chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bumps on his body; his hand swelling; the patient has "not been able to sleep" and has had "many sleepless nights"; canker sores; a fever of 100 degrees and 101 degrees; This spontaneous report was received from a consumer (the patient's grandmother) and refers to a male patient of unknown age. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (exact dose, lot # and expiry date not provided), used to reconstitute the vaccine. On an unknown date in approximately 2019, the patient was not able to sleep and had many sleepless nights since receiving dose of varicella virus vaccine live (oka/merck)(VARIVAX). It was reported that he had a "fever of 100 degrees and 101 degrees (units not reported) in spite of being on a schedule of acetaminophen (TYLENOL) and ibuprofen (MOTRIN)", which were instructed by an unspecified healthcare provider to administer in unspecified doses. The patient also experienced "canker sores", "unspecified bumps on his body and his hand swelling". His parents sought medical attention and visited an unspecified emergency room (date not provided). The outcome of nodule, pyrexia, aphthous ulcer, insomnia and peripheral swelling was not recovered. The relatedness between suspect therapies and the events was not reported.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M023169, expiration date: 13-JUN-2018), intramuscularly. No adverse effects were reported. Product quality complaint (PQC) was not involved. Administered doses of vaccines experienced the temperature excursion of >8 degrees Celsius but <25 degrees Celsius for 8 hours and 54 minutes. Data logger was involved. The previous excursions were between 0 to 2 degrees Celsius for 5 hours and 26 minutes and below 0 degrees Celsius for 3 hours and 5 minutes. Additional information has been requested.
The grandmother and mother report that this 6-month-old infant has been a bit fussy and out of sorts since he received immunizations two days ago and a little bit more so yesterday than the day before when he received the immunizations. This morning he seemed pretty much his normal self, although slightly fussy and was brought to daycare. There has been no fever, no congestion or cough, no vomiting or diarrhea, and no other specific symptoms. The remainder of the review of systems is noncontributory. In the daycare, the daycare provider noted that the child had taken a nap and then was awake. She was getting him ready for feeding but he was lying on the floor and she noted he was suddenly limp and pale and weakly responsive. She carried him around, checked his airway, removed clothing, and the infant remained very pale and limp. Mother was called and when she arrived, she said that he was so pale and limp that she was worried that he was dead. She brought him immediately to see doctor where she was equally concerned about the extreme pallor and limpness with hypoactivity. There was no fever measured at any time either there or in the emergency room where he was taken next by ambulance. His physical examination with the exception of the pallor and limpness has remained normal throughout these visits.  4/7/09 Received hospital medical records of 3/19-3/22/2009. FINAL DX: no discharge summary dictated,  Admitted for decreased LOC, anemia, leukocytosis. Records reveal patient experienced irritability, hypotonia, pallor, hypoactivity.  Seen by PCP & taken to ER by ambulance.  In ER, tx w/IVF, IV antibiotics.     Seen by PCP 3/23/09 & dx w/viral gastroenteritis & probable seizures.
Information has been received from a physician concerning a 7-month-old female with no allergies and a history of a three day hospitalization for cyanosis, breath holding and pallor following vaccination with Rotateq (WAES #0702USA04116) who on 16-MAY-2007 was vaccinated IM with a dose of Recombivax HB (manufacturer unknown). On 21-MAY-2007, the patient was vaccinated with an IM dose of Prevnar. On 21-MAY-2007 the patient became tired looking. On 22-MAY-2007, the patient became more fussy, sleepy and had a decreased appetite. On 23-MAY-2007, the patient started crying alot, had "some body movements", turned purple around the lips and mouth with facial pallor. The patient was taken to the Emergency Room (ER) where a partial work-up for sepsis excluding LP were done. The patient was alert and oriented x3 and in no distress. The patient was noted to have an apneic event. Tests were negative and the patient was sent home. Recommendations included use of home apnea monitoring. At the time of this report, the outcome was unknown. Upon internal review, apnea was considered to be an other important medical event. Additional information has been requested. All available medical records will be provided upon request.
