chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child was inadvertently given MMR and Varicella injections.  No adverse event at time of injection.  Error was discovered before parents left facility and was informed.  VIS for each vaccine had been given to parents prior to injections and possible side effects explained.  Explained to parents that each vaccine would not be counted a part of the series and child would need MMR and Varicella at appropriate age, suggested to wait until child is 18 months.  Understanding voiced.
Previously healthy 16 year old young man presenting with chest pain admitted for myopericarditis.   He was in his usual state of good health until 2 days ago when he experienced fever, chills and myalgias after receiving his 2nd dose of COVID pfizer vaccine. He improved until 5/2 when he developed a crushing, non-radiating, substernal chest pain which was waxing and waning in nature without specific alleviating factors. He had shortness of breath, but no palpitation, dizziness, or changes in pain on exertion vs rest. Family activated EMS who gave 325 mg of aspirin en route to the ED.   In the ED, he was afebrile and hemodynamically stable. He was mildly diaphoretic, but otherwise, unremarkable on physical exam. STAT EKG showed ST elevations in V5 and V6 and ST depressions in V1 and V2 as well as PR depressions, which persisted on repeated EKG. Given concern for myopericarditis, they ordered labs including CBC, CMP, troponin and inflammatory markers which were only remarkable for troponin of 1.94 and CRP 3.5. Chest x-ray was normal.    Cardiology was consulted and they recommended transthoracic echo which is pending. Cards also recommended starting Ibuprofen 600 mg q8 hrs and admission to cards for further management.
2 x 3" red whelt on left upper outer arm. Hot to touch. Gave Benadryl.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of PROQUAD (Merck) (lot number, expiry date unknown) that were improperly stored for many years and no adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Localized red and itching skin rash developed 8 days following the 1 st vaccine  at the injection site area. Size of area est. 2.5"Wx3 to 4" length.  Itching subsided  but redness remains PM after eruption day.
VR developed lightheadedness, warmth and nausea several minutes after injection. HR-86, BP: 140/90, SP02: 98%. Pt improved with out treatment. EMS services/ ER evaluation were offered and pt declined.  She elected to drive home as she felt much better after appx 45 minutes of observation in total.
I feel the pain as if I still had it, horrible; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   In January 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported it was been a year since patient had shingles. The patient already got vaccinated it was second dose.  The patient still feels the pain as if still it had, it was horrible. The patient did not want it for anyone. Additional supportive information: No follow up attempts possible as no contact information available.
My brother got the Pfizer 5/4 and started getting sick with a cough on the 7th and by the 10th he was getting more and more sick and ye was taken to the ER on the 14th and he started coughing up blood, he was out of it and pale and not able to move much.  On 5/15 in the hospital he was having a hard time breathing and they were trying to give him meds to make him better, they gave him antibiotics because his blood work showed infection, and Precedex to help him rest, and he passed away the same day, he was in good health before. They also said his heart rate was 201/123 and the doctors said pulmonary anema.  It escalated so quickly.
Patient received second dose of ANTHRAX to left deltoid on 1/5/2019, unknown time. On 1/6/2019, she reported noticing symptoms of redness and swelling at the site. Denies SOB, chest pain, fever, chills, nausea, vomiting. She presented to the facility around 0900 on 1/7/2019 noted for a left deltoid induration measuring 5cm that is warm and tender to touch. Erythematous but no surrounding rashes or lesions. Treatment: observation, warm packs to affected area. Vitals WNL. Return to facility tomorrow for recheck. Education regarding worsening signs/symptoms and educated to seek nearest care at ED for worsening condition.
Developed raised painful rash over (R) arm. Seen at urgent care. Improving and less painful but still red 4 days later.
Decreased sense of smell; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to lilacs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) 60 mg and unspecified birth control; both for unspecified indication and from unknown date and unknown if ongoing. On 17Apr2021, the patient experienced decreased sense of smell- can only smell smoke constantly. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event decreased sense of smell- can only smell smoke constantly was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072615 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072615:2st dose
Patient vaccinated Thursday approx. 2 PM. That evening he experienced severe chills. His arm was very sore, red, and very hot. Friday he went to facility, received a shot and prescription for cephalexin.
tested positive on rapid antigen test; tested positive on rapid antigen test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (unspecified if ongoing), notes: mild asthma; "peanut allergy" (unspecified if ongoing), notes: peanut allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 30Jan2022, outcome "unknown" and all described as "tested positive on rapid antigen test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive, notes: Rapid antigen. Clinical course: It was reported that, patient received his second dose of Comirnaty on 17Jun2021, began experiencing a headache and nausea and sore throat on 30Jan2022.He tested positive on rapid antigen test on 31Jan2022. Patient also has mild asthma and peanut allergy. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash and itchiness on day 3 and 4. Severe arm pain day 1 and 2. Fever day 1 and 2. Chills day 1-4
Ever since I received the vaccines, every time I donate blood, I have received a false positive test for syphilis.  I have no syphilis symptoms and haven?t had sex in 10 years.
