chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Patient experienced seizure like activity including eyes rolling, shaking, pale skin and sweating. After a few seconds, patient alert but experienced nausea and headache.  Patient was provided ice packs behind the neck, arms and groin. Once able to sit up, patient was provided with juice. After 30min, color back to baseline, no further nausea/headache. Patient able to sit up, stand slowly and ambulate  normally. Patient left the office with mom.
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac stress test normal, Impaired driving ability, Syncope
Clinical narrative: fainted; cannot drive; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2022, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant) and driving ability disturbed (Verbatim: cannot drive).  The outcome of the fainting and driving ability disturbed were not resolved.   It was unknown if the reporter considered the fainting and driving ability disturbed to be related to Shingrix.     It was unknown if the company considered the fainting and driving ability disturbed to be related to Shingrix.   Additional Information: GSK Receipt date: 08-SEP-2023 The reporter reported that since he received his Shingrix vaccine he had fainted five times in the past year. The reporter reported that he did not faint at the time the Shingrix was administer. Reporter reported the fainting was random with no warning. Patient had his heart checked by a cardiologist, stress test and they can find no reason for his fainting. The reporter called GSK because the TV commercial for Shingrix stated that it could cause fainting. Relayed to the reporter that was when the vaccine was administer usually. Reporter was trying anything to find an answer because he could not drive until he was fainting-free. Reporter had not received his second dose Shingrix because of his concern with fainting. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Headache, Injection site rash, Pain in jaw
Clinical narrative: HA, DIARRHEA, SITE RASH, JAW PAIN
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Drug ineffective, No adverse event, Product preparation error, Product preparation issue
Clinical narrative: 2 vial preparation was not mixed correctly. Only MenA (orange top) component vial was used and it was inadvertently mixed with 0.7 mL sterile diluent instead of vial of MenCWY component. It was administered into LD, pt tolerated well and did not experience any adverse reaction at this time. This is an ineffective vaccine though.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic aneurysm, Cardiogenic shock, Chronic respiratory failure, Coagulopathy
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART R57.0 CARDIOGENIC SHOCK 5/16/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 CHRONIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 CHRONIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 CHRONIC RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 5/16/2023 CHRONIC RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 ACUTE RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 ACUTE RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 5/16/2023 ACUTE RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 ACUTE RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 ACUTE RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 5/16/2023 ACUTE RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 RESPIRATOR DEPENDENCE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 RESPIRATOR DEPENDENCE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 RESPIRATOR DEPENDENCE R57.0 CARDIOGENIC SHOCK 5/16/2023 RESPIRATOR DEPENDENCE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dependence on respirator
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART R57.0 CARDIOGENIC SHOCK 5/16/2023 THORACIC AORTIC ANEURYSM, UNSPECIFIED PART D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 CHRONIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 CHRONIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 CHRONIC RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 5/16/2023 CHRONIC RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 ACUTE RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 ACUTE RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 5/16/2023 ACUTE RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 ACUTE RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 ACUTE RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 5/16/2023 ACUTE RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/16/2023 RESPIRATOR DEPENDENCE J96.00 ACUTE RESPIRATORY FAILURE 6/6/2023 RESPIRATOR DEPENDENCE J96.10 CHRONIC RESPIRATORY FAILURE 5/26/2023 RESPIRATOR DEPENDENCE R57.0 CARDIOGENIC SHOCK 5/16/2023 RESPIRATOR DEPENDENCE
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Ear pain, Headache, Injection site pain, Oropharyngeal pain
Clinical narrative: Patient seen today(9/13/23). Pt reports the day she received the vaccine she expienced spre throat, ear pain, headache and sore arm(from the injection site). A week later had right scalp pain ---3 days ago started with rash--- herpetiform right side of neck.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin, Rash, Rash vesicular
Clinical narrative: Patient seen today(9/13/23). Pt reports the day she received the vaccine she expienced spre throat, ear pain, headache and sore arm(from the injection site). A week later had right scalp pain ---3 days ago started with rash--- herpetiform right side of neck.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: We vaccinated with PFIZER COVID BIVALENT and were not aware that it was no longer authorized for use.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Also received at pharmacy:Covid 6/11/2021 Pfizer Lot# EW0187 Left arm injections/second dose. After or between these two vaccinations I took a B12 shot in my leg and I felt it all the way up my leg into my arm where i got the vaccines and it made my arm sore and swollen and hot to the touch and it was incredibly painful. I started dreading the B12 shot after that and it happens every time i have to take a B12 shot. It hurts less than the first few times but is still significant.  Also, metal items stick to or try to stick to my vaccine injection shots area. I learned this 9/12/2023. I waved metal around my arm and it caused my arm to hurt and burn up into my neck.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: We vaccinated with PFIZER COVID BIVALENT and were not aware that it was no longer authorized for use.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast conserving surgery, Intraductal proliferative breast lesion, Mammogram abnormal, Radiotherapy
Clinical narrative: Ductal carcinoma in situ left breast. Detected on screening/diagnostic mammogram. Grade 3. Underwent lumpectomy and radiation. Currently on tamoxifen.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Patient has developed Alopecia areata (AA) is a common autoimmune disease characterized by non-scarring hair loss. New onsets of AA have been associated with coronavirus disease 2019 (COVID-19).
