chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of FLUMIST was administered to a 50-year-old was received from a registered nurse concerning a 59-year-old male patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 10-Nov-2008: FLUMIST route of administration and confirmation from the reporter that no adverse events occurred from the administration of FLUMIST to a 59-year-old.
A half-dollar sized ulceration, peeling and slight oozing, with the injection site directly in the middle, with acute redness lasting approx 2 weeks. Tender only upon touch, no signs of infection.
Per hospital event report: "Wrong vaccine given to patient. Provider verbally told nurse to administer pneumovax 23, nurse misunderstood and administered prevnar 13."
Started with tender lymph nodes in axilla in injection side, that progressed up the neck throughout the day.  After 24hrs since Pfizer booster started with fatigue and chills, after 32 hours developed severe stomach pains with nausea and subsequent diarrhea that are improving but not resolved on pat vaccine day 5.
March25-burning itchy with 2 red spots on left arm near injection site March 26 one large oval red area warm ,itchy,burning same area ,dizzy week today
Day 1: Sore Arm Day 2: headaches, body aches, very sore arm, sharp pain through the L breast and L forearm Day 3: vaginal ulcerations-Behcets Day 5 (4/19/21): Intermitten heart pounding, vaginal ulcerations- hurts to void
Pfizer 4/22/21, 5/13/21. Positive on 7/19/22
Global Hair Loss, Vomiting, Diarrhea, Early Satiety, Nausea, Weight Loss  Treatment for alopecia areata  (intralesional steroid injections, topical steroid solution application, immunosuppression (systemic cyclosprorine)  Complete hair loss over the course of 6 months and has not returned at this time (9 months post vaccine)
feeling sick; Eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) and MALAISE (feeling sick) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (she always has Bronchitis after Flu shot) since an unknown date. Previously administered products included for an unreported indication: RSV VACCINE. Concurrent medical conditions included Chronic bronchitis, Asthma, Drug allergy (Intolerant of NSAIDS), Drug allergy (Intolerant of ACE Inhibitors) and Food allergy (Chocolates and eggs). Concomitant products included IRON DEXTRAN (IRON [IRON DEXTRAN]) for Anemia, TRAMADOL for Back pain, VITAMIN D3 for Fatigue, OMEPRAZOLE for GERD, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and EPLERENONE for Hypertension, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ECZEMA (Eczema). On an unknown date, the patient experienced MALAISE (feeling sick). At the time of the report, ECZEMA (Eczema) had not resolved and MALAISE (feeling sick) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-036980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received on 05-AUG-2021 contains significant information including concomitants were captured, other relevant history captured, new event was captured and patient demographic details were captured.
My esophagus has constricted and will not relax. I can still breathe but I have a hard time eating or swallowing. It's painful when food travels down my esophagus to my stomach. I've never had acid reflux or any esophogus problems in the past.
Sore Muscles, High Fever, Chills occurred roughly 12 hours after injection. Lasted roughly 9 hours. Resolved within 24 hours of initial injection.
Patient called approx. 1 1/2 hours post - vaccine to report to RPh that he felt light - headed when leaving the building (after waiting for bus ride). He was still feeling this way somewhat at time of call (~11:05am). He said no other sx except feeling "weird". RPh advised to call if additional sx & referred to primary provider if continued.
Swelling immediately after injection. Measured at 5 PM & was 9 cm x 10 cm.
Patient developed fever, flu like symptom abdominal rash 36 hours after receiving vaccines. Took tylenol, fluids, aspirin with some relief. Rash cleared up. Still with flu like symptoms.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
PHN; staph infection in and; autoimmune disease; rashes and shingles on her face, scalp, eyes and other areas of her body; rashes and shingles on her face, scalp, eyes and other areas of her body; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 27-MAR-2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date in April 2017 (reported as one month after receiving vaccine), patient suffered painful and debilitating rashes and shingles on her face, scalp, eyes and other areas of her body which resulted in multiple outbreaks and a diagnosis of post herpetic neuralgia and staph infection in and around both eyes (date unknown), as a result of zoster vaccine live(ZOSTAVAX). The zoster vaccine live(ZOSTAVAX) also caused other injuries, including but not limited to, muscle spasms, constant itching, scalp, fatigue and pain with one diagnosed as an autoimmune disease. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in the physical injuries identified above and limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX) vaccine. The patient sustained severe and disfiguring personal injuries and suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not reported.   The reporter considered all the events were serious due to disability. Upon internal review, ophthalmic herpes zoster, staph infection in and around both eyes,  autoimmune disease were determined to be medically significant.
Besides the temporary pain  in the arm and a bit of headache  for 2 days after the 1st Moderna Covid19 dose, I started developing gingivitis 3 days later and it worsen during the last 4 days. My gums are all read all over my mouth with no pain, no swelling of the gums, no bleeding or anything else. A deep color with the gums actually "shrinking". I am contacting my dentist to seek treatment next.
I ran high fever for 3 days, muscle ache, and then joints (all, including  bones in feet, ankles, wrist, thumbs and finger joints, hips, both knees (I had total done after falling and injuring my right knee but now all joints hurt and proceeded to get worse.  Lymph nodes swollen to point scalp began to swell with edema,  Lymph node biopsy done
deadly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "deadly". The patient date of death was unknown. It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: deadly
Severe arm pain 2 days following the vaccine dose #1. Seven days later arm pain started to come back. Unable to sleep due to amount of pain. Subsided after about 12 hours and went from severe to mild.
Initial unsolicited report received from a Nurse on 12-Dec-2017. This case involves a male patient (age was not reported) who was vaccinated with 0.5 ml single dose of ADACEL (Batch number: U5792AA, expiry date, dose in series and site of administration were not reported) via intramuscular route on 08-Dec-2017. Patient's ongoing illness, medical history and concomitant medications were not reported and it was reported that he did not receive any other vaccines. (Also reported as no known medication allergies). On an unknown date, one day after the vaccination, the patient woke up with a rash that was under arm at armpit area, also had the rash for 4 days as of today, 12-Dec-2017, and it had spread to abdomen, arms and legs. Patient also reported that there was a pinpoint, red, papular rash that was mildly itchy. Laboratory investigations were not reported. Patient received Zyrtec and Pepcid as a corrective treatment. The patient was not recovered from the event. List of documents held by sender: none.
Patient is a 36 yr/o female who is 34 weeks pregnant complained to her fiancé, that she wasn't feeling quite right after work, having difficulty breathing, and in a lot of pain but did not seek medical attention. The decedent woke husband around 0440 on 02/08 and stated she was having a very hard time breathing and needed to go to the ER. Emergency Services were contacted, while on Tx the decedent went into Respiratory Arrest, By-standard CPR initiated, resuscitate efforts attempted, the decedent was transported to ER, emergency bedside C-section performed, and the decedent was pronounced dead at 0542 by DR.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition or concomitant medication was not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a health care provider for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Pt recvd HIB on 01APR91; Subsequent to administering vax, it was noted that the vax was beyond its expiration date; @ the time of the report, no adverse exp had been noted;
Left shoulder injection site is red, swollen, itchy, and slightly bumpy like a rash/Upper arm is still red, itchy, swollen; Left shoulder injection site is red, swollen, itchy, and slightly bumpy like a rash/Upper arm is still red, itchy, swollen; Left shoulder injection site is red, swollen, itchy, and slightly bumpy like a rash/Upper arm is still red, itchy, swollen; Left shoulder injection site is red, swollen, itchy, and slightly bumpy like a rash/Upper arm is still red, itchy, swollen; migraines level headache; felt weak; joint pain and headache increased/sore shoulder; joint pain and headache increased; Body aches/body pain; 100 degree fever/Fever reached 101.4; Chills; sweats; No appetite; barely slept; Armpit hurt/Armpit hurts more; Slept on and off through the night; Dizziness; Shaky; Nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old non-pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID -19 VAC-CINE, solution for injection, Lot Number: EN6203, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 09Mar2021 17:00 as dose 2, single for COVID-19 immunization (age at vaccination: 44-years-old). Medical history included allergy to plants and drug hypersensitivity; includes allergic to erythromycin, cortisone injections and cilantro. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL), drospirenone, ethinylestradiol (LO-RYNA) and l-lysine [lysine] all medications were taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, Lot Number: EL9264, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 16Feb2021 17:30 as dose 1, single for COVID-19 immunization. The patient was not diagnosed with covid-19 before vaccination, and not tested for covid after vaccination. The patient had not received other vaccines within 4 weeks prior to the vaccination. The patient had received: Bupropion XL, Loryna, L-lysine, probiotics, multi in two weeks prior vaccination. On 10Mar2021 07:30, the patient experienced Left shoulder injection site is red, swollen, itchy, and slightly bumpy like a rash/Upper arm is still red, itchy, swollen, migraines level headache, sore shoulder, felt weak , joint pain and headache increased, body aches/body pain, 100 degree fever/fever reached 101.4, chills, sweats, no appetite, barely slept ,armpit hurt/armpit hurts more, slept on and off through the night, dizziness, shaky, and nausea. The patient had not received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
