chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles in eye; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Right after the patient got the Shingrix vaccine, she got shingles in her eye a year and a half ago and she was still struggling with it and now the patient requires cataract surgery. The reporter did not consent to follow-up.
Bursitis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Bursitis). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, BURSITIS (Bursitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: recieved - Non Significant information added
Pt developed localized redness and swelling over (L) Vastus Lateralis sites within 24 hrs. Now 2 wks later has an erythematous ring about 10 cm with 2 cm lump in middle. No longer tender.
Information was received from a medical assistant concerning unspecified patients (demographics not provided).  The medical assistant reported that an unspecified number of unspecified patients received doses of VAQTA on unspecified dates that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. This is one of three reports from the same reporter (see case # 1412USA007342 and 1412USA007353). Additional information has been requested.
This spontaneous case, initially received on 26-Oct-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 26-OCT-2016 to 26-OCT-2016. Dose regimen: 1 ml, Route of administration: Intramuscular. Batch number: 13249221A. No additional suspect drugs. Adverse event description: On 26-Oct-2016, the patient was accidentally given a 1 ml dose of the vaccine instead of a 0.5 ml (outcome: unknown, special circumstances: accidental overdose without adverse event).
approx 5 minutes after the vaccination she began to feel nauseaous, weak and then her hands began to cramp. I called EMS. In the meantime she was returned to the vaccination room and she wanted to lie on the floor. She stated she had a panic attack years ago with similar symptoms. We did not administer epinephrine or diphenhydramine . EMS brought her to the hospital.   Her husband returned later in the day and said that they thought it was a panic attack.
intense pain over total body, waves of more intense pain. nausea chills, feeling hot, temp 98.6 duration 8 hours, subsided to lower level pain for 24 hr nausea continued for 48 hrs no treatment
TD vaccine given 10/27/06.  Hives in the mouth, feet had swelling on same day and swelling at the site. went to ER at Hospital 10/30/06.  Was given steriods, IV, Benadryl IV, and sent home with a Z-Pack and steriods.
soreness at injection site and in armpit.; soreness in armpit of the same arm as injection site; This is a spontaneous report from a contactable consumer. A 63-years-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732), via unspecified route of administration on 20Mar2021 at 14:15, (at the age of 63 years) as a single dose for COVID-19 immunisation on left arm. Medical history was not reported. Concomitant medications were not reported. The patient also received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205), via unspecified route of administration on left arm on 04Mar2021, (at the age of 63 years) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. The patient received unspecified medications within two weeks of vaccination. On 26Mar2021 the patient experienced soreness at injection site and in armpit of the same arm as injection site. The patient did not receive any treatment for adverse event soreness at injection site and arm pit of the same arm as injection site. The clinical outcome of the event soreness at injection site and arm pit was recovering.   No follow-up attempts possible. No further information expected.
BODY ACHES; MALAISE; FATIGUED; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prevention of covid 19. No concomitant medications were reported. On 08-APR-2021, the subject experienced malaise. On 08-APR-2021, the subject experienced fatigued. On 10-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malaise, body aches, and fatigued. This report was non-serious. This case, from the same reporter is linked to 20210422648.
nausea; back pain; body pain; fatigue; chills; neck swelling; more in the back side of the neck, causing her pain.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 (age at vaccination was 34 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism (Consumer reports she has hypothyroidism) from an unknown date and unknown if ongoing. There were no concomitant medications. Reporter stated that the patient was vaccinated on 29Apr2021, Thursday. On 30Apr2021 at 05:00 PM (reported as Friday), the patient experienced nausea, back pain, body pain, fatigue, chills and neck swelling. The patient reported that the neck swelling was due to the two bumps both sides of neck and palm sized, and one more in the back side of the neck, causing her pain. Consumer called in requesting information about whether she should being vaccinated with second dose after these adverse effects with first dose. Outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch Number cannot be obtained.
PATIENT HAD FLU LIKE SYMPTOMS (BODY ACHES, FEVER, SORE THROAT) THAT STARTED MORNING AFTER VACCINATION.
