chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Influenza virus test, Metabolic function test, Myocarditis, N-terminal prohormone brain natriuretic peptide
Clinical narrative: Diagnosed with Acute Myocarditis (unspecified Myocarditis type) on 9 June 2023 after experiencing flu-like symptoms for 3 days.  Received chest X-ray, CT angiogram, CBC, Echocardiogram, ECG, and ekg.  Received 100mg doxycycline, 15mg Toreador, and discharged with 14 days of doxycycline.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Procalcitonin, Red blood cell sedimentation rate, SARS-CoV-2 test, Troponin, White blood cell count
Clinical narrative: Diagnosed with Acute Myocarditis (unspecified Myocarditis type) on 9 June 2023 after experiencing flu-like symptoms for 3 days.  Received chest X-ray, CT angiogram, CBC, Echocardiogram, ECG, and ekg.  Received 100mg doxycycline, 15mg Toreador, and discharged with 14 days of doxycycline.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/20/21 lot# EN6202;  Pfizer 4/13/21 lot# ER873;  Pfizer 12/4/21 lot# 59267100001
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Ear congestion, Ear infection, Ear pain, Hypoacusis, Nasopharyngitis
Clinical narrative: I had a really nasty cold that got into my ears, my ear is now perforated, I am not hearing as well as I should out of it now. I went into the Urgent Care after taking a home COVID-19 test that came back negative. I was given a Z-pack, prednisone to help clear up the infection. I went back to the Urgent care because my ears were still hurting me, I was prescribed ofloxacin ear drops to help clear up any infection that may be in my ears. I was advised to take a decongestant like MUCINEX to help.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test negative, Tympanic membrane perforation
Clinical narrative: I had a really nasty cold that got into my ears, my ear is now perforated, I am not hearing as well as I should out of it now. I went into the Urgent Care after taking a home COVID-19 test that came back negative. I was given a Z-pack, prednisone to help clear up the infection. I went back to the Urgent care because my ears were still hurting me, I was prescribed ofloxacin ear drops to help clear up any infection that may be in my ears. I was advised to take a decongestant like MUCINEX to help.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling of body temperature change, Laboratory test normal, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: My arm hurts and I can't stretch it and I can't breathe or speak. I get very cold and very hot in the neck.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Speech disorder
Clinical narrative: My arm hurts and I can't stretch it and I can't breathe or speak. I get very cold and very hot in the neck.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Moderna 1/27/21 lot# 031L20A;  Modern 2/24/21 Lot# 015M20A; Moderna 10/24/21 lot# 062E21A;  MOderna 4/12/22 Lot# 005M21A;  Moderna 11/1/22 Lot# 050D22A
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Pain, Pericarditis
Clinical narrative: Summary: Patient received Moderna vaccine and experienced pain that is suspected to be pericarditis.   Follow-up: Vaccine administration has been discontinued
Age: 79.0
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 2/22/21 lot# EL9267;  Pfizer 3/15/21 lot# EN6207; Pfizer 9/28/21 lot# Lot# FE3592;  Pfizer 10/12/22 lot# GJ6665
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient come in today for  a boostrix shot stating we didnt have the shot on friday. She was already rung out on friday and made an appt for today. After i administered the vaccine, the patient asked about her third vaccine paperwork. She now stated she received two shots on friday and got the t-dap and covid vaccine, and actually needed the hepatitis b vaccine.  So the patient received two doses of the t-dap vaccine, one on friday 6/9/23 and today 6/12/23.  she will follow up with us if she experiences any side effects
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Productive cough, SARS-CoV-2 test negative
Clinical narrative: 5/9/23 I had an ordinary cold, stuffy sinuses and cough. I had an intense sore throat that lingered longer than normal.  I had a productive cough that lasted for 3-4 weeks which is not common for me. I had an appointment with my doctor and was prescribed an antibiotic and steroids. This went away after I completed the two medications and now all is good.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood disorder, Blood test abnormal, Feeling abnormal
Clinical narrative: In May 2023I just wasn't feeling like myself and I went to the doctor.  She ran some tests. and we learned that my blood cells were enlarged.  I am now taking B Complex to see if that helps.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines 3/29/21 Pfizer no lot# available Pfizer 4/19/21 no lot# available 12/4/21 Pfizer FD0809
