chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Bone cancer metastatic, Breast cancer in situ, Hypotension, Hypoxia
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 ACUTE RESPIRATORY FAILURE I95.9 HYPOTENSION 9/7/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 8/8/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 9/7/2022 CANCER METASTATIC TO BONE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 CANCER METASTATIC TO BONE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 CANCER METASTATIC TO BONE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 CANCER METASTATIC TO BONE R09.02 HYPOXEMIA 8/8/2022 CANCER METASTATIC TO BONE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 ACUTE RESPIRATORY FAILURE I95.9 HYPOTENSION 9/7/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 8/8/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 9/7/2022 CANCER METASTATIC TO BONE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 CANCER METASTATIC TO BONE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 CANCER METASTATIC TO BONE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 CANCER METASTATIC TO BONE R09.02 HYPOXEMIA 8/8/2022 CANCER METASTATIC TO BONE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 HX OF BREAST CANCER IN SITU I95.9 HYPOTENSION 9/7/2022 HX OF BREAST CANCER IN SITU J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 HX OF BREAST CANCER IN SITU J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 HX OF BREAST CANCER IN SITU J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 HX OF BREAST CANCER IN SITU R09.02 HYPOXEMIA 8/8/2022 HX OF BREAST CANCER IN SITU
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Respiratory failure
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 ACUTE RESPIRATORY FAILURE I95.9 HYPOTENSION 9/7/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 8/8/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 9/7/2022 CANCER METASTATIC TO BONE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 CANCER METASTATIC TO BONE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 CANCER METASTATIC TO BONE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 CANCER METASTATIC TO BONE R09.02 HYPOXEMIA 8/8/2022 CANCER METASTATIC TO BONE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 ACUTE RESPIRATORY FAILURE I95.9 HYPOTENSION 9/7/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 8/8/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 9/7/2022 CANCER METASTATIC TO BONE J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 CANCER METASTATIC TO BONE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 CANCER METASTATIC TO BONE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 CANCER METASTATIC TO BONE R09.02 HYPOXEMIA 8/8/2022 CANCER METASTATIC TO BONE I26.99 ACUTE PULMONARY EMBOLISM 10/6/2022 HX OF BREAST CANCER IN SITU I95.9 HYPOTENSION 9/7/2022 HX OF BREAST CANCER IN SITU J96.00 ACUTE RESPIRATORY FAILURE 10/6/2022 HX OF BREAST CANCER IN SITU J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/9/2022 HX OF BREAST CANCER IN SITU J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/8/2022 HX OF BREAST CANCER IN SITU R09.02 HYPOXEMIA 8/8/2022 HX OF BREAST CANCER IN SITU
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Pfizer 2/11/21 Lot# EM9810;  Pfizer 3/4/21 Lot# EN6201;  Pfizer 11/16/21 Lot# Ew0172;  Pfizer 4/6/22 Lot# FK9896;  Pfizer 9/15/22 Lot# GH9694
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Breathing-related sleep disorder
Clinical narrative: BREATHING RELATED SLEEP DISORDER
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Syringe issue
Clinical narrative: Prepared a prefilled syringe for prevnar20. Attached needle to syringe. When administering vaccination and pressing in the plunger the contents squirted out of an apparent crack in the neck of the PFS rather than contents going into the arm. Prepared a new dose of Prevnar 20 and administered with out any issues.  No adverse reaction reported from patient.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 9/29/21 Lot# 30145BA;  Pfizer 3/29/22 Lot# FK9896;  MOderna 9/9/22 Lot# AS7145B;  MOderna Lot# AS7171B
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Anxiety, Arteriogram coronary normal, Brain fog, Cardiac monitoring normal
