chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACHY LEGS FROM THE HIP DOWNS THAT FEELS LIKE GOWNING PAINS; HEADACHE; This spontaneous report received from a consumer concerned a 34 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 23-APR-2021, the subject experienced achy legs from the hip downs that feels like gowning pains. On 23-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and achy legs from the hip downs that feels like gowning pains was not reported. This report was non-serious.
I read on an App that DR. has 2 patients who have developed Lupus and after the Pfizer vaccine. He is still studying the cases closely to report them; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On unspecified date, patient has developed Lupus after the vaccine. Treatment received was unknown. Reporter informed that has 2 patients who have developed Lupus after the Pfizer vaccine and was still studying the cases closely to report them. The outcome of event was unknown.  Information about batch/lot number has been requested.
Have a bullseye on her left arm about 3 to 4 inches long. Its red and raised and underneath it, it feels hard and itchy. Kind of tender and swollen
Disseminated Herpes zoster (shingles) requiring hospitalization and IV acyclovir - involving multiple dermatomes - unclear if there was CNS involvement as LP was not obtained.
Occurred approximately 36 hours post injection. Red, swollen, painful, hot at injection site. Significant swelling of entire upper arm. Pain at injection site and radiating up to neck. Lasted approx. 24 hours.
pt recv vax 6DEC96 & on 8DEC96 pt begin having pain in lt wrist;knees began hurting;rt hand was completely stiff & had trouble making a fit;shoulders,fingers, knees & ankles ached;fingers swollen;
Urticaria scattered of neck and upper chest within 10 minutes Skin reaction suspected secondary to vaccines provided in the clinic.  Patient was given Diphenhydramine 12.5mg/5ml, 2 mls po once and monitored for 30 min,  Hives subside without any noted worsening sxs.  Lung sounds clear, no wheezing. No edema noted of face, mouth, lips, or tongue.  Mother was provided handout on allergic reactions and advised to follow up sooner for worsening rash, swelling of mouth/face/tongue, difficulty breathing/feeding etc.  Advised she may administer Diphenhydramine 12.5ml/5mls, 2 mls po once every 6 hrs PRN allergic symptoms.  She stated she understood.  Subsequent vaccines will be provided after WCC only to allow for provider monitoring
Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: It was defrosted in room temperature 27OCT2021.  No concomitant medications were reported.  No treatment information was provided.
This patient received vaccinations on 02/12/01 around 11 AM. The mother noticed redness and swelling to right leg around 8 PM. The mother used a warm salty cloth.
Day 2 (May 23rd) after vaccination on May 22nd, 2009, my son developed weakness. Day 3 (May 24, 2009) after vaccination, my son had high fever in the 100's and sore throat. Day 4 (today May 25, 2009): my son's fever goes down but he has running nose, wheezing, and sore throat.  His running nose and wheezing may be related to his allergies.
This spontaneous report as received via a company representative from a registered nurse refers to a 12 years old female patient with milk allergy. The patient was vaccinated with dose 2 GARDASIL; (reported lot number H009746, expiry date 11-JAN-2015, route and dose not reported) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient fainted after receiving the 2nd dose of GARDASIL. The patient had previously received her first dose (date, dose and route not reported) without experiencing an adverse event. The patient did not receive any treatment. No relevant tests were performed. The patient seemed recovered after a few minutes. A reporter causality for fainted was not provided for GARDASIL. The registered nurse reported about 2 patients (sisters) who fainted after receiving the 2nd dose of GARDASIL: Linked case report is 1210USA008937. Additional information is not expected.
Started w/mild h/a following morning & next day h/a was so severe not relieved by APAP; It persisted until late afternoon & mild h/a on & off until next morning;
pt recv vax 8APR97 emesis began @ 3:00 9APR97 & again in AM seen 11AM 9APR97;nl VS, t100.7;
Information has been received from a registered nurse concerning a 6 year old female with no known drug allergies and a history of upper respiratory infection who on 09/26/1995 was vaccinated SC in the left arm with the first dose of varicella vaccine. Concomitant therapy at the time of vaccination included Pediazole and Phenergan VC for treatment of an URI. She was not currently on any medication. On approximately 09/26/2001, the pt developed a breakthrough case of 10-16 lesions on her buttocks, back, chest, legs and arms. She also developed pruritus. It was noted that she was afebrile. No treatment was implemented, and no medical attention was sought. The pt recovered on 10/01/2001. No further info is available.
black-blue" spot of approximately 5 inches, below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site). At the time of the report, VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site). At the time of the report, VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
I developed a red, swollen hard area surrounding the injection site 4 days after injection.  It has now become warm to the touch and itchy.  And this is 8 days post injection.  I was given MODERNA COVID19 EUA
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # L050908, expiration date reported as 14-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered does of vaccine experienced the temperature excursion of -4.8 degrees Celsius for 3 hours 4 minutes. There was previous excursion of 1.1 degrees Celsius for 7 hours 14 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 7 doses of improperly stored VAQTA, lot # M011116 with expiration date: 17-JUN-2017 and 1 dose of improperly stored VAQTA lot# L048456 with expiration date: 25-MAY-2017 (dose and route of administration were not reported) were administered to the patients. Administered doses of VAQTA underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023; No adverse event; Patients received the COVID vaccine a couple days after the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023).    The concomitant medication was not reported by reporter. The three patients received the COVID vaccine a couple days after the BUD. The date of administration 21-Feb-2023, 20-Feb-2023 and 22-Feb-2023. The vial was initially stored in the fridge on 18-Jan-2023 and 20-Jan-2023. The vial did not undergo any temperature excursions. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713020 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713020:adolescents/adults case
vaccine administered 5/18/2022, beyond use date 4/18/2022, expiration date 5/21/2022
Pt. passed out after receiving Tdap (approx 4-5 min after injection) fell and hit forehead - open lac required glue & MD visit.
