chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainted; sweats; fever; sustained injury; This case was reported by a other health professional via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), sweating, fever and injury. On an unknown date, the outcome of the faint, sweating, fever and injury were unknown.   It was unknown if the reporter considered the faint, sweating, fever and injury to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The age at vaccination was not reported. After receiving Shingrix, the patient had sweats and fever and next day, she fainted and sustained injury.
Information has been received from a medical assistant concerning 3 female patients who fainted after receiving the first dose of GARDASIL. Medical attention was sought. The patients recovered attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Pt. states that after receiving the 1st dose of Phizer 08/31/2021, started experiencing symptoms of high heart rate, headache, left arm swollen, underarm swollen. Primary visit 09/2021 Ultrasound preformed. Recommendation for Observation and delay of 2nd dose. Still continuing to experience symptoms. Primary visit scheduled for 10/11/2021.
This spontaneous case reported by a consumer, describes the occurrence of back pain (very bad backache) and tremor (shaking) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced back pain (very bad backache) and tremor (shaking). At the time of the report, back pain (very bad backache) and tremor (shaking) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Child demonstrates repetitive behavior she has never exhibited before. Child repeating hand motions and face touching never exhibited before. Child had significant swelling, pain, redness, swelling, irritation at site lasting more than a month.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 53.25 for dose administered on 03-Apr-2021   No concomitant and treatment medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (Patient Link).
The day after the RSV shot there was substantial blood following the urine.  This continue for a  for couple of days. After the advice of two cardiologists, we were advised to discontinue the warfarin as the bleeding blood is more  Dangerous than the prevention of a stroke, which is minuscule based on my husbands circumstances. Currently after  4 days of refraining from taking warfarin, the blood in the urine slowed substantially. My husband has an appt. With the urologist on Wednesday morning.  He also will be taking his INR reading tomorrow, Monday Oct. 23, to see if he needs to resume the warfarin.  He will be calling the cardiologist regarding  This. Currently there has nit been any treatment until he meets with the urologist on Wednesday morning.
Hours after the second Moderna shot I broke out in massive tiny itchy blisters all over my body. It took weeks to heal and fade.
clear liquid with a little blood leaked down arm when needle removed; clear liquid with a little blood leaked down arm when needle removed; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (clear liquid with a little blood leaked down arm when needle removed) and DEVICE CONNECTION ISSUE (clear liquid with a little blood leaked down arm when needle removed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced UNDERDOSE (clear liquid with a little blood leaked down arm when needle removed) and DEVICE CONNECTION ISSUE (clear liquid with a little blood leaked down arm when needle removed). On 09-Mar-2021, UNDERDOSE (clear liquid with a little blood leaked down arm when needle removed) and DEVICE CONNECTION ISSUE (clear liquid with a little blood leaked down arm when needle removed) had resolved.            Reporter did not allow further contact
hives, which spread to entire body except face/ scalp approx. 48 hours after second vaccine. treated with steroids and Benadryl.
This spontaneous report as received from a medical assistant refers to 5 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 20-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
REDNESS, SWELLING , AND PAIN INJECTION SITE./ APPLY ICE EVERY 20 MINUTES TO REDUCE SWELLING AND RELIEF PAIN
itching; sore arm; Hives/Welts; all over body rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), PAIN IN EXTREMITY (sore arm), URTICARIA (Hives/Welts) and RASH (all over body rash) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645B) for COVID-19 prophylaxis.     The patient's past medical history included Chronic obstructive pulmonary disease (had to take infusion and had a really hard time, with breathing.), Emphysema (had to take infusion and had a really hard time, with breathing.) and COVID-19 in August 2022.    On 04-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Aug-2023, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (sore arm), URTICARIA (Hives/Welts) and RASH (all over body rash). At the time of the report, PRURITUS (itching), PAIN IN EXTREMITY (sore arm), URTICARIA (Hives/Welts) and RASH (all over body rash) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received dose 1 on 02-Feb-2021 lot number unknown, dose 2 on 12-Mar-2021 lot number unknown and dose 3 on 12-Nov-2021 lot number 019F21A of Moderna.  Patient had a reaction that never had with the other 3. It started the day after on 05-Aug-2023. Patient had an all over body rash. Patient was miserable for 7 days with severe itching, welts, hives were breaking out everywhere, literally everywhere. Patient thought it was a mosquito bite at first, but it got worse and worse. Patient went to doctor and saw the Physician Assistant they didn't address it at all. Patient barely had a sore arm with the Bivalent in comparison with the other 3. Patient was not breaking out as bad, and every day she got 2 or 3 but it was getting better each day. Last Friday (date not provided), patient to the doctor for the rash and they insisted on a covid test which was positive. Later patient repeated the test for 5 times, but it was negative. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738199:Monovalent case
Pt had Pfizer vaccine, lost consciousness briefly and had seizure and lost control of bladder. EMS was called, pt declined to go to ED. Documents were signed and since pt had seizure and lost consciousness, report was filed. Pt was informed. Pt's friend picked up patient. Pt was urged to followed up with PCP and go to ED.
