chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Fever, body aches, diarrhea.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Redness and hives around site and on abdomen.  Also of note a bandaid was placed over injection site and once removed redness started to fade. Of note Bandaid  was "latex free" Mom refused to allow Benadryl to be given to child. Child observed for 20 minutes. No respiratory trouble or swelling noted.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 1/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 50.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Incorrect route - zoster vaccine; no adverse symptoms
Age: 96.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Deep vein thrombosis, Respiratory failure
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Headache, Laboratory test, Pharyngeal swelling, Septic shock, Throat tightness
Clinical narrative: hives, headache, throat tight and thick, septic shock
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: hives, headache, throat tight and thick, septic shock
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Bacterial infection, Fatigue, Hypersensitivity, Injection site cellulitis, Injection site erythema
Clinical narrative: Child presented with pain, fatigue, and noticeable enlarged, red, upper left arm.  Doctors observation states left arm very swollen, erythemic, and warm to the touch.  Doctors diagnosis states cellulitis (acute bacterial infection) treated with 10 day course of antibiotic (Augmentin) and allergic reaction treated with an antihistamine (Diphenhydramine)
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Child presented with pain, fatigue, and noticeable enlarged, red, upper left arm.  Doctors observation states left arm very swollen, erythemic, and warm to the touch.  Doctors diagnosis states cellulitis (acute bacterial infection) treated with 10 day course of antibiotic (Augmentin) and allergic reaction treated with an antihistamine (Diphenhydramine)
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE HYPOXIA
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient stated that she broke out into itchy hives on her arms, hands, back , and neck.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was accidentally stored in the freezer.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was accidentally stored in the freezer.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Staff member administrated the "Pink cap Moderna, 0.2ml"  The child was due to receive "Blue cap Moderna, 0.25ml"
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Reversible ischaemic neurological deficit
Clinical narrative: REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Staff member administrated the "Pink cap Moderna, 0.2ml"  The child was due to receive "Blue cap Moderna, 0.25ml"
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 2/8/2023,  2/12/2023,  1/14/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A third dose of the Shingrix vaccination was administered to the patient, no reactions have been reported thus far. The patient and the provider were contacted about the incident.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Angioedema
Clinical narrative: ACUTE NON ST ELEVATION MI ANGIOEDEMA, INIT
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 1.25
Sex: M
Vaccine: HIBV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: It was not an adverse affect ,  Tdap is accidently given instead of Dtap.  Baby left the clinic fine yesterday and mom did not call back regarding any issues. Nurse only realize it today when someone brought it to her attention. She immediately notified the DR. The DR will call mom to make aware
Age: 92.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: On 7/3/23, the patient was noted to have erythema and edema on her right upper extremity below the injection site (right deltoid).
