chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives covering entire back, back of neck, behind ears, back of upper legs (thighs).
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Crying, Dyspnoea, Erythema, Fatigue, Hypophagia
Clinical narrative: Starting within 24 hours of the vaccine and continuing for a week or more after, the following systems occurred in my baby: (1) a day after the vaccine (11/17/22), was extremely lethargic and hard to wake up (called pediatrician to ask for advice, said he was probably getting sick, which he wasn?t); (2) the next day (11/18/22) red in his diaper, but more active and alert (reached out to pediatrician again by phone and e-mail for advice); (3) 3 days after the shot (11/19/22), he started screaming for 6 hours straight, nothing would console him, barely drank anything during that time, almost took him to ER, but he was exhausted and finally fell asleep; (4) 11/21/22, weird shaking and catching breath during naps, would look scared and start crying when woke up; (5) 11/24/22 slept all day, very lethargic, hard to wake up. Spoke with pediatrician over the phone and he was checked at his 2 month visit.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Malaise, Somnolence, Tremor
Clinical narrative: Starting within 24 hours of the vaccine and continuing for a week or more after, the following systems occurred in my baby: (1) a day after the vaccine (11/17/22), was extremely lethargic and hard to wake up (called pediatrician to ask for advice, said he was probably getting sick, which he wasn?t); (2) the next day (11/18/22) red in his diaper, but more active and alert (reached out to pediatrician again by phone and e-mail for advice); (3) 3 days after the shot (11/19/22), he started screaming for 6 hours straight, nothing would console him, barely drank anything during that time, almost took him to ER, but he was exhausted and finally fell asleep; (4) 11/21/22, weird shaking and catching breath during naps, would look scared and start crying when woke up; (5) 11/24/22 slept all day, very lethargic, hard to wake up. Spoke with pediatrician over the phone and he was checked at his 2 month visit.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram head abnormal, Haemorrhagic stroke, Laboratory test normal, Neurological symptom
Clinical narrative: patient developed a hemorrhagic stroke within one week of receiving the vaccine patient started having symptoms within a few days of the vaccine
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Amino acid level normal, Arthralgia, C-reactive protein normal, Glycosylated haemoglobin normal, Guillain-Barre syndrome
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Hypoaesthesia, Light chain analysis increased, Neuralgia, Neuropathy peripheral, Pain in extremity
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Paraesthesia, Prostatic specific antigen normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Vitamin B12 normal
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Alanine aminotransferase normal, Amino acid level normal, Arthralgia, Feeling abnormal, Glycosylated haemoglobin normal
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Light chain analysis increased, Neuropathy peripheral, Pain
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Paraesthesia, Prostatic specific antigen normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sleep disorder
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 56.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Vaccination site pain, Vitamin B12 normal
Clinical narrative: 4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Lip swelling, Periorbital swelling, Rash
Clinical narrative: PATIENT HAD RASH OVER THE WHOLE BODY AND SWELLING UNDER EYE AND LIP. PATIENT TOOK BENADRYL AND SWELLING WENT DOWN
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Developed Afib and was hospitalized twice
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: ENTIRE UPPER LIP STARTED TO SWELL AND FEEL NUMB, AND LOWER LIP SLIGHTLY SWELLED IN CENTER OF LOWER LIP AND FELT NUMB
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Deafness unilateral, Decreased activity, Implantable defibrillator insertion, Injection site injury
