chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; headache; muscle pains; axillary inflammation/Axillary induration; Local induration/ Axillary Induration; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 02Nov2021 (Lot number: 3203080) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP", start date: 2006 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: , Time: 09:00, Anatomical location: Lt arm, Route of administration: Intramuscular, Lot number: EK5730), administration date: 17Dec2020, when the patient was 56 years old, for Covid-19 immunization; Bnt162b2 (Second dose: , Time: 12:00, Anatomical location: Lt arm, Route of administration: Intramuscular, Lot number: EK4176), administration date: 04Jan2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "headache"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "muscle pains"; INFLAMMATION (non-serious) with onset Nov2021, outcome "unknown", described as "axillary inflammation/Axillary induration"; INDURATION (non-serious) with onset Nov2021, outcome "unknown", described as "Local induration/ Axillary Induration". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient (Age:56; Unit: Unknown) was given the Pfizer Covid vaccine booster or COMIRNATY after which he developed headache, muscle pains and axillary inflammation. Event took place after use of product. Follow-up on 23Nov2021 was a follow up-spontaneous report from a contactable Physician. This Physician(patient) reported in response to HCP letter via follow-up letter which included that the patient provided information regarding the reported adverse event(s) with the use of the product and the patient considered the Pfizer product had a causal effect to the adverse event. The patient took booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). There were no prior vaccination.  No follow-up attempts are possible. No further information is expected.
pt recv vax 20OCT97 & that same day 20OCT97 20OCT97 pt exp double vision while driving home;pt f/u w/an eye MD & dx w/esotropia hyperopia;exp small angle esotropia w/double & distant vision;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 58-year-old female patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site wheal, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site wheal, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site wheal, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced welts, swelling and hot to touch at the injection site. No further details were provided. This case has been linked to the case US2019021287, reported by the same reporter.
Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 14-JAN-2011 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 08-FEB-2013, the patient was treated by a University medical center for an ongoing painful rash which was diagnosed as shingles and post-herpetic neuralgia.  Although shingles and neuralgia are incurable viral conditions, the patient was prescribed Acyclovir and hydrocodone bitartrate and acetaminophen (NORCO) for management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009733:
vaccine ended up on the patient's neck and shirt with no reported adverse event; did not receive the entire dose with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 73 years old male patient who did not receive the entire dose and vaccine ended up on the patient's neck and shirt with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  On 11-Nov-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ934AA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 11-Nov-2022, (latency: same day) the patient did not receive the entire dose with no reported adverse event (incorrect dose administered) and vaccine ended up on the patient's neck and shirt with no reported adverse event (accidental exposure to product) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, when administering FLUZONE HD QIV to a patient. When she administered the vaccine, there was almost no resistance when pushing on the plunger. A lot of the vaccine ended up on the patient's neck and shirt. The patient noted something cold on his neck and the pharmacist noticed a visible wet stain on the collar of the patient's shirt.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.; Sender's Comments:  01365664:
pt recv vax 10APR96 & pt devel chickenpox;f/u was recv which indicated no adverse rxn;
Initial report received from a healthcare professional on 06 December 2013. A 07-year-old female patient had received an intramuscular dose FLUZONE QIV (batch number and dose in series was not reported) in the left thigh on 05 December 2013. The patient had no illness at time of vaccination and had a medical history of seasonal allergies. Concomitant medications were not reported. On 06 December 2013, the patient developed a red area on the left thigh (area is 5cm in diameter and elevated 2 inches). No laboratory tests were done and corrective treatments were not reported. At the time of this report the patient did not recover. List of documents held by sender: None. Follow up information was received on 24 February 2014: It was updated that the patient was recovered from the event of red area on the left thigh; area is 5cm in diameter and elevated 2 inches. The vaccine was administered at private doctor's office/hospital. This adverse event was reported to the manufacturer.
herpes simplex keratitis of left eye/cornea; epiretinal membrane of the left eye; corneal erosion of the left eye; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, herpes simplex keratitis of left eye/cornea (ophthalmic herpes simplex), corneal erosion of the left eye, and epiretinal membrane of the left eye (macular fibrosis). The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events ophthalmic herpes simplex, and macular fibrosis were determine to be medically significant.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 49 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
15 y/o female given VARIVAX and GARDASIL while pregnant, uncertain age but likely 1st trimester. No adverse events but harmful for fetus.
Pt admitted on 8/15/2021 2 days ago with COVID-19 pneumonia. This morning he developed chest discomfort around 9:30 a.m. This progressed and his EKG progressed over time. He underwent a cardiac arrest and was resuscitated after 3 rounds of epinephrine, 300 mg amiodarone IV and debrillation x1. He was intubated on put on a ventilator. Pt was transferred to another Hospital via helicopter, taken emergently to cardiac cath lab. His LAB was occluded and stented.   Pt continues to be inpatient.
