chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from Department of Health and Human Services until 05-01-2023, sent via e-mail to my supervisor, and then forwarded to me on 05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Had already received earlier dose of Pfizer mRNA vaccine. Patient was given Pfizer Bivalent Vaccine Lot GJ 3270, on 06/07/2023 and tolerated well.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Symptom recurrence
Clinical narrative: STABLE ANGINA ANGINA, UNSPECIFIED 3/6/2023 &  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Redness, pain, and swelling at injection site, red itchy rash going down the top of the left arm.  Treating with Benadryl and Cortisone cream
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Rash pruritic
Clinical narrative: Redness, pain, and swelling at injection site, red itchy rash going down the top of the left arm.  Treating with Benadryl and Cortisone cream
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Partial seizures
Clinical narrative: FOCAL MOTOR SEIZURE 4/26/2023 ATRIAL FIBRILLATION, UNSPECIFIED FOCAL MOTOR SEIZURE 4/26/2023 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from agency until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Had already received earlier dose of Pfizer mRNA vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypertension, Myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY 4/24/2023 HTN (HYPERTENSION) ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY 4/24/2023 HTN (HYPERTENSION)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar spinal stenosis, Pulmonary embolism
Clinical narrative: MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE 4/21/2023 SPINAL STENOSIS OF LUMBAR SPINE
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from Department of Health and Human Services until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given. Patient was given Pfizer Bivalent Vaccine Lot GJ 3270, on 05/17/2023 and tolerated well.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: Moderna vaccine was administered outside of the clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------- ACUTE NON ST ELEVATION MI 5/1/2023 ACUTE NON ST ELEVATION MI
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Infarction, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED HYPOXIA
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Hypercoagulation, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 5/2/2023 ATRIAL FLUTTER, UNSPECIFIED    SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Patient was given Pfizer Bivalent Vaccine Lot GJ 3270, on 06/07/2023 and tolerated well.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Hypotension
Clinical narrative: HYPOTENSION 3/14/2023 GI HEMORRHAGE
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: FEVER 100.5 PAIN AND SWELLING TO  RIGHT AXILLA LYMPHNODES. SYMPTOMS BEGAN ON 06/12/2023 AFTER  VACCINE WAS ADMINISTERED.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Basophil count normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, Body temperature abnormal, Carbon dioxide normal
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Eosinophil count normal, Full blood count abnormal, Glomerular filtration rate, Haematocrit normal
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin normal, Hyperhidrosis, Immature granulocyte count, Laboratory test abnormal, Lymphocyte count
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count, Neutrophil count
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nucleated red cells, Platelet count normal, Red blood cell count normal, Red cell distribution width normal, Tinnitus
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Visual impairment, Vitreous floaters, White blood cell count normal
Clinical narrative: overheating, vertigo, tinnitus, eyes get white cobwebs,  profuse sweating. had to start metoprolol due to testing of heart condition.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Herpes zoster, Injection site pain, Neck pain, Paraesthesia
Clinical narrative: I was vaccinated on 6/1/23- over the next few days I had site soreness only ( no redness at site noted). On or about 6/8 evening I began to notice tenderness and rash under my hairline and on my left neck. Those on left neck appeared to be small  maculopapular like-no exudate, did not appear to be fluid filled however difficult to see due to area,.Over next day developed macular type-elevated lesions at left back of neck and into hairline that were pruritic and very tender.  A day or so late one appeard to have small blister like appearance -no exudate.A slight non sever shocking sensation intermittently that night. There was associate left neck soreness and the feeling of light" prickly" sensation over area as if one was wearing a wool item close to skin which lasted about a day NO fever or noted malaise, no other systemic symptoms in particular.  I decided to seek medical attention on or about day 5( 6/13) for concern of non healing and concern I had cellulitis. I was advised I had Shingles and no intervention was necessary as I had a mild case. I treated with OTC Calamine lotion and cortisone. I am improving - no new leisons noted and the ones present appear to be healing with much less itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular, Rash pruritic, Rash vesicular, Tenderness
