chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 34 year-old male was involved in a sole vehicle helmeted motorcycle crash in which he suffered impact to his left side resulting in a grade V splenic laceration. Active splenic artery extravasation was managed with repeated arterial embolization by interventional radiology resulting in hemostasis but with large volume hemoperitoneum. Increasing pleural effusion with evidence of left hemothorax with adjacent atelectasis led to increasing oxygen requirements necessitating chest tube placement. In preparation for eventual discharge post-splenectomy vaccines were ordered and administered. Approximately 2 hours following administration, the patient became tachycardic with heart rate in the 170s and tachypneic to the 50s with a fall in oxygen saturation requiring O2 at up to 15 L/min. Severe rigors developed requiring treatment with meperidine and diphenhydramine. The patient was transferred to intensive care for ongoing management of hemothorax and video-assisted thoracoscopic surgery (VATS). Future vaccine administration to be managed by Allergy and Immunology.
Initial unsolicited report received from a consumer on 23-Oct-2017. This case involves 9-year-old male patient who was vaccinated with dose of 0.5 ml FLUZONE QIV once via intramuscular route (batch number: U5319AA, expiry date, dose in series, site were not reported) on 14-Dec-2015. Patient's medical history and concomitant medications were not reported. On 15 Dec 2015, one day following the vaccination, patient experienced red, hot itchy parts all over his body. Lab data were not reported. Corrective treatment was reported as Benadryl with some relief. The outcome of the event was not reported. List of documents held by sender: none.
Patient was given a timer and asked to stay in the area.  He felt fine, so he walked to the bakery area and spoke with another pt, at the muffins display. He said his arm felt "weird" and said that happened to her, too.  He said he started feeling lightheaded and was leaning against the case.  He said, " I blinked, fell to the ground and next he saw people standing around him."  He said, no nausea, just lightheaded and he hit the side of his head lightly. Staff helped him into a wheelchair and took him to the office.  I spoke with him in the office and asked him if he wanted to go to the hospital.  I received this information from the patient when I asked him if he could tell me what happened.  He was sweating and pale, but no nausea, no disturbance in his vision and his blood pressure wasn't elevated.   He told me again that he took no regular medication,  but a couple of years ago he had been dizzy after a tetanus shot.  I asked again if he had any discomfort or pain anywhere and he said only his arm felt sore near the shot.   I asked again if he felt like he would like to go to the hospital and he said no.  His family came and picked him up.
78 y/o female, PMHx of DM, anemia, cancer, presented to ER due to cough and weakness on 11/8/21. Pt received booster shot on 11/4/21 and felt generalized malaise and mild cough approximately 24 hours after. Pt was hyponatremic at 123 (possible SIADH) and clinically dry.  Pt tested positive for Covid. Covid19 was treated with Regeneron, hyponatremia with hypertonic saline. Pt discharged home on 11/11/21.
1am, I woke with a stabbing pain running vertically from my eyebrow to my lip behind my left eye, pain quickly subsided and I went back to sleep.  When I woke up in the morning I had a numb triangular spot on my left nose, from my eye to my lip and extending laterally about 2 inches.  The numbness lasted approximately 1 month.
Patient felt nauseous the next morning and possibly fainted in bedroom. She banged her head against the sideboard of bed. She put ice on head and took BP reading (138/60) and temperature was 99.1 at 10 AM on 12/14/18. She went to see her PA at 1:30 PM to check EKG in office (came back normal). MD didn't say much about the injection site on arm. Sent patient to ER to get CT Scan for the fall [checked eye and head] and also did EKG again. Both results came out fine. At discharge BP was 140/? per patient. ER told pt. she had an infection on the left arm where injection was given.
5mins p/vax pt had sz (wet pants, got stiff, then drowsy);car very hot-mom took pt home;had sz as a young child-no cause found;no rx 10AUG95 tc to family mom contacted PMD who ordered EEG for tomorrow;sibling also has hx sz w/workup
Had shot, next day swelling and stiffness in neck, got worse went down deep into my shoulder with terrible pain, then it more out on the end of my shoulder, still with terrible pain, then went into my arm pit, and created my left arm to be totally numb and terrible pain in my bicep muscle area. Can?t lift arm, hand and arm is tingly and numb with severe pain.
