chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discussion with Mom - Dysautonomia symptoms have increased in frequency over the past year. Pt.'s History likely started before Gardasil but symptoms worsened 1 month after it. ... 12-08-15 Tachycardia, Family history Long QT -> EKG, 48-hr Holter WNL ... 04-21-21 seen by me for Int Chr Abd Pain, Family history Crohn's in mom -> Labs WNL  ... 09-08-21 seen by me for 12 3/12 yo WCC, Gardasil #1, Flu V x1 ... 11-02-21 ED: RLQ pain, Palpitations -> EKG, Pelvic USZ WNL ... 02-01-22 symptoms over the past year c/w Dysautonomia ...   Symptoms x1 yr intermittent Palpitations, lightheaded, labored breathing ...   Orthostatics HR increased 88 -> 114 ...   w/u WNL: EKG, ECHO, Treadmill, 2 wk Monitor ... 12-14-22 meets criteria for Dysautonomia / POTS ...   Orthostatics HR increased  71 -> 107, 116, 122
11 month patient received high dose flu vaccination with no adverse event; 11 month patient received high dose flu vaccination with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00820934) and transmitted to Sanofi on 20-Oct-2021.  This case involves a 11-month-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 20-Oct-2021, 11-month-old female patient received 0.7ml dose of supect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date were not reported) via an intramuscular route in the left thigh for prophylactic vaccination. (product administered to patient of inappropriate age and overdose).  It was reported "She wants to know what the side effets will be? the caller did not know for sure that the flu vaccination that was given to her daugher was fluzone HD for sure. she assumed there was only one high dose (HD) brand available. she will find out that info and the lot and expiry date and agreed to a call back".   This case was an actual medication error due to inappropriate age at vaccine administration and overdose (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Child received 18m health check vaccines on 7/07/17. On 7/15/17, child presented with a small firm minimally tender less than 1 cm nodule noted on left thigh without erythema or induration. Took: MOTRIN.
At first I had a sore arm and fatigue in the evening, headache and chills and slight fever, also. The next day, those continued. The sore arm lasted three days. No treatment.
Error: unauthorized age group (15-year-old, Pfizer EUA approved only for persons 16 years and older at time of administration. Parent signed consent form with incorrect DOB indicating age greater than 16 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
1st dose on 30Sep2019, 2nd on 01Feb2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th September 2019).   On 01-FEB-2023, the patient received the 2nd dose of Shingrix. On 01-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 30Sep2019, 2nd on 01Feb2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 06-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
BODY ACHE; CHILLS; SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills and sore at injection site was not reported. This report was non-serious.
It was sore then next day it turned into size of a saucer on his; Big huge bump that turned red/he got a great big huge bump that turned; Pain in arm; First Shingrix shot on 12 AUG 2020 / Second Shingrix shot on 19 SEP 2020; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 18th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, vaccination site erythema, pain in arm and drug dose administration interval too short. On an unknown date, the outcome of the extensive swelling of vaccinated limb and drug dose administration interval too short were unknown and the outcome of the vaccination site erythema was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, vaccination site erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The first shot didn't hurt. The second shot he got a great big huge bump that turned red. It was sore then next day it turned into size of a saucer on his arm. The bump went down it was still a little sore at the time of reporting but mostly ok. The patient received his first Shingrix shot on 12th August 2020 and his second Shingrix shot on 18th September 2020 which led to drug dose administration interval too short. The reporter consented to follow up.
fever/chills, left arm pain, mild dyspnea, chest pain, his implantable defibrillator shocked 3 times, fully body aches, dark urine, decreased appetite,  8 pound weight loss
Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoing), swollen and sore lymph nodes under left arm (ongoing), large bump on back (ongoing)
Vaccine was given on November 8th at approximately 12:30pm  in my right upper arm. Upon leaving, my arm was sore and I had some fatigue, and cough  The next morning November 9th at around 1:30am I was having chills. Around 08:30am I had woke up   and had a slight fever of 100.5 , I drank water and it went away, Also during this time I had a bad cough and chest congestion  November 10th I woke up around 7:30am extremely dizzy, my cough returned so I took two teaspoons of cough syrup and returned to my bed to lie down for an hour. 08:30am I woke up still remaining extremely dizzy and I also had an upset stomach, I felt nauseated so I continued to take my daily medication and made myself oatmeal for breakfast, I ate a few bites and vomited. I continued to vomit the next several hours, during this I aspirated and my oxygen level dropped to 68% on 3L of oxygen and I also had a 103.5 fever. Upon this time my Grandma and I decided to go to the ER, I was hospitalized for four days for Aspiration Pneumonia and a partly collapsed lung
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Had flu vaccination on Thurs approx 12:00 P.M. noon. Awakened on Friday 10/15/10 - head spinning neck and back sore/stiff, nauseated and vomiting which lasted about 36 hrs. Neck is still sore on 10/20/10. Arm also hurt.
