chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am breaking out with a rash on my arms and legs that hurt very much and itch at the same time. They form as small bumps on my skin that hurt very bad and itch at the same time. New bumps keep forming every day and spread.
Extreme vertigo, nausea, brain fog and fatigue that began approximately 36 post vaccine, followed by facial swelling .
Pt in for routine visit today 11/8/18 and noted to provider that she thinks she had reaction from SHINGRIX in August. Pt got 1st dose of SHINGRIX 8/10/18 around noon. Noted that evening severe exhaustion set in which lasted 3 days. She also had decreased appetite and ended up losing 8 lbs in 10 days. She had some nausea and general body aches for a few days. She noted her arm was sore and her right hand/fingers were a bit numb as well.
Recurrence of distal muscle weakness in LEs>UEs and worsening of length dependent sensory loss/paresthesias consistent with recurrent acute polyneuropathy. EMG/NCS testing consistent with acute  demyelinating polyneuropathy.
6/15 62y.o. male patient presenting to the ED with altered mental status. In the EC, patient became increasingly somnolent, hypoxic to 80% and was intubated for airway protection. He became hypotensive and was resuscitated with 30cc/kg fluids then started on Levophed.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 22-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.   This case was linked to MOD-2022-501575 (Patient Link).
Chills,fever,aches.fatigue Rest in bed, tylonol Still achy on second day, very tired
This spontaneous report was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored GARDASIL lot # K0061241, Expiration Date- 02-FEB-2017, (dose strength and route was unknown). No concomitant medication was reproted. No adverse event reported. No product quality was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
No other AE; Inadvertently administered an expired dose of MMR II to a patient; This spontaneous report was received from a physician referring to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 04-FEB-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expiration date 28-JAN-2022, lot number, dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.  It was reported that they inadvertently administered an expired dose of MMR II to a patient (expired product administered). the product did not experience any temperature excursions prior to administration.  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Patient given Moderna Bivalent Booster at 11:00am on 1/23/23 during Nurse Visit.  However, it was discovered after the patient left the clinic that the vaccine expired on 1/20/23, 3 days prior.   Our MGR contacted MODERNA directly and heard back on 1/26/23 that "the lot was tested and maintained the activity necessary to protect against SARS-CoV-2 (COVID-19) virus at the time of administration. "   Patient was contacted by MGR today, 1/26/23.
Vaccine breakthrough, symptomatic,   Inpatient admit 9/2-9/9.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 336 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
After vaccinated patient to waiting room to see if has any side effects. Patient became dizzy. After 5 min. Patient was well enough to drink water and home with mom.
THREE PATIENT HAD HEART ISSUES AFTER VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced three patient had heart issues after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from three patient had heart issues after vaccine. This report was non-serious.
Right leg showed signs of blood flow stoppage away from groin. Heavyset cough, wet, began as well (both on Monday 2 days after vaccination). Fully in CHF (congested heart failure AND blackening of right foot) and told by STAT home health nurse on her visit Wednesday at 8:00am to get him IMMEDIATELY to the Emergency Room! Was at Hospital from May 19-June 2, 2021. Was given transfusions for White Blood count abnormalities, was clearly showing serious and repeated (as many as 3x daily/night for up to 2 hours each) cognitive ?sundowners? signs to nurses. Began to choke often, twice my use of back pats to clear when nurses unavailable. Not normal! Began talking of God and his beliefs for the first time, with me after a week In treatment. So many brand new issues there is no way this was not vaccine related!
48 hrs post immun, 9mo old infant experienced hives over her entire body; Tx DPH; Seen in office; infant afeb;
Large lump, red splotch, tenderness and itching developed about 1 week following the injection. It lasted for 4-6 days. There was a bump at the injection site for a couple of weeks.
