chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects reports; one female patient was administered improperly stored RECOMBIVAX and ROTATEQ; This spontaneous report was received from a vaccine coordinator, regarding a 6-months-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 09-MAR-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 5/0.5 microgram/milliliger (mcrg/ml) (dose, route of administration and vaccination scheme were not reported; lot number R028529, expiration date 09-JUN-2021) as prophylaxis. Other suspect therapies include improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration and vaccination scheme were not reported; lot number 1658255, expiration date 07-FEB-2021) as prophylaxis (product storage error).  The call was due to a digital data logger, which showed that on 02-MAR-2020, the vaccines were stored in a temperature of 0.8 degrees Celcius (°C); for a timeframe of 5 hours and 9 minutes. On 04-MAR-2020, the vaccines were stored in a temperature of 0.9 °C for 11 hours; On 05-MAR-2020, the vaccines were stored in a temperature of -1.3 °C for 9 hours and 29 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006305:
Patient is a nurse identified sxs of potential allergic reaction and treated herself with diphenhydramine later that evening. Symptoms subsided quickly. Rash, Erythema Multiforme, Urticaria Pruritus and Chest tightness.
decline in condition, complaints of shortness of breath, recent unwitnessed falls, edema to bilateral lower extremities, incontinence of urine, tearfulness, low heart rate Pedal edema
This spontaneous report as received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On 13-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M036296; expiry date 14-NOV-2017 (dose and route of administration were not reported). Sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was not expired. No adverse effects were reported.
pt recv vax 3NOV94 & 4NOV94 devel vomiting, redness, itching, a hard lump @ the inj site & a swollen arm; 05NOV94 pt exp an upset stomach; local rxn lasted for 24 hr; the hard lump lasted for approx 5 days;
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # N008823, expiration date of 26-MAY-2018 or N017094, expiration date of 31-AUG-2018; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014.
Patient presented to the hospital on 10/19/22 with fevers and cough for a couple days. Tested positive for COVID on 10/19/22. Discharged on 10/24/22.
Left side facial droop 20 minutes after Improved within one hour still doesn't look right six days later. Chest pain and Headache on the drive home still have at 6 days later.  Dizziness fever of 104 left arm pain neck pain can't move my head lather knees buckle out from underneath me. Difficulty breathing facial rash
STARTED OUT WITH IRREGULAR PERIODS THEN MOOD SWINGS, SLEEP ISSUES, HOT FLASHES, NIGHT SWEATS, CONCENTRATION ISSUES, SEX ISSUES...ESSENTIALLY EVERY SINGLE SYMPTOM OF MENOPAUSE UNDER THE SUN I HAVE HAD. IT'S TERRIBLE!   I HAD 3-SHOTS IN 2013 (4/26/2013, 6/8/2013, 10/15/2013) AND WITHIN MONTHS --- MY ALWAYS NORMAL PERIOD --- TURNED INTO AN IRREGULAR ONE.   HAD SOME TESTING DONE OVER THE YEARS AND NOTHING CAME UP AT FIRST. WASN'T UNTIL MY HORMONE LEVELS COMPLETELY DROPPED IN 2021 THAT ANYTHING WAS ABLE TO BE DIAGNOSED.   SO I SUFFERED FROM 2014 THROUGH TODAY! THIS VACCINE RUINED MY LIFE. I'M LIKE A BLASTED GUINEA PIG NOW TO THE "WOMENS CARE" PROFESSIONALS. THEY HAVE NO IDEA HOW TO TREAT ME.   I FEEL TERRIBLE ALL THE TIME! AND MY HEALTH CONTINUES TO GO DOWN HILL. MY BODY HAS SHRIVELED UP. I'LL BE LUCKY TO MAKE IT TO 50 OR 60.
Patient reported she has had a previous anaphylactic reaction to IM cefepime; and Zofran. Patient carries an epi pen. Patient received vaccination due to agency recommendations stating she should. Patient received vaccine at 1100 and at 1105 eyes started itching, she had a tingling sensation all over body and developed red spots on arms. Patient was assessed by LPN who then contacted Clinic RN who reported she should continue to be monitored the the rest of the 30 minutes. Patient was advised she should be seen in the ER and refused to go and reports she has an epi-pen at home and believes if she takes Benadryl she will be fine. Patient denies and did not show symptoms of shortness of breath, or fatigue. Patient left clinic at 1130 under her own will and had her mom drive her home.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hep  B vaccine (manuf unk) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injections of hep B vaccine (manuf unk) on 8/7/97, 11/10/97, and 4/21/98. He also received injections of diphtheria and tetanus toxoids and pertussis vaccine (manuf unk) 9/18/97, 10/10/97, 1/30/98, and 10/23/98 and Haemophilus influenzae type B conjugate vaccine (manuf unk) 9/18/97, 11/10/97, 1/30/98 and 10/23/98. The subject's attorney alleged that "As a result of the mercury in the Thimerosal-containing vaccinations that the subject received he now suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning." The attorney further alleged that the subject "has developed severe neurodevelopmental disorder with associated high mercury exposure levels as a result of the vaccinations he received, and has suffered serious permanent injury." Onset and treatment of the events were not specified. The mercury poisoning in this report, with resultant neurodevelopmental disorders, is considered medically serious (OMIC).