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: body itching
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Cough, Headache, Hyperhidrosis, Oropharyngeal pain, Pain
Clinical narrative: 11:30a vomit  twice with fever 102 sweating and coughing then he took some nyquil stated at 9am has headache and bodyache  cough and sore throat
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia, Vomiting
Clinical narrative: 11:30a vomit  twice with fever 102 sweating and coughing then he took some nyquil stated at 9am has headache and bodyache  cough and sore throat
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Local  8cmx4cm swelling, erythema, pruritus
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A wrong vaccine was given to a 6-month-old baby. Patient should have received Pentacel (recommend for 2 months to 6 years old children) The patient received Kinrix (recommend for 4- to 6-year-old children)
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Cough, Dysphagia, Feeling cold, Hypoaesthesia oral
Clinical narrative: I received the flu shot around 05:30pm. The vaccine was Influenza vaccine, Quadrivalent Preservative Free. Around 9:30pm I started feeling I had something stuck in my troat, and it was painful to swallow. Around 10pm, the entire mouth was feeling tingling and numb, I started not being able to swollow properly and I started coughing. Around 10:30pm, I developed a burning sensetion on tongue and lips. I was not able to properly swallow and talk. Lips and face were swollen. I entered the ER around 11pm, there I started feeling cold and having a slight burning sensation on my chest. I recevied an EPIPEN and other medications around 12am. After around 1h, I was feeling better. Left ER around 2.45am.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Odynophagia, Oral discomfort, Paraesthesia oral, Sensation of foreign body
Clinical narrative: I received the flu shot around 05:30pm. The vaccine was Influenza vaccine, Quadrivalent Preservative Free. Around 9:30pm I started feeling I had something stuck in my troat, and it was painful to swallow. Around 10pm, the entire mouth was feeling tingling and numb, I started not being able to swollow properly and I started coughing. Around 10:30pm, I developed a burning sensetion on tongue and lips. I was not able to properly swallow and talk. Lips and face were swollen. I entered the ER around 11pm, there I started feeling cold and having a slight burning sensation on my chest. I recevied an EPIPEN and other medications around 12am. After around 1h, I was feeling better. Left ER around 2.45am.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder, Swelling face, Tongue discomfort
Clinical narrative: I received the flu shot around 05:30pm. The vaccine was Influenza vaccine, Quadrivalent Preservative Free. Around 9:30pm I started feeling I had something stuck in my troat, and it was painful to swallow. Around 10pm, the entire mouth was feeling tingling and numb, I started not being able to swollow properly and I started coughing. Around 10:30pm, I developed a burning sensetion on tongue and lips. I was not able to properly swallow and talk. Lips and face were swollen. I entered the ER around 11pm, there I started feeling cold and having a slight burning sensation on my chest. I recevied an EPIPEN and other medications around 12am. After around 1h, I was feeling better. Left ER around 2.45am.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Pain, Swelling
Clinical narrative: redness, pain, swelling for 4days
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: RESIDENT DIED WITHIN 30 DAYS OF COVID VACCINE ADMINISTRATION
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: After the initial injection site pain passed, a deep ache/pain set in my left for a day or so.  The pain has since been replaced with a numb/cold/tingly feeling in my left arm from around the site of the injection down just past my left elbow. My arm does not feel cold to the touch or appear any different from the rest of my skin; the sensation is deep inside my arm the way that the pain originally was.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaccination site coldness, Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: After the initial injection site pain passed, a deep ache/pain set in my left for a day or so.  The pain has since been replaced with a numb/cold/tingly feeling in my left arm from around the site of the injection down just past my left elbow. My arm does not feel cold to the touch or appear any different from the rest of my skin; the sensation is deep inside my arm the way that the pain originally was.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Death
