chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-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 29-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM).    No concomitant medication details was reported. It was reported that the patient had not reported any adverse reactions to this dose. Vial size was 0.4ml. The vial was initially stored in the refrigerator on 10-MAR-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Paitents have been administered from Vaccine that experienced a temperature excursion; Paitents have been administered from Vaccine that experienced a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Paitents have been administered from Vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Paitents have been administered from Vaccine that experienced a temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Paitents have been administered from Vaccine that experienced a temperature excursion). On 18-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Paitents have been administered from Vaccine that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Paitents have been administered from Vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Paitents have been administered from Vaccine that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Storage condition at the time of the excursion was reported as refrigerator. Maximum temperature reached was reported as 64°F. Excursion duration was reported as approximately 7 hours. Date vial moved from freezer to refrigerator was reported as unknown. They were returned to the refrigerator. No changes on visual inspection noting vaccine state. At the time they were unpunctured. The Tran date was reported as 18-Mar-2022.  The patient not had any adverse events post injection.  No treatment information was reported.
NO adverse reaction or treatment needed.  Patient received the monovalent pfizer dose instead of the bivalent booster.   The patient has been notified to return 2 months from this dose to receive the bivalent booster.
Patient stated she developed a blister around the size of a quarter on her right dorsal foot and ultimately ended up with all over pruritus and urticaria. states that it was pretty much head to toe.  She utilized high-dose Benadryl and topical cortisone and after stated resolution
Patient reported having redness followed by swelling under the arm with a fever. He took some ibuprofen but went to the doctor on Saturday because the swelling didn't go down and received some antibiotics. Patient currently doing better and the swelling subsided.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 10-MAY-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 28-DEC-2016, she was treated by a physician at a hospital for a blistering vesicular outbreak, which was diagnosed as a severe case of herpes zoster, also known as shingles. On or about 25-APR-2017, she received subsequent treatment from physician at a hospital for ongoing and worsening symptoms, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster infections. The patient has been prescribed acyclovir (ZORIVAX), famciclovir (FAMVIR), gabapentin, and lidocaine for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a pharmacist via company representative refers to two patients of unknown age and gender. On an unknown date, the two patients were vaccinated with ZOSTAVAX (dose, duration and lot were not reported). On an unknown date, the two patients experienced swelling at the injection site after administration of ZOSTAVAX. The outcome of experienced swelling at the injection site was unknown. Additional information has been requested.
Approximately 5 minutes post vaccination, while sitting outside pharmacy, patient began to feel dizzy and nauseous, pallor was noted in her face.  Asked patient to move to the ground, but she felt too nauseous and didn't want to throw up while laying down. Patient then moved to a hunched over position, as I sat in front of her to prevent her from falling forward onto the concrete if she were to pass out.  Blood pressure taken and noted as low 89/51.  Patient continued to be able to respond to questions and verbalized without exertion or issue.  Patient noted no difficulty breathing, no bluing of the lips, no tingling or swelling of the mouth, lips, or tongue.  She continued to note that she just felt dizzy and nauseous.  Cold compress applied to the back of the neck and cold water offered to patient as requested.  Repeat blood pressure taken after 8 minutes and BP had stabilized to 110/89. After 5 minutes patient noted a dizziness level of 5/10, versus a 10/10 when she first started feeling symptoms.  Continued to draw BP's every 5 minutes for 20 minutes and all remained stable and normal.  Patient was able to sit up after 10 minutes without worsening symptoms and color had returned to her face.  Asked patient to remain sitting for an additional 10 minutes.  After a total of 30 minutes post vaccination, I had the patient stand for 1 minute straight and walk up and down an aisle.  There were no issues with dizziness per patient and noted no issues in gait or stability.   The patient said that this had not happened to her before with any other vaccines and that she felt 100% better.  I instructed her to receive further vaccinations in a healthcare setting, like her primary care provider's office. I released her to continue her shopping, noting that she would return or call if any other issues arose.