Primary complaint: headache and anxious. Patient stated she did not eat or drink due to religion and usually gets nervous from shots. Patient lied down and felt better. Vital signs monitored. Patient stated she felt okay to drive home and requested to leave. She was advised to call 9-1-1 if any issues persist or any breathing problems occur.
Pt. was seen in E.R. when flu immunization was given. Then seen 2 days later with approx. 9 cm circle reddened, inflamed area on site of injection. Pt. describes pain from area and going into armpit same arm.
Complain of extreme dizziness that started on yesterday, 3/1/2021 at 5:30 PM and stopped on this morning, 3/2/2021 at 1:00 AM. Initially felt tired and washed out after injection on 1/25/2021 and 1/26/2021. States she is currently is little lightheaded.  Advised patient to seek healthcare is symptoms does not go away.
No adverse effects; the patient received one dose of MMR-II inadvertently by the intramuscular route; Information has been received from a pharmacist referred to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On approximately 05-JUN-2019 (reported as one week ago),  the patient received one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot number and expiration date was unknown) inadvertently by the intramuscular instead of subcutaneous and no adverse effects was reported(incorrect route of product administration and no adverse event). No product quality complaint(PQC) was found.
Attendee received first dose Pfizer vaccine at 12:45 in the right arm.  Lot# EW0217. Attendee was directed to observation area.   At 13:00 voiced complaints of dizziness and nausea.  911 was called. Attendee's skin was cool, clammy and pale.  Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down.  Continuous pulse oximetry applied.  13:03  Sitting in the chair HR:  58   BP:  115/65   RR:   16   O2Sat%:  100   13:08  While moving to the cot, the attendee did vomit x 3-4 times HR:  48   BP: N/A   RR:  N/A   O2Sat%:  100  13:15 - Attendee stated he felt better, no longer cool or clammy.  Paleness decreasing.   HR:  71   BP:  100/60   RR:  14    O2Sat%:  100
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Red pruritic wheal surrounding injection site for 72 hours. Treated with topical emollient and oral antihistamine
About an hour after receiving vaccinations patient got uncharacteristically fussy and drowsy. He fell asleep for about five to ten minutes. For the remainder of the day he had a loss in appetite, fussiness, hot to the touch despite lack of fever, and slept for over 10 hours.
Patient was given a dose from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vaccine was administered in the deltoid region . Initial expiration date was  09Oct2021 and  was extended to 27Oct2021. Concomitant medication use was unknown Treatment information was unknown
Couple hrs after vaccine, had pin prick pain at site of a previous shingles episode (front of thigh). Day after vaccine, vaccine site swelled to size of egg, became very pink to red, and was quite hot. I applied ice. Today (2nd day after injection), site has enlarged. Still tender, hot, and pink, and swollen.
pt vax hepta B. pt devel arthralgia which persisted for 4-5 months
Pt recvd vax October or November 1991 & devel a sterile abscess @ the site of inject; the abscess has resolved;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-JUN-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L045993 (dose and route of administration were not reported).
SEQUENTIAL USE OF JANSSEN COVID-19 VACCINE AFTER USE OF PFIZER COVID-19 VACCINES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: stroke, dementia, high blood pressure, and high cholesterol, and other pre-existing medical conditions included: The patient had no known medication allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown ,expiry: unknown ) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162.  On 13-SEP-2021, the patient experienced sequential use of janssen covid-19 vaccine after use of pfizer covid-19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use of janssen covid-19 vaccine after use of pfizer covid-19 vaccines was not reported. This report was non-serious.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA ACUTE NON ST ELEVATION MI 2/7/2022 -- RECURRENCE OF SAME SYMPTOMS
Puffy/watering eyes Constipation  Extreme Fatigue Shortness of breath Hot flashes/chills Insomnia
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection arm), PYREXIA (High fever (102.5F)), CHILLS (Chills) and HEADACHE (Strong headaches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection arm), PYREXIA (High fever (102.5F)), CHILLS (Chills) and HEADACHE (Strong headaches). At the time of the report, VACCINATION SITE PAIN (Pain in the injection arm), PYREXIA (High fever (102.5F)), CHILLS (Chills) and HEADACHE (Strong headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: high (High) high fever (102.5 F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.
