chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt some of the dose going down arm; Felt some of the dose going down arm; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient moved during the vaccination consequently some of the dose went down her arm.   The patient's medical history was not provided. No concomitant product use was reported.  On 19 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 16M20A) intramuscularly for prophylaxis of COVID-19 infection. It was reported that the patient moved during the vaccination consequently some of the dose went down her arm.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event felt some of the dose going down arm, was considered as recovered on 19 Feb 2021.  .; Reporter's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # 16M20A with no associated AEs. Causality for the medication error is not applicable.
significant pain in the arm; headache; Mild lightheadedness; nausea; This is a spontaneous report from a non-contactable healthcare professional. A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, on an unspecified date, experienced significant pain in the arm starting approximately 4 hours after injection lasting into the next day; a headache a few hours within injection; mild lightheadedness and; nausea. No treatment was received for these adverse events and the patient recovered from these events on an unspecified date. The adverse events were assessed as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient has been COVID-tested post vaccination on an unspecified date with unknown results.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
pt returned to flu clinic table & reported feeling dizzy, lightheaded; BP 164/70 sitting; 148/78 standing; pulse 80 regular;
flu like symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Fluarix Tetra.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms.
pt recvd vax 2nd series on 21MAY92, mom reports t107 that evening & pt was taken to ER;
covid 19 infection; covid 19 infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single 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 "covid 19 infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 84 year old male patient. On 15-OCT-2014 (reproted as today) the patient was vaccinated with PNEUMOVAX 23, injection (lot # J004080, expiry: 22-AUG-2014), 0.5 ml, right deltoid. It was reported that the patient was administered with expired PNEUMOVAX23 and also reported that potency supported and no adverse effects were noted by patient. No product quality complaint (PQC) was involved. The outcome of the events was unknown. No other information was reported. Additional information has been requested.
I was fine but at 5pm Monday 3/8 I felt nauseous. Tuesday I was nauseous really badly with bad chills. I went to bed. no fever. chills all night. wanted to throw up but didn't. Wednesday I had nausea but no chills and by noon Wednesday the nausea was gone and I was fine.
Breakthrough case admission after 4 vaccines Moderna 2/7/21 Lot# 038K20A;  Moderna 3/7/21 Lot# 030A21A;  Moderna 10/26/21 Lot# 017#21A;  Moderna 11/25/22 Lot# 057f22A
pt recvd vax 11AUG94 & w/in 24-48 hrs pt devel a local area of erythema which expanded to 4 inches in diameter pt c/o dizziness & not feeling well;  pt devel jerking & balance problems that progressed to szs;
Pt presented due to hypotension during dialysis session. He reported having diarrhea over the last week and is unsure if he has had fevers as he has not been checking his temperatures.  Unsure if he has any blood in the stool.  States that he does not produce any urine.  Complains of nausea and slight abdominal discomfort but no vomiting. He was found to be COVID positive upon arrival.
This spontaneous report as received from a healthcare professional (healthcare worker) refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (single dose vial) (lot # K019561, expiration date: 20-APR-2016; dose, frequency and route of administration were not reported). No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to the ED on 3/7/21, patient admitted to the hospital on 3/12/21. Patient presented to the ED and was subsequently hospitalized on 3/14/21. These visits are within 6 weeks of receiving COVID vaccination.
negative varicella titers; received 2 doses of VARIVAX on unspecified dates "approximately 20 years ago" and one dose of VARIVAX on an unspecified date "approximately 10 years ago"/after receiving 3 doses of VARIVAX; This spontaneous report was received from a physician assistant referring to an approximately 52 years old female patient. She had no pertinent medical history, or drug reactions/allergies. The patient received unspecified medications for diabetes.  In approximately 1999 (reported as approximately 20 years ago), the patient received 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, unit, route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in approximately 2009 (reported as approximately 10 years ago), she received one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, unit, route, lot number and expiration date were not reported) (extra dose administered).  After receiving 3 doses of varicella virus vaccine live (oka/merck) (VARIVAX), on 20-MAY-2019, the patient had blood work which showed negative varicella titers. No treatment was given. The patient had sought medical attention. The outcome of the event negative varicella titers was reported as not recovered. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Looks like chicken pox; Very itchy scabs on arms; Sores on arms; Chest and back burn sensation; Back pain; Chest pain/ Chest burning; Pain sensation; Very itchy rash on arms; This non-serious case was reported by a other health professional via call center representative and described the occurrence of chickenpox in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.  On 07-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than a month after receiving Shingrix, the patient experienced chickenpox (Verbatim: Looks like chicken pox), scab (Verbatim: Very itchy scabs on arms), ulcer of upper extremity (Verbatim: Sores on arms), burning sensation (Verbatim: Chest and back burn sensation), back pain (Verbatim: Back pain), chest pain (Verbatim: Chest pain/ Chest burning), pain (Verbatim: Pain sensation) and itchy rash (Verbatim: Very itchy rash on arms). The outcome of the chickenpox, back pain and chest pain were not reported and the outcome of the scab, ulcer of upper extremity, burning sensation, pain and itchy rash were unknown.  It was unknown if the reporter considered the chickenpox, scab, ulcer of upper extremity, burning sensation, back pain, chest pain, pain and itchy rash to be related to Shingrix.  It was unknown if the company considered the chickenpox, scab, ulcer of upper extremity, burning sensation, back pain, chest pain, pain and itchy rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 31-MAR-2023 The reporter was a Medical Assistant. The patient was not immunocompromised. He had reached to the Healthcare Professional (HCP) office the morning of the reporting and reported very itchy rash scabs, sores, on arms, chest and back burn and it pain sensation.  The HCP stated that, this had looked like kind of chicken pox. The reporter had consented to follow-up via email.
Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.
Received 2nd Covid vaccine on 12/3/2021.  On 12/9/2021 around 5pm, he got sick with nausea, stomach pains, nausea, vomiting, and diarrhea and is staying home from school on 12/10/2021..  The same exact  thing happened at 5am on 11/17/2021 and he had to stay home from school because of it and his first vaccine dose was on 11/12/2021.   I reported separately for the incident related to his first vaccine dose.
Skin Infection with redness, swelling, warmth pain, lump , low grade fever 99.1F,.  Treatment: Cleocin HCL -300mgs 3 times a day for five days.
Child was given 0.2 ml of undiluted COVID vaccine.   Tolerated vaccine well.  Spoke with Step father on 10/25/22 who reports side effects of fever, nausea, body ached and headache within 8 hours of getting vaccine.  Symptoms improved by morning.
Suspected Vaccination Failure; Got both shingrix vaccines and still broke out with shingles a month later; This case was reported by a physician and described the occurrence of suspected vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria GSK medically significant). 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 Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient who got both shingrix vaccines and still broke out with shingles a month later. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Fever 101.2, child complained of headache and joint pain specifically ankles and knees, and back pain.  Also complained of abdominal pain, and vomit.  In addition he had chills and the start of a runny nose. This exact same thing happened when this injection was given to my other child.
burning; big red blotchy; soreness in the arm; pain in the chest, It feels like there is something in the chest; tightening in the chest; broke out in hives, little by little there were hives in different parts of the bod; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives, little by little there were hives in different parts of the bod), BURNING SENSATION (burning), RASH MACULAR (big red blotchy), CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced URTICARIA (broke out in hives, little by little there were hives in different parts of the bod). On 01-Oct-2021, the patient experienced CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest). On an unknown date, the patient experienced BURNING SENSATION (burning), RASH MACULAR (big red blotchy) and PAIN IN EXTREMITY (soreness in the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives, little by little there were hives in different parts of the bod), BURNING SENSATION (burning), RASH MACULAR (big red blotchy) and PAIN IN EXTREMITY (soreness in the arm) was resolving and CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.
EXPERIENCED PAIN, SWELLING, REDNESS, INFECTION.  ERTHYEMIA WITHIN 6 HOURS.  AREA IF ERTHYEMIA INCREASED IN SIZE TO 9.5 CM TO 11 CM.  TENDERNESS AND INDURATION WITHIN 36 HOURS.  TREATED WITH KEFLEX, BENADRYL AND MOTRIN.  WILL RE-EVALUATE WITHIN 8 HOURS OF BEING SEEN.
Client was vaccinated with Pfizer vaccines for Covid on March 1 and April 1, 2021.  (dates approximate within a few days).  Developed Covid symptoms on 9/26/2021: headache, fever, fatigue, cough.  Reported as a case of breakthrough Covid illness in previously vaccinated person.
This case was reported by a consumer and described the occurrence of pain in upper extremities in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in upper extremities, local swelling and skin warm. On an unknown date, the outcome of the pain in upper extremities, local swelling and skin warm were unknown. It was unknown if the reporter considered the pain in upper extremities, local swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patients arm had a pretty good size lump larger than a quarter and it was warm and it was really hurting. The patient asked whether it was normal.
<30 lesions, macules and vesicles on chest, back face and scalp. DX varicella, TX Atarax.
