chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Itchy; Raised; Red; Slouchy; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives), ASTHENIA (Slouchy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Raised) and VACCINATION SITE ERYTHEMA (Red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Raised) and VACCINATION SITE ERYTHEMA (Red). On 11-Feb-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced ASTHENIA (Slouchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), ASTHENIA (Slouchy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Raised) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No new information
pt with history of vasovagal in medical settings felt dizzy, was laid to the ground, vitals WNL and pt felt better before leaving with family
"Covid Arm" - large bullseye-looking rash a few inches around/outside of vaccination point. Itched a lot, and hurt as well. Pain wrapped around towards armpit area. Also, had itchy rash on neck a few days later (not sure if related).
Within minutes of receiving the vaccine in the left deltoid, employee experienced numbness on the left side of face and weakness/numbness of the left arm and headache.  Weakness/numbness begain wearing off about 2 pm same date but had the headache throughout the night.  Rx'd with Motrin.  Symptoms resolved.
I had ongoing abdominal pain that wouldn't stop. On Nov 2021 made an appointment with specialist and kept appt. on Jan. 10, 2022. There I had an MRI and a pelvic exam (physical). It discovered adenomyosis and will be scheduled for hysterectomy surgery on Nov. 2022.
Got vaccinated. Got again for 4th time/suspected vaccination failure; Got again for 4th time, it was worse; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got shingles 3 times prior to vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated with Shingles vaccine The patient got again shingles for 4th time, and unfortunately it was worse, so he/she guessed it depended on the person's immune system. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a pharmacist refers to unspecified patients of unknown demographics. On an unknown date all the patients were administered with VARIVAX (Merck), that was reconstituted with frozen sterile diluent (Manufacturer unknown). The details of temperature excursion with the sterile diluent were unknown. Reporting pharmacist mentioned that he routinely stored sterile diluent in the freezer. No adverse symptoms were reported. Outcome of the event, incorrect product storage was unknown. Reporting pharmacist considered the event to be not related to VARIVAX (Merck). Additional information has been requested.
Patient presented with profound pancytopenia on 8/23/2021 WBC 1000 Hgb 4g/do Plt 2000
Information has been received from a nurse via a company representative referring to a 9 years old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medication were not provided. On unknown dates, the patient was vaccinated with two doses of VARIVAX (strength, dose, frequency, route, lot number and expiration date were unknown). In August 2016 (reported as last week), the patient was diagnosed with chicken pox. The patient had sought unspecified medical attention. The outcome of the chicken pox was not reported. The causal relationship between chicken pox and VARIVAX was unknown. Additional information has been requested.
CHILD RECEIVED SECOND DOSE AT AGE 11 BEFORE VACCINATIONS WERE AVAILABLE FOR 11 YEAR OLDS. CHILD'S MOTHER REPRESENTED CHILD AS AGE 12 YEARS OLD ON CONSENT.
Rectal 106.5 fever within 1st 24 hrs, mother took her own temp, so trust accuracy hers was 98.2. Axillary 104.8 fever just before rectal. Medical records state otitis. msv. Information has been received from a physician conerning a 9-week-old with a history of an ear infection 2.0 mL dose of ROTATEQ (Lot 655050/0778F). Concomitant vaccination administered on that same day and time included the first IM dose of PEDIARIX (Lot #AC21B074EA), the first IM dose of PREVENAR (Lot # B08666C) and the first IM dose of OMPC (Lot 653300/0227F). There was no illness at the time of vaccination. The physician reported that on 08-SEP-2006, at 0330, the patient woke with a fever. Axillary temperature was 105 and rectal temperature was 106. The patient was given TYLENOL and was taken to the ER. In the ER, a septic work-up was done with a WBC of 21.7 and IV ROCEPHIN was given. CSF, urine and blood cultures were all negative. Clinical impression was fever with bilaterial otitis media. On that same day, the patient was discharged from the ER to home. As of 09-SEP-2006, the patient's fever resolved. Subsequently the patient recovered from the otitis media. Additional information is not expected.
