chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to seven unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. From 26-APR-2016 through 03-NOV-2016, the patients received improperly stored doses of GARDASIL (lot # L040459 with expiration date 06-APR-2017; dose and route were not reported). The temperature and time frame that the vaccine was improperly stored at were reported as below: On 26-APR-2016, 34 Fahrenheit (F) for 24 hours; On 22-JUL-2016, 34 F for 16 hours 40 minutes; On 27-JUL-2016, 34 F for 16 hours 30 minutes; On 28-JUL-2016, 33 F for 15 hours 33 minutes; On 01-AUG-2016, 33 F for 64 hours 3 minutes; On 02-AUG-2016, 32 F for 14 hours 56 minutes; On 03-AUG-2016, 35 F for 16 hours 37 minutes; On 04-AUG-2016, 33 F for 16 hours 10 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; On 09-AUG-2016, 35 F for 16 hours 1 minute; On 15-AUG-2016, 35 F for 65 hours 30 minutes On 08-SEP-2016, 47 F for 17 hours 18 minutes; On 09-SEP-2016, 47 F for 15 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from an Immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of VAQTA (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports from the same source. The other linked reports are: 1211USA005919, 1211USA006714, 1211USA006716 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
slept 4 hrs post inject woke fussy; took forumla devel lethargic episode; seen by MD confirm lethargy; approx 5 hrs post vax also devel blistered rashes @ site of inject; afebrile w/o sz activity w/o fam hx of adverse reactions;
HEART...  SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not provided) via an unspecified route of administration, administered in left arm on 02Feb2021 as first dose, single dose for covid-19 immunisation. Medical history included diabetes, bipolar, seizure disorder and COPD (chronic obstructive pulmonary disease), all from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medications reported as patient received within 2 weeks of vaccination. The patient previously took buproprion hydrochloride (WELLBUTRIN). Patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. Prior to vaccination, the patient was diagnosed with COVID-19. On 10Feb2021 10:00, the patient experienced heart (also reported as sudden death 20 days after), and immediately had breathing issues, no arrhythmia, no adverse defibrillator reading recorded. Family saw decline immediately after injection, did not request autopsy and adverse medical decline reported to doctor following injection. The events resulted to doctor or other healthcare professional office/clinic visit. Treatment receive in response to the events and treated with cardiologist. The patient died on 10Feb2021.  The causes of death were heart (heart disorder) and breathing issues. An autopsy was not performed. Since the vaccination, the patient has been tested for COVID-19.; Reported Cause(s) of Death: HEART...  SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES
Patient was given 1st dose Covid vaccine of Moderna. Pt was 17 years of age and should have been given Pfizer. Patient did not have any adverse reactions to the Moderna vaccine. patient was given Pfizer for 2nd dose.
Symptoms of swelling, redness, and heat appeared morning after injection. Symptoms spread from upper arm, elbow and lower arm. Symptoms resolved on 10/5/18.
2 pulmonary embolisms, 1 DVT in right leg. Collapsed lung, cellular death in DVT leg. Also ventricular tachycardia. On Toprol XL and Eliquis for the rest of my life.
Vomiting x 1 after 4 mo vaccines. Now vomiting x 24 hours following 6 mo vaccines.
Pt expired during sleep 36 hrs after vaccine. 5/11/06 Received notes from PCP which revealed patient was 34 week preemie w/encephalopathy dx by EEG, intrauterine drug exposure (barbiturates, methadone & TCAs), seizure disorder, severe developmental delays, vascular ring, inguinal hernia & NG feeding tube.  PMH: apnea. Unclear whether pateint was deaf & blind.  Very poor suckle & continued on tube feeds.  Lived with foster parent & because of very poor prognosis was made DNR.  7/25/06 Received Death Certificate which stated COD as encephalopathy/ss
This spontaneous report as received from a physician refers to 84 years old female patient with psoriasis and hypothyroidism. The patient's medical history included lisinopril (manufacturer unknown) caused cough (Same Patient Link: MARRS # 1310USA010372). On 02-OCT-20132, the patient was vaccinated with a dose of ZOSTAVAX lot # J004600, exp. date 18-JUL-2014 (route and dose not reported). Concomitant therapies included SYNTHROID, vitamin D (unspecified) and losartan potassium (manufacturer unknown. On 03-OCT-2013, the patient experienced varicella-like rash in an unspecified location on the patient's body. The outcome of varicella-like rash was reported as not recovered/not resolved. There was no treatment given for the patient's event. It ws reported that the patient called physician (in Friday, 04-OCT-2013). Relatedness was not reported. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild type (WT) VZV strain or with the OKA/Merck vaccine strain. Varicella Zoster Virus (VZV) strain identification polymerase chain reaction (PCR) was performed in an approximately October 2013 (date sample obtained was 07-OCT-2013), date arrived to laboratory was 09-OCT-2013): final results were negative-adequate specimen, no VZV detected (sample: vesicle/lesion and swab of left hand). It was also reported that VZV DNA was not amplified and beta-globin DNA was amplified. Additional information has been requested.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the real cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 02-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigative results. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported.