This spontaneous report has been received from a registered nurse, concerning an unknown number of patients of unknown ages and genders. The patients´ medical history, concurrent conditions and concomitant medications were not provided. On 03-APR-2018 (reported as probably), the patients were vaccinated with improperly stored doses of VARIVAX lot # M046005 with expiration date 20-SEP-2019; lot # N022996 with expiration date 23-AUG-2019; lot# N020016  with expiration date 17-JUL-2019; lot # M046926 with expiration date 28-NOV-2018 and, lot # M046005 with expiration date 18-NOV-2018. Furthermore the patients were also vaccinated with improperly stored doses of PROQUAD lot # N025928, (rHA) with expiration date 18-MAR-2019 and, lot # N023001, (rHA) with expiration date 19-FEB-2019 and, ZOSTAVAX lot # N025569 with expiration date 13-DEC-2018 and, lot # N025387 with expiration date 02-DEC-2018 (doses, frequencies and routes of administrations were not provided) which were reconstituted with a properly stored sterile diluent. No adverse effect reported. The vaccines were stored at a temperature of 6 Fahrenheit degree to 14 Fahrenheit degree, time frame of 1 hour with a previous temperature excursion of (6 Fahrenheit degree to 14 Fahrenheit degree for 30 minutes). Digital Data logger was involved.
Presented to urgent care 9/13/21- stated she had right eye swelling that resolved with benadryl. Had flu like symptoms including headache and ongoing right eye blurry vision (hx migraines w/ blurry vision; patient reports blurriness is mild). Took tylenol without improvement. Given IM ketorolac in office. Advised to continue with supportive care at home.
approximately 2 weeks post second dose I started with a low level , high pitched tinnitus in the right ear. It has been constant since that time with no improvement or worsening. Occasional (approximately 5 days total) I've had days where I can also feel pressure in the right ear, discomfort with swallowing. On 2 occasions I've experienced a momentary intensity of the tinnitus but then it returns to the "normal" level
Rash Narrative: ON 1/13/2021 DEVELOPED ITCHY WELT 1"X 1.5" 1 WEEK LATER AFTER THE VACCINE IN AFTERNOON. ON 1/14 FELT MORE LIKE RASH, LESS RED BUT HAD ENLARGED TO 2"X3". RESOLVED ON 1/19/2021.
Dermatofibroma (8 mm-raised, hard lesion) in center of exact smallpox vaccination site that has caused extreme itching intermittently for the last 2 years.  Sometimes the pt scratching irritates the lesion breaks the skin the itching is so intense.  Referred to dermatology for biopsy/excisement.  Symptoms: Nodule, epidermal.
Hives, itching throughout body, mainly back, head, palms of hands. Taking Benadryl.
p/vax pt exp herpes zoster w/250 lesions on back, arm & down legs which were described as vesicles & papules;fever 101.5;
On 10/24/2018 around 2:30pm 17yo patient was given Influenza high dose vaccine in the office in error. Mom was notified to watch for local and/or systemic reaction overnight. Advised to follow the VIS sheet patient was given. Also notified by email the Department of Public Health. Called mom on 10/25/2018 @ 10:11am and stated son had no systemic reaction and only c/o his left arm being tender but no redness or swelling she was aware of. He did take ibuprofen for the tenderness but refused to use ice to the site. Staff of the Department of Public Health was recommended us to complete the VAERS report.
8 blotches of red area/ several splotches on trunk; Pruritus like rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (8 blotches of red area/ several splotches on trunk) and RASH (Pruritus like rash) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Crohn's and Autism spectrum disorder (ASD). Concomitant products included MESALAZINE (PENTASA), LAMOTRIGINE (LAMICTAL) and RISPERIDONE (RISPERDAL) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced RASH MACULAR (8 blotches of red area/ several splotches on trunk). 03-Mar-2021, the patient experienced RASH (Pruritus like rash). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, RASH MACULAR (8 blotches of red area/ several splotches on trunk) and RASH (Pruritus like rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Additional information received: updated patient demographics, relevant medical history (Crohns, ASD), concomitant medications (Pentasa, Lamictal, Risperadal), event start date and stop date. The event outcome changed (from not resolved to resolved). Other potential cause was Insect bites.
Began in the afternoon with soreness down arm, then through the night spread to the hand and upper breast (right). By am the next day unable to grasp item without extreme pain. Numbness, tingling, lightheadedness ensued. Mentioned to 5 other nurses, all had same sx; notified our employee health. Saw physician, he felt possible hit a nerve. Over next couple of days, noted joint pain in hips and legs. Subsided after about day 3-4; however, still have residual thumb pain.
administered Hiberix after it was reconstituted with sterile water; administered Hiberix after it was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 5p244, expiry date 21st March 2023) for prophylaxis.   On 25th January 2022, the patient received Hiberix. On 25th January 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that a patient was administered Hiberix after it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Initially I had flu like symptoms, a cough, slight fever 99.9 degrees subsequently 101.6 degrees and after two to three days was normal. General aches.
5days p/vax pt devel vomiting & lethargy; pt hosp & recovered
Incident occurred at about 6:50pm. The patient complained of pressure in her chest. Patient said she has a history of hypertension. She was asked to lay down for awhile. Checked blood pressure and heart rate. Patient was advised to follow up with provider. Pt felt over 90% better and declined assistance to her vehicle.