Clinical narrative: I was vaccinated on 6/1/23- over the next few days I had site soreness only ( no redness at site noted). On or about 6/8 evening I began to notice tenderness and rash under my hairline and on my left neck. Those on left neck appeared to be small  maculopapular like-no exudate, did not appear to be fluid filled however difficult to see due to area,.Over next day developed macular type-elevated lesions at left back of neck and into hairline that were pruritic and very tender.  A day or so late one appeard to have small blister like appearance -no exudate.A slight non sever shocking sensation intermittently that night. There was associate left neck soreness and the feeling of light" prickly" sensation over area as if one was wearing a wool item close to skin which lasted about a day NO fever or noted malaise, no other systemic symptoms in particular.  I decided to seek medical attention on or about day 5( 6/13) for concern of non healing and concern I had cellulitis. I was advised I had Shingles and no intervention was necessary as I had a mild case. I treated with OTC Calamine lotion and cortisone. I am improving - no new leisons noted and the ones present appear to be healing with much less itching.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Arm swelling , hand swelling, pain and warm to touch, came into office to be seen. Dr. saw patient same day appt. Dr. examined patient and gave dose of Benadryl. Patient's father advised what to watch for. Patient's father understood.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-03-01.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from Department of Health and Human Services until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or events as result of this dose of vaccine given.  Had already received earlier dose of  mRNA vaccine prior to his incarceration with us. Patient refused the Updated Pfizer Bivalent vaccine when he was offered on 06/ 07/2023 but said he would let us know if he changes his mind. Patient remains incarcerated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Toothache
Clinical narrative: About 27 hours after the injection, and after I was mostly thru strong muscle and joint pain, I had severe pain in the tooth that will need another crown; it was an 8:10.  It lasted about 5-10 hours (not sure as I did fall asleep and when I woke up it was largely gone). I had taken a Tylenol which helped for a while; the severe pain returned; I then took another Tylenol which didn't help; I took an ibuprofen and chewed on some cloves and that helped.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna bivalent booster dose was given 4 days after products expiration date. Lot# 044h22a.
Age: 79.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Axillary pain
Clinical narrative: I received my third Pfizer COVID-19 booster on 11/21/2022. Sometime thereafter, I would experience intermittent pain in the right armpit. This continues to this day. I developed the same issue after having received the four previous Pfizer COVID-19 vaccines and boosters. Last year, when I was being treated for breast cancer, I mentioned the armpit to my radiologist. She said that this issue has been reported by some people after they have received their COVID-19 vaccinations.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine administered to patient 8 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial septal defect, Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION ACUTE RESPIRATORY FAILURE ATRIAL SEPTAL DEFECT POST ACUTE MI 12/30/2022 &  2/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 1.67
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent Covid vaccine administered to patient 8 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent Covid vaccine administered to patient 8 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Monovalent mRNA vaccine administered for a bivalent mRNA dose.   We had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  This patient was released from our custody and transferred on 05/12/2023.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent Covid vaccine administered to patient 3 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent Covid vaccine administered to patient 3 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory failure
Clinical narrative: ACUTE MI RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent Covid vaccine administered to patient 2.5 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Rash
Clinical narrative: Patient said that she had diarrhea for 1 day after. Then a few days after the shot she developed a rash on the left side of her face, under her chin, and on her fingers.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent Covid vaccine administered to patient 3 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Hypoxia
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY HYPOXIA
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Tingling, pins and needles in right arm extending from elbow down to fingers, has not subsided.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash on arms
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Hypersensitivity, Immunisation reaction, Injection site reaction, Pain
Clinical narrative: Patient began with what was assumed an injection site reaction approximately 3 hours after vaccination. After 4 days of symptoms of redness, swelling, soreness, spreading rash and pain the patient went to her pcp and they prescribed an antibiotic which has helped with the redness as well as recommending  advil and an antihistamine. She is now tracking the rash movement as it is going down her arm. The physician believes that this may be an allergic reaction to the vaccine.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Swelling
Clinical narrative: Patient began with what was assumed an injection site reaction approximately 3 hours after vaccination. After 4 days of symptoms of redness, swelling, soreness, spreading rash and pain the patient went to her pcp and they prescribed an antibiotic which has helped with the redness as well as recommending  advil and an antihistamine. She is now tracking the rash movement as it is going down her arm. The physician believes that this may be an allergic reaction to the vaccine.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse Reactions
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Syncope, Vision blurred
Clinical narrative: The day of the vaccine I was fine The next morning I got up, got out of bed, made coffee, and soon felt very faint. Vision was starting to cloud from the outside to the center. I walked back to the bedroom and fainted on the floor. I collapsed straight down and luckily didn't hit my head on nearby furniture. I had to pull myself up by holding on the drawers of a large bureau. I didn't call my doctor, because I thought he would send me to the ER, and I was ok after that. I had a low grade fever and went to bed. If was the only time in my years that I ever fainted!