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient woke up on 05/13/2023 with an almost all over body rash/hives.  She went to urgent care 3 times, visited her dermatologist and took the following medications over the course of the next month: adrenaline, Benadryl, steroids, prednisone, Xolair, fexofenadine.  Patient still currently on prednisone.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 3/2/21 lot# 023M20A;  Moderna 3/30/21 lot# 030a21A
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ANGIOEDEMA, INIT 11/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain, Abdominal pain upper, Cholecystectomy, Cholelithiasis, Diarrhoea
Clinical narrative: Began having abdominal pain and nausea evening of 5/25, worsening at intervals. Went to Emergency Room on 5/27. Surgery on 5/29 to remove gall bladder.  Additionally I had food poisoning or a stomach "bug" on Feb. 9 - 12 - forceful diarrhea, vomiting, nausea, some stomach cramps. No medical treatment sought, resolved on its own.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Gallbladder enlargement, Hepatobiliary scan abnormal, Nausea, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Began having abdominal pain and nausea evening of 5/25, worsening at intervals. Went to Emergency Room on 5/27. Surgery on 5/29 to remove gall bladder.  Additionally I had food poisoning or a stomach "bug" on Feb. 9 - 12 - forceful diarrhea, vomiting, nausea, some stomach cramps. No medical treatment sought, resolved on its own.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/4/21 Lot# 018B21A;  Moderna 4/21/21 lot# 025B21A
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy breast, Breast mass, Mammogram abnormal, No adverse event
Clinical narrative: I did not have an adverse reaction to the vaccine. On 04/26/2023, a lump was found in my right breast during a routine mammogram. A biopsy was taken on 05/05/2023.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 2/1/21 Lot# EL9265;  pfizer 2/22/21 Lot# EL9267;  Pfizer 9/24/21 lot# FF2587;  Pfizer 4/1/22 lot# FK9894;
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD past. BUD was 4/19/2023.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Medication error, No adverse event
Clinical narrative: No adverse effects, medication error report only
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bullous haemorrhagic dermatosis
Clinical narrative: patient began to develop hemorrhagic bulla in the mouth 1 month after administration of the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, COVID-19, Cardiac stress test normal, Dyspnoea, Echocardiogram abnormal
Clinical narrative: I was schedule for an annual checkup, everything was fine, my blood pressure was a little high, he listens to my heart and found an Atrial fibrillation, I had Shortness of breath, I had COVID-19 over the holidays, a couple of days before Christmas, it was a mild case. I am seeing my Cardiologist and I schedule for a procedural in July.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension, SARS-CoV-2 test positive
Clinical narrative: I was schedule for an annual checkup, everything was fine, my blood pressure was a little high, he listens to my heart and found an Atrial fibrillation, I had Shortness of breath, I had COVID-19 over the holidays, a couple of days before Christmas, it was a mild case. I am seeing my Cardiologist and I schedule for a procedural in July.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Gait disturbance, Hypoaesthesia, Neuropathy peripheral, Pain
Clinical narrative: Pt started having what he describes as peripheral neuropathy. He said it was a pain that started from his chest and moved down to his feet. He now has difficulty walking with pain and numbness in his back.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 1/26/21 lot# 027L20A;  Moderna 2/23/21 lot# 029L20A;  Moderna 12/16/21 lot# 067H21A
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram normal, Laboratory test normal, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: For about 2 weeks before July 11, 2022,  I noticed my balance and leg strength were deteriorating.  At about 5am on July 11, 2022, I woke up with severe vertigo.  Was hospitalized for 3.5 days to rule out stroke, etc. Was diagnosed with "vestibular neuritis." Since then I have had continuing balance and leg strength issues. Have seen my PCP, a neurologist and physical therapist to deal with these issues. But it appears I likely have permanent nerve damage in some of the nerves that control balance. Permanent return to my previous health situation appears unlikely, I will probably be dealing with these issues for the rest of my life.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury, Scan with contrast normal, Vertigo, Vestibular neuronitis