Clinical narrative: on 12/7/21 went into full cardiac arrest.  VFib heart condition.  Spent the next 45 days in the hospital.  30 days in ICU, 18 days unconscious, 11 days on life support.  As a result have significant hearing loss in right ear, constant tinnitus, lung function is at 66%, scarring in heart, periodic pvcs, right shoulder damage.  ICD implanted in March 2022 which now restricts some extracurricular activities.  Doctors were not able to determine why I went into cardiac arrest.  I was a healthily individual.  Non smoker, low cholesterol, no blood pressure, active athletic individual.  Athletic activities has been impacted somewhat due to this event.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Laboratory test, Life support, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: on 12/7/21 went into full cardiac arrest.  VFib heart condition.  Spent the next 45 days in the hospital.  30 days in ICU, 18 days unconscious, 11 days on life support.  As a result have significant hearing loss in right ear, constant tinnitus, lung function is at 66%, scarring in heart, periodic pvcs, right shoulder damage.  ICD implanted in March 2022 which now restricts some extracurricular activities.  Doctors were not able to determine why I went into cardiac arrest.  I was a healthily individual.  Non smoker, low cholesterol, no blood pressure, active athletic individual.  Athletic activities has been impacted somewhat due to this event.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial fibrosis, Pulmonary function test decreased, Tinnitus, Ventricular extrasystoles, Ventricular fibrillation
Clinical narrative: on 12/7/21 went into full cardiac arrest.  VFib heart condition.  Spent the next 45 days in the hospital.  30 days in ICU, 18 days unconscious, 11 days on life support.  As a result have significant hearing loss in right ear, constant tinnitus, lung function is at 66%, scarring in heart, periodic pvcs, right shoulder damage.  ICD implanted in March 2022 which now restricts some extracurricular activities.  Doctors were not able to determine why I went into cardiac arrest.  I was a healthily individual.  Non smoker, low cholesterol, no blood pressure, active athletic individual.  Athletic activities has been impacted somewhat due to this event.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: WITHIN A MINUTE OR SO AFTER THE SHOT, THE PATIENT REPORTED THAT SHE FELT FAINT.  SHE PUT HER HEAD DOWN ON THE TABLE BUT THEN STARTED SWEATING PROFUSELY.  I GAVE HER SOME WATER AND PUT A COLD PACK ON HER NECK THEN HELPED HER TO LAY DOWN.  SHE FELT BETTER AFTER ABOUT 5 MINUTES OR SO AND AFTER ANOTHER 10 MINUTES SHE FELT GOOD ENOUGH TO GET UP AND WALK AROUND FOR A FEW MINUTES.  THEN SHE SAID SHE FELT FINE AND LEFT
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Gait disturbance, Induration, Pain, Peripheral swelling
Clinical narrative: Swelling and large red rash present from upper thigh to knee at largest. Grew for one day before starting to slowly ebb back. Was very, very hot to touch and felt hard under skin. Extremely itchy and uncomfortable. Painful as well. Could move/walk but favored other leg.  Treated with anti-itch cream and cooling cloths and ice. Swelling had gone down after 72 hours from shot and rash was still visible but not as vibrant and no heat present. Hard feeling had started to dissipate as well.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: Swelling and large red rash present from upper thigh to knee at largest. Grew for one day before starting to slowly ebb back. Was very, very hot to touch and felt hard under skin. Extremely itchy and uncomfortable. Painful as well. Could move/walk but favored other leg.  Treated with anti-itch cream and cooling cloths and ice. Swelling had gone down after 72 hours from shot and rash was still visible but not as vibrant and no heat present. Hard feeling had started to dissipate as well.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ageusia, Angina pectoris, Asthenia, Atrial fibrillation, Balance disorder
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Electromyogram, Epistaxis, Eye pain
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fall, Gait disturbance, Guillain-Barre syndrome, Haemoptysis, Headache
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Insomnia, Joint range of motion decreased, Magnetic resonance imaging, Muscle atrophy
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Nervous system disorder, Neuropathy peripheral, Optic neuritis, Pain in extremity
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Peripheral swelling, Post-acute COVID-19 syndrome, Thrombocytopenia
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombosis, Visual impairment, Walking aid user, Weight increased
Clinical narrative: Arm swollen pain, arm motion range couldn't lift arm, heart palpation nosebleed, spit up blood clotes fallen neuropathy, cane, thrombocytopenia, nerves attacted (AFib) heart pain musle loss Gullain Bar Syndrome Patient given Pfizer shot 4/2020. Patient began 1 1/2 hour later arm swollen legs num/needle pins in feet and legs. Coughing up bloot clots, lost muscle mas, weakness lost balance to walk, headaches, nauseous at stomach couldn't sleep heart paltation! Nosebleeds, arm range motion lost! Nerves attacted. Muscle mass lost, weight gain Brain to go blood clots in legs. Long Covid. Taste gone. Shots 4/16/21 Eye Sight low Pfizer Lot ER8732 5/07/21 Pfizer Lot EW0179 01/18/22 Pfizer Lot FD7218 7/04/22 PFR-BNT 30mcg/0.3mL Lot FM0173 11/15/22 Pfizer Bivalent 30mcg/0.3mL Lot GJ3277 Uptic Neuritis-Pain in eyes. I have Thrombocytopenia