This spontaneous report was received from a registered nurse referring to a 17 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
vaccine pseudo exacerbation; could barely walk for 36 hr; no bladder control for 48 hr; feeling hot and cold for 48 hr; This case was reported by a consumer via other manufacturer and described the occurrence of walking difficulty in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received Shingrix .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced walking difficulty, bladder incontinence, feeling hot and cold and exacerbation of pain. On an unknown date, the outcome of the walking difficulty, bladder incontinence and feeling hot and cold were recovered/resolved and the outcome of the exacerbation of pain was unknown.   It was unknown if the reporter considered the walking difficulty, bladder incontinence, feeling hot and cold and exacerbation of pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received 0.5 ml dose of Shingrix and experienced could barely walk lor 36 hours, no bladder control for 48 hours, leeling hot & cold for 48 hours. Doctor described the symptoms from the vaccine as pseudo exacerbation
Extreme fatigue, muscle weakness, muscle ache/soreness. Symptoms intermittent through out week. fatigue worsening during afternoon.
Arm became red, swollen and painful the day after the injection. It went away but came back on day 9.  It is still red, swollen and hot in a large circle 10 days post injection
Patient's wife, presented to the pharmacy on 12/1/18 indicating that patient's left upper arm has been hurting him since his flu shot. She described soreness and pain - when prompted, she did not indicate any loss of range of motion, numbness/tingling, no pain shooting down arm. I advised the use of pain relievers such as TYLENOL or NSAIDs as well as a heat pack to help with the pain. I advised he follow up with his PCP if pain continues.
The patient got up from the vaccine and sat in the chair.  He felt faint and his mother put him on the floor.   She immediately contacted the pharmacist and the pharmacist checked his pulse and talked to him.  His mom wanted him to be seen at the hospital so 911 was called and the ambulance took him to the ER.  He never passed out only felt like he was going to.   He felt better at the time he was taken away in the ambulance.
Rt arm edematous erythema and warm to touch from shoulder to elbow. Reported by pt-dizziness after inj. 2-3 hrs later pain upper arm with swelling.
This case was reported by a consumer (the subject) and described the occurrence of sinus infection in a 49-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included being "prone to sinus infections". Concurrent medications included LEVAQUIN. On 15 October 2009 the subject received 1st dose of ENGERIX B (20 ml, unknown). On 15 November 2009, 31 days after vaccination with ENGERIX B, the subject experienced sinus infection. At the time of reporting the event was unresolved.
itching really bad; This is a spontaneous report from a contactable pharmacist.  A 43-year-old female patient received the first dose of the bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899 and Expiration Date: Mar2021), intramuscularly on 17Dec2020 at 43-years-old at 0.3 mL, single for COVID-19 immunization. The vaccination was administered in a hospital. There was no history of previous immunizations with a Pfizer vaccine considered as suspect; and there were no additional vaccines administered on the same date of the Pfizer suspect; and there were no prior vaccinations (within 4 weeks). It was unknown if the patient had adverse events (AEs) following prior vaccinations. Medical history included obesity from an unknown date and unknown if ongoing, hay fever from an unknown date and unknown if ongoing. There was no family medical history relevant to the AEs. Concomitant medications included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication from an unspecified date to ongoing, metoprolol (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to ongoing, montelukast sodium (SINGULAIR) taken for hay fever from an unspecified date to an unspecified date, omeprazole (PROTONIX [OMEPRAZOLE]) taken for an unspecified indication from an unspecified date to ongoing. On 17Dec2020, the patient experienced: itching really bad; which was assessed as medically significant. There were no visits to an emergency room or a physician office as a result of the events.   The clinical course was reported as follows: The patient started itching really bad within five minutes of receiving the vaccine. The patient was given a shot of diphenhydramine hydrochloride (BENADRYL) and the itching stopped. This was the patient's first dose of COVID vaccine.  It was unknown to the reporter if the patient would continue the vaccine series. Therapeutic measures were taken as a result of itching really bad (pruritus). The clinical outcome of the event, itching really bad, was recovered on 17Dec2020. The causality assessment from the Primary Source Reporter was reported as related; via the Method of assessment.; Sender's Comments: A causal association between BNT162B2 and the event pruritus cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
It seem like side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (It seem like side effects) 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-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced VACCINATION COMPLICATION (It seem like side effects). At the time of the report, VACCINATION COMPLICATION (It seem like side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.