Clinical narrative: For about 2 weeks before July 11, 2022,  I noticed my balance and leg strength were deteriorating.  At about 5am on July 11, 2022, I woke up with severe vertigo.  Was hospitalized for 3.5 days to rule out stroke, etc. Was diagnosed with "vestibular neuritis." Since then I have had continuing balance and leg strength issues. Have seen my PCP, a neurologist and physical therapist to deal with these issues. But it appears I likely have permanent nerve damage in some of the nerves that control balance. Permanent return to my previous health situation appears unlikely, I will probably be dealing with these issues for the rest of my life.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Symptom recurrence
Clinical narrative: ACUTE DVT OF RIGHT PERONEAL VEIN 12/15/2022  -  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 7/7/21 Lot# Ew0173;  7/28/21 lot# Ew0173
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Dyspnoea, Fatigue
Clinical narrative: I could not lay down because I was having such a hard time breathing sitting up. I had noticed that my ankles were swelling, it had been about five days since I had laid down, I thought I would try to lay down to get my swelling down. As soon as I laid down, I felt like I was drowning, as if I was being squeezed extremely tight. I managed to get myself to the edge of the bed and slowly sat up and caught my breath. I called my sister who came and rushed me to the emergency room. Once there I was given an emergency breathing treatments so my airways could be open. They started taking my blood for test, chest x-ray, CT scan, PCR Rapid COVID-19 test, Influenza A and B. Everything came back negative and normal; they said I had a respiratory infection. I was released after five or six hours with antibiotic medication to help combat the infection. I do still get very fatigued, I am happy that I was able to retire this year.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza A virus test negative, Influenza B virus test, Joint swelling, Respiratory syncytial virus test negative, Respiratory tract infection
Clinical narrative: I could not lay down because I was having such a hard time breathing sitting up. I had noticed that my ankles were swelling, it had been about five days since I had laid down, I thought I would try to lay down to get my swelling down. As soon as I laid down, I felt like I was drowning, as if I was being squeezed extremely tight. I managed to get myself to the edge of the bed and slowly sat up and caught my breath. I called my sister who came and rushed me to the emergency room. Once there I was given an emergency breathing treatments so my airways could be open. They started taking my blood for test, chest x-ray, CT scan, PCR Rapid COVID-19 test, Influenza A and B. Everything came back negative and normal; they said I had a respiratory infection. I was released after five or six hours with antibiotic medication to help combat the infection. I do still get very fatigued, I am happy that I was able to retire this year.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I could not lay down because I was having such a hard time breathing sitting up. I had noticed that my ankles were swelling, it had been about five days since I had laid down, I thought I would try to lay down to get my swelling down. As soon as I laid down, I felt like I was drowning, as if I was being squeezed extremely tight. I managed to get myself to the edge of the bed and slowly sat up and caught my breath. I called my sister who came and rushed me to the emergency room. Once there I was given an emergency breathing treatments so my airways could be open. They started taking my blood for test, chest x-ray, CT scan, PCR Rapid COVID-19 test, Influenza A and B. Everything came back negative and normal; they said I had a respiratory infection. I was released after five or six hours with antibiotic medication to help combat the infection. I do still get very fatigued, I am happy that I was able to retire this year.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 3/16/21 lot# 045A21A;  Moderna 4/13/21 lot# 016B21A;  Moderna 11/19/21 lot# 039F21A;  Pfizer 6/3/22 Lot# FM755
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD past. BUD was 4/19/2023
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/16/21 lot# 045A21A;  Moderna 4/13/21 lot# 016B21A; Moderna 11/19/21 lot# 039F21A
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of consciousness, Mobility decreased
Clinical narrative: I passed out 6:30pm that night. My legs won't work right from that moment and I have a pain that goes up to my hips.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one dose Janssen
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD past. BUD was 4/19/2023
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina unstable, Symptom recurrence
