chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin patches; Developed into hives/ big red blotches; This is a spontaneous report from two contactable consumers calling on behalf of father in law. A 78-year-old male patient received bnt162b2, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt161b2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The first reporter is calling on behalf of father in law, 78 years old who received the second dose of the Pfizer vaccine 3 months ago. Patient developed skin patches and then developed into hives. He was admitted to the hospital and was seen by a dermatologist while in there, who performed a biopsy for allergies, and all tests came back negative. He has an appointment today (09Jul2021) to see his doctor. None of the doctors want to commit into saying it is caused by the vaccine. It was also reported that a few months after the patient received the vaccine, the patient started experiencing hives that won't go away, they look like big red blotches. Patient went to his doctor, but the doctor doesn't know what is causing the hives. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a health professional concerning a 15 year old female with no medical history, who on 12-FEB-2007 at 15:30 was vaccinated IM with a second dose of Gardasil (lot# 653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN LO, BENADRYL and TYLENOL EXTRA STRENGTH. Illness at the time of vaccination included bronchitis. It was noted that the patient may have not eaten all day. "At the patient's request she received the vaccination in her glut." After 2 to 3 minutes, the patient felt sick and began to hyperventilate. The patient's blood pressure went up and down and she complained of a left-sided headache. The patient was diagnosed with a migraine. It was noted that the patient was sent to the emergency room. A "CT of her head" was performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
frequent urination; urgent urination; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (frequent urination) and MICTURITION URGENCY (urgent urination) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL, AMLODIPINE BESILATE (AMLODIPIN (BESILAT) DEXCEL), CARVEDILOL, HYDROCHLOROTHIAZIDE (CARVEDIL D), DOXAZOSIN and ALOPURINOL for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced POLLAKIURIA (frequent urination) and MICTURITION URGENCY (urgent urination). On 16-Feb-2021, POLLAKIURIA (frequent urination) and MICTURITION URGENCY (urgent urination) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
Rash, difficult to breathe, achy, fatigued, dizzy, chest hurts when breathing in, stiff neck, nausea
Left shoulder pain developed shortly after injection. Pain has continued for almost 3 weeks, limiting movement.
I had my 1st shot on 4/7/21 and was called to be told it was not stored at the right temperature so I needed to come back and take my 2nd 1st shot. I did so on the designated date of 4/20/21. I was a little tired but around 11;30 started feeling tingling and numbness in my legs. I was up all night with severe body aches and shooting pain in my arm. When I woke the next day my arm was swollen, hot and very sore. By mid afternoon it had turned red and scaly and the swelling, pain and redness was from my shoulder to my elbow. I have been tired and achy, nut my arm is very painful.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated/he used vial then be placed back in a cooler with ice packs) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022 at 4:20 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 4:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated/he used vial then be placed back in a cooler with ice packs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (greater than 12 hours post puncture) were administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated/he used vial then be placed back in a cooler with ice packs) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Number of doses/vials: 6 doses/1 vial. On 15-Apr-2022, the vial was initially stored in the refrigerator. The vial was first punctured on 19-Apr-2022 at 1 PM central time. HCP reported after the vial was punctured, the vial would then be placed back in a cooler with ice packs and a data temperature logger monitoring the temperature inside the cooler. HCP reported no temperature excursion occurred inside the cooler according to the data logger. HCP stated she could probably send data logger data if needed but would have to get their IT department involved. HCP stated they made home visits to administer the vaccine to individuals. Once a dose was drawn up, the vial was immediately placed back in the cooler. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 5 minutes. No treatment information was reported.
Subject received vaccine on 11/5/2009 and experienced a miscarriage on 11/18/2009 at 2 weeks gestation. She has never had a flu vaccine before. She was also diagnosed with pneumonia around 12/9/2009 when she experienced malaise, fatigue, wheezing, difficulty breathing, shortness of breath and cough. The patient has a known case of asthma.
Fever, chills, body aches, stomach cramping, nausea, diarrhea - resolved as of 0900 on 10/17/18.
Redness, swelling and pain at injection site reported 24 hours post vaccination. Instructed patient to mark edge of redness and monitor for spreading. 4/7/2018 24 hours after 1st report patient with redness spreading past borders. Instructed to seek medical care. Patient seen in emergency department.
Narrative: Patient found to have necrotizing fasciitis to the right groin area, necessitating clean out and wound management 4 days post covid Vaccine
Came to ER on 11/27/21. Received 2nd dose of COVID vaccine on 11/17/21. Developed fever on next day  Until yesterday.  Developed dry cough and shortness of breath for last 3 days,  She went to an urgent care,  Saturation 86-88% on room air.  Transfer to ED for further management. Found to be COVID positive. Was placed on HFNC @4L. Placed on remdesivir and dexamethasone. Also placed on ceftriaxone and doxycycline.  Was admitted 11/27/21 for acute hypoxemic respiratory failure secondary to COVID 19 viral and suspected superimposed bacteria pneumonia , also have right middle lobe cavitary lesion . Was on room air on 12/3/21 which patient was discharged
After receiving the rabies vaccine on 6/16/03 patient experienced severe headaches and nausea.  He received the second dose on 6/21/03 and afterwards experienced the same symptoms as before only worse.  An MRI was performed which showed white spots in the brain.  There was also questionable arm weakness.  The patient was hospitalized and although his headaches never totally resolved he was discharged to home.
