chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 09-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Patient wife called clinic at 1156 am.  Patient lethargic, too weak to stand or walk, dry heaves.  Advised to call 911 and take to ER.  Called patient 3/17 for details.  States on 3/4/21 in the evening, he developed HA, chills, and body aches.  3/5/21 took a shower and became light-headed, near-syncope or syncopal episode reported by patient.  Wife gave him a Zofran ODT, which relieved the dry heaves.  He rested remainder of day.  Felt mostly better by 3/7/21, with remaining fatigue until 3/9/21.
Varivax 1/25/08, noticed redness, 1/26/08.  c/o headache & dizziness 1/27/08.  Denies headache today.  On exam noted 19 1/2 x 16 cm red indurated area on L shoulder, arm warm.  Dx L arm cellulitis vs poss. allergic reaction.  Tx today Keflex 500mg PO BID x10d.
Case number PHEH2014US019175 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 58 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly on 18 SEP 2014. It was reported that he was vaccinated with 1.0 ml dose of vaccine instead of 0.5 ml. No adverse events reported after the maladministration (vaccine overdose).
Pt received both ZOSTAVAX (without diluent) and PNEUMOVAX in one syringe as a single dose. Pt returned Sun (5/23/10) with a softball sized reaction with symptoms of only soreness & erythema. Pt returned again on Mon (5/24) with whole side of arm with erythema & no other symptoms on Tues. (5/25). Pt arm was only splotchy.
Rash on left arm at injection site 7 days after first dose; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021 the patient experienced rash on left arm at injection site 7 days after first dose. On an unknown date, the patient underwent nasal swab SARS Cov-2 test and the result was Unknown. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the adverse events. The clinical outcome of the event rash on left arm at injection site was recovered on unknown date in 2021 after 5 days of first dose before fading.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
This case was reported by a nurse via sales rep and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PCV-13 PNEUMOCOCCAL VACCINE) for prophylaxis. On 6th February 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of PCV-13 PNEUMOCOCCAL VACCINE. In February 2019, less than a week after receiving Shingrix, the patient experienced generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping. The patient was treated with ibuprofen. On an unknown date, the outcome of the generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping were unknown. It was unknown if the reporter considered the generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Nurse Practitioner. The patient received two vaccinations PCV-13 and a dose of SHINGRIX. On 7th February 2019, the patient walked in and complained on generalized joint pain, headache, chills, fatigue, and nausea, and trouble sleeping. The patient stated she had taken ibuprofen for symptoms.  No noticeable local adverse events. The nurse reviewed side effects of both vaccines with patient. The reporter agreed to be followed up.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 17Jun2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), when the patient was 33 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), PAROSMIA (non-serious) all with onset 01Oct2021, outcome "unknown" and all described as "I keep smelling smoke all the time even though there's no smoke and it gives me headaches". Additional information: Smelling smoke constantly and getting headache. She keep smelling smoke all the time even though there's no smoke and it gives me headaches. Follow-up attempts completed. No further information is expected.
23 year old female s/p syncope after 2nd Pfizer Covid19 vaccinaton to her left deltoid.  Pt was sitting outside and notified the nurse of being dizzy and thirsty.  While ambulating inside had a syncope episode of about three seconds and immediately awakening very anxious.  She does not remember the episode.  Post VS 114/72 100 28 and 100% O2 sat on RA  while in the supine position.  1307 f/u VS 100% RA with heart rate of 84 bpm.  C/O of dizziness and placed back into supine position with legs elevated on car .  Then placed on 10 lpm non rebreather  VS at 1318 106/67 84 24  Now sitting up with NAD , reported no symptoms.  Eating Cheetos and drinking a bottle of water.  Also placed on RA  At 1324 placed in seat, denies any symptoms at this time.  VS 98% RA    96/62 85 24  At 1331 89/63 85 24  Denies any symptoms, ambulated to the bathroom without help Patient reported systolic blood pressure in the 100s.  No complaints after ambulating   1137 pm 91/60 85 20     Patient reported feeling fine and requesting to go home.  Advised to f/u with PCP. DCd home with steady gait MAEW, NAD a+ox3  Ate all of the cheetos and drank all of the bottle of water 16.9 ounces          Reported no medical history Denies taking any medications Denies any allergies   Occurred at center   HCP notified of occurrence
Swelling and tenderness of joints of both hands. Onset 1 week after varicella vaccine and lasting 6 to 8 weeks.
Patient tolerated administration of vaccine well and was monitored in observation room by two RN's for 15 minutes and patient felt fine to leave. Patient left room and came back shortly after feeling very fatigued, nausea, and pain in both calf's- L leg worse than R , with red toes. Bilateral pedal pulses +2. Vitals: BP 130/67 HR 92 Sat 95% on room air. Gatorade given to sip on. RRT was ultimately called and patient was taken to ED.
