chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a other source (office manager) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L050909, expiry date: 14-JUN-2016. The temperature excursion were reported as -8.4 degrees C for 11 hours, -9.7 degrees C for 16 hours and -11 degrees C to -13.9 degrees 59 hours. No previous excursion reported. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
low grade fever; sore throat; fatigue; swollen glands; stiffness in both wrists and finger; stiffness in both wrists; red eye; This spontaneous report was received from 63-year-old male patient referring to himself. The patient had no pertinent medical history. On 12-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (frequency, lot# and expiry unknown) 1x0.5mL dose, subcutaneous for prevention of rubella. Concomitant therapies included acetaminophen, diazepam (VALIUM) and paroxetine hydrochloride (PAXIL). On 21-APR-2019, the patient experienced low grade fever (pyrexia), sore throat (oropharyngeal pain), fatigue, swollen glands (lymphadenopathy), stiffness in both wrists and a finger (joint stiffness) (musculoskeletal stiffness), red eye (ocular hyperaemia). Outcome of events was reported as recovering. Causality assessment was not reported.
Pt recv vax on 10/2/98; post vax pt exp shortness of breath, dizziness & nausea; tx=Epinephrine
Pt exp diarrhea since 24AUG91; also c/o stiff neck, fever, wt loss, lethargic @ times; soreness @ inject site; Seen by MD 27AUG91; given meds to replace fluids & return to MD as needed;
Fully vaccinated with booster, but still tested positive for COVID; Fully vaccinated with booster, but still tested positive for COVID; Fully vaccinated with booster, but still tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) 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: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "Fully vaccinated with booster, but still tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, COVID-19. The events did not result in causing hospitalization; prolongation of existing hospitalization; life threatening; disability or incapacitating; death; congenital anomaly or birth defect. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had  been tested for COVID-19. The patient had no known allergies. The facility type vaccine was temp vaccination site set up by local Health System.   The lot number for bnt162b2 was not provided and will be requested during follow up.
PATIENT WAS PROVIDED WITH AN EXPIRED VACCINE (2 DAY POST EXPIRATION); NO EFFECTS ?Moderna COVID-19 Vaccine EUA?
Swollen, redness, red ring around swelling, hot surface, itching after 3 weeks
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and slight temperature. On an unknown date, the outcome of the injection site pain and slight temperature were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and slight temperature to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that arm where she had the 2nd shot was so sore. The patient was asking was it ok to use heat or cold or take TYLENOL for the pain, would it be alright to use light therapy on it. The patient reported that the arm at site of injection was extremely sore and she had a low grade temperature. The patient just wanted to be sure this would not interfere with the vaccine. Lab Comments: On an unknown date, patient's body temperature was performed.
Soreness in the arm; Just wants to sleep all the time; Strong body aches; Completely worn out; Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), SOMNOLENCE (Just wants to sleep all the time), MYALGIA (Strong body aches), FATIGUE (Completely worn out) and ARTHRALGIA (Joint aches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness in the arm). In December 2021, the patient experienced SOMNOLENCE (Just wants to sleep all the time), MYALGIA (Strong body aches), FATIGUE (Completely worn out) and ARTHRALGIA (Joint aches). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm), SOMNOLENCE (Just wants to sleep all the time), MYALGIA (Strong body aches), FATIGUE (Completely worn out) and ARTHRALGIA (Joint aches) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-419551, MOD-2021-419562 (Patient Link).
Patient got light headed with signs of low blood pressure due to vaccine and pale skin. Patient was asked to be in pharmacy for 20 minute after vaccination in case of side effects. Patient mentioned that he did not have breakfast and he was provided with water. After 5 minute he was feeling better.
Patient moved during vaccination and less than 50% of vaccine was administered. Nurse administered another dose.
broke out w/rash all over body x/face;fine red areas w/some raised areas, whelps;was itchy & having some burnings; broke out in 20APR96;reported on 24APR96;saw MD in hosp ER 24APR96;
1st dose 23jun22, 2nd 13jul22; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th July 2022, the patient received the 2nd dose of Shingrix. On 13th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The patient reported that she received 1st dose of Shingrix and to her mistake, she returned to the pharmacy after 2 weeks instead of 2 months to receive her 2nd dose. The patient received the 2nd dose of Shingrix earlier than recommended interval. No other symptoms were reported.  Reviewed dosing schedule as per package insert and provided medical advise disclaimer.  The patient gave permission to follow-up with health care professional. The reporter consented to follow up. Additional supportive information: The patient received the 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccine schedule.