Warm to the touch; Felt her arm that was swollen, knot; Red mark the size of a baseball; It is painful; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Warm to the touch), PERIPHERAL SWELLING (Felt her arm that was swollen, knot), ERYTHEMA (Red mark the size of a baseball) and PAIN IN EXTREMITY (It is painful) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SKIN WARM (Warm to the touch), PERIPHERAL SWELLING (Felt her arm that was swollen, knot), ERYTHEMA (Red mark the size of a baseball) and PAIN IN EXTREMITY (It is painful). At the time of the report, SKIN WARM (Warm to the touch), PERIPHERAL SWELLING (Felt her arm that was swollen, knot), ERYTHEMA (Red mark the size of a baseball) and PAIN IN EXTREMITY (It is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Pt became vasovagal & fainted. Lasted a few seconds. Given H20/& monitoring
24/7 Headache. Finally diagnosed with New Daily Persistent Headache Months later.
Within a few hours after the vaccine was administered, I felt unwell and became progressively worse. For 36 hours after the vaccine, I experienced a crisis of energy, fatigue, and body soreness. It subsided after 36 hours. I expected that was a reasonable response for my already highly sensitive and overactive immune system (autoimmunity). What I didn't expect was two weeks later to erupt with shingles. I have had shingles twice in my earlier adult life, so I am familiar with the symptoms. This course has gotten worse over the last 2-1/2 weeks. There was no other change in my low-stress life with the exception of the Covid vaccine. I had been working hard to reduce my inflammation already with diet and lifestyle changes for the last 2 years with great success. It seems the vaccine triggered my immune system in such a profound way it pulled this dormant virus out. I was concerned to get the vaccine because of my autoimmunity but decided to do it anyway, hoping for the best. I don't know if it's advisable for people with existing immune conditions to tax their system this way. I know I'm paying a high price.
complete hair loss, no regrowth anywhere; This case was reported by a other health professional via call center representative and described the occurrence of hair loss in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number G7749, expiry date 3rd November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis and GARDASIL for prophylaxis.   On 8th August 2022, the patient received Boostrix (intramuscular), Boostrix Pre-Filled Syringe Device, Menveo (intramuscular) and GARDASIL. On 8th October 2022, 61 days after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's comment: The Medical Assistant (MA) from a dermatology office to reported a patient suffering complete hair approximately 2 months after receiving 3 vaccines from their primary provider. The primary provider referred the patient to this dermatology office for treatment. The reporter reported that all three vaccines were given on were administered on same day. The healthcare professional believed that the hair loss maybe due to the vaccines. (no other specifics known, like which vaccine the healthcare professional believed was the culprit). The reporter reported that there had been no regrowth of hair anywhere on the patient's body.  No other details were known. The reporter gave permission for GlaxoSmithKline (GSK) to contact the HCP at her dermatology office.  61 days after receiving Gardasil, the patient experienced hair loss. It was unknown if the reporter considered the hair loss to be related to Gardasil. The reporter consented to follow up.
swelling, injection site is warm to touch, hardness at injection site; swelling, injection site is warm to touch, hardness at injection site; swelling, injection site is warm to touch, hardness at injection site; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 20 months old and unknown gender patient who had hardness at injection site, injection site is warm to touch and swelling, while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, suspension for injection (strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Lot number was requested.  On an unknown date the patient had swelling, injection site is warm to touch, hardness at injection site (vaccination site induration) (vaccination site warmth) (vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was unknown if there were lab data/results available  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all.
12 hours after receiving the shot, I began to have fever (101.8), chills, and body aches. Approximately 24 hours after I had the vaccine I began to vomit and have diarrhea.  Approximately 36 hours after receiving the shot, I began to have excessive sweating that lasted 12 hours (up until the time I am writing this).
excessive hair loss over several days (shedding and large amounts of hair coming out in the shower)
fatigue, flu-like symptoms, cramping in the legs and neck,  severe back pain.  Slept 18 hours a day for three days
5/31 patient given full vial of Pfizer vaccine.  MD advised patient on what to monitor for and when to follow-up. 6/6 patient contacted to follow-up.  message left by MD
I woke up the next morning and I was very short of breath much more then usual, by the next day it was even worse and everyday after. By Feb. 10, 2021 I had low fever and difficulty breathing so I went to Urgent Care, after blood work, received chest X-ray, EKG, CT scan. It came back with pneumonia. My biggest quest is can safely take the second one or a different one, with emphysema you need protection. Thank you
Sore Arm after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm after Second Shot) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced MYALGIA (Sore Arm after Second Shot). At the time of the report, MYALGIA (Sore Arm after Second Shot) outcome was unknown.            no concomitant medications were reported. no treatment medications were reported.   Reporter did not allow further contact
Patient received second dose Pfizer vaccine on 2/18 1258.  Pt was inpatient status at the time of vaccine.  Procedures for inpatient vaccine were followed.  Attending MD,  and Clinical Nurse Specialist  had discussed patient case.  Patient was in hospital with acute on chronic combined systolic and diastolic heart failure and severe aortic stenosis.  Cardiology had recommended palliative care involvement with case, consult was completed on 2/17.   On 2/18 1815, palliative care received a call from patients family that they would like to pursue comfort measures treatment only.    Lot number EL9266  While unlikely vaccine administration related to patient demise, reporting to FDA since vaccine is EAU status.