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Patient developed a circular/ovoid area of erythema, edema and pain distal to the injection site.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Hypotension
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN HYPOTENSION
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chest X-ray, Chills, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: patient was present in the clinic for approx. 30 mins after vaccine was given and was not showing any s/s of adverse reaction. at approx 1:38pm patients mother called into the clinic and spoke with a triage nurse reporting patient was having uncontrollable chills, fever, nausea with vomiting, appeared pale, but denied SOB or chest pain. patient was advised to go to the ER by triage nurse and was evaluated at that time.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pallor, Pyrexia, Troponin, Vomiting
Clinical narrative: patient was present in the clinic for approx. 30 mins after vaccine was given and was not showing any s/s of adverse reaction. at approx 1:38pm patients mother called into the clinic and spoke with a triage nurse reporting patient was having uncontrollable chills, fever, nausea with vomiting, appeared pale, but denied SOB or chest pain. patient was advised to go to the ER by triage nurse and was evaluated at that time.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Incorrect dose administered, Infant irritability, Product preparation issue, Pyrexia
Clinical narrative: The Medical Assistant unknowingly reconstituted a vial of rotavirus (Rotarix Lot#379JY) with a ready-to-use syringe of rotavirus (Rotarix Lot#YL9YN). Thus, the patient received double the dose of the vaccine.   This was discovered on Thursday 7/6/23 when there was a discrepancy of vaccine inventory of rotavirus vaccines. The system indicated that there were 9 Rotarix Lot#YL9YN, while the clinic Vaccine Inventory on indicated that there were 10 Rotarix Lot#YL9YN --meaning that the vaccine was not documented to a patient's chart. I found a diluent for reconstitution for Rotarix Lot#379JY on the counter where it usually is stored, but the vial of Rotarix Lot#379JY in the system and the transfer adapter were already used. I contacted the Medical Assistant who took care of the pt that day and Medical Assistant confirmed that they unknowingly used the ready-to-use syringe Rotarix Lot#YL9YN that was stored in the system to reconstitute the lyophilized vaccine component Rotarix Lot#379JY.  Dr. contacted patient's mother and mother of patient reported that patient is fussy and takes a bit longer to eat. Patient had fever but has resolved for 2 days.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Body temperature increased, Headache, Injection site pain
Clinical narrative: pain in the back at both kidney areas appeared suddenly in less than an hour after vaccination, the pain in that area continues for days and it is still present. After covid19 vaccine pfizer first dose in November 2021, pain in the same area appeared and lasted for more than six months. On 6/28/2023 join pain suddenly appeared in finger joints and shoulder in right arm this pain still continue and did not improved after more than a week. Headache and light temperature that lasted for one week.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Renal pain
Clinical narrative: pain in the back at both kidney areas appeared suddenly in less than an hour after vaccination, the pain in that area continues for days and it is still present. After covid19 vaccine pfizer first dose in November 2021, pain in the same area appeared and lasted for more than six months. On 6/28/2023 join pain suddenly appeared in finger joints and shoulder in right arm this pain still continue and did not improved after more than a week. Headache and light temperature that lasted for one week.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute coronary syndrome
Clinical narrative: ACUTE CORONARY SYNDROME, UNSPECIFIED