Clinical narrative: Chronic fatigue, dizziness, headaches, brain fog, blurred vision, eye pain and pressure, anxiety, digestive issues, chest pain/palpitations
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test normal, Chest pain, Dizziness, Echocardiogram normal, Electrocochleogram
Clinical narrative: Chronic fatigue, dizziness, headaches, brain fog, blurred vision, eye pain and pressure, anxiety, digestive issues, chest pain/palpitations
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electronystagmogram, Eye pain, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Chronic fatigue, dizziness, headaches, brain fog, blurred vision, eye pain and pressure, anxiety, digestive issues, chest pain/palpitations
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Ocular discomfort, Palpitations, Tilt table test normal, Ultrasound Doppler normal
Clinical narrative: Chronic fatigue, dizziness, headaches, brain fog, blurred vision, eye pain and pressure, anxiety, digestive issues, chest pain/palpitations
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Chronic fatigue, dizziness, headaches, brain fog, blurred vision, eye pain and pressure, anxiety, digestive issues, chest pain/palpitations
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Light-headed dizziness some pains in my chest shortness of breath chills diarrhea feeling out of myself like weird
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal
Clinical narrative: Light-headed dizziness some pains in my chest shortness of breath chills diarrhea feeling out of myself like weird
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccine  Moderna 4/17/21 Lot# 048B21A;  mOderna 5/20/21 lot# 033B21A;  Moderna 12/18/21 Lot# 067H21A
Age: 31.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pruritus, Rash, Rash erythematous
Clinical narrative: Vaccines given at 12:40, patient did not exhibit s/s of reaction. Patient walked over to lab in clinic for blood draw and LVN assisting with blood draw saw rash on left arm. I was called to lab to assess patient, red rash noted to bilateral arms and across chest, patient c/o itching at site. Denied  s/s of SOB, itching at throat, n/v, LOC. NP from clinic onsite and called to lab, informed of situation and examined patient, ordered Kenalong 40mg IM once to be administered to patient. Medication administered at Left Deltoid without complications @1300.   1310: Patient's rash light pink in color, c/o itching at site. Denies that s/s are worsening. Patient given information on if s/s worsen to go to ER for care, if throat become itchy, SOB, swelling occurs, LOC call 911. Patient stated understanding, lives at home with mom, advised patient to inform mom if s/s progress.    Information about patient's status given to NP, advised patient to be d/c. D/C at 1:15.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/18/21 Lot# EN6207;  Pfizer 4/8/21 Lot# Ew0150
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Invasive ductal breast carcinoma, Lymphadenectomy, Mammogram abnormal, Radiotherapy
Clinical narrative: I went in for a routine mammogram where they found something on my right breast. My doctor ordered an MRI of my breast to get a better look at what had been seen on the mammogram. The MRI came back showing DCIF, grade 1 invasive, I had biopsies, my lymph nodes under my right arm have been removed, and two weeks of radiation. At this point in time, I do not need chemotherapy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 3/10/21 Lot# EN6199;  Pfizer 3/31/21 lot# ER8733;  Pfizer 11/30/21 lot# 330308D
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Laboratory test normal
Clinical narrative: I did not have an adverse reaction to the vaccine. On 04/01/2023, we had a heavy and wet snowstorm. On the street at my residence, we had a car that got stuck in the snow. I went out to help move the car and got lightheaded and laid down for about a minute. I got up and I still felt lightheaded. A neighbor recommended that I go to the emergency room. About 7 hours later, I did go to the emergency room. I was examined if I had a heart attack. All test was in normal range.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Biopsy skin, Joint swelling, Oedema, Pruritus, Rash
