chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via e-mail and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). On an unknown date (one year after the first dose of ZOSTAVAX), the patient was vaccinated with the second dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). The reporter queried if there would be any danger to a patient after receiving the second dose of ZOSTAVAX and if there could be any side effects that the patient would have to be warned of. Additional information has bene requested.
Provider ordered DTAP-IPV,  but DTAP-IPV-Hib-HepB (Vaxelis) was given.
miscarriage; Maternal exposure before pregnancy/separate pregnancy after the miscarriage; This spontaneous report was received from the patient's sister who is currently a 31-years-old female patient. The patient's pertinent medical history included miscarriage. The patient's current conditions included neurological diseases and reproductive issues. Drug/allergies were reported as yeast allergy that ran in the family. Concomitant medications were unknown by the reporter.  On an unknown date, also reported as at approximately age 18, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported) with indication reported as "vaccine" (prophylaxis). The reporter was not certain if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but stated that it was "the first one that came out".  On an unknown date, the patient became pregnant and had a miscarriage. It was verified that the vaccine was administered before the pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was a spontaneous abortion. The patient sough medical attention. It was unknown by the reporter if any treatment was given for the events, if laboratory diagnostics or studies were performed and no product quality complaint was reported. The outcome of the event was not provided.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the event was not reported.  Upon internal review, the event miscarriage was determined to be medically significant.  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2107USA005773: US-009507513-2107USA006557:
11:00 mom brought child for immunizations. She was given vaccines and waited 15 minutes without reactions noted. Pt left town with mom for vacation X 1 month. Not able to contact mom due to her being out of town but grandma contacted on 2/23/01 and she has no way to contact daughter.
Patient with fever 100.7F and fatigue on 2/27/21.  Okay next day, then in afternoon of 3/1/21 patient with tingling in face and body for approximately 30 minutes and some facial drooping on right side for approximately 5 minutes.  Patient able to talk, no arm drift, 7th CN intact.
Febrile seizure within 24 hours of both vaccines. Lasted 15 minutes. Seen in ER. Has been alternating TYLENOL and ibuprofen to prevent anymore fever.
Lymph node under arm is still swollen; still have an aching pain under my arm; heavy periods only 2 weeks apart.; heavy periods only 2 weeks apart.; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot Number: EW0186) via an unspecified route of administration in Arm Left on 15May2021 11:15 (age at vaccination: 41years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medication(s) included quetiapine (QUETIAPINE); zolpidem (ZOLPIDEM); prazosin (PRAZOSIN), all taken for an unspecified indication, start and stop date were not report-ed. Since the vaccination, the patient had been tested for COVID-19. The patient had historical vac-cine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot Number: EW0172) via an unspecified route of administration in Arm Left on 24Apr2021 03:00 PM (age at vaccination: 41years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. On 16May2021 the patient experienced lymph node under arm is still swollen, still have an aching pain under my arm, heavy periods only 2 weeks apart. Clinical course was reported as Lymph node under arm is still swollen. I still have an aching pain under my arm. My menstrual cycle is completely off, and it's been very heavy. I had two heavy periods only 2 weeks apart. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 07Jun2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Received first dose of Pfizer vaccine  in left deltoid on 4/8/21 at 7:30 am.  At 10:00 am, she called her niece and complained of extreme fatigue.  At 12:00 pm, she complained of worsening fatigue and blurry vision.  At 3:40 pm, she complained of loss of appetite but denied fever and chills.  The niece was unable to reach her by phone after 4 pm, so she came over to the decedent?s residence at 6:15 pm to check on her.  The niece found her lying face up in bed ?gasping for air.?  She then became unresponsive and EMS was called.  The decedent was pronounced at 8:11 pm after unsuccessful resuscitative efforts.  Autopsy showed hypertensive and atherosclerotic cardiovascular disease with marked partially calcific coronary atherosclerosis; marked pulmonary edema; and pleural effusions.  The brain was saved for neuropathology given the history of blurry vision.
entire body ached; Difficulty to move because everything is sore; Discomfort; muscles in the body are in continuous ache, sore and tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (entire body ached), MOVEMENT DISORDER (Difficulty to move because everything is sore), DISCOMFORT (Discomfort) and MYALGIA (muscles in the body are in continuous ache, sore and tender) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A29A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Blood cholesterol abnormal. Concurrent medical conditions included Asthma and AFib. Concomitant products included SIMVASTATIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PAIN (entire body ached), MOVEMENT DISORDER (Difficulty to move because everything is sore), DISCOMFORT (Discomfort) and MYALGIA (muscles in the body are in continuous ache, sore and tender). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (entire body ached), MOVEMENT DISORDER (Difficulty to move because everything is sore), DISCOMFORT (Discomfort) and MYALGIA (muscles in the body are in continuous ache, sore and tender) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included steroids. The patient takes steroids for asthma condition. The patient's muscles in the left arm were still very sore and tender. The patient is very active and does yoga and stretching.   This case was linked to MOD-2021-362546, MOD-2021-362552 (Patient Link).
