chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like there was something stuck in my throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (felt like there was something stuck in my throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced THROAT IRRITATION (felt like there was something stuck in my throat). On 04-Mar-2021, THROAT IRRITATION (felt like there was something stuck in my throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was unknown
Later on I felt sleepy went to bed; Woke up having seizures; it felt like my arm was broken; Flu vaccine given on 16Nov2022; Flu vaccine given on 16Nov2022; received bivalent vaccine as dose 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:30 as dose 2, single (Lot number: Gh9703) at the age of 57 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 16Nov2022 at 10:30 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Several Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01; Manufacturer unknown, Lot number: unknown), for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The following information was reported: SOMNOLENCE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "Later on I felt sleepy went to bed"; SEIZURE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "Woke up having seizures"; UPPER LIMB FRACTURE (hospitalization) with onset Nov2022, outcome "recovered" (21Nov2022), described as "it felt like my arm was broken"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 16Nov2022 at 10:30, outcome "unknown" and all described as "Flu vaccine given on 16Nov2022"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 16Nov2022 at 10:30, outcome "unknown", described as "received bivalent vaccine as dose 2". The events "later on i felt sleepy went to bed", "woke up having seizures" and "it felt like my arm was broken" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of somnolence, seizure, upper limb fracture. Clinical course: Patient stated that he took both his covid and flu shot. Later on, he felt sleepy went to bed. Woke up having seizures and it felt like his arm was broken. Called ambulance and went to the hospital. They were so severe he did not know what happened in the hospital. Only being kicked out and told to go home while he was still having seizures. But they are over now 21Nov2022. Onset date and time of events were also reported as 16Nov2022 10:30 (possible discrepant; pending clarification)
Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients.; Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients.; This spontaneous safety report, was received by a partner on 14-SEP-2023 and forwarded to agency on 15-SEP-2023, from a health care professional.  Due to the nature of the event, the causality between the events "Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients." and Vaxelis was not applicable.  Further information is expected.
he got the first dose on Feb of 2021 and the second dose on April of 2021... I wanted to see if he needed to get a third dose now or if he needs to restart; No AE/PQC reported; This spontaneous report has been received from a consumer regarding to himself a 41-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unspecified date in February 2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (dose, strength, route of administration, anatomical location, lot number, and expiration date were not provided). On an unspecified date in April 2021, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  The patient would like to know if he needed a third dose or if he should restart the vaccination series.  No additional adverse event was reported.
I had diarrhea for 3 to 4 weeks after my 1st shot. My Dr scheduled a colonoscopy , but it took 3 months to get it and there was nothing to report
On 12/28/05 child complained of vesicle on back by 12/29/05.  Had 12-15 chicken pox vesicles on trunk.  By 12/30/05 had 10 more lesions over body.  Exposed to chicken pox at school.  Had Varicella vaccine 1/31/96.  Mom called here no need to see further medical attention.  Benadryl and Tylenol given.  Child had no fever, did not feel bad.  Child recovered.
Moderna 100 mcg/0.5 IM injection lot 012M20A Rash on upper arm on injection arm. Soreness, itchy ant hot. Rash on over half of arm.  Still there after 4  days. No treatment.
Pt received Rotavirus vaccine at well exam on October 11, 2013. On October 17, 2013, she developed vomiting and bloody diarrhea. She was seen at Hospital on October 18, 2013 and diagnosed with intussusception. Treated w/air contrast enema w/complete resolution.
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD from lot # M036295 with expiration date on 13-FEB-2018 and also the lot # reported as M040143 with expiration date on 27-MAR-2018 (strength, dose, route of administration and anatomical location were not provided), that were reconstituted with a sterile diluent (manufacturer unknown) (lot #, expiration date, strength, dose and route of administration were not provided) for prophylaxis. The storage temperature was reported as 6 to 14 degrees Fahrenheit (°F) (8 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA010489:
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344665, 2018SA344695, 2018SA344670 and 2018SA344689. This case involves a 71 years old female patient in which 0.5 ml of FLUZONE HIGH DOSE was potentially out of range for 7 days between 32 Fahrenheit and 47 F and exposed to freezing temperature (lot number: UJ006AA, expiry date: 14-APR-2019) via unknown route in the left deltoid on 04-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 sender: none.
Rash on my face 1 week after the Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of facial rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced facial rash. On an unknown date, the outcome of the facial rash was unknown.   It was unknown if the reporter considered the facial rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced rash on face 1 week after the Shingrix shot. No further information reported.
Pt recv vax on 2/2/99; post vax pt exp erythematous, warm area around DTaP vax site-rt arm
Chills; malaise; tenderness; This is a spontaneous report from a contactable Nurse (patient). A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: el9269) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient received the first vaccine dose and was supposed to get the second dose this past Monday, but she reports that when she told the doctor that she was sore in her arm from getting her Tetanus vaccine the doctor told her she needed to wait 14 days before getting the second dose. Patient stated that following her first dose of the covid vaccine she experienced Chills, a general malaise and tenderness to her left hand for 2 days. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
approx 11 days post vax pt began running a temp 10hr of temp;temp spiked @ over 104;given APAP;lukewarm bath-temp & feeling bad;
rash, feels like sandpaper; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (1st dose received on an unknown date, refer case US2021AMR237256).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient received vaccine shot and still got a rash.  The rash felt like sandpaper. For tolerance of 3rd dose refer case US2021AMR237273.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237256:Same reporter US-GLAXOSMITHKLINE-US2021AMR237273:Same reporter
The patient is a 8 year old female who has had 4 COVID vaccines (11/05/2021, 12/03/2021, 05/25/2022, 08/26/2022), and after #1 (7d), #2 (9d), and #4 (3d) had an ecchymosis-like rash on bilateral antecubital fossae. She didn't have a rash after the 3rd. The latest, 6 weeks after the initial rash she had another rash which was pruritic (unlike previous).