Clinical narrative: In November 2022, I experienced terrible itching of both of my ankles. I also had a lot of ankle swelling, as I had just been traveling. I kept experiencing itching. I developed a pustular rash that extended from the tops of my feet to the area halfway up my calves. I thought that maybe this had been caused by a soap or detergent I had used, because I had recently used brands I didn't normally use. I went to my PCP, who diagnosed it as vasculitis, which she thought had been induced by amiloride I had recently taken. I then stopped taking amiloride and switched over to spironolactone, and everything seemed to clear up really well until early April 2023. During that period, the symptoms returned. I had the pustular rash in the same places as before again, only it was worse. This time around, the rash spread up my thighs, to my abdomen, to my chest, and to my back. I went back to the PCP. This time, she knew for certain that I had vasculitis, but she was unsure how to proceed. She didn't know whether I should discontinue other medications, or if we were missing something else skin-related. I was referred to a dermatologist. The dermatologist affirmed that it was vasculitis, and she decided to do a punch biopsy, the results of which just showed signs of vasculitis. She then gave me a Kenalog injection. After the Kenalog injection, everything cleared up, including the rash and the itching. Ultimately, the dermatologist concluded that the vasculitis was edema-related. She told me that when traveling, I should wear support hose and keep my legs elevated and then see if those help prevent future incidents of vasculitis. She also told me that if I had any more skin issues, I am to return to her office.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Rash pustular, Vasculitis
Clinical narrative: In November 2022, I experienced terrible itching of both of my ankles. I also had a lot of ankle swelling, as I had just been traveling. I kept experiencing itching. I developed a pustular rash that extended from the tops of my feet to the area halfway up my calves. I thought that maybe this had been caused by a soap or detergent I had used, because I had recently used brands I didn't normally use. I went to my PCP, who diagnosed it as vasculitis, which she thought had been induced by amiloride I had recently taken. I then stopped taking amiloride and switched over to spironolactone, and everything seemed to clear up really well until early April 2023. During that period, the symptoms returned. I had the pustular rash in the same places as before again, only it was worse. This time around, the rash spread up my thighs, to my abdomen, to my chest, and to my back. I went back to the PCP. This time, she knew for certain that I had vasculitis, but she was unsure how to proceed. She didn't know whether I should discontinue other medications, or if we were missing something else skin-related. I was referred to a dermatologist. The dermatologist affirmed that it was vasculitis, and she decided to do a punch biopsy, the results of which just showed signs of vasculitis. She then gave me a Kenalog injection. After the Kenalog injection, everything cleared up, including the rash and the itching. Ultimately, the dermatologist concluded that the vasculitis was edema-related. She told me that when traveling, I should wear support hose and keep my legs elevated and then see if those help prevent future incidents of vasculitis. She also told me that if I had any more skin issues, I am to return to her office.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 1/14/21 Lot# EL3249;  Pfizer 2/4/21 Lot# EM9810;  Pfizer 10/12/21 Lot# FC3183
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was administered Bivalent Covid-Pfizer 5-11yr dose that was past the 10 week thaw date. The thaw date was 4/21/23 and vaccine administered on 5/5/23
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angina pectoris, Asthenia, Axillary pain, Chest pain, Cough
Clinical narrative: 4/28/23 Got Vaccination  4/29/23 lymphnoyds swollen pain on my upper chest area and my armpit  5/4/23 I felt a tiny itching in my throat  5/5/23 I was dry coughing all day 5/6/23 OMG! I WOKE UP TO PAIN IN MY HEART GOT UP USED HE REST ROOM WHILE ON THE TOILET I FELT LIKE I WAS GOING TO FAINT/PASS OUT I PUT A COLD TOWEL ON MY HEAD THEN LAYED DOWN. WHEN I WOKE UP I SPOKE  TO DOCTOR. I WAS INFORMED TO GO GET A COVID TEST. DOCTOR PRESCRIBED TUSSIN COUGH MEDICATION   I WENT TO GET TESTED AND IT CAME BACK CLEAR NEGATIVE AND BEEN SICK EVER SINCE. I'M COUGHING FEELING CONGESTED SLIGHT HEADACHE NO ENERGY. STARTING TO BLOW OUT MUCUS TODAY