red hive; pretty swollen; warm to touch; little sore; not feeling up to herself,doesn't feel not quite well; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red hive), SWELLING (pretty swollen), FEELING HOT (warm to touch), PAIN IN EXTREMITY (little sore) and MALAISE (not feeling up to herself,doesn't feel not quite well) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031M20A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), MONTELUKAST SODIUM (SINGULAIR), ALBUTEROL [SALBUTAMOL], SALBUTAMOL (ALBUTEROL HFA) and ELUXADOLINE (VIBERZI) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (red hive), SWELLING (pretty swollen), FEELING HOT (warm to touch), PAIN IN EXTREMITY (little sore) and MALAISE (not feeling up to herself,doesn't feel not quite well). At the time of the report, URTICARIA (red hive), SWELLING (pretty swollen), FEELING HOT (warm to touch), PAIN IN EXTREMITY (little sore) and MALAISE (not feeling up to herself,doesn't feel not quite well) outcome was unknown.            Patient did not took any treatment for the events.    This case was linked to MOD-2021-047754 (Patient Link).
6 y/o male here to follow up after adverse reaction to flu shot. He got the flu shot here on 12/10/18. He has had flu shot before w/o issue. The next day mom noted his entire upper R arm was pink/hot to touch and swollen. No fevers, no hives/difficulty breathing, no joint aches/pains. He did seem tired. Mom took him to UC where she reports they did not remove the bandaid but just said it was an allergic reaction, but cave him Cephalexin 'just in case'. Mom didn't remove the bandaid until the next day then found that the skin looked like it was 'cut' and one side was blistered where the bandaid adhesive had been in contact with his skin. She says the actual injection site itself looked fine. He has never had an issue with bandaids before, so she thinks that perhaps the skin breakdown was due to the bandaid being on while the arm was swollen. It is looking better now. Exam R upper arm (delt) there is what appears to be an approximately 1 cm unroofed blister there the bandaid adhesive was anteriorly and a scabbed area where is was posteriorly. There is an additional small blister close to posterior axillary fold but mom thinks she caused this one. Injection site not hard or tender, not fluctuant, arm not red or swollen now.
1.  Palpitations:      These have completely resolved.  No further chest pain  or palpitations.  He really feels he is back to baseline. Veteran state that the symptoms have since stopped with his palpations and "heart pain" for the last couple of weeks.Reports that his sx started after receiving his 1sr Moderna vaccine
Patient was 17 years of age at the time of the vaccination.  Moderna boost doses are for those 18 years of age and older.  Patient previously received Pfizer for shot #1 and #2.
Flat small red blotches on face and vomiting 2-3 hours after shot was administered. Approximately 24 hours after reaction onset blotches resolving and keeping food down. Had milder similar reaction with HPV #2.
Child started with temp 102 degrees 5pm on 3-17-12 later in evening fine rash on trunk spreading to limbs by am. No blisters. Rash (red) turned blotchy. Fever continued even with MOTRIN alt. TYLENOL. Itching 3-19-12 face puffy and rash on face/hairline. Was given Amox 3-3-12 and completed on 3-13-12 mom unclear why given Amox.
Little discomfort in the arm, in the right arm for a while; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Little discomfort in the arm, in the right arm for a while".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
At event, provided vaccines for children. Client inadvertently given 2 doses IVP, I called pt / client's mother on 8/7/23 and report the incident. She stated patient is "fine", with no adverse effects from any of her shots.
CAUSED WHEEZING, HOARSNESS AND CHEST PAINS.  WHEEZING STARTED APPROX. 2-3 HOURS AFTER INJECTION ON 11/25/06 AND GOT PROGRESSIVELY WORSE AND I COULD NO LONGER CONTROL IT WITH MY ALBUTEROL RESCUE INHALER RESULTING IN A DOCTORS VISIT FOR A NEBULIZER TREATMENT  ON 11/27 AND BEING PUT ON 60 MGS. OF PREDNISONE WITH A 12 DAY TAPER AND A 3 DAY FOLLOW UP VISIT ON 11/30/06.
