chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle vaccine and then got the shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
REDNESS AND SWELLING FROM 10 INCHES ABOVE AND BELOW SITE OF INJECTION -severe soreness. Site of injection looked fine no discharge or redness arounfd injection site.
Started to have extra oral secretions under my tongue followed by sides of mouth followed by a metal taste which lasted about 25 minutes. The next day I could not taste anything. This lasted about 48 hours.
Headache, sweating, hot/cold flashes. Vital signs stable child went home with parent.
Initial symptoms after 1st vaccine: fatigue,  headache, chills,  severe nausea, muscle aches beginning 3hrs after vaccine and subsiding 25 hrs after vaccine Initial symptoms after 2nd  vaccine: severe fatigue, severe headache, chills, severe nausea, sever muscle aches beginning 3hrs after vaccine and subsiding 25 hrs after vaccine. Symptoms severe enough would have gone to urgent care but knew it was likely temporary as with first vaccine. Roughly same duration, but syptoms much more severe. Beginning mid May slight wheezing at night. Beginning end of June had serious inflammation from tendonitis but not resoving  within two weeks. Went to urgent care in Madison, WI late July because was not improving .  Have since realized every inflammatory response is times 10, from mosquito bites, to skin irritations, to swelling at my broken ankle, etc..
Itching developed 2 days after the injection on 08/25/22.  On 9/18/22 the patient has developed a sandpaper rash covering her body and the itching has continued.
10 days post 2nd Covid-19 Vaccine administration I had an anaphylactic response of unknown origin. Extremely itchy eyes, palms of hands, soles of feet, progressed to shortness of breath, Bradycardic, oxygen saturation in 80s even after administration of IM epinephrin, hypotensive, swollen face, neck and tongue, severe vomiting. EMS transported me to hospital mentioned above. IV started in ambulance where IV epinephrin, IV fluids, IV Benadryl, IV solumedrol were all given prior to arrival at the ER. ER then administered more steroids and anti nausea meds and sent me home after observation and stabilization with prescription for epi pen and prednisone.
I got the plus 65 flu shot, after five days I felt very ill. I contracted an upper respiratory infection, very congested, sore throat, and fever with chills. My congestion was so bad that at times I could not stop coughing and had issues breathing. I do get sinus congestion but I have not been sick for years, only seeing my doctor once a year for check-ups. This flu shot knocked me out and I am a  healthy person. I have not had a temperature for at least 15 years. The reason I am concluding that the flu shot made me ill is that my husband got the same 65 plus flu shot and got very sick after five days and our symptoms were similar. My husband had the pneumonia vaccine with no side effects.
This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with GARDASIL injection, lot # K010574, expiry date 08-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the improperly stored vaccines experienced three different temperature excursions (1.6 degrees Celsius for 3 hours and 54 minutes, 1.6 degrees Celsius for 1 hour and 22 minutes and 1.5 degrees Celsius for 1 hour and 22 minutes). No adverse effects were reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from an 89 year old male who in mid of July 2007, was vaccinated SC with a dose of Zostavax (Oka/Merck).  There were "several" concomitant therapy.  In mid of July 2007, the patient developed 2 to 5 itchy red bumps on his arms.  A biopsy of lesions revealed that they were bug bites.  Unspecified medical attention was sought.  A product quality complaint was not involved.  No further information is expected.
significant localized skin reaction, erythematous, raised and almost appeared blister like.  Provider instructed pt and mother to use ice and antihistamines. Parent verbalized understanding.   On July 20th I spoke with mother and reaction had improved 90%.
metallic taste in his mouth; This is a spontaneous report from a non-contactable healthcare professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced metallic taste in his mouth on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheaded, high bp. Pt rest for about 30 mins and bp decreased and pt light headless subsided. Pt was released back to observation area and pt went to checkout.
Pt presented to clinic w/unusual rash. Pt's husb stated the scattered lesions started like pustules. When pt arrived at clinic, she had scale-like itchy lesions to face, scalp, predominantly (L) arm and leg. 10/8/13 follow up phone call - lesions improving, decreased itching.
Patient states approximately 3-5 days after Yellow Fever vaccine, developed body aches. Denies any fever, chills, nauseam vomiting or diarrhea. States symptoms are improving.
On day 8 I awoke with an extremely itchy bump at the shot site. By the end of the day there were two bumps. On day 9 there was a 4? itchy red circle. It was warm to the touch but no pain. Just itchy.
This spontaneous report was received from a pharmacist and refers to an adult female patient (exact age was not reported). There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 16-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcg/ml injection (lot #, expiration date, site, dose and route of administration were not reported). The second dose of RECOMBIVAX HB 10/1.0 mcg/ml injection was administered on 29-NOV-2016 (lot #, expiration date, site, dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
Case number PHEH2013US014840 is an initial spontaneous report received from a nurse on 10 Jul 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: X12023) intramuscularly and did not receive MenA lyophilized conjugate on 10 Jul 2013. The nurse stated that she thought that it was saline at first. Once she realized the error, she reconstituted a dose of MENVEO and re-vaccinated with patient with the full dose. No adverse reaction was reported following the inadvertent administration.