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm, Angina pectoris, Cardiac valve disease, Exercise tolerance decreased, Laboratory test
Clinical narrative: About a week after my second Moderna vaccine my heart began pounding out of my chest multiple times a day It was quite painful. Nothing like this had ever happened before. I am very fit and healthy with no history of heart problems. I have since been diagnosed with two aneurysms and a heart valve that doesn't close properly.  The cardiologist is monitoring for a possible open heart surgery. I was a fitness model and I can no longer work out.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: About a week after my second Moderna vaccine my heart began pounding out of my chest multiple times a day It was quite painful. Nothing like this had ever happened before. I am very fit and healthy with no history of heart problems. I have since been diagnosed with two aneurysms and a heart valve that doesn't close properly.  The cardiologist is monitoring for a possible open heart surgery. I was a fitness model and I can no longer work out.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Urticaria
Clinical narrative: Developed hives on upper chest and neck, with some tightness in neck Noticed about 36 hours after injection (currently 48 hours after injection) Increased dosage of Claritin (usually take 5 mg; took 10 mg) Will contact dr in a couple days if they have not receded Had similar reaction (hives) a week after getting the Covid bivalent booster; went away in a few days
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood cholesterol normal, Blood test, Dyskinesia, Eye movement disorder, Fall
Clinical narrative: The patient presented to the clinic for a well child check up.  He had a history of intermittent dizziness and had two prior syncopal events (Nov 2022, Jan 2023).  He received his MCV4 and Men B vaccines and was instructed to sit and wait for 15 minutes (which he did).  He then went to the lab facility (inside the clinic) for a fasting blood draw.  Per report (Mom), he sat for a few minutes (less than 5), and was then asked if he felt fine and he said he did.  He stepped out into the hall and within 1 - 2 minutes, had a pre-syncopal event.  Mom states he said "I don't feel well - I need to sit down." He started to spill his coffee. Mom and LVN noted he was pale, his eyes rolled back, and he had bobbing of his torso and head but no tonic-clonic movements noted. He seemed to "crumple" down the wall and sat down. No apparent LOC.  No head trauma.  When asked, he recalls telling Mom he needed to sit down and then about 1 minute memory lapse.  He was carefully moved to an exam room and observed with repeat vital measurements (all were normal).  In clinic (before blood draw)  Orthostatic P/BP Pulse Lying: 61 PER MINUTE BP Lying: 103/64 Pulse Sitting: 79 PER MINUTE BP Sitting: 111/77 Pulse Standing: 80 PER MINUTE BP Standing: 102/73
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Full blood count abnormal, Glycosylated haemoglobin normal, Haematocrit normal, Haemoglobin increased, Laboratory test
Clinical narrative: The patient presented to the clinic for a well child check up.  He had a history of intermittent dizziness and had two prior syncopal events (Nov 2022, Jan 2023).  He received his MCV4 and Men B vaccines and was instructed to sit and wait for 15 minutes (which he did).  He then went to the lab facility (inside the clinic) for a fasting blood draw.  Per report (Mom), he sat for a few minutes (less than 5), and was then asked if he felt fine and he said he did.  He stepped out into the hall and within 1 - 2 minutes, had a pre-syncopal event.  Mom states he said "I don't feel well - I need to sit down." He started to spill his coffee. Mom and LVN noted he was pale, his eyes rolled back, and he had bobbing of his torso and head but no tonic-clonic movements noted. He seemed to "crumple" down the wall and sat down. No apparent LOC.  No head trauma.  When asked, he recalls telling Mom he needed to sit down and then about 1 minute memory lapse.  He was carefully moved to an exam room and observed with repeat vital measurements (all were normal).  In clinic (before blood draw)  Orthostatic P/BP Pulse Lying: 61 PER MINUTE BP Lying: 103/64 Pulse Sitting: 79 PER MINUTE BP Sitting: 111/77 Pulse Standing: 80 PER MINUTE BP Standing: 102/73
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Lipids normal, Malaise, Memory impairment, Metabolic function test normal, Pallor
