chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Went to My Doctors Office whom prescribed Betamethasone Dipropionate Cream,  15g at 0.05% 25mg antihistamine 3 X dayly
Vaccine administered without reconstitution; Vaccine administered without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, 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 Information: GSK Receipt Date: 18-NOV-2022 Reporter's comment: The nurse reported that they had a staff member only gave the patient this part of the vaccine without reconstituting it. The nurse stated he/she need the lot number to figure out which patient it happened to. Sometime between 7th November 2022 and 11th November 2022. No additional data was available. The reporter consented to follow-up. Additional Supportive Information: The patient received dose Shingrix vaccine without reconstituting it, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
suspended activities until 3pm on 11/14/19. headache, fatigue, all-over ill feeling (like a cross between flu & hangover). would have scheduled dose on another day if I anticipated these adverse reactions. rested, napped, took 1 aspirin for the headache (but never lost it until @28 hrs. after the injection.
Extreme pain in the arm that was injected (for multiple days after injection), pain radiating to the arm and back, fatigue, and chills.
GI SYMPTOMS WERE BACK; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE (LACK OF ANTIBODIES); ULCERATIVE COLITIS RELATED TO LUPUS SYMPTOMS RESOLVED; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis related to lupus, benign mass on breast, huge mass on other breast, unknown nature, lost all teeth from colitis and broke neck twice, no feeling on arm due to this. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, with frequency as 1 total administered on left arm on 19-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  It was reported that the patient called to ask for help regarding her situation and mentioned that the day after she got the vaccine, her ulcerative colitis symptoms went away (ulcerative colitis related to lupus symptoms resolved). The patient stated she felt little bit sick on 20-MAR-2021 (referring to symptoms from ulcerative colitis) after that she experienced regular bowel movements (BM), no diarrhea, no extreme pain, she was not wearing diapers, etc. And she stated having no side effects from vaccine. This lasted about 3 months. Before the pandemic, she had a mastectomy and biopsy scheduled but because it was deemed not an emergency surgery, it got postponed until this year.  On 16-AUG-2021, the patient experienced confirmed immunological vaccine failure (lack of antibodies). It was reported, during preoperative preparation laboratory data included: COVID-19 antibody test (NR: not provided) Negative. And on an unknown date, her gastrointestinal (GI) symptoms were back which made patient not want to get the surgery. The patient wants to get revaccinated so that she can get surgery.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure (lack of antibodies), ulcerative colitis related to lupus symptoms resolved and GI symptoms were back was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000196486.; Sender's Comments: V0:20211008750-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
FLUZONE HIGH-DOSE QUADRIVALENT was administered to a 9 month old with no reported adverse event; FLUZONE HIGH-DOSE QUADRIVALENT was administered to a 9 month old with no reported adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional in the .   This case involves a 9-month-old and a 3-year-old female patient who administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] to a 9-month-old and a 3 year old [Product administered to patient of inappropriate age].   The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Prophylactic vaccination.  On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Suspension for injection, lot UJ751AA and expiry date: 30-Jun-2022] via an intramuscular route in the left thigh for prophylactic vaccination.  The patient visit on 19-oct-2021.  It was a case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day].   It was reported "MD (Doctor of Medicine) and reviewed standard on children under 18 years. MD had question on what if the children experienced an adverse reaction do the parents contact Sanofi or contact them as the provider".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a registered nurse refers to a 66 year old female patient. On 19-SEP-2013, the patient was vaccinated with a doe of 0.5 ml VARIVAX (Merck), (lot number, expiry date was unknown), subcutaneous instead of ZOSTAVAX. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
12 hours after vaccine developed altered taste, altered smell, significant fatigue, poor concentration, headache with pressure in frontal area of head
A non-serious spontaneous report of flu, runny nose, stuffy nose, fever of 102 and headache has been received from a consumer concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 08-Oct-2010 for an unknown indication. On 09-Oct-2010, the patient experienced runny nose, stuffy nose, fever of 102 and headache. On 11-Oct-2010, the patient experienced flu. Treatment for the events was not provided. The outcome for the reported adverse events was ongoing.
