chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serotonin syndrome, Taste disorder
Clinical narrative: I had a massive headache for several days in September 2022. Then on 9/20/2022, I developed a very sore throat; it felt like I had rocks in my throat. By the end of that day, I developed a cough. It was a congested, productive cough. I finished my workday and then took a home antigen test and got a positive result. I called my physician on 9/21/2022 and arranged a telehealth appointment with her. She prescribed molnupiravir. I was to take four capsules twice a day for five days. I began taking the medication on 9/22/2022. During this time, I was extremely tired. I lost my senses of taste and smell at some point. I drank lots of tea with honey, because I know that honey has antibacterial properties. After three or four days of the antiviral, I began to feel better. It took several weeks before I began to regain my taste and smell, and even months later, things didn't smell or taste right. It's been several months since I had COVID-19, but I experience occasional swelling of the feet, though I don't know if it's related to that. I also had insomnia prior to having COVID-19, but since having it, my insomnia has been much worse. And then there are weekends in which I want to do nothing but sleep, but I don't know if it's because my body is worn down by that point. Before I had COVID-19, I had a history of depression. I had taken Zoloft until May 2021, when I was switched over to Cymbalta. After I began Cymbalta, I developed serotonin syndrome. I subsequently had to be taken off the Cymbalta, and I haven't taken any other antidepressants since then. Since having COVID-19, my depression has become even worse than before.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Facial paralysis
Clinical narrative: LEFT FACIAL PALSY
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Acute respiratory failure, COVID-19, Cough, Diarrhoea
Clinical narrative: The patient has a history of acute renal failure and CHF. She was brought to the ED by EMS on 4/13/23 with shortness of breath and generally feeling unwell. Symptoms included abdominal pain, vomiting, diarrhea, cough, and runny nose for the past few weeks. Ultimately, she was admitted 4/13/23 - 4/27/23. Discharge diagnoses include acute hypoxic respiratory failure, recent sepsis with septic shock secondary to UTI with E.coli bacteremia, and COVID+, among other diagnoses. An initial COVID PCR test performed in the ED was negative, however repeat COVID PCR testing on 4/14 was positive. Notably, the patient reported she tested positive for COVID in February 2023. The patient has received the primary COVID vaccine series and two boosters.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Escherichia bacteraemia, Malaise, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The patient has a history of acute renal failure and CHF. She was brought to the ED by EMS on 4/13/23 with shortness of breath and generally feeling unwell. Symptoms included abdominal pain, vomiting, diarrhea, cough, and runny nose for the past few weeks. Ultimately, she was admitted 4/13/23 - 4/27/23. Discharge diagnoses include acute hypoxic respiratory failure, recent sepsis with septic shock secondary to UTI with E.coli bacteremia, and COVID+, among other diagnoses. An initial COVID PCR test performed in the ED was negative, however repeat COVID PCR testing on 4/14 was positive. Notably, the patient reported she tested positive for COVID in February 2023. The patient has received the primary COVID vaccine series and two boosters.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sepsis, Septic shock, Urinary tract infection, Vomiting
Clinical narrative: The patient has a history of acute renal failure and CHF. She was brought to the ED by EMS on 4/13/23 with shortness of breath and generally feeling unwell. Symptoms included abdominal pain, vomiting, diarrhea, cough, and runny nose for the past few weeks. Ultimately, she was admitted 4/13/23 - 4/27/23. Discharge diagnoses include acute hypoxic respiratory failure, recent sepsis with septic shock secondary to UTI with E.coli bacteremia, and COVID+, among other diagnoses. An initial COVID PCR test performed in the ED was negative, however repeat COVID PCR testing on 4/14 was positive. Notably, the patient reported she tested positive for COVID in February 2023. The patient has received the primary COVID vaccine series and two boosters.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Central sleep apnoea syndrome
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE IDIOPATHIC CENTRAL SLEEP APNEA
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines ; mOderna 3/9/21 lot# 030A21A;  Moderna 4/6/21 lot# 017B21A;  Moderna 11/13/21 lot# 033F21A
Age: 76.0
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 2/25/21 lot# EN6202;  Pfizer 3/18/21 lot# EN6202;  PFizer 11/3/21 lot# FF8841;  Pfizer 4/13/22 lot# FK9896;  Pfizer 11/14/22 lot# GJ3277
