chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Flucelvax on 9/15/2021 along with her first COVID-19 vaccine. Flu clinic was on 10/13/2021 and patient showed up to receive flu shot while thinking the clinic was for COVID-19 second dose. I reached out to patient to inform her and addressed any concerns and or side effects that she might have experienced. Patient stated she had no side effects and that she felt fine and that she will look out for any future side complications that she might experience.
No additional AE reported; HCP accidently administered expired GARDASIL 9 to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.    On 28-FEB-2022 the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (once, lot # S022599, expiration date 25-FEB-2022; dose and route were not reported) for prophylaxis by a HCP accidently (expired product administered). Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had not experienced any temperature excursions. No additional event reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.       No concomitant medications were given No treatment information was provided    This case was linked to US-MODERNATX, INC.-MOD-2021-079441, US-MODERNATX, INC.-MOD-2021-079392, US-MODERNATX, INC.-MOD-2021-079302, US-MODERNATX, INC.-MOD-2021-079392 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079441: US-MODERNATX, INC.-MOD-2021-079392: US-MODERNATX, INC.-MOD-2021-079302:
ACHING BODY; SORE ARM; FATIGUE; HEADACHE; SHOOTING PAIN IN LEG; FEVER; DIZZY AND LIGHTHEADED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on any chronic medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dizzy and lightheaded. On 05-APR-2021, the subject experienced fever.  On 07-APR-2021, the subject experienced shooting pain in leg. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced aching body, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching body, sore arm, and fatigue, dizzy and lightheaded on 14-APR-2021, shooting pain in leg on 11-APR-2021, and fever on 06-APR-2021, and was recovering from headache. This report was non-serious.
Redness, swelling, pain, heat started 11/22/02-persists minimally as of 11/26/02.
body aches; pain in the arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), INJECTION SITE PAIN (pain in the arm) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Jan-2021, the patient experienced PAIN (body aches), INJECTION SITE PAIN (pain in the arm) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PAIN (body aches), INJECTION SITE PAIN (pain in the arm) and CHILLS (chills) outcome was unknown.      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.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Patient's contact information updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
PATIENT REPORTED SWELLING OF THE ARM THE SIZE OF BASEBALL, REDNESS, RASH, AND GENERAL MALAISE
he was in his usual state of health until about 230 this afternoon he started to have chills.  These progressed to shaking chills and rigors by 330.  He was at his Oncology office in the took his temperature which was 96 F.  However with concerns of infection he was referred to the emergency department.  Upon arrival here he still complains of chills and sweats.  He reports a small cough which feels like postnasal drip but denies shortness of breath, chest pain, abdominal pain, nausea vomiting, diarrhea or constipation, difficulty urinating or burning urination.  He denies skin lesions
Common cold symptoms  (cough, runny nose, etc.) within 48 hours of vaccine. Symptoms continued to worsen over the next two weeks; migraines, high fever, chills, sweats, fatigue, dizziness, diarrhea etc. Week 5 (October 5th) symptoms significantly increased - vomiting, diarrhea, high fever, dizziness, chills, sweats, etc. October 16th - symptoms continued, but severe chest pain started. Went to the hospital at 7pm with a 103 fever. 10/16 - Troponin I level tested three times: 1.83 on 10/16, 4.50 on 10/17, & 3.66 on 10/17. Vomiting, diarrhea, high fever, dizziness, chill, and sweats continued for entire hospital visit. Antibiotics given on 10/17; no change. Both Covid tests negative. Echocardiogram done on 10/18 - myocarditis confirmed. Sent home on 10/19 with anti-inflammatory drugs to take for 10-14 days.
Rash started 8 days after receiving booster shot for Covid-19.  First, the rash was located on neck, arm pits and groins. next day, throat was swollen. today is day 4, over the last days rashes (red plaques and bumps) are spread throughout the body. sensitive skin., soreness in armes, minor head ache, breathing normally.   treatment: Zyrtec x1 on day 2: Benadril 2x a day on day 3 and 4
Patient felt pain right after injection and couldn't lift her arm after approximately 6 hours of injection. She visited Emergency room and follow-up Dr. visit and also specialist. (X-ray check's done and also alternate physical therapy.
Erythema multiforme, seen on 8/24/2009 for Urticarial rash pharyngitis, treated with Loratadine and epipen given.
My lungs got really tight and I experienced chest pain.  I did use my rescue inhaler and continued Advair, but had to go to ER and be put on Prednisone.
got very ill; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) on 10-Dec-2020.  This case involves a patient of unknown demographics who got very ill (illness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he/she got very ill (illness) for four days with the INFLUENZA VACCINE afterward.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This non-serious spontaneous case, initially received on 19-Mar-2018, reported by other health professional, concerning a 13-year-old, adolescent patient of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 08-Feb-2018, the patient was administered with FLUCELVAX QIV that was stored out of recommended temperature (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
This case was reported by a other health professional via call center representative and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. In January 2019, the patient received SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced swelling and pain. On an unknown date, the outcome of the swelling and pain were recovered/resolved. It was unknown if the reporter considered the swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced swelling, soreness, the normal things expected following administration of SHINGRIX earlier this year and she was pretty sure they resolved. This case has been linked to the case US2019016618, reported by same reporter.