Information has been received from a physician concerning an 84 year old female with hypertension, no drug reactions/allergies who on 18-FEB-2008 was vaccinated with ZOSTER vaccine (therapy route, site unknown). Her concomitant medication was numerous medications (unspecified). She was irate that on 01-AUG-2008 she developed shingles and "never knew that efficacy in her age group is low percentage." She sought medical attention and "her physician stopped prescribing ZOSTER vaccine for the latter reason". At the time of report the patient didn't recovered. Additional information has been requested.
Woke up with a substantial headache as if dehydrated, shivering but not cold.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of VARIVAX (lot# N017698, expiry date 09-JUN-2019; lot# M038856, 14-SEP-2018, expiry date; lot# M047660, expiry date 02-DEC-2018; dose and route of administration not reported) for prophylaxis. Sterile diluent (unknown lot number and expiration date) used for reconstitution of VARIVAX was properly stored. No adverse effects were reported. Administered doses of vaccine were stored in -14 to -10 degrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions. The call was because of a "data logger".
Patient got her Imz on 11/4/14. She stopped by the pharmacy on 12/16/14 to report muscle soreness since getting IMZ. She went to dr which was going to order xray and possible physical therapy.
Woke up 3am today (7/31/07) c/o 'being itchy". Mom noted slightly red raised rash on arms and lower back. Cheeks 'red and blotchy but no rash "child does not have fever. Mo gave Benadryl.
pt into clinic @ 115PM observed several white raised pencil eraser sized bumps on anterior aspect of lt arm; same arm as immun given on; also c/o h/a; BP 128/80;
Patient woke up with a red, raised, itchy rash on the morning of 05/20/2010.  Rash was all over her body. Patient went to her private doctor who felt it was an allergic reaction to something in the vaccine (Tdap) that she received the day before.  She was treated with a Medrol pack and Atarax.
Sore arm; unauthorized age received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Patient mistakenly given both doses of the vaccine.  No concomitant and treatment information were reported by the reporter
A non-serious spontaneous report of we gave FLUMIST to a 58-year-old person was received from a nurse concerning a 58-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Oct-2009, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
CHILLS, HEADACHE, TIREDNESS, RUNNY NOSE, SCRATCHY THROAT, SORE AT INJECTION SITE DOWN TO ELBOW
Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no  appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.
COULD NOT DRIVE HOME; THREE DAYS SLEPT (NOT LIKE ME AT ALL); STOMACH WAS OFF; WAS DIZZY; SOME OF FINGERS WERE NOT FEELING RIGHT; HURTING FOOT/CONTINUES TO HURT FOOT/ TURNING IN FOOT; DO NOT HAVE THE STRENGTH; LEG GO NUMB/NUMB GOES UP ENTIRE LEG AND OTHER FOOT WAS STARTING; VERY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not drive home, three days slept (not like me at all), stomach was off, was dizzy, some of fingers were not feeling right, hurting foot/continues to hurt foot/ turning in foot, do not have the strength, leg go numb/numb goes up entire leg and other foot was starting, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very tired, could not drive home, three days slept (not like me at all), stomach was off, and was dizzy, had not recovered from leg go numb/numb goes up entire leg and other foot was starting, and the outcome of hurting foot/continues to hurt foot/ turning in foot, some of fingers were not feeling right and do not have the strength was not reported. This report was non-serious.
lightheadedness; fast heart rate; right arm tender; right arm red; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), HEART RATE INCREASED (fast heart rate), TENDERNESS (right arm tender) and ERYTHEMA (right arm red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPRIN) and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (lightheadedness), HEART RATE INCREASED (fast heart rate), TENDERNESS (right arm tender) and ERYTHEMA (right arm red). On 10-Feb-2021, DIZZINESS (lightheadedness) and HEART RATE INCREASED (fast heart rate) had resolved. On 20-Feb-2021, TENDERNESS (right arm tender) and ERYTHEMA (right arm red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Engerix B (Hep B vaccine) administered on 1-31-08.  Expiration date 1-25-08.  No ill effects noted.
Sore arm, chills starting 24 hours after, fever since around 6pm last night (99.3 - 100), body aches, headache, fatigue
A 55 year old male pt was bitten by a rabid raccoon (confirmed) and received post-exposure prophylaxis treatment of RabAvert and human rabies immune globulin (HRIG) Feb 02 to March 02. He received all 5 doses of RabAvert. The pt developed severe flu-like symptoms and bad headaches. The symptoms got worse with each dose. The pt is still experiencing severe headaches, body aches, and numbness in finger 10 months after completion of treatment.