Received Tdap, Hep A, and Typhoid Vi on 8/28/07. Patient began vomitting at 9:30 AM on 8/29/07 and also experienced diarrhea.  Patient became very dehydrated and was admitted to Hospital on 8/29/07. On 8/30th - patient much improved. Discharged on 8/30, stable and tolerating fluids well. 10/22/07-records received for DOS 8/29/07 and  9/6-9/7/07-DC DX: Dehydration, resolved. Vomiting and nausea, resolved. Diarrhea, resolved. Rheumatic disease. Side effect from Imuran. Second admission in month for vomiting and diarrhea and dehydration and both times it happened after she took her Prednisone and Imuran. Started with projectile vomiting. Previous episode this same month she blamed on Hepatitis A immunization.
Pt stated noticing pain and swelling about 8 days after the immunization. After day 9 the area from her shoulder to elbow started to bruise. Area was very dark and bruised today 12/20/20 when the patient was present in the pharmacy.
Right thigh swelling. Evaluated 2 days after vaccination. NVI, pulses WNL. Mild edema noted with erythema to injection site. Ace wrap applied. RX for BENADRYL and TYLENOL.
Breakthrough case admission after 3 vaccines: Pfizer 1/27/2021 batch/lot# EL9264; Pfizer 2/17/2021 batch/lot# EN6201; Pfizer 10/2/2021 batch/lot# FC3183.
Difficulty breathing, extreme fatigue. Went to Urgent Care. An irregular EKG, very high pulse (98) and low BP (87/50) resulted in my going immediately to the ED where another EKG was taken, plus ECHO. Catheritization followed. Takotsubo Cardiomyopathy was resulting diagnosis. Released from hospital and put on beta blocker (metropolol) but no additional ace-inhibitor because BP still very low. Currently we are almost 3 weeks from episode.
Patient received smallpox vaccination the afternoon of 02-04-2003. She experienced generalized body aches on 02-07-03 and felt this was to be expected. The generalized aches resolved over time, beginning around 02-14-03 the joints in her toes were red, swollen and very painful.Her joints in her hands were stiff and painful but, did not have redness or swelling.This pattern continued for at least two weeks and was severe.She did not have a physician visit. She has used Vioxx and Advil which helps but bothers her stomach to the point she only uses the medicine when symptoms are severe. Today on filing this report she continues to have symptoms. Her hands have improved, but her feet bother her almost daily.
12 hours after the second dose I felt very feverish. My fever progressively got worse and worse, and the next morning I woke up with severe nausea and couldn?t stop throwing up for over 12 hours. I also had a lot of Clem on my throat and dripping out of my nose.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included prenatal vitamins (unspecified) from on an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 13Apr2021 at 00:00, the patient was diagnosed with shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported event and included treatment with antivirals (unspecified). The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse concerning 3 pt's who were vaccinated with pneumococcal 23v polysaccharide vaccine (lot650327/0792P) and subsequently developed severe injection site reactions, which extended from the deltoid area to the entire arm. All 3 pts sought medical attention, outcomes were unk. The nurse requested a lot check be performed on lot 650327/0792P. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In follow up, the nurse reported that a 72 yr old white retired male pt with arthritis was vaccinated IM in the right deltoid on 26Oct05 at 1:30PM with his first dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant therapy included amlodipine besylate (Norvasc). She reported that the pt called the clinic on 31Oct05 with complaints of redness, swelling and warm to the touch at area where vaccine was given, onset of symptoms was 30Oct05. It was reported the pt was some better on 31Oct05. No further information was available.
received both vaccines, had an outbreak of shingles/ Suspected vaccination failure; shingles on face; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   In October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 3-Jun-2022 Reporter's comments: This case was reported by the patient. The patient received both of her Shingrix vaccines in 2019 in arm. After vaccination, the patient had an outbreak of shingles on her face. She has recovered from this episode. The consent to follow up was given. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Fever, nausea, fatigue, chills. Lasted most of day after the shot but was well the day after that.