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Lymphadenopathy, Malaise, Respiratory tract congestion
Clinical narrative: 4/28/23 Got Vaccination  4/29/23 lymphnoyds swollen pain on my upper chest area and my armpit  5/4/23 I felt a tiny itching in my throat  5/5/23 I was dry coughing all day 5/6/23 OMG! I WOKE UP TO PAIN IN MY HEART GOT UP USED HE REST ROOM WHILE ON THE TOILET I FELT LIKE I WAS GOING TO FAINT/PASS OUT I PUT A COLD TOWEL ON MY HEAD THEN LAYED DOWN. WHEN I WOKE UP I SPOKE  TO DOCTOR. I WAS INFORMED TO GO GET A COVID TEST. DOCTOR PRESCRIBED TUSSIN COUGH MEDICATION   I WENT TO GET TESTED AND IT CAME BACK CLEAR NEGATIVE AND BEEN SICK EVER SINCE. I'M COUGHING FEELING CONGESTED SLIGHT HEADACHE NO ENERGY. STARTING TO BLOW OUT MUCUS TODAY
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Secretion discharge, Throat irritation
Clinical narrative: 4/28/23 Got Vaccination  4/29/23 lymphnoyds swollen pain on my upper chest area and my armpit  5/4/23 I felt a tiny itching in my throat  5/5/23 I was dry coughing all day 5/6/23 OMG! I WOKE UP TO PAIN IN MY HEART GOT UP USED HE REST ROOM WHILE ON THE TOILET I FELT LIKE I WAS GOING TO FAINT/PASS OUT I PUT A COLD TOWEL ON MY HEAD THEN LAYED DOWN. WHEN I WOKE UP I SPOKE  TO DOCTOR. I WAS INFORMED TO GO GET A COVID TEST. DOCTOR PRESCRIBED TUSSIN COUGH MEDICATION   I WENT TO GET TESTED AND IT CAME BACK CLEAR NEGATIVE AND BEEN SICK EVER SINCE. I'M COUGHING FEELING CONGESTED SLIGHT HEADACHE NO ENERGY. STARTING TO BLOW OUT MUCUS TODAY
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the 10 week thaw date. 10 week thaw date was 4/21/23, vaccine given 5/5/23
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past the 10 week thaw date. 10 week thaw date was 4/21/23; vaccine administered 4/22/23
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abdominal discomfort, Abdominal pain, Decreased appetite, Fatigue, Pain
Clinical narrative: Pt. received vaccine on Friday, 05/05/23 at 4:10pm, within 2-4 hours she said she had an upset stomach, and pain. The pain got worst and she started Projectile Vomiting at 9pm. She projectile vomited a couple times, had a lot of abdominal pain. I called the on-call doctor, she said to give sips of water. During the night, pt. vomited over 7 times during the night. In the morning, she was very tired, and in pain, I called the doctor again, she said to stop all solid food for 8 hours, continue sips of water. Pt. napped most of the day, vomiting stopped. By evening she was able to have couple crackers. On Sunday 05/07/23, pt. started to feel a bit better and by the afternoon she was able to eat some solid food. On Monday morning, 05/08/23 pt. was feeling better,
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Somnolence, Vomiting, Vomiting projectile
Clinical narrative: Pt. received vaccine on Friday, 05/05/23 at 4:10pm, within 2-4 hours she said she had an upset stomach, and pain. The pain got worst and she started Projectile Vomiting at 9pm. She projectile vomited a couple times, had a lot of abdominal pain. I called the on-call doctor, she said to give sips of water. During the night, pt. vomited over 7 times during the night. In the morning, she was very tired, and in pain, I called the doctor again, she said to stop all solid food for 8 hours, continue sips of water. Pt. napped most of the day, vomiting stopped. By evening she was able to have couple crackers. On Sunday 05/07/23, pt. started to feel a bit better and by the afternoon she was able to eat some solid food. On Monday morning, 05/08/23 pt. was feeling better,
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Fatigue, Mobility decreased, Muscular weakness
Clinical narrative: pt stated when she woke up the morning after the shingrix vaccine she was tired. went back to sleep and woke up even more tired. she somehow ended up on the floor and couldn't get up. family came to her door and had to break it in because she couldn't get to the door. went to the hospital and was transferred to a rehab facility for 2 weeks. muscle weakness was so bad she needed therapy. she said it also affected her heart muscle.
