chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023/Suspected Vaccination failure; Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 29-OCT-2023, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023). 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 Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2023 The case was reported by patient's father. The patient was vaccinated in 2018. On 29 October 2023 patient was diagnosed with shingles. The exact date of vaccination was unsure. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter agreed to follow up from GSK.
Shakiness, nausea, increased breathing within 2 mins of getting vaccine. Pt declined SOLU-MEDROL, BENADRYL and ATIVAN. Sent to ER for eval.
This spontaneous report as received from a healthcare worker refers to two no pregnant female patients of unknown ages. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the two patients were vaccinated whether with doses of GARDASIL or GARDASIL 9, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were not reported. ON an unknown date, after the vaccination, the two patients experienced syncope described as "patients fainted". The patients sought medical attention through office visit on an unknown date. Treatment was not given for the adverse event, and it was unspecified if laboratory diagnostics studies were performed.  The outcome of syncope was reported as recovered on an unknown date. The relatedness between syncope and therapy with GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
After 12 hours from vaccine I had diarrhea; chill; swelling all my body; puffy both eyes and lips; puffy both eyes and lips; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03May2021 14:00 (Batch/Lot number was not reported) as single dose at the age of 31-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient was not pregnant. No other vaccine in four weeks. No COVID prior vaccination. No known allergies. Other medical history: she never had any reaction. On 04May2021 04:00 after 12 hours from vaccine she had diarrhea, chill, swelling all her body, puffy both eyes and lips. Events resulted in Emergency room/department or urgent care and Hospitalization. Therapeutic measures were taken as a result of events. COVID was not tested post vaccination. The outcome of events was recovered with sequelae.    Information on the Lot/Batch number has been requested.
Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 12:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 12:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was unknown if the patient had ever tested positive or been diagnosed with COVID-19. The vial(s) moved from freezer to refrigerator on 7-Sep-2022.  It was reported that the vaccines had undergone several temperature excursions in Aug 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.
0.25ml administered as 1st dose influenza vaccine for the 2017-2018 Flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was noted. Parents were informed and asked to bring infant to clinic for revaccination at no cost.
Blurred vision, fainting, paralysis on left side, numbness, tingling, lethargic, stuttering, headache, constipation, abdominal pain.
Started w/low grade temp. and fussiness @ 2PM. By 7PM temp increased 101. TYLENOL 0.8ml was administered q 4 hour starting 1/2 hr after immunizations @ 1015am. Redness & fussy t/o night. Up @ midnight w/temp. 102.4 and chills.
This case was reported by a pharmacist to a sales representative and described the occurrence of grand mal seizure in a teenager subject of unspecified gender who was vaccinated with Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix), for prophylaxis. On an unspecified date on or prior to 8/17/06, the subject received an unspecified dose of Boostrix. The lot number and expiration date were not provided. Seven days after vaccination with Boostrix, the subject experienced a grand mal seizure. No additional information was available at the time of reporting. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event was unspecified.
2 days after shot, started with sore throat, coughing, chest pain (from coughing), fever, congestion, runny nose that continued for just over one week. Taking antibiotics.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 05-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 07-MAY-2021 No concomitant medications were reported   No treatment information was provided
presented with left shoulder pain- diagnosed with bursitis- given NSAIDS and exercises to do at home.
Myalgias, confusion, high fever.  Tx: Acetaminophen, Ketavolac.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) and first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.  Three 17 year old college students were vaccinated with Moderna vaccine. It was the first vaccine.  Vaccine given right arm upper deltoid muscle for each patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: No new information- reporter confirmed no more information was available for this case.
soreness, body aches, Muscle spasms entire left side of body  ( vaccine in left arm
Patient admitted to hospital on 03/24/2021 for high fever and shortness of breath; these symptoms began in 3/17. Patient tested positive for COVID-19 on 03/21/2021 and again on 03/24/2021 despite being fully vaccinated against COVID-19. Patient died on 04/19/2021. COVID-19 is listed on the death certificate.   Death Certificate Information:  Part I Cause of Death:  A. Acute Hypoxic Respiratory Failure B. Suspected pulmonary embolism Part II: Significant Other Conditions:  COVID 19 subacutely
After the COVID-19 pizer second dose, I experienced intense sweats immediately, then about 2 hours later, I started experiencing these symptoms: staring off into the distance, unable to focus, slurred speech, confusion, pain in the arm, pounding head, and blurry vision, this went on for about 4 hours. For the next 3 days, I avoided driving as I felt I was indicated and had no reaction time. The consumption of alcohol did not happen the day before the shot day of or the days following event.
