chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Renal pain, Urinary retention, Urinary tract disorder
Clinical narrative: Called to report continued issues since receipt of 2021 Pfizer vaccines (primary series). He states he is under care for his multiple complaints. States "immediately" to 1-2 days after each vaccine he c/o fatigue, chest pain, ED, and more. He advised since last Oct22 he has had urinary issues, difficulty emptying bladder, severe bilateral kidney pain, hand swelling, poor appetite, chronic fatigue, nose bleeds x 7 months and more.   Pfizer #1 on 03/22/2021 and Pfizer #2 on 4/12/2021.  Lot numbers not available.  Hx covid disease (unsure)   While s/s vary, wax and wane, he has not received any further covid vaccines and wants to report it. Contact made on 5/11/2023. Review of his c/o CP "immediately after vaccination" that persists 1-2 years later 2-3 x/day as a sharp pain over heart that goes front to back w/o other s/s identified: Position does not influence, but activity does. he has had full cardiology w/u (12/2022-1/2023 were normal EKG, EST, CTA) and has never heard term myocarditis. His fatigue is chronic being unable to exercise more than 15 minutes w/o needing to lay down - he is unable to run anymore stating he use to be the one people tried to beat, now he is at bottom of his unit. He c/o flank pain since Oct 2022 under eval by HCP with no problems identified. He states for first 4 months post vaccine he was unable to perform, now can but has difficulty with erections. Seen by HCP, cardiology, neuro, GU, and MHS for reported health issues. PMH: pre covid vac/disease: spondylosis, lower back pain,  urology issues 2018, astigmatism, tinea pedis, anisocoria, rhinitis, gastroenteritis, dizziness -vertigo w/HA Jun-Dec 2015 tx in ER/ENT -dx vestibular migraine; plantar fascial fibromatosis 2015; chronic rhinitis 2018 w/headache, GU strictures. PMH post covid vac/disease chronic LBP x several years now with left hip/flank pain & urinary frequency under care of neurosurgery (negative GU workup for stones, masses, etc), h/o nose bleeds,  Sees MHS for anxiety, sleep issues-Insomnia PSH: urethroplasty for stricture 2005 and vasectomy 2022. Current meds: Gabapentin, lidocaine patch, Cymbalta (not taking), metoprolol tartrate (not taking), Trazadone (not taking).
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Asthenia, Dyspnoea, Fatigue, Heart rate increased, Malaise
Clinical narrative: I did not have an adverse reaction to the vaccine. I started feeling sick on 12/22/2022 with elevated heart rate, tired and trouble breathing. I went to the emergency room on 12/24/2022 and was admitted to the hospital for three days. I was diagnosed with RSV. It took me over a month to get my strength back. As of today, I am feeling better with no lingering symptoms.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Respiratory syncytial virus infection
Clinical narrative: I did not have an adverse reaction to the vaccine. I started feeling sick on 12/22/2022 with elevated heart rate, tired and trouble breathing. I went to the emergency room on 12/24/2022 and was admitted to the hospital for three days. I was diagnosed with RSV. It took me over a month to get my strength back. As of today, I am feeling better with no lingering symptoms.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Product administration error
Clinical narrative: 17mnths male here for 1st dose of varicella. MA requested Mother to hold child for medication administration and to prevent needle stick. Patient moved while vaccine administation. 1st attempt dose given was 2.1, as advise per immunization chief nurse, medcation was approved to administer with remaining dosage of 2.9 with 1 inch apart. MA proceed with administration of varicella vaccine.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Infection, Nausea
Clinical narrative: I had a breakthrough case of Covid-19 I had the following symptoms: sore throat fatigue nausea cough postnasal drip fever.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: I had a breakthrough case of Covid-19 I had the following symptoms: sore throat fatigue nausea cough postnasal drip fever.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Product dose omission issue, Vaccination error
Clinical narrative: A MEDICAL ASSISTANT  ADMINISTERED A PRESYRINGED VACCINE  TO THIS PATIENT, THEREAFTER PICKED THE EMPTY SYRINGE SHE HAD JUST ADMIN ISTERED  TO THE PATIENT AND INSERTED THE NEEDLE WITH NO VACCINE IN IT AGAIN THINKING SHE WAS PICKING UP PREVNAR THEN REALISED IT WAS EMPTY. SHE THEN BROUGHT OUT THNEEDLE WITHOUT INJECTING ANYTHING. MOM REALISED IT AT SAME TIME GOT UPSET AND REFUSED TO CONTINUE TO GIVE THE PREVNER.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given 0.2 mL of undiluted vaccine.  No Diluent added.  Patient observed in clinic for 30 minutes without any adverse reactions noted.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort
Clinical narrative: Tightness around and in the heart
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Acute respiratory failure, Atrial flutter, Coagulopathy
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/21/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 12/21/2022 ACUTE RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/21/2022 SYSTOLIC HEART FAILURE, ACUTE J96.00 ACUTE RESPIRATORY FAILURE 12/21/2022 SYSTOLIC HEART FAILURE, ACUTE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/21/2022 ATRIAL FLUTTER, PAROXYSMAL J96.00 ACUTE RESPIRATORY FAILURE 12/21/2022 ATRIAL FLUTTER, PAROXYSMAL
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Autoimmune disorder, Bile duct stenosis, Biopsy liver abnormal, Cholangitis sclerosing, Cholelithiasis
Clinical narrative: Lab work for annual physical showed elevated liver enzymes. Gallbladder ultrasound done. Gallstone and sludge found. Referred to gallbladder surgeon. She referred to liver specialist who referred for liver biopsy. This was done on February 9, 2023. Scarring was found in liver and bile ducts. Additionally, there were strictures and some thickening. Referred for ERCP scope. This was done on March 9, 2023. Two autoimmune diseases have been potentially identified: Primary Schlerosing Cholangitis and IgG4-related disease (liver).
