chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to his wife of unkonwn age. In 2012 (reported as 2 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route not reported). The patient developed a mild injection site reaction after receiving ZOSTAVAX (in 2012). The outcome of the event was reported as recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-FEB-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and for the long-term prevention of shingles and zoster related injuries and diseases. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 30-SEP-2015, the patient was treated by a physician and was diagnosed with herpes zoster ophthalmicus in the right eye. The patient was prescribed VALTREX and TYLENOL for management of her painful symptoms and chronic pain. On or about 04-DEC-2015, the patient, the patient sought subsequent treatment from a physician assistant for the onset of a rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed lidocaine and other pain medications for management of her painful symptoms and chronic pain, including but not limited to severe headaches related to her zoster related eye injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the lifetime prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, herpes zoster ophthalmicus in the right eye was determined to be medically significant. Additional information has been requested.
breaking out in sweats; Sore throat; Sore arm; Low grade fever; difficulty breathing (kind of shortness of breath) - labored breathing; Dry cough; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing), COUGH (Dry cough), HYPERHIDROSIS (breaking out in sweats), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing), COUGH (Dry cough), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever). On an unknown date, the patient experienced HYPERHIDROSIS (breaking out in sweats) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Feb-2021, COUGH (Dry cough) had resolved. On 16-Feb-2021, DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing) and PYREXIA (Low grade fever) had resolved. At the time of the report, HYPERHIDROSIS (breaking out in sweats), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   This case was linked to MOD-2021-015147.
Patient received vaccine past the beyond-use-date, and past the 14-day stability date (off-label). Recommended revaccination. No adverse events reported.
Currently no adverse effects. 1 year old patient was given adult dose of Hep  A Havrix adult dose  instead of pediatric dose. Questions we have are what are possible side effects?   After reading  CDC guidelines it appears to not have contraindications. Will the patient need a second dose?
a mother states her child got her shots on 04/06/01, Hep B #2, Hib #2, IPV #2, and Prevnar #2. At approximately 2 - 3 PM the infant had an elevated fever of 103, relieved with Tylenol and lasted 3 days, appetite decrease, and diarrhea and rash generalized all over her body on 04/07/01. reported here today for care.
received the first dose /on December 9, 2020 /it has been 7 months since his first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 9th December 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On 14th July 2021, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it had been 7 months since the patient's first dose of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination. The pharmacist stated that, the patient would receive dose 3, 3 to 5 months after dose 2. The reporter consented to follow up.
Joint pain, shoulders became hard and tender to touch, ganglion cyst, inflammation behind the eyes. Was prescribed Gabapentin to keep swelling down by healthcare provider.
Fever, chills, extreme fatigue, severe pain at injection site that radiates up the shoulder to the neck and down the arm to the elbow causing limited mobility
A report received from a health professional on 10/22/02, concerning a male vaccinee in his 70's who experienced diarrhea on 10/18/02, after receiving the Fluvirin vaccine on 10/18/02. That evening he developed "watery stools" every 2 hours which was persisting at the time of the report. The vaccinee has not recovered. The reporter has assessed the relationship of the medication to the event as unknown. Cross reference with PJP20020537.
Redness, warmth and induration (approx 3x3 inch) at injection site.
Vertigo, dizziness & nausea started 3 1/2 days after the first dose. Began at 2 AM in the morning on Feb. 14, 2021. Using meclizine 25 mg tablets 1-2 times a day since then. Had telemed conference with Dr, on Wed., Feb. 17, 2021. ENT appointment scheduled for April 2, 2021. Vertigo continues. Covid 19 (Pfizer vaccine) #2 on March 3, 2021.
Atrial Fibrillation.  Heart Rate was 160bpm for 4 hours. Treated at Hospital, Emergency Department.  Several months later suffered Capillary Brain Bleeding which caused severe Diplopia in the Left Eye.  Unable to see or woek for 3 months.  Treated at Hospital.  Ongoing Atrial Fibrilation now being treated with Eloquis blood thinners.
Pfizer bivalent given as dose one of COVID-19 series. Mother notified. No adverse reaction noted. Nurse who administered vaccine counseled on CDC covid-10 schedule.
Since shot on 10/14/04 left arm has been very sore at night time, symptoms: lying on back or site with left arm up it will ache a lot. Pain will extend down arm and into hand during nighttime. Through Dec04 arm seems to have bothered more and disturbs sleep some nights.
