chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
suspected vaccination failure; another attack; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (in 40's).   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had vaccine then better one was available then the patient had another attack.  The patient said that the patient did not want them again, it was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
The Patient stated that he had a moderate to severe swelling of his non-dominant arm along with arm pain; lost 5-10 pounds in the week; The Patient stated that he had a moderate to severe swelling of his non-dominant arm along with arm pain; This spontaneous report was received from a consumer referring to a 70 years old male patient. The patient's concurrent condition included sarcoidosis. No pertinent medical history and no drug reactions/allergies.  On 14-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot# and expiration date were unknown) intramuscularly, non-dominant arm for prophylaxis.  On 14-OCT-2019, the patient experienced a moderate to severe swelling of his non-dominant arm along with arm pain. The patient stated that he lost 5-10 pounds in the week since he had the vaccine. The patient had sought medical attention. The Patient spoke with his physician and was started treatment with cephalexin 500 mg one capsule twice daily. No lab diagnostics or studies performed. The arm swelling and pain have improved but not completely resolved and the outcome of the events was recovering. The outcome of weight decreased was unknown. The reporter considered the events to be related to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).
Pain at injection site, 16 days.   Dizziness. Fever. Chills. Muscle ache 72 hours.  Depression. Suicidal Ideation. 4 days.   Excessive Fatigue 15 days.
2/24/21 10:00 AM-2:30 PM, chills; 5:00 PM-10:00 PM, 101 deg. fever. 2/24/21-2/25/21 oxygen saturation dropped below 90 and pulse rate went from mid 70's to low to mid 90's. All vitals returned to normal by the morning of 2/26/21. No treatment performed. Self monitored for the term of the reaction.
From initial information received on 20Sep04 from a health care professional regarding an adverse event occurring, it was reported that staff members at a nursing home in Michigan received tetanus vaccine mistakenly for a PPD vaccine. The tetanus vaccine was given ID instead of IM and the pt's developed papular lesions. Information regarding the manf, lot number or site or admin of the Tetanus vaccine were not reported. It was not specified how many staff members at the nursing home were administered the wrong product. Their  recovery status was unk at the time of the report. From additional information received via telephone communication with the reporter, on 29Sep04, the correct phone number for the nursing home was provided as well  as the name and address. From additional information received via telephone communication with the reporter, on 29Sep04, the correct phone number for the nursing home was provided as well as the name and address. From additional information received via telephone communication with the reporter, on 29Sep04, from the nursing home supervisor, it was reported that there were six staff members who received tetanus toxoid, lot number U1048CA, ID, instead of PPD (manf unk): two staff members on 16Aug04 and four other staff members on 15Sep04. All had local reactions varying in severity and duration. A complete mailing address and fax number were provided. A request was sent to provide initial, gender, age, and if possible, a date of birth for each pt. Also additional information such as the adverse event, allergies, concomitant medications and any previous illnesses for each of the six staff members. It was reported that all six staff members have recovered. From additional information received on 05Oct04 from a health care professional, it as reported that the pt was a 26 pt was a 26 yr old female who received the Tet Tox ADS USP vaccination on 15Sep04. Two days post vaccination, on 17Sep04, the pt developed a red raised area 0.5mm in diameter. Reportedly the pt recovered from this event. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of cases 200403240, 200403241, 200403242, 200403243, and 200403244.
Initial report received from a healthcare professional on 21 AUGUST 2013. A 25-year-old female patient had received 0.1 ml intradermal dose of FLUZONE (batch number: UH717AA) intradermally on 21 AUGUST 2013. On 21 AUGUST 2013, the patient had inadvertently received expired dose of FLUZONE instead of 0.1 ml of Tubersol. The patient had no medical history; no illness at the time of vaccination and no known allergies. On 21 AUGUST 2013, at the time of administration, the patient experienced itching and knot in forearm. After 3 hours of vaccination, the patient experienced heaviness and pain in the arm. Laboratory investigations were not reported. The patient was given ZYRTEC (Cetirizine) and ice pack to the site (forearm) as corrective treatment. The outcome of the events was unknown. Documents held by sender: none.