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Anxiety, Blood glucose normal, Confusional state, Disturbance in attention
Clinical narrative: AFTER THE 2 VACCINES WERE ADMINISTERED, THE PATIENT WAS FINE. MOM, THE PATIENT AND MY SELF WERE WALKING OUT OF THE ROOM. I WAS IN FRONT AND MOM AND PT WERE BEHIND ME. I HEARD MOM SAY HELP. I TURNED AROUND AND SAW PT FALLING TO THE GROUND AND MOM WAS HOLDING HER ON ONE SIDE AND THEN A MEDICAL STUDENT CAME OUT OF THE OFFICE. DR. AND I WERE HOLDING HER ON BOTH SIDES BUT PT STARTED TO PASS OUT BEFORE WE COULD GET HER TO THE EXAM ROOM. WE IMMEDIATLEY LAYED HER DOWN ON THE FLOOR UNTIL WE COULD GET HER SETTLED. DR. CAME OUT OF THE OFFICE, TOO. PT "WAS OUT COLD" FOR AT LEAST 5 MIN. DR. WAS ABLE TO AROUSE HER BUT PT DIDN'T KNOW WHERE SHE WAS OR WHAT HAPPENEND. DR. HAD MOM MOVE IN SIGHT OF PT TO CALM HER. AT THIS TIME PT HR WAS  120s, PALE, NYSTAGMUS, UNABLE TO FOCUS, STARTED TO BECOME NAUSEOUS. WITH HELP, WE WERE ABLE TO MOVE PT INTO THE EXAM ROOM ON THE TABLE. PT WAS COMPLAINING SHE WAS COLD SO WE COVERED HER ON THE TABLE. SHE HAD HER HEAD AT 45 DEGREE ANGLE. SHE BEGAN TO COMPLAIN HER STOMACH HURT AND THEN SAID HAND WERE TINGLING AND SAID SHE COULD MOVE HER HANDS. THEN SHE GOT WARM.  ONLY TJE HANDS BECAME STIFF (DYSTONIC). SHE WAS DIAPHORECTIC AND SHAKING AT THIS TIME BP 79/42 HR 80s. WE HAD INJECTABLE DRUGS (COMPAZINE AND OTHERS) BUT PT WAS GETTING ANXIOUS ABOUT THE NEEDLES SO DR. TOOK A BENEDRYL  25MG CAPSULE AND POKED HOLES IN THE CAPSULE AND MADE HER TAKE IT THAT WAY. IT DID WORK WITHIN SECONDSTO RELEAVE THE DIAPHORECTIC. WE STARTED GIVING HER WATER AND PRETZELS. WE FOUND OUT SHE ONLY ATE WATERMELLON FOR BREAKFAST.SHE CONTINUSED TO RESTFOR ANOTHER 20-30 MIN WITH EATING. FELT BETTER, COLOR WAS COMING BACK TO HER AND FELT STRONGER SO SHE DECIDED TO GET UP AND TOOK 2 STEPS AND WAS CARRIED BACK TO THE TABLE. PT THEN WAS FREEZING AND THEN SHE FELL ASLEEP. DR. ADVISED MOM PT NEEDED TO GO TO THE HOSPITAL. DAD ARRIVED AT THIS TIME AND MOM AND DAD FELT AN AMBULANCE WOULD BE BEST. I CALLED THE AMBULANCE GAVE THEM THE HISTORY AND THEY ARRIVED APPROX. 15MIN LATER. THEY ASSESSED HER- GLUCOSE 130 ON METER, + ORTHOSTATIC HYPOTENSION AND AGREED SHE SHOULD GO TO HOSPITAL ED. THE TOTAL TIME IN THE OFFICE 12:15PM-2:15PM  WE DID CHECK THE VACCINATION AREA AND THERE WAS NO REACTION VISIBLE.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dystonia, Fall, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: AFTER THE 2 VACCINES WERE ADMINISTERED, THE PATIENT WAS FINE. MOM, THE PATIENT AND MY SELF WERE WALKING OUT OF THE ROOM. I WAS IN FRONT AND MOM AND PT WERE BEHIND ME. I HEARD MOM SAY HELP. I TURNED AROUND AND SAW PT FALLING TO THE GROUND AND MOM WAS HOLDING HER ON ONE SIDE AND THEN A MEDICAL STUDENT CAME OUT OF THE OFFICE. DR. AND I WERE HOLDING HER ON BOTH SIDES BUT PT STARTED TO PASS OUT BEFORE WE COULD GET HER TO THE EXAM ROOM. WE IMMEDIATLEY LAYED HER DOWN ON THE FLOOR UNTIL WE COULD GET HER SETTLED. DR. CAME OUT OF THE OFFICE, TOO. PT "WAS OUT COLD" FOR AT LEAST 5 MIN. DR. WAS ABLE TO AROUSE HER BUT PT DIDN'T KNOW WHERE SHE WAS OR WHAT HAPPENEND. DR. HAD MOM MOVE IN SIGHT OF PT TO CALM HER. AT THIS TIME PT HR WAS  120s, PALE, NYSTAGMUS, UNABLE TO FOCUS, STARTED TO BECOME NAUSEOUS. WITH HELP, WE WERE ABLE TO MOVE PT INTO THE EXAM ROOM ON THE TABLE. PT WAS COMPLAINING SHE WAS COLD SO WE COVERED HER ON THE TABLE. SHE HAD HER HEAD AT 45 DEGREE ANGLE. SHE BEGAN TO COMPLAIN HER STOMACH HURT AND THEN SAID HAND WERE TINGLING AND SAID SHE COULD MOVE HER HANDS. THEN SHE GOT WARM.  ONLY TJE HANDS BECAME STIFF (DYSTONIC). SHE WAS DIAPHORECTIC AND SHAKING AT THIS TIME BP 79/42 HR 80s. WE HAD INJECTABLE DRUGS (COMPAZINE AND OTHERS) BUT PT WAS GETTING ANXIOUS ABOUT THE NEEDLES SO DR. TOOK A BENEDRYL  25MG CAPSULE AND POKED HOLES IN THE CAPSULE AND MADE HER TAKE IT THAT WAY. IT DID WORK WITHIN SECONDSTO RELEAVE THE DIAPHORECTIC. WE STARTED GIVING HER WATER AND PRETZELS. WE FOUND OUT SHE ONLY ATE WATERMELLON FOR BREAKFAST.SHE CONTINUSED TO RESTFOR ANOTHER 20-30 MIN WITH EATING. FELT BETTER, COLOR WAS COMING BACK TO HER AND FELT STRONGER SO SHE DECIDED TO GET UP AND TOOK 2 STEPS AND WAS CARRIED BACK TO THE TABLE. PT THEN WAS FREEZING AND THEN SHE FELL ASLEEP. DR. ADVISED MOM PT NEEDED TO GO TO THE HOSPITAL. DAD ARRIVED AT THIS TIME AND MOM AND DAD FELT AN AMBULANCE WOULD BE BEST. I CALLED THE AMBULANCE GAVE THEM THE HISTORY AND THEY ARRIVED APPROX. 