Age: 80.0
Sex: M
Vaccine: COVID19-2, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Right arm hard to lift, sore across shoulders and arm that started about 4 days after vaccine administration.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varivax was administered 9 days after pt received MMR vaccine . Since both vaccines are live vaccines, spacing should be at least 28 days. Manufacturer has been contacted and concluded that such dose deemed invalidated.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysgeusia, Laboratory test
Clinical narrative: Very, Very bitter taste in the mouth. Frequently happened during the day about 1 hour after meals and other times like, when I woke up or in-between meals.  Lasted about 30-60 mins
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MMR was administered 23 days after pt received his first Varivax vaccine . Since both vaccines are live vaccines, spacing should be at least 28 days. Manufacturer has been contacted and concluded that such dose deemed invalidated.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Extreme diarrhea and vomiting. Some relief with immodium, but lasted over 48hrs
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Acute myocardial infarction, Arthralgia, Chest pain, Complication of device insertion, Echocardiogram normal
Clinical narrative: I had midline chest pain, pain that radiated down both arms to my elbows, it felt like my tongue fell asleep. I thought I had chest pains from some cheese I had eaten. My husband and I were talking, after 20 minutes I did not have any relief in my chest after taking my bra off, my neck was hurting, my tongue was feeling like it was asleep. I went to the emergency room my blood pressure was 134/85 which is high for me, the put leads on me for an EKG, it showed that I was having a STEMI. She instructed me to change my clothes so that they could get me upstairs to get me taken care of, they could not fit the stent in. I stayed in ICU for three days.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Electrocardiogram abnormal, Hypertension, Injection site pain, Intensive care, Neck pain
Clinical narrative: I had midline chest pain, pain that radiated down both arms to my elbows, it felt like my tongue fell asleep. I thought I had chest pains from some cheese I had eaten. My husband and I were talking, after 20 minutes I did not have any relief in my chest after taking my bra off, my neck was hurting, my tongue was feeling like it was asleep. I went to the emergency room my blood pressure was 134/85 which is high for me, the put leads on me for an EKG, it showed that I was having a STEMI. She instructed me to change my clothes so that they could get me upstairs to get me taken care of, they could not fit the stent in. I stayed in ICU for three days.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia oral
Clinical narrative: I had midline chest pain, pain that radiated down both arms to my elbows, it felt like my tongue fell asleep. I thought I had chest pains from some cheese I had eaten. My husband and I were talking, after 20 minutes I did not have any relief in my chest after taking my bra off, my neck was hurting, my tongue was feeling like it was asleep. I went to the emergency room my blood pressure was 134/85 which is high for me, the put leads on me for an EKG, it showed that I was having a STEMI. She instructed me to change my clothes so that they could get me upstairs to get me taken care of, they could not fit the stent in. I stayed in ICU for three days.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chondrocalcinosis, Pain in extremity, Peripheral swelling
Clinical narrative: I have Pseudogout the same hand where I got the shot in it gets super swollen and painful. I don't have a lot of information to add.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Atrial fibrillation, Lung adenocarcinoma, Mental status changes
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 7/10/2021 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I21.4 ACUTE NON ST ELEVATION MI 7/10/2021 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I21.4 ACUTE NON ST ELEVATION MI 7/10/2021 ALTERED MENTAL STATUS, UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 7/10/2021 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal abscess, Acute respiratory failure, Anaemia, Dyslipidaemia, Hypoxia
Clinical narrative: G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 INTRAABDOMINAL ABSCESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 INTRAABDOMINAL ABSCESS R09.02 HYPOXIA 4/16/2022 INTRAABDOMINAL ABSCESS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 DYSLIPIDEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 DYSLIPIDEMIA R09.02 HYPOXIA 4/16/2022 DYSLIPIDEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 ANEMIA R09.02 HYPOXIA 4/16/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 ANEMIA R09.02 HYPOXIA 4/16/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 HOSPITAL ACQUIRED PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 HOSPITAL ACQUIRED PNEUMONIA R09.02 HYPOXIA 4/16/2022 HOSPITAL ACQUIRED PNEUMONIA
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pneumonia