Information has been received from a health professional concerning a female with hypertension, mitral valve pro lapse and a penicillin allergy, who on 19, Oct 2006 was vaccinated with a third, 1 ml, intramuscular dose of hepatitis B virus vaccine rHBsAg (yeast) (lot# 647274/0205P) that had expired. Concomitant therapy included atenolol (TENORMIN), 50 mg, amlodipine besylate (+) benazepril hydrochloride (LOTREL), 10/20 mg, HCTZ/triamterene (DYAZIDE) and alprazolem (XANAX), 0.25 mg. It was reported that the injection hurt. At the time of the report the patient was recovering. There were no laboratory and diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. Over a year ago, on an unknown date approximately in 2014, the patient was vaccinated with ZOSTAVAX dose 1 (strength, frequency, route, lot # were not reported). On an unknown date, patient was vaccinated with ZOSTAVAX. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
I received my vaccine on 1/24 in my left shoulder. After about 3 hours, my neck (on the right side) and the back of my head were hurting. After a few days of mild symptoms (fever, chills, headache and not hungry), I was fine. However the pain in my neck only got worse. As of today 2/3, my lymph node is swollen so bad, and I am in so much pain with this swelling.
Erythema at injection site; URI symptoms (body aches, non-productive cough, and nasal congestion)
contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine". Clinical course: In this recorded HCP-PT (Health care professional- Patient) interaction from Jul2022, a Patient reported that her partner and she contracted COVID-19, 2-3 weeks after receiving their third Pfizer vaccine. Patient said that they got COVID like two or three weeks later. They didn't have it for like two and a half years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300256318 same reporter/drug/event, different patient;
2nd dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-May-2023 Pharmacist reported on 1st May 2023 that patient received the first dose of Shingrix in October 2021 and the 2nd dose had not been administered yet. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
pain at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient had recently received Shingrix and had experienced pain at the injection site.
Patient received Infanrix 6th dose; 7 YO received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 7-year-old male patient who received DTPa (Infanrix) (batch number 7ec55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 5 dose series on an unknown date).   On 28th December 2022, the patient received the 6th dose of Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On 28th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comments: A nurse stated that a patient was given an extra dose of Infanrix. She stated that the patient had already gotten the 5-dose series and then got a 6th dose on the day of reporting.   The nurse did not report that the patient had any side effects.   The nurse did not want to supply the patient's initials or date of birth. The reporter consented to follow up. Additional Supportive Information: The 7-year-old patient received 6th dose of Infanrix, which led to extra dose administered and inappropriate age at vaccine administration.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL. The manufacture provided 0.5mL per vial instead of 0.25mL/ Vial.
1350 - patient is vaccinated, immediately becomes lightheaded/dizzy. Patient placed in wheelchair and taken to medical waiting area. 1355 - Vitals 91/50, 70/min. Pt reports feeling dizzy, faint, nauseated, weak. Pt appeares clammy, sweaty, decreased verbiage. Pt reclined on stretcher, reported feeling better. 1405 - Vitals 87/52, 73/min 1415 - Vitals 103/61, 73/min. Starting to feel better, tolerated water, mint candy. Pt states he feels normal, denies nausea, denies dizziness, denies weakness. Drank water OK. Ok sitting, Ok walking. Escorted out to scheduling area at 1418
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and he had a fever but it only lasted 2 days. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021245483, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021245483:same reporter
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 26-JUN-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # H020002, expiry date: 08-AUG-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. 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, 1407USA012934, 1407USA012935, 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.
This spontaneous report was received from an other non-healthcare professional via company representative concerning to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included steroids (unspecified). On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (dosing details, route, frequency, lot# and expiration date unknown) for prophylaxis on unknown date (might be the reason of vaccination) the patient was hospitalized twice for unspecified period of time (length of stay in the hospital). The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) by the neurologist. The patient was seen by the physician and it was unknown if she had received any treatment. The outcome of the event acute disseminated encephalomyelitis was unknown. The reporter did not provide the causality assessment. Upon internal review, the event acute disseminated encephalomyelitis was assessed as medically significant.