Clinical narrative: RESIDENT DIED WITHIN 30 DAYS OF ADMINISTRATION OF P-20 VACCINE
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Day 1: Normal sore arm, no redness, no swelling. Day 5: Beginning about 11 am: redness which reached an area of about 4" wide by 2" high, slight itching, slight swelling, slight warmth, slightly sore, slight tingly feeling. 1:30 pm took one Children's Claritin (5 mg loratadine, an antihistamine). By 2:00 pm symptoms are beginning to subside.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Skin warm, Swelling
Clinical narrative: Day 1: Normal sore arm, no redness, no swelling. Day 5: Beginning about 11 am: redness which reached an area of about 4" wide by 2" high, slight itching, slight swelling, slight warmth, slightly sore, slight tingly feeling. 1:30 pm took one Children's Claritin (5 mg loratadine, an antihistamine). By 2:00 pm symptoms are beginning to subside.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: none.  No signs or symptoms were reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling, Skin warm
Clinical narrative: Patient came back to clinic stating itchy to left arm injection site, site was red .
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypercholesterolaemia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/25/2023 HYPERCHOLESTEROLEMIA
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: head issues
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for meningococcal A, C, W, Y - NOT meningococcal B.   Meningococcal B was grabbed and administered to the patient.  Monitored patient x 30 minutes. No s/s of adverse reactions.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Adult failure to thrive, Respiratory failure
Clinical narrative: J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/27/2023 FAILURE TO THRIVE SYNDROME, ADULT
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a 2nd dose of the Moderna Bivalent vaccine but the pharmacy standing order states that the patient should have only gotten one.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Staff. administraded the vaccine into the shoulder instead of the deltoid muscle. I now have SIRVA. Staff stated to me that she could not file after 2 days. This is an error.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hepatorenal syndrome, Hypotension
Clinical narrative: I95.9 HYPOTENSION 5/23/2023 HEPATORENAL SYNDROME J96.00 ACUTE RESPIRATORY FAILURE 5/24/2023 HEPATORENAL SYNDROME
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Developmental delay, Encephalitis, Failure to thrive, Hypersomnia
Clinical narrative: Encephalitis, Failure to Thrive, Hypersomnolance, Developmental Delay
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test, Magnetic resonance imaging
Clinical narrative: Encephalitis, Failure to Thrive, Hypersomnolance, Developmental Delay
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Injection site rash
Clinical narrative: RASH ON ARM WHERE SHOT WAS GIVEN STARTED 4 DAYS AFTER VACCINATION.  PT RECEIVED BOTH PREVNAR 20 AND ARXVY IN SAME ARM
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Asthenia, Cough, Decreased appetite
Clinical narrative: Hospitalized with symptoms of weakness, decreased appetite, temperature, and cough.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Diarrhoea, Hypotension, Pancreatitis acute
Clinical narrative: I95.9 HYPOTENSION 5/27/2023 ACUTE PANCREATITIS J96.00 ACUTE RESPIRATORY FAILURE 5/27/2023 ACUTE PANCREATITIS I95.9 HYPOTENSION 5/27/2023 DIARRHEA J96.00 ACUTE RESPIRATORY FAILURE 5/27/2023 DIARRHEA
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt was given the vaccines above on 9/12/23. The mother reports patient woke up this morning and noticed that his left thigh was swollen and hot to the touch around the vaccination site. She called the Clinic to make an appointment for evaluation. Pt. was seen by Dr. and given a prescription for antibiotics. The mother is to contact Dr. if symptoms do not resolve after the course of antibiotics.