15MIN LATER. THEY ASSESSED HER- GLUCOSE 130 ON METER, + ORTHOSTATIC HYPOTENSION AND AGREED SHE SHOULD GO TO HOSPITAL ED. THE TOTAL TIME IN THE OFFICE 12:15PM-2:15PM  WE DID CHECK THE VACCINATION AREA AND THERE WAS NO REACTION VISIBLE.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Nausea, Nystagmus, Orthostatic hypotension, Pallor
Clinical narrative: AFTER THE 2 VACCINES WERE ADMINISTERED, THE PATIENT WAS FINE. MOM, THE PATIENT AND MY SELF WERE WALKING OUT OF THE ROOM. I WAS IN FRONT AND MOM AND PT WERE BEHIND ME. I HEARD MOM SAY HELP. I TURNED AROUND AND SAW PT FALLING TO THE GROUND AND MOM WAS HOLDING HER ON ONE SIDE AND THEN A MEDICAL STUDENT CAME OUT OF THE OFFICE. DR. AND I WERE HOLDING HER ON BOTH SIDES BUT PT STARTED TO PASS OUT BEFORE WE COULD GET HER TO THE EXAM ROOM. WE IMMEDIATLEY LAYED HER DOWN ON THE FLOOR UNTIL WE COULD GET HER SETTLED. DR. CAME OUT OF THE OFFICE, TOO. PT "WAS OUT COLD" FOR AT LEAST 5 MIN. DR. WAS ABLE TO AROUSE HER BUT PT DIDN'T KNOW WHERE SHE WAS OR WHAT HAPPENEND. DR. HAD MOM MOVE IN SIGHT OF PT TO CALM HER. AT THIS TIME PT HR WAS  120s, PALE, NYSTAGMUS, UNABLE TO FOCUS, STARTED TO BECOME NAUSEOUS. WITH HELP, WE WERE ABLE TO MOVE PT INTO THE EXAM ROOM ON THE TABLE. PT WAS COMPLAINING SHE WAS COLD SO WE COVERED HER ON THE TABLE. SHE HAD HER HEAD AT 45 DEGREE ANGLE. SHE BEGAN TO COMPLAIN HER STOMACH HURT AND THEN SAID HAND WERE TINGLING AND SAID SHE COULD MOVE HER HANDS. THEN SHE GOT WARM.  ONLY TJE HANDS BECAME STIFF (DYSTONIC). SHE WAS DIAPHORECTIC AND SHAKING AT THIS TIME BP 79/42 HR 80s. WE HAD INJECTABLE DRUGS (COMPAZINE AND OTHERS) BUT PT WAS GETTING ANXIOUS ABOUT THE NEEDLES SO DR. TOOK A BENEDRYL  25MG CAPSULE AND POKED HOLES IN THE CAPSULE AND MADE HER TAKE IT THAT WAY. IT DID WORK WITHIN SECONDSTO RELEAVE THE DIAPHORECTIC. WE STARTED GIVING HER WATER AND PRETZELS. WE FOUND OUT SHE ONLY ATE WATERMELLON FOR BREAKFAST.SHE CONTINUSED TO RESTFOR ANOTHER 20-30 MIN WITH EATING. FELT BETTER, COLOR WAS COMING BACK TO HER AND FELT STRONGER SO SHE DECIDED TO GET UP AND TOOK 2 STEPS AND WAS CARRIED BACK TO THE TABLE. PT THEN WAS FREEZING AND THEN SHE FELL ASLEEP. DR. ADVISED MOM PT NEEDED TO GO TO THE HOSPITAL. DAD ARRIVED AT THIS TIME AND MOM AND DAD FELT AN AMBULANCE WOULD BE BEST. I CALLED THE AMBULANCE GAVE THEM THE HISTORY AND THEY ARRIVED APPROX. 15MIN LATER. THEY ASSESSED HER- GLUCOSE 130 ON METER, + ORTHOSTATIC HYPOTENSION AND AGREED SHE SHOULD GO TO HOSPITAL ED. THE TOTAL TIME IN THE OFFICE 12:15PM-2:15PM  WE DID CHECK THE VACCINATION AREA AND THERE WAS NO REACTION VISIBLE.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia, Sudden onset of sleep, Tremor
Clinical narrative: AFTER THE 2 VACCINES WERE ADMINISTERED, THE PATIENT WAS FINE. MOM, THE PATIENT AND MY SELF WERE WALKING OUT OF THE ROOM. I WAS IN FRONT AND MOM AND PT WERE BEHIND ME. I HEARD MOM SAY HELP. I TURNED AROUND AND SAW PT FALLING TO THE GROUND AND MOM WAS HOLDING HER ON ONE SIDE AND THEN A MEDICAL STUDENT CAME OUT OF THE OFFICE. DR. AND I WERE HOLDING HER ON BOTH SIDES BUT PT STARTED TO PASS OUT BEFORE WE COULD GET HER TO THE EXAM ROOM. WE IMMEDIATLEY LAYED HER DOWN ON THE FLOOR UNTIL WE COULD GET HER SETTLED. DR. CAME OUT OF THE OFFICE, TOO. PT "WAS OUT COLD" FOR AT LEAST 5 MIN. DR. WAS ABLE TO AROUSE HER BUT PT DIDN'T KNOW WHERE SHE WAS OR WHAT HAPPENEND. DR. HAD MOM MOVE IN SIGHT OF PT TO CALM HER. AT THIS TIME PT HR WAS  120s, PALE, NYSTAGMUS, UNABLE TO FOCUS, STARTED TO BECOME NAUSEOUS. WITH HELP, WE WERE ABLE TO MOVE PT INTO THE EXAM ROOM ON THE TABLE. PT WAS COMPLAINING SHE WAS COLD SO WE COVERED HER ON THE TABLE. SHE HAD HER HEAD AT 45 DEGREE ANGLE. SHE BEGAN TO COMPLAIN HER STOMACH HURT AND THEN SAID HAND WERE TINGLING AND SAID SHE COULD MOVE HER HANDS. THEN SHE GOT WARM.  