Tinnitus, both ears/head, no change since onset on 4.21.2021; foul smelling urine began 4.19.2021, improved 4.25.2021 no treatment
Itching - rash on left side of body - left arm, lower back, stomach, left leg - thigh & behind left knee. Patient reported event on 9/26/12 & rash still prominent in all areas stated above. So far patient has been treating with Calamine lotion.
Her left are was swollen, painful. She still can not move her arm due to the pain. The area is hot and she also experienced flu like symptoms.
Constant pain in left arm from site of injection to wrist.   Used cold pack for several days and then when pain persisted, heating pad.  To date, pain is constant.
headache; fatigue; feels lowsy; received a third dose by accident; This case was reported by a consumer via call center representative and described the occurrence of headache in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 3rd January 2020) and Shingrix (2nd dose received in 24th June 2020).   On 23rd August 2021, the patient received the 3rd dose of Shingrix. On 23rd August 2021, less than a day after receiving Shingrix, the patient experienced headache, fatigue, feeling unwell and extra dose administered. On an unknown date, the outcome of the headache, fatigue and feeling unwell were recovering/resolving and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the headache, fatigue and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient. The patient received a 3rd dose of Shingrix by accident on the day of reporting still after received 2 dose of Shingrix which led to extra dose administered. The patient had a headache, fatigue, and feels lowsy but was starting to feel better. The patient did not know the lot number and expiration date of the product. The reporter did not consent to follow-up. The patient declined to provide health care professional details.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 19-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA009749: US-009507513-1811USA012585: US-009507513-1811USA012586.
Face paralysis; Neck pain; Eye lid palpitations; Problems with the eyes; Swelling  of the eyes; Eyes burn; Face numbness; Headache; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Face paralysis) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FACIAL PARALYSIS (Face paralysis) (seriousness criterion medically significant), NECK PAIN (Neck pain), BLEPHAROSPASM (Eye lid palpitations), EYE DISORDER (Problems with the eyes), EYE SWELLING (Swelling  of the eyes), EYE IRRITATION (Eyes burn), HYPOAESTHESIA (Face numbness), HEADACHE (Headache) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, FACIAL PARALYSIS (Face paralysis), NECK PAIN (Neck pain), BLEPHAROSPASM (Eye lid palpitations), EYE DISORDER (Problems with the eyes), EYE SWELLING (Swelling  of the eyes), EYE IRRITATION (Eyes burn), HYPOAESTHESIA (Face numbness), HEADACHE (Headache) and HYPERSENSITIVITY (Allergic reaction) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.    Patient had a COVID positive test or diagnosis in Jan2021. She had no past medical history or allergies before vaccination and hadn't took any other vaccines within 1 month prior to Moderna. She went to doctor office every week for a month and took Steroid that inflated her like a pig. Patient symptoms sometimes worsened and other times improved. Patient had the same symptoms after booster since 31-jan-2022.  Concomitant medication was not provided Treatment information was not reported.  Company comment: This is a spontaneous case concerning a 41-year-old female patient with no medical history reported, who experienced the expected serious(Medically significant) and AESI  event of facial paralysis, as well as non serious events of neck pain, blepharospasm, eye disorder, eye swelling, eye irritation, hypoaesthesia, headache and hypersensitivity after the first dose of mRNA1273 vaccine. The outcome of the events was not recovered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-483642 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no medical history reported, who experienced the expected serious(Medically significant) and AESI  event of facial paralysis, as well as non serious events of neck pain, blepharospasm, eye disorder, eye swelling, eye irritation, hypoaesthesia, headache and hypersensitivity after the first dose of mRNA1273 vaccine. The outcome of the events was not recovered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
p/vax father reporter 10PM mom noted pt felt feverish;estimated about 100;pt retired for the noc;swelling, warmth & redness extending to the elbow of lt arm;MD felt was infected area d/t dirty needle;also induration lt arm;APAP given
Pins and needles feeling throughout body. Especially arms and legs. Muscle tightening and cramping, most concentrated to hands, feet and jaw. Jaw pain. Headache. Fatigue.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (12Jul2022) Positive, notes: Return of symptoms on day 12 after starting Paxlovid and positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had not received other medication in 2 weeks. Patient was received Paxlovid for COVID 19 Treatment. Return of symptoms on day 12 after starting Paxlovid and positive test result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.