chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). an unknown date, the patient experienced RASH (Rash). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and RASH (Rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Adverse event rash added.
Severe swelling, welts (hives from elbow to shoulder. Severe pain - Hydrocortisone cream, BENADRYL 50mg
Flu like symptoms; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
The patient developed a rash of about 20 'spots' on the day after being vaccinated, reported by the health care professional on 12/11/2000. The parents of the patient have called weekly reporting that the rash returns weekly since vaccination and resolves each time within 3 days. It was suggested the patient be taken to see her primary care physician. The patient did not have a rash at the time of the visit. On 02/08/2001 the mother stated that the child continued to have intermittent rashes of 1 to 5 spots that appeared like "chicken pox". The spots go away quickly but are raised blister like spots that itch. The patient has no other history of reactions or health problems. On 02/22/2001 the nurse reported the patient continues to break out every 7 to 14 days with 5 to 10 lesions that resolve several days later. Additional information has been requested.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vial was stored in refrigerator on 22-Sep-2021, there were no temperature excursions. The patient did not experience any adverse event.   No treatment medications were provided.
third dose 10 months after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (In 2021, the patient received 1st and 2nd dose of Twinrix).   On 4th August 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   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: 04-AUG-2022 Reporter's Comment: The reporter reported that, a patient received the third dose of Twinrix out of schedule as he received it 10 months after the 1st dose of Twinrix. The reporter consented to follow up. Additional Supportive Information: The patient received the 3rd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Employee received flu vaccine, the patient had facial numbness and tingling that persisted. Dx Bell's palsy. Pt treated with steroids and recovered after with steroids and recovered after taper dose. This lasted acutely x 3 days, gone by one month.
The evening after I received the Shingrix vaccine, I experienced nausea & shaking chills
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 12-DEC-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001820: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Severe aches, pains, headache, chills, nausea and vomiting that lasted for 2 full days following vaccination. Unable to keep anything down from 0100 on 2/19 to 2/21 0900. This was following the first shot and now I am terrified to get second vaccine as many folks say second vaccine symptoms are worse.
I had bumps appear under my arm a couple of days after the first shot on 4/3/21. After my second shot on 5/3/21 I had rashes/hives break out all over my body.
myocarditis; tiredness for 2 months; fever; night sweats; feeling unwell; swollen lymph glands; lost 15 pounds; dose 1 on 26Feb2021, dose 2 in Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: EN6202) as dose 2, single for covid-19 immunisation in Clinic. The patient was not pregnant when administration. Known allergies: dairy & preservatives. Other medical history: some digestive. The patient took some vitamins & Blood pressure, & coloresterol pre in 2 weeks. The patient didn't receive other vaccines in 4 weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3242, Location of injection: Arm Left), administration date: 26Feb2021 01:30 PM, when the patient was 81 years old, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The following information was reported: MYOCARDITIS (medically significant) with onset 01Mar2021 14:00, outcome "recovered", described as "myocarditis"; FATIGUE (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "tiredness for 2 months"; PYREXIA (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "fever"; NIGHT SWEATS (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "night sweats"; MALAISE (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "swollen lymph glands"; WEIGHT DECREASED (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "lost 15 pounds". The events "myocarditis", "fever", "night sweats", "feeling unwell", "swollen lymph glands" and "lost 15 pounds" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of myocarditis, fatigue, pyrexia, night sweats, malaise, lymphadenopathy, weight decreased.  The lot number for bnt162b2 was not provided and will be requested during follow up.
It was reported that a 56 year old female pt was vaccinated with Menomune lot number UB244AA, SC in the left arm as dose #2 and Twinrix, lot number 234B6, IM in the left deltoid as dose #3 on 11/26/02 at 3:30pm. Pt started itching at approximately 6pm, on same day as vaccination. She developed hives soon after. Pt also experienced difficulty breathing, coughing, wheezing, hoarseness and tightness in her throat. Pt took 25mg of Benadryl at 11pm, that night and then took 50mg of Benadryl at 3pm on 11/27/02. Pt was seen in doctor's office at county health dept on 11/27/02 at 2:30pm. The pt no longer had hives and her lungs were clear. Reportedly, the pt recovered. The case is closed.
approx 3 hrs recvd shot pt started screaming, high-pitched constant screaming; mom gave APAP prior to vax & every 3 1/2-4 hrs p/shots for 3 days; didn't check pt's temp but called MD; took pt to ER;
Large local reaction with swelling, redness and warm to touch. Measured 8 cm wide by 8.5 cm long. Symptoms started to resolve 48 hrs after injection. No decrease in function of the affected limb. No breathing issues.
CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills. This report was non-serious.
The following day I began to have a headache, fatigue, severe joint pain, heart palpitations, Within the last month my vision has been blurred. Two weeks ago I began having high blood pressure, which I have never had. I was started on blood pressure medication on Monday.
5 hrs after vaccination, legs started to ache. Took Ibuprofen "All my bones ached esp hips and thighs". "Shooting pain in head". Extremely sensitive to touch. "It hurts to touch my hair". No fever. No redness, or swelling or discomfort at site of injection. No cough, sore throat or rash. R chest pains for 3 days. Missed work, saw Dr. Recovered on 4th day.
battling acute laryngitis; experiencing swelling; This spontaneous case was reported by a patient and describes the occurrence of LARYNGITIS (battling acute laryngitis) and SWELLING (experiencing swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LARYNGITIS (battling acute laryngitis) and SWELLING (experiencing swelling). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LARYNGITIS (battling acute laryngitis) and SWELLING (experiencing swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided   Reporter did not allow further contact
No adverse event; Dose was administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after the expiration date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 047C22A) 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 (Dose was administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after the expiration date.) 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 (Dose was administered after the expiration date.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The manufacture date was 24-Mar-2023. The unknown vial was initially stored in the refrigerator 07-Mar-2023 and did not underwent any temperature excursions. All three vials remained in the correct refrigerated storage until administration with no temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720851, US-MODERNATX, INC.-MOD-2023-720845 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720851: US-MODERNATX, INC.-MOD-2023-720845:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones were in pain), VACCINATION SITE WARMTH (red and hot rash on injection site), VACCINATION SITE ERYTHEMA (red and hot rash on injection site), VACCINATION SITE RASH (red and hot rash on injection site) and NAUSEA (nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bones were in pain), VACCINATION SITE WARMTH (red and hot rash on injection site), VACCINATION SITE ERYTHEMA (red and hot rash on injection site), VACCINATION SITE RASH (red and hot rash on injection site), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (body chills). At the time of the report, BONE PAIN (bones were in pain), VACCINATION SITE WARMTH (red and hot rash on injection site), VACCINATION SITE ERYTHEMA (red and hot rash on injection site), VACCINATION SITE RASH (red and hot rash on injection site), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (body chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.  Treatment information included ibuprofen (Advil).
2 HR p/vax,pt crying,t103ax, cried nonstop next sev days;19AUG94-to MD, also had hives on head/face;sent home,tx w/apap. 20AUG-contd to cry, returned to md, tx w/ apap & codeine; settled down w/in 1hr, no further prob,MD rec DT only
This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. On 04-SEP-2014 the patient was vaccinated with expired PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014 (also reported as 01-AUG-2014) intramuscular (dose, dose number and anatomical location were not reported). No known adverse effects. No concomitant therapies were reported. The outcome of the event was unknown. Additional information is not expected because reporter refused additional contact.
Given Rsv vaccine on Friday afternoon.  No side effects but a little soreness at injection site.  Next day (Saturday) I was doing errands, driving, I noticed a strange feeling in my head as I turned corners.  No other problems.  finished my errands and came home.  Ate dinner, watched tv.  Told my husband I had some feelings of vertigo.  Went to bed but became nauseous, vomited a little bit, fell asleep.  Slept all night.  Husband awakened me and turning my head while flat in bed caused me to feel vertigo.  I slept all day except for being helped to bathroom and drinking a little water.  Slept all night Sunday,  Still vertigo and unsteady, ate a little on Monday.  Drank more water and felt a little better when in bed when I moved my head.  Still weak and dizzy when up.  Better each day as vertigo cleared but then weak and unsteady on my feet due to not eating or drinking much for days.  Went to ER on Friday, Nov. 17, 2023.  Tests, exam for vertigo.  Determined I was dehydrated and weak from being in bed and not eating or drinking enough.  I am much better today, walking better, eating well and drinking some Pedalyte as directed by Dr.  I do not know if it is from the vaccine but seemed to me to be. My doctor thinks it might be a situation of something else causing the vertigo at the same time as I got the vaccine.  Will never know but I think you should know in case other old people develop this.
Patient present to ED on 5/3 with leg pain.  found to have blood clot in left leg via ultrasound.  started on rivaroxaban and discharged
This nurse gave the 3rd dose of Pfizer (Booster) 13 days earlier than six months from the second dose. This nurse read the CDC Card as 03 and it was 23.