ONLY TJE HANDS BECAME STIFF (DYSTONIC). SHE WAS DIAPHORECTIC AND SHAKING AT THIS TIME BP 79/42 HR 80s. WE HAD INJECTABLE DRUGS (COMPAZINE AND OTHERS) BUT PT WAS GETTING ANXIOUS ABOUT THE NEEDLES SO DR. TOOK A BENEDRYL  25MG CAPSULE AND POKED HOLES IN THE CAPSULE AND MADE HER TAKE IT THAT WAY. IT DID WORK WITHIN SECONDSTO RELEAVE THE DIAPHORECTIC. WE STARTED GIVING HER WATER AND PRETZELS. WE FOUND OUT SHE ONLY ATE WATERMELLON FOR BREAKFAST.SHE CONTINUSED TO RESTFOR ANOTHER 20-30 MIN WITH EATING. FELT BETTER, COLOR WAS COMING BACK TO HER AND FELT STRONGER SO SHE DECIDED TO GET UP AND TOOK 2 STEPS AND WAS CARRIED BACK TO THE TABLE. PT THEN WAS FREEZING AND THEN SHE FELL ASLEEP. DR. ADVISED MOM PT NEEDED TO GO TO THE HOSPITAL. DAD ARRIVED AT THIS TIME AND MOM AND DAD FELT AN AMBULANCE WOULD BE BEST. I CALLED THE AMBULANCE GAVE THEM THE HISTORY AND THEY ARRIVED APPROX. 15MIN LATER. THEY ASSESSED HER- GLUCOSE 130 ON METER, + ORTHOSTATIC HYPOTENSION AND AGREED SHE SHOULD GO TO HOSPITAL ED. THE TOTAL TIME IN THE OFFICE 12:15PM-2:15PM  WE DID CHECK THE VACCINATION AREA AND THERE WAS NO REACTION VISIBLE.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness, swelling, itchy-treatment Benadryl. Resolved in 24 hours.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Brain fog, Cardiac stress test abnormal, Electrocardiogram, Fatigue
Clinical narrative: PALPITATIONS WHILE STANDING - NEW INCREASED HEART RATE ON STANDING GREATER THAN 30 BEATS PER MINUTE UNSTEADINESS WHILE STANDING/WALKING - NEW BRAIN FOG - WORSENING SINCE JANUARY 2023 FATIGUE - WORSENING SINCE JANUARY 2023  YMPTOMS OF BRAIN FOG AND PAPLIGATIONS HAVE IMPROVED AFTER INCREASING DOSAGE OF CONCERTA FROM 27 TO 36 MG PER DAY AND AFTER ADDING ADDITIONAL SALT AND ELECTROLYTES TO DIET, INCLUDING 1-3 SALT TABS (1000 MG EA) PER DAY.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Laboratory test, Magnetic resonance imaging, Palpitations, Therapy change
Clinical narrative: PALPITATIONS WHILE STANDING - NEW INCREASED HEART RATE ON STANDING GREATER THAN 30 BEATS PER MINUTE UNSTEADINESS WHILE STANDING/WALKING - NEW BRAIN FOG - WORSENING SINCE JANUARY 2023 FATIGUE - WORSENING SINCE JANUARY 2023  YMPTOMS OF BRAIN FOG AND PAPLIGATIONS HAVE IMPROVED AFTER INCREASING DOSAGE OF CONCERTA FROM 27 TO 36 MG PER DAY AND AFTER ADDING ADDITIONAL SALT AND ELECTROLYTES TO DIET, INCLUDING 1-3 SALT TABS (1000 MG EA) PER DAY.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound Doppler
Clinical narrative: PALPITATIONS WHILE STANDING - NEW INCREASED HEART RATE ON STANDING GREATER THAN 30 BEATS PER MINUTE UNSTEADINESS WHILE STANDING/WALKING - NEW BRAIN FOG - WORSENING SINCE JANUARY 2023 FATIGUE - WORSENING SINCE JANUARY 2023  YMPTOMS OF BRAIN FOG AND PAPLIGATIONS HAVE IMPROVED AFTER INCREASING DOSAGE OF CONCERTA FROM 27 TO 36 MG PER DAY AND AFTER ADDING ADDITIONAL SALT AND ELECTROLYTES TO DIET, INCLUDING 1-3 SALT TABS (1000 MG EA) PER DAY.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arterial occlusive disease, Cerebrovascular accident, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Gait inability, Lip erythema, Lip swelling, Pain
Clinical narrative: A little after 24 hours from vaccine developed swelling and erythema in both feet. Woke up next morning with swelling/erythema of left lower lip corner and right thenar eminence. Felt like needed to itch inside her skin. Ibuprofen helped pain but could not walk due to swelling/pain. No pitting edema.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: A little after 24 hours from vaccine developed swelling and erythema in both feet. Woke up next morning with swelling/erythema of left lower lip corner and right thenar eminence. Felt like needed to itch inside her skin. Ibuprofen helped pain but could not walk due to swelling/pain. No pitting edema.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Epilepsy, Generalised tonic-clonic seizure