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A HCP called our pharmacy today 6/15/23 to notify us that they had verified that the patient received the same vaccine the day before they got the dose here.  The HCP said they got the Bivalent dose on 10/28/22 and then I confirmed that they got the Bivalent dose here on 10/29/22.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient received vaccine on 12/4/22 and then a few days later she noticed that her neck was stiff and sore and spasming.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 0.33
Sex: F
Vaccine: PNC13, RV1
Symptoms: Oral mucosal eruption, Rash macular
Clinical narrative: Macular rash around mouth.  baby otherwise well appearing, eating well.  Of note, she had pentavalent rotavirus previously from different provider, so this was her first rotarix.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arrhythmia, Dizziness, Electrocardiogram ambulatory abnormal, Pain in extremity
Clinical narrative: I had a sore arm after receiving the vaccine for about a day. I have a history of congestive heart failure since 2015. In 05/2023, I went to see my doctor as I noticed a change in my heartbeat. I felt very lightheaded. I wore a heart monitor, and I was diagnosed with a heart arrhythmia. I now take a higher dosage of metoprolol. I will follow-up with my doctor within the week.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported a red circle 1 day after injection, on day 2 she comes in and shows a small bruise at injection site and a lump about 1/2 " below that measures about 1" x 1/2 ". This is sore to the pt, no redness noted.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Barium double contrast, Flatulence, Haematochezia, Intussusception
Clinical narrative: Patient presented to ER after mother noticed one bloody BM. Diagnosis was intussusception, treated with air enema. Patient passed gas after reduction, tolerated a diet, and appeared without abdominal tenderness on exam
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: Hub failure upon vaccination. Patient did not receive any vaccine through needle, all vaccine leaked from hub failure.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Wrong product administered
Clinical narrative: This patient was scheduled to have Pediarix (DTap/Hep B/ IPV) but received Kinrix (DTap/ IPV) and Engerix (Hep B). All vaccine doses and scheduled vaccines are the same.  The patient did not receive the suggested combined vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient Received Kinrix on 06/13/2023 in the left Deltoid. Mom verbalized that pt. woke up this morning with her left arm "Swollen and Hurting". Per mom, Patient had also a slight fever. Patient Examined by provider and diagnosed with "Local Adverse Effect of Vaccine". Prescription of Diphenhydramine sent to the pharmacy. Mom instructed to observe patient and take her to ER if she experiences difficulty breathing.
Age: 0.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20
Symptoms: No adverse event, Product administration error
Clinical narrative: On 6/9/23 at 10:30 am the patient was administered multiple vaccines. PCV20 and KINRIX were administered in error.  The patient had no signs or symptoms of distress after vaccines were administered.   The patient was monitored over 30 minutes after administration of the vaccines.  Patient remained stable.  No signs or symptoms of distress were noted.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia, Pulmonary embolism
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Urticaria
Clinical narrative: Hives outbreak  triggered childhood asthma
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Carbohydrate antigen 125, Chemotherapy, Dyspnoea
Clinical narrative: stage 4 ovarian cancer started as pain under right shoulder blade, much abdominal pain, trouble breathing hospitalization for fluid around lung chemotherapy-7 cycles debulking surgery chemotherapy-3 cycles current treatment-avastin infusion every 3-4 weeks
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Ovarian cancer stage IV, Pleural effusion, Surgery
Clinical narrative: stage 4 ovarian cancer started as pain under right shoulder blade, much abdominal pain, trouble breathing hospitalization for fluid around lung chemotherapy-7 cycles debulking surgery chemotherapy-3 cycles current treatment-avastin infusion every 3-4 weeks
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: LEFT BELLS PALSY
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered product that was expired by 8 days
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Benign prostatic hyperplasia, Bradycardia, Lower urinary tract symptoms, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 5/2/2023 BPH W LOWER URINARY TRACT SYMPTOMS ACUTE PULMONARY EMBOLISM 5/2/2023 HX OF ALCOHOL USE DISORDER ACUTE PULMONARY EMBOLISM 5/2/2023 ATRIAL FIBRILLATION, UNSPECIFIED    BRADYCARDIA
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris, Symptom recurrence
Clinical narrative: STABLE ANGINA ANGINA, UNSPECIFIED 3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: UNDER 50 YEARS OF AGE WITH NO IMMEDIATE  ADVERSE EFFECT
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Respiratory failure
Clinical narrative: ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 11.0
Sex: M
Vaccine: COVID19-2, HPV9
Symptoms: Lymph node pain
Clinical narrative: Tender axillary lymphadenopathy on the right, no erythema, no fever
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received adult dose of Havrix (Hep A) vaccine
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT POPLITEAL VEIN