PATIENT RECEIVED J&J COVID VACCINE ON 4-11-21 AND REQUESTED  (AND RECEIVED) A PFIZER DOSE
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 16:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19; Positive, notes: Positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: If vaccine received: Yes, Other medication in 2weeks: No. Anti viral details: Paxlovid for COVID 19 Treatment,Treatment start date was 21Sep2022 and stop date was 25Sep2022.  Follow-up attempts are completed. No further information is expected.
More than 36 days after first dose without receiving 2nd dose; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after first dose without receiving 2nd dose) and LYMPHADENOPATHY (swollen lymph nodes ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after first dose without receiving 2nd dose) and LYMPHADENOPATHY (swollen lymph nodes ). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after first dose without receiving 2nd dose) and LYMPHADENOPATHY (swollen lymph nodes ) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.
Vaccinated with Pfizer COVID19 on 07/28/21 and 08/18/21. Presented to ER on 12/26/21 with COVID19. Presented to the ed with 3 weeks of shortness of breath found to have NSTEMI, acute CHF, and covid positive. Labs remarkable for BNP >3000, troponin 15. SCR 2.4. patient doing well on room air and dexamethasone and remdesivir held. CXR with cardiomegaly. Nephrology consulted for new AKI on CKD. Cardiology consult; rec cath but patient declining due to risk of worsening AKI/CKD, patient agreeable to stress. Currently awaiting d/c of covid precautions for stress test. Patient underwent cardiac PET scan done suggestive of mild ischemia. Patient was offered cardiac catheterization which patient declined stating for now he will continue taking medications and follow up with cardiology in the office.   Prior to discharge patient was feeling back to baseline health and did not need any oxygen.  Discharged on 1/5/22
No additional AE; temperature excursion; This non-valid, spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-NOV-2020, the patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# 1676322, expiration date 21-APR-2021, and lot# 1684149, expiration date, 25-JUN-2021, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# 1637648, expiration date 19-JUN-2022, and lot# 1637651, expiration date was reported as 30-JUN-2022, but upon internal validation established as 09-JUN-2022, hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# R034382, expiration date 04-JUN-2021, hepatitis a vaccine, inactivated (VAQTA) lot# S034358, expiration date 11-JAN-2021, and lot# T014835, expiration date 17-JUL-2021 and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot# S029542, expiration date 10-JUN-2021 (exact doses, site and route of administration were not reported for any); all for prophylaxis.  Administered doses of vaccines underwent a temperature excursion of 34.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Data logger was involved. No additional events were reported.
Pinched middle finger, got a 1/4 diameter blood clot under skin.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 12:00 (Batch/Lot Number: er8735) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The most recent COVID-19 vaccine was administered in facility. The patient experienced pinched middle finger, got a 1/4 diameter blood clot under skin on 09May2021 13:00. Patient was scheduled to go there tomorrow for the second dose. Had an accident yesterday and pinched the right middle finger. Usually when that happens, he gets a boil and it fills with a clear liquid pus. This time, it turned into a giant blood clot, well not giant but about a quarter inch in diameter in the tip of his finger. He has never had that happen before. He may have never damaged his finger in that way before. That is why it turned into a blood clot and not clear fluid. Patient was worried a little with the blood clot because he knew it has been an issue. When he first got a little worried about the blood clot, he thought he would take 2 aspirin and it might thin the blood a little bit. Patient ate some pineapple because he heard that was a blood thinner too. No treatment received for event. The patient underwent lab tests and procedures which included nasal swab: negative on 10Jun2020. Outcome of the event was unknown.  Information on lot/batch number was available. Additional information has been requested.
I felt a tingling sensation between my chin and my lower lip, it got a little swollen.  It lasted two days. I also felt heat all over my face where my mask used to be, it lasted several minutes.
