chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she may have had anaphylaxis with it; Initial information received on 20-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 78 years old female patient where she may have had anaphylaxis with it after receiving vaccine Influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Allergy to antibiotic and Hypersensitivity.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient may have had anaphylaxis with it (anaphylactic reaction) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved.   She stated that last year she received Flublok and had an allergic reaction that was not anaphylaxis. She described the reaction as lip swelling, chest tightness, and throat swelling. She took an allergy pill prior to receiving Flublok last year. She says, "it was sort of ok. They just monitor me for 3 hours." She believes she may have had more of a problem with a Fluzone vaccine in the past. She does not know the particular Fluzone vaccine with which she may have had more trouble. She was asked and she does not believe it was the high-dose Fluzone. She believes it was many years ago that she had Fluzone and she may have had anaphylaxis with it. She is not sure. She may have had Fluzone that was drawn from a multi-dose vial, but she is unsure of that too. Product used : Used Still using product : No  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.  Seriousness criteria- Medically significant for event.
Information has been received from a Medical Assistant, for GARDASIL and SINGULAIR, a Pregnancy Registry product, concerning an 18 years old female patient with no known medical allergies. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 2 of GARDASIL on 13-JUN-2012 (lot number, date, dose and route not reported0. Secondary suspect therapies included SINGULAIR (dose and indication not reported). Concomitant medications included prenatal vitamins, ZOLOFT, fluticasone propionate, ADVAIR, albuterol (manufacturer unknown) and ALLEGRA. Subsequently, the patient became pregnant with an estimated LMP of 27-APR-2012 and an EDD of 01-FEB-13. Initial exposure to GARDASIL was at 6 week(s). The patient was exposed to GARDASIL and SINGULAIR during the first trimester. An ultrasound was conducted on 05-JUL-2012 to confirm pregnancy. The patient had not been hospitalized during the pregnancy. No treatment information was reported. Follow up pregnancy questionnaire has been received from the nurse practitioner concerning the patient with anxiety disorder and asthma. The patient's medical history included anemia, syncope and collapse and no previous pregnancies. The patient was vaccinated with (lot # 0026AE) dose 2 of GARDASIL (dose and route not provided) on 13-JUN-2012. Additional concomitant medications included iron (unspecified). An ultrasound was performed on 05-JUL-2012 due to amenorrhea and to confirm dates. The patient's last menstrual period was on 16-MAY-2012 and the EDD was of 01-FEB-2013 versus 20-FEB-2013. Follow-up information has been received from a nurse practitioner concerning an 18 year old female patient with a history of backache and dipped tobacco. The patient had no obstetric history of previous pregnancies. Other suspect therapies included SINGULAIR. Concomitant therapies included iron (unspecified), prenatal vitamins (unspecified), ZOLOFT, fluticasone propionate, ADVAIR, ALBUTEROL and ALLEGRA. The patient became pregnant with LMP of 16-MAY-2012 and EDD of 01-FEB-2013. Initial exposure to GARDASIL was at 4 week(s). Laboratory tests included MSAFP (alpha-fetoprotein test) done on 21-AUG-2012 (negative), nuchal translucency (20-JUL-2012 - negative) and PNL - metabolic panel (20-JUL-2012 - "WNL"). It was reported that, on an unknown date the patient experienced pruritic urticarial papules and plaques of pregnancy (PUPPS). On 24-JAN-13, at 39 weeks gestation, the patient delivered a normal male infant weighing 4166.53 gms (9 lbs 3 oz) (no complication during labor/delivery was reported). There was no congenital anomalies and other complications or abnormalities. The pregnancy outcome was live birth. Action taken regarding montelukast sodium was not reported. The outcome of PUPPS was unknown. The relatedness for PUPPS was unknown for GARDASIL and SINGULAIR. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6210), in right arm, on 03Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 03May2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "prostate cancer radiation", start date: 2020 (unspecified if ongoing). Concomitant medications included: TADALAFIL, start date: 03Jan2022; ROSUVASTATIN, start date: 01Jul2020, stop date: 20Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Inappropriate dose of drug administered; OFF LABEL USE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autistic disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced inappropriate dose of drug administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate dose of drug administered and off label use was not reported. This report was non-serious.
PER PT ON THE EVENING OF 8/31/20 PT EXPERIENCED REDNESS AND SORENESS AT SITE OF INJECTION. THE PAIN AND RASH PEEKED AT AROUND THURSDAY AND GOT BETTER ON FRIDAY. BY 9/820 PT WAS FEELING ALMOST 100%. PT STATES HER WHOLE MUSCLE SECTION WAS SORE, SHE HAD A RASH AND FELT HEAT FROM THE MUSCLE SITE.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot #M042322 with expiration date of 21-FEB-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. Data logger was involved. There were not previous excursions. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002222: US-009507513-1705USA002243: US-009507513-1705USA002244.