Age: 67.0
Sex: F
Vaccine: RSV, FLU4, RSV
Symptoms: Diplopia, Laboratory test
Clinical narrative: PATIENT EXPERIENCED DOUBLE VISION
Age: 67.0
Sex: F
Vaccine: RSV, FLU4, RSV
Symptoms: Diplopia, Strabismus
Clinical narrative: PATIENT EXPERIENCED DOUBLE VISION
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Feeling hot, Throat irritation
Clinical narrative: Light headness with hot feeling, Scratch thoat with feeling of closing; Increase Blood Pressure, Anxiety
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Light headness with hot feeling, Scratch thoat with feeling of closing; Increase Blood Pressure, Anxiety
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Pyrexia
Clinical narrative: 2.5 degrees of fever headache
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Dose was inadvertently administered to the patient after excursion due to power outage .Patient was notified same day. Patient did not report  any side effects.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: nothing known as of yet. pt has been contacted she was given two HD flu shots instead of one flu + one prevnar
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Significant tinnitus, ringing in ears. Has not gotten any better with time. Had not had COVID prior to receiving the shot.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, COVID-19, Dialysis, End stage renal disease, Hyponatraemia
Clinical narrative: Date of Admission: 9/7/2023   Date of Discharge: 9/8/2023   Issues to be Addressed at Follow-up: Restarting BP meds (he will likely do on his own)   Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   9/8/2023  3:50 PM MRSA SCREENING CULTURE In process NARES   9/7/2023  9:30 PM BODY FLUID CULTURE In process PERITONEAL DIALYSIS FLUID   9/7/2023  2:10 PM BLOOD CULTURE 2 Preliminary BLOOD   9/7/2023  1:50 PM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) COVID-19 DISEASE   ? ESRD ON PERITONEAL DIALYSIS   ? HYPONATREMIA
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcus test negative
Clinical narrative: Date of Admission: 9/7/2023   Date of Discharge: 9/8/2023   Issues to be Addressed at Follow-up: Restarting BP meds (he will likely do on his own)   Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   9/8/2023  3:50 PM MRSA SCREENING CULTURE In process NARES   9/7/2023  9:30 PM BODY FLUID CULTURE In process PERITONEAL DIALYSIS FLUID   9/7/2023  2:10 PM BLOOD CULTURE 2 Preliminary BLOOD   9/7/2023  1:50 PM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) COVID-19 DISEASE   ? ESRD ON PERITONEAL DIALYSIS   ? HYPONATREMIA
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Impaired driving ability, Injection site infection, Injection site reaction
Clinical narrative: Discussed suspect local reaction, but can also have early secondary infection at site, would Rx Keflex 500 mg po BID x 7 days, also recommend using Ibu 600 - 800 mg BID - TID, Benadryl po, warm compress, rest. Work excuse note written and printed for patient, would excuse today and tomorrow. No current obvious ill symptoms to account for chills, sweating, vomiting, if symptoms recurring, then would recheck at that time.  Recommend submit VAERs form for reaction left upper arm - relayed to MA working with provider today. Return in about 2 days (around 9/15/2023) for if not improving.