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event but administered moderna vaccine that had expired
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture
Clinical narrative: Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------- ACUTE MI 4/30/2023 ACUTE MI ACUTE MI 4/30/2023 RIGHT ANKLE FX INIT ACUTE MI 4/30/2023 RIGHT ANKLE FX INIT
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event but administered moderna product that was expired by 15 days
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site discomfort, Injection site pain, Neck pain, Pain in jaw
Clinical narrative: pt reported pain extending through the neck and into jaw, as well as pain and discomfort at injection site.  pt denied any loss of mobility, discomfort in upper shoulder above injection site,  site not noticeably red,  not feeling weak or dizzy, does report headache. recommended returning to pharmacy to investigate injection site, over the counter nsaids, and seeing nurse or doctor to assess pain
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA 4/6/2023 TRANSIENT CEREBRAL ISCHEMIA
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient administered pediatric Engerix instead of adult
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Homeless, Hypoxia
Clinical narrative: HYPOXIA 3/22/2023 HOMELESSNESS, UNSPECIFIED HYPOXIA 3/22/2023 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA, INIT 3/26/2023 BMI 45-49.9 ADULT ANGIOEDEMA, SEQUELA 4/3/2023 BMI 45-49.9 ADULT
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Mom reported swelling & redness at injection site, fever ( Max 103) , decreased appetite and fussiness
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On 6/6/2023, I realized I had been sneezing more than usual that day. I took a home antigen test and got a positive result. I then emailed my doctor for guidance. My doctor told me to self-isolate, get plenty of rest, and take in plenty of liquids. She also told me to contact her if any additional symptoms appeared. Aside from the increased sneezing on the first day, the only other symptoms I experienced were occasional coughing and fatigue. My symptoms were not severe enough to necessitate treatment with medication.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Syncope
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 5/1/2023 SYNCOPE I21.4 ACUTE NON ST ELEVATION MI 5/1/2023 ACUTE NON ST ELEVATION MI
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event but administered moderna vaccine that was 4 days expired
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event but administered moderna product that was expired by 10 days
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: legally blind
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriosclerosis, Hemiparesis, Hypoxia, Intermittent claudication, Muscular weakness
Clinical narrative: HYPOXIA 3/30/2023 HX OF ATRIAL FIBRILLATION HYPOXIA 3/30/2023 ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA HYPOXIA 3/30/2023 WEAKNESS OF LEFT ARM HYPOXIA 3/30/2023 CLAUDICATION DUE TO PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral vascular disorder
Clinical narrative: HYPOXIA 3/30/2023 HX OF ATRIAL FIBRILLATION HYPOXIA 3/30/2023 ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA HYPOXIA 3/30/2023 WEAKNESS OF LEFT ARM HYPOXIA 3/30/2023 CLAUDICATION DUE TO PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event but administered expired moderna vaccine
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Medication error, No adverse event, Underdose
Clinical narrative: Patient was born on 11/1/22. Patient is a 6 month old who received the incorrect COVID vaccine at her initial visit on 5/2/23 (she received 0.2mL of Moderna bivalent booster for 6mo-5yo). This was caught after receiving her second vaccine on 5/30/23 when she received correct 0.25mL of Moderna bivalent for 6mo-11yo. This is reported as a medication error, no adverse reaction occurred.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: the patient had no symptoms after given the vaccine
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient completed the series unknowingly in 2020 and did not require a 3rd dose. This was discovered after administration. No treatment was necessary.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Blood magnesium normal, Blood potassium decreased, Cardiac flutter, Cardiac monitoring abnormal, Chest X-ray normal
Clinical narrative: Employee started having a fluttering feeling in her chest and felt like her heart rate was fast along with difficulty taking a deep breath due to pain on the left side of chest. She was seen in the ER and diagnosed with PVC's. She is currently still having symptoms and is to follow up with Cardiology. Potassium and fluids given in ER.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Full blood count normal, Heart rate increased
Clinical narrative: Employee started having a fluttering feeling in her chest and felt like her heart rate was fast along with difficulty taking a deep breath due to pain on the left side of chest. She was seen in the ER and diagnosed with PVC's. She is currently still having symptoms and is to follow up with Cardiology. Potassium and fluids given in ER.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Metabolic function test abnormal, Troponin normal, Ventricular extrasystoles
Clinical narrative: Employee started having a fluttering feeling in her chest and felt like her heart rate was fast along with difficulty taking a deep breath due to pain on the left side of chest. She was seen in the ER and diagnosed with PVC's. She is currently still having symptoms and is to follow up with Cardiology. Potassium and fluids given in ER.