I have received both of my vaccinations. March 10th for the 1st dose and March 31st for the 2nd. I was using the nuvaring at the time but had to stop usage before this started happening. I have noticed odd bruising, imbalances in my hormones and my menstrual cycle has stopped for 2 months. Since Feb 14th, I have been bleeding nonstop and soaking through products up to the present day. I've been very dehydrated and have taken pregnancy tests and have gotten negative results. I have known conditions that could cause this. I have also read other places that this is happening to other menstruating people. it has been a large concern and is causing me stress in addition to making my regular life difficult.
Presented to supervisor on 11/16/11, with red, swollen areas on (L) arm. Patient reported pain in (L) arm all night. She saw PCP who stated areas and pain probable reaction to pneumonia vaccine given 11/14/11.
Patient is a 16yo seen for her first dose of the COVID-19 vaccine. She was seated in the back seat of the car. Shortly after receiving her vaccine (within a few minutes), she chose to move to the front passenger seat of the car, and after sitting in the passenger seat she became lightheaded and lost consciousness. Syncopal event was witnessed and lasted a few seconds. She spontaneously regained consciousness, and complained of some lightheadedness and tunnel vision. No significant confusion was noted, her responses to questions were appropriate. Initial pulse was thready and heart rate initially difficult to auscultate. Pale color noted on the face. Initial pulse approximately 50bpm. Breath sounds clear with good air exchange. Patient was placed in a reclined position with feet on the dash.  She quickly recovered and repeat heart rate was auscultated at approximately 70bpm, stronger pulse noted. She was noted to have improvement and she was then driven out of the vaccine site after obtaining consent from her mother (who was the driver) and parked beside EMS. BP was 100/50 and HR 68-72, SaO2 97%.  Lightheadedness resolved and she was feeling well, at her baseline.  She was monitored for 30 min then allowed to leave with her mother, she was at her baseline at last evaluation. Per history review with her mother, she has had 2 prior episodes of syncope with pin removal from hand after surgery and IV placement.
I had a fever and a lot of upper respiratory congestion. I lost sense of smell for 1 day. I had  a lot of chills and a sore throat, and lots of coughing. I still have some symptoms today and it's day 7. I'm on PAXLOVID.
Patient Broke out in whelps around site of the vaccine an hour after the vaccine was given. Patient went to urgent care the same day and received a steroid shot and the whelps disappeared the next day. The whelps returned 5/1/19 and were worse than before. This time the rash spread to both arms and down the patient's sides and groin area.
Dizziness, vomiting, diarrhea, headache on  the left side, stiff eyes, ear ache left ear,  heart racing, tired easily, left shoulder stiff, muscles on left side of upper back very tense, left wrist sore, left nostril swollen and sore inside and swelling of the face mostly on the left side. Doctor visit, prescribed promethazine and told to take acetaminophen.  Labs were ordered.
SLIGHTLY SORE ARM; FELT TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced slightly sore arm. On APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slightly sore arm and felt tired was not reported. This report was non-serious.
This spontaneous prospective pregnancy report as received from a physician and a patient refers to a 25 year old female patient. There was no information about the patient's concurrent conditions, medical history and drug reactions or allergies provided. On 21-DEC-2016, the pregnant patient was vaccinated with a dose of GARDASIL injection, lot # reported as M031557 (verified to be invalid), expiration date 07-APR-2019 to prevent human papillomavirus (HPV) infection (site, dose and route of administration were not reported). Concomitant vaccines included influenza virus vaccine (unspecified) (reported as a flu shot) administered on 21-DEC-2016, 15 minutes prior to receiving GARDASIL. At the time of report, the patient was 17 weeks pregnant. The last menstrual period (LMP) date was 24-AUG-2016 (calculated based on number of weeks of pregnancy at the time of report). Estimated date of delivery (EDD) was 31-MAY-2017. Initial exposure to GARDASIL was at 17 weeks of pregnancy (second trimester). No adverse effects reported. Lab diagnostic studies included test for Down syndrome for the patient's unborn child (date and result were not reported). No product quality complaint was involved. The pregnancy outcome was pending. Additional information has been requested.
sickest have ever been; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves patient who experienced sickest have ever been (Illness), after receiving vaccine INFLUENZA VACCINE  Relevant medical history, concomitant medications and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, the patient developed a non-serious sickest have ever been (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Experienced vaccinator, RN was vaccinating the VR and during the attempt to deploy the syringe, the needle separated from the syringe.  The Vaccinator was certain that the needle separated prior to the actual deployment of the syringe.  The Vaccinator wasted the dose and removed the needle from the VRs arm and administered a new dose.  The Vaccinator discussed the situation with CPT who then discussed the incident with the VR.  The VR demonstrated understanding of the situation.