Symptoms occurred 1 hr after vaccine given. Diaphoretic, paleness, weakness including "legs giving out", dizziness, itching.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with MMR II (Lot number not provided) subcutaneously into anterior lateral thigh and VARIVAX (Merck) (vaccination site, route and strength unknown) (Lot number not provided) at the same time on 17-AUG-2012 (reported as "one week ago"). No concomitant medications were reported. On an unknown date in August 2012 the patient experienced rash after receiving MMR II and VARIVAX (Merck) at the same time. No treatment information was reported. The outcome of rash was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Information has been received from a physician concerning a female who on approximately 16-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 30-MAY-2007, 2 weeks after vaccination the patient experienced painful rash on lower extremities.  The physician identified it as possibly being leukoplastic angitis.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Muscle soreness, fever, body aches, headache, nausea, joint pain, dizziness beginning within 4-6 hours after vaccination. 24 hours later symptoms are slowly improving.
LOCALIZED SWELLING, ERYTHEMA, TENDERNESS AT INJECTION SITE, SYSTEMIC FEVER/CHILLS
Myalgia CHILLS for 12 hours, swollen lymph nodes Narrative:
Pt recvd 1st dose of Engerix-B 17JUL90 & exp no adverse reaction; recvd 2nd dose 20AUG90; MD felt that pt should delay the 3rd dose until p/delivery & lactation was finished; no adverse events exp p/any dose of vax;
Blurry vision both eyes; This is a spontaneous report from a contactable consumer, reported for herself. A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (at the age of 55-years-old) as a single dose for covid-19 immunization. Medical history included asthma, drug hypersensitivity, glaucoma, angle closure glaucoma. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of 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. The patient had known allergies with sulfa. The patient's concomitant medications were not reported. On 29Apr2021 02:00, the patient experienced blurry vision both eyes and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment. Outcome of the event was recovered, on an unspecified date in Apr2021. Device Date was 22May2021.  Follow-up attempts are needed. Further information is expected.
Case number PHEH2014US018105 is an initial spontaneous report from a pharmacist received on 08 Sep 2014. This report refers to an 18-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M11077 and expiry date: not reported), at a dose of 0.5 ml intramuscularly on 28 Aug 2014. It was reported that, the patient accidentally received an expired MENVEO vaccine. No adverse event reported following this medication error (expired vaccine used).
Acute hypoxemic respiratory failure. ED visit and hospitalization. This visit was within 6 weeks of receiving the COVID vaccine.
12/21/09 Developed hives on face, trunk and extremities, PCP was notified and started on BENADRYL P.O. 12/22/09 Severity increased-phone call to PCP-continued on BENADRYL. 12/23/09 Severity increased-PCP office visit. Started on orapred and VISTARIL. 12/24/09-Improved significantly.
mom states p/pt recvd shots SEP92 that @ noc p/receiving shots temp went to 105 & pt became limp; mom took pt to MD; MD checked pt & said fever could poss becoming from ear infection; MD advised to given DT only;
Couple of hours after receiving immunizations, she started to get hives, her chest was burning and having minimal chest pain. The next day was out of breath and that night Trouble breathing. Hives continue to happen off and on. Patient has continued not to feel Normal and chest tight.
started Saturday  on his calf and up his knees to his thighs in the morning and by the afternoon  it got redder and skin started to get hot but the night it went to his arms and wrist and shoulder and back and up to the neck.   then on Sunday he was getting blotches on his legs on the front and the back. his skin was getting puffed up around the blotches and then it started to spread to his feet. Monday saw the doctor was told its a  Induced eruption  rash- full body. was given steroids- methylprednisolone 4 mg DOSPK prescription is a 6 tablet 1st day and decrease  tablet each day for 6 days.  The itch currently is at a low level and Dr. Did advise not to get the 2nd dose.
