chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.55.  Concomitant medication was not provided.  On 31-Mar-2021, Excursion time was 9 AM and temperature was 32. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 30-Mar-2021 and was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46 and 4 PM: 44, 5PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when temperature data logger registered 34 or 35 degree F.  Treatment information was not reported.
Pt reported on 10/26/18 at 9;20am a hard itchy spot where the shot was given. She did not report it was painful.
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated on 17Feb2023 they accidentally administered 1 dose of the primary series of Moderna COVID-19 Vaccine after the manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient had no allergies. Patient had no relevant medical history.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated on 17Feb2023 they accidentally administered 1 dose of the primary series of Moderna COVID-19 Vaccine after the manufacturing expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated on 17Feb2023 they accidentally administered 1 dose of the primary series of Moderna COVID-19 Vaccine after the manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medication details was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated no Adverse events were reported. No treatment medication details was reported.
Patient administered Moderna vaccine with possible temperature excursion; Patient administered Moderna vaccine with possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine with possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine with possible temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine with possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine with possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine with possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine with possible temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
Resident stated her arm began to itch at 3:00 am on 1-26-21. Later, it became red. Red area on arm is oval-shaped and is 7.5 cm x 5.5 cm and is indurated. Resident states she has no pain, just itching.
4 year old patient was administered Flublok vaccine / no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1965 (Expiry date 30-Jun-2020) via intramuscular route in the left thigh on 01-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction 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.
Patient was at the pharmacy to receive a Flucelvax. Patient was given a Moderna in error. Patient received PFIZER on 9/9/2021
Had Td on 05/07/02-12non on 05/07/02 evening skin feel itchy. No rash present; 05/08/02, lower lip started to feel swollen and itchy; took Claritin. On 05/09/02 eye area started to feel itchy. Suggested to call physician. Denies any trouble breathing.
Patient developed body aches 2/08/21 and loss of taste. She is covid+ today.
Patient passed out shortly after vaccination, nursing staff attended patient, used an alcohol swap, patient came to, pulse rate taken (86), patient was in chair during the duration of this. Patient was given juice, water, snack and was laid at an examination table. Was assessed by a nurse and after the patient was cleared she was walked /escorted to her vehicle out of the vaccination site by a security guard.
Getting over a horrible case of shingles. Had both shots/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Getting over a horrible case of shingles. Had both shots/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received both the doses of Shingles vaccine.  The patient stated that you can still experience the shingles. The reporter reported that he or she just getting over the horrible case of shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
PATIENT STARTED HAVING A WARM, ITCHY, SLIGHTLY SWOLLEN ARM THE EVENING OF 10/25/2018. PRESENTED AT THE PHARMACY 10/27/2018. ADVISED PATIENT TO GIVE HER DOCTOR'S OFFICE ON CALL NUMBER A CALL TO LET THEM KNOW OF THE SITUATION AND SEE IF THEY WOULD LIKE TO EVALUATE/TREAT. PATIENT SAID SHE WOULD PHONE THE DCOTOR'S OFFICE.
My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and nausea the night of receiving the vaccine.  My second dose of the vaccine was 2/8/2021. I felt tired the night of receiving the vaccine and went to bed a 8pm. I woke up at 6:10am on the 9th with a severe migraine, severe nausea and dizziness. I ate a small amount and laid back down. I got out of bed at 9am and noticed both of my eyes and face were swollen and my throat was swollen. At this point I called my doctor and spoke to a nurse on the phone, she was short saying I needed to go to ER. Personally, I did not feel it was necessary at the time so I took a Benadryl and Ibuprofen. Throughout the day I continually got worse experiencing the same symptoms as the morning including sharp chest pain, restricted breathing, a low grade fever of 100.4, severe lower back pain and leg numbness. I took more ibuprofen and  placed heat on my back. I took ibuprofen PM and woke up the morning of the 10th feeling better. Still have headache, lower back pain and swelling but is better than yesterday. I will notify my doctor today of the event that occurred yesterday (2/9/2021).
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unknown patients of unknown age. On an multiple unknown dates, these patients were vaccinated with GARDASIL (lot # K010215, Exp: 05-MAY-2017). It was called because of Digital Data Logger. These vaccines were stored under 1.2 degree Celsius for one hour. There was no 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.
sore arm; sick; chills; throwing up almost everyday for a month; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (sick), CHILLS (chills) and VOMITING (throwing up almost everyday for a month) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 IN EXTREMITY (sore arm), ILLNESS (sick), CHILLS (chills) and VOMITING (throwing up almost everyday for a month). At the time of the report, PAIN IN EXTREMITY (sore arm), ILLNESS (sick), CHILLS (chills) and VOMITING (throwing up almost everyday for a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-242091 (Patient Link).
31 year old female patient received expired dose of Typhim VI vaccine with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via non-healthcare professional via Global Medical Information (Reference number- 00852442).  This case involves a 31-year-old female patient who received expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI], (expired product administered).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number not reported and expiry date: 11-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Caller states that a doctor's office contacted them today (11/10/2021) because they had administered Typhim VI which expired a month ago (10/11/2021) to a 31 year-old female patient. Pharmacist has no other information about patient or event. Pharmacist states that the doctor's office administered the immunization, but vaccine was expired when this pharmacy dispensed it".   It was not reported if the patient received a corrective treatment.  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 the 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.  There will be no information available on the batch number for this case.
Shot given strangely high upon arm at shoulder level- pain immediate, & continued to worsen. Went to MD now 1 mo later still cannot raise arm & arm in pain.
Vomiting, abdominal pain, loose stools. Resolved within 24 hrs.
Erythema, warth, induration from just below shoulder to mid lower arm develpoed the night after vaccine was given.  I saw the patient the following morning, diagnosed him with cellulitis, and started Keflex 500mg 4/day for 7 days.  Note that vaccines from 2 lots are listed below--this is due to the first lot was a multidose vial that did not have enough for a full dose in it.  This was wasted and a single dose vial (second lot #) was used, but was drawn up in the same syringe as the first vial/lot.
Fever + rash first noticed 3-20-04. Treatment with Aveeno, Benedryl
Prior to vaccination, patient stated that she always "passes out" when she receives vaccinations, but it had been several years since her last vaccine.  About 5 minutes after receiving vaccine, patient appeared to have seizure-like response with stiff body posture, eyes wide open, and unresponsive for about 10-15 seconds.  When patient became responsive, she was unaware of what had just happened.  Patient was follow-up with the next day, and stated that she was fine.  Patient was encouraged to contact her physician for follow-up.
Entire left arm became severely swollen, red, hard, warm to touch.  This gradually subsided over the course of the next 5 days.
The Lot Number might read: 039B21A. The label is not entirely clear about the first character.  I had mild chills and fever, off and on, in the evening of the first dose, and I noticed chills on the next day, at times. Normal injection site pain, with only mild swelling, upper right arm. General, mild fatigue and feeling rather wiped out. Started a persistent very painful headache about an hour after the vaccination, front of forehead, which has not subsided as of 4/18/21. This is, to the best of my knowledge the only symptom remaining. OTC pain medication does very little to help with the pain.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was vaccinated with a booster dose (0.25mL) of Moderna Covid-19 vaccine from a vial that had been out in room temperature beyond 12 hrs.) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 25-Mar-22 and administered on 29-Mar-22 from a vial that had been out in room temperature beyond 12 hours) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2022 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was vaccinated with a booster dose (0.25mL) of Moderna Covid-19 vaccine from a vial that had been out in room temperature beyond 12 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 25-Mar-22 and administered on 29-Mar-22 from a vial that had been out in room temperature beyond 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was vaccinated with a booster dose (0.25mL) of Moderna Covid-19 vaccine from a vial that had been out in room temperature beyond 12 hrs.) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 25-Mar-22 and administered on 29-Mar-22 from a vial that had been out in room temperature beyond 12 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was unknown whether patient had experienced a similar event in the past, any allergies (medications, food and other products), had ever COVID positive test or diagnosis. No concomitant medications were reported. It was unknown if the Adverse event caused patient to seek medical care (office visit, Urgent care, ER) and if other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The vial was initially stored in the refrigerator was on 25 March 2022, date on which vial was first punctured was 28 March 2022 at 10:30 am the date of administration of vaccine was on 29 march 2022 at 3:30 pm. The vail was stored at room temperature post puncture. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius equals to 46 degree Celsius to 77 degree farad) was 30.5 hrs. No treatment medications were reported.
Thumping sound in ears especially with higher pitched noises. Lasts for about an hour. Has happened about 2x a week since vaccination.
Spouse states she took him to the ER, was feeling weak and experiencing high temperature ER diagnosed it as serum sickness from the vaccine.
pt recv vax 17OCT96 & 31OT96 pt devel a mild rash on back, cold & runny nose;no further details provided;
CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported . The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest pain. Treatment medications (dates unspecified) included: glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.
p/vax pt devel generalized stiffness & shakes w/o fever, chills, nausea, vomiting, urticaria, hives or angioedema;exam c/w cog wheeling w/inc muscle tone dystonic rxn;responded as expected to DPH IM;
A month later I had face paralysis (Bell?s palsy) on the right side of my face  . And was advised my my eye doctor this could be because of the vaccination.  I can barely eat or drink , hold liquids in my mouth , speech is interrupted, blurry vision in my right eye. And a host of other things including coping emotionally.
felt ill after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose: 1st, Date: 28Jan2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 030L20A), administration date: 28Jan2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 2nd, Date: 25Feb2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 010A21A), administration date: 25Feb2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 3rd , Date/Time: 04Nov2021 Moderna, Anatomical site of injection: Arm , Route of Administration: Intramuscular, Batch/Lot number: 033F21A), administration date: 04Nov2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt ill after each vaccine".
Rash and irritating pain began on Sun. Feb 14. Under right breast, right side of torso and right side of back. Rashes were in a direct line from front to back. Rash and pain began to increase therefore visited a doctor via MD live.  Dr. diagnosed as shingles and prescribed Prednisone (20 mg x2 for 5 days) and Valacyclovir (1Gram tab x3 day for 7 days). No outcome yet as I'm currently on day 6 of shingles.
Janssen COVID-19 Vaccine EUA The day after the vaccine I experienced fever, headache, nausea, body pains, and fatigue for the entire day.