chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received FluLaval Tetra 2020-2021 season, Flulaval Tetra Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, Flulaval Tetra Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. The action taken with Flulaval Tetra Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug 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 details were reported as follows: The nurse reported that patient was inadvertently administered with frozen flulaval tetra and havrix vaccines (frozen temperature ranging  minus 8.2 to minus 13.4 degrees Celsius for 7 hours), which led to incorrect storage of drug. The mobile cooler went too cold. The reporter asked whether there was need to revaccinate the patient. No other patient or vaccine details were available. The reporter consented to follow up. This is 1 of the 7 cases, reported by same reporter. Note:As per information reported in source document suspect field, vaccination date was captured as 6th May 2021, and clarification has been raised for the same.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter
Body Aches; Chest Pain; Chills; Asthma Attack; Muscle Pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 (Lot number: ff2589) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; LEXAPRO. The following information was reported: PAIN (non-serious) with onset 04Oct2021 19:00, outcome "not recovered", described as "Body Aches"; CHEST PAIN (non-serious) with onset 04Oct2021 19:00, outcome "not recovered", described as "Chest Pain"; CHILLS (non-serious) with onset 04Oct2021 19:00, outcome "not recovered", described as "Chills"; ASTHMA (non-serious) with onset 04Oct2021 19:00, outcome "not recovered", described as "Asthma Attack"; MYALGIA (non-serious) with onset 04Oct2021 19:00, outcome "not recovered", described as "Muscle Pain". Therapeutic measures were not taken as a result of pain, chest pain, chills, asthma, myalgia.  Additional Information: if other vaccine in four weeks: No, if covid prior vaccination: yes, other medications in two weeks: breo inhaler, Lexapro, if covid tested post vaccination: No. patient had known allergies: No  No follow-up attempts are possible. No further information is expected.
+ erythema to left deltoid. Tender to left axilla and + supra elavicular nodes fever, malaise, body aches, headache.
pt devel a temp of 102 2wks following vax;No further details were provided;
Hard; Itchy; Red circle; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 16-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red circle). At the time of the report, VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Respiratory  issues; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 2021, for Covid-19 immunization. The following information was reported: RESPIRATORY DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Respiratory  issues".  Additional information included: The patient had higher risk because of respiratory issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant social worker concerning an approximately 13 year old female patient with no allergies or drug reactions and no pertinent medical history who "4 years ago" (in 2007) was vaccinated with the first dose of GARDASIL (route, dose and lot number not reported). "4 years ago" (in 2007) was vaccinated with the third dose of GARDASIL (route, dose and lot number not reported). Concomitant medication included KEPPRA. The social worker stated that she had received the report about the patient via phone conversation. The social worker stated that the reporter did not speak the language. "15 days after the first dose of GARDASIL" (in approximately 2007), the patient began with seizures. The patient experienced a seizure, lost consciousness and went to the emergency department. During the hospital stay the patient had a electroencephalography (EEG) conducted (results were not provided) (also reported as no laboratory diagnostic studies performed). The medical assistant stated that the patient was healthy before the GARDASIL was given. The patient was diagnosed with juvenile chronic epilepsy and had been seen by a neurologist. The patient did not receive any treatment for the event. The social worker stated that the reporter wanted the report to be kept confidential. The social worker refused to give any additional information concerning the patient. The physician was contacted and stated that he did not know the patient and was not able to give any additional information. At the time of the report the patient had not recovered. Additional information has been requested.
pt recvd vax & 3PM became irritable, high pitched, crying & kept getting worse, became inconsolable, mom noted stiffness of arms, legs; swallowing problems; pulling @ head & ears; t103 fever axillary; no vomiting;
Tired; Fatigue; Body Aches; Fast Heartbeat; Headache; Dizziness; Shivering/Chills; Stomach Pain
Per healthcare division guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
High-tone pelvic floor dysfunction - office visit; within 6 weeks of receiving the COVID vaccine.