Age: 1.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was given Kinrix instead of separate Hep B and Polio vaccines.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Body fluid analysis, COVID-19, Culture, End stage renal disease
Clinical narrative: Date of Admission: 9/7/2023   Date of Discharge: 9/8/2023   Issues to be Addressed at Follow-up: Restarting BP meds (he will likely do on his own)   Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   9/8/2023  3:50 PM MRSA SCREENING CULTURE In process NARES   9/7/2023  9:30 PM BODY FLUID CULTURE In process PERITONEAL DIALYSIS FLUID   9/7/2023  2:10 PM BLOOD CULTURE 2 Preliminary BLOOD   9/7/2023  1:50 PM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) COVID-19 DISEASE   ? ESRD ON PERITONEAL DIALYSIS   ? HYPONATREMIA
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hyponatraemia, Laboratory test, Peritoneal dialysis, Peritoneal fluid analysis, Staphylococcus test
Clinical narrative: Date of Admission: 9/7/2023   Date of Discharge: 9/8/2023   Issues to be Addressed at Follow-up: Restarting BP meds (he will likely do on his own)   Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   9/8/2023  3:50 PM MRSA SCREENING CULTURE In process NARES   9/7/2023  9:30 PM BODY FLUID CULTURE In process PERITONEAL DIALYSIS FLUID   9/7/2023  2:10 PM BLOOD CULTURE 2 Preliminary BLOOD   9/7/2023  1:50 PM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) COVID-19 DISEASE   ? ESRD ON PERITONEAL DIALYSIS   ? HYPONATREMIA
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. We returned to the facility to revaccinate wih the current 2023-2024 vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered
Clinical narrative: 3rd HPV given in error
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. We returned to the facility to revaccinate wih the current 2023-2024 vaccine.
Age: 6.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Rash
Clinical narrative: Pt to clinic for vaccines. Pt was due for 3rd DTaP and 2nd Varicella vaccines.  Pt was given both vaccines and informed to wait in clinic 15 minutes after vaccines administered. One minute after leaving the room, pt's stepmother comes out stating pt is having a reaction to the vaccines. When entering the room, stepmother points at a rash under the patient's eyes. Pt has pinpoint rash located under both eyes. Pt remained in the clinic for 15 minutes after administration. Pt did not have rash noted anywhere else. Pt denied pain or difficulty breathing.  Pt referred to Pediatrician for follow up. Pt's stepmother informed to take pt to ER if any difficulty breathing.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. We returned to the facility to revaccinate wih the current 2023-2024 vaccine.
Age: 27.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: At the injection site of the Varicella the patient reported swelling/redness/itching on 9/8/23 (size of a half dollar coin).  At the injection site on 9/9-9/11 the patient developed vesicles (the size remained that of a half dollar coin). The patient continued to complain of itching and burning sensation.  The patient will contact our office if any worsening symptoms, if not our office will follow up in 1 week with her.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. We returned to the facility to revaccinate wih the current 2023-2024 vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. We returned to the facility to revaccinate wih the current 2023-2024 vaccine.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. We returned to the facility to revaccinate wih the current 2023-2024 vaccine.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Injection site cellulitis, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Palpitations, dizziness, erythema and heat at site consistent with cellulitis, malaise
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Palpitations
Clinical narrative: Palpitations, dizziness, erythema and heat at site consistent with cellulitis, malaise
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash, Rash vesicular
Clinical narrative: Patient had soreness/redness and heat at the injection site.  3 days later, patient developed "shingle-like" rash on the left abdomen extending towards her back.  Rash is still present as of 9/13/23 but has gotten better
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. Patient choose to talk to her doctor and be vacinated on a later date.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Delusion, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: About 10 hours after shot I started having the chills.  I spiked a fever and developed body aches and shaking .  I developed a headache and nasal congestion. Followed by nausea and felt delusional. I took an advil at 1:30 am  and my symptoms subsided and I was able to go to sleep.   I took another Advil in the morning I think around 7 .  As of this writing @ 2 pm, I have low grade body aches , headache and feel like I have a cold.   I will take another Advil in an hour or two and expect to feel better by tomorrow.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: About 10 hours after shot I started having the chills.  I spiked a fever and developed body aches and shaking .  I developed a headache and nasal congestion. Followed by nausea and felt delusional. I took an advil at 1:30 am  and my symptoms subsided and I was able to go to sleep.   I took another Advil in the morning I think around 7 .  As of this writing @ 2 pm, I have low grade body aches , headache and feel like I have a cold.   I will take another Advil in an hour or two and expect to feel better by tomorrow.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. Patient choose to talk to her doctor and be vacinated on a later date.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Blood test abnormal, Giant cell arteritis, Red blood cell sedimentation rate increased, Ultrasound scan
Clinical narrative: In October 2021 I was diagnosed with Giant Cell Arteritis. Since it is an autoimmune system, my pharmacist recommended that I report it in case there were other similar cases that could be correlated to the vaccine. It is equally possible the disease is not related to the vaccine.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was given the 2022-2023 flu vaccine. Under direction of the manufacturer and the Immunization Action Coallition we were instructed to revacinate as soon as possible. Patient choose to to be revacinated on Friday.