Large local allergic reaction (hives and swelling) adjacent to site. No history of allergy to eggs or antibiotics. Given prednisone and Benadryl.
Received Moderna vaccines on 4/13/21 and 5/11/21 while pregnant. Tested positive for COVID-19 by PCR on 7/9/21 on hospital admission screening to labor and delivery unit. Delivered infant on 7/9/21. History of COVID-19 positive by PCR on 12/13/20. Unknown if symptomatic.
Itching started first, I expected soreness it was a little sore, next morning arm was red a slightly swollen at the injection site, more discomfort (all things I expected), next day swelling tripled in size, hot to the touch, could not longer move my arm, itching out of control, saw doctor on this day.
Vaccine was administered too high and patient lost mobility of left arm for 2 days.  She regained mobility after 2 days but still has tenderness as she is reporting to the pharmacy.  Recommended to ice if needed and ibuprofen and to follow up with her pcp if it gets worse or doesn't start to get better.  Patient's pcp was also notified and stated they would follow up with her.
Feeling cold; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold) and MYALGIA (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING COLD (Feeling cold) and MYALGIA (Sore arm). At the time of the report, FEELING COLD (Feeling cold) and MYALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received on 11-JUN-2021. Updated event outcome from unknown to recovered for the events FEELING COLD (feeling cold) and MYALGIA (Sore arm).
Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor vomiting in first half of the day; I couldn't eat due to nausea and minor vomiting in first half of the day; couldn't eat due to feeling weak and lightheaded; couldn't eat due to feeling weak and lightheaded; I was hot and cold throughout the day; Unable to locate thermometer to take temperature; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm 25Feb2021 02:00 PM at single dose for COVID-19 immunisation. Patient medical history included asplenic, cochlear implant, survived bacterial meningitis, PTSD, anxiety, depression, neck and back pain and allergies. Allergies to medications, food, or other products: Bactrim. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Tizanidine, clonazepam, Lamictal and singular. On 26Feb2021 11:00 AM, the patient had experienced severe headache centered in forehead radiating slightly back Ice on patient's head made the headache worse Tylenol helped a bit, couldn't eat due to nausea, minor vomiting, feeling weak and lightheaded, hot and cold throughout the day. Unable to locate thermometer to take temperature and visual impartment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of event is Recovering.  Information on the lot/batch number has been requested.
Patient presented to the ED 9/21/21 per direction of PCP due to abnormal outpatient labs (SCr). Patient initially reported he had no COVID symptoms. In a later interview, he admitted to an developing cough with white mucus production.  His POC and lab antigen tests came back positive for Sars-CoV-2 on 9/21/21. The patient was treated for his primary diagnosis of AKI on CKD and discharged 9/26/21. The patient remained mildly symptomatic (cough and mucus production) and became asymptomatic by discharge. He did not require any treatment for COVID infection while inpatient, but he was educated on monoclonal antibody treatment available outpatient.
Patient was due for her HEPLISAV-B  second shot on 05/31/22 per her new hire process, so she presented to Health Dept. this morning 06/01/22 for the second dose. She had the respiratory allergic reaction after 5 minutes vaccination, she did not feel good and started to cough more in order to clear her throat. She felt headache also.  Sent patient to Clinic ER from the employee health. Patient received the Benadryl and Steroid. She felt better after treatment.
This spontaneous report was received from a physician and a healthcare worker concerning an unknown number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016, the patients were vaccinated with doses of improperly stored doses of VAQTA (Lot # L042486; expiration date: 12-DEC-2016 and Lot # L045713; expiration date: 14-JAN-2017) (dose and route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 18 degrees C for 22.5 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Got awake morning following vaccination feeling much like I did when I first became ill with COVID. Spent whole day in bed. No appetite. Felt a little  better next day but knew I was about to pass out so laid down in hallway where my husband found me. Got better as day went on and feel fairly well today.  Also had a mild case of night sweats last night. They were awful  when I actually had COVID - for about  2 weeks.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
Mistakenly adminstered a HIBERIX and a ACTHIB.  DTap that was supposed to be given was not.
Itching and hives on right arm and leg, scalp. Fatigue, mild nausea.
mother had pictures mild redness and swelling day 1 redness and swelling worsening within the 24-36 mark deeper redness and noticeable swelling late Saturday night (lateral view in the photos). Sunday 3, the redness and swelling had improved The redness and swelling is much better this morning (provider did assess the patient) no treatment needed
RUE swelling/erythema, pain at injection site no discernible abscess/infection.