pt presents with  red spots that are itchy and tender to touch. Pt says she got her second COVID-19 vaccine on Saturday 2/27/21 and the bumps started that night. Pt mentions when she got her first COVID-19 vaccine she got bumps on her arm that were itchy and eventually went away. Pt denies feeling ill with these bumps.
Rec'd varicella - district supplied - had redness, warmth and swelling 24 hours later - states he has not had chicken pox illness prior - size = 10 cm diam. with a more red center.
I started to have spotting and tested positive for pregnancy the same day. I did 6 home pregnancy tests. It had been five to six weeks since my last period. I got my second COVID-19 shot the next day.  II got a fever that night which lasted for about 8 hours as well as a Migraine.  felt very dizzy after getting my shot and still feel some dizziness after five weeks. My heart felt like it was beating very fast three times. I was out of breath like I had been running. Two days later I had a miscarriage. My bleeding lasted for three days and the cramping was very painful. I passed a sac like object. It was not like a normal period. I had a blood test three days later and my hormone levels had come down. I was no longer testing positive for pregnancy. 3rd pregnancy Due date unknown.
Patient has been having left arm pain. Developed acute, partially occlusive left subclavian deep vein thrombosis found on duplex on 4/16/21. She was started on lovenox  and will have further work-up.
2 nights ago tested positive for covid on a home test. Saturday morning started vomiting. Cough and sinus. vaxxed and boosted.Tested at home and positive for COVID 6/11. Began having nausea and vomiting yesterday into this am, no diarrhea, no BM for a few days  Today, his upper abdomen became more swollen and painful so presented to the ED  States had bowel obstruction due to colon cancer, had "18 inches" of colon removed  Had followup colonoscopy 4.5 years ago and told needs repeat in December of this year.  Discharged on 06/16/2022
This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered several doses of improperly stored GARDASIL 9 injection (lot # M041990 with expiration date at 28-JUN-2019; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine were exposed to a temperature between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) for 28 minutes. There was a prior temperature excursion reported (date unspecified) during which vaccine was exposed to a temperature between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) for 64 minutes. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received in December 2017, refer case US2019GSK020472). In February 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced significant pain at injection site, headache, swelling at injection site about size softball, the injection site was hot and red. The redness lasted 2 months and remained about the size of a 50 cent coin. Third day the said it itched. Itching lasted about 5 days. For both of these the sought no medical attention, and it resolved.
Patient  got up to go to the bathroom at 4:30 AM 2 days after he was vaccinated experienced dizziness and fell.  He was not injured.  I spoke with patient at 9:00 AM this morning and he was still experiencing some dizziness.  Patient plans to call his PCP today
Initial report received on 24 October 2011 from the patient's daughter who is a health care professional. A 79-year-old female patient who had an URI (upper respiratory infection) at the time, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number UH444AB) on 23 October 2011 at 19:00 pm and 3.5 hours later on the same day at 22:30 pm the patient experienced swelling of the tongue. Another of the patient's daughters who is a nurse, and who had administered the flu vaccine, administered the patient 100 mg of BENADRYL (route not reported). The patient did not required a physician visit and no relevant diagnostic tests or laboratory data were performed. It was noted the patient had medical history of HTN (hypertension) that was currently being treated with NORVASC and CARDURA, but KNA (no known allergies). The patient had received a flu vaccination last year, but it was not reported whether she had experienced any adverse events with that vaccination. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Baseball-sized rash near injection site on left arm. Selling, races, itchiness, aching. Lasted 8 days.
in her right arm there is a ball; herpes in the mouth; Herpes in the back of her ear; herpes in vagina near anus; red spicks in body; itching; rash; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus) and ERYTHEMA (red spicks in body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shoulder pain. Concomitant products included MELOXICAM for Shoulder pain.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus), ERYTHEMA (red spicks in body), PRURITUS (itching) and RASH (rash). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at a dose of 500 dosage form and FLUCONAZOLE for Adverse event, at a dose of 150 milligram. At the time of the report, LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus), ERYTHEMA (red spicks in body), PRURITUS (itching) and RASH (rash) outcome was unknown.            The patient following the vaccination with the 2nd dose reported that, in October in their right arm there was a ball and experienced herpes in the mouth and in the back of their ear, herpes in their vagina near their anus and red spicks in their body. Reportedly, the patient had rash and itching.
