chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of swelling under left eye, flat red itchy rash, and hives has been received from a nurse and a physician concerning a five-year-old female subsequent to FLUMIST. Medical history included Down's syndrome, trigonocephaly, hypothyroidism, and alopecia. The patient had no known allergies. On 19-Sep-2008, the patient received FLUMIST for flu immunization. The patient also received DTaP, IPV, MMR, and VARICELLA vaccines on the same day. About 40-45 minutes after receiving FLUMIST on 19-Sep-2008, the patient developed swelling under the left eye (1/4 size of an egg) and a flat red itchy rash that disseminated throughout her body. She developed hives on the back of her neck, one on her trunk, and one behind her left ear. The patient's mother brought her back to the physician's office. She had no difficulty breathing and no distress. The patient was treated with oral diphenhydramine in the office 40 minutes after the events started and the swelling and rash improved. The hives disappeared within a few hours and the patient had no other problems. The physician spoke to the patient's mother who indicated the patient "has been fine" since the events. The nurse indicated the physician thought the events were caused by FLUMIST because it was the only vaccine the patient had never had before. Additional information was received from the physician on 30-Sep-2008 and incorporated into the above narrative which included the outcome of the events.
Immediately, post vaccinations both sole of feet turned bright pink. lower extremities slightly pink also. Within 2-3 minutes color began to turn normal when laid him down. When held uprigh, turned bright pink again.
severely started with feet itching, base of wrist . Then Center scape and nap of the neck . Rash between breast . Thighs, neck ,most itching on left side .Welps up after itching. sometimes eyelids.
Pt developed fever within 12 hours of vaccination. Pt then had a febrile seizure lasting 25-30 minutes and required IV valium to abort seizure. 8/15/06 Received medical records from hospital which reveal patient was admitted 6/28/06 & d/c home 6/29/06 w/final diagnosis of febrile seizure 1 day s/p vax.  Seen in ER at another hospital w/temp 103 & witness general tonic-clonic seizure which resolved with valium.  Labs were WNL in ER.  Transferred to a hospital.  LP, CT, EEG, labs & cultures including herpes were done & WNL.  Neuro consult done & started antibiotics.  9/1/06 Received medical records from PCP which reveal patient was well child on visit of 6/27/06/ss
Flu shot - very painful administration now 3 1/2 wk after shot and arm pain is increasing.
Soreness injection site; Headache; Loss of appetite; Feeling flush; Achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, in left arm, on 24Jul2021 15:15, at the age of 46-year-old, at dose 1, single for covid-19 immunization. Medical history included anxiety, depression and arthritis. Concomitant medication included citalopram. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced soreness at injection site, headache, loss of appetite, feeling flush and achy on 25Jul2021 03:00. The reporter assessed the case as non-serious. No treatment was administered for the events. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Lower lyphatic encephalitis; delusional rem disorder; delusional rem disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD-2023-717862 (MODERNA).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: ENCEPHALITIS (medically significant), outcome "unknown", described as "Lower lyphatic encephalitis"; RAPID EYE MOVEMENT SLEEP BEHAVIOUR DISORDER (non-serious), DELUSION (non-serious), outcome "unknown" and all described as "delusional rem disorder".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course :The patient  no allergies,no other medical history.The patient received treatment for covid-19 with Paxlovid from 15Jun2022 to 19Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right ankle and mid-lower tibia pain (sharp). Pain moved to toes. BP 141/76 (pulse 95).
Stiff neck has persisted for over 2 weeks.  Unexplained bruise appeared 8 days after vaccine on left side of buttocks.
sick on her stomach; arm swollen; headache; vomited; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick on her stomach), PERIPHERAL SWELLING (arm swollen), HEADACHE (headache) and VOMITING (vomited) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (headache) and VOMITING (vomited). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick on her stomach) and PERIPHERAL SWELLING (arm swollen). The patient was treated with OMEPRAZOLE for Blood pressure, at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form. On 04-Mar-2021, VOMITING (vomited) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (sick on her stomach), PERIPHERAL SWELLING (arm swollen) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: 130 (High) heart rate went up to 130 bpm.         No concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 13th out of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case of Patient 1
Information has been received from a registered nurse and the child's mother, concerning an approximately 2 year old male child with heart abnormalities, epilepsy, chronic pulmonary heart disease and other obstruction of duodenum who last year or the year before (2007 or 2007) was vaccinated with 0.5 mL of PNEUMOVAX (lot # not reported). The nurse reported that the child's mother called and reported that her son's doctor told her that the vaccine "did not take" and he would need to be re-vaccinated. The child was seen in the office for unspecified medical attention. The nurse reported that the child has not recovered. No additional information was available. Additional information has been requested.
Due May 1st 2019. Night of injection the site became sore. The next day there was a hard, painful knot at the site. The injection was on February 28th and it is now March 3rd and it is still painful to move arm and knot is still present. Between the size of a quarter and a ping pong ball.