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Heart rate increased, Nasal congestion
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I contacted my provider and got a prescription for PAXLOVID. It made me sick after two days, so I stopped taking. I took over the counter medicine to help me with my symptoms. I had chest congestion and nasal congestion. I had trouble with a dry unproductive cough. I got a prescription for a steroid and an antibiotic, and the cough finally got better. In 04/2023, I got sick again with chest congestion. I got another prescription for steroids and antibiotic. As of today, I am feeling better. In a couple of weeks, I am to contact my doctor and get a referral for a pulmonologist. When I lay down, I feel my heart beating. If I get up to fast, I notice my heartbeat goes up quickly. I do get tired very easily.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I contacted my provider and got a prescription for PAXLOVID. It made me sick after two days, so I stopped taking. I took over the counter medicine to help me with my symptoms. I had chest congestion and nasal congestion. I had trouble with a dry unproductive cough. I got a prescription for a steroid and an antibiotic, and the cough finally got better. In 04/2023, I got sick again with chest congestion. I got another prescription for steroids and antibiotic. As of today, I am feeling better. In a couple of weeks, I am to contact my doctor and get a referral for a pulmonologist. When I lay down, I feel my heart beating. If I get up to fast, I notice my heartbeat goes up quickly. I do get tired very easily.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Hypoxia
Clinical narrative: ACUTE DVT, UNSPECIFIED VEIN HYPOXIA
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 1/16/21 lot# EL3249;  Pfizer 2/6/21 lot# EM9810;  Pfizer 10/1/21 lot# EW0183;  Pfizer 6/9/22 lot# FP7BS
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 2/10/21 lot# EL3249;  Pfizer 3/4/21 lot# EN6202
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site and a circular area approximately 6-7 inches is red, swollen and febrile.  Urgent care PA and a dermatology NP advise that it appears that the injection was given SubQ (should be administered IM.  Treated with Cold Compress and NSAIDS and was prescribed Augmentin and triamcinolone Acetonide topical cream and mupiricin ointment.  After 24 hours of antibiotics there appears to be no improvement (it looks bigger)
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic cyst, Hypotension, Imaging procedure abnormal
Clinical narrative: I95.9 HYPOTENSION 10/17/2022 LIVER CYST I95.9 HYPOTENSION 10/17/2022 ABNL LIVER IMAGING
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Symptom recurrence
Clinical narrative: ACUTE PERICARDITIS, UNSPECIFIED 12/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 1.75
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Wrong product administered
Clinical narrative: Vaccines were pulled for a different patient and were mistakenly given to this patient
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Hypoxia, Pyrexia
Clinical narrative: The patient has a history of dementia. She was brought to the ED by EMS on 4/20/23 for evaluation of weakness. In the ED, she was noted to initially be hypoxic requiring 2L via nasal cannula. Ultimately, the patient was admitted 4/20/23 - 5/3/23. She developed a fever overnight into 4/22. A COVID test was performed on 4/22 and resulted positive. Discharge diagnoses included acute hypoxic respiratory failure in the setting of COVID-19, among other diagnoses. She was able to be weaned to room air prior to discharge. Of note, the patient has received the primary COVID vaccine and two boosters.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: The patient has a history of dementia. She was brought to the ED by EMS on 4/20/23 for evaluation of weakness. In the ED, she was noted to initially be hypoxic requiring 2L via nasal cannula. Ultimately, the patient was admitted 4/20/23 - 5/3/23. She developed a fever overnight into 4/22. A COVID test was performed on 4/22 and resulted positive. Discharge diagnoses included acute hypoxic respiratory failure in the setting of COVID-19, among other diagnoses. She was able to be weaned to room air prior to discharge. Of note, the patient has received the primary COVID vaccine and two boosters.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Hypoxia
Clinical narrative: HYPOTENSION HYPOXIA
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Gastritis, Gastrointestinal inflammation, Nausea
Clinical narrative: Patient experienced severe abdominal pain and nausea. Pt went to emergency department Thursday and Saturday. Two CT scans of abdomen showed severe inflammation of stomach and intestines.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute left ventricular failure, Acute respiratory failure, Asthenia, Bacteraemia