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Blood glucose normal, Cardio-respiratory arrest, Nausea, Pallor, Posture abnormal
Clinical narrative: After given HD flu, pt was seated and started to slouch over, became pale with respiratory distress appearing to have VASAL VAGALE per MD. CODE called, then CODE/EMS called after pt became unresponsive with sternal rubs. CODE TEAM responded. Code was called at 11:18 AM. Patient was in exam room pale, slumped over after receiving a flu shot. Code and EMS called. Patient then became responsive and code was changed back to code. Patient states he did eat this morning. Placed on 3L of oxygen. Pt denies chest pain, shortness of breath, or headache. Pt was given Zofran 4 mg ODT under the tongue at 11:27 AM for nausea per Dr. Patient states he felt better at 11:29 AM. EMS arrived
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Presyncope, Respiratory distress, Unresponsive to stimuli
Clinical narrative: After given HD flu, pt was seated and started to slouch over, became pale with respiratory distress appearing to have VASAL VAGALE per MD. CODE called, then CODE/EMS called after pt became unresponsive with sternal rubs. CODE TEAM responded. Code was called at 11:18 AM. Patient was in exam room pale, slumped over after receiving a flu shot. Code and EMS called. Patient then became responsive and code was changed back to code. Patient states he did eat this morning. Placed on 3L of oxygen. Pt denies chest pain, shortness of breath, or headache. Pt was given Zofran 4 mg ODT under the tongue at 11:27 AM for nausea per Dr. Patient states he felt better at 11:29 AM. EMS arrived
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Pfizer covid 5-11year vaccine as dose 2. Dose 1 was Moderna 6mo-5yr.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Patient states they began feeling flu-like symptoms (body aches, chills, tiredness) the day after the vaccination. Patient has been taking OTC acetaminophen to help with symptoms.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed diffused hives(2-3) in bilateral lower arms within 15 minutes of injection. Non itching and no other symptoms. Gave 50mg po Benadryl per protocol and patient discharged home without any urgent complications. Patient is stable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The patient received 1st moderna dose (mono)  on 12.5.21 at store, patient received 2nd moderna dose (bivalent) 10.20.22 at store. patient received pfizer dose on 7.22.23. No adverse events happened at any time. Patient circle that they have chronic health conditions and seizure disorders which what would at the time though would satisfy getting the 3rd dose. Not documented in notes however pharmacist at the time spoke to the patient and decision was made. No one can tell a patient they are not moderate or severely immunocompromised.
Age: 25.0
Sex: M
Vaccine: HEPAB, HPV9, MMRV, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: There was no adverse event. I am reporting this because I give patient a Varicella vaccine, a MMRV instead of MMRII
Age: 61.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event
Clinical narrative: NONE AT THIS TIME
Sex: F
Vaccine: PNC20
Symptoms: Altered state of consciousness, Decreased appetite, Mobility decreased, Pain
Clinical narrative: I was practically unconscious, I was not hungry, I couldnt move and barely go to the restroom and it took a long time to get a very small distance to the restroom. Very sore and achy. No appetite for 48 hours and I regularly eat very good. I am recovered now-9/13/23. ***I choose not to list DOB and Age***
Age: 60.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event
Clinical narrative: NONE AT THIS TIME
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient stated that she the typical achiness and fever,  then her arm started to feel warm, red and swollen. She stated it has been getting worse everyday with the swelling moving down her arm. She showed her arm it was enlarged and red.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Pt was fine after getting shot on 9/7 then on the morning of 9/9 pt woke up with redness, sore swollen arm with lumps under skin. states it was warm to touch. no other symptoms. Pt stated it mostly went away on 9/11. today 9/13 their was only a small red area not warm to touch and no lumps.