I received dermatographism on my entire body from the FIRST booster I had back in 10/2021 exactly 13 days after the vaccine. I had no skin rash with the first two vaccines, so I thought it was a coincidence/stress induced. I was up to 40 mg of cetirizine a day to control the rash.   I received the most recent booster 9/9/22. Tonight, on day 13 afterwards, the dermatographism rash has returned on my skin.
This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INJECTION SITE SWELLING (on her right arm, it swelled up, it got red, it had a rash on it), INJECTION SITE ERYTHEMA (on her right arm, it swelled up, it got red, it had a rash on it) and INJECTION SITE RASH (on her right arm, it swelled up, it got red, it had a rash on it) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE SWELLING (on her right arm, it swelled up, it got red, it had a rash on it), INJECTION SITE ERYTHEMA (on her right arm, it swelled up, it got red, it had a rash on it) and INJECTION SITE RASH (on her right arm, it swelled up, it got red, it had a rash on it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (on her right arm, it swelled up, it got red, it had a rash on it), INJECTION SITE ERYTHEMA (on her right arm, it swelled up, it got red, it had a rash on it) and INJECTION SITE RASH (on her right arm, it swelled up, it got red, it had a rash on it) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Benadryl cream is the other treatment medication reported by reporter
We noticed a rash on his face, neck, chest and back 9 days after vaccination. He had a low grade fever, headache and was tired. The next day the rash spread to upper arms then upper legs. Day 12 after vacc. symptoms began to fade.
09/06/22 presents to ED for "fever". PMHx of "afib not on thinners, HTN, HLD"
On May 12, 1999 the patient presented to the physician with approximately 5-6 lesions which were described as grape clusters on an erythematous base. The pt was afebrile, it was indicated that the pt's mother and brother had similar episodes.
11 days after 2nd vaccine my heart went into AFIB.   Difficulty breathing, and EKG confirmed AFIB.  Prescribed Eloquist
Presented to ED on 8/3/21 for throat swelling since 7/21/21 after getting Covid vaccine, gradually getting worse. Patient with dramatic lymphadenopathy, started after Covid vaccine.  Yesterday started on antibiotics by primary care doctor.  CT negative for abscess. After Toradol and Decadron he is able to swallow and has significant improvement of his symptoms. Discussed with him and his mother that he should take ibuprofen and Tylenol every 8 hours to control pain and swelling.  Continue antibiotics as prescribed by primary care doctor. The patient (and their family) is comfortable with further observation of his symptoms at home
5 minutes after receiving the Moderna COVID vaccine, patient reported numbness/tingling on the inside of his mouth and tongue. No changes in vitals. Patient given Benadryl 50 mg once. 20 minutes later, patient reported no symptoms. Monitored for an additional hour, no symptoms.
Great fatigue, double vision, droopy eyelids for 2 weeks now and still ongoing.
This spontaneous report as received from a female patient of unknown age regarding herself. Current condition of the patient included drug allergy with penicillin and blood pressure. On an unknown date in 2007 the patient was vaccinated with ZOSTAVAX dose 1 (as mentioned one time vaccine) at clinic. Concomitant medication reported was unspecified blood pressure pill. On an unknown date, the patient broke out with shingles around her tailbone. Treatment given for event was acyclovir ointment 30 grams. Patient's blood work was done a month ago approximately in January 2014 for cholesterol test. The outcome of broke out with shingles around her tailbone was unknown. Relation between the ZOSTAVAX and the event was unknown. Product quality complaint was not reported. Patient sought medical attention. Additional information has been requested.
Within a few days after receiving the ZOSTAVAX vaccine, the patient developed shingles on her arm, where she received the vaccine. It was a painful rash. Her doctor prescribed acyclovir to treat the shingles.