he mentioned having back pain; 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.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "he mentioned having back pain".  Additional Information: The person on the line mentioned he received two Pfizer COVID-19 vaccines a year or more ago, and wanted to know if he needed another dose. Caller mentioned he wasn't sure of the lot numbers because the vaccination card had the information close but mentioned the numbers . Additionally, he wanted to know where he could get his vaccine appointment for the booster. Finally, when asked if there was anything else I could assist him, he mentioned having back pain, but that he would go to a clinic to check himself.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SEVERE ABDOMINAL PAIN; SEVERE BLOATING; LEG PAIN; CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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 and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced severe abdominal pain. On 18-MAY-2021, the subject experienced severe bloating. On 18-MAY-2021, the subject experienced leg pain. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-MAY-2021, and had not recovered from severe abdominal pain, severe bloating, mild headache, and leg pain. This report was non-serious.
Approximately a few hours after my booster shot (Dose 3) I experienced the following symptoms: Low grade fever, Diarrhea, Fatigue, Joint pain and There was like a siren in my ear as well and it won't go away. I did not take any medications and gave it time to go away. The other symptoms went away after a few days (low grade fever and fatigue) but the siren in my ears (Both ears) did not stop and it just became louder. I noticed it wasn't going away so I had to go to my ENT and had it checked. I was advised that it was known for people who got the booster shot to experience this kind of symptom. She prescribed me with Fish oil, Vitamin D3, Vitamin C.
no adverse effects; patient have been administered doses of improperly stored vaccines; This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 30-MAR-2020, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S023645 with expiration date of 10-MAR-2022(upon internal validation),0 .5 milliliter, intramuscular in the right thigh for prophylaxis; pneumococcal conj vaccine (unspecified)(PNEUMOCOCCAL CONJ VACCINE (UNSPECIFIED)) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID). No adverse event was provided.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008883:Original Case : 2003USA002275 US-009507513-2008USA008876:Original Case : 2003USA002275 US-009507513-2008USA008875:Original Case : 2003USA002275 US-009507513-2008USA008877:Original Case : 2003USA002275 US-009507513-2008USA008878:Original Case : 2003USA002275 US-009507513-2008USA008879:Original Case : 2003USA002275 US-009507513-2008USA008880:Original Case : 2003USA002275 US-009507513-2008USA008881:Original Case : 2003USA002275 US-009507513-2008USA008884:Original Case : 2003USA002275 US-009507513-2008USA008886:Original Case : 2003USA002275 US-009507513-2008USA008887:Original Case : 2003USA002275 US-009507513-2008USA008889:Original Case : 2003USA002275 US-009507513-2008USA008889:Original Case : 2003USA002275 US-009507513-2008USA008890:Original Case : 2003USA002275 US-009507513-2008USA008891:Original Case : 2003USA002275 US-009507513-2008USA008892:Original Case : 2003USA002275 US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
7 days following my vaccination I developed circular swelling  around the injection site. Approximately 6cm in diameter. Swollen enough,  my shoulder feels still when lifting my arm above my head. Also developed an mild erythematous papular rash that is mildly itchy.
On 6/29/2021 I received the first dose of the Pfizer vaccine a few days after that i started feeling really  jittery this went on and on after about a week i started having shakes the i couldn't control my head would turn to the side and just shake then i would lose all my strength in my hand and legs and fall down on 7/15/2021 i was taken to the hospital by my wife and there my blood pressure shot up very high and i started too have these episodes again while there, they rushed me down to CAT scan to make sure there wasn't any blood clots which it wasn't so they referred my to a neurologist  because they couldn't figure out what was going on. I have never went through anything like this before taking the shot .
This spontaneous report as received from a physician refers to a patient who was vaccinated with the first dose of GARDASIL at a health care facility over 2 years ago. The patient did not receive any the subsequent doses for GARDASIL after their initial injection. The patient was being seen through the physician's office and the physician re-started the series for the patient recently. Additional information has been requested.
No adverse event; Dose-1-21-AUG-2021 Dose-2-01-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-AUG-2021 Dose-2-01-SEP-2021) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    No Medical History information was reported.   On 27-Jan-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-AUG-2021 Dose-2-01-SEP-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-AUG-2021 Dose-2-01-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medication was provided Two days after vaccine process of clearing skin from plaques stopped and remained plaques on upper back and buttocks that had not gone away. Knees were clear. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-624327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Live-non-significant follow up. Updated narrative