Clinical narrative: The patient presented to the clinic for a well child check up.  He had a history of intermittent dizziness and had two prior syncopal events (Nov 2022, Jan 2023).  He received his MCV4 and Men B vaccines and was instructed to sit and wait for 15 minutes (which he did).  He then went to the lab facility (inside the clinic) for a fasting blood draw.  Per report (Mom), he sat for a few minutes (less than 5), and was then asked if he felt fine and he said he did.  He stepped out into the hall and within 1 - 2 minutes, had a pre-syncopal event.  Mom states he said "I don't feel well - I need to sit down." He started to spill his coffee. Mom and LVN noted he was pale, his eyes rolled back, and he had bobbing of his torso and head but no tonic-clonic movements noted. He seemed to "crumple" down the wall and sat down. No apparent LOC.  No head trauma.  When asked, he recalls telling Mom he needed to sit down and then about 1 minute memory lapse.  He was carefully moved to an exam room and observed with repeat vital measurements (all were normal).  In clinic (before blood draw)  Orthostatic P/BP Pulse Lying: 61 PER MINUTE BP Lying: 103/64 Pulse Sitting: 79 PER MINUTE BP Sitting: 111/77 Pulse Standing: 80 PER MINUTE BP Standing: 102/73
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Presyncope, Red blood cell count increased, Specific gravity urine normal, Urine analysis normal, Vitamin D decreased
Clinical narrative: The patient presented to the clinic for a well child check up.  He had a history of intermittent dizziness and had two prior syncopal events (Nov 2022, Jan 2023).  He received his MCV4 and Men B vaccines and was instructed to sit and wait for 15 minutes (which he did).  He then went to the lab facility (inside the clinic) for a fasting blood draw.  Per report (Mom), he sat for a few minutes (less than 5), and was then asked if he felt fine and he said he did.  He stepped out into the hall and within 1 - 2 minutes, had a pre-syncopal event.  Mom states he said "I don't feel well - I need to sit down." He started to spill his coffee. Mom and LVN noted he was pale, his eyes rolled back, and he had bobbing of his torso and head but no tonic-clonic movements noted. He seemed to "crumple" down the wall and sat down. No apparent LOC.  No head trauma.  When asked, he recalls telling Mom he needed to sit down and then about 1 minute memory lapse.  He was carefully moved to an exam room and observed with repeat vital measurements (all were normal).  In clinic (before blood draw)  Orthostatic P/BP Pulse Lying: 61 PER MINUTE BP Lying: 103/64 Pulse Sitting: 79 PER MINUTE BP Sitting: 111/77 Pulse Standing: 80 PER MINUTE BP Standing: 102/73
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vitamin D deficiency, pH urine normal
Clinical narrative: The patient presented to the clinic for a well child check up.  He had a history of intermittent dizziness and had two prior syncopal events (Nov 2022, Jan 2023).  He received his MCV4 and Men B vaccines and was instructed to sit and wait for 15 minutes (which he did).  He then went to the lab facility (inside the clinic) for a fasting blood draw.  Per report (Mom), he sat for a few minutes (less than 5), and was then asked if he felt fine and he said he did.  He stepped out into the hall and within 1 - 2 minutes, had a pre-syncopal event.  Mom states he said "I don't feel well - I need to sit down." He started to spill his coffee. Mom and LVN noted he was pale, his eyes rolled back, and he had bobbing of his torso and head but no tonic-clonic movements noted. He seemed to "crumple" down the wall and sat down. No apparent LOC.  No head trauma.  When asked, he recalls telling Mom he needed to sit down and then about 1 minute memory lapse.  He was carefully moved to an exam room and observed with repeat vital measurements (all were normal).  In clinic (before blood draw)  Orthostatic P/BP Pulse Lying: 61 PER MINUTE BP Lying: 103/64 Pulse Sitting: 79 PER MINUTE BP Sitting: 111/77 Pulse Standing: 80 PER MINUTE BP Standing: 102/73
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Pt noted next day bruising at injection site and surrounding area of redness
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient had warm red area that extended majority of length of arm the following day after immunization
Age: 79.0
Sex: M
Vaccine: PNC20
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Gastroenteritis viral, Hyperhidrosis
Clinical narrative: Aches, pains, sweats, fever 103.5, extreme fatigue, coughing and shortness of breath .  Two days after vaccine, visited Walk in. No tests given, diagnosed with stomach virus. Coughing continued and was seen by Dr., pulmonologist, was diagnosed and treated for pneumonia  - Feb. 7, 2023.