Severe watery diarrhea 14 days, extreme fatigue 30 days, dizziness and lightheaded, severe nausea 7 days, lack of appetite 20 days. 8 lb weightloss the first two weeks, dehydration treated with IV fluids in hospital ER on 03/29/2021. In the first 24 hours, attempts to take blood pressure at home were unsuccessul. Monitor continually read "error".  Assume it was either too high or too low to be measured? Monitor worked successfully afterwards. Albumin and A/G ratio. Abnormal appearance of urine with Ketones and abnormal epithelial  cells. Negative salmonella. campylobacter, e coli, Ova parasite, C diff, etc.  NOTES: 1. After the adverse effects from the 03/04/2021 dose, ER physician recommended waiting to get second COVID vaccination until my body had sufficient time to heal.  Due to being very wary that the event could have been related to the vaccine, I waited until Octover 2021 to get the second dose.  The same adverse events occurred starting 4 days after the vaccination took place.  Pfizer lot FF2590 administered on 10/18/21.  All symptoms, ilness, etc. were similar except this time there was loss of concsiousness resulting in collapsing off of toilet and striking head when falling on tile floor forehead first. In and out of consciousness for 5 hours. Diarrhea lasted 29 days with this event, and fatigue was about 5 weeks (unable to get out of bed more than 10-30 minutes at a time). Did not follow up with a provider until December 2021. Labs were good at that time, with the exception of low hemoglobin, RBC.   2. Agent is listed as contact, as he is my PCP. However, I wasnt able to get in to see him when March 2021 first event occurred so I used a telehealth company. The Dr. here eventually referred me to labs and eventually CT scan.
Case previously recorded as MA2009-4316. Initial case report received from physician via agency, on 16 NOV 2009. A 6 month-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 1009231P) i.m. on 16 NOV 2009. No adverse effect was reported. Agency reference no.:NA09-008284.
Second shot was due on 03JUN2021 but she missed it due to her sinus infection; Sinus Infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Infection) and PRODUCT DOSE OMISSION ISSUE (Second shot was due on 03JUN2021 but she missed it due to her sinus infection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced SINUSITIS (Sinus Infection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second shot was due on 03JUN2021 but she missed it due to her sinus infection). At the time of the report, SINUSITIS (Sinus Infection) had not resolved and PRODUCT DOSE OMISSION ISSUE (Second shot was due on 03JUN2021 but she missed it due to her sinus infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medications includes antibiotics.
got the first 2 doses of the Pfizer COVID 19 vaccine/tested positive for COVID; got the first 2 doses of the Pfizer COVID 19 vaccine/tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP7543), in left arm and in Apr2021 as dose 2, single (Lot number: EW0150) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (ongoing); "High cholesterol" (ongoing); "high blood pressure" (ongoing); "muscle aches" (ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); ROSUVASTATIN CALCIUM taken for blood cholesterol increased (ongoing). Past drug history included: Lisinopril for high blood pressure. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "unknown" and all described as "got the first 2 doses of the Pfizer COVID 19 vaccine/tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive. Clinical course: It was reported that the patient's symptoms are extremely light and that her doctor doesn't recommend that she take PAXLOVID.    No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: LOSS OF VISION SHORT TERM-Mild, Systemic: Flushed / Sweating-Mild
COVID break-through case: Patient tested positive for COVID 07/28/2021; greater than 14 days following last COVID vaccine. Patient is symptomatic.
