chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received concerning a 20 month old pt who on 5/24/01 was vaccinated, SC, in the right thigh with a 1st dose of MMRII (lot D024L-invalid lot). Concomitant therapy included a 4th dose, IM, in the left thigh of (Acel-Imune). There was no other concomitant medication. There was no illnesses at the time of vaccination. On 5/24/01, the pt experienced fever of 101F and 2 "nickel-sized" blisters at both injection sites. The outcome status is unknown. Follow-up information has been received from a health professional who reports the reaction was from the band aid applied after the injection, not from the vaccine. Additional information has been requested.
Left arm. Initillially only had tingling sensations, tirednesss, redness, soreness, and swelling. After a full week, the swelling and redness grew 3x in size plus new symptom of itchiness. It is much better today on day 10, almost gone.  I am a helathcare provider (Psychologist) and monitoring it mindfully best I can. My MD and I plan to have me take my 2nd dose at hospital setting just in case, she wants me to take Benadryl and/or Claritin on the day of the 2nd dose, have that person clean my arm thoroughly, and wait 30min before I go home. We are unsure if this is delayed allergic reaction or bacterial infection.
Pustules lips. Rash feet - macular. Swelling eyelids. Difficulty swallowing. TX BENADRYL, Prednisone ER.
On 10/11/2022 I started feeling COVID-19 symptoms. I developed body aches; headache; nasal drip; sneezing; and 102.0 fever for 2 -3 days. Tested positive on 10/12/2022 and was prescribed a 5 day course of PAXLOVID. I also noticed that once I completed the medication I started getting light headaches.
Pt reportedly received pneumococcal vaccine and subsequently, developed lobar pneumonia (RML), 2 years later. Vaccine failure?
Information has been received from a female licensed practical nurse, with asthma, who on 18-Dec-2008, splashed a VARIVAX (Oka/Merck) in her eye when she was drawing it up.  She reported that it was a fairly large amount and made the eye run.  She flushed water and was still experiencing mild discomfort.  She reported that a physician at the practice looked at the eye and gave her a prescription.  Additional information has been requested.
Chills, triggered my vertigo.  I took an additional meclazine and slept until it wore off.
Patient has a two inch diameter area of redness that is itchy but not painful. This area is on the left deltoid where the vaccination was given.
Pain in extremity; Achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity) and VACCINATION SITE PAIN (Achiness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient was taking blood pressure medication). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity) and VACCINATION SITE PAIN (Achiness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, PAIN IN EXTREMITY (Pain in extremity) and VACCINATION SITE PAIN (Achiness at injection site) had resolved. Not Related          Concomitant medications included cholesterol medication, blood pressure medication.   Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) in July 2009. The medical assistant reported that on 19-JUL-2012, the patient was in the office to receive dose 2 of GARDASIL (lot #, dose and route not reported) which would be late. No other co-suspects and no concomitant medications were reported. No symptoms were reported. No treatment information was reported. Additional information has been requested.
Patient developed diarrheal illness associated bilateral feet and hands weakness 3 days after getting the vaccination. This continued to progress, eventually affecting his arms and legs over the next month. He then came to hospital for his weakness as he was unable to walk on 5/9/2021.  His diarrhea resolved after about 1 week. but the weakness and numbness continued to progress.
This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 9th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th July 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. On 12th July 2019 at night, the patient went to the pharmacy and reported that she was diagnosed with Shingles. There was a discrepancy in the reported outcome of the event shingles. In database, the outcome was mentioned as recovering/resolving and in the database, it was autoloaded as not recovered/not resolved. However outcome of the event is captured as autoloaded in database.
This spontaneous report as received from a healthcare worker via field representative refers to a patient of unknown age. No information about medical history, drug reactions and allergies was specified. The healthcare worker stated that recently on unspecified dates, four unspecified patients were administered PNEUMOVAX 23 injection (lot#, dose, route, not reported). No concomitant medications were reported. According to the healthcare worker the four patients experienced high fevers after the administration of the PNEUMOVAX on unspecified dates. There was no product quality complaint. The outcome of high fever is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    Patient registry ID was reported as 5712511.  No concomitant medication information was reported. No treatment information was provided.
Out of system,  It's a vastly shot that I got; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Out of system,  It's a vastly shot that I got) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Out of system,  It's a vastly shot that I got). At the time of the report, FEELING ABNORMAL (Out of system,  It's a vastly shot that I got) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
she got the 1st dose at 16 years old, she is now 22 and never got the second and third dose; NO additional AE/NO PQC reported.; This spontaneous report was received from a consumer concerning a 22 years old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unspecified date in 2014, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided); the consumer reported that she never got the second and third dose (inappropriate schedule of product administration).     No adverse event reported.
Loss of feeling in both legs from below knees. 2 minutes. One half hour later same symptoms for 1 minute followed by left foot drop. Two hours later loss of feeling in left ankle with foot drop.