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, Product administration error
Clinical narrative: Administration error; given 3 vaccines
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event but administered expired covid moderna vaccine
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hyperhidrosis, Impaired work ability, Influenza like illness
Clinical narrative: In either late August or early September 2022, I had fever, sweating, and body aches. It felt three times worse than the worst flu I have ever had. I went to a drive-thru testing facility and tested positive for COVID-19. I self-isolated and treated my symptoms with OTC TheraFlu. I called my doctor's office. I was advised to just take aspirin to manage my symptoms. I was also told that if my symptoms worsened, I could just call him back for further treatment options.  I stayed in bed for about four or five days. By the end of the first week, I began to feel better, though I still had a lot of fatigue.  Altogether, I self-isolated for two weeks and avoided contact with other people. After about two weeks of recuperation, I went back to work. I wore the mask at work and elsewhere in public, and I still wear a mask about 99% of the time.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: In either late August or early September 2022, I had fever, sweating, and body aches. It felt three times worse than the worst flu I have ever had. I went to a drive-thru testing facility and tested positive for COVID-19. I self-isolated and treated my symptoms with OTC TheraFlu. I called my doctor's office. I was advised to just take aspirin to manage my symptoms. I was also told that if my symptoms worsened, I could just call him back for further treatment options.  I stayed in bed for about four or five days. By the end of the first week, I began to feel better, though I still had a lot of fatigue.  Altogether, I self-isolated for two weeks and avoided contact with other people. After about two weeks of recuperation, I went back to work. I wore the mask at work and elsewhere in public, and I still wear a mask about 99% of the time.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Normal labour
Clinical narrative: HYPOTENSION 1/25/2022 NORMAL LABOR
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Diabetic retinopathy, End stage renal disease, Glomerular filtration rate, Nephrogenic anaemia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 DM 2 W BILAT MODERATE NONPROLIFERATIVE RETINOPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 CKD STAGE 5 (GFR <15) ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 ANEMIA DUE TO CKD
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Type 2 diabetes mellitus
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 DM 2 W BILAT MODERATE NONPROLIFERATIVE RETINOPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 CKD STAGE 5 (GFR <15) ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 ANEMIA DUE TO CKD
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: admistration error-double dose of mmr
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: administered expired moderna vaccine --left patient message to return call
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine - left message with patient to call us back
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Welts on back  High fever for 24hours
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash morbilliform
Clinical narrative: rash - measles-like on trunk
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The patient came to the pharmacy to see if he needs another bivalent dose. Upon reviewing the database and his patient profile, I discovered that he was inadvertently given a 2nd bivalent dosage of Moderna Bivalent (by myself) in November 2022, although he had already received a Pfizer Bivalent dose in September 2022. At the time a 2nd bivalent dose was not approved. Currently determining if patient requires an additional bivalent dose at this time.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma-chronic obstructive pulmonary disease overlap syndrome, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/28/2022 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/7/2023 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) HYPOXIA 11/28/2022 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Thalamic stroke
Clinical narrative: ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY 4/26/2023 TINGLING SENSATION
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve thickening, Arrhythmia, Carditis, Chest pain, Echocardiogram
Clinical narrative: Mitral Valve Thickening, Aortic Valve thickening, Tricuspid Regurgitation, Chest pains, heart inflammation, Heart Palpitations, Heart Arrythmia. All ongoing, 18 months later.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Mitral valve thickening, Palpitations, Tricuspid valve incompetence
Clinical narrative: Mitral Valve Thickening, Aortic Valve thickening, Tricuspid Regurgitation, Chest pains, heart inflammation, Heart Palpitations, Heart Arrythmia. All ongoing, 18 months later.
