower lobe infiltrate.
Expired vaccine.  Pfizer expiration date: 02/2022 State Expiration date : 05/31/2022
Patient reported to the nurse at his second COVID vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped.
Initially, the following morning, I was weak, dizzy, sick to my stomach and had fatigue and all-over muscle aches and pains plus a very sore left arm. Shortly thereafter I began to have severe pain in my neck and upper shoulders. This pain lasted almost an entire week. I do have degenerative cervical disc disease which was diagnosed in February of this year and had several weeks of physical therapy which helped immensely. The vaccine appeared to exacerbate this condition in my opinion because it occurred the very next day in combination with muscle aches all over.
26 patients received the vaccine prepared without the final inverting after diluent added; 26 patients received the vaccine prepared without the final inverting after diluent added; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2.  This is a spontaneous report from a contactable pharmacist. This Pharmacist reported similar events for 26 patients. This is 6th of 26 patients. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller wanted information about needing to revaccinate patients with the COVID 19 vaccine in the instance where all preparation steps were followed except gently inverting the vial 10 times after adding the diluent. The caller stated that the vial color and appearance was off white with no particulate matter. Caller stated 26 patients received the vaccine prepared without the final inverting after diluent added.  Follow-up (08Feb2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (09Feb2021): New significant information received from a contactable pharmacist, which include that the pharmacist never reported any adverse event and that the event in the report was all a confusion and everything was fine. HCP did not provide fax number or mailing address and does not wish to be contacted any further.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020521662 same reporter/drug/event, different patient
Dx: ALTE. Evening of vaccine, patient became limp and cyanotic after a period of fussiness. No fever. No seizure activity reported. Mom gave CPR; rescue breaths. 911 contacted. Patient began crying shortly after CPR. Seen in ED; lumbar puncture. Nurse follow up on 06/02/04 states: Acute life threatening event.
45 minutes after vaccination, thought she had an almond stuck in her throat - drank copious amounts of water.  Restless, itchy eyes all night.  Woke up the next morning - eyes, lips and right side of throat swollen.  Benadryl x 24 hrs, no further flu shots (ate almonds with no problem since then).
On 7/19/10 (day imms given) pt began c/o nausea and not feeling well approximately 7pm. Thurs AM about 5AM began vomiting till about 1230pm fever began about 1130AM Temp of 101. By 1610 that afternoon pt feeling some better, no nausea, no stomach ache, no emesis.
I give the wrong vaccine. I need it to given to Tdap but I actually give the DTaP.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates, the patients were administered improperly stored PEDVAXHIB (lot # J010385, expiration date: 28-MAY-2016; lot # K004540, expiration date: 03-DEC-2016; lot # J015435, expiration date: 13-OCT-2016) (dosage, strength and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Chills/nausea/vomit - 8 PM. Passed out.
Dizziness, anxiety, severe headache, with improvement after observation. Vitals wnl.