Patient came in for a booster dose (0.25ml) and was given a full dose (0.50ml).
MD dx pt devel Haemophilus influenzae B epiglottitis approx 42 days p/vax; pt was hospitalized, intubated, treated w/Cloramphenicol & released; PE showed  12-hr hx of inc difficulty in breathing w/drooling, t102.8, Resp 32, stridulous breat
SkinRash Narrative: Fine red rash itching to abdomen. Also itching to injection site r arm. Advised to take otc diphenydramine or loratidine
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 10-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number L040415, expiration date 13-APR-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19; her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), 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's relevant medical history included: "disabled" (unspecified if ongoing), notes: HCP called on behalf of her son who prescribed Paxlovid due to being diagnosed with Covid-19. 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 "her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: prescribed Paxlovid due to being diagnosed with Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: prescribed Paxlovid due to being diagnosed with Covid-19. HCP reports that her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19. HCP reports that another HCP would not honor the prescription for Paxlovid due to her son having a G-tube. HCP was asking if the Paxlovid pills can be broken or crushed and administered via a G-tube.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Rxn to HPV. Bump at injection site started growing that night, pain and swelling present at visit 10/2/14. Temp 98 F. Erythematous halo around both vaccines, mildly tender but not exquisitely so 8.5 x 7. BENADRYL given.
FLUMIST on 12/6/12. Fever, cough, congestion on 12/9/12.
Patient inadvertently given Fluarix when requested Fluad. Patient was made aware of error.
3 doses of Menactra given with third dose on 7/1/21, second dose on 8/16/19, first dose 8/15/14.  Office had no records of second dose or information that pt had been seen elsewhere so dose was given 7/1/21 thought to be second dose.  Office received records on 7/6/21 from another office indicating that second dose had been given 8/16/19.
seizure; vomiting; vagal response; fainted; unconscious; This case was reported by a consumer via call center representative and described the occurrence of fainting in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than an hour after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fainting (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), vagal reaction and vomiting. On an unknown date, the outcome of the fainting, unconscious and vagal reaction were recovered/resolved and the outcome of the seizure and vomiting were unknown.   It was unknown if the reporter considered the fainting, unconscious, seizure, vagal reaction and vomiting to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient's father reported the case. The age at vaccination was not reported. The patient recently had a flu vaccine. Within 10 min after getting the dose, he had a vagal response. He fainted and was unconscious for 5 to 10 min. Then less than a day after vaccination, he started seizing and vomiting. The patient was taken to the emergency room. The reporter stated, the patient had similar experiences when he was young following injections or blood draws.
New onset N/V/D fevers within two weeks of first COVID-19 vaccination. Required hospitalization and GI w/u revealed diffuse severe proctocolitis, potential pancolitis with deep ulcers concerning for Crohn' s disease. (no family or previous history of such).
Headache, Myalgia, Fever, CHILLS, WEAKNESS, INJECTION SITE PAIN Narrative:
Have not had a menstrual cycle since getting covid vaccine.; Have not had a menstrual cycle since getting covid vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 16:30 (Lot number: EW0179) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUATION DELAYED (non-serious), outcome "not recovered" and all described as "Have not had a menstrual cycle since getting covid vaccine.". The event "have not had a menstrual cycle since getting covid vaccine." and "have not had a menstrual cycle since getting covid vaccine." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder, menstruation delayed.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior and post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Have received the flu vaccine every year without incident and was 100% well when I received it. Received my vaccine at 12pm. By 2 pm had hot hard painful lump so I took 1 gram of oral tylenol. By 4pm had 101 fever and lump had increased to 4 inches in diameter and was raised 1 inch from surrounding tissue applied an ice pack for half hour. By 8 pm that night lump had increased to six inches in diameter and remained one inch raised and it was incredibly painful home from work at that time and ice pack applied, temperature remained >101 degrees. Fell asleep, woke up at 2300 with 102.7 temp and rigors. Lump in arm remained 6 inches in diameter and incredibly painful. Took another gram of tylenol and reapplied ice. Continued to have a fever >101 until the morning of October 3 despite taking antipyretics around the clock. In the morning of Oct 3 noted that the lump with still 6 inches in diameter but not nearly as raised or hard and less painful than previously. Notified my employee health RN as I had received the vaccine at work which is mandatory by my employer. i did end up missing one day of work on October 2nd as I still had a fever 101-102 degrees.