a persistent rash on my head and parts of my upper body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The mother's vaccination history included: Covid 19 vaccine (Dose 1), for covid-19 immunisation; Covid-19 vaccine (Dose 2), for covid-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "a persistent rash on my head and parts of my upper body". The event "a persistent rash on my head and parts of my upper body" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information included Receiving the covid 19 Vaccine (2 plus the booster) Patient had a persistent rash on my head and parts of my upper body. I have to been to two dermatologist and my primary care physician, none of whom has been able to determine the cause. Patient  have taken two rounds of steroids and have used Zyrtec, an over the counter antihistamine as recommended by the CDC, to try to eliminate this, but to no avail. Perhaps you can help me determine what in the vaccine could possibly have caused my problem so patient can finally eliminate the rashes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Infected with SARS-CoV-2 despite receiving the Moderna vaccine series with booster.  Dates of vaccination 4/5/21, 5/5/21, 12/6/21.
5SEP95 mom states pt presented 13AUG95 w/hives, low grade fever, peeling skin & hands; requesting pt be seen by a dermatologist today; 6SEP95 MD saw child-tentative dx of infected dermatitis or eczema;
Bleeding from the hands; exzema fully on both hands; This spontaneous case was reported by a consumer and describes the occurrence of HAND DERMATITIS (exzema fully on both hands) and SKIN HAEMORRHAGE (Bleeding from the hands) 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.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced HAND DERMATITIS (exzema fully on both hands). On an unknown date, the patient experienced SKIN HAEMORRHAGE (Bleeding from the hands). At the time of the report, HAND DERMATITIS (exzema fully on both hands) had not resolved and SKIN HAEMORRHAGE (Bleeding from the hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left 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), 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 and 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment, brand: Pfizer, from 30Jan2023 to 03Feb2023.  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.
No adverse event.  Administration error to report.  Sterile water diluent for live virus vaccines was used to reconstitute the powder instead of the diluent included in the package.
Upon administration of vaccines, infant cried very forcefully, immediately, and then abruptly held breath and became flaccid with facial redness and then duskiness for a few seconds. Recovered entirely immediately.
Patient presented with flushing and rash on face within 3 minutes of vaccination. Her throat started to itch and she was experienced difficulty swallowing without dyspnea. EMS was contacted and obtained vitals upon arrival. Patient was stable with BP of 185/95 and 02 sat of 98% on room air. Vitals remained stable and although rash noticeably improved during observation, the tracheal symptoms did not. Patient was transported to ER by daughter and followed up with me after her treatments. She was given antihistamines and corticosteroids and symptoms subsequently resolved.
skin condition something like Vitiligo from middle of his neck to his chest/strange streak on his neck where the skin looks like there is no pigment in there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0172) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST (ongoing); CETIRIZINE HYDROCHLORIDE taken for drug hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Suspect Product: First Vaccine   , Batch/lot number: EW0172   , Dosage text: Second dose, left arm , Indication for use in the case: COVID-19    , Date of start of drug: 05Apr2021    , Action(s) taken with drug: Unknown), administration date: 05Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: SKIN HYPOPIGMENTATION (non-serious) with onset Jul2021, outcome "recovering", described as "skin condition something like Vitiligo from middle of his neck to his chest/strange streak on his neck where the skin looks like there is no pigment in there".  Additional information: Patient stated that he was vaccinated in April and after his Second Shot, he doesn't know if this was a reaction, but after he was in the sun in July, he got this strange streak on his neck where the skin looks like there is no pigment in there. Patient states it is weird because he has always tanned and had a lot of melanin. He states it looks like the disease where a person starts losing melanin. He asked is that a possible side effect.  No follow-up attempts are possible. No further information is expected.
G40.919 EPILEPSY, INTRACTABLE 3/31/2023 UTERINE FIBROIDS
Very painful left arm from shoulder through the elbow, hard to lift arm up or find comfort sleeping.
Acute onset, high fever with hallucinations, nausea, vomiting, severe body aches such that patient was curled in a ball for 24 hours.  Cough and wheezing, shortness of breath.  Similar but less severe reaction last year.
Pt vax; devel small area of erythema & edema, size of silver dollar at inject site.  After 24 hrs upper arm swelled further to size of baseball & was painful.  No lymph node swelling, & pt felt ill.