chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients were involved and date of administration was 11-Jan-2023, lot numbers were unknown to the HCP. No treatment medication was provided by reporter. This case is for 52nd patient out of 100 male patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
The patient experienced two separate rashes. 1) The day after the vaccine Patient experienced a rash on the arm (right) that was injected with the vaccine. 2) An unusual looking rash on the lower right leg at the bottom of the shin just above the ankle. This rash is approximately 6 inches long (horizontally) and 2 inches wide. Bright red, solid uniform color.
My arm still hurts; My arm still hurts & bothers me at night disturbing my sleep; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and sleep disturbance. On an unknown date, the outcome of the pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and sleep disturbance 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's arm still hurts and bothers them at night disturbing sleep.
pt has sharp pain in the area around the admin site...pt has a md visit planned 7/29/21
This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166.
3:30 a.m. Sweats, medicine was pouring out of my pores it smelled sickly sweet.  Got a headache like no migraine I've ever had, diarrhea,  nausea, dizziness.  It lasted all fucking day.  Just NOW I'm feeling somewhat back to normal.  As it was happening my arm where I got that shot the bump started to go down to my elbow until finally my arm does not hurt anymore
The CDC rep. who called me about my V-Safe response said a breakthrough Covid infection in a fully vaxxed and boosted person is an adverse event and should be reported. I had to seek medical care several times while sick. During the first three days of mild symptoms - slight runny nose and sneezing - I continued to test negative on home rapid tests. Day 4 I had a splitting headache on one side of my head. I was encouraged by a representative from the CDC's V-Safe program to report my breakthrough case of COVID to VAERS, since I was fully vaccinated and boosted and had just received the Moderna bivalent booster just a little over two months before contracting COVID earlier this month. I believe that the extreme dizziness I reported on this form was related to Lagevrio, the COVID anti-viral I took, so I am also reporting that to the FDA on Form FDA 3500B. Dizziness is a common side effect for Lagevrio, and I believe that the prescribed dosage of four 200 mg. capsules twice a day was too much for me, since I only weigh 86 lbs. I reduced the dosage to three 200 mg. capsules twice a day, and that helped my dizziness.   Please feel free to contact me if you have any questions about my responses. I was unable to type fast enough to keep from getting kicked off the online form, and I couldn't get the calendar links to work correctly on the downloaded form, so I had to print it, fill it out by hand, and then fax it to you. Oops, the FAX # was busy for three days, so I had to resort to mailing it.
misery; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling miserable (Verbatim: misery). The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR034524   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had second of two shots and they set you back a couple days, but patient never want to be in that kind misery again. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR034524 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR034524:Same reporter
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown resluts, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication within 2 weeks of vaccination. The patient received Anti-viral drug (Paxlovid) as COVID 19 treatment from 08Jul2022 to 12Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        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 medication was reported. Treatment drug information was not given.   This case was linked to MOD-2021-163978 (Patient Link).
I'm not certain if these adverse events are due to vaccine want to report what I have experienced. I felt run down couple days. My heart rate was elevated, spiking blood pressure changes, mild headaches and chest aches. I'm still exp the symptoms now that I'm on Lisinopril and Metformin.
Fever of 101 degrees Fahrenheit, numbness and tingling of tongue, nausea, abdominal pain, "weird" sensations all over body.
post herpetic neuralgia; herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 31-AUG-2009, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles.  On an unspecified date,subsequently to the vaccionation, the patient presented shingles and post-herpetic neuralgia.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Woke up on 4/16 at 3:15a with chills and fever. After taking some Tylenol and drinking water and some green tea the symptoms resolved upon waking on 4/17. I was also able to eat a light breakfast and dinner on 4/16.
Pt was taken to ER 5 days after MMR vaccine via ambulance for febrile seizure. Temperature in ER was 105.4 rectally.
*Seizure/Seizure-like episode 21 days after receiving Dose #2 of Pfizer Covid-19 Vaccine   (blurry vision, total loss of consciousness, body convulsions lasting about 2 minutes, gasping, slight moaning, foaming at the mouth, then at least 5+ minutes to regain full consciousness)
Pt recvd vax & exp severe h/a, watery eyes, ear pain, fever & vomiting;
Patient reported slight dizziness after receiving the vaccine but resolved after 30 min observation; employee denied experiencing any trouble breathing, difficulty swallowing, dizziness, fainting,  On 1/29/2021 (7 days post vaccine), she started experiencing a 3-4 cm swelling in the right deltoid with an itching erythematous rash on both arms and hands without associated difficulty breathing, swallowing, or hypotension.  Patient took oral diphenhydramine and applied topical tacrolimus cream and Sarna which helped control night itching.