Gross hematuria; This spontaneous case was reported by a patient and describes the occurrence of HAEMATURIA (Gross hematuria) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 06-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HAEMATURIA (Gross hematuria). At the time of the report, HAEMATURIA (Gross hematuria) was resolving.            Concomitant medication was not provided. Patient experienced gross hematuria; bleeding started 6 days post vaccination. Very heavy bleeding with blood clots which lasted for 8 hours. Primary care verified as no UTI. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027514 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027514:Same reporter, different product
Patient was given Moderna Vaccine at age of 17.  Moderna indicated for >18 years of age.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine unspecified (manufacturer unspecified). Subject's medical condition included systemic lupus erythematosus. On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 systemic lupus erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improvement management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators, using xMAP technology. SLE patients who exhibited disease flare and significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In approximately May 2018 (reported as beginning of May), the patient was vaccinated with a dose Oka/Merck VARIVAX reconstituted with sterile diluent, subcutaneous for prophylaxis. In approximately 2018 (reported as 2 weeks after first dose), the patient experienced varicella like rash. The patient called her primary care provider. No treatment was given and the rash subsided (in 2018). The outcome of rash vesicular was reported as recovered/resolved. Causality assessment was not provided.
Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild
2cm x 4cm area that is red and swollen. Parent just noticed today and brought her straight in at 3:30 PM (8/29/07). Pt denied any other symptoms. Vital signs normal. Keflex was given, pt's parent instructed to watch and if gets any worse call Dr. or go to ER.
Pneumo 23: Severe decrease in ROM of extremity could not lift arm. Upper arm swollen but no redness. Painful. HD FLUZONE: fever-low grade temp, general malaise, severe fatigue, arthralgias, persistent headache, nausea. Bad leg and foot cramps. Addendum: Resolved by 12/27/17.
Patient was given flu shot twice.  He came into pharmacy to get moderna vaccine and received fluad.  He had previously received the flu shot last month.
Received booster 2/3, on 2/5 that  night tongue, neck & underarms swelled up, had a hard time eating, drinking & swallowing without extreme pain. Went to the ER for treatment & received a shot for pain & a shot of steroids for the swelling. I also received steroids to take home for the week.
RASH ON BOTH ARMS: DRY SCALEY PATCHES TGHAT ITCHED SO MUCH MY SCRATCHING RESULTED IN BRUISING & BROKEN SKIN IN SOME PLACES. APPLYING SKIN LOTION (EUCERIN) TWICE A DAY TO RELIEVE THE ITCHING. NOT MUCH RELIEF.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported. It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vial. The vial haven't undergone any temperature excursions.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Burning in left eye when sleeping at night Pressure in left eye during the day Constant cigarette smoke smell all the time
Redness & swelling on right thigh. Diagnosed with cellulitis. Prescribed Keflex tid x 5 days.
Pain in (R) shoulder and arm to wrist - 7PM 10/13/15 (R) shoulder and upper arm locked. 10/14/15 applied heat and ice pack, ARNICA Gel, Acetaminophen continuously. Shoulder still sore and stiff at 12/11/15. Have consulted Dr, 11/13/15 - personal physician, chiropractor 12/11/15.
Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was having a flare up of sjogrens. Dry mouth and dry eyes were worse. Dry cough, chest discomfort was the most difficult to deal with and GERD issues got worse
Myalgia, Nausea Vomiting, FATIGUE; CHILLS Narrative:
Student returned stated arms were itching one hive noted under chin mom present did not want IM Benedryl given gave 25mg Benedryl by mouth per mom request. Symptoms did not worsen and subsided.
PT SAID HER THROAT FELT SWOLLEN AND HAD DIFFICULTY SWALLOWING; DR TOLD HER TO TAKE SOME BENADRYL SO SHE TOOK 1 CAPSULE AND SYMPTOMS RESOLVED.
Initial report was received on 05 October 2012 from a consumer who is also the patient. A 64 year-old female patient with no reported past medical history had received on 04 January 2012 ADACEL (lot number, route and site of administration not reported) and experienced "right away" a feeling of "arm on fire" and then later the same date, had chills, nausea, vomiting, aches and pains. A few weeks after vaccination on 27 February 2012, the patient was driving in the car and "went blank". The patient pulled over and called a friend who took the patient to the ER (emergency room). The patient was hospital for two weeks and had numerous tests (results not reported). Treatments were not reported. The patient had no illness at the time of vaccination. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comment: This case was reported by the patient's relative via interactive digital media. The reporter stated that his/her cousins took Influenza vaccine every year in November, they did not like it, because they had still got sick as usual at the time of reporting, so they did not see a point of it. The reporter thought that the event might had been related to product/device. Additional supportive information: This case was one of the three case reported by the same reporter for different patient. Follow-up would not possible as no contact details were available.   The case was amended on 13-Jan-2023: The product name was updated from Flu vaccine to Influenza vaccine and event causality was updated from yes to possible.; Sender's Comments:  US-GSK-US2023AMR001600:same reporter US-GSK-US2023AMR001584:same reporter
Rash: sore trunk, swollen lymph nodes. Treated with Tylenol, Benadryl and Calamine.
Site of injection red, swollen and tender. Informed to give Tylenol for pain and use ice packs/cold compresses to area.
Probable local reaction to MMR, Hep A? IPV? R arm swollen, hot to touch. Meds Atarax, Keflex.
Red, Swelling, Arm pain, whole body tired, mild fever, no energy for the 3 days.  But body tired, arm pain and swelling for a week.  Although swelling  was gone, my arm pain without stopped. Also, shoulder pain appeared.  Then I could not put up my arm and carry grocery stuff.  I even could not wear my bra.     I went to  see my PCP through tele-visit and she recommended me to have physical therapy.