chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.
Approximately 5 inch red spot that looked burned. Complained of pain upon touch, slight swelling on lower arm below elbow and moderate swelling of upper arm. Onset started at 18:00 on 12/15/02. Patient does not feel he has a temperature.
Both arms red, swollen, hot to touch, very tender, Dtap, IPV, PCV given.
Improperly strored VARIVAX administration; This spontaneous report was received from a physician regarding to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.      On 19-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T012551, expiration date 10-APR-2022 for prophylaxis (dose and route of administration were not reported).  The improperly stored suspect vaccine experienced a temperature of 6 degrees Fahrenheit (°F) to 14 °F, with an average of 11.8 °F) for 31 hours; no previous temperature excursion was reported.  The call was made due to a digital data logger. No adverse symptoms were reported.
Bacterial infection and swollen shoulder at the site of injection. It was itchy and extremely hot-to-touch! She could not sleep on the side and could not wear a long sleeve shirt to cover the arms because it hurt so much. She went to urgent care and got prescribed clindamycin 300mg 1 cap 3 times daily for 10 days. She followed-up with the urgent care center Friday 12/10/2021 after being on the antibiotic for 2 days since Tuesday 12/07/2021.
Left thigh diffusely swollen.  Patient able to bear weight without difficulty.  Adequate perfusion, no focal area of fluctuance.
Patient admitted as outpatient for colonoscopy prep when she tested positive for COVID-19. She was discharged and rescheduled for the procedure at a later date.
Approximately 1 1/2 post #3HB, client complained of nausea.  Hives began on chest, then neck and face.  Eyes swelled shut.  Eventually total body hives.  To family MD, given Zyrtec and Benadryl PO.
Myalgia, UrticariaPruritus, fatigue, chills, swollen glands Narrative:
This spontaneous report as received from a physician refers to a 84 year old patient. On unknown date the patient was vaccinated with ZOSTAVAX (dose, route unknown). On unknown date, the patient experienced zoster-like rash at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. This is one of two reports received from the same source. Additional information has been requested.
Expired vaccine was administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
LEFT UPPER ARM HURTING; SLIGHT AND POUNDING HEADACHE; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 17676, and batch number: 17676) dose was not reported, administered on 28-MAY-2021 15:50:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced left upper arm hurting. On 28-MAY-2021, the subject experienced slight and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight and pounding headache, and left upper arm hurting. This report was non-serious.
Edema to hands and feet, face. Hives under arms (per mother). Was seen and released at emergency room. Oral steroids given. To use OTC, BENADRYL, at home, as needed.
Moderna COVID-19  - 1 to 2 days after injection, left arm (LA received treatment) was sore to the point I couldn't lift my arm above my shoulder.  Day 3, felt fine. I could lift arm without any issues.  Day 4 to 5, started feeling the worse kind of fatigue, mild headache, all over body ache like my actual joints hurt and head feels pressure like it is in a fog.  I have a stuffy nose.  It is now February 5th and I still feel this way.  Everyone else I talked to had  just a sore arm and recovered within a day or two.  This is my 1st shot and I go back on February 26th for second shot.  I was asked by pharmacist that administered vaccine to report any side effects since this is a new vaccine.
Singles, had vaccine\ suspected vaccination failure; shingles; nerve pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with tramadol. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. At the time of reporting patient age 79 was rough. The patient had vaccine 4 and half years ago of reporting. They said it only last 4 to 5 years.  The patient stated got shingles 2 times. Nerve pain was unbearable, had to take tramadole pain killer for 1 night and day just to get some sleep. The reporter stated would be talking to physician about getting another vaccine. This disease was a curse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
gave a patient and expired Sanofi flu vaccine from last year by mistake with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 46 years old female patient who had expired sanofi INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] vaccine from last year by mistake with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   It was reported that patient had an expired sanofi flu vaccine from last year (2021) by mistake with no reported adverse event (expired product administered) (latency: same day) (formulation, dose, route, administration site, batch and expiry date was unknown) for Immunization.  On 29-Aug-2022 she also received a 0.5ml 1X(once) dose of the same vaccine (strength, formulation was unknown ,lot UJ696AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for Immunization No reaction was observed in the HCP (health care professional) office  Action taken : not applicable.  Outcome: 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 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.
As soon as immunization was administered, patient complained of dizziness, which resolved after laying down for a few minutes.
Injection site redness, induration, rash reported by mother.  Client not seen in clinic.  Site reaction less red than previous day.  Parent to contact physician if site gets worse.  Mother had applied aquafor gel and 4 by 4 to site.
Fatigue, paresthesia in the lower extremity, muscle aches. Of note did have COVID within 35 days of receiving the vaccine but working in a Nursing home.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
DEVICE ISSUE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 6 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and other pre-existing medical conditions included: No reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. Age at time of vaccination 58 years old. No concomitant medications were reported. On an unspecified date, the patient experienced device issue, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from injection site pain, and device issue. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Information has been received from a physician concerning an 18 year old female patient with fatigue, depression and insomnia who was vaccinated with the first, second and third dose of GARDASIL on 06-AUG-2007, 06-NOV-2007 and 04-MAR-2008 respectively. Concomitant therapy included ZOLOFT, SEROQUEL and maybe CORTEF. The physician reported that after the third dose vaccination with GARDASIL, the patient experienced chronic fatigue and EPSTEIN-BARR syndrome. The physician also reported that about two weeks after the vaccination, on approximately 18-MAR-2008, the patient was diagnosed with EPSTEIN-BARR syndrome. Thyroid test( results not provided) and EPSTEIN BARR test were performed. The EPSTEIN-BARR test was positive. The patient sought medical attention in the office. It was reported that the patient was unable to attend her last semester of high school due to fatigue. At the time of the report the patient had not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. The patient's chronic fatigue and EPSTEIN BARR syndrome were considered to be disabling by the physician. Additional information has been requested.