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Endoscopic retrograde cholangiopancreatography, Hepatic enzyme increased, Immunoglobulin G4 related disease, Scar, Ultrasound biliary tract abnormal
Clinical narrative: Lab work for annual physical showed elevated liver enzymes. Gallbladder ultrasound done. Gallstone and sludge found. Referred to gallbladder surgeon. She referred to liver specialist who referred for liver biopsy. This was done on February 9, 2023. Scarring was found in liver and bile ducts. Additionally, there were strictures and some thickening. Referred for ERCP scope. This was done on March 9, 2023. Two autoimmune diseases have been potentially identified: Primary Schlerosing Cholangitis and IgG4-related disease (liver).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Cardiac failure congestive, Cardiogenic shock, End stage renal disease
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 10/6/2022 COVID-19 DISEASE R57.0 CARDIOGENIC SHOCK 10/29/2022 COVID-19 DISEASE R57.9 SHOCK, UNSPECIFIED 10/29/2022 COVID-19 DISEASE G62.9 PERIPHERAL NEUROPATHY 10/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.0 CARDIOGENIC SHOCK 10/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 10/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY G62.9 PERIPHERAL NEUROPATHY 10/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 10/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.9 SHOCK, UNSPECIFIED 10/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G62.9 PERIPHERAL NEUROPATHY 10/6/2022 ESRD (END STAGE RENAL DISEASE) R57.0 CARDIOGENIC SHOCK 10/29/2022 ESRD (END STAGE RENAL DISEASE) R57.9 SHOCK, UNSPECIFIED 10/29/2022 ESRD (END STAGE RENAL DISEASE)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Shock
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 10/6/2022 COVID-19 DISEASE R57.0 CARDIOGENIC SHOCK 10/29/2022 COVID-19 DISEASE R57.9 SHOCK, UNSPECIFIED 10/29/2022 COVID-19 DISEASE G62.9 PERIPHERAL NEUROPATHY 10/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.0 CARDIOGENIC SHOCK 10/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 10/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY G62.9 PERIPHERAL NEUROPATHY 10/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 10/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.9 SHOCK, UNSPECIFIED 10/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G62.9 PERIPHERAL NEUROPATHY 10/6/2022 ESRD (END STAGE RENAL DISEASE) R57.0 CARDIOGENIC SHOCK 10/29/2022 ESRD (END STAGE RENAL DISEASE) R57.9 SHOCK, UNSPECIFIED 10/29/2022 ESRD (END STAGE RENAL DISEASE)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/14/2022 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/14/2022 ACUTE RESPIRATORY FAILURE J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/14/2022 ACUTE RESPIRATORY FAILURE
Age: 40.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site red and swollen. Site initally red, warm and raised to the touch. member asymptomatic and voices no complaints. cardio respiratory unremarkable. vitals 129/84 bp72 rr16 spo2 99%. member advised to seark immediate care for any concerning syptoms that may arise approximatly 4 days out from recieving vaccination.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction.  Vaccine given beyond expiration date
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ischaemic stroke, Spinal compression fracture, Thoracic vertebral fracture
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 T9-T10 VERTEBRAL STABLE BURST FX, INIT I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 T9-T10 VERTEBRAL STABLE BURST FX, INIT I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 HX OF ISCHEMIC STROKE I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 HX OF ISCHEMIC STROKE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 LATE EFFECT OF STROKE I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 LATE EFFECT OF STROKE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arteriogram carotid normal, Cardiac function test normal, Computerised tomogram head abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: On October 26,, 2022,  I had symptoms of numbness & tingling in my right hand and above my lip (right side only).  Symptoms were  mild. Late evening I also had those symptoms plus a slight drop in right foot.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lacunar stroke, Magnetic resonance imaging head abnormal, Paraesthesia, Paraesthesia oral, Peroneal nerve palsy
Clinical narrative: On October 26,, 2022,  I had symptoms of numbness & tingling in my right hand and above my lip (right side only).  Symptoms were  mild. Late evening I also had those symptoms plus a slight drop in right foot.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Thalamic infarction
