chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:51 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2021-405858 (Patient Link).
Felt a bit sore at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Felt a bit sore at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (Felt a bit sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Felt a bit sore at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information and concomitant medications reported.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-030354 (Linked Report).; Sender's Comments:  MOD-2021-030354:crosslinked by reporter
Pt recvd 1st dose of Hep B vax 18AUG(2 & w/in 36 hrs devel aseptic meningitis & was hospitalized; sx consisted primarily of severe h/a & stiff neck; MRI was performed & was shown to have a communicating hydrocephalus; had no neurologic sx;
Narrative:  75yo male with the following problem list: PROBLEM LAST MOD PROVIDER HTN - Hypertension (SCT 38341003) (ICD-10-CM 08/13/2021 I10.) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 08/13/2021 Gout (SCT 90560007) (ICD-10-CM M10.9) 08/13/2021 Tobacco user (SCT 110483000) (ICD-10-CM Z72.0) 08/13/2021 Squamous cell carcinoma of tongue (SCT 08/13/2021 276952000) (ICD-10-CM C02.9) Aortic valve stenosis (SCT 60573004) (ICD-10-CM 08/13/2021 I35.0) History of aortic valvuloplasty (SCT 08/13/2021 119481000119105) (ICD-10-CM Z98.890) Hearing loss (SCT 15188001) (ICD-10-CM H91.90) 08/13/2021 Had not been under facility care until 7/2021 with new cardiac diagnosis. Pt had self presented to outside community emergency facility on 8/20/21 due to chest pain & difficulty breathing. Pt then died at this hospital on 8/20/21. Pt had received a covid vaccine on 2/18/2021 at a outside source. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Redness, swelling, tenderness, itching, and fever at injection site and up to 4 in diameter around site.
Patient noticed swelling on 05/26/2011 late evening around 9.00 pm and started putting ice pack. On Saturday and Sunday pain got worst and patient went to ER and got oral antibiotic and pain medication RX from DR. Her swelling is in control with meds today on 06/01/2011.
Pt developed symptomatic Ventricular Tachycardia and was converted to NSR with 150 mg IV amiodarone.  ECHO at ED revealed 45% EF, consistent with myocarditis.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 15-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 232 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cough  Fever, unspecified fever cause  Loss of taste  Loss of smell  Nasal congestion  Acute nonintractable headache, unspecified headache type
About 2 to 3 days after moderna vaccination, patient had rash with flu-like symptoms, headache, fatigue and a temperature of 100.2 F. Rash started from the neck down to the trunk.  Patient did not used any medication to relief  the symptoms. Patient sought consult to to her Primary Provider who did a covid test which was negative and did some blood works which was also normal. Provider told her it is just hives and she has swollen lymph nodes.  She also claims that Provider did not mention if her symptoms could be due to the moderna vaccine administered to her.  Symptoms lasted about a week and resolved spontaenously
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours, on 16-JAN-2012 at 7:30 and 17-JAN-2014 at 7:30, the vaccine was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 18-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
redness and swelling of eyes; redness and swelling of eyes; Bottom lip is swollen; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at single dose for Covid-19 immunization. The patient Medical history was not reported. Concomitant medications included Botox, 2 days prior to the vaccination. The patient experienced redness and swelling of eyes, Bottom lip is swollen. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-OCT-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
p/vax pt awoke w/ c/o nausea, T101.5 oral;seen by MD but said not to be r/t td;
soreness; phantom smell; Red spots in vision; Irritated brain; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness), PAROSMIA (phantom smell), OCULAR HYPERAEMIA (Red spots in vision), IRRITABILITY (Irritated brain) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (soreness), PAROSMIA (phantom smell), OCULAR HYPERAEMIA (Red spots in vision), IRRITABILITY (Irritated brain) and FATIGUE (Tiredness). At the time of the report, PAIN (soreness), PAROSMIA (phantom smell), OCULAR HYPERAEMIA (Red spots in vision), IRRITABILITY (Irritated brain) and FATIGUE (Tiredness) 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.    No Treatment medications was provided by the reporter.    Reporter did not allow further contact
This spontaneous report as received from a medical assistant, refers to multiple patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Covid vaccine was given approximately at 9:15 am. Symptoms started approximately 5 minutes after injection.  Patient stated that it was hard for him to breath.  Stated he felt weak.  Patient continued to talk to nursing team and was alert.    BP was 150/84- .  0.3mg Epinephrine was given in left thigh.  Ambulance was called at 9:25 am. Ambulance arrived at approximately 9:40 am and left with patient approximately 9:50 to transport to  ER.