Clinical narrative: GENERALIZED CONVULSIVE EPILEPSY EPILEPSY, UNSPECIFIED
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: entire Right upper arm was red, swollen, tender,  painful to move; Seen on Friday, today, area improved but site still red, swollen sore approx 7 cm diameter
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient inadvertently given lower "booster" dose instead of higher dose recommended for unvaccinated children.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Shock, Symptom recurrence
Clinical narrative: HYPOTENSION SHOCK, UNSPECIFIED 2/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Child received lower "booster dose" instead of higher dose recommended for unvaccinated children.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tiredness, Fever, Severe Headache, Vaccination area swollen red and hot.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Vaccination site warmth
Clinical narrative: Tiredness, Fever, Severe Headache, Vaccination area swollen red and hot.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Men A mixed with sterile diluent instead of Men c y w -135 liquid conjugate
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: LPN inadvertently gave the wrong COVID vaccine. She gave a pediatric dosage 5-11 orange top to an adult without diluting.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Malaise, Rash, Rash erythematous
Clinical narrative: patient called an hour after shot saying he is having rash and not feeling well. when he came to pharmacy, he was almost collapsing his wife brought him in, he was having difficulty breathing , high heart rate, and rash red, high patches all over his body ..admistered  EPI-PEN and called EMS, he left the store with them symptoms improved 15-20 minutes after the epi-pen injection.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events reported - wrong vaccine given
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Vaccine was not diluted prior to injection
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administrated Shingrix not due
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Full blood count, Pain in extremity, Pyrexia
Clinical narrative: right arm redness and pain, with fever
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood culture, C-reactive protein, Febrile convulsion, Full blood count, Generalised tonic-clonic seizure
Clinical narrative: Complex febrile seizure and rash. 7/6-7/7 Generalized tonic clonic seizures all <1min, 3 in less than 24hrs. Non-specific erythatmous papular rash very localized emerging on 7/7
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Laboratory test, Rash, Rash erythematous, Rash papular
Clinical narrative: Complex febrile seizure and rash. 7/6-7/7 Generalized tonic clonic seizures all <1min, 3 in less than 24hrs. Non-specific erythatmous papular rash very localized emerging on 7/7
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: At the time of administration no signs or symptoms were shown. Vaccination was given at 2:10 pm on 7/7/2023.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Beyond use date 07/01/2023 dispensed on 07/06/2023
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Hyporesponsive to stimuli, Hypotonia, Oxygen saturation decreased, Pallor
Clinical narrative: patient became hypotonic, pale in color, and less responsive within 5 minutes of vaccine administration. Oxygen saturation dropped to 60. Patient resumed normal color and oxygen saturation about 5 minutes following.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Hyperresponsive to stimuli, Hypotonic-hyporesponsive episode, Oxygen saturation decreased, Pallor
Clinical narrative: patient became hypotonic, pale in color, and less responsive within 5 minutes of vaccine administration. Oxygen saturation dropped to 60. Patient resumed normal color and oxygen saturation about 5 minutes following.