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 BACTEREMIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 BACTEREMIA R09.02 HYPOXIA 4/15/2023 BACTEREMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 WEAKNESS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 WEAKNESS R09.02 HYPOXIA 4/15/2023 WEAKNESS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 HYPERKALEMIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 HYPERKALEMIA R09.02 HYPOXIA 4/15/2023 HYPERKALEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS R09.02 HYPOXIA 4/15/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 ACUTE RENAL FAILURE, UNSPECIFIED J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 ACUTE RENAL FAILURE, UNSPECIFIED R09.02 HYPOXIA 4/15/2023 ACUTE RENAL FAILURE, UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 4/15/2023 DIASTOLIC HEART FAILURE, ACUTE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 4/15/2023 DIASTOLIC HEART FAILURE, ACUTE
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Bile duct stone, Chronic respiratory failure, Hyperkalaemia, Hypoxia, Pancreatitis acute
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 BACTEREMIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 BACTEREMIA R09.02 HYPOXIA 4/15/2023 BACTEREMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 WEAKNESS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 WEAKNESS R09.02 HYPOXIA 4/15/2023 WEAKNESS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 HYPERKALEMIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 HYPERKALEMIA R09.02 HYPOXIA 4/15/2023 HYPERKALEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS R09.02 HYPOXIA 4/15/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 ACUTE RENAL FAILURE, UNSPECIFIED J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 ACUTE RENAL FAILURE, UNSPECIFIED R09.02 HYPOXIA 4/15/2023 ACUTE RENAL FAILURE, UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 4/15/2023 DIASTOLIC HEART FAILURE, ACUTE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 4/15/2023 DIASTOLIC HEART FAILURE, ACUTE
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 BACTEREMIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 BACTEREMIA R09.02 HYPOXIA 4/15/2023 BACTEREMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 WEAKNESS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 WEAKNESS R09.02 HYPOXIA 4/15/2023 WEAKNESS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 HYPERKALEMIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 HYPERKALEMIA R09.02 HYPOXIA 4/15/2023 HYPERKALEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS R09.02 HYPOXIA 4/15/2023 CHOLEDOCHOLITHIASIS W ACUTE PANCREATITIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 ACUTE RENAL FAILURE, UNSPECIFIED J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 ACUTE RENAL FAILURE, UNSPECIFIED R09.02 HYPOXIA 4/15/2023 ACUTE RENAL FAILURE, UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 4/15/2023 DIASTOLIC HEART FAILURE, ACUTE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 4/20/2023 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 4/15/2023 DIASTOLIC HEART FAILURE, ACUTE
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: Patient did not report any adverse events
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac failure, Ejection fraction decreased, Open angle glaucoma, Pleural effusion
Clinical narrative: ACUTE PULMONARY EMBOLISM 12/1/2022 BILAT OPEN ANGLE GLAUCOMA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 BILAT OPEN ANGLE GLAUCOMA ACUTE PULMONARY EMBOLISM 12/1/2022 BILAT PLEURAL EFFUSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 BILAT PLEURAL EFFUSION ACUTE PULMONARY EMBOLISM 12/1/2022 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 12/1/2022 BILAT OPEN ANGLE GLAUCOMA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 BILAT OPEN ANGLE GLAUCOMA ACUTE PULMONARY EMBOLISM 12/1/2022 BILAT PLEURAL EFFUSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 BILAT PLEURAL EFFUSION ACUTE PULMONARY EMBOLISM 12/1/2022 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered 3 days past expiry date. Patient does not report any adverse reactions from vaccine. Pfizer did not have data to support vaccine stability past the expiry date. The information we received from the Pfizer would lead us not to recommend re-vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pruritus, Inflammation, Pruritus, Rosacea, Skin tightness
Clinical narrative: On June 12 in the am I noticed raised welts on my left cheek, near the left ear, just below where sideburns would be on a man.  On June 18 I noticed what looks like rosacea on my left cheek and additional welts in the same place as June 12. Left cheek to the ear is itchy and is raised. Cheek skin feels tight.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: On June 12 in the am I noticed raised welts on my left cheek, near the left ear, just below where sideburns would be on a man.  On June 18 I noticed what looks like rosacea on my left cheek and additional welts in the same place as June 12. Left cheek to the ear is itchy and is raised. Cheek skin feels tight.