Clinical narrative: G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 INTRAABDOMINAL ABSCESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 INTRAABDOMINAL ABSCESS R09.02 HYPOXIA 4/16/2022 INTRAABDOMINAL ABSCESS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 DYSLIPIDEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 DYSLIPIDEMIA R09.02 HYPOXIA 4/16/2022 DYSLIPIDEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 ANEMIA R09.02 HYPOXIA 4/16/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 ANEMIA R09.02 HYPOXIA 4/16/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 10/7/2022 HOSPITAL ACQUIRED PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/7/2022 HOSPITAL ACQUIRED PNEUMONIA R09.02 HYPOXIA 4/16/2022 HOSPITAL ACQUIRED PNEUMONIA
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Balance disorder, COVID-19, Dizziness, Muscle fatigue
Clinical narrative: Around April 22, 2023, around certain times of day, I would get dizziness then it would go away. I did not have any other symptoms, just dizziness. Not long after this started, I was diagnosed for COVID-19, I was not given medication. I cannot really tell you when COVID-19 was gone, as I am now experiencing, muscle fatigue, weakness, the dizziness. poor balance. My doctor had prescribed medication to help me with the dizziness.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Around April 22, 2023, around certain times of day, I would get dizziness then it would go away. I did not have any other symptoms, just dizziness. Not long after this started, I was diagnosed for COVID-19, I was not given medication. I cannot really tell you when COVID-19 was gone, as I am now experiencing, muscle fatigue, weakness, the dizziness. poor balance. My doctor had prescribed medication to help me with the dizziness.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Coagulopathy, Leukocytosis
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/3/2022 LEUKOCYTOSIS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/3/2022 ANEMIA
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Atrial flutter, Cardiac arrest, Hypotension, Metastases to lymph nodes
Clinical narrative: Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 5/29/2021 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 5/29/2021 ATRIAL FLUTTER, UNSPECIFIED I95.9 HYPOTENSION 5/29/2021 CANCER METASTATIC TO RETROPERITONEAL LN I95.9 HYPOTENSION 5/29/2021 HYPOTENSION I95.9 HYPOTENSION 5/29/2021 SAB, UNSPECIFIED W CARDIAC ARREST
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 5/29/2021 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 5/29/2021 ATRIAL FLUTTER, UNSPECIFIED I95.9 HYPOTENSION 5/29/2021 CANCER METASTATIC TO RETROPERITONEAL LN I95.9 HYPOTENSION 5/29/2021 HYPOTENSION I95.9 HYPOTENSION 5/29/2021 SAB, UNSPECIFIED W CARDIAC ARREST
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: None, so far.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Respiratory failure, Subarachnoid haemorrhage
Clinical narrative: vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/20/2021 TRAUM SUBARACH HEMORR W/LOC UNS DUR INIT ENC
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Breast swelling, Headache, Injection site bruising, Lymphadenopathy, Pain
Clinical narrative: Bruising above the injection site; swelling all the way down the arm, into the lymph nodes, and breast; soreness, shakes, aches, low grade fever, headache
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Bruising above the injection site; swelling all the way down the arm, into the lymph nodes, and breast; soreness, shakes, aches, low grade fever, headache
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Benign prostatic hyperplasia, Hypotension, Hypoxia, Ischaemic stroke
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 PULMONARY ARTERY HTN I95.9 HYPOTENSION 1/28/2022 PULMONARY ARTERY HTN J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 PULMONARY ARTERY HTN R09.02 HYPOXIA 2/15/2022 PULMONARY ARTERY HTN I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 1/28/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 2/15/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 ASPIRATION PNEUMONIA I95.9 HYPOTENSION 1/28/2022 ASPIRATION PNEUMONIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 ASPIRATION PNEUMONIA R09.02 HYPOXIA 2/15/2022 ASPIRATION PNEUMONIA I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) I95.9 HYPOTENSION 1/28/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) R09.02 HYPOXIA 2/15/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 HX OF ACUTE KIDNEY INJURY I95.9 HYPOTENSION 1/28/2022 HX OF ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 HX OF ACUTE KIDNEY INJURY R09.02 HYPOXIA 2/15/2022 HX OF ACUTE KIDNEY INJURY
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia aspiration, Pulmonary arterial hypertension, Respiratory failure
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 PULMONARY ARTERY HTN I95.9 HYPOTENSION 1/28/2022 PULMONARY ARTERY HTN J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 PULMONARY ARTERY HTN R09.02 HYPOXIA 2/15/2022 PULMONARY ARTERY HTN I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 1/28/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 2/15/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 ASPIRATION PNEUMONIA I95.9 HYPOTENSION 1/28/2022 ASPIRATION PNEUMONIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 ASPIRATION PNEUMONIA R09.02 HYPOXIA 2/15/2022 ASPIRATION PNEUMONIA I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) I95.9 HYPOTENSION 1/28/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) R09.02 HYPOXIA 2/15/2022 BPH (BENIGN PROSTATIC HYPERPLASIA) I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/29/2022 HX OF ACUTE KIDNEY INJURY I95.9 HYPOTENSION 1/28/2022 HX OF ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2022 HX OF ACUTE KIDNEY INJURY R09.02 HYPOXIA 2/15/2022 HX OF ACUTE KIDNEY INJURY