second vaccine 8-26-2019, first on 9-17-2018; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th September 2018).   On 26th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix on an unknown arm more than six months after the first dose of Shingrix vaccine. (Inappropriate schedule of vaccine). The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
No additional AEs or PQC reported; Caller reported expired dose of PROQUAD was administered.; Confirmed with caller vaccine was administered IM; This spontaneous report as received from a physician and an unspecified reporter and refers to a 4-year-old male patient. The patient's concurrent conditions, medical history, or medical history were not provided.       On 26-MAR-2022, the patient was accidentally vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T032150 and expiration date 20-MAR-2022 0.5 milliliter, intramuscularly in the right arm for prophylaxis. No adverse events were reported.
shaky for a few days post vax;w/in 3 days pt back to nl;
Patient presented to the ED and was subsequently hospitalized for weakness within 6 weeks of receiving COVID vaccination.
pt recv vax 3MAY96 & 4JUL96 pt was exposed to chickenpox;21JUL96 pt exp breakthrough chickenpox all over;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported). Lot # of the M-M-R II the patient received could be one of the following numbers: lot # K014832 with expiration date: 14-SEP-2016, K021152 with expiration date: 02-NOV-2016 and K015375 with expiration date: 18-SEP-2016. But it was not specified which lot # the patient received. All the lot # had been verified to be a valid lot number for M-M-R II. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
felt weak; I was standing at the window and fell into it".; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received BNT162b2 (COMIRNATY), on 06Apr2021 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, The first shot didn't bother me. It was on 16Mar2021), administration date: 16Mar2021, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "felt weak"; FALL (non-serious), outcome "unknown", described as "I was standing at the window and fell into it".". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clinical course: It was reported that about the third day or so patient began noticing some symptoms that lasted a long time. She couldn't get up and felt weak. Was really weak. Standing at the window and fell into it. She couldn't get back, holding onto and didn't have anyone here to help her. Finally, she got back on her feet. She should have called, but she didn't. And now it's been a year and she is unable to get the COVID shot to protect her. She wants to know should go and get the shot and see what it does or should I get an alternative. She doesn't know what her antibodies are, she don't want COVID. She was starting to get out more and going to be exposed. She wants to be protected. Patient states that, given that we only have a vaccine to prevent the disease and an antiviral to treat it, she will take her chances and go get the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed shingles to left side of face on May 30th 2021 Started treatment same day as diagnosis of Valacyclovir 1 gm Q8H Overall case was mild and lasted approximately 1 week
This spontaneous report was received from a physician concerning a a 7 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with 6 doses of RECOMBIVAX HB (route of administration, lot # and expiration date were not provided). On an unknown date, the patient was found to have not seroconverted (hepatitis B antibody negative). The outcome of hepatitis B antibody negative was unknown. This is one of two reports received from the same reporter (MARRS # 1611USA004289). Additional information has been requested.
This spontaneous report as received from a medical assistant concerning to about 6 unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant medication was not provided. The reporter stated that between 21-MAY_2015 and 18-MAY-2015, the aforementioned patients received doses of improperly stored PEDVAXHIB (dose, dose number, route of administration, lot number or expiration date were not provided). No adverse effects were reported. Additional information has been requested.
PT REPORTED MIGRANE LIKE HEADACHE WITH OUT AURA SHE ALSO REPORTED SOME DIZZINESS WE ADVISED HER TO LIE DSWN AND TO HYDRATE COLD PACK WAS PROVIDED, PT REPRTED THAT SHE WILL TAKE TYLON AFTER LEAVING OBSERVATION, SHE WAS IN OBSERVATION FOR APPROX 30 MIN
This report was received from Pfizer and was assigned manufacturer report number 2016118803 for PREVNAR 13. This was originally reported by a physician regarding a 71 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot and expiration date were not reported). Other suspect therapy included PREVNAR 13 which the patient was vaccinated on 17-FEB-2016. The patient's concomitant therapies were not reported. On 17-FEB-2016, the patient developed a low grade fever that escalated to 104 F degrees at still had the fever at the morning at the time of the report. On 24-FEB-2016, the patient experienced extreme redness and swelling at the injection site. On an unknown date, the patient had a neomycin allergy which had come up with ZOSTAVAX and the physician was concerned about an allergic reaction. At the time of the report, the outcome of the patient developed a low grade fever was reported as not recovered and the outcome of the patient experienced extreme and at the injection was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
patient came in to get moderna 2nd dose ( 0.5 ml) and got booster dose moderna half dose 0.25 ml . No adverse symtoms . patient was notified to come in to get remaining half dose right away but did not come in
RED SPOT UNDER SKIN; BODY ACHES; HEADACHE; PAIN IN ARM; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included hematomas, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and drug abuse and drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 30-APR-2021, the subject experienced pain in arm. On 01-MAY-2021, the subject experienced body aches. On 01-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced red spot under skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 02-MAY-2021, and pain in arm on 01-MAY-2021, and was recovering from red spot under skin. This report was non-serious.