No additional AE/PQC information; a dose of ROTATEQ was administered to a patient after undergoing a temperature excursion; Dose of ROTATEQ was reported as 0.5 mL; This spontaneous report has been received from a medical assistant and a healthcare professional (qualification unknown) referring to a 9 weeks old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided   On 01-DEC-2021, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) after undergoing a temperature excursion (lot# 1742428 has been verified to be a valid lot number and expiration date was 01-SEP-2022; 0.5 mL orally) for prophylaxis (product storage error and incorrect dose administered). The vaccine was within desired temperature during administration. The administered dose experienced the temperature excursion of 50 Fahrenheit (F) for 5 minutes which was detected by a digital data logger. The reporter also noted that a dose of Pneumococcal Vaccine CONJ 13V (CRM197) (PREVNAR 13) that underwent the same temperature excursion was also administered to an unspecified patient. No previous temperature excursions were reported. There was no additional adverse event.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA001317:
This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. The patient's spouse reported told to nurse that the patent had red streaks on arm post injection. The reporter did not remember the patient who was just spouse mentioned on phone while calling into the office and the patient refused treatment in the office for the adverse event. The reporter did not agree to follow up from GlaxoSmithKline.
I noticed my left arm is swollen, red, warm to the touch, sometimes itchy on Dec 31,2020. Contacted via phone and e-mail, Occupational Health Services on 1/1/2021. I also saw  an ED physician at on 1/1/2021 who said a local inflammation reaction was unlikely, probably cellulitis, and prescribed doxycycline. The affected area of my arm was marked to follow progression of red, warm area.  Began doxycycline 1/1/2021. Next morning red, warm area of arm is now outside of marked area and down to below my elbow.  I have an appointment with Occupational Health on Monday, January 4,2021.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS activated; patient's mother declined EMS transport to the hospital; patient appeared to recover from syncopal episode within 30 minutes
Rash over the body, itching and redness 12 hours after injection.  It continues to the present day 11/04/2021.
this is one of 4 individuals, out of 25 vaccines, to devel a red, hard knot @ the inj site following receipt of flu vax;
severely itchy rash on inner thighs, thought it was poison ivy, it may be, it's sticking around a long time.
Presented with SOB; covid + x1 day; Acute on Chronic respiratory failure with hypoxia secondary to COVID-19 pneumonia,he was continued on supplemental oxygen, Patient was at his baseline on O2 10 lpm.He was given IV steroid, vitamin C, zinc sulfate and Singulair, ID is following, continue him on albuterol MDI.Patient has been started on empiric antibiotic per ID. Completed Remdesivir .DDimer 1.48, Ferritin 694.
Bruising/swelling, indurated area approx. 1 1/2" (circular) R deltoid. C/0 headache X 4 days, fever 100.8 to 102 (oral) X 3 days.
Admission Date: 8/24/2022 Discharge Date:  8/28/2022  PRESENTING PROBLEM: Primary sclerosing cholangitis [K83.01] Abdominal pain [R10.9] Elevated LFTs [R79.89] Intractable abdominal pain [R10.9] COVID-19 virus infection [U07.1] Cholangitis [K83.09]   HOSPITAL COURSE: The patient is a 59-year-old female with a history of PSC, chronic back pain, essential hypertension, remote history of Roux-en-Y gastric bypass, herpes simplex, and chronic pruritus due to PSC who presented with increasing abdominal pain, febrile illness and elevated LFTs..  Patient does have a history of PTC with biliary drain placed on 03/16/2022 at  which was removed on 04/05/2022.  At the time of admission she was found to have elevated LFTs.  CT scan of the abdomen pelvis showed no acute changes.  Patient was also found to have COVID infection, but chest x-ray was negative, and the patient's O2 saturations were stable on room air.   Patient was admitted to the hospital service and started on Zosyn.  GI was consulted.  Was also consulted, as it was initially felt the patient likely would need repeat PTC drainage.  MRCP was consistent with PSC with active cholangitis, with several areas of narrowing.  The case was discussed with attending, who felt that there was no need for intervention.  Hepatology initially felt that the patient would require PTC with brushings of the bile ducts, as CA 19 9 is elevated.  With antibiotics the patient's abdominal pain significantly improved and LFTs also returned to near normal levels.  With clinical improvement and improved LFTs, it was felt the patient did not require PTC drainage at this time.  Patient's case is to be discussed by GI with the soft tissue tumor board on 09/13.  Patient also has an appoint with on 09/13 and was encouraged to keep this appointment.   The patient did have positive COVID test, with fever on admission however was otherwise asymptomatic with regards to her COVID infection, and was not treated with Paxlovid, remdesivir or dexamethasone.   As patient was clinically stable, she was transition from Zosyn to Augmentin, to be continued to complete a 14 day course of treatment, and discharged to home on 08/28.
PT DEVELPD FEVER 105.2F IN 6-8 HOURS AFTER ADMIN OF .5CC DTP VAX. BY FOLLOWING MORNING SHE WAS DOWN TO 100.5 WITH NO OTHER SYMPTOMS.