Age: 44.0
Sex: F
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: Adult patient was given a pediatric vaccine (proquad). Per CDC, dose may be counted towards her MMRV vaccine series and does not need to be repeated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Beyond use date 07/01/2023 dispensed on 07/06/2023
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received a 1st dose of Bexsero vaccine on 06/06/2023 came back 07/072023 received Trumenba as 2nd dose. Vaccines are not interchangeable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Beyond use date 07/01/2023 dispensed on 07/06/2023
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reactions reported.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: BUD date was not reviewed prior to administration of vaccine. Lack of attention to detail on date written on vaccine box. Nurse contacted Pfizer and validated that vaccine is still viable up to 2 days past the BUD date.  Manager contacted patient?s mother to explain incident reviewed details.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Feeling cold, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient became dizzy after leaving vaccination room, sat down, and fainted in a chair. Patient was unconscious for 20-30 seconds, had very brief convulsive activity, then came to. Patient was lightheaded, cold, clammy, pale (intermittently), profusely sweaty, and mildly nauseous for about 30-40 minutes afterward. The patient was driven home by the spouse who was present (ambulance denied). Patient reported to be back to normal after a 2 hour follow-up.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pallor, Seizure, Syncope
Clinical narrative: Patient became dizzy after leaving vaccination room, sat down, and fainted in a chair. Patient was unconscious for 20-30 seconds, had very brief convulsive activity, then came to. Patient was lightheaded, cold, clammy, pale (intermittently), profusely sweaty, and mildly nauseous for about 30-40 minutes afterward. The patient was driven home by the spouse who was present (ambulance denied). Patient reported to be back to normal after a 2 hour follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge
Clinical narrative: Following administration and engagement of retractable safety syringe a drop of clear liquid leaked out of the patient's arm; possible insufficient dose.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Nurse gave Menveo instead of Bexero .
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Scar, Varicella
Clinical narrative: full body rash; pox on her legs/Chicken pox; some minor scarring present.; This spontaneous report has been received from a nurse practitioner via field-based employee (FBE) referring to her daughter, an 18-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On approximately 10-MAY-2023 (reported as "in May 2023" and "it has been approximately 4 weeks since administration of varicella virus vaccine live (oka/merck) (VARIVAX)"), the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis via injection (strength, lot #, and expiry date were not provided).  On an unknown date in May 2023 (reported as approximately 1 month ago), the patient experienced a full body rash (rash), and approximately 7 days later, developed pox on her legs (also reported as chicken pox) (varicella). At the reporting time, the patient was still healing with some minor scarring present (scar). The reporter also had questions regarding administration of subsequent doses of varicella virus vaccine live (oka/merck) (VARIVAX), specifically, if her daughter should still be given the second dose. The patient had sought for medical attention. Treatment was given for the adverse events. It was unknown if any lab/diagnostic tests were performed. The outcome of events rash and varicella was recovering, and outcome of event scar was unknown.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and events was related (reported as the patient had a reaction to the first dose of varicella virus vaccine live (oka/merck) (VARIVAX)).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product storage error
Clinical narrative: HCP called to report TE on PROQUAD and it was inadvertently administered. HCP also inadvertently administered PROQUAD and VARIVAX at the same time; HCP also inadvertently administered PROQUAD and VARIVAX at the same time; No additional AE/PQ; This spontaneous report has been received from a licensed practical nurse concerning a 12-month-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was inadvertently vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number W024967 with expiration date 05-FEB-2024 (dosage regimen, frequency and route of administration were not provided) (Product storage error). On the same date, the patient was also vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), both vaccines were administered as prophylaxis (dosage regimen, frequency, route of administration, lot number and expiration date were not provided) (Accidental overdose). No additional adverse events were reported (No adverse event).
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; Improper storage of product in use; This spontaneous report was received from a pharmacist and refers to a 12-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was underwent temperature excursion at 70 Fahrenheit degrees (F) for 9 minutes. On 08-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, lot #W025273, expiration date not reported, but upon internal validation established as: 10-AUG-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). It was also reported another lot # W0252273 with expiration date: 02-JUN-2023, but it is an invalid lot # for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product, and also the registered nurse stated that this lot # was incorrect. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE for inadvertent administration of PROQUAD following a TE.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 08-JUN-2023, the patient was inadvertently vaccinated with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA))(PROQUAD) injection (0.5 ml, lot # X011437 has been verified to be valid, expiration date reported as established as 18-JUL-2024; strength, and route of administration were not provided) for prophylaxis following a temperature excursion (TE) (product storage error). The storage temperature of the vaccine was 6.4 degree Celsius for a time frame of 191 hours. There was no previous temperature excursion. TE assessment was not evaluated, and products were not back in recommended range. No symptoms were reported. No additional adverse event (AE)/product quality complaint (PQC).