1 day p/vax pt devel an inj site rxn characterized by erythema, induration & pruritus;pt recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax lot# 4978139;
History of Present Illness Pt is 57 y o M with PMH of HTN and DM. Presented do ER with c/o SOB going on since last few days getting progressively worst prompting him to come to ER. Associated with non productive cough, subjective fevers and chills. Denies chest pain, N/V/D or palpitations. Denies recent travel or sick contacts. In ER pt was initially stable, saturating ~ 94% on 4 L. Then desaturated to mid 80s requiring 15 L. Labs were significant for hyponatremia, elevated BS~ 400, elevated creatinine and anemia. COVID PCR came back positive. Pt is put on bipap and transferred to ICU for closer monitoring.  Currently c/o cough and  feels very short of breath.   Discharge Diagnosis #Acute hypoxic resp failure in the setting of Covid pneumonia.  #Thrombocytopenia new and acute.  # AKI.   #History of hypertension.  #History of diabetes mellitus.. #Hyponatremia  Hospital Course Pt is a 57 yr old male with a past medical hx of DM and HTN was admitted with a co shortness of breath.Pt on admission is afebrile and has wbc count of 3 and creatinine of 1.7. Pt tested positive for COVID19. CXR showed bilateral patchy infiltrates. Pt was started on remdesivir, dexamethasone and Ceftriaxone and azithromycin. Pt on 15 liters of high flow O2.  Pt given one dose of actemra on 12/13/21. Admitted to PCU but had worsening hypoxia. Decision made to transfer to ICU . Started on abx. On bipap overnight at 100%.  Respiratory status worsened and she was intubated.  She was treated for acute kidney injury hyponatremia and thrombocytopenia and was evaluated by ID service intensivist nephrology service hematology service.  Eventually patient went into cardiopulmonary arrest as a CODE BLUE and expired
Excessive crying and irritability with fever starting 24 hrs after vaccine administration and continuing for 36 hrs total. Patient unable to sleep for close to 36 hrs due to excessive fussiness. Patient seen at about 30 hours into reaction. No source on exam. Urine negative- see below. By 48 hrs the reaction had subsided - patient was eating and sleeping normally again. No treatment except TYLENOL for fever over 101.
Started have problems walking  and had issues with left leg than would fall and couldn?t get up on own than dr said drop foot than left arm and hand turned unusable than a walker than on dec 22nd 2022 was told she had ALS and than in February bed ridden than in hospice and my wife passed on June 19th almost one year to the day of the vaccination
shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder sore) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ARTHRALGIA (shoulder sore). At the time of the report, ARTHRALGIA (shoulder sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received. Significant FU. AE Outcome and patient gender and age group added. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder sore) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ARTHRALGIA (shoulder sore). At the time of the report, ARTHRALGIA (shoulder sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received. Significant FU. AE Outcome and patient gender and age group added.
This spontaneous report was received from a physician regarding a 14 year old male patient. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL 9. No concomitant medication was reported. On an unknown date the patient experienced generalized rash all over his body which lasted for a while. The outcome of generalised rash was reported as resolved at the time of reporting. Causality between generalised rash and GARDASIL 9 was unknown. Additionl information has been requested.
I am still very fatigued, no appetite, weakness, and stomach ache; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; This is a spontaneous report from a non-contactable health professional. A 43-year-old non pregnant female patient received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration in Arm Left on 21Jan2021 as single dose for covid-19 immunisation. Facility where COVID-19 vaccine was administered was hospital. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clonazepam. Known allergies is none. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection), on 21Jan2021 in the left arm at single dose for COVID-19 immunisation. On 22Jan2021 the patient experienced Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving. The patient stated that I am still very fatigued, no appetite, weakness, and stomach ache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Dec2020. Outcome of the events were not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Right upper arm swelling, pain warmth.  Rx: cool compresses/ibuprofen.
Atypical measles. Initially patient had severe URI/bronchiolitis symptoms for 2 weeks following vaccinations. Then broke out in rash consistent with measles on 01-16-12.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, dose route and frequency unknown. On 08/MAR-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 2, lot#:0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
AT 5PM; PT BEGAN EXPERIENCING VIGOROUS SHAKES AND CHILLS AT HOME. PT ENDED UP UNABLE TO MAKE IT TO THE BATHROOM AND HAD AN ACCIDENT IN BED. CHILLS WERE UNABLE TO BE RESOLVED WITH HEAT PACK OR EXTRA BLANKETS. SYMPTOMS RESOLVED AT SOME TIME OVERNIGHT OF WHICH PT IS UNAWARE OF WHEN AS THEY WERE ASLEEP. PT IS CURRENTLY FEELIGN WELL AS OF 11AM 4/8/22 WITH ONLY SLIGHT DEHYDRATION.
Within 10 minutes of receiving the vaccine, client reports he had a very stiff neck. This went away in 15 minutes. On Sunday, 10/29 at 3 a.m., client woke up covered in sweat and had a cough with muscle aches. Since that time, client states symptoms are progressively getting worse. These SX include fever, chills, sore throat, muscle aches, fatigue, cough, headache and runny nose. Today went to the doctor. Lungs were clear. Was told he didn't have the the flu, bronchitis or strep throat. Client was given steroids for itching to his skin. Was told to go to the health department to fill out a VAERS.