chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore at the injection site; A report was received from a consumermber concerning a  65 years old, female patient was participating in the mRNA-1273 Emergency Use Program and experienced arm was sore at injection site.  No relevant concomitant medications were reported.  On 18Jan2021,prior to the onset of the event(s), the patient received their first shot of two planned doses of mRNA-1273 (LOT/BATCH 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the event(s) was/were unknown/not reported.
Temp of 101.4 highest, 100.8 later in the day, 100.0 the next day,  body, muscle and joint aches
A consumer who is pregnant called to report that she was administered GARDASIL 9 on 9/29/2022.; No additional adverse events (AE's) were reported; This spontaneous prospective pregnancy report as received from a consumer refers to a 34 year old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.     On 29-SEP-2022 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular, use as directed to prevent human papilloma virus infection.  The patient became pregnant with last menstrual period (LMP) of 15-MAR-2022 and estimated date of delivery (EDD) of 20-DEC-2022. The initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 28 week(s) (exposure during pregnancy). It was reported that the patient is scheduled to deliver the baby by caesarian section on 15-DEC-2022. No additional adverse event was provided. At the reporting time the outcome of the adverse event was reported as not recovered. The action taken of the adverse event as well as the causality assessment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.
Sore right shoulder/arm, Extreme fatigue and hot sweats.  No issue the morning of day two.
Body/muscle aches, chills, diarrhea, cough, loss of sense of taste and smell
then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches; the next day his arm was sore; then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches; Initial information received on 22-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to cases 2023SA294438(CLUSTER) and 2023SA293461(CLUSTER).  This case involves an unknown age male patient who developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches, the next day his arm was sore after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023, the patient received a dose 0.7 ml of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, expiry date: not reported lot U8084BA via unknown route in unknown administration site for immunization.  On 09-SEP-2023 the patient developed then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches (rash macular) (vaccination site erythema) and the next day his arm was sore (pain in extremity) 1 day following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Reportedly, The caller received Fluzone High Dose QIV on 08Sep2023. This was the second year that he has received the high dose vaccine. Last year he did not have any reactions. After his flu vaccine last year, he received a Covid-19 bivalent shot by Moderna. He got a very bright red reaction to that vaccine. It was quite demarcated, almost like a tattoo. He was so concerned about the reaction to that Covid shot that he went to an urgent care. A nurse practitioner thought it might be cellulitis. She drew a circle around it and told him to seek medical help if the area moved outside the circle. It did not get bigger and went away on its own. After the Covid shot, he received a pneumonia shot. He said, "I had a little reaction to the pneumonia shot", but did not elaborate. Most recently, after the Fluzone High Dose QIV on 08Sept2023, the next day his arm was sore. He then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days. The area was about 1 x 5 x 3 inches. This reaction was not as obvious as the reaction he had to the Covid shot. The redness was lighter and more blotchy.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event Rash macular, was Unknown for the event Pain in extremity and was Recovered / Resolved on an unknown date for the event Vaccination site erythema.
flare up of MS Symptoms; This spontaneous report was received from a currently 57-year-old male patient, via Sanofi, who was reporting on himself. The patient's concurrent conditions included multiple sclerosis. The patient's past medical history, concomitant therapies and previous drug reactions or allergies was not provided.  On 05-NOV-2019, the patient started therapy with teriflunomide (AUBAGIO) 14 milligrams (mg) coated tablet, at a dose of 14 mg daily (QD), orally for multiple sclerosis (MS) (lot number reported as 1802217 and expiration date reported as 30-MAY-2023).   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylactic vaccination (formulation, strength, dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number, and expiration date were not reported).  On an unknown date, the patient was hospitalized three days after pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as it caused a flare up of MS symptoms (multiple sclerosis relapse). It was not reported if the patient received a corrective treatment for the event.  Therapy with teriflunomide (AUBAGIO) was continued. The outcome of the event multiple sclerosis relapse was not reported. The reporter considered the event multiple sclerosis relapse to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causal relationship between the event multiple sclerosis relapse and therapy with teriflunomide (AUBAGIO) was not provided.  Upon internal review, the event multiple sclerosis relapse was considered to be medically significant.