Age: 67.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Injection site nodule, Pruritus, Pyrexia, Skin warm
Clinical narrative: patients left are has a red hot and itchy. started the day after the injection. patient also had a fever that resolved 24 hours after shot. patient claimed knots were felt in the arm where injection was.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: The received the first dose on 3/29/2022 (lot u008315  8/15/2023) and second dose on 3/17/2023 (lot w013165   12/14/2024).; injection site reaction consisted of redness and swollen; injection site reaction consisted of redness and swollen; injection site reaction tender to the touch; This spontaneous report was received from a medical assistant and referred to a 42-year-old non-pregnant female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included colecalciferol (VITAMINE D), birth control pills, inhalers and iron supplement.  On 29-MAR-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #U008315, expiration date: 15-AUG-2023, strength, anatomical location and route of administration were not provided) administered for prophylaxis.  On 17-MAR-2023, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #w013165, expiration date: 14-DEC-2024, strength, anatomical location and route of administration were not provided) administered for prophylaxis (Inappropriate schedule of product administration).  On an unknown date in 2023 (after receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient experienced injection site reaction consisted of redness and swollen (Vaccination site swelling; Vaccination site erythema), it was also tender to the touch (Vaccination site pain). At the time of reporting, the outcome of events vaccination site swelling, vaccination site erythema and vaccination site pain was recovering. The causal relationship between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: The received the first dose on 3/29/2022 (lot u008315  8/15/2023) and second dose on 3/17/2023 (lot w013165   12/14/2024).; injection site reaction consisted of redness and swollen; injection site reaction consisted of redness and swollen; injection site reaction tender to the touch; This spontaneous report was received from a medical assistant and referred to a 42-year-old non-pregnant female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included colecalciferol (VITAMINE D), birth control pills, inhalers and iron supplement.  On 29-MAR-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #U008315, expiration date: 15-AUG-2023, strength, anatomical location and route of administration were not provided) administered for prophylaxis.  On 17-MAR-2023, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #w013165, expiration date: 14-DEC-2024, strength, anatomical location and route of administration were not provided) administered for prophylaxis (Inappropriate schedule of product administration).  On an unknown date in 2023 (after receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient experienced injection site reaction consisted of redness and swollen (Vaccination site swelling; Vaccination site erythema), it was also tender to the touch (Vaccination site pain). At the time of reporting, the outcome of events vaccination site swelling, vaccination site erythema and vaccination site pain was recovering. The causal relationship between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/No adverse effects reported; HCP called to report inadvertent administration of an expired dose of MMR II.  Dose expired on 4/15/2023, and was administered today (4/17/2023). No adverse effects reported.  No additional AE/No PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified demographics . There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-APR-2023, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II) injection, 0.5 mL, lot# U011993 with expiration date 15-APR-2023 (dose number, frequency, route and site of administration were not reported) for prophylaxis (expired product administered). No adverse effects were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: tested positive for shingles; This spontaneous report was received from a physician via company representative and refers to a 15-year-old patient of unspecified gender. There was no information regarding the patient's medical history, concurrent condition or concomitant therapies details reported.  On an unknown dates, the patient was vaccinated first and second doses with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient developed shingles after being fully vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). No further information was provided. No additional adverse event or product quality complaint was reported. The outcome of the event was not reported.   The causality between the event and suspected vaccine was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2304USA008295:Original Case : 2304USA008287 2304USA008293:Original Case : 2304USA008287 2304USA008294:Original Case : 2304USA008287
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, No adverse event