After first injection 05/02/2011, complained of trouble learning and not being able to "remember anything". Second injection was in July 2011- suspected headache as delayed result but cannot document date. Began exhibiting "nervous" and "hyper" movements like she is moving around to cover up trembling. Final injection on 11/7/2011. Leg tremors began 11/21/2011. Sudden circulation problems being chronically cold although she feels warm and has very sweaty hands. January 31, 2012 she had swollen, hard lymph node in neck. Complaints and frustration that school work is becoming a challenge, feels dyslexic. Spring of 2012 collapsing during volleyball, having trouble moving legs, considered exhaustion & stress. By mid April a wart virus spreading. In May, 2012 sees sports doctor and begins physical therapy. May 25, 2012 MRI and first full body convulsion in machine. August, 2012 trouble breathing, full body convulsions, taken to ER. Continued feeling that she has moments of dyslexia and "can't learn". October 9, 2012 referred to neurologist- prescribed 300-600mg Gabapentin. October 12, 2012 EEG for epilepsy is negative. November 19, 2012 Rheumatologist diagnoses Reflex Neurovascular Dystrophy (although it is not a real fit), agrees with Gabapentin. Tremors/seizures worsen by February 2013. February, 2013 began weekly acupuncture for heavy metal poisoning with hopes to improve brain/nerve communication. March, 2013 noticed decline in severity of tremors. April, 2013 performance has improved, going vegan to improve health. July, 2013 begin treatment with chiropractor to reconsider any physical alignment issues. September, 2013 wart virus on hands is still spreading, cryo treatment by dermatologist.  Chronic sweating hands makes keeping them bandaged a challenge. October 2013 family doctor concurs with RND diagnosis and dismisses my vaccine reaction concern. As of 2015, patient truly believes all of these symptoms.
Information has been received from a registered nurse concerning a 35-year-old male with asthma and no drug allergies who on 02-FEB-2007 was vaccinated subcutaneously with a first dose, 0.5 mL, of varicella virus vaccine live (Oka/Merck) (Lot # 655065/1142F). Concomitant therapy included Pulmicort, albuterol, Allegra, Nasonex, Zantac and Neurontin. On 09-FEB-2007, a week after vaccination, the patient experienced five rashes on his body. Medical attention was sought. On 20-Mar-2007, the patient still had two areas that were visible but healing. No treatment was required and no laboratory tests were performed. At the time of reporting no date of recovery was reported for the event of rash, as it was considered to be self limited. On 23 MAR 2007, the patient received his second dose of varicella virus vaccine live (Oka/Merck). There was no product quality complaint involved. No further information is available.
ILL POST COVID VACCINE; This solicited report received from a patient via RRA-18356: Nurse  from Janssen for STELARA Crohns concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with Ustekinumab (solution for infusion, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, therapy start 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 numbers. No concomitant medications were reported. On an unspecified date, the patient became ill post covid-19 vaccine. The patient was hospitalized from 26-FEB-2022 to 28-FEB-2022. It was reported that the health professional was aware about it. The number of days of hospitalization was reported as 2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with ustekinumab was not reported. The outcome of ill post covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and ill post covid vaccine was not related; and between ustekinumab, and ill post covid vaccine was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220310725-covid-19 vaccine ad26.cov2.s-ill post covid vaccine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related. 20220310725-Stelara-ill post covid vaccine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.
Pt stated she had heavy/numbness in arm about 20mins after getting the vaccine and lasted about 15-20mins.
Pt. began to awaken at night with hallucinations (visual), which persisted all day long x 2 different occasions. Pt's personality changed also. Also had abscess where shot given.
Swelling, rash and blister around both eyes. Burning and itching. Still affected today March 6, 2017.
it was administered just the adjuvant; it was administered just the adjuvant and then the correct reconstituted dose; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 57ljn, expiry date 14th April 2023) for prophylaxis.   On 30th September 2021, the patient received the 2nd dose of Shingrix. On 30th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was inadvertently administered just the adjuvant alone of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient wanted to know what was in the adjuvant and was it safe. The health care professional mentioned that, correct reconstituted dose was already administered immediately after error. The reporter consented to follow up.
pt rcvd vax; pt exp metal flavor in mouth; pt felt flu-like symptoms; tests showed pt failed to seroconvert;
MAJOR BLOOD CLOT IN LEG; UNABLE TO WALK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), patient woke up out of bed and had a major blood clot in leg and was unable to walk. Patient had just got home from the hospital and was in a hospital for five days and had no idea why got that blood clot, because patient was in pretty good shape and just wanted to report. Patient reported shot became the only thing which was done in the last ten years different. So patient did not know. It just seemed really weird to patient that woke up and had a mass of blood clot in life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to walk and major blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0; 20210755344-COVID-19 VACCINE AD26.COV2.S-major blood clot in leg, unable to walk. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Chest tightness, shortness of breath, dizziness, sore throat, cough, itchy red eyes.