chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose received 2 hours after the 6 hour vial puncture expiration; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose received 2 hours after the 6 hour vial puncture expiration) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose received 2 hours after the 6 hour vial puncture expiration). On 23-Mar-2021, EXPIRED PRODUCT ADMINISTERED (dose received 2 hours after the 6 hour vial puncture expiration) had resolved.        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.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 041L20A)  with no associated AEs.
Pt arm is red and tender 2 days post injection. States after working out redness has become less defined but more spread out. Pt does not complain of any other symptoms besides the local reaction. Pt will continue to monitor injection site and will report back to us in a few days if it does not improve.
This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways, from a contactable consumer reporting for herself. This female patient of an unspecified age (currently 72 year-old) received a single dose of a pneumococcal vaccine (unknown trade name) and a dose of P13 haemophilus influenza vaccine, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced anxiety. She recovered on an unspecified date. Pfizer is a marketing authorization holder of pneumococcal vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.
Inflammation in left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 29-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in left arm) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLAMMATION (Inflammation in left arm). At the time of the report, INFLAMMATION (Inflammation in left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Details regarding concomitant and treatment medications were not provided.
Continued tingling in right arm from elbow up to jaw with feeling of pressure on right shoulder from first dose. Now additional feelings of electrical shocks in arm from elbow to jaw. Also, pain radiating down right leg  with feelings that inside of leg is being pulled from ends of hip to ankle and twisted at the same time.  Unable to stand for more that 1-2 minutes with extreme pain.  Seeked treatment with Primary Care Physician and specialist Dr. At examination, determined that I had no reflexes on my entire right side and sent for Cervical MRI and Lumbar MRI.  Diagnosed with Cervicalgia, Myalgia, Spondylosis with radiculopathy, and prescribed Gabapentin, 300mg, 3xday and a transforaminal epidural steroid injection under fluoroscopic guidance.  If this does not find relief, my primary will refer me to a neurologist.
Fever to 103 on 11/13/02. Varicella like rash on 11/15/02
Behavioral changes. Aggressive. Fatigue-sleeping longer. Re-started napping. Then developed congestion and cough. Sib (+) H1N1 flu. Treated for sinusitis 11-05-09.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORUMLA,
Had a ache and ear ache on right side of head i also felt some small bumps on head. went to urgent care on 18 and they said it was a build up wax and got it treated with ibuprofen . head still ache and bumps got worse. on the 20TH  i went back to urgent care because symptoms got worse with shoulder and neck ache. I was diagnosed with shingles.
INJECTION SITE HAS LARGE, RED, RAISED SPOT WHICH IS HOT TO TOUCH.
DTAP given, but expired 06/10/2023. Spoke with parent. No adverse events at this time, but will continue to follow.
Given 4 month vaccines as per guidelines. Swelling in right thigh 4 hours later.
A little bump at the injection site/ golf ball size; A little itchy at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (A little bump at the injection site/ golf ball size), VACCINATION SITE PRURITUS (A little itchy at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE NODULE (A little bump at the injection site/ golf ball size), VACCINATION SITE PRURITUS (A little itchy at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE NODULE (A little bump at the injection site/ golf ball size), VACCINATION SITE PRURITUS (A little itchy at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  Treatment information was not provided.
Began to have problems with diarrhea; Had some achy joints and felt tired the next day; Had some achy joints and felt tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Began to have problems with diarrhea), ARTHRALGIA (Had some achy joints and felt tired the next day) and FATIGUE (Had some achy joints and felt tired the next day) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), ATENOLOL and SIMVASTATIN for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ARTHRALGIA (Had some achy joints and felt tired the next day) and FATIGUE (Had some achy joints and felt tired the next day). On an unknown date, the patient experienced DIARRHOEA (Began to have problems with diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTOBISMOL) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Began to have problems with diarrhea) had not resolved and ARTHRALGIA (Had some achy joints and felt tired the next day) and FATIGUE (Had some achy joints and felt tired the next day) 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.
This case was considered medically important (OMIC). Information regarding Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a consumer regarding a 4 year old male patient who experienced autism. At 14 months of age, the patient received the fourth dose on 1/9/2002. The patients concurrent illness include gastrointestinal disorder (since birth) and anxiety. Indication for Hib titer vaccine was immunisation. Product was administered on 1/9/2002. Dose regimen was 1 dose 1 time per day intramuscular. Previous dose of Hib titer vaccine was administered first dose 12/12/00, second dose 2/2/01, third dose 4/6/01. Concomitant medications included Fluoride, Flintstones multiple vitamins (vitamins nos) and Miralax (macrogal). The patient was diagnosed with autism in Aug 2005. Since the diagnosis, the patient has received Prevacid 15 mg daily for ulcers in small bowl and Prozac 8mg daily for anxiety and overall behavior. As of the date of the report, the patient has not recovered. No additional information was available at the time of this report.