Injection site rash, redness, minor itching and swelling along lateral aspect of left upper arm, starting at injection site and moving to front of arm. Noticed it this morning, 1-12-2021 and I got vaccine 12-30-2020
Fever, chills, fatigue; pt taken to ER 8/5/07. Placed in ICU dept at hospital. Discharged 8/6/07. 9/10/07-records received DC DX:acute fever and rigors. abnormal liver function tests. acute leukopenia. C/O fever, nausea and vomiting ill since 8/1/07-Tired. Diarrhea. Dysuria. Temperature 105.
3 days p/vax small quarter size erythematous area @ inj site > to 3" by 5";warm erythematous area;devel rash under skin (not seen by reporter described by mom p/visit in office);Augmentin, DPH;
Moderna vaccine was administered outside - reported by patient. I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/9/2021 ADENOCARCINOMA, TAIL OF PANCREAS. I21.4 ACUTE NON ST ELEVATION MI 12/22/2021 ADENOCARCINOMA, TAIL OF PANCREAS I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/22/2021 ADENOCARCINOMA, TAIL OF PANCREAS R29.810 LEFT FACIAL MUSCLE WEAKNESS 12/13/2021 ADENOCARCINOMA, TAIL OF PANCREAS I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/9/2021 ADENOCARCINOMA, TAIL OF PANCREAS I21.4 ACUTE NON ST ELEVATION MI 12/22/2021 ADENOCARCINOMA, TAIL OF PANCREAS I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/22/2021 ADENOCARCINOMA, TAIL OF PANCREAS R29.810 LEFT FACIAL MUSCLE WEAKNESS 12/13/2021 ADENOCARCINOMA, TAIL OF PANCREAS I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/9/2021 ATRIAL FIBRILLATION, PAROXYSMAL I21.4 ACUTE NON ST ELEVATION MI 12/22/2021 ATRIAL FIBRILLATION, PAROXYSMAL I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/22/2021 ATRIAL FIBRILLATION, PAROXYSMAL R29.810 LEFT FACIAL MUSCLE WEAKNESS 12/13/2021 ATRIAL FIBRILLATION, PAROXYSMAL I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 12/9/2021 ACUTE ST ELEVATION MI, UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 12/22/2021 ACUTE ST ELEVATION MI, UNSPECIFIED I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/22/2021 ACUTE ST ELEVATION MI, UNSPECIFIED R29.810 LEFT FACIAL MUSCLE WEAKNESS 12/13/2021 ACUTE ST ELEVATION MI, UNSPECIFIED.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.          No adverse event reported for the patient.  No treatment medications were reported.
Approximately 10-14 days after injection, I developed hives all over my body that change location daily, are itchy, and my skin is very inflamed. I have many swollen lymphnodes and the rashes migrate but always end up on my neck daily at some point. It?s been nearly 3 weeks since this began with no improvement, and benadryl only gets rid of the itchiness but nothing more.
pt recv vax; stomach cramps, hot ; v & d; sl HA & tiredness; sl soreness & tired, cont for few days; better 1jul95;
fever; chills; headache; This is a spontaneous report from a sponsored program. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had fever, chills and headache after the first dose. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
frequent low volume urination; fatigue; chills; low fever (99.7); stomachache; This is a spontaneous report from a contactable consumer.   A 47-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  Medical history included Kidney transplant: Nov2019, Nephrectomy: 04Dec2020, laminectomy: 07Jan2021, craniotomy: 23Jan2021.   The patient's concomitant medications were not reported.  The patient experienced Potential COVID-19 vaccine reaction six days after first dose: frequent low volume urination, fatigue, chills, low fever (99.7), stomachache.  Outcome for events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed right arm swelling and tenderness at site of vaccination, progressive, clearly Cellulitic / right axillary adenopathy.  Given Keflex with resolution. Temp increase to 103 degrees.
Information has been received from a consumer concerning his/her cousin, a 60 year old female who 4-5 weeks ago (in approximately August 2010), was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). Now, the patient was experiencing burning and pain on her back only no rash had broken out. Caller wanted to know if ZOSTAVAX (Merck) would cause this pain no additional information could be provided. The consumer didn't report his/her cousin's final outcome at this time. No further information is available.
A report was received from a health care professional on 2/24/04 concerning a 16 year old female vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
20 minutes after receiving the immunizations, the child c/o of being thirsty and the mother gave her orange juice.  The child immediately vomited and starting having severe difficulty in breathing. Medical Records received on 2/2/2005 states pt experienced wheezing and allergic reation.
Fever,  temperature of 101.4; Chills; Tired; Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose); Sore Left Arm (within 24 hours of first dose); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th Feb-2nd dose)), PYREXIA (Fever,  temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)). On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose)). On an unknown date, the patient experienced PYREXIA (Fever,  temperature of 101.4), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th feb-2nd dose)), PYREXIA (Fever, temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.4 (High) 101.4 F.         Patient reported unspecified blood pressure and statin medication as concomitant medication.   This case was linked to MOD-2021-021749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Significant Follow up added. Dose details and action taken was updated.  Concomitant and treatment medication information added. New Event Vaccination site pain was added.