The excursion expiration date of 7 days thawed in refrigerator was followed because of the Pfizer email approving  the 7 days. Store policy was to follow the expiration of 5 days.
Chickenpox like rash over entire body, Small itchy blisters that lasted weeks.
Shortly after receiving her vaccine, I was notified that patient had onset of SOB, chest pain, lightheadedness, and severe headaches. No lip/tongue/throat swelling noted.  Initial BP 78/40, repeat 109/80.  O2 sat and HR WNL. Pt taken to ER for further evaluation.
This spontaneous report has been received from a physician referring to two to three patients of unknown age or gender. The patients had not medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On unknown dates, the patients were vaccinated with the first, the second and the third doses of ROTATEQ (strength, dose, route, lot # and expiration date were not reported) by oral route as rotavirus vaccination. Approximately in 2017 (reported as over last couple of months), the patients were diagnosed with rotavirus, after the patients had completed the 3 dose series of ROTATEQ. Stool samples were sent on an unspecified date to an unspecified laboratory, for confirmation of rotavirus and the results from the laboratory were positive for rotavirus. The patients were treated and subsequently, on unknown dates in 2017, they recovered from the event. No additional information was provided. The causal relationship between the event and the suspect therapy was not provided. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. Follow up information has been received from the same physician on 04-MAY-2017, regarding a 7 year old patient of unknown gender. On 02-AUG-2010, the patient was vaccinated with third dose of ROTATEQ (lot number # and expiry date not reported). On 28-MAR-2010 and 27-MAY-2010, patient received the first and second  vaccine doses, respectively. This is one of the three reports received from the same reporter. Additional information is not expected. Patient's age, age at vaccination, start date of the suspect therapy and narrative were updated.; Sender's Comments: US-009507513-1704USA008747: US-009507513-1705USA004198:
The patient was administered an improperly stored dose of ROTATEQ; No adverse event; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.   On 11-MAR-2020, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose and frequency were not provided), lot #1660112, expiration date 18-OCT-2020, taken orally for prophylaxis.   The reporter stated that on that date, the vaccine dose administered was improperly stored (product storage error). The vaccine presented a temperature excursion with temperature above 47°F and 52.1°F for 15 minutes. Another previous temperature excursion was above 47°F and 55°F for 21 minutes.
03/25/2021, He had severe reaction. That evening he was vomiting and shakes. He was fatigue, fever, and muscle aches. He said he could not breath and was constantly vomiting. I called 911 and the did a monitor on him and take him to bed. I was told to prepare better. The did not take him to the hospital, he vomited the entire night. He went to the doctor telehealth on 03/26/2021, the next morning, he was sent straight to the ER. He stayed in the hospital a few hours, they wanted to admit him, but we could not. Post Vaccine trauma was the diagnosis. He does currently have a autoimmune disorder as he did in the beginning. He was sick from 03/25/2021 to 03/29/2021. From there he has a lot of health issues. He has now been suffering from chest pain. 04/05/2022, He had a ER follow-up. He is having severe anxiety, and dizziness and faint spells. He has just gotten off a heart monitor 04/12/2022, he had it 14 days recording for the doctors to view. He heart rate is as high as 214. He has episodes wear his chest hurts and shortness of breath.
It started to become red and sore later in the day. Overnight it became more painful and the red area was hot to the touch and was approximately 2" in diameter. It stayed this way even after 2 days and continued to get bigger and more painful. It continued to be bright red in color and warm to the touch. I drew a black marker line around the edge of the red 48 hrs after injection, and the next morning it had spread beyond the borders of the black marker. I then made an appointment for later that day with my primary nurse practitioner. She indicated that a skin infection may have developed and prescribed Cephalexin 500mg for 7 days. She also encouraged warm compresses to ease the discomfort. 24 hours after starting the antibiotics, the pain and inflammation were reduced and are no longer visual after almost a week later.
My arms are burning, my legs are burning, my skin hurts.; Is enhancing my illness; Pain all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (My arms are burning, my legs are burning, my skin hurts.), ILLNESS (Is enhancing my illness) and MYALGIA (Pain all over) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (My arms are burning, my legs are burning, my skin hurts.), ILLNESS (Is enhancing my illness) and MYALGIA (Pain all over). At the time of the report, BURNING SENSATION (My arms are burning, my legs are burning, my skin hurts.), ILLNESS (Is enhancing my illness) and MYALGIA (Pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-261484 (Patient Link).
Child has 2 inch long hard indurated blanching red macular rash on left ant thigh site of ProQuad vaccine 2 days ago. No fever, doesn't feel ill at all.
Elevated Heart rate, extremely high blood pressure. Hospital ER {Cardizem administered), two days in the telemetry unit. Now diagnosed with supraventricular tachycardia, scheduled for ablation Sept. 24, 2021.
ACHE IN LEFT ARM COULD NOT LIFT ARM ACHED ALL OVER CHEST TIGHTNESS
Hives on body spreading 1/2 - 1 after vaccine administration.  Came back to office:  Benadryl, epinephrine and columediol given.
