chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrible rash all over torso and legs; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 days after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced a horrible rash all over his/her torso and legs. The patient received Shingles vaccine 8 days before the rash began. The patient asked could the vaccine had caused the rash. Additional supportive information: The follow-up would not possible, as no contact details were available.
1st day- L arm sore, diaphoretic, feeling slightly weak, had a headache, took 2 Tylenol with tremp relief 2nd day - woke up with L arm sore and a knot on vaccine area, Left eye swollen, no impairment of vision, no pain, no itching , no discharges. 3rd/ 4th No distress, feeling weak all weekend , eyes remain swollen, no pain, discharges, no redness 5th day - Back at work eye status no changes
Headache, achy, itchy, red, swollen area. Took ibuprofen, CORTAID cream and BENADRYL.
Severe Large area of Redness approximately 8 inches in size, similar to a cellulitis,  Area of injection is hot, very swollen, Headache x5 days so far , severe neck and back pain  fatigue malaise  Using Tylenol and Advil OTC pain medication
Slight soreness in arm. 4:00AM next day when i awoke, i had an upset stomach, slight chills, faint feeling.  Immediately, took 1 Aleve, and by 5:30, i was already feeling better.  All symptoms went away, INCLUDING the soreness in my arm.  I really didn't feel good at all.  I never miss work, but i was very close to calling in sick.
he got the first shot on 04Mar2021 and last week they called him and he received his second dose on Sunday, 21Mar2021.; He stated he had no reaction, only his arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 04Mar2021, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "He stated he had no reaction, only his arm hurt"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2021, outcome "unknown", described as "he got the first shot on 04Mar2021 and last week they called him and he received his second dose on Sunday, 21Mar2021.".  Additional information: Patient's age was reported as 73, with unknown units.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3:15pm - 4:00pm 1st time patient had a flu shot.  Within 15 minutes after giving flu vaccine, patient complained of feeling like something was in her throat, also very little bit of puffiness in cheeks. She could breathe ok. Administered 50mg Benadryl IM. Took Blood pressure (130/91). Patient felt light headed. Patient lied down. Called 911. EMT arrived approx 15 min later. B/P was 140/85. Decided to take to ER because complaining of light headed.
Chest pain, rash, general joint pain, leading to skin necrosis.  Diagnosed as leukocytoclastic vasculitis.  Extensive skin grafts to repair damage on both legs and feet.
After being in hot tub, developed chest tightness, dizziness, fatigue, and decreased appetite. Shortly after developed fever (103). Developed nausea and emesis (x10) around 3:00 AM on 02/18/2014. Treated with Advil and small sips of fluids at home. Came to urgent care at 9:52 AM on 02/18/2014 and was feeling well.
Facial Paralysis, facial droop, slurred speech - Diagnosis of Bell's Palsy
This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunization. The patient experienced high fever, headache, back ache, chills and hair fall on an unspecified date in Apr2021. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Breakthrough case admission after 4 vaccines Moderna 01/28/2021 Lot# 012L20A;  Moderna 2/25/21 lot# 004M20A;  Moderna 11/10/21 lot# 033F21A;  Moderna 4/21/22 lot# FM9992
Arm at injection site was sore, red, and hot to touch for 3 days. He also had a fever for 48 hours which began 12 hours post vax.
has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 039A21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (due to her medication Ocrevus) and Multiple sclerosis (at the age of 30, year late 1996- early 1997). Concomitant products included OCRELIZUMAB (OCREVUS) from an unknown date to 15-Dec-2012 for Multiple sclerosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine). At the time of the report, VACCINATION COMPLICATION (has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Antibody test: non-reactive (abnormal) non-reactive, no antibodies after 3 doses of the vaccine.         Reporter stated that after 3rd dose it was not bad, a little, nothing major and just probably Migraine.  No treatment information was provided.   This case was linked to MOD-2021-294520, MOD-2021-294611 (Patient Link).
Patient did not get any of the dose; Medication spilled on patient's arm; Medication spilled on patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20-MAY-2024) for prophylaxis.   On 02-MAR-2023, the patient received the 2nd dose of Shingrix. On 02-MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: Patient did not get any of the dose), accidental exposure to product (Verbatim: Medication spilled on patient's arm) and exposure via skin contact (Verbatim: Medication spilled on patient's arm). The outcome of the accidental underdose, accidental exposure to product and exposure via skin contact were unknown.   Additional Information: GSK receipt date: 2-Mar-2023 The reporter consented to follow-up via postal. The patient was administered a dose of Shingrix and while administering, the needle detached from the syringe and the medication spilled on the patient's arm and she is fairly certain that she did not get any of the dose, which led to accidental underdose, accidental exposure to product and exposure via skin contact.