Patient is a 81 y.o. female patient of MD with history of COPD, chronic resp failure, anxiety, and depression who presented to Hospital with acute delirium, UTI, and asymptomatic Covid19 positive on 12/11/22. She was S/P left hip fx and surgery at hospital on 11/24/22. She presented from SNF where she was receiving rehab after her hip surgery (otherwise, pt lives with her granddaughter).    Acute metabolic encephalopathy - resolved Acute, complicated UTI Presented w/confusion, UTI, and COVID Metabolic encephalopathy related to UTI and COVID infection MRI of brain showed cerebral volume loss with chronic microvascular ischemic changes. Received one day of Keflex, pt tolerated - was transitioned to IV ancef for 3 days - Will be discharged with Keflex for the rest of 10-day antibiotic course (6 remaining days)   Covid-19 Virus Infection - asymptomatic Acute on Chronic Hypoxic Respiratory Failure - resolved Date of onset of symptoms: asymptomatic Symptoms present on admission: asymptomatic but now requiring  Date of covid positive test: 12/11/22 Vaccination status: vaccinated Imaging: CXR (12/11) no acute cardiopulmonary abnormality, will order CTPA pending after fluids  Oxygen requirements on admission: 2-4  liters, 2L at baseline Received corticosteroids and remdesivir while inpatient.   COPD - w/o exacerbation Chronic respiratory failure - resolved Home oxygen of 2L, currently on baseline O2 supplementation Continue on discharge home regimen albuterol nebulized as needed Xopenex puffer as needed, and Trelegy Ellipta (formulary equivalent)   S/P left hip fracture and femur surgery (11/24) Adv to f/u 2 weeks post-op, pt unable to follow-up as presented to hospital on 12/11 Staples from hip surgery removed here in hospital on 12/14 Continue on discharge home vitamin D3, pain medications, PT/OT/SW c/s   Anxiety/depression Continue on discharge home Zoloft 150 mg daily and mirtazapine 7.5 mg at bedtime Continue on discharge melatonin as aided pt in obtaining restful sleep.
Seizure; Patient passed out; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Patient passed out) in an 18-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Patient passed out) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Patient passed out) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Age at vaccination not reported.  Concomitant medications not reported.  Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pt had uneventful 1st Pfizer COVID vaccine on 5/28.  5/31 he presented to our hospital after a V fib cardiac arrest.  Pt did well with immediate CPR and cardioversion on the scene but he had no hx of major heart disease.  Minor LV dysfunction ( LV 45%).  It turned out on that the next day 6/1 pt developed fever and then COVID was checked and  was positive.  He then developed true covid and was treated.  Echo revealed a new dilated CM with reduced EF.   I feel his arrest was more likely related to the active covid or his DCM but wanted to report in case given the temporal association
Client developed exaggeration of her symptoms of benign tumor at base of brain, i.e.-dizziness and problem with depth perception for 48 hrs after receiving Hep B vaccine.
Itches; A rash 1.5-inch in diameter at inject site; bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (A rash 1.5-inch in diameter at inject site) and VACCINATION SITE SWELLING (bumps) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa allergy) and Food allergy.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (A rash 1.5-inch in diameter at inject site) and VACCINATION SITE SWELLING (bumps). At the time of the report, VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (A rash 1.5-inch in diameter at inject site) and VACCINATION SITE SWELLING (bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Headache, Myalgia, CHILLS, FATIGUE Narrative:  Other Relevant History:
Starting about 24 hours after receiving her vaccines, patient's left thigh, at the injection site, was swollen, red in color and hot to the touch. Over the next 15 hours, these symptoms continued and spread to her other (right) leg, bottom, back, stomach, arms, hands, feet and face. She also had patchy redness and hives periodically for about three days after receiving her vaccines.
tenderness of arm/arm hurts; Headache; This is a spontaneous report from a contactable Consumer. An unspecified age female Consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number/Expiry date: not provided) via unspecified route of administration as a 2ND DOSE, SINGLE for COVID-19 immunization on 27Jan2021. The patients past medical history and concomitant medications were not reported. On an unknown date, the patient experienced tenderness of arm/arm hurts and Headache. The patient took Ibuprofen since she could not bear the pain. She had asked if it was ok to take Ibuprofen. Consumer had called about the Pfizer COVID-19 vaccine and says she got the second dose yesterday. She said she thought was stupid to report this side effect of a headache and her arm hurts. She says that she read somewhere or heard that taking Ibuprofen with COVID issues or the vaccine is not recommended so she wanted to verify this before she did that and takes Ibuprofen or Tylenol. She said that she is having a common side effect that everyone had. Caller declines to complete a report and requests to be transferred to Pfizer Medical Information for her question. No further details captured, reported, or documented at this time. The reporters contact information was available. It was unknown if the reporter was the prescribing HCP. Outcome of events was unknown.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable Consumer. This Consumer(patient) reported new clinical information.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Shaky; Flu like symptoms; Achy; Bad chills; Had a fever a little over 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees). At the time of the report, TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: 99 (High) a fever a little over 99 degrees.         No concomitant medications reported. No treatment information was provided.
Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be a risk + advised reporting + revaccination Child had no ill effects thus far
29 year old male patient. Immediately at the time of vaccination, he refers "feeling bad" he is sweaty, he refers to feeling dizzy. Manifests musculoskeletal weakness refers to feeling thirsty and hungry. He is oriented x3. Paramedic is called immediately to take vitals. Glucose 71, BP 128/77, Sat 99%, Pulse 87. He is transported in a wheelchair to the evaluation area.
Patient complained of diaphoresis and feeling cold. BP 177/96, HR 86, RR 20, o2 sat 100%. Patient reported that she has high blood pressure but does not take blood pressure medication as they were stopped by PCP. Given acetaminophen x 1 for diaphoresis & Instructions to follow-up with PCP regarding BP.
Excessive local redness/warmth/induration 2.75 in. in diameter.
slight sore throat; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
tender; redness on her arm appeared 2-3 days later which started on the front of her deltoid; same typical side effects; itchy; fever; tired; felt crappy; arm was really sore; good bit of swelling about 1/2 inch and diameter of 2 inches; redness; itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy), TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PRURITUS (itchy). On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (same typical side effects). On 27-Feb-2021, the patient experienced TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid). At the time of the report, VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy) and TENDERNESS (tender) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient was due for 4 month vaccines. Per Mother's request he received 2 of the 4 month schedule vaccines. I had another nurse check vaccines to be given. We read Rotateq as Dec 20 20. Vaccines administered. When I went to enter Rotateq in the patient's chart I could not find the LOT number. I checked Roteq again and noted the date printed was 5 Dec 2020. I immediately let the patient's PCP know. I also went to my Supervisor and called the patient's Mother to inform her of the incident and that son would need to repeat Rotateq. I removed the vaccine from the refrigerator and wrote expired on it and gave it to my supervisor. I also filled out an unusual occurrence form. No harm came to the child but he will have to repeat  Rotateq.
Pt walking and c/o unable to see, pale, diaphoretic and lightheaded.  W/C to med eval station for further evaluation. Vision returned after 2 minutes, Gatorade and water offered. EMS evaluated with VS  90/60, HR 70, Sat's 98%.  Lying on cot with parents at side. No further visual impairment. Able to see without any blurring or peripheral impairment. EMS continue to monitor, taking fluids, no s/s neuro deficit present with assessment. Able to stand with no c/o's dizziness. BP 110/70 HR 88 Sat 98 RA. Continued recover, parents decline any hospital transportation. Ambulatory discharge with parents and contact pediatrician for any further symptoms. Reviewed with parents well hydrated today and s/s anaphylactic reaction. Pt to be vaccinated 2nd dose in med eval area when he returns for 2nd dose, parents verbalized understanding.
Information has been received form a RN concerning a 3 year old female with no medical Hx and no allergies who on 08/24/2001, was vaccinated SQ in the LA with a first dose of varicella virus vaccine, live. Concomitant vaccines that day included a 3rd dose IM in the RA of Hepatitis B virus vaccine rHBsAg (yeast) and a 3rd dose IM in the LA of poliovirus vaccine inactivated. There was no other concomitant medication. On 06/25/2004. the pt's mother called the office and reported that her child had chicken pox. The pt was treated with diphenhydramine  (Benadryl) and colloidal oatmeal baths (Aveeno). No product quality complaint was involved. Follow up information indicated that the pt's sibling had chicken pox on 06/11/04 and the mother called the office 06/25/2004 to report that the pt now had chicken pox. There were no labs or diagnostic tests performed and the pt recovered.  It was also reported that the two other pt's were vaccinated with a  dose of varicella virus vaccine live and developed chicken pox (WAES0406USA02545) and the pt sister, (WAES 0406USA02749).  Additonal information is not expected.
Information has been received from a physician concerning a patient who two months ago, approximately 26-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route no reported) and got shingles. At the time of the report, the patient's out come was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Observed for 15 minutes after vaccine. About 30 minutes later in my car, felt sharp shooting pains in left neck.  About 8 hours after receiving first dose,  started coughing up blood, bright red, with streaks and clots.  No cough, fever.  Seen in ER with chest xray and ct scan with contrast.  No resolve. On second day after receiving vaccine? Continue to experience bright red sputum. No resolve.
pt recvd vax & started fever, t 103.8 & had a rash; went to MD dx of measles rxn;
Low grade fever 99.1-99.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever 99.1-99.4) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Low grade fever 99.1-99.4). At the time of the report, PYREXIA (Low grade fever 99.1-99.4) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1-99.4 High.         No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact