chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018). Concomitant products included FLUARIX TETRA and Hep A vaccine. On 9th October 2017, the patient received BEXSERO .5 ml. On 10th October 2017, 1 days after receiving BEXSERO, the patient experienced injection site pain, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site erythema and injected limb mobility decreased were unknown. The reporter considered the injection site pain, injection site erythema and injected limb mobility decreased to be possibly related to BEXSERO. Additional details were received as follows: On 6th October 2017, the patient received a dose of FLUARIX QUADRIVALENT (batch number: 572KT, expiry date: 25th May 2018) in right deltoid and Hepatitis A vaccine (non GSK, batch number: N005796, expiry date: 26th May 2018) in left deltoid. The patient received a dose of BEXSERO at 10:30 in left deltoid. The patient experienced soreness in left arm. There was a very minimal surrounding ring of erythema on left deltoid with moderately decreased left shoulder range of motion secondary to pain. The area was tender to palpation but without swelling or induration. The concomitant Hepatitis A vaccine was considered as a non GSK vaccine considering the batch number information from the linked case US2017157942. This case was one of the 3 cases, reported by the same reporter for the patients who experienced events after the same lot number of BEXSERO.
No additional AE reported; Nurse does state second dose of GARDASIL 9 was administered to a patient 2 weeks from the first dose; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.  On an unknown date in March 2022, 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)  administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and 2 weeks from the first administration was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) instead of 2 months (product use issue). The nurse inquired if the third (3rd) still needed to be administered at 6 months. No additional adverse event details.
"Arthritic" type pain in joints of fingers, toes, wrists, neck, lower back, top part of feet, arched of feet, left knee felt crippled (then both knee's had moderate pain).
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 41-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: Product Complaint Investigation results.
None.  Pediarix was given as 4th.- it is only to be  used for 1, 2, 3.  Pt had no problems.
Myocarditis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were provided.  Patient developed myocarditis 48 hours after receiving his first Moderna COVID vaccine.  The patient is still in the cardiac ICU in stable condition and improving.  Treatment of the event was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Large localized redness, swelling and inflammation extending to entire upper arm and to scapular region of back.
PATIENT FELT A WARM RUSH RIGHT THROUGH HER BODY RIGHT AFTER THE VACCINE WAS ADMINISTERED. HER HEART RATE WENT UP AND SHE FELT LIGHTHEADED, NAUSEOUS AND  A "HEAVINESS ON HER CHEST". THE CHEST HEAVINESS BECAME WORSE, HER SKIN FELT CLAMMY AND SHE HAD THIS RED FLUSHED LOOK ON HER FACE. 911 WAS CALLED AND AFTER EXPLAINING THE SYMPTOMS AND WITH HER HISTORY OF A STROKE, 911 INSTRUCTED US TO HAVE THE PATIENT SWALLOW 3 ASPIRIN 81MG.   911 ARRIVED, MONITORED HER HEART RATE, HER BLOOD PRESSURE (EXTREMELY HIGH)  AND DID AN  ECG. EVERYTHING LOOKED NORMAL, AND BLOOD PRESSURE SLOWLY CAME DOWN AS WELL AS HEART RATE. 911 RECOMMENDED PT TO MONITOR HER SYMPTOMPS AND IF NEEDED TO GO TO EMERGENCY ROOM. PATIENT ALSO ADMITTED SHE HAS PANIC ATTACKS NOW AND AGAIN, AND USES LORAZEPAM PRN (VERY SELDOM THOUGH).
Three hours after vaccination, pt reported pain on upper right arm especially when she tried to move it, and small fever the day after. Followup a week later: pain bearable, hand shakes (right arm) when trying to move, no swelling, muscle weakness - Guillain-Barre like syndrome; was given pain medication & muscle relaxant in urgent care.
Received the booster on Friday, 2/25/2022. Woke up with a fever, chills, and body aches on Saturday, 2/26/2022. Had low grade fever and headache on Sunday, 2/27/2022. Still felt sick Monday, 2/28/2022 and called out of work. Returned to work and felt recovered on Tuesday, 3/1/2022.
Patient immediately became light headed/dizzy and appeared to faint for a second before regaining conciousness and improving rapidly. EMS responded to seen and evaluated patient on site. Vitals are as follows: BP: 105/67, pulse: 62, respirations: 12, blood glucose: 110, O2 sat: 99%.  After evaluation patient was deemed fit to return home.  She had not eaten yet and was nervous about injections in general; EMS believed this were the causative factors before releasing her.
The healthy 34 year old physician with no prior adverse vaccine reactions began experiencing mild nausea approximately 9 hours after receiving vaccination, followed by fatigue approximately 11 hours after the vaccine. She awoke from sleep approximately 15 hours after receiving the vaccine with a temporal artery temperature of 102.9F with associated chills, myalgias, arthralgias. This continued until approximately 30 hours after vaccine administration. 30 hours after vaccination her temporal artery temperature was 100.9. She had a COVID PCR test 34 hours after vaccination that was negative. Severe fatigue and mildly elevated temperature continued, limiting her ability to report to work for a total of 4 days.
Pt. stated "I started feeling a lot of dryness on my throat 10 min. after getting vaccinated.  Vital signs taken 147/62, 100% O2Sat, HR 78, R 16.  No difficulty breathing or swallowing.  At 3:35pm  pt. reported feeling better and think she is ready to go home.  At 3:40pm pt. went home with family member.
Patient developed fatigue, shortness of breath, myalgias, restless sleep, feeling of "menthol" in his chest Elevated CK levels
Remove the wax in her ears; mild hearing loss at 8 khz; ringing in her ears, high pitched & constant, it's in both ears/ongoing; Canceled second dose appointment; Had a pretty hard lump; It had a pretty hard lump, which was warm to touch; hard lump; It had a pretty hard lump, which was tender; It had a pretty hard lump, which was itchy; some swelling in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears) and PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm). On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment). On 26-Apr-2021, the patient experienced TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing). On an unknown date, the patient experienced CERUMEN REMOVAL (Remove the wax in her ears) and HYPOACUSIS (mild hearing loss at 8 khz). At the time of the report, VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears), PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment), HYPOACUSIS (mild hearing loss at 8 khz), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Acoustic stimulation tests: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: VAER form appended
7MAY97 pt recv vax 420PM pt had temp 104, 105 ax last dose APAP given 4hr ago;pt just lying down;instructed to give APAP & take to ER if temp not down in 1/2hr;8MAy called gave APAP, temp resolved;had vomiting &  diarrhea during noc;
severe abdominal pain; Bloating ;  Passing fluids, both ends;  resulting in a 4.6 Lb weight loss in a six hour period
Onset of peripheral type Bell (L) facial palsy. Negative Lyme Disease Western Blot. Put on  Prednisone 1 week po
10/31 3pm malaise, lo graade fever, nausea, fatique 11/2 AM rash on left side of back spreading to side to groin, lymph nodes swelling and pain.  11/3 Dr visit dx with shingles due to immune supression effect of flu vaccine, at which time I was prescribed Acyclovir.
CLIENT RECEIVED VACCINATION AND WAS FINE.  HE RETURNED 30 MINUTES AFTER COMPLAINING OF FEELING LIGHT HEADED AND DIZZY.  HE ALSO STATED THAT HIS TONGUE WAS TINGLING.  NO RESPIRATORY DISTRESS AND HE WAS ALERT AND ORIENTED.  VS 16:30  HR 76, R 12, BP 142/102, VS 17:00 HR 70, R 14., BP 152/122.  STABLE.  BENADRYL WAS ADMINISTERED@ 16:30.  SYMPTOMS NO LONGER PRESENT @ 17:00 VS CHECK.  ADVISED TO MAKE APPOINTMENT WITH PCP FOR HTN.  HE STATED UNDERSTANDING AND HAD A DRIVER TO TAKE HIM HOME AFTER ADMINISTRATION OF BENADRYL.
PATIENT REPORTED REDNESS AT INJECTION SITE AND GROWING AS THE DAYS WENT ON. SHE SAID IT WAS SWOLLEN, TENDER TO TOUCH, BUT NOT ITCHY. SHE REPORTS TO NEVER HAVE HAD AN ISSUE WITH PREVIOUS INJECTIONS
I got the first Pfizer vaccine and within 45 minutes. My face went completely numb. I have blurry doubled vision and a horrible headache. Which lasted for over a week.
Pfizer 4/29/21 and 5/20/21. Positive on 1/11/22
Headache, Myalgia, Anaphylaxis, Fever, HYPERtension, oral thrush Narrative:
came down with mild symptoms of shingles; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 30May2021 as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unknown date in Jun2021, 2 weeks later after first dose, the patient came down with mild symptoms of shingles. The patient received treatment for event. Patient stated she was on Valtrex right now and was wondering if she was able to get the second dose of Pfizer's COVID vaccine. Her second dose was due 20Jun2021 and the doctor told her to wait until her symptoms of shingles lightened up and suggested she receive the Shingrix vaccine as well. Patient was asking how long should she wait to get the COVID vaccine if she were to get the Shingrix vaccine. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Fever 103 - mom gave Ibuprofen 3 ml but the fever stayed up all the night. Mom says she did not check the temp again - she says the child was still hot to touch. The fever went away the next day some, but was hot to touch again at night. Apparently only one time the temp was taken with a thermometer. The next day the child started with diarrhea in the afternoon, approx 3-4 very loose stools per day.