Twelve hours following her vaccination with Moderna, the patient experienced chills, PO temperature of 103.0, vomiting, muscle weakness, tiredness and a feeling of being delusional.  The patient took 2 Aleve and was able to fall back asleep for the night.  The second day she continued to vomit and her temperature was unknown.  She started developing mouth sores within 24 hours.  She had a difficult time tolerating food which she attributed to her inability to retain her two daily doses of Hydrocortisone due to her vomiting.  Within 72 hours she began to tolerate foods better.  Her temperature was unknown at that time.  Within 96 hours, the patient describes herself as 50% improved with a PO temperature of 99.
Day 3 vaccine site developed large welt approx 5 inches in diameter was hard and itchy.  10mg of daily Zyrtec 50mg of Benedryl and hydrocortisone did not bring the welt down but the welt did not grow further either.   on day 4 took another 50mg of benedryl at 3:30am and applied hydrocrotisone again.  At approx 8am rubbed some CBD cream on it at 1:30 applied some clobetasol cream perscribed by my allergist listed on earlier page the welt is currently a little less hard and slightly less itchy.
While administering the dose of vaccine running down the patient's arm from the injection site/No AE; While administering the dose of vaccine running down the patient's arm from the injection site/No AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56-years-old male patient received vaccine 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (single dose syringe, lot UT7005JA and expiry date 30-Jun-2021) via unknown route in the arm for prophylactic vaccination and while administering the dose of vaccine running down the patient's arm from the injection site (underdose and syringe issue) on an unknown date.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was case of actual medication error due to vaccine underdose. It was also a case of syringe leak (on same day).  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 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
COVID Pfizer Pediatric dose 5-11 years was ordered. However COVID Pfizer Infant / toddler 6 mo -4 years dose was administered. No adverse reactions reported at the time of discharge.
Child broke out in rash on head, neck and RT leg, with some redness and swelling at injection site.
Annika had a temperature of 100 or greater that started the evening she received the vaccines (which was a Friday) until Monday.  By the end of the week she had flu like symptoms and starting having thick drainage come out of her ears.  I took her in the following Monday and was diagnosed with a double outer ear infection which she battled on and off for three weeks.  About three weeks after the vaccines she started to vomit up alot of her formula every time she ate.  On May 15th (about a month out from her immunizations) she was admitted to the hospital for dehydration and that evening had her first of many focal seizures.  The physician on call performed a spinal tap and it came back positive for pnuemococal menigitis and also a pnuemoccocal infection in her blood system.  She was put on IV antibiotics and was sedated for the next week and half until the swelling around her brain went down and was discharged from the hospital 16 days from admission.  She now has a moderate to severe hearing loss and is involved in both PT and OT for motor delays. 60 day follow up states she has motor delays and has a moderate to severe hearing loss becasue of her bacterial meningitis. She will have a disability for her life. She was admitted with bacterial meningitis a month after she received her immunizations. She ran a temperature the whole weekend after the shots and then within a week she had an unexplained outer ear infection which never resolved until tubes were put in on 5/31/02 which was after she was treated for the meningitis.