Age: 79.0
Sex: M
Vaccine: PNC20
Symptoms: Pain, Pneumonia, Pulmonary oedema, Pyrexia
Clinical narrative: Aches, pains, sweats, fever 103.5, extreme fatigue, coughing and shortness of breath .  Two days after vaccine, visited Walk in. No tests given, diagnosed with stomach virus. Coughing continued and was seen by Dr., pulmonologist, was diagnosed and treated for pneumonia  - Feb. 7, 2023.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient received both vaccines together on 3/31/2023  in the left arm. She reported for the first time on 7/1/2023 that she was still experience pain in her left arm from the vaccines on 3/31/2023. I asked if she had called the pharmacy prior to that date and she said no. She stated she did not have any reaction after the vaccines except just general dull pain. There was NO major swelling, rash nor it did not heat up after the vaccine. The patient stated she did have any injuries either to report on her left arm. I asked if she fell or has had pain in the left arm prior and she stated no. She stated she is still having trouble fully lifting her arm
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Redness and swelling at injection site, muscle ache and chills
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Anti-aquaporin-4 antibody negative, Blindness, CSF glucose increased, CSF lymphocyte count normal, CSF monocyte count increased
Clinical narrative: Patient received vaccines on June 11, 2023. Patient developed bilateral blurry vision followed by gait instability on June 19, 2023. Patient was admitted to the hospital on June 20 with complete bilateral blindness. and gait instability. Patient transferred to ICU with lethargy on June 21 and got intubated for airway protection. Patient underwent MRI of orbit concerning for possible demyelinating or autoimmune process on 6/21/23. MRi brain on same day concerning for acute disseminated encephalomyelitis. Patient started on 1000mg Solumedrol on 6/22 and completed 5 days of pulse steroids. Started on IVIG for 5 days on 6/26 due to lack of response.  Patient remains unresponsive in our ICU on mechanical ventilation.
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: CSF oligoclonal band absent, CSF protein, CSF red blood cell count, CSF white blood cell count negative, Central nervous system lesion
Clinical narrative: Patient received vaccines on June 11, 2023. Patient developed bilateral blurry vision followed by gait instability on June 19, 2023. Patient was admitted to the hospital on June 20 with complete bilateral blindness. and gait instability. Patient transferred to ICU with lethargy on June 21 and got intubated for airway protection. Patient underwent MRI of orbit concerning for possible demyelinating or autoimmune process on 6/21/23. MRi brain on same day concerning for acute disseminated encephalomyelitis. Patient started on 1000mg Solumedrol on 6/22 and completed 5 days of pulse steroids. Started on IVIG for 5 days on 6/26 due to lack of response.  Patient remains unresponsive in our ICU on mechanical ventilation.
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Endotracheal intubation, Gait disturbance, HIV test negative, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient received vaccines on June 11, 2023. Patient developed bilateral blurry vision followed by gait instability on June 19, 2023. Patient was admitted to the hospital on June 20 with complete bilateral blindness. and gait instability. Patient transferred to ICU with lethargy on June 21 and got intubated for airway protection. Patient underwent MRI of orbit concerning for possible demyelinating or autoimmune process on 6/21/23. MRi brain on same day concerning for acute disseminated encephalomyelitis. Patient started on 1000mg Solumedrol on 6/22 and completed 5 days of pulse steroids. Started on IVIG for 5 days on 6/26 due to lack of response.  Patient remains unresponsive in our ICU on mechanical ventilation.