Pt. c/o rt. upper arm pain shortly after receiving the vaccine and the next day the entire arm was painful. Pt. reported this to nurse on 10/1/08 and pain was subsiding. By 10/2/08 pain was 0.
Patient developed a headache & then had a seizure. Called 911, patient came out of seizure while paramedics were with him and was taken to the hospical
Patient called and stated that she had severe pain at the injection site, pain radiating throughout the shoulder and under the arm. She also stated that she was red in the face and felt flushed.
Patient was given vaccination & about 5 mins later she fainted. She fell backwards & hit her bottom & her head on the ground. She came to in a few seconds, but left the pharmacy 20 mins later & her head hurt. The next day she complained of a sore rear & intermittent headaches.
Patient began experiencing joint pain all over within a few days. Especially in joints of feet and hands.
Pruritic rash, 4 days after flu shot.  Medrol dosepak, allegra and zantac administered.
Information has been received from a registered nurse for the Pregnancy Registry for concerning a 15 year old female with no medical history and no drug reactions/allergies, who on 01-Oct-2007, 03-Oct-2007 and 08-Apr-2008 was vaccinated intramuscularly with first, second and third doses, respectively, of 0.5ml of GARDASIL (lot #'s: 658560/1062U, 658563/1063U, 659439/1267U) and became pregnant. Concomitant therapy on 01-Oct-2007, included MENACTRA. On 08-APR-2008 the patient was diagnosed with ovarian cyst. The patient sought unspecified medical attention with another physician. On unspecified date abdominal CT scan for ovarian cyst was performed (results not reported). On unspecified date the patient took urine pregnancy test that positive (LMP=18-Mar-2008). Outcome unknown. No further information available. Additional information has been requested.
Suddenly, the Friday after receiving my vaccine, I developed hives all over my rear end. The following Tuesday, it spread to my sides and down my legs to my knees. I went to immediate care, and no one can tell for sure what the cause is. I was taking a medication that has rash as a possible side effect, but I had never experienced that side effect with this medication before. I spoke with my dermatologist who also did not know what the cause was but advised that I take Claritin and Benadryl. Last night 10/12/2022 was the first night in many nights that I was not woken up with horrible itching and today, I haven't had any issues.
pt recv vax 10DEC97 & reported for eval 24hr later w/an 8x10cm painful, warm, red, indurated area @ inj site;
haD PCOS; Lower back pain; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome and low back pain. On an unknown date, the outcome of the polycystic ovarian syndrome and low back pain were unknown.   It was unknown if the reporter considered the polycystic ovarian syndrome and low back pain to be related to HPV vaccine.  Additional information was provided as follows: The patient received HPV vaccine and experienced polycystic ovarian syndrome and lower back pain . The case has been linked with the case number- US2020AMR248063, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR248063:same reporter
In March 2023, I went in for my yearly mammogram, it showed something in my right breast. My doctor scheduled me for an ultrasound for the next week, that confirmed the lump in my right breast. I was scheduled for a biopsy that came back positive for invasive carcinoma. The doctor scheduled an MRI to make sure that the cancer had not spread to any other areas of my body. It was confirmed that it had not spread, I will be having surgery in June.
PATIENT INJECTION SITE BECAME INFLAMMED 4 DAYS FOLLOWING VACCINE. THE AREA IS ITCHY, SLIGHTLY WARM, RED COVERING A LARGE PORTION OF UPPER ARM, AND PATIENT REPORTED HER SKIN PEELED.
Upper abdominal pain, radiates to back, diarrhea and stomach upset with eating, started 10 days after vaccine on 9/21/21 and isn't improving
sore left eye lid/ bump on lid/ irritation in corner of eye; canker sore on left side of tongue; cystic acne on left shoulder; This is a spontaneous report from a contactable consumer or non-HCP. A 34-year-old female patient received BNT162B2 (Pfizer BIONTECH COVID 19 mRNA Vaccine; lot number EN6208 as a second dose administered in arm Left for COVID-19 immunisation on date 13Mar2021 at 12 pm( patient is 34 years of age at the time of vaccination). Medical history was not reported. Concomitant medication was not reported. On 20Feb2021 at 1pm,patient received BNT162B2(Pfizer BIONTECH COVID 19 mRNA Vaccine; lot number EL9264, as 1st dose on left arm.  No allergies to medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 16Mar2021, patient experienced  canker sore on left side of tongue, cystic acne on left shoulder and sore left eye lid/ bump on lid/ irritation in corner of eye. No therapeutic measures were taken. The clinical outcome of the events canker sore on left side of tongue, cystic acne on left shoulder and sore left eye lid/ bump on lid/ irritation in corner of eye was not recovered.
stiffness of my neck and shoulder; Not able to speak; Alopecia; fever; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Alopecia), MUSCULOSKELETAL STIFFNESS (stiffness of my neck and shoulder), APHASIA (Not able to speak) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Jan-2022, the patient experienced PYREXIA (fever). On 27-Jan-2022, the patient experienced ALOPECIA (Alopecia). In July 2022, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness of my neck and shoulder) and APHASIA (Not able to speak). At the time of the report, ALOPECIA (Alopecia) had not resolved and MUSCULOSKELETAL STIFFNESS (stiffness of my neck and shoulder), APHASIA (Not able to speak) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not reported.  Patient had fever next day after booster shot. 2 weeks later, had alopecia on beard and 2.5 month later, had alopecia on hair. It was still continuing as of 28-Jul-2023. In Jul-2022, patient was not able to speak and had sever stiffness of neck and shoulder. Treatment medication was not reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Mom noted hive like rash from waist to feet that started on Tuesday after school that persisted through Sunday 9/8/19.  Administered Children's Benadryl as directed.
PT DESCRIBED HERSELF HAVING THE WORSE HEADACHE SHE HAS EVER HAD IT LASTED THE DAY OF THE VACCINE ALONG WITH FEVER, CHILLS, AND VOMITTING.
The patient had a Pfizer COVID vaccine as her first dose.  Made an appointment with us for her second dose and we only offer Moderna COVID vaccine.  The vaccinator missed that the patients first dose was Pfizer on the vaccine card and gave the patient the Moderna vaccine for her second dose.
Chills and joint pain the evening and night of the vaccine; migraine the day following the vaccine
Delayed (8 days after injection) onset of local injection site redness, swelling, pain and warm to touch. MOP declines any fever following the vaccination. MOP observed the reaction get approx. 3 inches in diameter. Redness, swelling, pain and warm to touch symptoms lasted approximately 5-6 days. Bruising onset following the redness for approximately 14 days, 1 inch red mark still remains at injection site, no other symptoms currently.
Dizzy, nausea for 3 days  Nausea is resolved but still very dizzy and my pcp prescribed Meclizine which helps for a awhile
Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and CHILLS (Chills) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Initial report was received from a healthcare professional on 10 April 2012. The reporter for this case is the same as case number: 2012-03809 and 2012-03810. A 63-year-old female patient received a right deltoid (RD) intramuscular injection (dose one) of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc. lot number U4308BA, (corresponding sanofi pasteur Ltd. lot number C4063) on 21 March 2012. The patient's past medical history was not reported. The patient had an allergy to "Indomethesone". Illness at time of vaccination was reported as tenosynovitis of finger from cat bite. Other vaccinations within four weeks prior to vaccination were reported as none. Concomitant medications included: pravastatin, lisinopril, allopurinol, Acetylsalicylic Acid (ASA), colchicine, ZIAC, multivitamin, and folic acid. The patient experienced a lump, itching, redness, mild tenderness and warm to touch at injection site on 28 March 2012, which required a doctor visit. The patient as already on an antibiotic, AUGMENTIN. Treatment included the addition of antibiotic BACTRIM. The reporter stated the symptoms resolved. The patient's outcome was reported as recovered on unspecified date. Follow-up information was received from a health care professional on 25 May 2012. Based upon new information provided, this case has been upgraded to serious. The patient was a 75-year-old female. The patient was diagnosed with cellulitis on 28 March 2012 and treated with AUGMENTIN XR 1000/62.5mg 1 tablet by mouth twice daily for 10 days that was started on 23 March 2012 and ended on 30 March 2012. The patient was already taking this medication for the cat bite. The patient's past medical history (PMH) included hyperlipidemia, gout, hypertension and lipoma of face. No date of recovery was obtained. The patient's outcome remained recovered. Documents held by sender: None.
Roughly 12 to 16 hours after receiving the vaccine I stated with some fatigue and body aches. I took tylenol and motrin twice during the 12 hour shift at the scheduled times. I was working night shift when this happen and came home and went to bed 24 hours after receiving the vaccine. The time I went to bed had fatigue, headache, body aches with neck and back pain. Took tylenol and motrin before going to sleep. When I woke up at 4pm, 31 hours after receiving the vaccine I had, sore throat, head congestion, severe body aches and headache. I attempted to get up since I was scheduled to work at 7pm and then got dizzy. I took tylenol and motrin, put a heating pad on my back, drank some hot tea and went back to bed for the night. Woke up at 7:30am almost 2 days after receiving the vaccine still with headache, body aches and fatigue. The sore throat and head congestion seem to have subsided. Took more tylenol and motrin and went back to bed. Still at this time feel just tired and body aches, mostly in the neck and back.