01/28/11 - small area erythema and induration with some discomfort 01/31/11 - erythema significantly reduced, 2mm induration, no pain or discomfort 02/02/11 - itchy & sensitive but exam without change from 01/31.
Given IPV in SQ area of right arm developed large area of erythema and edema 22cm x 13cm 36-48 hours later felt c/w local reaction.
Local swelling and erythema 24 hrs after vaccine. Resolving at 48hrs.
A week after the booster, I experienced severe pain when breathing.  I went to the ER the next day and was diagnosed with multiple blood clots in my lungs (a subsequent doppler of my legs showed no clots there).  They immediately started blood thinners.  I was admitted to the hospital and stayed one night.
Was hospitalized 6 days after receiving the 1st dose of Pfizer covid vaccine. Was instructed by my primary care doctor to go to the ER immediately for a resting heart rate of over 140. Was admitted to the cardiac unit for 2 days. Referred to a cardiologist. Had a racing heart, ER physician and cardiologist said it was absolutely a drug allergy to the Pfizer covid vaccine. They could not explain why my heart rate was so high and while I was monitored it went to over 160.
15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became numb.  I administered benadryl 30 minutes after receiving the vaccine.  The symptoms came and went throughout the next 4 hours.  I administered a second dose of benadryl 4 hours after the vaccine and that seemed to reduce the symptoms greatly.  My temperature was slightly elevated during this 4 hour period, as well.  I took tylenol and that was effective. I had no further symptoms overnight or today.  My concerns were about whether or not I should get second vaccine.
Pt c/o itch neck, shoulders, & head, progressed to upper chest & ears; Hives then appeared in same areas; Given DPH & sodu medrol; pt denies throat swelling or reps distress rx for Prednisone & vistaril
Currently there is no adverse reaction to report. Per the CDC a report should be made even if there is no adverse reaction due to Rotarix being given IM instead of by mouth.
Diagnosis of shingles rash on 7/15/13, treated with Valtrex (mid thoracic torso).
DIZZINESS IMMEDIATELY AFTER ADMINISTRATION, PATIENT HAS SENSATION OF HOT FLASHES AND BLURRED VISION WHICH RESOLVED FEW MINUTES LATER.
sore arm; fever(100.5F); A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, fever(100.5f).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) sore arm, fever(100.5f).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, fever(100, 5f) was unknown.
Several hours after, rectal irritation and cramping. Abdomen cramping and pain with bloating. Continued for 4 days with only relief being a heating pad or warm bath.  As days went by the pain seemed to be in the center lower region of the abdomen and painful.  Other symptoms of malaise, sore arm at site, fatigue.  No fever, loss of appetite, diarrhea vomiting .  Contacted Dr. and was examined. Urinalysis saw some blood but it was retaken and normal.  Blood seemed normal with a slight elevation in something but didn't seem to be a concern.,  Retook blood test and then it was normal but another slight elevation in something else.  Ret taking the blood work in 2 weeks.  I am fine now.
Pt described mild flu-like symptoms that lasted 3 days. Fatigue. Temp 101 degree.
got sick and went to the ER; given the booster shot too soon/6-8weeks after 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (got sick and went to the ER) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the booster shot too soon/6-8weeks after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick and went to the ER) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the booster shot too soon/6-8weeks after 2nd dose). At the time of the report, ILLNESS (got sick and went to the ER) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the booster shot too soon/6-8weeks after 2nd dose) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided. Patient was he was given a booster shot 6-8 weeks after he was administered the 2nd vaccine.
Rash, started 4-6-13, then leg red, swollen with broken vessels, 4-9-13 at hospital for evaluation of blood clot. Neg work up at hospital refer to Hematology. 4-11-13 - all symptoms have completely resolved.
The night of my vaccine a day after I got a weird feeling in my mouth, a weird taste. I didn't feel myself the rest of the day, I didn't want to think about it. I thought it was anxious feeling. Went to bed and woke up and noticed my tongue was swollen and it was really sore. That was my main thing. Then underneath my arm, breasts, it was very sore. Then my glands seemed very clogged. I got a very full inflamed feeling in my entire body. I kept thinking this will pass so it wasn't until 03/17/2021 I finally went in to the doctor. So I was sick for a full 2 weeks. I even had heart palpitations. I also had diarrhea. I went on steroids and Mucinex, allergy medication, and Prednisone. I had to meet with an allergist as well, they told me that I shouldn't get second dose. They thought it was a reaction to the PEG. The prednisone helped my tongue overnight, but I didn't get the same response with the other symptoms. I was very frustrated because my medical bills are very high, and I was just trying to do right by getting vaccinated. I still get lymphatic drainage. Also, a cough is still present. I have had multiple doctor visits. I have taken Prilosec per doctor, but not helping at all. I am having abnormal periods that still happening today. I had a doctor's visit this past week, but I cancelled it due to the cost of medical bills.