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; Improper storage of product in use; This spontaneous report was received from a pharmacist and refers to an 11-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was underwent temperature excursion at 70 Fahrenheit degrees (F) for 9 minutes. On 09-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, lot #W025273, expiration date not reported, but upon internal validation established as: 10-AUG-2024, administered for prophylaxis (anatomical location, and route of administration were not provided). It was also reported another lot # W0252273 with expiration date: 02-JUN-2023, but it is an invalid lot # for varicella virus vaccine live (oka/merck) (VARIVAX), and also the registered nurse stated that this lot # was incorrect (product storage error).  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; improperly stored PROQUAD that was inadvertently administered to a patient; This spontaneous report was received from the Registered Nurse, and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 15-JUN-2023, the patient was inadvertently vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) injection, 0.5 milliliter, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (product storage error). There was no additional adverse event.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Pyrexia, Rotavirus test positive
Clinical narrative: bloody stools; positive for Rotavirus; fever; This spontaneous report has been received from an other health professional (reported as HCP) referring to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On an unknown date in 2023, the patient was administered with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided).  On 18-JUN-2023, the patient had 100.2 (unit not provided) fever (pyrexia).  On 19-JUN-2023 (also reported as the day after the child had 100.2 fever), the patient was administered with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided).  Then the patient was afebrile for 2 days. On 23-JUN-2023, the patient had a 100.4 (unit not provided) fever with bloody stools (haematochezia). On the same date, the patient went to the emergency room (ER). In the ER, the patient performed PCR stool panel test and came back positive for rotavirus (rotavirus test positive).  The patient had sought for medical attention. The outcome of all the events was unknown by reporter.   The causality assessment between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and all the events was not provided.  Upon internal review, the event haematochezia was determined to be medically significant.
Age: 0.75
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HBP reported that a 9 month old child received MMRII and VARIVAX at 9 months instead of 12 months.; No additional AE; This spontaneous report was received from consumer and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On unknown dates, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, albumin status unspecified (both strength, dose description, lot #, expiry date, route of administration, and indication were not provided) at 9 months instead of 12 months (product administered to patient of inappropriate age). No additional adverse event (no adverse event) and no product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMRV
Symptoms: Interchange of vaccine products, No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 26-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (dose and route of administration not reported) lot number w029552, expiration date 14-MAR-2024 for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (interchange of vaccine products) that also suffered a temperature excursion of 8 degrees Celsius for 1536 hours (product storage error).  No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The PROQUAD also suffered from a non supported temerature excursion; No Additional AE/PQC reported; the patient was given PROQUAD instead of MMR II; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered), subcutaneous injection, lot #W029552, expiration date: 14-MAR-2024 (dose, dose number, route of administration and indication were not provided).   On an unknow date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had been improperly stored in the temperature of 8 C for 936 hours (product storage error). No additional adverse event (no adverse event) and product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP calling to report a child was inadvertently given an expired dose of PROQUAD.; This spontaneous report was received from a medical assistant and refers to a child patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) diluted in sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter (strength, lot #, expiry date, route of administration, and indication were not provided). The vaccine had no previous temperature excursion. No additional information or adverse events were reported.
Age: 21.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Product dose omission issue
Clinical narrative: Missed dose AE filed due to patient never received 2nd dose of Varivax series; 5 Years ago a 21 year old was inadvertently administered ZOSTAVAX instead of VARIVAX; No additional AEs or PQC reported.; Reporting AE for HCP.  HCP reports "5 Years ago a 21 year old was inadvertently administered ZOSTAVAX instead of VARIVAX".  No other information provided.  No additional AEs or PQC reported. Did not have any further information as to why the; This spontaneous report was received from Other Health Professional and refers to a 26-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unknown date in 2018, the patient started therapy with zoster vaccine live (ZOSTAVAX) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, HCP reports that "5 Years ago a 21 year old was inadvertently administered ZOSTAVAX instead of VARIVAX".  No other information provided. No additional AEs or PQC reported. Did not have any further information as to why the error occurred. AE filed as product confusion due to reason unknown. Missed dose AE filed due to patient never received 2nd dose of VARIVAX series.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: was administered the medication at -2 degrees Celsius; No additional AE; This spontaneous report was received from a consumer referring to (herself) a 23-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On unknown day(reported as 'about one month ago'), the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis(Prodct storage error).  On unknown dates, the suspect vaccine experienced a temperature excursion of -2 degrees Celsius for 72 hours. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Skin laceration
Clinical narrative: as a result of moving broken vials of VARIVAX. The AE consisted of a cut finger; as a result of moving broken vials of VARIVAX. The AE consisted of a cut finger; This spontaneous report was received from an office manager and refers to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 05-JUL-2023, she got a cut of her finger (skin laceration) while she was moving broken vials of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection that were used as prophylaxis.  She recovered from the event on an unspecified date of July 2023. The causal relationship between the event of skin laceration and the suspect vaccine was not provided.