AFTER RETURNING TO WAITING AREA, PATIENT BEGAN TO FAINT.  IMMEDIATELY REGAINED CONSCIOUSNESS AND STAYED IN AREA.  PATIENT WAS VERY PALE AND HAD BRIEF NAUSEA.  BOTH HAD SUBSIDED WITHIN ABOUT 5 MINUTS.  PATIENT CONTINUED TO STAY IN THE AREA FOR 20-25 ADDITIONAL MINUTES AND SINCE HAS ONLY A SORE ARM.  PATIENT WAS VERY NERVOUS AND ARM WAS VERY TENSE UPON ADMINISTRATION.
Information has been received from a physician concerning a 15 year old female patient who on 07-DEC-2007 was vaccinated IM with the first dose of Gardasil (lot# 659437/1266U). Concomitant therapy included LOESTRIN. On 07-DEC-2007 the patient experienced pain at the injection site. Medical attention was sought. As of 21-DEC-2007 the patient's pain at the injection site persisted. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008.  Initial information has been received from a physician concerning a 15 year old female student patient who on 07-DEC-2007 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot# 659437/1266U).  Concomitant therapy included LOESTRIN.  On 07-DEC-2007 the patient experienced pain at the injection site.  Medical attention was sought.  As of 21-DEC-2007 the patient's pain at the injection site persisted.  No quality complaint was involved.  Follow-up information received from the registered nurse indicated that the patient had pain at the injection site for 2 weeks.  Additional information has been requested.
New onset c/o itching reported approximately 1 to 2 hrs post initial Hepatitis B Vaccine with scattered erythematous papules. Was treated with antihistamine. Further vaccine discontinued. Follow up with primary doctor.
Headache, Myalgia, FATIGUE, CHILLS, SLEEPY, SORE THROAT, JAW PAIN Narrative:
I received my Moderna booster on a Friday afternoon. Saturday early morning, I did not feel well (as expected), but almost fainted twice. I was standing in the kitchen, started to get really hot and nauseous, got ringing in my ears, and my vision started to fade to black. I sat on the floor before I actually fainted and didn't end up fainting. Once my vision come back, I stood up to go to the bathroom because I was still feeling nauseous, and then it happened again. I laid on the floor for about 5 minutes, and the nausea, heat and ringing went away. It didn't happen again after that, although I did feel pretty sick for the next 18 hours.
Received dose 2 of COVID vaccine on 1/21/21.  On 3/25/2021 the patient developed fever, nasal congestion, cough, and loss of taste/smell.  Tested positive for COVID.
A patient received her first dose of Gardasil 9 at age 11 and the second dose at age 16; No adverse effect reported; This spontaneous report was received from a pharmacist referring to a 16-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   On an unknown date (also reported as at 11 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, indication, anatomical site, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV) infection.      On an unspecified date (also reported as at 16 years old), the patient was possibly vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, indication, anatomical site, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV) infection (Inappropriate schedule of vaccine administered). No adverse effects were reported.
Localized swelling, hardness, warm to touch, itching, pain. Affected area is approximately 4x4 inches wide and raised.