Extremely heavy period the month after receiving third vaccination of Pfizer. 16 year old daughter has only experienced light to average periods of 3-4 days in length. This month is having an extremely heavy period, combined with bad cramps. Currently is on day 5 of her period which is still rather heavy
pt recvd vax & 1-2 days p/vax exp pain & stiffness of lt shoulder & lt side of neck for 2 1/2 wks;
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves four year patient who received vaccination with FLUZONE QUADRIVALENT (batch number UT6259KA, expiry date 30-JUN-2019) intramuscular in left arm on 13 Oct 2018. It was a case of actual medication error due to vaccine underdose as children ages 4 years and up were inadvertently given the 0.25mL of FLUZONE QUADRIVALENT. It was unknown if any 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 holder's 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 sender: none.
Clinic nurse administered vaccine and had patient wait in room, mother yelled out and that clinic nurse responded and then yelled out for a doctor as patient had passed out. Doctor and second nurse entered room, patient had been sitting a chair so no fall occurred.  Patient was then awake but not responsive, vitals were taken and a Rapid response was called. Patient then came-to and asked what happened and had her sip on apple juice as she was pale. Rapid Response Team came and had her lay on the exam table. 15-20 mins later patient's color mostly returned and she felt well enough to walk out of the clinic when she was accompanied by a nurse.
This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 28th January 2019, less than an hour after receiving SHINGRIX, the patient experienced tiredness, muscle pain, injection site muscle pain and influenza-like symptoms. On an unknown date, the outcome of the tiredness, muscle pain, injection site muscle pain and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the tiredness, muscle pain, injection site muscle pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 years or 56 years. The patient received 1st dose of SHINGRIX in an unknown deltoid and within 1 hour ended up in bed for 4 hours. The patient experienced tiredness, muscle ache, pain in vaccinated deltoid, massive flu symptoms, and pain was worse after waking up from sleep. The reporter gave consent to follow up. The nurse did not want to give address or date of birth.
I started to get joint pain in the knees, ankles, elbows, and wrists. I got a rash on both of my forearms and chest. The rash went away, but I am still having joint pain ten days after the vaccination.
mom reports 15mins p/vax pt began to sneeze & itch; face became edematous & red; called 911 was transferred to hosp tx for allerg rxn;
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. The patient's past medical history included shingles (1st episode) and shingles (2nd episode in 2012). Previously administered products included ZOSTAVAX (in 2012, vaccinated 3 mos following resolution of 2nd episode). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, burning sensation, tenderness and insomnia. The patient was treated with gabapentin, TYLENOL, SKELAXIN and narcotics, nos. On an unknown date, the outcome of the pain in arm, burning sensation, tenderness and insomnia were recovered/resolved. The reporter considered the pain in arm, burning sensation, tenderness and insomnia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported localized pain he felt following SHINGRIX in his left arm. The healthcare professional said pain was 8 by 10 and described as burning, tenderness that lasted for 7 days. The healthcare professional stated he couldn't sleep the night he got the vaccine due to the pain. The pain decreased over the 7 days. The healthcare professional took TYLENOL 650 mg Q6 hours for 7 days, gabapentin 300 mg QD for 7 days, and SKELAXIN 300 mg QHS for 5 days. The healthcare professional stated SKELAXIN did not help with the pain but he still took it anyways in attempt to relieve pain. The healthcare professional stated he almost resorted to prescription narcotics for the pain but got some relief after receiving some ultrasound. The healthcare professional denied any other signs or symptoms of adverse events following vaccination, like redness or swelling. The healthcare professional stated the vaccine caused the adverse events but did not seek care at emergency room, did not require hospitalization. He was able to resume work 5 days post vaccination. He works part time and this did not affect his work schedule. The healthcare professional did not have information about vaccine lot number, expiration, date of administration on him. Waiting for his nurse to call back with this information. The healthcare professional stated this adverse event was reported by another GlaxoSmithKline employee but he didn't know the person's name.
no adverse effects; Temperature excursion; This spontaneous report was received from physician referring to a 4-month-old male patient. The patient's historical vaccine included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) on 05-FEB-2023 and 04-APR-2023, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on 04-APR-2023, pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) on 04-APR-2023 and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) on 04-APR-2023. Concomitant medications included colecalciferol (VITAMINE D), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). The patient's concurrent condition was not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion, and the vaccine was not viable according to manufacture. On 05-JUN-2023, the patient was vaccinated with the second dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968386, expiration date reported as 24-MAY-2024 but upon internal validation established as 23-MAY-2024, administered orally (PO) by a physician in private doctor's office/hospital for prophylaxis (strength and dose were not provided) (product storage error). The vaccine was purchased with public funds. Alarm believed to be due to sensory issues, and temperatures were monitored with back up logger. Temperature was in range, new data logger was currently in use. No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Soreness in my arm for a few days, exhaustion 3 hours after injection, and itchiness around the injection site around day 2
fever; This is a spontaneous report from a Non-contactable consumer. A elderly male patient (age not reported; above 65 years) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown, whether prior to the vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient had been tested for COVID-19. On 09Feb2021, the patient experienced fever. It was unknown, whether patient received any treatment. Outcome of the event was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Headache, body aches, nausea, chills, fever,constipation, Stomach gas
Hot red itchy area around injection site.  Arm has been sore for over a week now but just started with itching and burning on the site.
inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 071F21A and 033c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Past medical history of the patient including allergies (medications, food and other products) was unknown.  No concomitant medication was reported.  It was unknown if patient ever had COVID positive test or diagnosis.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was none.  It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  1 vial was involved. On 27-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment information was provided.