Patient developed erythema & discomfort of the left lateral upper arm a few days after receiving PCV23 & Flu shot in same location. She was given a 5-day burst of steroids as her asthma was also flaring up as well.
Headache, Myalgia, Diarrhea, Palpitations & Tachycardia Narrative:
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 45-year-old male patient who received FLUARIX QUADRIVALENT (batch number MM773, expiry date 30th June 2015). On 28th October 2014, the patient received FLUARIX QUADRIVALENT (intramuscular). On an unknown date, the dose was an unknown dose. On 28th October 2014, 4 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the swelling arm was not recovered/not resolved. It was unknown if the reporter considered the swelling arm to be related to FLUARIX QUADRIVALENT. Additional information received: The pharmacist reports that a patient was given the flu vaccine on Tuesday, 28 October 2014. He received the vaccine on his left arm/left deltoid muscle. The patient started experiencing swelling on his right arm near the antecubital area about 4 hours after receiving the vaccine. The patient has not recovered from this event and is going to see the doctor today (31 October 2014).
Patient was given MENVEO and BEXSERO vaccines. While waiting during the 15 minute post immunization period, mom yelled for help. Dr. and CMA entered exam room and found patient sitting in chair. Dr. felt that patient was having syncopal episode with posturing. Patient was gotten up and had another episode with jerking and then left arm weakness. Vitals were taken and 911 was called. Patient was transferred to Hospital ED for assessment.
Extreme flare up of Crohn's symptoms. Treatment: increased dosage of Lialda; long term use of Canasa; begin Budesonide; BRAT diet. After 4 months only slight improvement has occurred. Still experiencing major flare up.
11 x 10cm red wheal, hot to touch on left upper arm. Mom noted area on 10/27/09, circled area when it continued to increase in size she returned to health dept. Mom contacted Dr. on 10/28, who recommended TYLENOL. Dr. saw child on 10/29 and recommended BENADRYL.
On 06/24/02 mother called said baby has had a rash, high temp and irritable for a couple of days. She called doctor and he said "could be a reaction from MMR." Describe rash with elevation, drainage-more like "heat rash." Discussed need to follow physician order. Re: Tylenol. Encourage to see physician to have rashed looked at. Mom made appt for pm visit. Mom said doctor thought it was from MMR. Tylenol and Benadryl prescribed.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old white and not Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced mild cough, leg pain, tiredness and lack of appetite. The patient had contacted an health care professional who advised him to monitor his symptoms. On 11-APR-2021, patient took polymerase chain reaction (PCR) test, Laboratory data included: Covid-19 PCR test (NR: not provided) Positive. On an unspecified date, the patient experienced confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210424495-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Immediately following the injection, pt  had syncopal episode with loss of consciousness for approximately 15-20 seconds. Pt lowered to floor and placed in trendelenburg. BP 100/43, HR 47 and O2 sats 100%.  BP then dropped as low as 56/32. Pt alert and  oriented and states that his hands felt tingly. and HR in 40's.  Cold compress applied as pt was pale and diaphoretic.  BP continued to be alert and oriented. BP increased to 103/50 within 5 minutes of lowest BP and HR of 70.  Pt states he is starting to feel better. Within 15 minutes of vaccine, BP increased back to 117/83. Pt sat up and BP 134/75. Pt up to chair and BP 139/71. Pt reports he is feeling much better now. Mother called and after approximately 1 hour drove patient home with patient back to baseline before leaving clinic.
25NOV92 devel fever, which was treated effectively w/ASA; 26NOV92 devel chest discomfort & fever; seen by MD 27NOV92 & CXR taken dx w/pneumonia rt lung; tx Amoxicillin x 10 days, Seldane & cough med;
Trouble standing , trouble using arms and leg . possible Guillain Barre. Cystocele went in and Retocele appaered. incontience
I have a fever, and chills, and body aching all over. I have had a headache and feel like I have the flu....so much so I can't work or sleep.....The injection site is sore but I counted on that....just taking over the counter TYLENOL ....
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX that was stored at 21.6F for 25 days (600 hours). It was unknown if the patient sought medical attention. The patient was not experiencing any known symptoms. This is one of several reports received from the same source. Additional information has been requested.
Pateint woke up the morning after vaccine with symptoms of a stroke.  He was unable to swallow and had trouble speaking.
Later in day of vax, developed lumbar pain and left thigh pain. Thigh pain a little better with ibuprofen. Discomfort persisted, not well described. Presented here for exam, expecting physical therapy rx, on 3.19.19, and rash typical of shingles (several days old, vesicles starting to crust) noted left paralumbar about L4.
Patient presented to emergency department on 11/22/2021 with INR of 9, low blood pressure, generalized weakness, and fatigue. He was found to be COVID-19 positive during screening for admission. He remained asymptomatic for COVID-19 infection during admission and required no management. Patient was discharged home on 11/26/2021.
Sore arm on day of shot and second day of shot third day swollen lymph node under arm pit near chest