Age: 0.5
Sex: F
Vaccine: COVID19, DTAPIPVHIB, FLU4, PNC13
Symptoms: Discontinued product administered
Clinical narrative: patient received a monovalent Pfizer-BioNTech and/or Moderna COVID-19 vaccine after April 18, 2023,
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Arthralgia, Arthritis, Arthritis bacterial
Clinical narrative: ACUTE NON ST ELEVATION MI 4/12/2023 LEFT KNEE JOINT PAIN BACTERIAL ARTHRITIS OF LEFT KNEE ACUTE NON ST ELEVATION MI 4/12/2023 ACUTE NON ST ELEVATION MI
Age: 35.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: Patient desired MMR- gave Proquad (pediatric dose MMR-Varicella)) instead of MMR No adverse effects
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic nephropathy, Hypotension, Hypoxia, Type 2 diabetes mellitus
Clinical narrative: I95.9 HYPOTENSION 4/23/2023 DM 2 W RENAL MANIFESTATION R09.02 HYPOXEMIA 4/14/2023 DM 2 W RENAL MANIFESTATION
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Coronary artery disease, Facial paresis, Hemiparesis
Clinical narrative: Pfizer vaccine was administered outside of the source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------- R29.810 LEFT FACIAL MUSCLE WEAKNESS 4/17/2023 CAD W STABLE ANGINA
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Delivery, Maternal exposure before pregnancy
Clinical narrative: T78.3XXA ANGIOEDEMA, INIT 6/24/2022 NORMAL DELIVERY T78.3XXD ANGIOEDEMA, SUBSEQ 10/19/2022 NORMAL DELIVERY T78.3XXS ANGIOEDEMA, SEQUELA 6/30/2022 NORMAL DELIVERY
Age: 20.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was given immunization that was expired on 6/14/23,.  Expired vaccine not pulled from fridge at time of given vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac monitoring, Electrocardiogram
Clinical narrative: Developed AFIB
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic neuropathy, Hypotension, Intervertebral disc degeneration
Clinical narrative: HYPOTENSION 5/4/2023 DM 2 W NEUROLOGICAL MANIFESTATION HYPOTENSION 5/4/2023 CERVICAL DISC DEGENERATION
Age: 42.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Vaccination site bruising, Vaccination site induration, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient presented to office with vaccine site bruising to the site, skin was hard and lumpy, warm to the touch. swollen. Based off documentation from clinical staff patient was given TDAP in this arm. Patients states she was informed she was given MMR in that arm because she declined TDAP in the arm in question.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Anaemia, Chest pain, Generalised anxiety disorder
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 3/29/2023 ACUTE NON ST ELEVATION MI GENERALIZED ANXIETY DISORDER I21.4 ACUTE NON ST ELEVATION MI 3/29/2023 ANEMIA I21.4 ACUTE NON ST ELEVATION MI 3/29/2023 CHEST PAIN
Age: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Incontinence, Pyrexia
Clinical narrative: Fever over 101 degrees for 5 days and lost the toileting ability.  Has not regained the toileting ability
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Developed whole body hives 4 hrs after the vaccine. No wheezing or breathing problems. Parents are Benadryl and the hives resolved by the next day. This is his first time getting the MenQuadFi, his first meningococcal vaccine was Menactra in 2018.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Thrombosis
Clinical narrative: blood clots
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient states she started to develop a rash from her right wrist on 6/18/23 around lunchtime. She believed it was a reaction from her Clindamycin and stopped the medication. She took a Claritin to help with itching. She called the Clinic. She reported the rash on her back was dried up, but had a rash on both arms and her chest that were new. Healthcare provider instructed to take Benadryl now and continue every 6-8 hours. If patient was experiencing difficulty breathing or swelling/tingling in her face, instructed to call EMS or seek immediate medical attention. Patient stated she was a retired nurse and was stable. Follow-up appointment was scheduled for 06/20/23 to determine if the rash was related to Clindamycin vs. vaccine reaction.