This spontaneous report as received from a physician refers to a 24 year old female patient. The patient's medical history included drug allergy to amoxicillin and MACROBID. On 12-JUN-2017, the patient was intramuscularly vaccinated with first dose of GARDASIL 9 in left deltoid lot # M041212 exp 21-JUN-2019 as routine vaccination. Concomitant therapies included vitamin D. On 12-JUN-2017, the patient began to experience redness, tingling, burning, swelling, and pain in both hands "within 2 hours" of receiving the dose of GARDASIL 9. The physician called this adverse experience "induced carpal tunnel." The patient sought medical attention by consulting the physician today, 13-JUN-2017. He recommended that the patient take an unspecified anti-inflammatory medication, BENADRYL, and wear a wrist splint. At the time of this call, the patient has not initiated these recommended treatments. The physician reports that the patient had difficulty gripping her steering wheel of her car today. The patient was at the time of the report sitting in his office with her hands on her lap, palms up, and her hands are "red in color." During the same visit in which the patient received GARDASIL 9 on 12-JUN-2017, the patient was prescribed DIFLUCAN for an unrelated health reason that pre-existed the GARDASIL 9. The physician did not know, at the time of this report, if the patient has taken any DIFLUCAN. The outcome of the event was not recovered. The relatedness between the event and the vaccination was not reported.
immed p/vax 12OCT94 pt felt dizzy & lightheaded while was walking home; later that PM felt very tired & overall aching; no fever noted; 13OCT93 exp extreme fatigue; rested most of the day & is feeling better now 14OCT94; rt arm sore;
Patient had an adverse event at the site of injection which lead to swelling of the arm. Patient's doctor suggesting she visit the ER to rule out blood clots.
Same day of vax, the pt spent the night away from home. The following night at bath time, her mother notices swelling at injection site with redness, and hot to touch. A red rash on buttocks and back of thigh. On the following day (2 days post vax) arm the same but rash is almost gone. Pt was seen by an MD and prescribed Cephalexin.
I had the regular standard temperature for a couple of days but then my left arm started hurting and noticed it was raised red sore and feverish. Went to ER to have it looked at and it was cellulitis. Was put on Keflex four Per day for seven days
This study case was received from the investigator in the trial on 29 May 2013. A 35-year-old male subject was found to have other primary cardiomyopathies 12 days after receiving the following vaccines on 10 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported) and anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included normal troponin, abnormal ECG and abnormal echocardiogram on 17 April 2013. Treatments were not reported. Past medical history included high blood pressure and palpitations/pounding heart without exercise. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
There was no adverse event. The dose that the patient received had gone through one freeze thaw excursion. After talking with Pfizer and reviewing the information provided, the safety and efficacy of the vaccine was not jeopardized.
Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F); Dose administered greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 07-Mar-2021 at 09:18 AM vial was initially punctured and kept at room temperature range (8 degree to 25 degree C, 46 degree  to 77 degree F) for about 28 hours. It mentioned that the vial did not undergo any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Significant information: Suspect drug details updated.
Hives within inches of injection site after 24 hours. Headache and rapid heartbeat within 10 hours. Sharp and dull muscle spasms and tightness. Soreness in the injection arm.
After the third dose of the Pfizer vaccine the patient, who was seated, reported feeling dizzy and like she was "blacking out." The patient lost consciousness for a few seconds. An ambulance was called but after being evaluated the patient declined to visit the hospital.
She has been sick for a long time; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She has been sick for a long time"; BRONCHITIS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 36 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history atopy: contact dermatitis and allergic rhinitis. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, 'choking' cough, increased heart rate and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamine, oral steroid and cool compress. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Acute respiratory failure with hypoxia. He was admitted to the hospital and treated for community-acquired pneumonia.  He was discharged home when no longer hypoxic, doing well on room air, feeling improved, sent home on Levaquin and steroid taper. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Initial and follow-up information has been received from a nurse concerning a 10 year old male who on 13-AUG-2008 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (lot no. 660082/1977U) into the right deltoid. Concomitant therapy included the first dose of HAVRIX (lot no. AHNVB289BA) given intramuscularly and tuberculin in purified protein derivative (lot no. 62412) given intradermal. On 15-AUG-2008, "within 48 hours of the vaccination", the patient developed a local reaction after administration of VARIVAX. He developed an approximately 2 inch in diameter, raised red area at the injection site, which was erythema, tenderness, local pruritic and swelling without significant induration. There was no follow specified unless not improved. At the time of this report, the outcome was unknown. The patient sought unspecified medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biological Evaluation and Research and was released. This is one of several reports received from the same source. Additional information is not expected.