Difficult Breathing.  Rapid Heart Rate. 9/9/09 ER records received DOS 9/4/09. Assessment: Atrial flutter with rapid ventricular rate and cardioversion. Developed angina, left-sided jaw pain. Heart rate 150-160. Tachycardia. Cardioversion. Discharged to home.
Worsening of psoriatic arthritis occurred a couple days after the first dose of the vaccine. The psoriatic arthritis flare last approximately 7 days. The psoriatic arthritis flare included worsening neck pain. Neck pain was mild prior to receiving the vaccine.
Received vaccine at 2:30 PM. Symptoms began 6 PM that day, stomachache, vomiting, temp 101.3, muscle and back ache, swollen left eye, redness, asthma-had to go to PMD for asthma treatment. Recovery took 5 days. Return to work 11/12/2001. Pt had had her first flu shot last year.
pt recvd flu vax & devel influenza leading to probable death; this pt & 1 other devel influenza following flu vax & both were reported about to expire, but no f/u info was obtained;
Possible inaccurate injection site: pt states given too high in arm/shoulder in deltoid - complaint of lack of range of motion and shoulder pain.
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/23/2021.
The Injection site became red and swollen (half dollar size); the injection site became red and swollen (half dollar size); she is fatigued; This is a spontaneous report received from a contactable consumer (patient friend). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 21Apr2021 (reported as yesterday) as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021 (reported as this morning), the patient experienced injection site became red and swollen (half dollar size), and she is fatigued. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-AUG-2015, the patient received a dose of M-M-R II (lot#, expiration date, dose and route of administration were not reported) that was inadvertently reconstituted with improperly stored sterile diluent (dose one, lot# reported as L016272, expiration date 24-FEB-2018, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Interface dermatitis- Small, itchy, fluid filled blisters on middle finger of left hand appeared 12/13/2021. Blisters grew and appeared to become infected. Saw healthcare provider 12/22/2021. Diagnosed either eczema or herpetic whitlow (HSV). Provider took samples for HSV and varicella tests.Finger became red, and blisters crusted over. On 1/3/2022, notice the fluid blisters on both hands, and no improvement to middle finger of left hand. On 1/4/2022, returned to healthcare provider. Learned HSV and varicella tests were negative, and provider diagnosed cellulitis of middle finger of left hand. Prescribed cephalexin. Infection in middle finger of left hand responded quickly, but by 1/6/2022, small, fluid filled blisters had become more numerous on both hands, spreading to palms, the tops of both feet, and the bottoms of both feet. Consulted with physician via telephone on 1/7/2022 and sent photographs by email. He recommended use of triamcinolone acetone 0.5% ointment, which was applied three times daily. By 1/10/2022, blisters had spread past the wrists of both arms, from the shoulders to elbows, and from the feet to both knees. No fever, or symptoms other than itchiness. Sent additional photos to physician. physician. Spoke with physician via telephone. telephone He had consulted with dermatologist who diagnosed interface dermatitis (ID). Prescribed prednisone and additional triamcinolone acetone ointment (as if writing, not yet given).
Patient states she had extreme nausea & vomiting. No rash, no fever, no injection site reaction. In hospital during day & evening. Full recovery by next day.
Staff member c/o dizziness, sweats, ringing in ear, vital signs 99%02 RA, rr 18, hr 120 BP 132/78 temp 98.1 po benadryl and tylenol given. EMS called. transferred to ER for further evaluation.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: A GRANULE BLISTER AT SITE OF INJECTION WITH REDNESS AND SWELLING IN THE SURROUNDING AREA-Mild, Additional Details: Patient reported a blister with fluid the size of granule at the injection site with redness and swelling at the surrounding area.  Pt will monitor and report if there is any worsening or no improvement after a few days.
This case was reported by a consumer (the subjects mother) and described the occurrence of crying in a 5-week-old female subject who was vaccinated with DTaP vaccine (Manufacturer unknown). A physician or other health care professional has not verified this report. On an unspecified date in June 1999 the subject received unspecified dose of DTaP vaccine (details unknown). In June 1999, immediately after vaccination with DTaP vaccine, the subject experienced crying and within hours of vaccination had developed red hives all over her body. The subject sought medical attention at a doctors office. The subject was treated with TYLENOL. The events were resolved within 24 hours. The consumer reported that the subject has received other vaccinations since, but no pertussis vaccinations. The physician documented the event at that time. The subject went on to develop bronchial asthma at the age of 3 to 4, but outgrew it.