PT STATED SORE THROAT AND COUGH ALSO FEVER OF 100.6.  TEMP RETURNED TO NORMAL AFTER TWO DAYS.
Woke up to very swollen arm and a red patch rash that was about 3 inches by 3 inches - got worse during day & iced and took MOTRIN & TYLENOL. Slight fever that night. Lasted for several days.
Fever of 101.3 F, headache, body ache, restlessness, bone pain (same arm as injection)
Information has been received from a Nurse Practitioner (N.P.) concerning a 43 year old female with asthma and no drug reactions/allergies who on 06-OCT-2010 was vaccinated in her left deltoid with a dose of PNEUMOVAX 23 (lot#667418/0978Z). There was no concomitant medication. On 07-OCT-2010 (adverse event onset date was reported as "06-OCT-2010"), the patient at an appointment with another nurse practitioner, disclosed that she developed a reaction at the injection site that included swelling, redness, itching and soreness. The patient then followed up with the reporting nurse practitioner, who was the vaccinating provider, later on 07-OCT-2010, a site examination revealed a 4 diameter, irregular reddened area at the site of the injection. The patient had been treated earlier on 07-OCT-2010 with an antihistamine as well as ZANTAC. The patient was not seen since 07-OCT-2010. There was no lab diagnostics studies performed. At the time of the report, the outcomes were unknown. No further information is available.
Pharmacist reported a missed dose for the GARDASIL 9 3-dose regimen; This spontaneous report was received from a pharmacist and refers to a 26 -year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On unspecified date in October 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. The pharmacist reported a missed dose for the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 3-dose regimen. The pharmacist stated, that the patient has still not received the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) per the prescribing information schedule.
Extreme nausea since shots. Had 2nd shot on April 3, 2021 and Nassau has been so bad and so constant that I am unable to do my daily routine. I have to wonder if it has caused a flare up of pancreatitis
Pt. was given Moderna Booster at Dosage of 0.5mL instead of 0.25mL. No Adverse events yet to report.
pt recvd flu vax 12OCT92 & during dialysis tx on 14OCT92 devel sudden onset of chills & fever 102 p/ 1 hr treatment; also had clotted graft; exp exacerbation of herpes simplex;
This spontaneous report as received from a healthcare business professional via a field employee referring  to a currently 13 year old female patient, who was the healthcare business professional's daughter. The patient's concomitant medication, pertinent medical history, drug reactions/allergies and concurrent condition were not reported. Since 2016 (reported as within the last 2 years) the patient was vaccinated with first dose and second dose of GARDASIL 9 (route, strength, batch/lot # and expiration date were not reported) for vaccination. On an unknown date, the patient experienced injection site redness and tenderness after receiving both doses of GARDASIL 9. The patient's mother "contacted the (unspecified) physician who instructed the patient to use ice at the injection site (on unspecified dates) which helped reduce the injection site redness and tenderness." Lab diagnostics/studies were unknown. Action taken with the suspect vaccine was not applicable. The patient recovered from the events on an unknown date. The causality assessment was not reported.
Developed what appears to be an olecranon bursitis in the same arm as the one he received the Covid-19 vaccine in.
Information has been received from a registered nurse concerning a 68 year old female with no relevant medical history or allergies who on 18-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). There was no concomitant medication. On 20-JUN-2008 the patient experienced injection site reaction. The nurse stated that the patient had "erythema, swelling and felt warmth at the injection site." The patient was treated with compresses. The patient's events persisted. Additional information has been requested.
PATIENT REPORTED RASH ON BOTH ARMS AND LEGS AND SMALL ITCHY DOTS ON BACK.
onset of fever (101.6 oral) on 28JUL93; later devel red streaks from site toward armpit; seen @ hosp ER on 29JUL93; infect present treated w/Duracef;
Deep fatigue, body aches, dizzy spells, shortness of breath lasting for 3-4 months. Arm pain at injection site was intermittent and lasted for several months. The dizzy spells were severe and were most acute within one month of the second dose; at one point I fainted.  Nausea after the first several weeks of taking the second dose. I still don't feel as well as I felt before the vaccinations.
Pt recvd 2 doses of Engerix-B vax & exp arthralgia follwoing both injects;
This spontaneous report has been received from a medical assistant concerning multiple patients of unknown demographics. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On unknown dates, the patients were vaccinated with improperly stored doses of  PROQUAD, lot # L041629, expiry date: 22-APR-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of PROQUAD were exposed to a temperature of 9C and 11C, and were out of range for 30 minutes. A data logger was used to track the temperature and there were no prior excursions.  No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. As of 14-DEC-2016, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. On 20-DEC-2016, a call was received from the medical assistant who stated that he/she was unable to provide any further information. Additional information has been requested.; Sender's Comments: US-009507513-1610USA010044:US-009507513-1610USA010046:US-009507513-1610USA010047:US-009507513-1610USA010048:US-009507513-1610USA010049 US-009507513-1610USA004694:,MERCK 1610USA010050:Mfr number.