Clinical narrative: On October 26,, 2022,  I had symptoms of numbness & tingling in my right hand and above my lip (right side only).  Symptoms were  mild. Late evening I also had those symptoms plus a slight drop in right foot.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Cardiac failure, Cardiac failure congestive, Cardio-respiratory arrest
Clinical narrative: patient developed sx on 5-8-23 of covid  with shortness of breath, fever, cough, developed septic shock.  admitted at hospital and deceased 5-15-23 with dx of acute hypoxic resp failure, sepsis, acute kidney injury , chronic kidney disease, chf with preserved EF had hypotension not requring vasopressors, given linezolid and zosyn, iv decadron, nebs, full course remdesivir , had code and was unable to be resuscitated
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Cough, Death, Dyspnoea, Hypotension
Clinical narrative: patient developed sx on 5-8-23 of covid  with shortness of breath, fever, cough, developed septic shock.  admitted at hospital and deceased 5-15-23 with dx of acute hypoxic resp failure, sepsis, acute kidney injury , chronic kidney disease, chf with preserved EF had hypotension not requring vasopressors, given linezolid and zosyn, iv decadron, nebs, full course remdesivir , had code and was unable to be resuscitated
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Sepsis, Septic shock
Clinical narrative: patient developed sx on 5-8-23 of covid  with shortness of breath, fever, cough, developed septic shock.  admitted at hospital and deceased 5-15-23 with dx of acute hypoxic resp failure, sepsis, acute kidney injury , chronic kidney disease, chf with preserved EF had hypotension not requring vasopressors, given linezolid and zosyn, iv decadron, nebs, full course remdesivir , had code and was unable to be resuscitated
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Second dose of Monovalent Covid Vaccine was administered on 4/20 after the deauthorization was made.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient was not supposed to receive a Hep B vaccine
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Angiogram normal, Chest pain, Decreased appetite, Electrocardiogram normal
Clinical narrative: Patient (plans to retire in Dec 2023) called to report continued issues since receipt of 2021 Pfizer vaccines (primary series). He states he is under care with HCP's for his multiple complaints. States "immediately" to 1-2 days after each vaccine he c/o fatigue, chest pain, ED, and more. He advised since last Oct22 he has had urinary issues, difficulty emptying bladder, severe bilateral kidney pain, hand swelling, poor appetite, chronic fatigue, nose bleeds x 7 months and more.   Pfizer #1 on 03/22/2021 and Pfizer #2 on 4/12/2021.  Lot numbers not available.  Hx covid disease (unsure)   While s/s vary, wax and wane, he has not received any further covid vaccines and wants to report it.  Contact made with agency on 5/11/2023 see case.   review of his c/o CP "immediately after vaccination" that persists 1-2 years later 2-3 x/day as a sharp pain over heart that goes front to back w/o other s/s identified: Position does not influence, but activity does. he has had full cardiology w/u (12/2022-1/2023 were normal EKG, EST, CTA) and has never heard term myocarditis. His fatigue is chronic being unable to exercise more than 15 minutes w/o needing to lay down - he is unable to run anymore stating he use to be the one people tried to beat, now he is at bottom of his team. He c/o flank pain since Oct 2022 under eval by HCP with no problems identified. He states for first 4 months post vaccine he was unable to perform, now can but has difficulty with erections. Seen by HCP, cardiology, neuro, GU, and heath system for reported health issues.  ----------------------  PMH: pre covid vac/disease: spondylosis, lower back pain,  urology issues 2018, astigmatism, tinea pedis, anisocoria, rhinitis, gastroenteritis, dizziness -vertigo w/HA Jun-Dec 2015 tx in ER/ENT -dx vestibular migraine; plantar fascial fibromatosis 2015; chronic rhinitis 2018 w/headache, GU strictures   PMH post covid vac/disease chronic LBP x several years now with left hip/flank pain & urinary frequency under care of neurosurgery (negative GU workup for stones, masses, etc)  h/o nose bleeds,  Sees heath system for anxiety, sleep issues-Insomnia PSH: urethroplasty for stricture 2005 and vasectomy 2022
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Erectile dysfunction, Exercise tolerance decreased, Fatigue, Flank pain