Flushed; HEADACHE; Fatigue; chills; This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Flushed), HEADACHE (HEADACHE), FATIGUE (Fatigue) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary sarcoidosis on 15-Jun-2015. Concurrent medical conditions included Iodine allergy, Penicillin allergy, Drug allergy (Sulfa drug allergy), Drug allergy (Compazine) and Food allergy (Shell fish). Concomitant products included MOMETASONE FUROATE (NASONEX) from 15-Jun-2000 to an unknown date for Allergy, POTASSIUM from 01-Jun-1990 to an unknown date for Hypokalemia, CYANOCOBALAMIN (B 12) from 15-Jun-2015 to an unknown date for Nutritional support, PREDNISONE from 15-Jun-2015 to an unknown date and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jun-2019 to an unknown date for Pulmonary sarcoidosis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FLUSHING (Flushed), HEADACHE (HEADACHE), FATIGUE (Fatigue) and CHILLS (chills). In February 2021, FATIGUE (Fatigue) and CHILLS (chills) had resolved. At the time of the report, FLUSHING (Flushed) and HEADACHE (HEADACHE) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that she was fatigued for 3 days with chills no fever.  No treatment drugs were reported
Pt lost ability to ambulate with his walker.  Extreme weakness.  Fever.  Flulike body aches.
AFTER RECEIVING 2nd DOSE PFIZER-FELT SUDDEN ONSET OF HEADACHE .  COMPLAINED OF NAUSEA.  COLD COMPRESS APPLIED TO FOREHEAD AND BASE OF NECK (OCCIPITAL). NAUSEA SUBSIDED, HEADACHE IMPROVED.  BOTTLE OF WATER PROVIDED AFTER 10 MINUTES.   INDIVIDUAL WAS OBSERVED TO HAVE CONSUMED LUNCHABLE, MOUNTAIN DEW, POTATO CHIPS, AND SWEDISH FISH CANDY IMMEDIATELY POST VACCINATION.  SIGNS AND SYMPTOMS DEVELOPED WITHING 10 MINUTES AFTER FOOD CONSUMPTION.
No Adverse event. Patient's mother reports administration error. Says injection was given too low on arm below deltoid.  Mother showed red mark on patient's arm when came back to report was below deltoid about midway between shoulder and elbow.
3/3/22  5:30 pm  Increasing soreness in left arm at injection site.                     9:00pm  Went to bed - just didn't "feel right"                                        During the night woke up with fever and generalized muscle aches ( flu like symptoms)  3/4/22   6:00am   Flushed, fever, red face, arm soreness, generalized muscle aches, swollen underarm glands on left side, massive headache. Slept off and on all day - did not get out of bed.   3/5/22    No fever, no flushed face. Swollen underarm lymph gland remains sore. Extremely tired. 3/6/22   Underarm lymph gland still enlarged, no fever, arm is not sore 3/7/22   Underarm lymph gland still sore but lessening 3/8/22   underarm lymph gland still enlarged but not sore
EXCESSIVE CRYING 4-5 HOURS AFTER VACCINATIONS WITH FEVER (100 DEGREE), REDNESS AND SWOLLEN AT INJECTION SITE.
Patient stated that she received her first does of Moderna Covid-19 vaccine and ill that evening. She complains of generalized malaise, muscles aches, pain, and nausea.
Information has been received from a pharmacist concerning a 68 year old male patient with medical history of diabetes and hypertension and without drug reactions/allergies. On 21-APR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K023624, expiration as 19-FEB-2016, dose, route were unspecified). Concomitant medication included unspecified diabetic and blood pressure medications. The patient came back to the pharmacy on 23-APR-2015, because there was red, raised, itchy, quarter sized area around the vaccine injection site (start date April 2015). The pharmacist reported that there was no rash present. No lab diagnostic studies were performed and no treatment was given for the events. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.
SWELLING AND REDNESS AROUND SMALLPOX VACCINATION SITE; QUICKLY SPREADING.