Fainted; Thirsty; Shaking; Look pale; Hypotension; Arm soreness; Nausea; CHILLS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy (environmental allergy) and Dust allergy (environmental allergy). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, MONTELUKAST for Asthma, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), THIRST (Thirsty), TREMOR (Shaking), PALLOR (Look pale), HYPOTENSION (Hypotension), MYALGIA (Arm soreness), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (Fever). On 24-Apr-2021, SYNCOPE (Fainted), TREMOR (Shaking), PALLOR (Look pale) and HYPOTENSION (Hypotension) had resolved. At the time of the report, THIRST (Thirsty), MYALGIA (Arm soreness), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (Fever) outcome was unknown.   The action taken with mRNA-1273 in response to the event was not applicable.  The treatment medications included Tylenol (paracetamol) and Advil (Ibuprofen).  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea, myalgia, pyrexia and chills are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea, myalgia, pyrexia and chills are consistent with the product safety profile
Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics evaluated the patient on-site. The patient was hypertensive (229/129). EKG demonstrated NSR, rate 85 bpm, no ST elevation. Paramedics transported the patient to Emergency Department. In the ED, the patient developed centralized chest pain, diaphoresis, and right jaw pain, but denies shortness of breath, nausea/vomiting, focal weakness, fever or chills. The patient remained hypertensive (184/85). Physician administered 325mg PO Aspirin, 0.2mg PO Clonidine, and 1 inch topical Nitroglycerin. The labs and imaging did not present evidence of myocardial infarct or intracranial hemorrhage. Due to symptoms on presentation, the patient was admitted to rule out ACS. Upon admission, the patient stated the chest pain "comes and goes", but is not currently having any chest discomfort. Admitting physician administered 5mg PO Amlodipine, 5mg PO Lisinopril, labetalol 10mg  IV, and prophylactic Lovenox. As of 4/16, the patient had not been discharged, but their hypertensive urgency and chest pain have resolved and will be treated outpatient. Internist planning patient's discharge.
Developed Bell's Palsy on April 9,2021. Sought medical help at ER on April 12,2021. Did MRI and echo due to being stroke like symptoms. Tests were clear. Doctor determined it to be Bell's Palsy. Treated with antivirals and steroids and also given both prescriptions to take at home. Saw PCP within a week to check. As of today, July 1 2021 an some better but still have mouth drooping. Neurologist, that I saw last week seems to think it should get better. Not better yet.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored dose of ROTATEQ (lot # K016313, expiration date 31-MAY-2016, strength and dose not reported), oral. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Reported small localized reaction later that evening but after 12 hours was more significant.  Had redness (~5 inches in diameter), swelling and pain.  Patient also had a low grade temperature (100.9)Treatment included antihistamines three times a day and Tylenol and ice packs to area as needed.
RN note: Patient received vaccine at 1615, at 1620 patient stated she was dizzy and seeing stars, quickly after patient was unresponsive and eyes rolled back and patient postured and was shaking slightly. Patient remained in chair and did not fall, RRT and emergency responders notified. Patient recovered in under 1 minute. Initial vitals signs at 1622 BP: 98/64, HR 101, Respirations 34, SpO2 99%. Paramedics arrived at 1630 and BP at that time was 113/72, HR 114, Respirations 30, SpO2 99%. Patient stated no current  medications or medical history. Patient handoff given to Paramedics and she left with them per our recommendation. Also reviewed that patient should follow up with her doctor regarding getting the second dose of the vaccine.