Clinical narrative: Patient (plans to retire in Dec 2023) called to report continued issues since receipt of 2021 Pfizer vaccines (primary series). He states he is under care with HCP's for his multiple complaints. States "immediately" to 1-2 days after each vaccine he c/o fatigue, chest pain, ED, and more. He advised since last Oct22 he has had urinary issues, difficulty emptying bladder, severe bilateral kidney pain, hand swelling, poor appetite, chronic fatigue, nose bleeds x 7 months and more.   Pfizer #1 on 03/22/2021 and Pfizer #2 on 4/12/2021.  Lot numbers not available.  Hx covid disease (unsure)   While s/s vary, wax and wane, he has not received any further covid vaccines and wants to report it.  Contact made with agency on 5/11/2023 see case.   review of his c/o CP "immediately after vaccination" that persists 1-2 years later 2-3 x/day as a sharp pain over heart that goes front to back w/o other s/s identified: Position does not influence, but activity does. he has had full cardiology w/u (12/2022-1/2023 were normal EKG, EST, CTA) and has never heard term myocarditis. His fatigue is chronic being unable to exercise more than 15 minutes w/o needing to lay down - he is unable to run anymore stating he use to be the one people tried to beat, now he is at bottom of his team. He c/o flank pain since Oct 2022 under eval by HCP with no problems identified. He states for first 4 months post vaccine he was unable to perform, now can but has difficulty with erections. Seen by HCP, cardiology, neuro, GU, and heath system for reported health issues.  ----------------------  PMH: pre covid vac/disease: spondylosis, lower back pain,  urology issues 2018, astigmatism, tinea pedis, anisocoria, rhinitis, gastroenteritis, dizziness -vertigo w/HA Jun-Dec 2015 tx in ER/ENT -dx vestibular migraine; plantar fascial fibromatosis 2015; chronic rhinitis 2018 w/headache, GU strictures   PMH post covid vac/disease chronic LBP x several years now with left hip/flank pain & urinary frequency under care of neurosurgery (negative GU workup for stones, masses, etc)  h/o nose bleeds,  Sees heath system for anxiety, sleep issues-Insomnia PSH: urethroplasty for stricture 2005 and vasectomy 2022
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Laboratory test normal, Peripheral swelling, Renal pain, Urinary retention
Clinical narrative: Patient (plans to retire in Dec 2023) called to report continued issues since receipt of 2021 Pfizer vaccines (primary series). He states he is under care with HCP's for his multiple complaints. States "immediately" to 1-2 days after each vaccine he c/o fatigue, chest pain, ED, and more. He advised since last Oct22 he has had urinary issues, difficulty emptying bladder, severe bilateral kidney pain, hand swelling, poor appetite, chronic fatigue, nose bleeds x 7 months and more.   Pfizer #1 on 03/22/2021 and Pfizer #2 on 4/12/2021.  Lot numbers not available.  Hx covid disease (unsure)   While s/s vary, wax and wane, he has not received any further covid vaccines and wants to report it.  Contact made with agency on 5/11/2023 see case.   review of his c/o CP "immediately after vaccination" that persists 1-2 years later 2-3 x/day as a sharp pain over heart that goes front to back w/o other s/s identified: Position does not influence, but activity does. he has had full cardiology w/u (12/2022-1/2023 were normal EKG, EST, CTA) and has never heard term myocarditis. His fatigue is chronic being unable to exercise more than 15 minutes w/o needing to lay down - he is unable to run anymore stating he use to be the one people tried to beat, now he is at bottom of his team. He c/o flank pain since Oct 2022 under eval by HCP with no problems identified. He states for first 4 months post vaccine he was unable to perform, now can but has difficulty with erections. Seen by HCP, cardiology, neuro, GU, and heath system for reported health issues.  ----------------------  PMH: pre covid vac/disease: spondylosis, lower back pain,  urology issues 2018, astigmatism, tinea pedis, anisocoria, rhinitis, gastroenteritis, dizziness -vertigo w/HA Jun-Dec 2015 tx in ER/ENT -dx vestibular migraine; plantar fascial fibromatosis 2015; chronic rhinitis 2018 w/headache, GU strictures   PMH post covid vac/disease chronic LBP x several years now with left hip/flank pain & urinary frequency under care of neurosurgery (negative GU workup for stones, masses, etc)  h/o nose bleeds,  Sees heath system for anxiety, sleep issues-Insomnia PSH: urethroplasty for stricture 2005 and vasectomy 2022
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract disorder