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Laboratory test, Lethargy, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Mechanical ventilation
Clinical narrative: Patient received vaccines on June 11, 2023. Patient developed bilateral blurry vision followed by gait instability on June 19, 2023. Patient was admitted to the hospital on June 20 with complete bilateral blindness. and gait instability. Patient transferred to ICU with lethargy on June 21 and got intubated for airway protection. Patient underwent MRI of orbit concerning for possible demyelinating or autoimmune process on 6/21/23. MRi brain on same day concerning for acute disseminated encephalomyelitis. Patient started on 1000mg Solumedrol on 6/22 and completed 5 days of pulse steroids. Started on IVIG for 5 days on 6/26 due to lack of response.  Patient remains unresponsive in our ICU on mechanical ventilation.
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Treponema test negative, Unresponsive to stimuli, Vision blurred, White matter lesion
Clinical narrative: Patient received vaccines on June 11, 2023. Patient developed bilateral blurry vision followed by gait instability on June 19, 2023. Patient was admitted to the hospital on June 20 with complete bilateral blindness. and gait instability. Patient transferred to ICU with lethargy on June 21 and got intubated for airway protection. Patient underwent MRI of orbit concerning for possible demyelinating or autoimmune process on 6/21/23. MRi brain on same day concerning for acute disseminated encephalomyelitis. Patient started on 1000mg Solumedrol on 6/22 and completed 5 days of pulse steroids. Started on IVIG for 5 days on 6/26 due to lack of response.  Patient remains unresponsive in our ICU on mechanical ventilation.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Chills, Oropharyngeal pain, Pain, Pharyngitis streptococcal
Clinical narrative: I came down with strep throat over the weekend of 5/20/23. It began with an achy throat and a low grade temperature and body aches. I was diagnosed with it on Monday, 5/22/23. I was prescribed 10 days of penicillin.  I finished the course of medication. Then in the evening of 6/14/23 I began to feel an achy throat again. Overnight on 6/14/23 and on 6/15/23 I also had a low temperature, chills, and body aches. I was diagnosed with strep throat again on 6/15/23 and prescribed 10 days of amoxicillin.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Streptococcus test
Clinical narrative: I came down with strep throat over the weekend of 5/20/23. It began with an achy throat and a low grade temperature and body aches. I was diagnosed with it on Monday, 5/22/23. I was prescribed 10 days of penicillin.  I finished the course of medication. Then in the evening of 6/14/23 I began to feel an achy throat again. Overnight on 6/14/23 and on 6/15/23 I also had a low temperature, chills, and body aches. I was diagnosed with strep throat again on 6/15/23 and prescribed 10 days of amoxicillin.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Lip dry, Lip swelling, Peripheral swelling
Clinical narrative: PATIENT HAD THIRD DOSE ON SHINGRIX ON 6/20 (prior shots in 2019 were not reported on registry)  AND CALLED PHARMACY TODAY TO REPORT ADR INITIALLY IT WAS INFLAMMED ARM AND REDNESS WITH SWELLING to the size of a baseball. SHE HAS SINCE DEVELOPED A REDNESS WITH FOCUS BEING ON HER ARMS AND CENTRAL FACE (CONCENTRATED AROUND SINUS PASSAGES AND FOREHEAD) AND RASH/BUMPS IN SOME LOCATIONS. SHE DENIED PROBLEMS BREATHING, BUT DOES HAVE SWELLING OF THE LIPS AND DRY LIPS. I COUNSELED HER TO TAKE ANTIHISTAMINES (CLARITIN OR ALLEGRA ONCE DAILY) AND TAKE 1-2 BENADRYL AT BEDTIME AND TREAT ANY PAIN/fever SYMPTOMS WITH TYLENOL.  I also counseled on using hydrocortisone 1% 2-3 on face avoiding eyes and prn on other locations that are causing itching. SINCE THIS HAS BEEN GOING ON FOR >WEEK I SUGGESTED SHE CONTACT MOUSHOURES (I LEFT A VM WITH THE OFFICE INFORMING THEM OF THE ISSUE) AND SUGGESTED SHE MAY NEED STERIOD.  I encouraged her to seek care if fever or problems breathing begin.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT HAD THIRD DOSE ON SHINGRIX ON 6/20 (prior shots in 2019 were not reported on registry)  AND CALLED PHARMACY TODAY TO REPORT ADR INITIALLY IT WAS INFLAMMED ARM AND REDNESS WITH SWELLING to the size of a baseball. SHE HAS SINCE DEVELOPED A REDNESS WITH FOCUS BEING ON HER ARMS AND CENTRAL FACE (CONCENTRATED AROUND SINUS PASSAGES AND FOREHEAD) AND RASH/BUMPS IN SOME LOCATIONS. SHE DENIED PROBLEMS BREATHING, BUT DOES HAVE SWELLING OF THE LIPS AND DRY LIPS. I COUNSELED HER TO TAKE ANTIHISTAMINES (CLARITIN OR ALLEGRA ONCE DAILY) AND TAKE 1-2 BENADRYL AT BEDTIME AND TREAT ANY PAIN/fever SYMPTOMS WITH TYLENOL.  I also counseled on using hydrocortisone 1% 2-3 on face avoiding eyes and prn on other locations that are causing itching. SINCE THIS HAS BEEN GOING ON FOR >WEEK I SUGGESTED SHE CONTACT MOUSHOURES (I LEFT A VM WITH THE OFFICE INFORMING THEM OF THE ISSUE) AND SUGGESTED SHE MAY NEED STERIOD.  I encouraged her to seek care if fever or problems breathing begin.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Localized Redness               Swelling                Itchyness