The MA who gave him the shot did not roll or agitate the vial before drawing it up into the syringe and administering the vaccine; This spontaneous report was received from a nurse prescriber and refers to an adult male patient of unknown age. No information regarding his concurrent conditions, medical history, drug allergies/reactions and concomitant medications were provided.      On an unknown date, the patient was vaccinated with the three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  for prophylaxis (dose, route, anatomical site of vaccination, lot number and expiration date were not reported).   The nurse reported that the patient noticed the medical assistant who vaccinated him did not roll or agitate the vial before drawing it up into the syringe and administering the vaccine (product preparation issue).
Two hours after flu shot was given pt had hives, red blotches, soreness, itchy skin on legs and arms. He itched all over body. Took him to ER. Was given BENADRYL & steroids, sent home. Cont w/ med for 2 days. Cleared.
Fever of 102.5 within 2-3 hours of getting vaccine, severe muscle pain, diaphoresis, chills, fatigue.
Extreme fatigue, flu like symptoms, low grade fever for 3 days. Improvement starting to be seen on April 1st, return to work possible on April 2nd, normal activities resume.
This spontaneous report as received from Registered Nurse refers to unspecified number of patients of unknown demography. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot #L038135, expiry: 27-MAY-2017) (incorrect product storage). No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to cases 1608USA005032 and 1608USA012662 (same reporter link). Additional information has been requested.
HEAD AND CHEST CONGESTION, HOARSE VOICE, PHLEGM, BODY ACHES, CHILLS, SWEATS DIFFUSE, LOSS OF TASTE AND SMELL, RUNNY NOSE
Dose given to 1 patient after 12 hours opened; temperature excursion where the vaccine went to room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given to 1 patient after 12 hours opened) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion where the vaccine went to room temperature for more than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 2:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given to 1 patient after 12 hours opened) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion where the vaccine went to room temperature for more than 24 hours). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose given to 1 patient after 12 hours opened) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion where the vaccine went to room temperature for more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  It was reported that the vial was stored post punctured at room temperature. The time vial was exposed to room temperature for 27 hours.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Added additional reporter details.
Immediate burning. For weeks following vaccination arm hard to lift and had no strength. Also have permanent knot and discoloration at injection site. Pain in my arm is still there. Received vaccine following birth of my child.
This case was reported by a physician and described the occurrence of swelling in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), for prophylaxis. On an unspecified date, the subject received 3rd dose of INFANRIX (.5 ml, unknown, right upper thigh) and the same day began to experience swelling. The swelling resolved a couple of days later. The physician considered this swelling event probably related to vaccination with INFANRIX. It was also reported that with previous DTAP vaccinations, the subject experienced swelling, feeling out of sorts and mumbling. The reporter did not know if the previous DTAP were GSK vaccines. At the time of reporting, the outcomes of the events were unspecified.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unknown date in 2013, unspecified number of patients were vaccinated with GARDASIL. These doses were from GARDASIL that was exposed to multiple excursions of less than 32F over the course of the month of September 2013. At the time of this call, the healthcare worker did not have the lot numbers or the administration information available, since the excursions and administrators occurred at another facility and was supposed to gather the details of the dates of the excursions, the nature of the excursions, the lot numbers of the doses that were administered, the dates of administration, and the patient identifiers, and fax them. No additional information was available at this time. Additional information has been requested.
I tested positive for covid 19. I am now an inhaler and albuterol and Flonase. No symptoms to the vaccine. I am still having some light symptoms of covid but it is helping with the medicine I am taking today.