rash developed 24 hrs post admin, developed zoster-like vesicles 48hrs post. admin with extended area of redness surrounding rash. Advised pt. to apply cold compresses, take diphenhydramine if needed. Pt later, from different advice from another health care practitioner applied hot compresses, condition seemed to worsen. Pt made appt with PCP 96 hrs post admin. PCP determined local reaction, continue cold compresses.
Intussusception Hospitalization & reduction with enema  No surgery Discharged 36 hours later
Myalgia, Fever, chills, night sweats, day sweats, general body aches Narrative:  Employee states: within 5 hours of administration of dose #2, she developed fever (Tmax 101.4 F with acetaminophen 1000mg) with subsequent chills/night sweats, day sweats with additional myalgias and general body aches. States "feels as though my skin is on fire" pain rated as 7/10
My child's entire personality changed.  She became upset with routine change, she began waking up in the middle of the night complaining that her ears hurt (while she still had language), she hardly slept anymore, she began to look depressed. She didn't recognize anyone (not even her own mother), she didn't talk anymore, she began banging things together like a child of a few months old.  She had no eye contact left, no happiness, did not want to eat any food or drink, she became clumsy, walked on her toes, began spinning, grinding her teeth.  She no longer had interest in people, toys, going outside. There was nothing left of who she was for the last two years.  This was a child who previously spoke in full sentences and had a very large vocabulary.  She used to wake up in the morning look for me and tell me she loved me.  Then she did not know who I was or that I even existed anymore.  She became so hyper, unfocused and then would want to just stay in her room.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included COVID-19 in November 2020.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No Concomitant product use was reported. No treatment information was provided.
Covid 19+ 08/25/2021 with onset 08/24/2021
vomiting; fever of 99.4; 6 month old female patient was receiving the Fluzone HD; 4 month old female patient was receiving the Fluzone HD; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who experienced vomiting (vomiting), fever of 99.4 (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunization; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunization; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (Cong13-V) for Immunization.  On 04-Feb-2020, the patient received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AB and expiry date: 29-Jun-2020 via unknown route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious vomiting (vomiting) and fever of 99.4 (pyrexia) (reported as later in the day, unspecified) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  Laboratory data was not reported.  Final diagnosis was vomiting and fever.  It was not reported if the patient received a corrective treatment.  The outcome of the events was Unknown at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About two weeks after I received the MMR vaccine on July 20, 2009 I developed a low grade headache, nausea and diarrhea.  The night of August 5, 2009 probably about 1:00 in the morning of August 6 I got back into bed and my left knee popped both audibly and pain wise.  My knee hurt but I went back to sleep.  The next morning my left knee was swollen up like a balloon and quite painful.  It continued to swell that day and get more painful.  The next morning, August 7 when I got up my right knee was swollen even more than the left and very painful.  That day I went to the ER and was put on crutches, told to take ibuprofen and given an immobilizer.  None of this helped and the next day I went to my doctor's office.  Dr. told me my knees were full of fluid and tested me for Lyme disease.  I didn't mention the MMR vaccine as I had no idea this could be a reaction to that.  My knees got worse, the headache and general tiredness also continued.  I rested over the weekend and my knees started to deflate.  On Monday morning, August 10 I woke to find my right index finger swollen and all of my fingers were aching but especially my right hand.  The next morning my right middle finger was also swollen and painful.  I kept taking ibuprofen (600mg every 6 hours) for several days.  As the swelling subsided and the pain decrease I reduced the dose to 400mg twice a day.  My joints all ached from head to toe and today is the first day I haven't taken ibuprofen during the day.  My hands and knees still are bothering me slightly but there has been a general decrease in pain and I see no swelling at this time.