Clinical narrative: Patient (plans to retire in Dec 2023) called to report continued issues since receipt of 2021 Pfizer vaccines (primary series). He states he is under care with HCP's for his multiple complaints. States "immediately" to 1-2 days after each vaccine he c/o fatigue, chest pain, ED, and more. He advised since last Oct22 he has had urinary issues, difficulty emptying bladder, severe bilateral kidney pain, hand swelling, poor appetite, chronic fatigue, nose bleeds x 7 months and more.   Pfizer #1 on 03/22/2021 and Pfizer #2 on 4/12/2021.  Lot numbers not available.  Hx covid disease (unsure)   While s/s vary, wax and wane, he has not received any further covid vaccines and wants to report it.  Contact made with agency on 5/11/2023 see case.   review of his c/o CP "immediately after vaccination" that persists 1-2 years later 2-3 x/day as a sharp pain over heart that goes front to back w/o other s/s identified: Position does not influence, but activity does. he has had full cardiology w/u (12/2022-1/2023 were normal EKG, EST, CTA) and has never heard term myocarditis. His fatigue is chronic being unable to exercise more than 15 minutes w/o needing to lay down - he is unable to run anymore stating he use to be the one people tried to beat, now he is at bottom of his team. He c/o flank pain since Oct 2022 under eval by HCP with no problems identified. He states for first 4 months post vaccine he was unable to perform, now can but has difficulty with erections. Seen by HCP, cardiology, neuro, GU, and heath system for reported health issues.  ----------------------  PMH: pre covid vac/disease: spondylosis, lower back pain,  urology issues 2018, astigmatism, tinea pedis, anisocoria, rhinitis, gastroenteritis, dizziness -vertigo w/HA Jun-Dec 2015 tx in ER/ENT -dx vestibular migraine; plantar fascial fibromatosis 2015; chronic rhinitis 2018 w/headache, GU strictures   PMH post covid vac/disease chronic LBP x several years now with left hip/flank pain & urinary frequency under care of neurosurgery (negative GU workup for stones, masses, etc)  h/o nose bleeds,  Sees heath system for anxiety, sleep issues-Insomnia PSH: urethroplasty for stricture 2005 and vasectomy 2022
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Chronic kidney disease, Glomerular filtration rate, Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/18/2022 LEFT ANKLE FX INIT  ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/18/2022 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE  ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/18/2022 CKD STAGE 3A (GFR 45-59)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Diabetic nephropathy, Hypertension, Hypoxia
Clinical narrative: NEUROPATHY 12/1/2021 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE RESPIRATORY FAILURE 9/10/2022 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOXIA 9/9/2022 NONTRAUMATIC ACUTE KIDNEY INJURY NEUROPATHY 12/1/2021 DM 2 W RENAL MANIFESTATION ACUTE RESPIRATORY FAILURE 9/10/2022 DM 2 W RENAL MANIFESTATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 DM 2 W RENAL MANIFESTATION HYPOXIA 9/9/2022 DM 2 W RENAL MANIFESTATIONNEUROPATHY 12/1/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 9/10/2022 ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 ACUTE RESPIRATORY FAILURE HYPOXIA 9/9/2022 ACUTE RESPIRATORY FAILURE NEUROPATHY 12/1/2021 HTN (HYPERTENSION) ACUTE RESPIRATORY FAILURE 9/10/2022 HTN (HYPERTENSION) ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 HTN (HYPERTENSION) HYPOXIA 9/9/2022 HTN (HYPERTENSION)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY 12/1/2021 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE RESPIRATORY FAILURE 9/10/2022 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOXIA 9/9/2022 NONTRAUMATIC ACUTE KIDNEY INJURY NEUROPATHY 12/1/2021 DM 2 W RENAL MANIFESTATION ACUTE RESPIRATORY FAILURE 9/10/2022 DM 2 W RENAL MANIFESTATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 DM 2 W RENAL MANIFESTATION HYPOXIA 9/9/2022 DM 2 W RENAL MANIFESTATIONNEUROPATHY 12/1/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 9/10/2022 ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 ACUTE RESPIRATORY FAILURE HYPOXIA 9/9/2022 ACUTE RESPIRATORY FAILURE NEUROPATHY 12/1/2021 HTN (HYPERTENSION) ACUTE RESPIRATORY FAILURE 9/10/2022 HTN (HYPERTENSION) ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 HTN (HYPERTENSION) HYPOXIA 9/9/2022 HTN (HYPERTENSION)
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Quarter size red mark presented at MMRV injection site within 24 hours, with considerable soreness. Swelling around red mark spread to a peak diameter of 4.5 inches about 48 hours after injection, then slowly subsided. The area was warm to the touch and itchy. No fever and no rash, only considerable localized redness, swelling, and pain. DTaP injection site was unremarkable.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fatigue, Insomnia, Pain