Age: 18.0
Sex: F
Vaccine: HEPAB, MENB
Symptoms: Wrong product administered
Clinical narrative: patient received Twinrix instead of Trumenba
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine administered outside.  was 6/3/23 and vaccine given on 6/8/23.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: Vaccines administered by RN.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/9/23.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/9/23.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/9/23.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Magnetic resonance imaging abnormal
Clinical narrative: Approximately two weeks after the second COVID vaccine taken on July 16, 2021 I began to experience low back pain on the left side and knee pain on my left knee - discussed with my primary care doc an MRI was done - had previously approximately one year prior a slight tear in the meniscus and the MRI showed some arthritis I started physical therapy and kept doing PT for over a year with no improvement went to an osteopath doctor for 6 months with no improvement still experiencing low back pain and pain in both knees no falls or explanation other than a adverse reaction to the vaccine
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/8/23.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Unknown adverse drug events at this time - patient received expired medication on 6/16/2023 - expiration date of Lot is 6/10/2023
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Dry mouth
Clinical narrative: EXTREME DRY MOUTH
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: Severe pain, swelling, local rash, and hot to the touch, and temporary flu symptoms (nausea, heart palpitations, mild fever, aches) on Day 2 for about 4 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Severe pain, swelling, local rash, and hot to the touch, and temporary flu symptoms (nausea, heart palpitations, mild fever, aches) on Day 2 for about 4 hours.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram abnormal, Computerised tomogram head normal, Computerised tomogram neck, Dizziness
Clinical narrative: June 13-malaise,sore arm   June 14-malaise, sore arm  June 15-same  June 16 dizzy spell/spinning while working out at gym?lasted  15-20 minutes? June 18 dizzy spell?room spinning June 19 severe spinning, felt faint, eyes displayed severe Nystagmus June 20 same symptoms
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging normal, Malaise, Nystagmus, Pain in extremity, Paranasal cyst
Clinical narrative: June 13-malaise,sore arm   June 14-malaise, sore arm  June 15-same  June 16 dizzy spell/spinning while working out at gym?lasted  15-20 minutes? June 18 dizzy spell?room spinning June 19 severe spinning, felt faint, eyes displayed severe Nystagmus June 20 same symptoms
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Retention cyst, Symptom recurrence, Vertigo
Clinical narrative: June 13-malaise,sore arm   June 14-malaise, sore arm  June 15-same  June 16 dizzy spell/spinning while working out at gym?lasted  15-20 minutes? June 18 dizzy spell?room spinning June 19 severe spinning, felt faint, eyes displayed severe Nystagmus June 20 same symptoms
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Fever, fatigue, pain in both arms, red swelling hives in left upper arm, chills.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, fatigue, pain in both arms, red swelling hives in left upper arm, chills.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Poss allergic reaction to vaccine after dose (1) developed sig red hives all over body and more on the arm of injection site. Severe redness/tenderness to arm (injection site)
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Palpitations
Clinical narrative: Heart palpations Myocarditis
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cyanosis, Heart rate increased, Lethargy, Malaise
Clinical narrative: Male child 9 years old here for second / final pediatric Pfizer vaccine with mother here, see times/date above stated "I am so hungry" before vaccine mom reports ate rice and brown sugar before arrival, appeared appropriate during (1430) vaccination, after waited in mom's arms then fainted 1-5 min (No fall) carried to cot, vitals taken, awoke after min on cot supine, 1433 B/P 94/58 HR 98 SPO2 100% RR 23 1443 after Capri Sun juice box and talking laying down noted and stated episodes of heart palpitations with circumoral cyanosis. (1437) 94/58 98 P 100% O2 (1440) P 108 (1441) HR 92 (1445) Dr called patient circumoral cyanosis & feeling "sick" and looking worried when HR elevated felt palpitations during increased HR episodes. 1445 MD called, EMS emergency called due to episodes of increased HR to 121 cycling up and back to 90's. When HR increased 115-120 client reports palpitations, appears lethargic but awake, circumoral cyanosis (green or blanching around lips) 1450 observing, 96/63 P 121 SPO2 100%. 1454 Paramedics here - father of client came, family prefers, desires child to by taken now by ambulance to Hospital ER. Dr. given report by RN, RN, Mgr. All here aware of all above.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Supine position, Syncope