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given oral Rota at 8 months of age. Rota needs to be given between 6-32 weeks only.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Depressed mood, Gastrointestinal disorder, Lip discolouration
Clinical narrative: Weakness in legs, and body, cold, weight loss, hair loss, muscle mass depleted, abdomen went through what is called a Metamorphosis, sound of ocean in right ear up to now, upper lip became white, and is still white. Pain here and there. And I often feel sadness, but with God, I am still standing.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy, Muscular weakness, Nasopharyngitis, Pain, Tinnitus
Clinical narrative: Weakness in legs, and body, cold, weight loss, hair loss, muscle mass depleted, abdomen went through what is called a Metamorphosis, sound of ocean in right ear up to now, upper lip became white, and is still white. Pain here and there. And I often feel sadness, but with God, I am still standing.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weakness in legs, and body, cold, weight loss, hair loss, muscle mass depleted, abdomen went through what is called a Metamorphosis, sound of ocean in right ear up to now, upper lip became white, and is still white. Pain here and there. And I often feel sadness, but with God, I am still standing.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cardioversion
Clinical narrative: New onset atrial fibrillation 6/1/2023 requiring hospitalization and cardioversion on 6/4/2023.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was diluted incorrectly. Diluted with a 0.2ml instead of 2.2 mls. Patient communicated no signs or symptoms by 5pm
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Rash, Rash erythematous, Sensory disturbance
Clinical narrative: Had to travel overseas so I got the second dose of Moderna covid-19 vaccine.  Since that evening I have problems  on and of with tingling/ numbness in both feet?s and both hands. Left side are worse and it also get worse when sleeping. Sometimes it feels like I stepped in something wet with my left foot but I have not., the foot are dry.  The last year I have red dots and bumps all over my body beside my face.
Age: 34.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Fibromyalgia, Irritable bowel syndrome
Clinical narrative: Caller mentioned that at the end of the year 2020 she began exhibiting signs of IBS (clarified as irritable bowel syndrome) and fibromyalgia.; Caller mentioned that at the end of the year 2020 she began exhibiting signs of IBS (clarified as irritable bowel syndrome) and fibromyalgia.; This spontaneous report was received from a consumer and refers to an approximately 37-year-old female patient. The patient's pertinent medical history, concomitant medications, and drug reactions/allergies were not reported. The patient was not pregnant.  On an unknown date in June 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose/3 total, administered intramuscularly (IM) (strength, lot#, expiry date, and anatomical location were not provided), vaccination to prevent 9 types of HPV related cancer.  On an unknown date in 2017, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose/3 total, IM (strength, lot#, expiry date, and anatomical location were not provided).   On an unknown date in December 2017, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose/3 total, IM (strength, lot#, expiry date, and anatomical location were not provided). The patient stated that she received the three doses at the recommended intervals per the prescribing information.   During year 2020, on an unknown date, the patient started therapy with lentinus edodes mycelium (AHCC), daily, as an immune boosting supplement (strength, formulation, dose, lot#, expiry date, and route of administration were not provided).   On an unknown date in 2020 (reported as at the end of the year 2020), the patient began exhibiting signs of irritable bowel syndrome (IBS) (Irritable bowel syndrome) and fibromyalgia (Fibromyalgia). The patient sought medical attention at unspecified time for treatment (treatment was unspecified), and her healthcare provider recommended that she stop taking the supplement. At the time of reporting, the patient was recovering from the events of IBS and fibromyalgia. It was reported that she had mostly recovered from the symptoms of IBS and fibromyalgia as the symptoms had minimized. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable; while, with lentinus edodes mycelium (AHCC) was considered as withdrawn with positive dechallenge result.  The reporter considered the events were not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The causal relationship between the events and lentinus edodes mycelium (AHCC) were not provided.
Age: 50.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a patient received the vaccine at 50 years old.; No additional AE reported; This spontaneous report was received from a pharmacist regarding a 50-year-old patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.   The pharmacist asked if there were any benefits to administering HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to a 50-year-old patient as they had an incident a few months back (specific date not provided) when the 50-year-old patient received the vaccine (as prophylaxis, no more vaccination details were provided) (product administered to patient of inappropriate age). No additional adverse event (AE) was reported (no adverse event).