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient physician electronically sent a prescription to the pharmacy we filled the prescription and gave the vaccination. After giving the patient the vaccination we looked up the patient in the doctors office system and noticed that the patient already received the Prevnar 20 vaccination in January 2023. Patient was notified by provider and pharmacy of duplicate vaccination. Pharmacist followed up with patient the next day to check for any adverse reaction.  Patient stated that he had no signs of adverse reaction.
Age: 49.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Blood glucose normal, Chest discomfort, Hypoaesthesia, Palpitations, Visual impairment
Clinical narrative: Shortly after receiving her Flucelvax immunization, the patient started to experience heart racing, chest tightness, and visions changes, eventually followed by arm/leg numbness.  No anaphylaxis symptoms.  EMS was called and paramedics responded.  They found her BP 140/128 and blood sugar levels normal.  Patient was taken to Hospital for further evaluation due to arm numbness.  Patient has previously tolerated yearly flu shots with no adverse effects.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: MALAISE; VOMITING; HEADACHE; This spontaneous report received from a consumer concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced malaise, vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, headache and malaise was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000295817. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as this report indicates it is a follow up for identified adverse events for multiple unnamed patients post vaccination. There is no product quality issue or allegation regarding vaccine efficacy in the information reported). The case does not meet the definition for a product quality complaint (pqc) or explicitly allege a potency issue based on the PQC evaluation/investigation performed. This case is a duplicate of 20230910756. This case, from the same reporter is linked to 20220926249.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: BRAIN BLEED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no other kind of brain difficulties bleeding or clots ever before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, three days after receiving the vaccine, the patient experienced brain bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230913855-Brain bleeds. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism, High cholesterol and Disorder gastrointestinal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, URSODIOL, RIFAXIMIN, LIOTHYRONINE SODIUM (CYTOMEL), LORAZEPAM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CYANOCOBALAMIN (VIT B12) and PARACETAMOL (TYLENOL) for an unknown indication.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, the patient experienced COVID-19 (Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023). At the time of the report, COVID-19 (Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023) outcome was unknown. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2023-739850 (Patient Link).
Sex: M
Vaccine: UNK
Symptoms: Cardiac arrest
Clinical narrative: One man (Moderna) was injected 2 x: then cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (One man (Moderna) was injected 2 x: then cardiac arrest) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (One man (Moderna) was injected 2 x: then cardiac arrest) (seriousness criterion medically significant). At the time of the report, CARDIAC ARREST (One man (Moderna) was injected 2 x: then cardiac arrest) outcome was unknown.            Concomitant medications were not reported.   Patient had injected with Moderna Vaccine twice and then had cardiac arrest.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-739941.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of Cardiac arrest. The event occurred after the second dose of SPIKEVAX COVID-19 VACCINE NOS. As reported the patient was vaccinated with Moderna vaccine two times and had cardiac arrest. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739941:Same reporter
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria chronic
Clinical narrative: chronic severe urticaria or hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (chronic severe urticaria or hives) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, 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 an unknown date, the patient experienced URTICARIA CHRONIC (chronic severe urticaria or hives). At the time of the report, URTICARIA CHRONIC (chronic severe urticaria or hives) outcome was unknown.            No concomitant medications were reported.  On 20-Oct-2022, the patient received the Moderna Bivalent Covid-19 booster vaccine at an unreported dose, route and frequency of administration for Covid-19. It was reported that since receiving the vaccine, the patient had experienced chronic severe urticaria or hives.  No treatment medications were provided.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Myocarditis
Clinical narrative: A Women (Age 25 Moderna) Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (A Women (Age 25 Moderna) Myocarditis) in a 25-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (A Women (Age 25 Moderna) Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (A Women (Age 25 Moderna) Myocarditis) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company comment:  This is a spontaneous case concerning a 25-year-old, female patient with no reported medical history, who experienced the expected serious (medically significant) event of Myocarditis after the administration of an unknown dose of mRNA-1273 vaccine. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-739860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739860:Same reporter