I was just very tired and I was sore. The site was sore and red and a raised bumb where the shot was. It didn't go done. Around the second shot it went down. Monday morning after the shot I could not sore and could not raise my arm, the lymph nodes were swollen. I missed my mamogram because my underarm was so swollen. I am still swollen. I had excessive saliva, it was weird I just know it started after and I was super tired and exhausted. I just stopped being tired, I was eating and exercising healthy.
About 24 hours after the shot, I was extremely chilled all over and very tired. I went to bed and tossed and turned half of the night. I woke up in the middle of the night with a fever and took Tylenol to decrease my temp (high was 101.1F). That morning (12/2) I was having chest pressure and my heart rate was elevated anytime I stood up. I stayed home from work to rest. That evening (12/2) I took an IBPROFEN and the pressure seemed a little better. The next morning (12/3) my heart rate was still elevated when standing or doing anything besides laying down (135bpm while brushing my teeth) and I couldn't seem to catch my breath. I stayed home from work and went to Urgent care at about 10AM that day (Friday 12/3).
Elevated heart rate of 145. Elevated respiration.  Severe joint pain. Body ached.  Fatigue.  All symptoms continued for st least 24 hours.   Taking Tylenol and plenty of water.
I had a rash that developed on my chest, neck, and chin. I took pictures to document. I also have had a stiff neck and headache since the day after the shot and have needed to take Advil daily to relieve the pain. I have gone to the Chiropractor and had and adjustment and stem therapy. Called my primary care physician and she offered a Toradol shot but have declined at this time since Advil seems to be helping.
The doctor found an enlarged lymph node in the right groin area during a routine examination. He suggested I make an appointment with a general surgeon for further evaluation.
Patient reported being light-headed and dizzy within a couple minutes of vaccination and "light-headedness" continued for about 30 minutes.
Information has been received from a registered pharmacist concerning a couple of patients who were vaccinated with ZOSTAVAX (Merck) (lot# not reported) and then got shingles. The pharmacist did not know the specific number of patients. At the time of reporting, the patients' outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the pharmacist. She mentioned in the letter that she could not provide more information about the adverse reaction. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg is hurting) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right leg is hurting). At the time of the report, PAIN IN EXTREMITY (right leg is hurting) outcome was unknown. No concomitant product use was reported No treatment information was provided. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable. Reporter did not allow further contact.
R arm injection site, warm, painful, swollen, red started 1/12/21. .( Dx Cellulitis - local reaction to COVID vaccine )
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 06-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
RDW was borderline low at 10.7%; Went to ER with severe vertigo; platelet numbers were within range on the high side (310K) but MPV quite low (7.6 fL on a range of 10.5 fL - 13.6 fL); This is a spontaneous report from a contactable Consumer (patient). A 54-year-old female non pregnant patient received first dose of BNT162B2 (Solution for injection, lot number: EL3248, Expiration date; unknown), via an unspecified route of administration on 23Jan2021, 15:15 at single dose for COVID-19 immunization. The patient's medical history includes bipolar II, left bundle branch block, Known- soya allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg, lamotrigine 200mg, lurasidone hydrochloride (LATUDA) 20 mg. Patient not received other-vaccine-in-four weeks. Other-medications-in-two weeks includes Wellbutrin 450mg, Lamotrigine 200mg, Latuda 20 mg. On 06Feb2021 19 :45, patient went to emergency room with severe vertigo. In CBC taken there, platelet numbers were within range on the high side (310K) but MPV quite low (7.6 fL on a range of 10.5 fL - 13.6 fL). RDW was borderline low at 10.7% (normal range 11%-16% range). No idea when the blood count issues started. Patient received treatment for vertigo, meclizine/PT, for MPV. Patient had covid-prior-vaccination, had covid-tested-post-vaccination. Covid test post vaccination [{covid test type post vaccination=Other, covid test name post vaccination=saliva test, covid test date=28Jan2021, covid test result=Negative}]. The outcome of the event was recovering.
No adverse event; Inappropriate age at vaccine administration; Patient received a vaccine that underwent a temperature excursion; Patient received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) in a 5-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion). On 16-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration).    The patient had a weight of 16 (unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported by reporter.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/26/2021 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/26/2021 SHORTNESS OF BREATH D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/26/2021 ATRIAL FIBRILLATION, UNSPECIFIED D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/26/2021 ABNL CHEST XRAY
EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.