Patient developed hives all over body.  Symptoms began today (8/17/23) at lunch, on his left arm, then started to spread.  Is very itchy.      OTC Benadryl 12.5mg/5mL, 20mL admin in office @ 1:45pm, 8/17/23.    Prescription for Prednisone 10mg tablets, tapering dosing over next 5 days sent to pharmacy for patient.
dizzy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and DIZZINESS (dizzy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (not reported).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and DIZZINESS (dizzy). At the time of the report, FATIGUE (Tired) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068593 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068593:
Varicella Pneumonia; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for varicella pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event varicella pneumonia was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, varicella pneumonia was determined to be medically significant.
Patient sat down in waiting area of pharmacy after receiving vaccine. Within a few minutes patient was feeling faint, lightheaded, and dizzy. Patient fainted and did not respond verbally for a few minutes. EMS was called. Within few minutes, patient came to and became responsive. EMS checked out patient and patient refused to be transported to hospital.
Pt standing in line following vaccine. Pt reports getting dizzy and slid down wall to floor (-) head trauma. Reports didn't eat prior to vaccine. Pt sitting/lying in bed eat and drinking. BP 83/44, MAP 54; HR 63; repeat BP wnl; pt started feeling better - BP 120/77; HR 80. SpO2 98%. No apparent distress. Patient stable, released from vaccination site and was recommended to f/up with HC provider. Mother able to take pt home; amb w/o difficulty.
They also stated that they got Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (They also stated that they got Covid) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1), Moderna covid-19 vaccine (Dose 4, booster), Moderna covid-19 vaccine (Dose 3, booster) and Moderna covid-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (They also stated that they got Covid). At the time of the report, COVID-19 (They also stated that they got Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. They did not have their vaccination card with them at the time of the call but they stated that they had 2 initial and 2 boosters, the last recorded was on 21-Apr-2022 but the latest one was not recorded as they did not bring the vaccination card with them. No treatment medications were reported.
Localized redness, warmth and tenderness at injection site about 6cm. Temperature max 103F.
SWELLING IN FILLER LIP ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; BURNING PAIN ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; HEADACHE; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; DIZZINESS; FELL DOWN; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included panic attacks. The patient was previously treated with hyaluronic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for panic attacks. On APR-2021, the subject experienced fell down. Laboratory data included: Body temperature increased (NR: not provided) 99.5 F. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced swelling in filler lip on left side of upper lip from middle of lip to end of top lip. On 12-APR-2021, the subject experienced burning pain on left side of upper lip from middle of lip to end of top lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and low grade fever on 08-APR-2021, was recovering from muscle aches, and fatigue, had not recovered from burning pain on left side of upper lip from middle of lip to end of top lip., dizziness, and swelling in filler lip on left side of upper lip from middle of lip to end of top lip., and the outcome of fell down was not reported. This report was non-serious.
booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen; booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen) and EXPIRED PRODUCT ADMINISTERED (booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen) and EXPIRED PRODUCT ADMINISTERED (booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date). At the time of the report, PRODUCT STORAGE ERROR (booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen) and EXPIRED PRODUCT ADMINISTERED (booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Vaso vagal response with 1st covid vaccine  Vital Signs: HR 70 Resp 14 O2Sat 98  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  As a precaution, pt waited 15 min in triage area with RN. Juice and snack taken. Pt escorted to vehicle by RN without incident. Parents waiting. Pt denied symptoms with 2nd vaccine.  Pt denied symptoms of vaso vagal response. Tolerated 2nd vaccine without incident.
4 hours later shortness of breath. Rx Albuterol inhaler MDZ at home x 3 times. 10 hours later hives. Rx BENADRYL x 2 days. 12/10/2009 PCP record for 12/3/2009,  patient with c/o's rash and SOB.Local reaction at injection site Rx'd topical steroid oint, Albuterol inhaler. Dx Vaccine reaction.
Very achy; Stiff Muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very achy) and MUSCULOSKELETAL STIFFNESS (Stiff Muscle) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Penicillin allergy and Soy allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second 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 (Very achy) and MUSCULOSKELETAL STIFFNESS (Stiff Muscle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Very achy) and MUSCULOSKELETAL STIFFNESS (Stiff Muscle) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: significant follow up received on 16 JUL 2021, Patient Demographics, Vaccine information and event updated.
Increased body temperature (mostly torso) Headache/migraine Slight cloudiness/fuzziness in my head.
No additional AE reported; Nurse reported ROTATEQ was administered after a temperature excursion to a patient on Feb 23, 2023. No further information provided. No additional AE reported. No PQC reported.  Name of vaccine involved (including lot/exp): ROTATEQ (W029695 1/29/2024; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (formulation defaulted to oral liquid, route of administration defaulted to oral, exact dose was not reported) lot #W029695 was valid, expiration date 29-JAN-2024, for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered after temperature excursion. The vaccine was storage in temperature reported as 18 degrees Celsius for 3 hours 50 minutes. The vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had not previous temperature excursion, no additional adverse events were reported (product storage error) (no adverse event).  This is one of several reports received from the same reporter.