Clinical narrative: Male child 9 years old here for second / final pediatric Pfizer vaccine with mother here, see times/date above stated "I am so hungry" before vaccine mom reports ate rice and brown sugar before arrival, appeared appropriate during (1430) vaccination, after waited in mom's arms then fainted 1-5 min (No fall) carried to cot, vitals taken, awoke after min on cot supine, 1433 B/P 94/58 HR 98 SPO2 100% RR 23 1443 after Capri Sun juice box and talking laying down noted and stated episodes of heart palpitations with circumoral cyanosis. (1437) 94/58 98 P 100% O2 (1440) P 108 (1441) HR 92 (1445) Dr called patient circumoral cyanosis & feeling "sick" and looking worried when HR elevated felt palpitations during increased HR episodes. 1445 MD called, EMS emergency called due to episodes of increased HR to 121 cycling up and back to 90's. When HR increased 115-120 client reports palpitations, appears lethargic but awake, circumoral cyanosis (green or blanching around lips) 1450 observing, 96/63 P 121 SPO2 100%. 1454 Paramedics here - father of client came, family prefers, desires child to by taken now by ambulance to Hospital ER. Dr. given report by RN, RN, Mgr. All here aware of all above.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PT. ADMINISTERED PFIZER COVID VACCINE 8 DAYS EARLY. DR. NOTIFIED AND STATED "NOT CONCERNED", THAT BOOSTER TIME REDUCED FROM 5 TO 3 MOS. PT. INFORMED AND ADVISED TO CALL DR. WITH ANY QUESTIONS
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Aphonia
Clinical narrative: Loss of voice after Pfizer shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6198), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: APHONIA (non-serious), outcome "not recovered", described as "Loss of voice after Pfizer shots". The event "loss of voice after pfizer shots" required physician office visit. Therapeutic measures were taken as a result of aphonia.  Additional information: It was reported that loss of voice after Pfizer shots went to Clinic 12 times. Botox with no positive results. Never Pfizer again. Prior Vaccinations reported as Manufacturer Moderna Batch/Lot number was 1394; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144501 same reporter/patient/AE, different dose;US-PFIZER INC-202300224013 same reporter/patient/AE, different dose;
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory bowel disease, Laboratory test normal, Mobility decreased, Rash, Rash erythematous
Clinical narrative: Clot blood; Bruise; The bruises are painful to the touch; Vaccination site pain; Heaviness in leg; left arm does not lift up all the way without pain.; left arm does not lift up all the way without pain.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2023 at 20:00 as dose 2, single (Lot number: FW1331) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (At 14:00:00, DOSE 1, SINGLE, Lot number: unknown, Location: Arm left), administration date: 21Oct2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Apr2023 at 20:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CONTUSION (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Bruise"; THROMBOSIS (medically significant) with onset 17Apr2023, outcome "not recovered", described as "Clot blood"; LIMB DISCOMFORT (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Heaviness in leg"; TENDERNESS (non-serious) with onset 17Apr2023, outcome "not recovered", described as "The bruises are painful to the touch"; VACCINATION SITE PAIN (non-serious) with onset 17Apr2023, outcome "not recovered"; PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 17Apr2023, outcome "not recovered" and all described as "left arm does not lift up all the way without pain.". The events "clot blood", "bruise", "the bruises are painful to the touch", "vaccination site pain" and "heaviness in leg" required physician office visit. Therapeutic measures were not taken as a result of thrombosis, contusion, tenderness, vaccination site pain, limb discomfort, pain, mobility decreased. Clinical course included that the patient started noticing bruising signs about a week after COVID shot. 6 weeks later, there were now dozens of bruises appearing on both legs from the knees to the ankles. It appeared to be blood clot formations. Color ranges from red to light pink to brown and light purple. Also, for a full 6 weeks since the most recent COVID shot, her left arm did not lift up all the way without pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash papular, Skin warm