Rash on the arm at the site of injection. Lasted about 24  hours. Very itchy Treatment- Hydrocortisone  cream
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis (dose, route, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010803: US-009507513-1705USA001583: US-009507513-1705USA001585:
I passed out; dizziness; I was out; I was sweating profusely; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (I passed out) (seriousness criterion medically significant), DIZZINESS (dizziness), FEELING ABNORMAL (I was out) and HYPERHIDROSIS (I was sweating profusely). At the time of the report, LOSS OF CONSCIOUSNESS (I passed out), DIZZINESS (dizziness), FEELING ABNORMAL (I was out) and HYPERHIDROSIS (I was sweating profusely) 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.   No concomitant medications provided. No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Per DH: Regarding The VSIR  on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Information has been received from a company representative and a nurse concerning a 17 year old female patient who on 26-APR-2007 was vaccinated with Gardasil (lot # 657621/0387U). On 26-APR-2007 the patient experienced body ache, cough, sore throat and a nose bleed. The nurse reported the following: The patient did not go to dance class that night which is unlike her. On 27-APR-2007, the patient went to 'Six Flags:" and only went on one ride which is unlike her. The patient did nothing over the weekend. The patient had 3 nose bleeds that started on 29-APR-2007 and the 3rd nose bleed lasted from 1:15 am on 30-APR-2007. The patient did not go to school on 30-APR-2007. The patient will see her primary care physician for follow-up. The patient was not recovered at the time of the report. Additional information has been requested.
It was reported that a 62 year old male with a history of angioimmunoblastic lymphadenopathy (AILD), which was currently in an inactive stage, was vaccinated with a 0.5ml dose of penumococcal vaccine 14 polyvalent. Prior to the vaccination, the patient presented with spiking fevers and diffuse lymphadenopathy with an IgG monoclonal gammopathy. Lymph node biopsy was consistent with AILD. He had Coombs positive hemolytic anemia and thrombocytopenia despite adequate megakaryocytes on marrow aspiration and biopsy. Due to incomplete control with corticosteriods, the patient received a short course of doxorubicin and vincristine. The patient was maintained on tapering doses of prednisone alone for 5 months. At a time of inactivity of the disease, the patient was on 10mg/day of prednisone and he received the vaccine. Three weeks after vaccination, the patient suddenly experienced shortness of breath, fever, diffuse adenopathy, and organomegaly. The patient's disease course was poorly controlled by high dose corticosteriods and bacterial sepsis developed. A repeat biopsy revealed immunoblastic sarcoma. After treatment with cyclophosphamide, vincristine, doxorubicin, and prednisone, the patient was in remission again. No further information is available.
Of course heat in injection area and small fever but I am worried about her having spasms or convulsions, mostly when eating, she will bite down extremely hard and start full body shakes and she has a strong neck and has been able to hold her head up fine for a couple of months but since her vaccinations she acts like her head is to heavy for her to hold up.
Information has been received from an office manager concerning a 65 year old female consumer with no known allergies or pertinent medical history who on 19-DEC-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant vaccination and therapy included influenza virus vaccine (unspecified) and tetanus toxoid. Subsequently, 2 weeks after vaccination on 02-JAN-2008 the patient developed shingles. The lesions were on her left buttocks. Medical attention was sought, the patient called the physician. There were no lab studies performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Medical attention was sought, the patient called the physician on 02-APR-2008. There was no product quality complaint involved. Additional information is not expected.
Arm very sore. Went to doctor and he ordered an MRI. Found out the tendon in the right arm was 50 percent torn.  Went to orthopedic doctor. Started physical therapy. Arm still in pain.  Continue with the orthopedic doctor. Will probably need shots in the arm and maybe continued physical therapy.
High fever, light headed beginning about 8-9 hrs after vaccine, 102 degrees for next 18 hrs, then 99 degrees for next 24 hrs, then normal but felt poorly for next 2 days.  Arm swollen, red and hot half way down to wrist for 5 days.
Near syncope. Carpo-pedal spasm. Went to Hospital ER for treatment.