chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergies; a patient is given an undiluted vaccine dose; a patient is given an undiluted vaccine dose; Patient has had no previous doses of Covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 6-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 as dose 1 (orange cap), 0.2 ml single (Lot number: GK1657, Expiration Date: 29Aug2023) at the age of 6 years, in right deltoid for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Atopic dermatitis" (ongoing); "cough" (unspecified if ongoing); "wheezing" (unspecified if ongoing); "shortness of breath" (unspecified if ongoing); "allergy to eggs" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN HFA taken for cough, wheezing, dyspnoea (ongoing); EPINEPHRINE taken for food allergy (ongoing). The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 06Jun2023, outcome "unknown", described as "Patient has had no previous doses of Covid vaccine."; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 06Jun2023, outcome "unknown" and all described as "a patient is given an undiluted vaccine dose"; HYPERSENSITIVITY (non-serious) with onset 06Jun2023, outcome "unknown", described as "allergies". Additional information: The event a patient is given an undiluted vaccine dose was reported as serious (hospitalization). The patient was prescribed Fluticasone nasal spray for allergies and Acetaminophen to take as needed for fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 3:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:40 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.03 for dose administered on 02-Mar-2021 and 76.11 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 26, 27, 29, 32, 33, 35, 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A administered on 30-Mar-2021 underwent temperature excursion with temperature range of 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.
swollen glands plaque in the throat pain in the lower back fever dizziness tiredness nausia poor appetite  I didn't go to the doctor because I don't have insurance
No adverse event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    The concomitant medication was not reported by reporter. It was reported that, the patient received vaccine after the beyond use-by date. The treatment medication was not reported by reporter.
Lymphadenopathy in left axillary side, lasted until February 1st (4 days) Also experimented fatigue, malaise and  headache. Took Acetaminophen for pain.
Severe Nausea, Fever, Chills, Backache, Headache, Sore injection site.  Worst I've ever felt except when I had the flu. Symptoms lasted one day, except for fever and sore injection site. Those lasted 2 days.
Excessive redness swelling and pain at the injection site measuring over 8 inches across. needing Benadryl, a course of prednisone.
having some bleeding on the administration site of the vaccine; might have considered that they have hit a wrong vessel; This is a spontaneous report from a contactable Pharmacist reported for a consumer (patient). A 50-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had some bleeding on the administration site of the vaccine. The reporter wanted to get recommendations as to the administration of a possible third dose (it's safety and possible timing) to a patient who feared that they might not get the recommended dose to elicit full efficacy of the PFIZER-BIONTECH COVID-19 VACCINE following that her 2nd dose was administered on a manner where she bleed. Immunizing authority might have considered that they have hit a wrong vessel upon the administration of the vaccine, thus the bleeding on the patient's end. Now, patient was suggesting to have a 3rd dose as she was afraid that vaccine came out alongside with her blood. The reporter also gave an additional information that they would consider these events normal and not report this because on his own opinion, having some bleeding on the administration site of the vaccine didn't merely state that the vaccine/drug comes out of alongside with it. However, he only would like to be certain about this. The reporter wanted to know if patients receiving 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE who did not experienced any side effect should be concerned about vaccine efficacy. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a certified medical assistant (CMA) concerning a 4 year old male child with no medical history or drug allergies who on 30-JUL-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (LOT# "658137/0791U") into left thigh. Concomitant vaccines included diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV) (manufacturer unknown) into the left thigh and poliovirus vaccine (manufacturer unknown) into right thigh. On 31-JUL-2007 the patient developed an area of redness between injection sites on his left thigh that was about 4" diameter. The patient sought unspecified medical attention. No other symptoms were noted. The patient's present status was not reported. Additional information has been requested.