11/18 sore lymph nodes under arms and in groin, 11/25 developed "subjective" fever, decrease appetite and unable to sleep. 11/29 rash all over except for legs. by 12/1 rash was faint and only a sore arm. 12/6 headache
Constant dizziness; Headache; Body pain; nausea; vomiting; chills; Blood pressure went up as high as 260/114; Dry mouth; Fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Systemic lupus erythematosis and Drug allergy (Allergy to sulfur). Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE, HYDROXYCHLOROQUINE and AZATHIOPRINE for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) (seriousness criterion medically significant), DRY MOUTH (Dry mouth), TACHYCARDIA (Fast heartbeat) and CHILLS (chills). On 29-Apr-2021, the patient experienced DIZZINESS (Constant dizziness), HEADACHE (Headache), MYALGIA (Body pain), NAUSEA (nausea) and VOMITING (vomiting). On 28-Apr-2021, HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) had resolved. At the time of the report, DRY MOUTH (Dry mouth), TACHYCARDIA (Fast heartbeat), DIZZINESS (Constant dizziness), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body pain), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 260/114 (High) 260/114 bpm and 193/110 (High) 193/110 bpm.         Patient self-treated her pain with OTC acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-101591 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a Registered Nurse concerning a 22 year old female with psychiatric disorders and a history of pyelonephritis who was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (lot#660616/0570X) on 29-JAN-2009. There was no concomitant medication. Subsequently, the patient developed urinary tract infection. After receiving the dose, she complained of high fever of 102 degrees F along with burning sensations when she urinates. She also had increased frequency of urination. Urine analysis showed presence of leukocyte, protein, but no blood. The patient was treated with CIPRO for 1 week. Urine culture was negative. At the time of reporting the patient was recovered. The patient had received her first dose of GARDASIL on 16-OCT-2008. The patient sought medical attention and was seen by the nurse. Additional information has been requested.
Round, hot, red rash on vaccinated arm 9 days after administration. Cetirizine taken for 2 days. Rash resolved.
This spontaneous report as received from a nurse practitioner refers to 7 unspecified patients of unknown ages and genders. On unknown date in August-2017, the patients were vaccinated with PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (route: subcutaneous). The vaccine was stored at a temperature of 32 F (foreign heat) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6F to 14 F for total 6.5 hours. The call was because of the data logger. No adverse effects were reported.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA000128:
tested positive; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he had first vaccine on 26Jan2021, and then he tested positive on 28Jan2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Same symptoms as with previous 2 shots and more cysts developed. I had 10 cysts surgically removed.
The patient complained of soreness, redness, and warmth around the vaccination site the day after injection. The affected area was 2" wide x 4" long and was slightly raised. After 3 days the area was still slightly sore, but the redness was gone.
Rash and hives on my extremities and back, pale, Abdominal pain, headache
Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 20-AUG-2013, was vaccinated with a dose of GARDASIL (lot # H020002, exp: 08-AUG-2015) 0.5 ml, intramuscularly, which was improperly stored. The nurse reported that GARDASIL was exposed to a temperature of 62F for 360 hours from 06-AUG-2013 to 20-AUG-2013. The nurse did not have patient or physician details available at the time of call. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Multiple patients were administered a dose of improperly stored GARDASIL 9, MMR II, PNEUMOVAX 23, ROTATEQ; no adverse symptoms were reported; This spontaneous report Was received from a nurse referring to a multiple patient of unknown age and gender. The patients pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not provided.     On an unknown date, a unspecified patients was inadvertently administered with an improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot numbers r025729 and r025728 have been verified to be a valid number; expiration date: 18-JUN-2021), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (lot numbers R030813 and S007813 have been verified to be a valid number; expiration dates: 24-OCT-2020 and 14-MAR-2021 respectively),  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number S012244 had been verified to be a valid number; expiration date 09-FEB-2021), (strength, dose, frequency, route of administration, and anatomical location was not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (S001101 and s005875 have been verified to be a valid number; expiration dates: 21-OCT-2020 and 30-NOV-2020 respectively) (strength, dose, and frequency was not reported), all vaccines for prophylaxis. The  temperature  excursion was at above 9 degree Celsius (C) (18 C), for a time frame of 28 hours and 30 minutes, and  no had the previous temperature excursion. It was reported that the call was due to data logger. No adverse symptoms were reported.  This case was determined as non-valid due to lack of patient identifiers.
lump appeared; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, She got vaccinated on Monday Feb 22nd with the first dose and the next day a lump appeared a little below the injection site in her arm, like the vaccine infiltrated however it does not hurt on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.