(12/9) 4:30P in afternoon experienced a certain tightening. Could still talk and use my jaw but by 9:30 my jaw seized up. Stayed like that for 2-3 days and on the 10th saw a dentist and was diagnosed with TMJ. Found that it may be attributed to chewing gum for 6-10hrs a day. Issued Ibuprofen for treatment but never picked up prescription. Took Advil 400mg to help with pain. Will be following up to get a mouth guard to help with TMJ.
side effects from the Parkinson's medication; diagnosed with Parkinson's disease; a worsening on the tremors more on her hands and her thumb; got off balanced; This spontaneous case was reported by a physician and describes the occurrence of PARKINSON'S DISEASE (diagnosed with Parkinson's disease) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkwon) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood and Tremor (1 year ago patient started with tremors but on Jun 2021 patient experienced a worsening on the tremors more on her hands and her thumb and she got off balanced). Concurrent medical conditions included Parkinson's disease (2 months ago patient was diagnosed with Parkinson's disease) in June 2021, Diabetes and Hypertension. Concomitant products included APIXABAN (ELIQUIS) for Clot blood, CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA) from 14-Jun-2021 to an unknown date for Parkinson's disease.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced PARKINSON'S DISEASE (diagnosed with Parkinson's disease) (seriousness criterion medically significant), TREMOR (a worsening on the tremors more on her hands and her thumb) and JOINT DISLOCATION (got off balanced). On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects from the Parkinson's medication). At the time of the report, PARKINSON'S DISEASE (diagnosed with Parkinson's disease), TREMOR (a worsening on the tremors more on her hands and her thumb), JOINT DISLOCATION (got off balanced) and ADVERSE DRUG REACTION (side effects from the Parkinson's medication) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications are reported.  There was no information on lot numbers on the patients vaccination card.  Patient would like to receive a third dose .  One year ago patient started with tremors but on Jun 2021 patient experienced a worsening on the tremors more on her hands and her thumb and she got off balanced  Company Comment : Based on the current available information a temporal association between the use of the product and the start date of the events is unlikely, however, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the start date of the events is unlikely, however, a causal relationship cannot be excluded.
This form is to report that a vaccine shot was mistakenly administered to a person , info above) that was under the age of 18 y/o by me.  There were no adverse reactions, allergic reactions, or any symptoms other than mild soreness at the injection site, confirmed with the individual receiving the vaccine.
I know that took it got it/suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine and got the shingles, so the patient said that do not take the shot everyone, as the patient knew that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.   No treatment information was provided.
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional by phone. This case involves a 12 years old female patient who was vaccinated with two doses (first and second dose) of MENACTRA and ADACEL on 28-Nov-2017 and 21-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was vaccinated with HPV vaccine on 21-Jan-2019. On 21-Jan-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6143AA, expiry date: 22-Feb-2019) via intramuscular route in the left arm. On 28-Nov-2017 she also received a 0.5 ml dose of the same vaccine (lot number: U5823AB and expiry date: 22-Feb-2019) via intramuscular route in the left arm. On 21-Jan-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6104AA, expiry date: 02-Nov-2020) via intramuscular route in the left arm. On 28-Nov-2017 she also received a 0.5 ml dose of the same vaccine (lot number: C5228AA and expiry date: 26-Jun-2019) via intramuscular route in the right arm. It was also a case of actual medication error due to extra dose administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by the sender: none.
20 hrs after vaccination; mild fatigue, mild headache, mild chills, upper arm pain and weakness (unable to lift arm above head) 2-5 days after vaccination;  moderate upper arm pain, MODERATE GRADE 3 FATIGUE, MILD TIGHTNESS IN CHEST, mild chills, mild aching-symptoms felt identical to seasonal allergy flare except no cough, itchy eyes, or nasal congestion 6-10 days after vaccination, all side effects resolve except mild upper arm pain 11-14 days after vaccination, tenderness in upper arm (unsure if related to vaccination)
Pt also had a reaction to the first dose.  Pt onset approximately 10 minutes after receiving the vaccine with c/o generalized itching and throat irritation.  VS 112/76 HR 84 RR 20 SPO2 97%on room air Pt had taken Benadryl 50 mg prior to immunization at 1415 Prednisone 40 PO given at 1515  VS 76-20  117/76 1540-119/80 79-20, pt continues to c/o itching, jittery, and throat feeling scratchy.  Resps even and regular.   1545-She was evaluated by facility medical director who deemed her fit to return to home and f/u with ED if symptoms worsened and to take additional Benadryl 50 at 1815.
I had vaccination on 03/29/2021. On 03/31/2021 my colon started to flare-up. I took some Ibuprofen. It cleared up but started to flare-up with my Diverticulosis every 3 weeks thereafter.  I hadn't had a flareup in over a year prior. I would usually go a year or 2 without a flare-up prior to this vaccination.  This is excessive for myself and my diverticulosis.