Clinical narrative: UNSTABLE ANGINA 12/8/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/10/21 lot# 029A21A;  Moderna 4/7/21 lot# 016B21A
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 2/26/21 Lot# EN6202;  Pfizer 3/19/21 lot# EF2613;  Pfizer 9/1/21 lot# FC3183
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: NO KNOWN ADVERSE REACTION REPORTED
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 11/24/21 lot# FH8028;  Pfizer 12/17/21 lot# FE3594
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD past. DUD was 4/19/2023
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Mental status changes, Pyrexia
Clinical narrative: Patient presents to the ED on 5/3/23 with difficulty in breathing, fever, chills, and respiratory distress. Also mental status decline. Tested positive for COVID on 5/3/23. The patient was admitted to critical care and was put on oxygen support. and treated. He was discharged home on 5/15/23.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Patient presents to the ED on 5/3/23 with difficulty in breathing, fever, chills, and respiratory distress. Also mental status decline. Tested positive for COVID on 5/3/23. The patient was admitted to critical care and was put on oxygen support. and treated. He was discharged home on 5/15/23.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone decreased, Endocrine ophthalmopathy, Graves' disease, Hot flush
Clinical narrative: All vaccines by Pfizer: After 2nd vaccine on 4/16/21, approximately 2nd week of June, I started noticing under my eyes very puffy, I also began having hot flashes, racing heart, insomnia and dropped wt from 123 to 114 in a short time. I was traveling at the time and when returned home in August I set up an eye doctor appointment. This appoint was canceled by the office twice. On Oct. 25th, I was referred by my eye doctor to see a Graves eye disease, also I had blood work done that confirmed I had Graves Disease plus T.E.D. Thyroid Eye Disease.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, Periorbital swelling, Thyroxine free normal, Weight decreased
Clinical narrative: All vaccines by Pfizer: After 2nd vaccine on 4/16/21, approximately 2nd week of June, I started noticing under my eyes very puffy, I also began having hot flashes, racing heart, insomnia and dropped wt from 123 to 114 in a short time. I was traveling at the time and when returned home in August I set up an eye doctor appointment. This appoint was canceled by the office twice. On Oct. 25th, I was referred by my eye doctor to see a Graves eye disease, also I had blood work done that confirmed I had Graves Disease plus T.E.D. Thyroid Eye Disease.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/28/21 Lot# ER8730;  Pfizer 4/18/21 lot# ER8729;  Pfizer 12/18/21 lot# FJ8757
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD past. BUD was 4/19/2023
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/30/21 lot# ER8730;  Pfizer 4/20/21 lot# EW0162;  Pfizer 11/18/21 lot# FH8027
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/19/21 lot# ER2613;  Pfizer 4/9/21 lot# EW0158;  Pfizer 11/15/21 lot# FG3527;
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiogenic shock
Clinical narrative: CARDIOGENIC SHOCK
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Cardioversion, Electrocardiogram
Clinical narrative: Afib for the first time in my life within 24 hurs after the booster.  Monitored heart rate 47 to 137 beats/ minute.  Had a cardio version that failed. Increased my Metoprolol Tartrate from 50mg BID to 75mg BID. My hair has been falling out at an alarming rate since increasing the Beta Blocker.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 63.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arteriogram carotid, Cerebral infarction, Computerised tomogram head, Echocardiogram, Magnetic resonance imaging head
Clinical narrative: Acute infarction left MCA distribution
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD pass. BUD was 4/19/2023
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/31/21 Lot# 025B21A;  Moderna 4/30/21 lot# 048B21A
Age: 41.0
Sex: M
Vaccine: PNC20
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Inflammation, Injection site inflammation, Magnetic resonance imaging
Clinical narrative: SIRVA diagnosis for ongoing nerve and muscle pain, inflammation in left shoulder and arm since injection of 8-May-2023
Age: 41.0
Sex: M
Vaccine: PNC20
Symptoms: Myalgia, Neuralgia, Scan with contrast, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA diagnosis for ongoing nerve and muscle pain, inflammation in left shoulder and arm since injection of 8-May-2023
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 11/28/2022 & 11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 51.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 1/31/2023 &  1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 61.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passes. BUD was 4/19/2023
