chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided. On unknown date in 2017(reported as since March 2017), the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot M036059 with an expiration date on 03-JUN-2019 (strength, dose and route of administration were not reported) as prophylaxis, which was exposed to a temperature from 47 to 77 Fahrenheit degrees for 12 hours. There were no previous temperature excursions. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter.. Sender's Comments: US-009507513-1707USA006643.
Severe arm pain. Unable to move arm away from body. Pain wakes me up at night.
Suspected vaccination failure; Has gotten shingles multiple times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Has gotten shingles multiple times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a consumer via  interactive digital media. The reporter stated that everyone client he/she had that was bullied into getting that shingles vaccine and had gotten shingles multiple times.  The reporter further stated that another poisonous jab. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR050711 and US2023AMR050710, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR050711:same reporter - Female patient case US-GSK-US2023AMR050710:same reporter - Male patient case
administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients..; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Severe leg pain; body pain; He had elevated sendimentation rate via blood work; Prevented our son from being able to walk properly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 12:30 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TENEX. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicillin. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "Severe leg pain"; PAIN (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "body pain"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "He had elevated sendimentation rate via blood work"; GAIT DISTURBANCE (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "Prevented our son from being able to walk properly". The events "severe leg pain", "body pain", "he had elevated sendimentation rate via blood work" and "prevented our son from being able to walk properly" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. Therapeutic measures were not taken as a result of pain, red blood cell sedimentation rate increased, gait disturbance.  Additional Information: Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination patient has not been tested for COVID-19. Severe leg pain that has lasted over 4 days that has prevented our son from being able to walk properly- he could not go to school, have a backpack etc. due to his body pain. He had elevated sedimentation rate via blood work taken by his Pediatrician. Leg pain still not resolved. Taking both Motrin and Tylenol and still no improvement. Device Date : 19Nov2021  Follow-up attempts are completed. No further information is expected.
WITHIN THREE HOURS AFTER VAX, FACE BECAME REALLY FLUSHED, WOKE UP AT 2AM WITH SEVERE CHILLS, BODY & JOINT ACHES AND STIFF NECK ALONG WITH POUNDING HEADACHE.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted.
Nursing staff prepared MENVEO using the incorrect or corresponding conjugate component, vaccine had to be repeated as recommended per manufacturer. The manufacturer also has now provided us with little bands that connect the powder and diluent bottles together in the box. Nursing staff was also re-educated on preparation for MENVEO. Vaccine was re-administered to Pt. and prepared appropriately.
Flu like symptoms without fever, Did a COVID-19 antigen and PCR (positive). Honey lemon cough drops and regular bedside paraphilias.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 09-SEP-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 328 hours with 29 C and 248 hours with 33 C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient who had vaccine that was mixed with the wrong diluent, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine for Immunisation. On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5422AA, expiration date- 15-Sep-2019 via unknown route. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event 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 fevered, red, macule, warm, approx 6 cm in diameter.
PATIENT STATES RECEIVED SHOT AROUND 430PM 1/27/21. BY130AM WOKE UP WITH EXTREME PAIN ALL OVER BODY, JOINTS FELT LIKE THEY WERE ON FIRE, MIGRAINE, INTENSE NAUSEA , DIZZINESS, CHILLS, FEVER DIARRHEA, AND WAS NOT ABLE TO STAND UP OR SIT UP OR ABLE TO EAT FOR 2 DAYS. STATES SHE WAS STILL SHAKY AND WEAK AND STILL HAD A HEADACHE ON FEBRUARY 2, 2021.  PATIENT ALSO TOLD ME THAT SHE HAD COVID IN NOVEMBER.
-Left shoulder pain after immunization  -Developed throbbing/aching pain in the left shoulder within 24 hours of immunization  -transient twitching in his left hand  -pain and stiffness in left arm interfering with sleep  -Aspirin and topical biofreeze have given slight relief
Noticed a lump in left lower neck. Removal on 1/28/22 and was determined to be Follicular B-Cell lymphoma.  Axillary lymph node enlargement noticed in December 2021.
No period for 2 months since 3/8, super heavy period on 5/8-5/10
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comments: The nurse reported that Havrix was administered after the expiration date.  No additional adverse event (AE) details available per health care professional (HCP).  The HCP gave consent for safety team follow up. Additional Supportive Information: The patient received an expired Havrix, which led to expired vaccine used.
Pt. had a papulovesiucular rash > 12 papules 1 vesicle is scalp.
Child received DTap, PCV7 in RL (right leg) (IM) intramuscular, Hep A #1 in LL (left leg) (IM) intramuscular. Approximately 10:30 am mom brought child back to clinic at 4:15 p stating child will not walk. No other problems noted. "Seems like she doesn't want to walk" mom says. I observed child to stand, but would not walk, when she pushed her legs away, I felt her resist. I instructed mom to put in warm bath or take to hospital. She will try warm bath, exercise legs first before going to hospital. Note, 12-10-08 spoke with mom, child walking much better after got home last nite. No visit to Dr or hospital.
HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date; Patient received vaccine 3 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 3 days after use by date) and PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 4:06 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Feb-2022 at 4:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 3 days after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 3 days after use by date) and PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided.  There was one vial which was been administered after 30 days on fridge (30th day was on 06-Feb-2022). The patient received 1 booster and 1 primary dose. On 09-Feb-2022 the patient received the vaccine almost 3 hours after the first puncture. HCP stated that there was no temperature excursion during the administration of that vial ( the vials were in the fridge). It was reported that the patient experienced no adverse events.  No Treatment Medications were provided.
Pt had full body rash only excluding palms of hands and soles of feet.  Per mom rash started 7/22/10.  Mom states had similar reaction in July, 09 after shots. Also started 8 days after shots, but because it wasn't as severe she did not bring her in.
Patient came to pharmacy as MD recommended she get the shingles shot. Later that day she felt light-headed, fainted x 2, aches, pains. Cleared up. Next day developed cough, cold, congestion, wheeze. Sought medical attention 6 days later. MD stated possible viral syndrome from injection but may also have SX of increased serum reaction. Still minor congestion and sore throat. MD recommended SX management and feels should resolved without incident.
Headache, Myalgia, Arthralgia, Fever, Employee reported that she had pain at injection site, chills, fever, headache, joint pains, muscle or body aches, fatigue or tiredness Narrative:
Initial report received pharmacist on 18 October 2013. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route intramuscular, lot # U4718AA and site of vaccination was right deltoid) on 16 October 2013. She reported that she had difficulty breathing the evening the vaccination was administered. Symptom resolved. List of documents held by sender: none.
Pt was vaccinated with vax in 1994. Pt was exposed to live wild type varicella. Subsequently the pt had a titer drawn which was negative.
Severe body pain; Neck pain; Shin pain; Chills; Joint pain; Both legs are hurting/ Mild aching in the arms/ Thigh pain; Back hurting; Muscle pain; A spontaneous report was received from a 49-years-old female, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain/ myalgia, joint pain/ arthralgia, thigh pain/ both legs hurting/ mild aching in the arms/ pain in extremity, back hurting/ back pain, neck pain, shin pain/bone pain, chills, and severe body pain/ general body pain.   The patient's medical history included COVID-19 virus. No relevant concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J208) intramuscularly, for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient had mild aching in the arms, muscle pain, thigh pain, and joint pain. She reported that both legs and back were hurting.   On 25 Dec 2020, the symptoms continued along with chills. The patient stated that maybe the chills were due to the severe body pain. The patient also had neck pain and shin pain. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, muscle pain, joint pain, thigh pain, both legs hurting, back hurting, chills, mild aching in the arms, neck pain, shin pain, and severe body pain, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 16-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Chills, "feverish", site tenderness and swelling, general myalgias, onset 2 hrs after injection.
Patient reported having a ?pepper? taste in the mouth about 3 minutes  after vaccine administration. Patient thereafter reported having a tingling sensation in the mouth and lightheadedness about 6 minutes after vaccine administration. Patient laid down and vital signs were taken; BP-126/68, HR-100. Patient drank 1/2 of 16oz. bottle of water and a 12oz  of a sports drink. Vitals were rechecked 13mins after the first set; BP- 120/62 HR- 64. Patient reported feeling better afterwards I.e lightheadedness had subsided and no tingling sensation.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Adverse event: Vaccine was administered 3 weeks after beyond use date and is less effective. Treatment: Pt returning to our office for additional vaccine based on Pfizer and State recommendations.
Significant pain in arm almost 7 weeks later.  Arm is stiff and causing back/neck pain.
About 12 hours later after 2nd dose, she started with really bad ringing in her ears; She felt like she was confused; Light headed; She had fever; aches; pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (About 12 hours later after 2nd dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PYREXIA (She had fever) and MYALGIA (aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (About 12 hours later after 2nd dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PYREXIA (She had fever), MYALGIA (aches) and PAIN (pain). At the time of the report, TINNITUS (About 12 hours later after 2nd dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PYREXIA (She had fever), MYALGIA (aches) and PAIN (pain) outcome was unknown.            patient was treated with Tylenol for fever and aches.
Both legs are swollen and red w/fever. Vaccines given (10/9/19) fever started (10/10/19) green diarrhea (10/11/19)
Received a dose of Hep A vaccine whihc was intended for his sibling.   No adverse effects were assessed by or reported to the practioner
The initial injection was only adjuvant, the product had not been mixed.  Adjuvant only was administered into the right arm.  A properly reconstituted Shingrix was then administered into the left arm