Information has been received from a registered nurse referring to 2 patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 10-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # N001530, expiration date 13-JAN-2019, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported.   The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved.    This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007602: US-009507513-1709USA007603: US-009507513-1709USA007605: US-009507513-1708USA007019:
RA was rashed and raised. It was about 2" wide by 3" length and warm to touch. No induration.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) on 09-OCT-2015 from a pharmacy for its intended purpose: the prevention of shingles. On an unspecified date [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered from dry eyes, blurred vision, Raynaud phenomenon, numbness, tingling, muscle weakness, muscle pain, fatigue and tiredness, and was later diagnosed with Lupus. The patient also suffered and was diagnosed with acute renal failure. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Lupus and acute renal failure were determined to be medically significant. Lupus, acute renal failure, and blurred vision were considered to be disabling. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to five unspecified patients of unknown age and gender. The reporter stated that on an unspecified date in May 2014, the five patients were vaccinated with an improperly stored RECOMBIVAX HB (dose 1, intramuscular, strength, anatomical location, lot # and expiration date not reported). The pharmacy technician informed that the RECOMBIVAX HB was exposed to a temperature of 55F for 1 hour on 13-MAY-2014. No adverse effects were reported. No further relevant medical information was provided. Additional information has been requested.
itching on face began approx 35minp/vax & spread to arms, trunk & legs;blotchy redness accompanied itching;DPH given & relieved itching;
Pt with onset of HA and SOB. HA and SOB became so severe she called 911 to get transported to the ED on AM of 3/31/21. Does have hx of Migraines. Has been non-complaint with Migraine prevention meds. But reports this HA feels different and is more severe.
pt recv vax 28FEB97 & got rash on buttocks;not seen then as r/t vax;chickenpox rash appeared 9MAR97 about 20 on back w/mild fever;everyday more spots, all over face, belly arm site;pt threw up 12MAR & 14MAR 2x each day;18MAR vomited 2x;
A spontaneous report was received from a  consumer concerning a 82-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on her legs/ urticaria, a very bad rash/ rash, blood was coming out in her stool/ hematochezia, ulcerative colitis/ colitis ulcerative, her lips swollen/ lip swelling, her face turned red and hot/ erythema, she feels her teeth burning/ oral discomfort, lips turned blue/ cyanosis, had a 98 °F temperature/pyrexia and had a lump on her back/ vaccination site mass.   The patient's medical history as provided by the reporter included prior breast cancer. No relevant concomitant medications were reported.    On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 011A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced hives on her legs and a very bad rash. She had to go back to the ER (emergency room) because blood was coming out in her stool, she had a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis, she had never had that before. On an unspecified date she had her lips swollen, her face turned red and hot and she feels her teeth burning. Her lips turned blue. The patient had a 98 ° F temperature and she had a lump on her back. The event ulcerative colitis and hematochezia were medically significant. Treatment for the events included Benadryl.   Lab data included on an unspecified date, the patient had a 98 ° F temperature and underwent a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis on 27-FEB-2021.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, hives on her legs, a very bad rash, blood was coming out in her stool, ulcerative colitis, her lips swollen, her face turned red and hot, she feels her teeth burning, lips turned blue, had a 98 °F temperature and had a lump on her back was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
vaccine was administered with 1"needle, could have not reached the Deltoid muscle; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th April 2022, the patient received the 1st dose of Shingrix. On 5th April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: The patient weight was more than 200 Pounds.  According to information, the vaccine administration required a 11/2 gauge needle. The vaccine was administered with 1 gauge needle.  The dose did not reached the deltoid muscle, which led to Intramuscular formulation administered by other route. No lot number and expiration date available.