No sense of smell; Hot burning rash on left arm; rash throughout arm an into wrist/hot burning rash on left arm; Lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at injection site), ANOSMIA (No sense of smell) and BURNING SENSATION (Hot burning rash on left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Drug allergy (Bactrim). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 02-Jan-2010 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site). On 21-Jan-2021, the patient experienced ANOSMIA (No sense of smell) and BURNING SENSATION (Hot burning rash on left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 23-Jan-2021, VACCINATION SITE MASS (Lump at injection site) had resolved. On 08-Feb-2021, BURNING SENSATION (Hot burning rash on left arm) had resolved. At the time of the report, ANOSMIA (No sense of smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Event details updated, added detailsof second dose of moderna vaccine, added medical history and also added race and ethnic group of patient
This case was reported by a nurse and described the occurrence of swelling of the thigh in a 1-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 11 May 2005, the subject received the 5th dose of Infanrix (lot AC14A009BA) in the left thigh. Concurrently the patient also received haeomophilus influenzae tetanus toxoid conjugate vaccine (ACTHib) in the right arm. On 12 May 2005, one day after vaccination with Infanrix the nurse reported that the subject experienced "whelping which was hard, red and swollen" at the injection site. The subject was treated with a warm compress. The events "resolved within a few day", on an unspecified date in May 2005. The nurse considered the events to be related to vaccination with Infanrix.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (route, dose and lot # not reported). The temperature excursion was found to be supported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Itching; rash; warmth where injection was adminstered; This is a spontaneous report from a contactable consumer (Patient reported for himself).  A 65-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, in left arm on 10Mar2021 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient medical history included high blood pressure, high cholesterol and COVID-19. Patient had no known allergies. The concomitant medication of the patient included carvedilol, atorvastatin and telmisartan. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had COVID prior the vaccination. Patient was not tested for COVID post vaccination. On 12Mar2021 12:00 the patient experienced itching, rash and warmth where injection was administered. Patient did not receive any treatment for the reported events. Outcome of all the reported events was not recovered.  No follow-up attempts are possible. No further information is expected.
48 hours after vaccine administration erythema 9 x 6 cm left upper arm (L) shoulder and upper arm (deltoid) pain. Improved after 48 hours w/discomfort. Swelling at site. Patient afebrile. Treatment: NSAIDS, TYLENOL for discomfort, elevate, cool compresses-call back with worsening symptoms which were reviewed.
Patient received Moderna for dose 1.  Patient wanted Pfizer to begin with, so consented to Pfizer being given for second dose.
Case number PHEH2014US019687 is an initial spontaneous report received from a medical assistant on 28 SEP 2014. This report refers to a 43 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2014 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
fever beginning 2:00a.m. (100.6F), with mucle, joint aches, fatique lasting ubtil approx. 4:00 a.m. 4/10/21 when temperature returned to normal, and generally felt back to normal except sleepy. TooK inruprofen every 8 hours at outset.
This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the pertinent medical history, drug allergies or reaction and concomitant therapies was reported. On 11-OCT-2016, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # L038135, expiration date 27-MAY-2016) (exact dose and route of administration were not reported). The vaccine was stored 24 hours in 1 degrees C. The previous temperature excursion was 24 hours at highest temperature 22 degrees C. Data logger was not involved. No adverse effect was reported. Additional information has been requested.
Information has been received from a medical technologist concerning a 39 year old female who on 12-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662842/1296X). 10 hours after vaccination on 12-OCT-2009 the patient developed swelling at the injection site of the left upper arm. The patient then developed tingling and numbness of the left arm. The patient went to an office. It was unknown if treatment would be required. At the time of the report, the patient had not recovered. Follow up information has been received from the medical technologist. No additional AE information provided. This is one of several reports received from the same source. Additional information has been requested.
Rt deltoid sl swelled redness noted area approx 35mm x 60mm no firm induration noted; Dev 16-20 hrs following inj mom reports adm APAP q 4hrs & cold compress to area;
I experienced a breakthrough case of COVID-19 with a very runny nose, sneezing, fever, cough, tiredness, lost of appetite.
Fever of 104 for 4 days, caughing very high. Lungs feeling with liquid, about half way on right side.