During sleep, came down with chills and headache. By 9am got out of bed, took a shower and felt better.
Body aches and feverish 8 hrs post vaccination still had body aches next day, not as bad. Ibuprofen prn.
I believe the shot was given too high in my shoulder, about less than an inch below my shoulder joint and developed excruciating pain in my shoulder joint. After a couple weeks it didn't subside, so I reached out to my PCP and set an appointment with an orthopedic doctor. The orthopedic prescribed ibuprofen and EXCEDRIN and ordered physical therapy. I started the PT at the beginning of this week and have a regimen of PT scheduled over the next month. An X-ray was performed but was advised if the PT doesn't help within this next month an MRI will then be scheduled for possible further treatment.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 5 (booster), single (Lot number: GH9697), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about Covid treatment yes, Reporter type patient, vaccine was received, No other medication in 2weeks, Product COVID 19 Treatment, start date 27Mar2023, stop date 01Apr2023. This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process. Refer to the below table for details. Product Quality Group Provided investigational results for Comirnaty the investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9697. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker, via a company representative, refers to patient 1 of 2 female patients (age not provided). A healthcare worker told the company representative that there was an article from a press out today (08-NOV-2013). The article reported that 2 patients who are sisters claimed that GARDASIL caused ovarian failure. Dosing information, route of administration and lot number of GARDASIL were not provided. The outcome of ovarian failure was not provided. This case is linked to case 1311USA005122 (patient 2 of 2 female patients). Additional information has been requested.
Gave the pt 0.5 ml dose vs. 0.25 ml dose of Moderna for booster.  Will discuss with pt when she returns my call.  Side effects should be the same as with 2nd dose
the rash is on her face, eye lid and ear/ painful; the rash is on her face, eye lid and ear/ painful; Suspected vaccination failure; Shingles; headach only on the left side; needle pain in her scalp/scalp prickly pain; needle pain in her scalp/ scalp prickly pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3Z4KL, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number AS9CM, expiry date unknown) for prophylaxis.   On 18th March 2018, the patient received the 1st dose of Shingrix. On 18th May 2018, the patient received the 2nd dose of Shingrix. On 4th January 2020, 657 days after receiving Shingrix, 596 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, scalp pain and prick pain. On 5th January 2020, the patient experienced painful rash and eyelid rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, headache, scalp pain, prick pain, painful rash and eyelid rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, scalp pain, prick pain, painful rash and eyelid rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was pervious GSK employee. The patient developed a headache only on the left side of her head on Saturday 4th January 2020. The patient also had needle pain in her scalp. The rash appeared on Sunday on 5th January 2020 and she went to urgent care. The patient was given generic Valtrex 1 gram three times daily for 7 days. It was reported that the rash was on her face, eye lid and ear. The patient denied any in her eye. It was painful. The patient stated that she has an appointment with her primary care physician. Emergency room visit required. The reporter consented to follow up. This case was considered as suspected vaccination failure as details laboratory confirmation was unknown at the time of reporting.
Fever, vertigo, chest pain and in  arm. My hands fall asleep at night in bed. Tachycardia remained until November but increasingly isolated.
Itchy rash on the arm; Rash is all over her front body; Spot of the injection is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on the arm), RASH (Rash is all over her front body) and VACCINATION SITE PRURITUS (Spot of the injection is itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (allergic to aspirin,codeine and sulfa drugs.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on the arm), RASH (Rash is all over her front body) and VACCINATION SITE PRURITUS (Spot of the injection is itchy). At the time of the report, RASH PRURITIC (Itchy rash on the arm), RASH (Rash is all over her front body) and VACCINATION SITE PRURITUS (Spot of the injection is itchy) outcome was unknown.            No Treatment information provided
Two days after vaccination Pt began complaining of nausea which still persists intermittently to this  day. She now has difficulty eating from the nausea and lost 7 pounds. She also began experiencing dizziness, blurred vision and shortness of breath. On 10/16/2021 she went to hospital due to dizziness, blurred vision and chest pain when Dr. informed us she was having vertigo from the vaccine.
Pt felt lightheaded while shopping so she sat down.  We asked if she had eaten today and got her some crackers and water.  She sat down in a chair for a few moments then began convulsing.  Moved her to the floor and EMTs showed up immediately after.  Convulsions lasted about 30 seconds.  Incident occurred approx. 30 minutes after administration of H1N1 vaccine.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced diarrhea and malaise. On an unknown date, the outcome of the diarrhea and malaise were recovered/resolved. It was unknown if the reporter considered the diarrhea and malaise to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The caller reported that 1 to 2 days after receiving SHINGRIX, the patient experienced diarrhea and malaise that resolved 5 to 6 days later.
Ten days after receiving MMR and varicella vaccines, had blotchy pink/red rash lasting 2-3 days.
patient states severe fatigue the first 2 days and continued fatigue for one week after, but not as severe