Clinical narrative: On Thursday I had a little irritated throat 04MAY2023 on 05MAY2023 I felt tired on 06MAY2023 I felt pretty fatigued and had to take a nap at the Hotel.  The fatigue and body aaches continued through 08MAY2023 me thinking it was jet lag.  09MAY2023 I got an email someone had tested positve  in our vaction/tour group for COVID-19 and I took a home test and spoke with my Doctor who prescribed medications and I qaurantined for five days being vey tired and achy with no fever, I had terrible insominia. 13MAY2023 I was definitely improved getting better daily and I mask when going out with the fatigue easing and in the next few days I will go back to my exercise routine.  I used my inhaler once during this time an Abutrerol inhaler.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On Thursday I had a little irritated throat 04MAY2023 on 05MAY2023 I felt tired on 06MAY2023 I felt pretty fatigued and had to take a nap at the Hotel.  The fatigue and body aaches continued through 08MAY2023 me thinking it was jet lag.  09MAY2023 I got an email someone had tested positve  in our vaction/tour group for COVID-19 and I took a home test and spoke with my Doctor who prescribed medications and I qaurantined for five days being vey tired and achy with no fever, I had terrible insominia. 13MAY2023 I was definitely improved getting better daily and I mask when going out with the fatigue easing and in the next few days I will go back to my exercise routine.  I used my inhaler once during this time an Abutrerol inhaler.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Glaucoma, Visual acuity tests abnormal
Clinical narrative: In April 2022 when I visited the eye doctor, I had a visual acuity test and they told me I had glaucoma.  My dad also had glaucoma.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised anxiety disorder, Hypotension, Septic shock, Urinary tract infection
Clinical narrative: HYPOTENSION 10/27/2022 GENERALIZED ANXIETY DISORDER  HYPOTENSION 10/27/2022 SEPTIC SHOCK  HYPOTENSION 10/27/2022 UTI (URINARY TRACT INFECTION)
Age: 56.0
Sex: M
Vaccine: FLUR4
Symptoms: Acute respiratory failure, Dyspnoea, Gait inability, Intensive care, Laboratory test
Clinical narrative: Malaise, fever, difficulty breathing, inability to walk, tingling in hands leading to transverse myelitis, c2-c7, tetraplegia, acute respiratory failure.  Still on life support and quadriplegic
Age: 56.0
Sex: M
Vaccine: FLUR4
Symptoms: Life support, Malaise, Myelitis transverse, Paraesthesia, Pyrexia
Clinical narrative: Malaise, fever, difficulty breathing, inability to walk, tingling in hands leading to transverse myelitis, c2-c7, tetraplegia, acute respiratory failure.  Still on life support and quadriplegic
Age: 56.0
Sex: M
Vaccine: FLUR4
Symptoms: Quadriplegia
Clinical narrative: Malaise, fever, difficulty breathing, inability to walk, tingling in hands leading to transverse myelitis, c2-c7, tetraplegia, acute respiratory failure.  Still on life support and quadriplegic
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt previously received Pediarix and Rotarix on 5/9/23.  On 5/18/23 pt was given the vaccines again along with PedvaxHIB and Vaxneuvance.  No adverse outcome, no treatment needed
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given the dose too soon. Patient received her first Meningococcal ACYW (Menactra) & Tdap on 7/8/2022 and then was given MedQuadFi & Tdap on 05/12/2023
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Autoimmune disorder, Erythema, Feeding disorder, Laboratory test, Oral lichen planus
Clinical narrative: I was diagnosed with an autoimmune disease called Oral lichen planus on March 07, 2023, I was having difficulty eating, and also soreness and redness and shallow sores along my gums and teeth. I was prescribed magic mouthwash and mouth rinse.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Stomatitis
Clinical narrative: I was diagnosed with an autoimmune disease called Oral lichen planus on March 07, 2023, I was having difficulty eating, and also soreness and redness and shallow sores along my gums and teeth. I was prescribed magic mouthwash and mouth rinse.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered at inappropriate site
Clinical narrative: injection was administered to close to a previous given vaccination and also was  given  to low from deltoid area on left arm.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, Gastric ulcer, Ischaemic stroke
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 8/31/2022 CHEST PAIN I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 8/31/2022 ACUTE GASTRIC ULCER I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 8/31/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Blood test, Eye pain, Headache, Magnetic resonance imaging head
Clinical narrative: Optic neuritis within one week of vaccine - permanent vision loss, eye pain, blurred vision, headaches,etc.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Optic neuritis, Ultrasound eye, Vision blurred
Clinical narrative: Optic neuritis within one week of vaccine - permanent vision loss, eye pain, blurred vision, headaches,etc.