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF RIGHT POPLITEAL VEIN
Age: 59.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, End stage renal disease, Glomerular filtration rate decreased, Hypotension, Metabolic encephalopathy
Clinical narrative: HYPOTENSION 3/24/2023 CKD STAGE 5 (GFR <15) HYPOTENSION 3/24/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART HYPOTENSION 3/24/2023 METABOLIC ENCEPHALOPATHY HYPOTENSION 3/24/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART HYPOTENSION 3/24/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART
Age: 38.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/18/2023 ACUTE DVT, UNSPECIFIED VEIN I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/18/2023 ACUTE DVT, UNSPECIFIED VEIN I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/18/2023 ACUTE DVT, UNSPECIFIED VEIN
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, ANTERIOR WALL HYPOTENSION 11/12/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 52.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 19.0
Sex: M
Vaccine: UNK
Symptoms: Acute myocardial infarction, Myocarditis, Pericarditis
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/29/2023 ACUTE PERICARDITIS, UNSPECIFIED I30.9 ACUTE PERICARDITIS, UNSPECIFIED 4/29/2023 ACUTE PERICARDITIS, UNSPECIFIED I51.4 MYOCARDITIS 5/2/2023 ACUTE PERICARDITIS, UNSPECIFIED
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXEMIA
Age: 61.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 58.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient arrived for 1 st covid vaccine, Patient  given Moderna biv infant dose from pink yellow vial intead of dose from moderna biv blue top.
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 69.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passes. BUD was 4/19/2023
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cardiogenic shock, Hypotension, Hypoxia
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOTENSION HYPOXIA CARDIOGENIC SHOCK
Age: 28.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: DTap and HIB ordered, Quadracel and HIB administered.
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 3/7/2023 &  1/30/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Fatigue, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Patient presented to the ED with fatigue, nasal congestion, and chills. Patient was treated and discharged on 5/4/23.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina unstable, Symptom recurrence
Clinical narrative: UNSTABLE ANGINA 12/20/2022,  1/1/2023,  12/19/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Burning sensation, Feeling abnormal, Paraesthesia
Clinical narrative: NDC:58160-0823-11 The day of the shot I felt a burning kinda near my armpit on the left side like it was on fire. I  started itching on the left side and had red rash on the left side. I had a blister that I cleaned it with alcohol and Neosporin. My joints were hurting really bad. I felt like I was hit with a car. A tingling feeling in my right hand. I took zyrtec on that day and then today 6/12 I took benadryl. I took aleve.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: NDC:58160-0823-11 The day of the shot I felt a burning kinda near my armpit on the left side like it was on fire. I  started itching on the left side and had red rash on the left side. I had a blister that I cleaned it with alcohol and Neosporin. My joints were hurting really bad. I felt like I was hit with a car. A tingling feeling in my right hand. I took zyrtec on that day and then today 6/12 I took benadryl. I took aleve.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 12/24/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 58.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passes. BUD was 4/19/2023
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 12/14/2022 &  1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 71.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK, UNK
Symptoms: Blood test abnormal, Hypoaesthesia, Laboratory test normal, Pain, Paraesthesia
Clinical narrative: Started to be awakened at night with numbness is different parts of my body.  Sometimes sharp pains and sometime tingling.  I have never experienced anything like that before and just waited for several months thinking it would go away.  I went to my doctor and he suggested it was carpel tunnel and then saw my pain management doctor and he suggested the same thing.  I had the test and it was determined that it was not carpel tunnel.  My Primary doctor then did blood work and the work came back with a marker.  I was then sent to see Dr. She started me on Methotrexate and folic acid.   After about 6 months, at the third visit Dr. told me I have Rheumatoid Arthritis.