16JUN92 mom reported rxn to DTP #1; 10MAR92 pt recvd 1st DTP & slept approx 4 hrs 2PM awoke w/shreaking & screeching cry;  cont cry until 8 or 830PM (3-3 1/2hrs); pale, red & hot lt thigh, knot & bruise inject site;
Morning after shot, fever between 100-101F; chills; aches (joints, neck, head); aches (joints, neck, head); aches (joints, neck, head); lethargy; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: CR8736, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:45 as a dose 2 single (age at vaccination 32-year-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ilex paraguariensis leaf/panax ginseng root/paullinia cupana seed/rhodiola rosea root (GNC HERBAL PLUS ENERGY FORMULA) taken for an unspecified indication. The patient historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:45 as a dose 1 single (age at vaccination 32-year-old) for covid-19 immunisation for covid-19 immunisation. The patient previously took amoxicillin, sulfamethoxazole (SEPTRA)trimethoprim and experienced drug allergy. On 24Apr2021 09:45 the patient experienced morning after shot, fever between 100-101f, chills, aches (joints, neck, head) and lethargy. The patient underwent lab tests and procedures which included pyrexia: 100-101 fahrenheit on 24Apr2021. Patient did not receive other vaccine in four weeks of vaccination. Patient received metabolism GNC energy and vitapak as other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Therapeutic measures were taken as a result of the events. Events were reported as non- serious. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Vaccine expiration 06/31/2022 from manufactory date of October 2021 was given 1 day after medication expiration - no adverse signs or symptoms. Patient reported no problems when contacted.
Large hive at injection site. Very itchy and warm. Hive is the about 3 inches by 1 inch
This report is being filed after the papers on the event where found when clinic was closed. Shortly after 1st moderna dose while in observation patient noted that he felt a funny sensation in his throat that felt on several other occasions upon exposure to know environmental and food allergies. he noted that this symptom always responded to benadryl and never required epi pen. there were no signs of distress nor other signs or symptoms of allergy. He appeared somewhat anxious and 50 mg of Benadryl Po liquid was given, with observation this symptom completely resolved and no other signs or symptoms developed. He was discharged form the clinic and advised at this time not to receive the second dose of moderna norother mRNA vaccine and follow up with his PCP or allergist to assess for second dose or consideration for Janssen as second dose. He was advised to go to ER if allergic symptoms subsequently developed.
Arm swollen and red in a 3 in x 4 in area with deep bruising and small gathering of white spots.
Client had live vaccine on April 24.  Patient returned for second dose of vaccine on June 19.  Reported to nurse that discovered she was pregnant right after received first vaccination, but was unaware of pregnacny at time of vaccination.  Patient reports spontaneous abortion at apporoximately 6 weeks gestation on June 13.
Reddened 2 inches diameter. inflamed, itchy, warm at injection site. Started out smaller. Started  Claritin 1/6/21. Less reddened 1/7/21
Woke up with sudden, total sensorineural hearing loss in left ear believed to be due to viral insult to left cochlea.  I had not been sick at all in the week prior to onset.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL8982), on 11Feb2021 as dose 2, single (Lot number: em9809) and on 23Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The patient was provided with antiviral treatment of Paxlovid from 18Jul2022 to 23Jul2022. adverse event: From Paxlovid, horrible taste in mouth the entire time of taking it, nonstop. Still residual bad taste on 01Aug2022. There was no other medication within 2 weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
Flushing, tachycardia, received IM Benadryl 25 mg and oral hydration, monitored and recovered
Missed dose; No additional AE reported; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. No medical history, concurrent conditions nor concomitant medications were reported.  On 05-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (prefilled syringe, lot # W001494, expiration date 15-SEP-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  The patient received a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and then missed the second dose (Missed dose). Pharmacist stated that the patient was okay and declined to be contacted any further. No "AE" follow up letter was sent. No further information provided. No additional adverse event (AE) reported (No adverse event). No product quality complaint (PQC) reported.
arm is hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine day before reporting and his/her arm was hurting like crazy. The follow-up would not possible as no contact details were available.
Stomach pain similar to ulcer began approximately 4 days post 2nd shot and continues to cause discomfort daily
PT CAME IN ON 7/7/19 TO PICK UP RX AND SHE INFORMED ME OF HER REACTION TO THE SHOT. IT STARTED A DAY OR TWO AFTER AND HER ARM BECAME VERY SORE, EXTREMELY TENDER TO THE TOUCH, SWELLING, REDNESS (THAT STARTED TO SPREAD UNDER HER ARM) AND THEN PAIN IN THE ARM FOR QUITE AWHILE .