Rash identified by doctor as shingles at injection site. Doctor prescribed Acyclovir.
Soreness and bruising in arm of Tdap.  Still purple one week later.  Soreness in arm that covid vaccine was given 4/6/21.  Mild fever.  Severe fatigue - have to take a nap everyday.  Comes on suddenly.  Light headed.  Always hungry.
Was diagnosed with pulmonary emboli in right lung x 2 on 9/16/21 at time of routine oncology follow up visit  Had a scheduled CT Scan with the above findings   O2 Sat was 97%
Around 8:00 a.m. on 6/25/22, when walking outside of house, client noticed photophobia. Then, noticed double vision. Vision has decreased  since 6/25/22
couldn't hold a cup with the tremors; tremors; felt weak; very weak; very dizzy; chills; fever of 104; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (couldn't hold a cup with the tremors), TREMOR (tremors), ASTHENIA (felt weak), ASTHENIA (very weak) and DIZZINESS (very dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALTRATE + D PLUS, VITAMIN B NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced TREMOR (couldn't hold a cup with the tremors), TREMOR (tremors), ASTHENIA (felt weak), ASTHENIA (very weak), DIZZINESS (very dizzy), CHILLS (chills) and PYREXIA (fever of 104). At the time of the report, TREMOR (couldn't hold a cup with the tremors), TREMOR (tremors), ASTHENIA (felt weak), ASTHENIA (very weak), DIZZINESS (very dizzy), CHILLS (chills) and PYREXIA (fever of 104) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-060719 (E2B Linked Report). This case was linked to MOD-2021-060719 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060719:
Complaining of rash. Started Friday July 1st with blisters, itching, and fever to 101.7.
-Very sick 12 hrs after 2nd shot.   Unable to get out of bed, headache, chills, fever. - 2 weeks after 2nd shot 2/15/2021I developed tongue and vaginal ulcers.  Saw my dr.   Negative std rest.   No resolution why this happened.  -7/2/2021 began to feel weird, off balance, rash on inner elbow.  -7/6/2021 mouth ulcers appear.   Very painful one in my tongue. -7/9/2021 vaginal ulcer appear.   Very painful and worse than last time.    -At this time I?m feeling awful.  Skin hurts, headaches, tired, vision issues, low grade fever.   -7/16/2021 visit the Dr(ob/gyn).   Bloodwork and cultures taken.   Waiting on results. - 7/19/2021 finally starting to feel normal again.   But feel like something is wrong with me.
High fever 104.5 the evening of shot along with chills.  1st trip to urgent care on 04/28/21. No testing,  doc recommend Tynol for fever. Fever decreased with meds but would spike once meds wore off.  6 days later welts/hives appeared along backside with swelling in groin area & left side of lips. 2nd trip to urgent care 05/02/2021 doc treated for allergic reaction by administrating a steroid shot plus prescribed 10mg of Cetirizine, Prednisone along with an Epi pen.  Fever was at bay for 2 days but then resummed
urinary tract infection; body is sore / his body was sore; had a fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), MYALGIA (body is sore / his body was sore) and PYREXIA (had a fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient had no medications, food and other products allergies. The patient never had COVID. The patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection), MYALGIA (body is sore / his body was sore) and PYREXIA (had a fever). At the time of the report, URINARY TRACT INFECTION (urinary tract infection), MYALGIA (body is sore / his body was sore) and PYREXIA (had a fever) was resolving.            No information on concomitant medication was reported.  It was reported that the patient had all shots and was due for a booster. The patient went to the urgent care and they treated him for urinary tract infection. The event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The symptoms were improving.  No information on treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow-up information received included reporter's details, patient's demographic details (gender and height), events and event related information added.
Varivax administered 12-3-97 by unknown provider. We didnt start seeing this patient until 10-6-98. Presented in office today with possible modified chicken pox lesions less than 10 total.