Experienced tingling/prickly feeling down my entire right arm with beginning of rash within 1 hour of receiving the vaccine.  Took Benadryl which helped.  Also developed a white tongue and ulcer sore during the night after receiving the vaccination.  Have had random spurts of sharp prickling pain in various parts of my body throughout the day today.  My right arm (same side as injection) has been itchy today.
Patient had usual discomfort at time of injection with quick recovery.  Mother reports that patient complained "a day later" that his arm (left deltoid) was itching and mother subsequently she noticed an area of redness around the injection site (8-10cm by her tracing on patient's arm) and the area looked swollen.  The area did not hurt but continued to itch.  It did not interfere with his usual activities and he had no fever, headache, or other symptoms.  Mother presumed that the itching, redness and swelling was a typical reaction to the DTaP administered; however the redness lasted more than a day and the itching persisted for over two weeks which prompted mother to call.  At an office visit on 12-17-07 the left arm appeared normal except for a 1-2mm crusted lesion at the central part of the deltoid area and presumably the injection site.  He was observed to make superficial scratching of the shoulder but in general did not seem to cause any distress.  Located on the postero-lateral aspect of both arms, in a symmetrical fashion were some dry crusted palpable papules consistent with dry skin eczema.  The right deltoid, where MMR and IPV were administered, had no lesions or itching. He had no axillary lymph nodes and small, about 1cm, non-tender anterior cervical lymph nodes.
4 day of second jab May 1, 2021 soar at site also red and swelling. Itching began around the swelling site about 2;00a.m. About 8:00a.m rash around site on right on and later that morning both arms had a rash. Called Blue cross and blue shield they requested go emergency care I called emergency cate they said they didn?t want to give me anything that may interfere with my vaccination.  Rash spread to both arms , legs and stomach. Went to my doctor on Monday May 3, 2021. Rash cleared but ringing in right ear still with me.
Stomach hurt; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032b21a and 031b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt) outcome was unknown.            No concomitant medication was provided. Ibuprofen had not helped.   This case was linked to MOD-2021-424354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow contains no new information.
Erythema at site of injection - 30 mm x 25 mm.   Warm to touch.
Information has been received from a health professional concerning a male patient who was vaccinated with a dose of varicella virus vaccine live. In approximately February 2006, the patient's unvaccinated sister developed chickenpox. Subsequently the patient developed a serious case of chickenpox breakthrough. He had more than 50 lesions on his eyes, mouth and the top of his feet which was treated with acetaminophen (TYLENOL). It was reported that the patient's brother (WAES0603USA02701) also developed a small breakthrough case. The patient's chickenpox was considered to be an other important medical event (OMIC). Additional information has been requested.
Pt recvd a series of 3 Engerix-B vax; 1st & 2nd doses were in JUN91, JUL91, & uneventful; Recvd 3rd dose in AUG91 & exp tightness in throat, upper chest on 2AUG91; treated in ER w/EPi, DPH; events resolved p/3 hrs;
COUGH; STUFFY NOSE; WATERY EYES; RUNNY NOSE; SNEEZING; ITCHINESS ON NECK AND SHOULDERS; COLD; HEADACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and drug allergy. The patient was allergic to sulfa drugs, ciprofloxacin, and iodine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced cold. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced itchiness on neck and shoulders. On 13-MAR-2021, the subject experienced runny nose. On 13-MAR-2021, the subject experienced watery eyes. On 13-MAR-2021, the subject experienced stuffy nose. On 13-MAR-2021, the subject experienced sneezing. On 13-MAR-2021, the subject experienced cough. Laboratory data included: Body temperature (NR: not provided) felt little warm and took temperature but reported no fever. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, stuffy nose, sneezing, and cough on 13-MAR-2021, and cold, tired, and itchiness on neck and shoulders on 11-MAR-2021, was recovering from watery eyes, and had not recovered from runny nose. This report was non-serious.
I tested positive for COVID-19 on December 1, 2022. I began to experience symptoms two days prior to testing positive, I went for a check up to my cardiologist on February 9th. I previously seen my cardiologist July 2022 and I was fine, then recently seeing them I was diagnosed with left brunch branch block. July 2022 or previously, this has never happened before and developed after the booster and after COVID. Still waiting to hear back about what's happening and my doctor thinks it may be permanent and I may not recover.
Pt. left the vaccination room and walked over 2 isles and then up past the middle of the store. Pt grabbed the mother's arm and the mom helped her slow her decent to floor. Mom stated pt. fainted and unresponsive for a couple of minutes. Pt. regained  consciousness and needed no further treatment.