Chills; restless leg the night of the vaccine administration; insomnia; swollen lymph nodes on the side of the injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 10:15 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 21Oct2021, outcome "recovering", described as "Chills"; LIMB DISCOMFORT (non-serious) with onset 21Oct2021, outcome "recovering", described as "restless leg the night of the vaccine administration"; INSOMNIA (non-serious) with onset 21Oct2021, outcome "recovering", described as "insomnia"; LYMPHADENOPATHY (non-serious) with onset 21Oct2021, outcome "recovering", described as "swollen lymph nodes on the side of the injection". Therapeutic measures were not taken as a result of chills, limb discomfort, insomnia, lymphadenopathy.  Additional Information: Facility type: vaccine Public Health Clinic/Administration facility. No other vaccine in four weeks. No COVID prior to the vaccination. No COVID tested post vaccination. No known allergies. Adverse event: Chills, restless leg the night of the vaccine administration, insomnia, swollen lymph nodes on the side of the injection  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and refers to about 10% of 60 female patients of unknown age. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates (reported as when the patients were children), the patients were vaccinated with M-M-R II, RECOMBIVAX HB and with VAQTA for prophylaxis (frequency, route of administration, lot# and expiration date were not reported for any of the vaccines). On unknown dates between January 2017 and June 2018, vaccine titers were performed as part of prenatal testing on 60 patients, who were substance abusers (it was unknown what substance was being abused) since unknown date (linked with case #1808USA002950). About 10% of that population had negative titers for one or all of those vaccines. The outcome of the events was unknown. The relatedness between the events of substance abuse and negative titers and vaccination with M-M-R II, RECOMBIVAX HB and VAQTA was not reported. Upon internal review, the event of substance abuse was determined to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA002950:
the skin in hands and between fingers was peeling during 3 or 4 weeks; This spontaneous case was reported by a nurse and describes the occurrence of SKIN EXFOLIATION (the skin in hands and between fingers was peeling during 3 or 4 weeks) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 027C21A) for COVID-19 vaccination.     Patient had no allergies and no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (the skin in hands and between fingers was peeling during 3 or 4 weeks). On 04-Jul-2021, SKIN EXFOLIATION (the skin in hands and between fingers was peeling during 3 or 4 weeks) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is not under any concomitant or regular medication. It was reported that patient had no symptoms after dose 1. It was reported as the symptoms were ongoing but not as drastic as in the beginning with residual effects. Patient did not seek any medical care and not experienced a similar event in the past. It was also reported that the symptoms were improved. No treatment has been given but patient had to wash skin constantly with dove soap and water.   This case was linked to MOD-2022-636339 (Patient Link).
The patient was given the VIS form and stayed  in the room with me for 15 minutes since it was his first flu shot. Approximately 30 minutes later he returned to the area with another employee who stated he complained of feeling "fuzzy". I had him sit down and I asked him how he was feeling,He said he felt fine but he came back to see me because his fellow employee insisted. His blood pressure was 118/82. I asked him if he had eaten this morning and he said he only had been drinking coffee  and hadn't had enough sleep the night before. I gave him my protein bar and asked someone to get him some juice. I had him finish the protein bar and juice and retook his blood pressure ten minutes later and it was 118/-80. He said he felt much better and I told him to please come back if he was feeling poorly again. He didn't return.
This spontaneous report as received from a vaccine cooridnator refers to a 13-year-old male patient. The patient's medical history was not reported. On 11-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021315, expiration date 07-AUG-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175:  US-009507513-1802USA005176: US-009507513-1802USA005178: US-009507513-1802USA005179:
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, medical history or concomitant therapy was not reported.  On 15-MAR-2017 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# reported as M039453, expiration date 19-DEC-2017) for prophylaxis.  The patient had last received a dose of radiation treatment "10 weeks ago" instead of the recommended guideline of 3 months from the Advisory Committee on Immunization Practices (ACIP) and therefore may have been immunosuppressed at the time of administration.  No Adverse effects reported. Additional information has been requested.
Sore arm; Body aches; fever; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu (Route was Intramuscular and Injection site was Left deltoid and the lot number was 52772.) on 19-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu.    On 26-Oct-2021 at 1:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021 at 1:08 AM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.   No concomitant medications were provided by the reporter. It was reported that no treatment was needed for the patient
Family reported patient developed a high fever (104.0 F) exactly one week following the injection of the flu vaccine.
needle was not properly attached to the syringe, so it only injected part of the dose with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and demographics who was injected part of the dose of Influenza Quadrival A-B vaccine [Fluzone Quadrivalent] as needle was not properly attached to the syringe, so it only injected part of the dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received only a part of the dose of suspect Influenza Quadrival A-B vaccine Suspension for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site for immunization, as the needle was not properly attached to the syringe, so it only injected part of the dose with no reported adverse event (incorrect dose administered) (latency: same day). Information on the batch number was requested.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  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 and Regulatory Authority 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.   Additional information was received on 17-Oct-2023 from Other healthcare professional: Case was upgraded from non-case to valid case and event of incorrect dose administered was added. Text amended accordingly.