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: LOW BLOOD PRESSURE; This spontaneous report received from a patient concerned a 71 year old male. 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. Concomitant medications included lisinopril. On an unspecified date, the patient experienced low blood pressure. Laboratory data (dates unspecified) included: Blood pressure Low, stabilized (within 6 months). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low blood pressure. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 20-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE on 27-Oct-2021 and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 19-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Jun-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023).    No concomitant medication was reported.  No treatment information was reported.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: daptacel vaccine was given 4 days past the expiration with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was given 4 days past the expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jun-2023, the patient received a 0.5 ml, total (once) dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot C5893AA, expiry date: 21-Jun-2023, strength: standard) via intramuscular route in right thigh for Immunization.  On 26-Jun-2023 the patient had daptacel vaccine past the expiration with no reported adverse event (expired product administered) (Latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.83
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of expired fourth daptacel dose at just under 23 months of age, rather than 15-20 months of age with no reported adverse event; administration of expired fourth daptacel dose at just under 23 months of age, rather than 15-20 months of age with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old female patient who was administered expired fourth dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at just under 23 months of age, rather than 15-20 months of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (HIB); PCV15 and tozinameran (Pfizer Biontech COVID-19 vaccine) all for Prophylactic vaccination.  On 28-Jun-2023, the patient received a dose 0f 0.5 ml (dose 4) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5893AA; expiry date: 21-Jun-2023) via intramuscular route in right thigh for Prophylactic vaccination (Immunisation).  On 28-Jun-2023 the patient was administered expired fourth dose of Daptacel at just under 23 months of age, rather than 15-20 months of age with no reported adverse event (expired product administered) (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired dose of daptacel with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was inadvertently administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine (Polio Vaccine) for Prophylactic vaccination.  On 27-Jun-2023, the patient received a dose 2 dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection lot C5893AA expiry date: 21-jun-2023 via intramuscular route in the right thigh for prophylactic vaccination (immunization).  On 27-JUN-2023 the patient developed a non-serious inadvertently administered an expired dose of daptacel with no reported adverse event (expired product administered) on the same day following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered an expired dose of daptacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vertigo
Clinical narrative: pt came to the site for vaccination. verified pt name, dob, and  allergies. pt counseled on possible side effects. vaccine administered. pt  felt vertigo after MCV vaccine administered. waited a couple of minutes before  vaccinating with HPV. pt stayed for observation and released. pt left in  stable condition.    BP 95/65
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-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 12-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023) 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 (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023).    Vaccine was administered to a resident. It was stored as specified per recommendations until administration.  Concomitant medication was not provided. Treatment information was not reported.