8 days after vaccine - injection site turned red. sore, warm to the touch.  I began to itch continually, all over my body.  Nothing seemed to stop this uncomfortable itching.  Unable to sleep  for 2 nights because of the discomfort.  Began taking Benadryl which helped some -but blood pressure shot up to 155/88 (with meds usually runs  122/78).  Not sure if the spike was the vaccine or the amount of Benadryl to try and eliminate the itching.  As of this date 2/21/2021 itching has continued.  The injection still showing now a pink color as opposed to the red at the time of the adverse reaction started.
pt's mom called and pt had chills and red swollen arms. told her this is normal but she is complaining of dizziness.  she does have vertigo.
Fatigue; Chills; Severe diarrhea: needed to use bathroom every hour or two, including throughout the nights; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxitriptan (5-HTP) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced fatigue, chills and severe diarrhea which needed to use bathroom every hour or two, including throughout the nights. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event diarrhea and included treatment with loperamide hydrochloride (IMMODIUM). Since the vaccination, the patient had been tested for COVID-19. On 30Apr2021, the patient underwent nasal swab test, SARS CoV-2 test and the result was negative. The clinical outcome of the event severe diarrhea: needed to use bathroom every hour or two, including throughout the nights was resolved on an unspecified date in 2021, after a duration of 5 days; while that of the events fatigue and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This 80 year old white  female received the Covid shot on  3/10/21    and went to the ED and was admitted on 3/15/21 with the following diagnoses listed below. Pneumonia Pulmonary embolism
No Adverse event; administered with a bivalent vaccine after more than 12 hours post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture) and NO ADVERSE EVENT (No Adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No known allergies, no parental vaccine exposure.  The patient's past medical history included Behavioural disorder. Concurrent medical conditions included Asthma. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) from 19-Dec-2022 to an unknown date for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture).    Patient received 1st dose of Moderna COVID-19 vaccine on 11-Apr-2021. Patient received 2nd dose of Moderna COVID-19 vaccine on 09-May-2021. Patient received 3rd dose (1st booster) of Moderna COVID-19 vaccine on 29-Dec-2021.  The vial was first punctured on 16-Dec-2022 and the patient got the vaccine on 19-Dec-2022. Treatment information was not provided.
Received the vaccine and has an active Covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received the vaccine and has an active Covid-19 infection) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received the vaccine and has an active Covid-19 infection). At the time of the report, COVID-19 (Received the vaccine and has an active Covid-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Pt's mother noticed a small red, swollen wheal around injection site. Pt states that it hurts but she had no fever. Mother gave her TYLENOL and BENADRYL. I advised mother to take pt to an ER if it gets worse and spreads.
pt recv vax 11AM started screaming about 2:30, noted was red 7 swollen, hot;pt had HIB & IPV in lt leg;exam 2 inj points lt thigh w/erythema about 3x3cm, warm extends to knee from extremities;
Pt complained of pain at time of injection, most painful shot she has had, thought it was high on arm, thought immunizer had trouble with plunger.  Shoulder has bothered her since. Currently throbbing at night and disturbing ability to sleep even though she is taking naproxen for sprained wrist in same arm that occurred 2 days prior to vaccination.  Pt sprained wrist on Tuesday, came in for naproxen Rx on Thursday and got flu shot while here to pick up. Pt feels discomfort not related to sprain event.
Breakout of hives; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: EW0170) via an unspecified route of administration in the left arm on 30Apr2021 at 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. Concomitant medications included triamcinolone acetonide (NASACORT) started on unknown date for pollen allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On 17May2021, the patient underwent Rapid test and the result was found negative. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 at 13:00 the patient experienced breakout of hives It began around1:00 PM with hives appearing on buttocks and right hip. Hives spread to chest, back, arms, and thighs overnight. On 23May2021, At 7:00 AM patient took one 10 ml dose of children's Benadryl (liquid). The hives went away within 1-2 hours. Therapeutic measures were taken as a result of breakout of hives and included treatment with 10 ml dose of children's Benadryl (liquid) started on 23May2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event breakout of hives was recovered on 23May2021.  No follow-up attempts are needed. No further information is expected.
The evening after his bivalent vaccine, he developed a rash on his hands, feet, and legs.  The rash was itching.  Benadryl seemed to help for a while but then the rash would return. He took 75mg of Benadryl that evening over several hours.  He had trouble the next day, as well.  By 10/1/22, the rash had improved and the patient did not have anymore trouble.  He also had no trouble with throat swelling or breathing.