Information has been received from a licensed practical nurse concerning a 1 day old patient whose 18 year old mother with morbid obesity, on marijuana and tobacco use, a history of Chlamydia and no drug reactions or allergies on 02-DEC-2010, was vaccinated with her first dose of GARDASIL (Lot # and expire date not reported), 0.5 ml, intramuscularly. Concomitant therapy included azithromycin, prenatals, azithromycin, DIFLUCAN, and ampicillin. The licensed licensed practical nurse indicated that the patient's mother was pregnant at time of vaccination. Her last menstrual period was on 12-NOV-2010 and the estimated delivery date was on 19-AUG-2011. Licensed practical nurse stated that on 21-DEC-2010, urine and blood tests were performed to the patient and they were positive. The nurse reported that she delivered the baby in May 2011 (exact date unknown), on week 27. The baby went to the neonatal intensive care unit (NICU). At the time of the report the patient's outcome was unknown. Upon internal review, the baby was delivery at 27 weeks was determined to be an other important medical event. The mother's experience has been captured in (WAES # 1101USA00115). Additional information has been requested.
broke out with a rash on buttovk, sides, thighs, sow spreading, was told it is granuloma annulare. Appeared after vaccine. Stil having shingles, not as severe
This case was reported by a healthcare professional and described the occurrence of diarrhea in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 1 July 2014, the subject received 2nd dose of ROTARIX (oral, batch number not provided). Less than one month after vaccination with ROTARIX, the subject experienced diarrhea. The subject was hospitalised. At the time of reporting, the outcome of the event was unspecified. The event was first suspected to be due to vaccination with ROTARIX but was later considered as unrelated to vaccination with ROTARIX. The healthcare professional reported another case of diarrhea after vaccination with ROTARIX (see case A1083107A).
shakes and quivers in her arms and legs; numbness and tingling in her left arm that eventually traveled to her entire left side of her body; numbness and tingling in her left arm that eventually traveled to her entire left side of her body; buzzing in her head; This spontaneous report was received from a nurse (patient's aunt) and refers to a 23-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for HPV prevention. On 20-JUN-2019, the patient experienced numbness and tingling in her left arm that eventually traveled to her entire left side of her body and buzzing in her head. On unknown date in July 2019 (reported as one month ago), she starting having shakes and quivers in her arms and legs. On an unspecified date, the patient sought medical attention and was sent to an unspecified neurologist, who ordered unspecified blood tests (reported as "blood work", thyroid and creatine phosphokinase (CPK)) (results not provided) and unspecified magnesium supplements, that did not help. The neurologist sent the patient to outpatient physical therapy 3 times a week for the last 2 weeks, without any improvement. The outcome of numbness and tingling in left arm that eventually traveled to entire left side of the body and buzzing in head was reported as eventually improved on an unknown date in 2019. The outcome of tremor was reported as not recovered/not resolved. There was no causality assessment provided by the reporter.
severe headache; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious courtesy case received via consumer.  This case involves an unknown age and unknown gender patient who had severe headache after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy.   On an unknown date in Oct-2021, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On an unknown date in Oct-2021 the patient had an event of severe headache (headache) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  it was reported, After shot, got severe headache. Went to ER. Multiple daily headaches, ever since that day, for 2 years   it was unknown if any lab data/test results available.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Not Recovered / Not Resolved for the event.
This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose, dosage schedule, route of administration, lot number and expiration date were not provided). On an unknown date PNEUMOVAX 23 vaccine was improperly stored and administered to unknown number of patients. The vaccine was exposes to 9 degrees C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter. Additional information has been requested.
The patient was diagnosed with intussusception on 3/5/14.  Patient received Rotateq on 2/27/14.
Onset of rash all over torso and upper body a few hours after the shot. Still not resolved 32 hours after second shot
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The pharmacist call about the administration of expired Moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.
pt recvd 1st Hep B vax & broke out w/small hives sometime during the noc; rash was itchy, was on the arms, chest & neck, & lasted about 2 days;
irritable,crying;refused food &water;t-100C;dx:ADR tp DTP & dehydration.
patient received phizer covid shot and around 2 minutes later become to feel woozy, he sat down, then the pharmacist came to check on him and could not respond to questions asked, we called 911 immediately, and then passed out. he maintained breathing and pulse throughout time passed out. ems arrived on scene within 5 minutes he then came to and was able to respond to questions. but was taken to hospital for further testing. patient states he thinks he had a panic attack
5/28/14 Woke up with a hard lump on both arms where shots were given.  There was no redness or tenderness.  5/29/14 Pt woke up and the lump on the left arm had gotten bigger (4x4.5 inches) Right arm remained the same size (1.5 inch circle) but both lumps had become very red.  Pt was examined by MD.  No medication given.
fussy & crying since inj given on 7APR:seen in office on 9APR;to given Ibuprofen & APAP;
Anaphylaxis, Patient's throat closed due to swelling. Occurred 4 hours post dose, was administered epinephrine in Urgent care and transferred to hospital.