Patient under 16 and received both doses of Pfizer covid 19 vaccine 3/27/2021, 4/17/2021
experiencing swelling at injection site, pain and arm is hot to touch; experiencing swelling at injection site, pain and arm is hot to touch; experiencing swelling at injection site, pain and arm is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (experiencing swelling at injection site, pain and arm is hot to touch), VACCINATION SITE SWELLING (experiencing swelling at injection site, pain and arm is hot to touch) and VACCINATION SITE PAIN (experiencing swelling at injection site, pain and arm is hot to touch) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905 and 015M20A) for COVID-19 vaccination.     Concomitant products included CAPTOPRIL, CARVEDILOL (COREG), POTASSIUM, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE, ROSUVASTATIN, ESCITALOPRAM and OMEPRAZOLE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (experiencing swelling at injection site, pain and arm is hot to touch), VACCINATION SITE SWELLING (experiencing swelling at injection site, pain and arm is hot to touch) and VACCINATION SITE PAIN (experiencing swelling at injection site, pain and arm is hot to touch). At the time of the report, VACCINATION SITE WARMTH (experiencing swelling at injection site, pain and arm is hot to touch), VACCINATION SITE SWELLING (experiencing swelling at injection site, pain and arm is hot to touch) and VACCINATION SITE PAIN (experiencing swelling at injection site, pain and arm is hot to touch) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Redness and swelling of upper arm from elbow to shoulder. Warm to touch, pruritic (Left Arm) DX: Allergic Skin Reaction
Thrombocytopenia with onset 12 days after vaccination. Vaccine occurred on 3/15/21, thrombocytopenia (platelet count of 0) discovered on 3/27/21 in the context of GI bleed (hematemesis) and drop of Hemoglobin from 11.2 (baseline) to 8.3.
Shingles shot in pharmacy. Soreness around shot area. Swelling, rash hot, itchy, extreme headache. April 17 Saw Dr allergic reaction to shot. (Ice and BENADRYL) rash and raised bumps were getting larger, burning through my head. Apr. 27, 013 went to clinic, give DECADRON 7 in long 2 in wide rash difficult to swallow.
Pt recvd DTP went home w/o problems 3 hrs later pt went limp for 6-8 minutes; taken to ER & adm for observation;
35 yo male received the first dose of the Moderna COVID-19 vaccination on 12/31/2020. Received second dose on 1/26/2021. On 4/17, pt undergoes COVID-19 testing with symptoms of muscle/body aches and new loss of taste/smell. Nasopharyngeal swab obtained 4/17 at 1036. Coronavirus POCT rapid test resulted positive a few hours later.
Patient?s mother called clinic stating her daughter was seen last week and received HPV-9 and MCV4 IM vaccines. Mother states that patient is complaining of numbness, swelling, and tingling in Right arm that started today 5/3/2021. Mother unsure which vaccine was given on that side. Reviewed chart and confirmed that HPV-9 was given IM in Right deltoid on 4/30/2021. Spoke to patient. Pt. states she is ?able to move her arm, but it is painful?, and says her ?whole arm feels numb and kind of tingly? able to wiggle fingers. Instructed to put an icepack on the site to bring down swelling and instructed to go to the clinic to have arm and site examined by a medical provider, as numbness and tingling are not normal side effects.
Case number PHEH2011US05842 is an initial spontaneous report received from a pharmacist on 30 Sep 2011. This report refers to a male patient of unknown age. He was vaccinated with MENVEO (batch number: unknown) intramuscularly in early or mid Sep 2011 (exact date unknown). The pharmacist stated that this patient received MENVEO that had been reconstituted with an expired MenA lyophilized conjugate vaccine component (expiration date: Aug 2011); the MenCYW-135 liquid conjugate vaccine component was not expired. No additional information was available, including vaccine batch number and patient identifying information at the time of this report.
Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. 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.
Skin rash. BENADRYL 12.5 mg/5 ml given.
Swelling and rash at injection site. Patient was seen at a urgent care facility. Description of visit was faxed to our office. Urgent care prescribed Prednisone.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the improperly stored doses of VARIVAX (dose, lot # and expiration date were not reported) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered dose of vaccine experienced the temperature excursion between -9 to 8 degrees Celsius for 5 hours and 15 minutes. Data logger was involved. There were no previous excursions  reported. Additional information has been requested.
Burning sensation around the lips, particularly the bottom lip at the edge of lip/lining.  It started within four hours of the vaccine and has continued now for 24 hours.  Slight burning in the throat that lasted for a few hours and stopped. Is this a side effect or a reaction?  The same burning sensation happened in both the throat and lips after the first dose within two hours but went away by the next day. After the first dose, burning in throat lasted a day and the lips went from burning sensation to tingling around the entire lips for one day.