Age: 59.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Feeling abnormal, Peripheral swelling, Pharyngeal swelling, Rash, Rash macular
Clinical narrative: Spoke with Patient and he was in on Monday and received Prevnar 20 and Shingrix (#1). He felt puny as expected on Monday and Tuesday, but today he felt horrible--emesis x 3, hands swollen (still swollen and not able to make a fist), red spotted rash all over his body, and feeling of throat swelling. His co-workers took him to Hospital and he was given the following medications:  Benadryl Pepcid Prednisolone Epi-Pen--he was advised that if this happens again it could be much worse
Age: 59.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Vomiting
Clinical narrative: Spoke with Patient and he was in on Monday and received Prevnar 20 and Shingrix (#1). He felt puny as expected on Monday and Tuesday, but today he felt horrible--emesis x 3, hands swollen (still swollen and not able to make a fist), red spotted rash all over his body, and feeling of throat swelling. His co-workers took him to Hospital and he was given the following medications:  Benadryl Pepcid Prednisolone Epi-Pen--he was advised that if this happens again it could be much worse
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Neuropathy peripheral
Clinical narrative: G62.9 NEUROPATHY 5/31/2022 UNINTENTIONAL WEIGHT LOSS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cervix carcinoma, Metastases to pleura, Neoplasm malignant
Clinical narrative: ACUTE RESPIRATORY FAILURE 12/6/2022 CANCER METASTATIC TO PLEURA  ACUTE RESPIRATORY FAILURE 12/6/2022 CERVICAL CANCER, UNSPECIFIED
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: VACCINE WAS DILUTED WITH STERILE DILUNT FOR LIVE VIRUS VACCINES USE FOR MMR & VZV
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Covid vaccine got left out possibly over night. Fridge door was slightly opened. One bivalent vial was left on the counter in the med room without a sticky note.  Patient was given a dose of the vial that was left out.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pruritus
Clinical narrative: pt received Prevnar 20 and approximately one hour later pt started to have redness and itching below the injection site. pt in office 2 days later to have it evaluated and was determined to have hypersensitivity to the vaccine. antihistamine given to pt for syptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Ear congestion, Ear pain, Exposure to SARS-CoV-2
Clinical narrative: On Sunday morning May 7, 2023 I began to have head congestion, severe headache, extreme tiredness. My husband began having these same symptoms on Friday afternoon May 5, 2023. He tested positive at The Walk-in clinic for Covid on Sat May 6, 2023. He had just been asked to go back into the office 1 day per week starting Wed April  26, 2023 . He learned he was exposed to a work colleague who followed the CDC guidelines literally and came into work after 5 days, even though she was still feeling sick.   After my husband?s Covid-19 test came back positive, I asked to also be tested, but the clinic provided guidance to not get tested.  After I started to feel intense symptoms I decided to get tested on Wed May 9th at the The walk-in clinic. My test came back Covid-19 positive.   My symptoms worsened to included fever (102), chills, severe left ear congestion, tinnitis, ear pain, and very bad headache, head congestion.   Today is Friday May 19th and I am still testing positive, although the positive signal is now much more faint. I still have a runny nose, sinus and head congestion, left ear tinnitis,  and tiredness. My husband tested negative for the first time this morning (Day 15).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: On Sunday morning May 7, 2023 I began to have head congestion, severe headache, extreme tiredness. My husband began having these same symptoms on Friday afternoon May 5, 2023. He tested positive at The Walk-in clinic for Covid on Sat May 6, 2023. He had just been asked to go back into the office 1 day per week starting Wed April  26, 2023 . He learned he was exposed to a work colleague who followed the CDC guidelines literally and came into work after 5 days, even though she was still feeling sick.   After my husband?s Covid-19 test came back positive, I asked to also be tested, but the clinic provided guidance to not get tested.  After I started to feel intense symptoms I decided to get tested on Wed May 9th at the The walk-in clinic. My test came back Covid-19 positive.   My symptoms worsened to included fever (102), chills, severe left ear congestion, tinnitis, ear pain, and very bad headache, head congestion.   Today is Friday May 19th and I am still testing positive, although the positive signal is now much more faint. I still have a runny nose, sinus and head congestion, left ear tinnitis,  and tiredness. My husband tested negative for the first time this morning (Day 15).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive, Sinus congestion, Tinnitus