itching; felt not his best/terrible and sick described as having no energy and could hardly move; headache suspected as migraine; sore arm muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm muscle), PRURITUS (itching), FATIGUE (felt not his best/terrible and sick described as having no energy and could hardly move) and HEADACHE (headache suspected as migraine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (benadryl). Concomitant products included FINASTERIDE and TAMSULOSIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm muscle). On 27-Feb-2021, the patient experienced FATIGUE (felt not his best/terrible and sick described as having no energy and could hardly move) and HEADACHE (headache suspected as migraine). On 28-Feb-2021, the patient experienced PRURITUS (itching). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, HEADACHE (headache suspected as migraine) had resolved. On 04-Mar-2021, FATIGUE (felt not his best/terrible and sick described as having no energy and could hardly move) had resolved. On 05-Mar-2021, PAIN IN EXTREMITY (sore arm muscle) and PRURITUS (itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes blood pressure medication.
Numbness in the arm of the injection; Both of my legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (Numbness in the arm of the injection) and HYPOAESTHESIA (Both of my legs and feet) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INJECTION SITE HYPOAESTHESIA (Numbness in the arm of the injection) and HYPOAESTHESIA (Both of my legs and feet). At the time of the report, INJECTION SITE HYPOAESTHESIA (Numbness in the arm of the injection) and HYPOAESTHESIA (Both of my legs and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Pt given PREVNAR 13 as part of catch up vaccine. Pt is delayed due to parental deferral. Given vaccine 7/13 and seen 7/19 dx with RLL pneumonia (clinical).
Pt recv vax on 6/23/98; on 1/22/99 pt exp bumps on left upper back then a vesicular red rash to chest & LA; dx=herpes zoster
This spontaneous report was received from a registered nurse and refers to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA013888:
Tongue numbness loss of tastes.  Chin, cheek and lip lower. Loss of taste  right half of all.
Warm to touch, tender, swollen - about 5x3 inches, itches, erythema. Local reaction. No systemic effects reported.
Temp 104.5 within 24 hours of immunizations. Pt had septic URI admitted for 48 hours to local hospital then sent home. All cultures no growth. CBC normal.
Slight pink rash above left eye. It progressed over the next couple days to form a vertical line of blisters (5 of them) that took a long time to fade. It has been nearly two months and it is still visible.
Out of sorts for a couple days after receiving the combination of vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 24Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rsv vaccine (RSV VACCINE), on 24Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 24Oct2023, outcome "unknown", described as "Out of sorts for a couple days after receiving the combination of vaccines". It was unknown if therapeutic measures were taken as a result of malaise.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of sore developed at injection site in a 68-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 26 August 2011 at 11:30 the subject received unspecified dose of FLULAVAL (unknown, left arm) and experienced inappropriate route of vaccination. On 19 September 2011, 24 days after vaccination with FLULAVAL, the subject experienced a dime sized opened sore on arm to the injection site [sore developed at injection site], a scab had formed over the sore, fell off and she has been unable to stop the bleeding. The physician felt like the vaccine was injected between skin and muscle instead of directly into the muscle. At the time of reporting the sore developed at injection site, injection site scab and injection site bleeding were unresolved.
Pt was administered HAVRIX in left deltoid, then YF-VAX SQ in the right arm. Very shortly after administration of the second vaccine the patient said he did not feel well and described it as lightheadedness. His arm was clammy to the touch and he laid his head in his hands. We checked his blood pressure and it was 79/44. 911 was called. He remained responsive but clammy, lightheaded, and pale. Repeat BP was 68/54. He was given water to drink and 1 glucose tablet. He reported no nausea and was still responsive. Repeat BP was now to 100 systolic. EMS arrived and verified his BP was on upward trend. They instructed him to walk around with them. After about 15 minutes, EMTs cleared him to go and did not recommend taking him to the hospital. They took him to his car with his mother. His mother chose to take him to his pediatrician for follow-up today.
15 minutes, post vax, the pt experienced lightheadedness, saw orange spots and had difficulty performing tasks (putting straw in bottle) and fell to hands and knees. She tried to get up and fell backwards but was caught by teacher. She experienced headache (frontal, forehead( for about 3 hours after. Her mother spoke with doctor who stated it was a vagal syncope incident. 24 hours, post vax, her arm is sore but not red.
I received only the Pfizer booster vaccine at this location on 9/30/21. About 2 hours after receiving my booster shot, a rather large patch of redness appeared just below the injection site . Returned to pharmacy today 10/4/21 & showed it to vaccinator. He noticed a good-sized black & blue mark at vaccine site & said he noted same effect on another who was also on a blood thinner. I reported I was there not about the black & blue mark but rather patch of redness. He said he'd never seen that before. Recommended I file this report & he was reporting it also on his end. Redness still there but getting lighter each day. No treatment was offered nor given. I was expecting that. I just felt it should be reported.
pt recv vax 1DEC97 & mom stated pt had rash on body that wasn't there prior to vax;mom instructed to take child to MD: