chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient would not get a period for 2-4 months; This spontaneous report was received from a medical assistant via company representative and refers to her 12 -year-old daughter. The patient's concurrent conditions and drug reactions or allergies were not reported. The patient's mother had ovarian issues.   On unknow dates in 2015, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, lot #, expiration date and route were not reported) for HPV vaccination. Concomitant therapies included medroxyprogesterone acetate(PROVERA).     The patient did not have any immediate adverse events.  At the age of 12 years in 2018, the patient started period. The first few periods were normal (the patient received her period monthly), but after that, the patient would not get period for 2-4 months (amenorrhoea). When the patient's period were more, than 3-4 months apart she took medroxyprogesterone acetate(PROVERA), pills 10 mg  as needed.  The medical assistant stated: "I don't think this is because of GARD ASIL".  At the time of the report, the outcome of amenorrhoea was not reported.
22SEP c/o epigastric pain, anorexia;23SEP n/v;24SEP to MD ofc where IV was attempted;25SEP hydrated w/IV fluids;26SEP guaiac positive stool;purpura, petechial on legs;dx Henoch-Schonlein purpura;ankle pain, unable to walk d/t ankle pain;
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX 0.5 ml, subcutaneously, lot# M027343 with expiration date: 01-JUN-2016. Administered doses of VARIVAX were exposed to 8.6 Fahrenheit degrees for 25 hours. Data logger was used. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Within 1 hour, severe headache, frontal head pain, dizzy; Within 5 hours, facial swelling on both cheeks; within 24 hours, fever, elevated heart rate, swollen left side of neck (injection side) near lymph nodes, chills, body aches (back), tingling tongue on left-side only, scratchy throat.
The patient had a prolonged hospitalization primarily characterized by his dependence on mechanical ventilation.  He remained dependent on the ventilator for approximately the 1-2/3st of his hospitalization with difficulties centering on current pneumonia and secretion management.  He also had significant anxiety but eventually was able to work with psychiatry medication management and respiratory therapy.  He was liberated from the ventilator but continued to require tracheostomy collar with high-flow oxygen support.  He worked with physical and occupational therapy.  He was seen by the Nutrition Service. His mental status remained intact throughout his hospitalization and his wife was supportive at his bedside He was very clear throughout his hospitalization about his expectations and his knowledge of his prognosis. Work on disposition had begun but he had a recurrent episode of pneumonia and his respiratory status continued to decline.  He did not want to be placed back on the ventilator but was agreeable to noninvasive positive pressure support.  Unfortunately this did not improve his respiratory status and he continued to decline as the expectation of not surviving was cleared him.  He died on June 23rd at 5:58 p.m.
several pt devel a dermatitis rxn @ the inj site 2 days p/vax;
severe sepsis; altered mental status; diagnosed with an acute upper respiratory infection; pneumonia; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 17-SEP-2014, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Within one  week after receiving zoster vaccine live (ZOSTAVAX), the pt suffered altered mental status and was diagnosed with an acute upper respiratory infection, pneumonia, and severe sepsis.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The events of altered mental status, acute upper respiratory infection, pneumonia, and severe sepsis were determined to be disabling events.
LIFE WENT FROM VERY HEALTHY TO INVALID BENT OVER WITH PAIN; SHORTNESS OF BREATH; OTHER ILLNESSES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very healthy. 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced life went from very healthy to invalid bent over with pain, shortness of breath, and other illnesses. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from other illnesses, and the outcome of life went from very healthy to invalid bent over with pain and shortness of breath was not reported. This report was non-serious.
Approximately 5-10 post vaccine, patient reported lightheadedness. We were alerted and I found patient lying across 2 chairs in the waiting area. She reported she was feeling better after lying down and was able to drink some water and eat a banana and some sugared candy over the next 20 minutes. She remained lying down or sitting for 1 hour post vaccine and at that time the patient reported feeling fine and felt comfortable leaving our facility. I called her 1 hour post departure and patient reported continuing to feel fine.
HYPERtension SWOLLEN ARM, HAND AND FINGERS Narrative:  AT TIME OF VACCINATION- PATIENT APPEARS TO HAVE HAD AN ANXIETY REACTION AND WAS OBSERVED FOR ONE HOUR ICE WAS APPLIED TO THE ARM SWELLING AND PATIENT RELEASED
Pt had spent 10 mins in the observation hall when he w.. as reported to be feeling light-headed and his vision, blurry. Mother reported that he had nothing for breakfast b/4 the vaccination appointment. V/S taken was bp 98/57, rr 14, Hr 80, O2 96% RA, T. 95 degrees. When writer offered some drinks and snack, the Pt accepted the offer. 2 small packs of apple juice and 2small packs of crackers were consumed by the Pt. A recheck of the v/s showed the following readings. bp 98/64 , Hr 69, O2 99% RA .Pt and mother stayed for about 15 extra mins before the Pt verbalized feeling okay and ready to leave. He left in the company 0f mom unassisted
Patient woke up this morning with a rash on his forehead. He describes it as an allergic reaction type of rash. It does not itch.
11day p/vax pt broke out in rash all over body & began to have difficulty breathing. seen in ER, epinephrine & benadryl
redness @ inject iste of 24MAR became febrile on 27MAR AM (101-104) by 9:00PM had elevated to 105-106 w/sz; treated in ER by MD for febrile sz due to immunization;
a fever with seizure like convulsions; This spontaneous report was received from a consumer referring to her 2 or 3 years old son. There was no information about the patient's drug reactions, allergies, pertinent medical history, and concomitant therapies provided.  In 2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown)(strength, dose, route, lot # and expiration date were not reported) for prophylaxis.    In 2007, the patient experienced a fever with seizure like convulsions. The outcome of the event was reported as recovered (reported as it took about 10 days for the symptoms to go away). The causality assessment was not provided.
Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was sitting in post vaccine waiting area when she alerted EMT she was feeling lightheaded and dizzy. RN  joined and began to assess client. Vitals at 1600: blood pressure 126/80 pulse 84, respirations 18. Alert and oriented. No swelling noted. Client denied shortness of breath. Per client no history of allergies or reaction to vaccines in the past. Client asked for water. PHN  joined team, client instructed to take small sips of water. Client mentioned she had not ate yet and thought maybe it was related to that. Client informed she would be observed another 15 mins due to current symptoms. 1608 client stated feeling warm, anxious, and still lightheaded. PHN offered client benadryl and client accepted. Per client husband came with her and was going to drive her home. Benadryl 50mg was given orally at 1609. Vitals: blood pressure 144/90, pulse 76, respirations 18. Client informed staff she felt hands were shaky and body was warm. Client alert and oriented, no swelling noted. Vitals at 1616: 140/90, pulse 60, respirations 16. At 1622 client stated feeling better, did not want to wait rest of remaining time. Client was advised to consult primary provider prior to receiving second dose Pfizer. Client also given ER precautions. Husband was waiting in parking lot and was going to drive client home. Client left facility with a steady gait at 1630.
Pt was given the yellow fever vaccine via sq injection into the left arm. After about 5min when pt stood to leave pt said she felt heavy and became dizzy. Pt was instructed to sit back down, and from the sitting position she passed out for a few seconds. I checked pt's breathing and asked for 911 to be called. Pt then regained consciousness and was informed of what happened, and that the EMS system was activated. RPh stayed with pt to monitor while ems could arrive. EMS checked pt and pt said she felt fine and didn't want to go to the hospital.
Information has been received from a physician assistant (P.A.) concerning a 5 years old patient who reported that she visited her aunt who on 28-JUL-2010 was vaccinated with VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011) and slept on the same bed as her and developed a mild case of chicken pox on approximately 30-JUL-2010 within a day or so of the visit. The niece has lesions on her back that are itchy. The P.A. reported that on an unspecified date, the patient had been vaccinated. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician assistant indicated that the 5 year old female patient who on 28-JUL-2010 slept with her aunt who on the same day was vaccinated with the first dose of VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011) SC at right arm. The next morning the 5 year old patient developed chickenpox. This is one of several reports obtained from the same source. Additional information has been requested.
came to clinic 1/5/21.  states had vaccine 12/28/20.  noticed last night arm itching, tender, hot, redness.  marked redness - approx. 1.5 x 2 inches.  redness size not changed, shifted position slightly (less than 1/4 inch).  warm to touch.  has not taken meds
Menveo without proper reconstitution; Menveo without proper reconstitution; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA902A, expiry date 31-JAN-2024) for prophylaxis.   On 13-MAR-2023, the patient received Menveo. On 13-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo without proper reconstitution) and inappropriate dose of vaccine administered (Verbatim: Menveo without proper reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The nurse enquired that one day before reporting, a patient received the liquid portion only of Menveo without proper reconstitution and asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Narrative:  Pt is a 92y.o. male who died on 05/08/2021 w/ h/o CHG, CAD, HLD, GERD, DM, BPH. Pt received Moderna Covid-19 Vaccination 2/2 on 05/05/2021. Pt began receiving hospice care starting on 03/19/2021. Pt did not want anymore hospitalizations, no more test, no IV AB. His wishes are to remain in his home and be comfortable. Unlikely Moderna Covid-19 vaccine caused/contributed to pt death.
12-29-2020 1330- Shot administered Tasted lemon for 1 hour after shot Just slight soreness of injected arm 12-30-2020 0500 Woke up with fever of 100.7 Body aches Headache Congestion Slight dizziness Fever spiked to 101.5 during the day Very fatigued 12-31-2020 0500 Woke with fever of 100.5 Still had body aches and mild headache congestion and slight dizziness 12-31-2020 0800 fever gone 12-31-2020 0900 body aches gone headache gone dizziness gone 12-31-2020 1100 Headed back to work
tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Noted a small red bump; cranky x 3 days; no fever; clingy; no itchy; eating less; no rashes; no known insect bites; varicella vaccine was given in that spot 8 days ago.
Severe allergic reaction; Dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Dizziness) and HYPERSENSITIVITY (Severe allergic reaction) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042821A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (Dizziness). On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergic reaction). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was provided as c band acupuncture device.  It was reported that the pharmacist suggested the patient not to get the second dose as the patient had allergic reactions.
Pfizer Covid vaccine dose 2 given 16 days after dose one. Vaccine administration error.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Lymph Node Swelling-Medium
Headache (after 2nd dose); Fever (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (after 2nd dose)) and PYREXIA (Fever (after 2nd dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa drugs).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 23-Feb-2021, the patient experienced HEADACHE (Headache (after 2nd dose)) and PYREXIA (Fever (after 2nd dose)). At the time of the report, HEADACHE (Headache (after 2nd dose)) and PYREXIA (Fever (after 2nd dose)) outcome was unknown.            Patient takes medication for her thyroid and blood pressure.  No treatment medication was reported   This case was linked to MOD-2021-374481, MOD-2021-374553 (Patient Link).
- Tenderness deltoid muscle - Erythematous pruritic macular lineal rash encircling deltoid areas - Patient had Td without problem. This one is Tdap
Fevers, chills, weakness; localized swelling/ erythema/ warmth.
tonsillar swelling, difficulty swallowing, palpable lymph nodes in neck. Started within minutes of getting vaccine. Took 50 of benadryl at 0830. noticed improvement in swelling by 0900. Resolved by end of day.
Narrative: 100yo pt passed away on 8/17/21. Pt with h/o: Chronic kidney disease stage 3 (SCT 4331 Atrial fibrillation (SCT 49436004) Aortic stenosis (SCT 60573004) Osteopenia (ICD-9-CM 733.90) Adjustment Disorder with Anxiety (ICD-9-Hyperlipidemia (SCT 55822004) Osteoarthritis (ICD-9-CM 715.90) Asthma (ICD-9-CM 493.90) Benign hypertension (SCT 10725009) Glaucoma (ICD-9-CM 365.9) Arrhythmia (ICD-9-CM 427.9) Pt had received covid vaccinations on 1/8/21 & 2/5/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
When patient came in for second dose of vaccine, during screening, he expressed a number of symptoms he experienced after dose #1. The 3 days after dose #1 after he experienced typical side effects (chills with no fever, fatigue and lethargy). After 3 days, he continued to experience symptoms such as left arm pain with occasional bilateral arm pain, heart palpitations and "heavy beating," what he described as "adrenaline surges or shocks," a "spiky feeling in hand, numbness arms and hands bilaterally but left much worse than right. I was concerned that, given the patients age and symptoms, espicially left sided arm pain and cardiac rhythm abnormalities, that he need evaluation for myo/pericarditis before continuing the series. I advised him to contact a doctor for evaluation and told him I would fill out a VAERS report.
Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on R thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. Within the first 15 hours following the injection I began experiencing extreme full body pain, neck, back, arms, legs, hands, and fingers. As well as experiencing a major headache equivalent to migraine pain. The pain was intense and lasted around 36 hours. Pain had subsided within 48 hours excluding pain at injection site that continued but was significantly milder.
Patient was given bivalent Moderna vaccine (6mo-5yr) instead of Moderna monovalent (6mo-5yr). Provider informed of vaccine given. Patient parents aware and stated child was fine, mother denies temperature, rash, vomiting or shortness of breath at this time. Reassurance given.
24hrs p/vax arm very sore, fever 102 ear probe, rt deltoid swollen, warm & red;tender to painful to touch
Patient has had fainting issues in past with vaccinations. About 5 seconds after injection, the patient fainted, fell asleep,  started to snore, then had seizure symptoms. After about one minute, the patient woke up and said he was okay. He was observed in the room for 2 hours, given hydration, towels, a pillow, and a fan to keep him comfortable. Signs and symptoms were normal when before he was allowed to leave after 2 hours.
Is it normal to have site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is it normal to have site pain) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Is it normal to have site pain). At the time of the report, VACCINATION SITE PAIN (Is it normal to have site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication was provided.   Reporter did not allow further contact
Case number PHEH2016US028706, is an initial spontaneous report received from a consumer on 31 Oct 2016. This report refers to a 46 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch  number: not reported) at a dose of 0.5 ml intramuscularly on 10 Oct 2016. On 20 Oct 2016, reported as 10 days after vaccination the patient experienced muscle pain in back, neck and headache. The patient went to  the hospital and her white cell count was up (results unspecified). She was treated with vancomycin. She stayed in the hospital for a day and her diagnosed was viral unknown. The outcome of the event viral infection was reported as condition improving and of other events was not reported. The causality of the events was not reported.
Within 24 hours of vaccination developed painful L shoulder. Pain has persisted since vaccination unless taking consistent NSAID medications.
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not  reported. The healthcare professional (HCP )reported that the patient had an anaphylactic reaction to an unknown flu vaccine back in 2014.
Child received DTaP, Hep B, IPV, (PEDIARIX) HIB, PCV on 5/6/10. Mother stated that child had hives on the night of 5/6/10. Next morning he had a fever of 101 axilliary. He was seen at physician tx center and tied to increase fluids.