3.19.21:Dry mouth started 30 minutes after receiving vaccine. Felt sick/drugged and dry mouth for 6 hours.  Sensation lessened in next 3 hours. Slept and no symptoms 3.20.21 3.26.21: Soreness in muscle area, about 2 x 1 inch square patch about an inch below injection site on left arm.  Soreness continued 3.26.21 to 3.28.21 evening when sore area became a red blotch that itched. 3.29.21: Applied over the counter steroid cream over area in morning and site no longer itched. 3.30.21: Red blotch area no longer red nor itchy.
stroke level blood pressure; stroke level blood pressure; some strange cardiology and neurology issues; some strange cardiology and neurology issues; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (medically significant), HYPERTENSION (medically significant), outcome "unknown" and all described as "stroke level blood pressure"; CARDIAC DISORDER (non-serious), NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown" and all described as "some strange cardiology and neurology issues"; TINNITUS (non-serious), outcome "unknown". The events "stroke level blood pressure", "some strange cardiology and neurology issues" and "tinnitus" required physician office visit. Clinical course: Patient felt very strongly that she was having some strange cardiology and neurology issues since getting her vaccine last year. She received a Pfizer vaccine. She has visited some local physicians that have all dismissed her symptoms as unexplainable and told her there was nothing else to be done. Her symptoms range from stroke level blood pressure to tinnitus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On a date in 2012 an expired dose of INFLUENZA, 0.2 cc of MedImmune/Lot Number YK 2015, was nasally administered to an eight year old child. The vaccine lot expired at midnight on a day before, 2012. The vaccine was provided at a public health department during a walk-in clinic. The public health nurse responsible for the medication error mistakenly selected an expired vaccine which had been set aside in the immunization refrigerator. At the time, the expired MedImmune vaccine (two boxes) was banned together by the immunization nurse-coordinator and isolated from the active seasonal INFLUENZA vaccines. In addition, no other lot of non-expired MedImmune vaccine was available and the parent specifically requested MedImmune to avoid the injectable route of administration. The selection of an expired medication is the medication error. In the future, expired vaccine will more clearly be identified and removed from the general vicinity of non-expired vaccines. Current refrigeration storage of vaccine make these improvements possible. In addition, the public health nursing staff will received reminder training on checking all vaccine lot expiration date before administration of immunization, which is standard operating procedure established in the department's policy and procedure manual. The Division of Public Health Immunization consultant and the local public health department medical advisor were consulted regarding the medication error. The invalid dose of MedImmune has been documented in the Immunization Registry. The parent was contacted by the Health Officer regarding the medication error and the recommendation to re-vaccinated the child in 30 days (as MedImmune is a live-virus vaccine). The health department administrator will contact the parent (about a month after) regarding the revaccination.
Insomnia/couldn't sleep; Felt weird; Anxious; This case was reported by a nurse via sales rep and described the occurrence of insomnia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced insomnia, weird feeling and anxiety. On an unknown date, the outcome of the insomnia, weird feeling and anxiety were unknown.   It was unknown if the reporter considered the insomnia, weird feeling and anxiety to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient could not sleep, insomnia, felt weird and anxious. The reporter consented to follow up.
This spontaneous report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication protection against seasonal influenza virus on unknown dates, Batch no: U57507, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced administered an AFLURIA dose that was exposed to temperatures down to 34 F for about two hours/medication error (non serious, outcome: Resolved). No adverse reaction has been reported since administration. Action taken: discontinued. Event treatment: #Details manually to be entered#, Rechallenge/Dechallenge information: #Details manually to be entered#. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#.
Patient is 3 months from having second Moderna shot. Although this is far out and he has a history of CVA's, the number of people coming in with PE/DVT/CVA/cardiac arrest around 3 months after their second shot is ALARMING. It needs to be investigated. Patient had CVA 10/2020 and was on clopidogrel, statin, and aspirin. He was driving and became disoriented and had tingling and weakness to L side. RN in ED notes mild LLE drift. Cannot walk due to L leg weakness. CT head negative for bleed however has  history of intracranial hemorrhage. TIA vs CVA. No IV TPA. Medical management.
EXPIRED HIB VACCINE GIVEN TO PT. WILL ORDER A PRIVATE HIB TO REVACCINATE PT IN A MONTH
59 yrs old female with a medical history of mild asthma and migraines. Patient report feeling chest thingness 5-10 mins after getting the Pfizer booster. She denies any other medical symptoms.  vitals : 161/96, HR 86, pulse ox 99%. patient was observed and check during approx. 15 minutes, vitals and physical exam stables. patient report feeling better, patient was offered to be transfer to hospital if she continue feeling the thingness. Patient report feeling better and refused the offered to go to hospital.  She felt comfortable going home. recommended to call her doctor or go to ED if she does not feel well. No other concerns or symptoms were reported.