Pt reports several hours after receiving flu shot she had feeling like she had problems swallowing saliva. Feeling progressed. Advised to seek ER care. Went to Hospital ER. Evaluated and treated with steroids.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (unknown age and gender). The patients' medical history or concurrent condition were not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL (batch/lot# K006117, expiration date as 14-JAN-2017, dose and route were unspecified). No adverse effect was reported. Additional information has been requested.
Went into anaphylactic shock with 5 minutes.  Throat started to itch, ears were popping and the left side of my face began to feel pressure.  My wife injected me with my EpiPen.  Within 10-15 minutes, the symptoms began to recede.
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (DILUENT MRK INJ) used to reconstitute the VARIVAX was properly stored. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
pt recv vax & began w/itching sensation all over body & a strange h/a p/24hr;the itching cont @ time of report 5 days later;pt referred to her MD;prev flu vax uneventful;no allergy to eggs;
Stomach cramps, Chills, shivering, aching (fever?); next day, extreme fatigue, some achiness, and slightly upset stomach. Expanding red, swolleness at site of injection. (dime to 50cent piece by Sunday).
Intense stomach/side cramps for 2 days after vaccination. Painful, doubled-over, grab your stomach type of cramps.
This spontaneous report as received from a Medical Assistant refers to 4 months old infant, gender not reported. On 12-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
the next morning I discovered a rash about 3-6 inches long on my arm that spread to my chest and ribcage and on the inside of my arm and possibly my back. low grade fever 99.1. fatigued. the rash is quite possibly in my eye. (feels like pink eye or a sty)
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tremors and back pain-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: emergency and EMS were called, patient left the pharmacy with them. Initially she was fine after the vaccination, but came back a few minutes later complaining of severe back pain and difficulty breathing. She developed tremors a couple of minutes later.
Moderna COVID?19 Vaccine  On 1/12/2021  in the late afternoon/evening I developed arm pain at the injection site like I did on day 1 and 2. Then the next morning, 1/13/2021, I woke up with what looked like welts on my upper left arm. They were tender, red and hard/lumpy. A few hours later I had a slight rash on my lower left fore arm (closer to my wrist). The rash has gone away, bit the redness on my upper arm is still there and is warm to touch. It's a little tender still, but not hard feeling.
Arthralgia, Fever, SOB, FATIGUE, CHILLA, PAIN/SWELL INJ SITE Narrative:
Patient c/o tightness in face, itching in back of throat, and rash on face and back of neck was noted.
Lethargy and "achy" the first day after the second injection. increase in symptoms through that day and overnight. The following day unable to get up out of chair/walk. Confused and disoriented. Wheezing and SOB. Had to call an ambulance for transport to ER. Admitted. Became completely unresponsive. Testing revealed Ammonia level of 104. Liver function studies/scans negative for liver problems. MICU for 10 days, rehab for 3 weeks.
The shot been making my a1c going high it, in February my a1c was at 5.1 before the shot and after the shot it jumped to 9.1; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date was not reported), via an unspecified route of administration, in left arm (at the age of 50-years-old), on 05Feb2021 10:00, at dose 1, single for covid-19 immunization from health facility. Medical history included high blood pressure and known allergies to soy oil. There were no concomitant medications. 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-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient reported that the vaccine shot making his a1c high. In Feb2021 his a1c was at 5.1 before the shot and it jumped to 9.1 after the shot on 01Mar2021 while his blood sugar and blood pressure were nominal. Therapeutic measures were taken as a result of the events with doctor visit. The outcome of the event was not recovered.
Some lumps have shown up in veins noticeable in hand veins; Swelling of lymph nodes near throat.; Bothering of lymph nodes near throat; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food or other products. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient had some lumps which had shown up in veins noticeable in hand veins and swelling of lymph nodes near throat which was bothering. The patient did not receive any treatment for the events. The clinical outcome of the events some lumps which had shown up in veins noticeable in hand veins and swelling of lymph nodes near throat which was bothering were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.