Age: 71.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK, UNK
Symptoms: Rheumatoid arthritis, Sleep disorder
Clinical narrative: Started to be awakened at night with numbness is different parts of my body.  Sometimes sharp pains and sometime tingling.  I have never experienced anything like that before and just waited for several months thinking it would go away.  I went to my doctor and he suggested it was carpel tunnel and then saw my pain management doctor and he suggested the same thing.  I had the test and it was determined that it was not carpel tunnel.  My Primary doctor then did blood work and the work came back with a marker.  I was then sent to see Dr. She started me on Methotrexate and folic acid.   After about 6 months, at the third visit Dr. told me I have Rheumatoid Arthritis.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Pain
Clinical narrative: Dull, centralized back pain extending into the chest; breathlessness. Dissipated over time, no interventions. Episode lasting < 10 minutes. Isolated incident, presenting on second dose only.
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 67.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD passed. BUD was 4/19/2023
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate vaccine for patients age
Age: 2.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; HBP called to report a TE with PROQUAD.  Administered. TE case reference 02388618. Vaccine was stored in the refrigerator instead of the freezer from 4/17/2023 until 5/11/2023 (a total of 552 hours). Administered on 5/10/2023.; This spontaneous report was received from a medical assistant referring to a 2-year-old patient of unknown gender.  The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 10-MAY-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live albumin status recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot # W039840 with expiration date on 12-JUN-2024, administered subcutaneously for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided) (product storage error). The administered dose of the vaccine experienced a temperature excursion (TE) as it was stored in the refrigerator instead of the freezer (from 17-APR-2023 to 11-MAY-2023) for a total of 552 hours. Additionally, it was confirmed that no adverse effects occurred.
Age: 2.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HBP called to report a TE with PROQUAD.  Administered. TE case reference 02388618. Vaccine was stored in the refrigerator instead of the freezer from 4/17/2023 until 5/11/2023 (a total of 552 hours). Administered on 5/10/2023.; This spontaneous report was received from a medical assistant referring to a 2-year-old patient of unknown gender.  The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 10-MAY-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live albumin status recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot # W039840 with expiration date on 12-JUN-2024, administered subcutaneously for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided) (product storage error). The administered dose of the vaccine experienced a temperature excursion (TE) as it was stored in the refrigerator instead of the freezer (from 17-APR-2023 to 11-MAY-2023) for a total of 552 hours. Additionally, it was confirmed that no adverse effects occurred.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; PROQUAD administered to patient after TE occurred.; This spontaneous report was received from Other Health Professional and refers to a 4-year-old of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAY-2023, after a temperature excursion, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, unk, lot #W032152, expiration date: 07-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature: 73 F, Time frame: 51 hours, 30 minutes, 0 seconds, Previous temperature excursion: No. No adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2305USA008554: US-009507513-2305USA008345:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Complex regional pain syndrome, Hyperaesthesia, Pain in extremity
Clinical narrative: product origin unknown; complex regional pain syndrome (CRPS);  This literature marketed report was received from authors of a published article, titled as stated above, and refers to a 14-year-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (reported as HPV vaccine, but manufacturer was not known) (dose, route and site of administration, lot # and expiration date not provided) for prophylaxis (product origin unknown).  On the same day as the second dose of either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was administered, the patient experienced bilateral pain in the upper and lower extremities, including hyperesthesia/hyperalgia and temperature asymmetry. On an unknown date, reported as 11 days after symptom onset, she was diagnosed by her health care practitioner (HCP) with complex regional pain syndrome (CRPS); the HCP attributed the event onset to the HPV vaccine. On an unknown date, 49 days after onset, her symptoms resolved; thus the patient recovered from CRPS. The action taken with the suspect vaccines regarding the events was not applicable.  