Cellulitis at injection site, admitted to the hospital; This serious case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received Shingrix (intramuscular, unknown deltoid). In MAR-2023, 6 days after receiving Shingrix, the patient experienced injection site cellulitis (Verbatim: Cellulitis at injection site, admitted to the hospital) (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotics Iv (Drug Name Unknown)). The outcome of the injection site cellulitis was resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.     It was unknown if the company considered the injection site cellulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter who was physician's office manager reported that a patient received shingrix in early March 2023 and 6 days after vaccination she developed cellulitis at the injection site (cellulitis, recovered).  The patient was admitted to the hospital for a few days and was treated with IV antibiotics. No further information was reported. The reporter gave consent to follow-up.; Sender's Comments:  US-GSK-US2023056835:Same reporter
The child complained of severe headaches, extreme fatigue, muscle aches and heaviness in arm/legs bilaterally. Symptoms persisted until 4/01 and slowly abated.
Seizure, temp of 103.2. No site reaction. Rx Tylenol and Motrin.
Symptoms: Hives and itchiness all over body, neck and face., started around 7: AM ( 1 day after shot). Treatment: Over the counter Cortizone 10 Anti- Itch cream.  Rash and itching stop at around 7:PM next day ( 2 days after shot)
An extreme headache began within 30 minutes.  A few hours later I started a low grade fever and vomited.  I slept most of the day.  The extreme headaches kept me from working for a total of five days.  When I went back to work, I struggled with painful headaches for the next week.  It was over two weeks before the headaches regressed to a manageable state and about a month before I got back to normal.
2nd injection mucle cramps in legs/ sick to stomach. Voice became hoarse 3rd shot light headed, abdominal pain kidney pains sick to stomach right hand could not write, muscle cramps, lump in throat. Low grade fever 96.5 stomach bloated last shot stomach got worse left abdominal hurt unable to eat/ problems with digestive, acid reflux.  Lost 30 lbs by end of last shot.  Have been to digestive Dr. Did a colon and stomach scoped test all negative. 1 year later abdominal pain, digestive problems, difficulty digesting foods,  ziphoid area is swollen and become worse with exercise. Muscle cramps in legs, arms, stomach area.  Seeing digestive disease doctor and going back to gastrointestinal Dr.
Aapproximately 2 pm on Saturday patient began feeling sick at her stomach, felt weak, complained of feeling light headed and felt as though she would pass out, low grade fever, and experienced hot/cold chills in the evening.  I told her it is probably normal and just a side effect of the shots. On Sunday morning felt a little better but still felt weak and is complaining of neck and headache pain and feels as though she will throw up if she turns her head.
SORENESS IN ARM; 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 ulcerative colitis, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.
Patient received two doses of sinovac, D1 4/2/2021 and D2 6/9/2021, patient received Moderna Dose 1 on 1/10/2022. patient came to get moderna dose 2 today.
chills, body aches, fever, stomach ache 11 1/2 hours after vaccine administered. Lasted for 36 hours. Took Tylenol 650mg Q4hrs as needed.
Information has been received from a certified medical assistant concerning a 75 year old female with asthma, sulfa, penicillin, Macrobid and Actonel allergy and a history of skin cancer in the past and pneumonia in the past who on 22-MAY-2007 was vaccinated intramuscularly with a 0.5 mL dose of the Pneumovax 23 (Lot # 655501/1035F). Concomitant therapy included Advair, ("ASTHMANEX"), LORTAB and PROVENTIL. On 23-MAY-2007 the patient developed cellulitis. The cellulitis was not at the injection site but underside of the same arm. There was no visible reaction on the injection site. At the time of the report, the patient had not recovered. The reporter requested a lot check. A Lot check of concern was requested. The records of the testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Pt. received  a dose of the Pfizer COVID-19 vaccine after completing Moderna COVID-19 Vaccine primary series.
Developed temp 101.2 on 12/30/2020.  Treated with Tylenol.  The following day, the patient complained of chest pain and was sent to ED for evaluation.  He was transferred to Hospital and admitted with altered mental status.  He returned to the Nursing Home on  01/01/2021 with no acute findings and has been stable since that time - Dx was lethargy and altered mental status.
12 noon received shot 4-25-17. 8 pm - metallic taste and severe nausea. Called 911 - Ambulance to E.R.