Clinical narrative: Clot blood; Bruise; The bruises are painful to the touch; Vaccination site pain; Heaviness in leg; left arm does not lift up all the way without pain.; left arm does not lift up all the way without pain.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2023 at 20:00 as dose 2, single (Lot number: FW1331) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (At 14:00:00, DOSE 1, SINGLE, Lot number: unknown, Location: Arm left), administration date: 21Oct2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Apr2023 at 20:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CONTUSION (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Bruise"; THROMBOSIS (medically significant) with onset 17Apr2023, outcome "not recovered", described as "Clot blood"; LIMB DISCOMFORT (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Heaviness in leg"; TENDERNESS (non-serious) with onset 17Apr2023, outcome "not recovered", described as "The bruises are painful to the touch"; VACCINATION SITE PAIN (non-serious) with onset 17Apr2023, outcome "not recovered"; PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 17Apr2023, outcome "not recovered" and all described as "left arm does not lift up all the way without pain.". The events "clot blood", "bruise", "the bruises are painful to the touch", "vaccination site pain" and "heaviness in leg" required physician office visit. Therapeutic measures were not taken as a result of thrombosis, contusion, tenderness, vaccination site pain, limb discomfort, pain, mobility decreased. Clinical course included that the patient started noticing bruising signs about a week after COVID shot. 6 weeks later, there were now dozens of bruises appearing on both legs from the knees to the ankles. It appeared to be blood clot formations. Color ranges from red to light pink to brown and light purple. Also, for a full 6 weeks since the most recent COVID shot, her left arm did not lift up all the way without pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Inappropriate schedule of product administration, Limb discomfort, Mobility decreased, Pain
Clinical narrative: Clot blood; Bruise; The bruises are painful to the touch; Vaccination site pain; Heaviness in leg; left arm does not lift up all the way without pain.; left arm does not lift up all the way without pain.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2023 at 20:00 as dose 2, single (Lot number: FW1331) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (At 14:00:00, DOSE 1, SINGLE, Lot number: unknown, Location: Arm left), administration date: 21Oct2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Apr2023 at 20:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CONTUSION (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Bruise"; THROMBOSIS (medically significant) with onset 17Apr2023, outcome "not recovered", described as "Clot blood"; LIMB DISCOMFORT (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Heaviness in leg"; TENDERNESS (non-serious) with onset 17Apr2023, outcome "not recovered", described as "The bruises are painful to the touch"; VACCINATION SITE PAIN (non-serious) with onset 17Apr2023, outcome "not recovered"; PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 17Apr2023, outcome "not recovered" and all described as "left arm does not lift up all the way without pain.". The events "clot blood", "bruise", "the bruises are painful to the touch", "vaccination site pain" and "heaviness in leg" required physician office visit. Therapeutic measures were not taken as a result of thrombosis, contusion, tenderness, vaccination site pain, limb discomfort, pain, mobility decreased. Clinical course included that the patient started noticing bruising signs about a week after COVID shot. 6 weeks later, there were now dozens of bruises appearing on both legs from the knees to the ankles. It appeared to be blood clot formations. Color ranges from red to light pink to brown and light purple. Also, for a full 6 weeks since the most recent COVID shot, her left arm did not lift up all the way without pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness, Thrombosis, Vaccination site pain