The reporter considered CRPS to be related to either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). It was also reported that this case of CSRP was identified by the health care practitioner as being potentially linked to HPV vaccination.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: fever; possible secondary transmission of virus; This spontaneous report was received from Physician and refers to a 19-month-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-MAY-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 26-MAY-2023, the patient experienced possible secondary transmission of virus. On the same day, HCP states that the patient was visited by a relative (not a patient of HCP) the same day the patient was vaccinated. On 27-MAY-2023, the relative developed a rash the next day. On 28-MAY-2023, HCP states that the patient continues to have a fever today (HCP does not believe VARIVAX caused this). On the same day, by sunday relative was diagnosed with chickenpox. HCP believes the relative was not vaccinated. Limited information is available for this case as the HCP chose not to give full demographics and needed to end the call due to being in front of a patient. HCP states he is happy to follow up with any correspondence sent form. No Additional AE/PQC. At the time of reporting, the patient was recovering from the event of fever, the patient was recovering from the event of possible secondary transmission of virus. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding fever was reported as Not Applicable. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding possible secondary transmission of virus was reported as Not Applicable.   The reporter considered fever to be not related to varicella virus vaccine live (oka/merck) (VARIVAX). The causal relationship between possible secondary transmission of virus and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion.; No additional AE; This spontaneous report was received from a registered 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 an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W025274, expirtion date 10-AUG-2024, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The vaccine underwent temperature excursion before administration for 5 hours 51 minutes in 24.4 degree Fahrenheit (F) (Product storage error). No other adverse events were reported.  Lot number #W025274 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Neuropathy peripheral
Clinical narrative: neuropathy; chronic inflammatory demyelinating polyneuropathy (CIDP); This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), patient suffered neuropathy and chronic inflammatory demyelinating polyneuropathy (CIDP). As a result of these symptoms, patient was seen and treated by medical providers and was still under their care.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, the events of neuropathy and CIDP were considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Nurse reported AE for improperly stored administered GARDASIL 9. Declined full patient demographics. No additional AE/PQC.   GARDASIL 9 w013388 exp 12/16/24 previous excursion  ----administered lot  6/2/23; This spontaneous report was received from an 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 02-JUN-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #w013388, expiration date: 16-DEC-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion (product storage error). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2306USA003034:MSD
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Extra dose administered, Gingival discolouration, Gingival pain, Myalgia
Clinical narrative: no immunity shown on the serologic labs; she needed to receive MMRII vaccination for work. Her other concern was that she is told she only needs to receive one; bleeding gums; Painful patchy white dots on gums; Painful patchy white dots on gums; stomach ache; nausea; muscle fatigue; This spontaneous report was received from a consumer referring to herself (34-year-old female patient). Her historical condition included thyroidectomy. Concomitant medications included levothyroxine sodium (SYNTHROID). She denied providing information about drug reaction/allergies.  On unknown day when she was a child, the patient was potentially (she did not have records nor documented proof) vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 02-JUN-2023, the patient was vaccinated with one dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (0.5 mL, lot #415124 which was verified as non-valid upon internal review, expiration date was reported as 13-FEB-2024 but could not be confirmed due to non-valid lot #, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered).  On unknown day, there was no immunity shown on serological laboratory which is why she needed to receive the extra dose for work. On 03-JUN-2023, the patient developed painful patchy white dots on gums, stomach ache, nausea and muscle fatigue. On 06-JUN-2023, the patient experienced bleeding gums. At the time of reporting, the patient was recovering from the events. The action taken with the suspect vaccine regarding the events was not applicable.  The relatedness between the events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection was not provided.