Upon vaccination of flu, vaccine content leaked from the connection between the hub of needle and the base of the needle thus inadequately administering the correct flu dose (0.5 ml). contacted on call doctor and recommends that patient will need to get additional vaccine in order to fulfill correct dose amount today or they would need to return a different day to obtain a full dose.
Woke up on 12/27/2021 with vision loss - went to opthamologist - sent to Emergency Department for MRI - high blood pressure also diagnosed at same time.  Vision loss progressed over 2 weeks - no official diagnosis yet (symptoms that of an eye stoke though).  Currently being medicated for hypertension as well.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Patient's blood pressure was 114/80 pulse 68. Symptoms resolved after 15 minutes.
After giving the vaccine, patient complained of a flushing feeling across her body. While waiting for 15 minutes after the vaccine, patient began to feel light headed and dizzy. She complained that her vision became cloudy. Her color was extremely pale and said she felt like she was going to pass out. We gave her a bottle of water and a bottle of orange juice. I sat with her and her mother to monitor her. After drinking most of the juice, she began to feel better and her vision was back to normal.  She never lost consciousness. After about 30 minutes, she felt well enough to leave.
Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,
syncopal episode 1min p/vax then again 1hr later;then 1 wk later had 2 more episodes of syncope for 30sec;afterwards pt was awake & alert, responsive;
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Big swelt close to the injetion site , per patient the area is stiff-Medium
Initial and follow-up information has been received from the Pregnancy Registry via a health professional concerning an 18 year old female with asthma who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (Lot #657868/0523U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). Subsequently, it was discovered that the patient was pregnant. The patient's last menstrual period was on 26-JUN-2007 and the estimated date of delivery was 04-APR-2007. A pregnancy test was performed, results positive. On 12-SEP-2007 an ultrasound was performed revealing an 11 week and 7 day intrauterine pregnancy. On 27-SEP-2007 an amniocentesis was scheduled, results not reported. On 23-OCT-2007, an elective termination of Pregnancy was performed. At the time of the report the patient's outcome was unknown. Upon internal review, elective termination was considered an other important medical event. Additional information has been requested.
On 11/13/2021, patient went to ER for Left eye not shutting all the way, and for left facial drooping with smiling - per mom, started in the morning when patient woke up.
vaccination during pregnancy 33 weeks; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccination during pregnancy 33 weeks) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 016C21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Aug-2020 to an unknown date for an unknown indication.   On 31-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Aug-2020 and the estimated date of delivery was 19-May-2021. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (vaccination during pregnancy 33 weeks). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 31-Mar-2021, EXPOSURE DURING PREGNANCY (vaccination during pregnancy 33 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: unknown (Positive) Positive. On an unknown date, Ultrasound abdomen: unknown (Inconclusive) Unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients Estimated date of Conception is 01-SEP-2021.  Treatment medicines were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13-May-2021 updated reporter details, updated patient demographics, relevant lab tests, concomitant medicines, pregnancy details, 2nd dose details, vaccine facility details
Patient report that he had chills/ fever 4 hours after the vaccine... lasted till 11 pm that night... also nauseous after 11 pm and couldn't sleep... around 130am he started having headaches, nose bleeding... symptoms lasted for 2 weeks
Pt came in with red, swollen and hot area on R arm where DTaP was given. Pt was seen by FNP. He was given Motrin for pain and Cephalexin 25mg.
This spontaneous report was received from a medical assistant and refers to 24 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # reported as M020900 with an expiration date: 27-APR-2018, subcutaneously for prophylaxis (dose and frequency were not reported). Administered doses of VARIVAX experienced temperature excursion of 6.2 degree Fahrenheit for 14 hours and 28 minutes, on 02-AUG-2016; 6.2 degree Fahrenheit for 13 hours and 45 minutes on 05-AUG-2016; 6.2 degree Fahrenheit for 14 hours and 10 minutes on 11-AUG-2016, 6.2 degree Fahrenheit for 13 hours and 59 minutes on 22-AUG-2016, 6.2 degree Fahrenheit for 61 hours and 50 minutes on 29-AUG-2016. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. Lot number M020900 is an invalid lot number for VARIVAX. As of 17-NOV-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA009328:, MERCK 1610USA001427:Mfr number.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX on right arm. The day after receiving SHINGRIX, the patient experienced arm soreness. After 1 day, the event resolved. This is 1 of the 3 linked cases reported by the same reporter.
101.8 fever, vertigo, shaking for hours, vomiting on myself, couldn't walk to bathroom wthout -assistance husband had to help me
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 19.57.  Concomitant medication information was not provided by the reporter.  Vaccine was moved to fridge on 09-Feb-2021. Vial was moved to clinic on 20-Mar-2021. Batch number 031A21A on 20-Mar-2021 underwent temperature excursion was at 09 AM, temperature was 34, temperature excursion was at 10 AM temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 PM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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 Fisher 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 the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).