Clinical narrative: Clot blood; Bruise; The bruises are painful to the touch; Vaccination site pain; Heaviness in leg; left arm does not lift up all the way without pain.; left arm does not lift up all the way without pain.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2023 at 20:00 as dose 2, single (Lot number: FW1331) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (At 14:00:00, DOSE 1, SINGLE, Lot number: unknown, Location: Arm left), administration date: 21Oct2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Apr2023 at 20:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CONTUSION (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Bruise"; THROMBOSIS (medically significant) with onset 17Apr2023, outcome "not recovered", described as "Clot blood"; LIMB DISCOMFORT (non-serious) with onset 17Apr2023, outcome "not recovered", described as "Heaviness in leg"; TENDERNESS (non-serious) with onset 17Apr2023, outcome "not recovered", described as "The bruises are painful to the touch"; VACCINATION SITE PAIN (non-serious) with onset 17Apr2023, outcome "not recovered"; PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 17Apr2023, outcome "not recovered" and all described as "left arm does not lift up all the way without pain.". The events "clot blood", "bruise", "the bruises are painful to the touch", "vaccination site pain" and "heaviness in leg" required physician office visit. Therapeutic measures were not taken as a result of thrombosis, contusion, tenderness, vaccination site pain, limb discomfort, pain, mobility decreased. Clinical course included that the patient started noticing bruising signs about a week after COVID shot. 6 weeks later, there were now dozens of bruises appearing on both legs from the knees to the ankles. It appeared to be blood clot formations. Color ranges from red to light pink to brown and light purple. Also, for a full 6 weeks since the most recent COVID shot, her left arm did not lift up all the way without pain.
Sex: U
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No additional AE; a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions or concomitant drugs were not reported.   On 15-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (1 dose, lot#: w036242, expiration date: 01-OCT-2024; strength was not provided) orally for prophylaxis and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection (1 dose, lot#: u7536aa, expiration date: 30-SEP-2025; strength was not provided) orally for prophylaxis (incorrect route of product administration). On 15-JUN-2023, the patient was also vaccinated with rotavirus vaccine live oral 1V (ROTARIX) (formulation, strength, indication, route of administration, lot#, and expiration date were not reported). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: Incorrect route of product administration, No adverse event, Product administration error
Clinical narrative: No additional AE; a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions or concomitant drugs were not reported.   On 15-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (1 dose, lot#: w036242, expiration date: 01-OCT-2024; strength was not provided) orally for prophylaxis and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection (1 dose, lot#: u7536aa, expiration date: 30-SEP-2025; strength was not provided) orally for prophylaxis (incorrect route of product administration). On 15-JUN-2023, the patient was also vaccinated with rotavirus vaccine live oral 1V (ROTARIX) (formulation, strength, indication, route of administration, lot#, and expiration date were not reported). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions or concomitant drugs were not reported.   On 15-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (1 dose, lot#: w036242, expiration date: 01-OCT-2024; strength was not provided) orally for prophylaxis and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection (1 dose, lot#: u7536aa, expiration date: 30-SEP-2025; strength was not provided) orally for prophylaxis (incorrect route of product administration). On 15-JUN-2023, the patient was also vaccinated with rotavirus vaccine live oral 1V (ROTARIX) (formulation, strength, indication, route of administration, lot#, and expiration date were not reported). No additional adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: She received her first dose of GARDASIL 9 about 3 years ago and did not receive the second dose yet.; No additional AEs were reported; This spontaneous report as received from a pharmacist, referring to a currently 27 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   In 2020 (reported as about 3 years ago), 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) (1 dose (1 dosage form), route, strength, lot number and expiration date were unknown) for prophylaxis. She did not receive the second dose yet (inappropriate schedule of product administration). No additional adverse event was reported. No further information provided.