Clinical narrative: tested positive for shingles; This spontaneous report was received from a physician via company representative and refers to a 11-year-old patient of unspecified gender. There was no information regarding the patient's medical history, concurrent condition or concomitant therapies details reported.  On an unknown dates, the patient was vaccinated first and second doses with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient developed shingles after being fully vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). No further information was provided. No additional adverse event or product quality complaint was reported. The outcome of the event was not reported.   The causality between the event and suspected vaccine was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2304USA008295:Original Case : 2304USA008287 2304USA008287:Original Case : 2304USA008287 2304USA008294:Original Case : 2304USA008287
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: tested positive for shingles; This spontaneous report was received from a physician via company representative and refers to a 6-year-old patient of unspecified gender. There was no information regarding the patient's medical history, concurrent condition or concomitant therapies details reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient developed shingles after being fully vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). No further information was provided. No additional adverse event or product quality complaint was reported. The outcome of the event was not reported.   The causality between the event and suspected vaccine was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2304USA008287:Original Case : 2304USA008287 2304USA008293:Original Case : 2304USA008287 2304USA008294:Original Case : 2304USA008287
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: tested positive for HPV; This spontaneous report was received from a consumer referring to herself, a 30-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unspecified date in 2006, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection (product circular number: uspi-v501-i-2304r022; strength, dose, route of administration, and anatomical location were not reported) for HPV prevention.  On an unspecified date (reported as "recently" and "a few days ago"), the patient received a pap smear and tested positive for HPV. The patient's healthcare provider relayed to her that it could be HPV types 16, 18, or 45. The patient requested additional testing to find out the exact type of HPV she contracted. The patient contracted it between 2021 and now. The patient was treated for this event and the healthcare provider suggested her to get HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient had an appointment on 21-APR-2023. The outcome of the event was not recovered. The causal relationship between the event and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired GARDASIL 9 (T036444 / 04/09/2024) was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, lot #T036444, expiration date: 09-APR-2023 (also reported as 04/09/2024, conflicting information), administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered). The patient was not reporting signs/symptoms of adverse events (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hep B, adolesent or pediatric 12-FEB-2003/hep B, adolesent or pediatric 22-APR-2004; hep B, adolesent or pediatric 17-NOV-2002/hep B, adolesent or pediatric 12-FEB-2003; This spontaneous report has been received from a physician, via medical records and immunization record from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (# 2211USA009542), concerning a 13-week-old, female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 17-NOV-2002, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) adolescent or pediatric, administered intramuscularly(IM) (exact dose, lot #, expiration date, site of administration were not provided). On 12-FEB-2003 (inappropriate schedule of product administration), the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) adolescent or pediatric, administered IM (exact dose, lot #, expiration date, site of administration were not provided). On 22-APR-2004 (inappropriate schedule of product administration), the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) adolescent or pediatric, administered IM (exact dose, lot #, expiration date, site of administration were not provided). According to immunization record, on 12-FEB-2003 and 22-APR-2004, the patient was vaccinated with diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) (discrepant information).   This is one of two reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2211USA009542:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion Product administered; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion with -10 Celsius degrees for 59 minutes. There was no previous temperature excursion.  On 26-APR-2023, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (1x dose, lot # W035464, expiration date 06-MAY-2024; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP called in to report patient was administered expired dose of VAQTA and wanted to know about revaccination for the patient. . No Additional AE/PQC.; This spontaneous report was received from a other health professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2023, the patient was vaccinated with one dose of hepatitis a vaccine, inactivated (VAQTA) lot# U004366, expiration date: 01-OCT-2022, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).