Moderna COVID-19 Vaccine EUA: Myocarditis Patient received Janssen Vaccine on 3/17/2021 and Moderna on  11/08/2021. Presented to ED on 11/12/2021 c/o N/V for the past 4 days following COVID booster on 11/8. Reports he usually goes to hemodialysis MWF, but missed 11/10 due to N/V. Reports mild abdominal pain and cramping. No diarrhea.  ECG on presentation shows SR with occasional PVCs, left axis deviation, LVH, ST and T wave abnormality leading to a diagnosis of NSTEMI. Troponin I, HS = 23,376 on 11/12 @ 0807, 24455 on 11/12 @ 1232, peaking at >25000 on 11/12 @ 1908, 14269 on 11/14/2021. Cardiologist documented cardiomyopathy high likely nonischemic, probably related to vaccine booster and possible inflammatory,  response. D/C dx's: Acute respiratory failure with hypoxemia - resolved on room air, Sepsis, SIRS - POA, met criteria with leukocytosis & tachycardia, probably non-infectious SIRS fromo myocarditis but pneumonia not excluded - tx'd w/empiric antibiotics. D/C'd home w/homehealth services to follow.
Reaction to DTAP #5. Swollen, red bump on right deltoid 8cm by 8cm. Tx: Ibuprofen.
Profuse watery diarrhea lasting 10 days following the third dose of Rotateq. Remained well hydrated throughout.
Pt reported to me today that she experienced a lot of swelling after the vaccines were administered and now over a month later still has pain in her arm going down the arm not just injection site.
Patient received vaccine dose #1.  15 minutes later she fainted.  She passed out for no more than 2-4 minutes with no injuries.  When she awoke, it took her about 1-2 minutes to become fully coherent.  There were no other adverse reactions or side effects.  EMT was called and upon arriving asked her some basic questions.  Turns out she had not eaten all day so they determined the fainting was for this reason and had nothing to do with the vaccine.
Got moderate sinus inflammation, scratchy throat, felt like I had the flu, that lasted 9 days. Stayed home from work 2 days.
Developed rash over entire body about 1 hr after vaccine with edema of lips, chin and ears. Treated at MD office with IV Benadryl was released after 3 hours on prednisone and Zantex at present. Client had allergic reaction to Nexum, had been clear of rash x 2days did not inform nurses of Nexum allergy.
Severe side effects; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of ADVERSE DRUG REACTION (Severe side effects) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Severe side effects) (seriousness criterion hospitalization). At the time of the report, ADVERSE DRUG REACTION (Severe side effects) outcome was unknown.            Concomitant product was not provided by the reporter.  It was reported that patient was experiencing severe side effects after her second dose of the vaccine and the patient was in Hospital. According to patient's husband, the patient had similar side effects after the 1st shot, so patient's husband was convinced that the vaccine has something to do with her condition. At the time of the report, the patient was home, but her enzymes were still up.  Company Comment : Very limited information regarding this event has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.     This case was linked to MOD-2021-190273 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07 Jun 2021 included no new information.; Sender's Comments: Very limited information regarding this event has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.
pt recv vax 16MAY96 & 29MAY96 pt exp numbness in feet & legs;12JUN96 pt exp numbness in buttocks;unspecified lab work was negative;MRI was done pt dx w/transverse myelitis;
Child was given Varivax on 10/13/99.Seen by MD on 11/9/99 & dxed w/ vaccine induced varicella & otitis media.Tx w/ Augmentin for otitis media.
Became febrile Fri, 6-28, after receiving Dtap, not sleeping well, underneath eyes red, then cont'd temp thru Mon AM temp 102 degrees to 105. TYLENOL PRN. Office visit 7-1-13; possible roseola.
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 77-year-old female patient who received BOOSTRIX (batch number TB2R2, expiry date 2nd December 2019). The patient's past medical history included cat bite. On 15th February 2018, the patient received BOOSTRIX. In February 2018, less than a month after receiving BOOSTRIX, the patient experienced itchy rash and erythropapular rash. The patient was treated with DEXILANT, trazodone and XANAX. On an unknown date, the outcome of the itchy rash and erythropapular rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash and erythropapular rash to be related to BOOSTRIX. Additional information was reported as follows: The case was previously reported to the doctor. The patient was homebound. After vaccination with BOOSTRIX, the patient broke out with rash. Initially the rash appeared near the injection site, further it moved down to her left arm and past her elbow. The reporter described the rash as itchy red bumps. The physician of the patient treated her with two kinds of creams and pills.