Anthrax dose #6 was administered on 11 Sep 04 in his right deltoid.  He immediately felt burning at the injection site.  Within twenty minutes, he was "warm all over", and had a recurrence of the headache with pressure behind the eyes, neck pain, left arm numbness, cramping sensation in the back muscles, and arthralgias.  That evening he began to experience the left hamstring cramping that was present after dose #4.  Today he rates his headache as 4-5/10, the arthralgias as 8-10/10.  The muscle spasms in his back are not related to any particular position or activity.
Approximately 2 - 3 hours after receiving immunizations for  deployment, pt experienced abdominal pain, nausea, chills and headache.
Patient had a positive test for SARS-CoV-2 . He was tested during routine surveillance in a homeless shelter. He had no symptoms
I noticed a week after I received the shot that I was short of breath and fatigued. It got increasingly worse and I developed chest pain and hypertension. Eventually I had an echocardiogram which showed reduced cardiac function of 40%. I was told the most likely explanation was myocarditis from the vaccine. My last echo was 54%, I am taking metoprolol for the hypertension which has improved and my symptoms are also much better though still present.
Patient reports everything fine when receiving vaccine, on 1/5/2021 patient reporting injection site is swollen, red, hard, and hot to the touch.
This spontaneous report as received from a healthcare worker refers to multiple female infants between the ages of 2 and 4 months. It was reported that the patients had no medical history and no drug reactions or allergies. On an unknown date the patients were vaccinated with ROTATEQ, oral. It was reported that the patients were not on any medications concomitantly. On an unknown date the patients had difficulty swallowing during administration. It was reported that the patient sought medical attention and also reported that the event occurred in office. It was reported that no treatment was given for the events. There was no lab diagnostics studies performed. It was also reported that the did not experience any further difficulty with swallowing after administration. The action taken with the therapy with ROTATEQ was unknown. The outcome of dysphagia was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. There was no product quality complaint reported. This is one of the two reports from the same source. Additional information has been requested.
About one week after receiving the Moderna booster I developed a case of dermatographia. At first I thought it was hives, as my father had recently tested positive for covid and developed hives a few days in. But after dealing with the issue for a few days I realized it wasn't occurring except where I was lightly brushed or scratched. It has continued with varied intensity since that date and persists today. If I scratch my skin lightly I will develop a welt along the scratch site within about five minutes. It becomes severely itchy and if left alone it will go away completely within about 30m to 1hr.  I have considered all environmental factors that could've changed during that time and have been able to rule them out through testing. At this time the only changes I know of that coincided with the onset of the dermatographia was the receipt of the booster a week prior and an exposure to covid a few days after the booster. I got covid tested starting on the exposure date and tested every couple of days for over a week. I have never tested positive for covid.
Patient developed local swelling , described as "golf ball sized" in L leg following the Hep A and Flu vaccines. Patient also developed a fever of 103.9F and was inconsolable for 2 hours afterwards. It is reported in the Allergy work-up documentation that local swelling has also occurred after doses of DTaP (infanrix) and MMR. Even when vaccines are spaced out, it appears that the same reaction occurs. The allergy clinic recommended pre-treating vaccinations with oral antihistamines  prior to or topical steroids status-post vaccination to lessen swelling.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-APR-2018 and 07-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
5-19-14 - GARDASIL vaccine given at local health dept. 5-27-14 - pt mother calls health dept to state patient has been reporting problems since "night of injection". S/S include rapid heart rate, no appetite, diarrhea and dizzy. Took her to local health clinic - no dx made, no treatment, s/s persist. I enc take her to E.R. and told her I would do VAERS. I not be able to contact pt or mother since 5-27-14. 3 attempts made.
Patient's daughter called and said that her mom was having a very severe reaction to the flu shot. She was having fever, flu like symptoms, nausea, felt like vomiting, muscle aches and joint issues
Injection was given at about 5:50 pm (time not on Vaccination record card) and pain in right arm at injection site began approx 9:00pm and increased during night of 3/17/21. Awoke with headache, low fever, joint pain.  Continued all day 3/18/21 with temperature reaching 101.6 degrees F  at about 10 pm.  Temp broke during the night. I awoke on 3/19/21 with no headache, temp of 97.6 degrees F and my usual joint pain.  I felt much better, but fatigued. The fatigue was gone completely Sat. 3/20/21.
Resident was desated, into the 80's, short of breath.  We went him to the hospital same day as vaccine given
Unknown reaction; This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The patient experienced adverse reaction. Type of reaction to first dose was not reported in request. The reporter does not have additional details.