Sleep disturbances (once for roughly one hour in the middle of the night). Every night since onset.
I started experiencing abdominal pain and fever on 10/1. I was told to take ibuprofen for the fever and Pepcid and Pepto Bismol for the abdominal pain. I was admitted to the hospital for an appendectomy on 10/8. The doctors found my appendix had completely ruptured.
"Covid arm" , approximately 9 days after 1st Moderna shot I thought I had a bug bite on my arm below the injection site.  It was warm, itchy, red and slightly raised.  Since that time it has grown in size, reduced in redness, does not itch, very warm to touch, raised red edge.
Chills, nausea, headache, achy joints/muscles for 24 hrs
No adverse event, patient/spouse reported having no symptoms or side effects 3 days after vaccination.  Patient came for "second covid vaccination" and was processed through system as Pfizer vaccine instead of the Moderna vaccine he had received for initial dosage due to several factors/miscommunication.  Patient received Pfizer vaccine on 8-16-21 instead of the 2nd Moderna dose that he expected, but he did not vocalize which vaccine just brought in his card at last step of process.  Intern administering vaccine did not remember to confirm with patient/double check the vaccine card and administered Pfizer vaccine (which was processed through Rx system mistakenly due to miscommunication with patient).  Patient/spouse were concerned about receiving different manufacturers/differnet mRNA vaccines so VAERS report has been filed to report error.  No adverse effects or side effects from vaccination, patient was just concerned that they received 1 dose of Moderna then 1 dose of Pfizer 4 weeks later instead of both Moderna doses.
Welts on various places beginning on the 8th, breathing difficulty beginning on the 9th.
On November 17, 2012 patient noticed redness on left arm where the PNEUMOVAX vaccine was administered. Pt went to a walk-in clinic on 11/18/12 to receive antibiotics for a cellulitis reaction. On 11/20/12 patient came to pharmacy because reaction was not getting better.
Felt like collapse; Hot press; Tingling of the stomach; achy arms and shoulders; Extremely tired; Right side hurts as if some one kicked/ Right arm still hurts; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of the stomach), FEELING HOT (Hot press), FEELING ABNORMAL (Felt like collapse), ARTHRALGIA (achy arms and shoulders) and FATIGUE (Extremely tired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017A21A and 017A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PARAESTHESIA (Tingling of the stomach), ARTHRALGIA (achy arms and shoulders), FATIGUE (Extremely tired) and MYALGIA (Right side hurts as if some one kicked/ Right arm still hurts). On 02-May-2021, the patient experienced FEELING HOT (Hot press). On 03-May-2021, the patient experienced FEELING ABNORMAL (Felt like collapse). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of the stomach), FEELING HOT (Hot press), FEELING ABNORMAL (Felt like collapse), ARTHRALGIA (achy arms and shoulders), FATIGUE (Extremely tired) and MYALGIA (Right side hurts as if some one kicked/ Right arm still hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: increased (High) Heart rate increased.         No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Was very fussy the night of vaccinations, stopped screaming and had a seizure.  Per ER report and doctor.
pt screamed from 930AM to 2PM 26MAY92 p/recvd DTP; mom called MD told to given APAP & cool cloth on inject site to relieve pain & soreness;
No additional AE; A 19 year old Patient was administered the 0.5mL VAQTA Pediatric Formulation instead of the VAQTA Adult Formulation; A 19 year old Patient was administered the 0.5mL VAQTA Pediatric Formulation instead of the VAQTA Adult Formulation; This spontaneous report was received from a nurse and refers to a 19-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 11-MAR-2021, the patient was vaccinated with hepatitis a pediatric dose of vaccine, inactivated (VAQTA), 0.5 milliliter (route of administration, lot# and expiration date were unknown) for prophylaxis instead of an adult formulation of hepatitis a vaccine, inactivated (VAQTA). No adverse event was reported.
Atrial Fibrillation; his heart was racing and was something very unusual; This is a spontaneous report from a contactable consumer (patient himself). An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient mentioned that he was a pretty healthy at 80 years old. He and his wife got vaccinated for the 1st shot last 05Jan2021. He experienced no side effects for a week. On 12Jan2021, he experienced his first ever episode of atrial fibrillation and said that his heart was racing and was something very unusual. He mentioned that his I-watch first notified him of this and he went to consult his doctor who confirmed this. He was prescribed with baby aspirin but had not taken it yet. Outcome of events were unknown.   Information about batch/lot number has been requested.