5 minutes after receiving the vaccine, she was having a venipuncture performed and she had a syncopal episode < 5seconds and vomited 4 times
Rash on right arm above elvow to middle of hand; All red dots and blotchy/spots around her elbow; Blotchy; Little Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on right arm above elvow to middle of hand), INJECTION SITE ERYTHEMA (All red dots and blotchy/spots around her elbow), RASH MACULAR (Blotchy) and DIZZINESS (Little Dizzy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Autoimmune disorder NOS and Heart disease, unspecified. Concomitant products included PREGABALIN, VITAMINS NOS, COLECALCIFEROL (D3), PROBIOTICS NOS, LEVETIRACETAM, ALPRAZOLAM, SERTRALINE, METOPROLOL SUCCINATE (TOPROL), VERAPAMIL, ZOLPIDEM TARTRATE (AMBIEN) and AZITHROMYCIN for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Jan-2021, the patient experienced RASH (Rash on right arm above elvow to middle of hand), INJECTION SITE ERYTHEMA (All red dots and blotchy/spots around her elbow), RASH MACULAR (Blotchy) and DIZZINESS (Little Dizzy). At the time of the report, RASH (Rash on right arm above elvow to middle of hand), INJECTION SITE ERYTHEMA (All red dots and blotchy/spots around her elbow), RASH MACULAR (Blotchy) and DIZZINESS (Little Dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was provided.
Patient received 2nd dose of Jynneos vaccine on the left forearm. Patient had a syncopal episode upon seeing the bleb at the site of vaccination. The episode lasted for about 10 seconds. Observation time was extended an additional 15 minutes and 3 sets of vital signs were taken all within normal limits. Bilateral lower extremities were elevated, ice packs were applied and water was provided. Patient expressed relief of symptoms and left the facility safely once the observation period finished.
Chest pain starting evening the day after shot. Peaked that night before slowly fading into the following day.
Patient started leaning over in chair 5-10 minutes after receiving shot. She was with her spouse who was helping her sit up straight.
Wheals appeared within about 3 hours of vaccination, involving only the face, neck, and chest.  No additional symptoms other than increased fussiness. Resolved spontaneously without treatment within about 24 hours.
2.5"x1.5" area of solid red, swollen skin, itchy. Resolved with Benadryl.
fever; body aches; sore arm; A spontaneous report was received from a consumer concerning a 42-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu like symptoms (fever, sore arm, and body ache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events flu like symptoms (fever sore arm, and body ache) and was treated with ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu like symptoms was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Woke up to itching and burning down neck, back and sides. Her psoriasis doubled and spread.
Rash at site of injection, itching, on 9/16 felt like she was being pricked at injection site, itching seems to be getting better on 9/17. Informed patient to try hydrocortisone OTC cream for a few days then go to MD if not better.
Information has been received from a nurse practitioner, referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9(strength, dose, anatomical location, administration route, lot number and expiration date were not reported); then, on 18-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) and finally on 22-DEC-2016, the patient was vaccinated with the third dose of GARDASIL 9 (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) all the doses used for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects were reported.
no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to an adult patient at the age between 19 and 24 years old. On an unknown date in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 23-OCT-2020. There was no reactions or problems with the patient. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA010526: US-009507513-1908USA010527: US-009507513-1908USA004659:
Fever, lethargy,extreme weakness, cough, sneezing, diarrhea, couldn?t eat or drink
103 fever, chills, arm pain at injection site, headache. Fever lasting 1 day, arm pain lasting 3-4 days.
Patient states she has a "dollar bill" size red area where she was given vaccine - states area is warm to the touch.
Pain and swelling in my leg, difficultly walking, sore ankle, shortness of breath, high blood pressure. I went to my podiatrist and he diagnosed my leg issue as deep vein thrombosis. Later, I was prescribed anticoagulants. Also, I am currently still dealing with shortness of breath. I went to my podiatrist and he diagnosed my leg issue as Deep Vein Thrombosis. Later, I was prescribed Anti-Coagulants. Also I am currently still dealing with shortness of breath.