Received report from mother on 01/23/2023, of patient having throat swelling, redness from shoulder blade to elbow, that began the evening injection administered and lasted until Sunday and patient did not go to the hospital.
Child agitated after vaccination & had nightmares.  By next day developed significant "lump and swelling" and inflammation in vaccinated arm.  Child had to wear too-large t-shirts because of extent of swelling.  Decreased mobility for several days. Was taken to see primary care physician, and remains under care 4 weeks later. Symptoms gradually decreasing, but nightmares continue.  Father has also experienced Arthus-type reaction after vaccinations.
PT EXP. EDEMA OF ENTIRE UPPER LEFT ARM WITH ERYTHEMA AND ITCHING. ARM WAS CHECKED 4-25-89 AND APPEARED NORMAL. REACTION APPEARED 6 DAYS AFTER IMMUNIZATION
PREVNAR 13 vaccination dates: 14Nov2017, 12Dec2017, 09Jan2018 18Feb2018, night: high fever with 38.9, treated with TYLENOL and acetaminophen, recovered 27Feb2018: running nose, cough 28Feb2018: high fever with 38.5 01Mar-04Mar: cough, hard breathing, crying, vomiting, lower appetite 05Mar: diagnosed as pneumonia till now: diarrhea, lower appetite, weight loss treatment from 05Mar to 09Mar: IV drop methylprednisolone, azithromycin, ceftriaxone sodium; oral ZYRTEC, Montelukast (MSD), Levocabastine; aerosol inhalation terbutaline, budesonide and ipratropium bromide Night of 05Mar: serious diarrhea, average 5-10 times/ day till now. Vomiting on 07Mar when receiving azithromycin. Lab test of stool on 06Mar and 11Mar found not infection or virus, probiotics and montmorillonite powder received.
1MAR92 pt seen @ hosp for urticaria; dx w/viral illness or due to MMR inject on 27FEB92; pt given DPH 2MAR92; pt seen again urticaria & edema, t100.5 R; dx allergic dermatitis given DPH;
Excessive thirst, urinating a lot, blood check determined very high blood sugar level. Diagnosed two weeks after symptoms began. Is now on insulin.
My chest hurts and is getting worse on the left side. As if I've done a hard chest day at the gym and pulled something, however, I haven't worked my chest muscles in the gym in 2 weeks. It makes it hard to breathe.
A few hours after I woke periodically with thorn, pricker, stiff feeling throughout body. Still have pricker feeling all over, neck, jaw, stabbing in ears, all teeth hurt and still do.  Next morning left side of body loss of feeling, it remains like that. Only feel half of tongue,throat, neck when swallowing, drinking,cough,yawn,etc. Soreness around heart next morning continues all day,everyday.  Squeezed muscles, nerves in face and back of neck causing blurred vision when I lean head forward. Menstrual bleeding for 6 weeks. Finally stopped on 10/21.
Patient c/o redness, swelling, and tenderness to Left Deltoid.  At the ED, the area measured 4cm, and it was NOT warm to the touch.  The Vital Signs were stable.  There was no wheezing or SOB.  She was discharged with Tylenol with Codeine, and Cipro to take if the redness extended beyond the measured area.  After being followed-up at home, she stated it resolved the next day and she never took the antibiotic.
On 1-2-08 woke up with rash & got worse throughout the day.  Rash was small red spots/blisters.
Information has been received from a physician concerning an attorney who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine administered one year after the first dose. The physician received an email which reported that the patient was "very sick" and was taking an unspecified medication for the "illness." At the time of the report the patient's outcome was unknown. Additional information has been requested.
was only injected the adjuvant component of Shingrix; was only injected the adjuvant component of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The age at vaccination was reported. The pharmacist reported that a patient was only injected the adjuvant component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No adverse event was reported. The reporter consented to follow up.
Severe chills for about five hours Very sore injection site (unable to lift arm) slowly improving as of third day after vaccination Pain in both kidneys for several hours Leg pain and general muscle weakness for 18 hours
Pt received injection (L) deltoid on Tuesday 9/21/10 @ 10 AM. Over the course of the day his mobility diminished to the point where he could not lift his arm to eat or drive. He slept in a chair Wed. Some improved. Today (Thur) more improved but still limited ROM for abduction.
Chronic urticaria. Full body hives appeared on 12/21/21. Treated with bendryl and prednisone for 6 days. Then continued to manage symptoms with zyrtec once a day. The rash is reduced 90% with daily zyrtec. Without zyrtec, the rash returns in 24 hours. This continues to be the case as of today, 3/13/22, although it seems to be improving very gradually. I tired a second course of prednisone and montelukast which did not improve the rash.