Clinical narrative: On Sunday morning May 7, 2023 I began to have head congestion, severe headache, extreme tiredness. My husband began having these same symptoms on Friday afternoon May 5, 2023. He tested positive at The Walk-in clinic for Covid on Sat May 6, 2023. He had just been asked to go back into the office 1 day per week starting Wed April  26, 2023 . He learned he was exposed to a work colleague who followed the CDC guidelines literally and came into work after 5 days, even though she was still feeling sick.   After my husband?s Covid-19 test came back positive, I asked to also be tested, but the clinic provided guidance to not get tested.  After I started to feel intense symptoms I decided to get tested on Wed May 9th at the The walk-in clinic. My test came back Covid-19 positive.   My symptoms worsened to included fever (102), chills, severe left ear congestion, tinnitis, ear pain, and very bad headache, head congestion.   Today is Friday May 19th and I am still testing positive, although the positive signal is now much more faint. I still have a runny nose, sinus and head congestion, left ear tinnitis,  and tiredness. My husband tested negative for the first time this morning (Day 15).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myoclonus
Clinical narrative: Middle ear myoclonus
Age: 40.0
Sex: F
Vaccine: PNC15, PNC15
Symptoms: Angiogram pulmonary, Anticoagulant therapy, Pulmonary embolism
Clinical narrative: Pulmonary Embolism. Treated with Eliquis
Age: 40.0
Sex: F
Vaccine: PNC15, PNC15
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism
Clinical narrative: Pulmonary Embolism. Treated with Eliquis
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Brain fog, COVID-19, Cough, Discomfort, Fatigue
Clinical narrative: On 5/5/2023, I felt fine until the evening. I went downhill very fast at that point. I had flu-like symptoms that included body aches, brain fog, fatigue, and runny nose. The postnasal drip caused me to have a cough. I had a fever of 100.6. That night, I didn't sleep well, because my symptoms caused me to be uncomfortable and restless. On 5/6/2023, the symptoms continued. At about 2 PM that day, I took a home antigen test and got a positive result. I called my PCP's office and arranged to have a telehealth visit on 5/7/2023 at about 9:40 AM. I had the telehealth visit, during which I was prescribed a light dose of Paxlovid. which I began taking that day. The symptoms continued the same as before. At about 8 PM, I took my second dose of the Paxlovid. By bedtime, my head felt clear, and the brain fog was gone. I slept well that night. I remained in isolation, but I felt fine all the way up until the afternoon of 5/11/2023, which is when I tested negative.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza like illness, Pain, Poor quality sleep, Pyrexia, Restlessness
Clinical narrative: On 5/5/2023, I felt fine until the evening. I went downhill very fast at that point. I had flu-like symptoms that included body aches, brain fog, fatigue, and runny nose. The postnasal drip caused me to have a cough. I had a fever of 100.6. That night, I didn't sleep well, because my symptoms caused me to be uncomfortable and restless. On 5/6/2023, the symptoms continued. At about 2 PM that day, I took a home antigen test and got a positive result. I called my PCP's office and arranged to have a telehealth visit on 5/7/2023 at about 9:40 AM. I had the telehealth visit, during which I was prescribed a light dose of Paxlovid. which I began taking that day. The symptoms continued the same as before. At about 8 PM, I took my second dose of the Paxlovid. By bedtime, my head felt clear, and the brain fog was gone. I slept well that night. I remained in isolation, but I felt fine all the way up until the afternoon of 5/11/2023, which is when I tested negative.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: On 5/5/2023, I felt fine until the evening. I went downhill very fast at that point. I had flu-like symptoms that included body aches, brain fog, fatigue, and runny nose. The postnasal drip caused me to have a cough. I had a fever of 100.6. That night, I didn't sleep well, because my symptoms caused me to be uncomfortable and restless. On 5/6/2023, the symptoms continued. At about 2 PM that day, I took a home antigen test and got a positive result. I called my PCP's office and arranged to have a telehealth visit on 5/7/2023 at about 9:40 AM. I had the telehealth visit, during which I was prescribed a light dose of Paxlovid. which I began taking that day. The symptoms continued the same as before. At about 8 PM, I took my second dose of the Paxlovid. By bedtime, my head felt clear, and the brain fog was gone. I slept well that night. I remained in isolation, but I felt fine all the way up until the afternoon of 5/11/2023, which is when I tested negative.
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Employee stated she just did not feel well. No treatment or signs and symptoms noted at time of reaction.
Age: 1.58
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 1.5
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Cholelithiasis, Magnetic resonance imaging abdominal abnormal, Ultrasound abdomen abnormal
Clinical narrative: In September of 2022, I started having trouble with bowel movement. I was advised to go to urgent care or emergency department. After an MRI and Ultrasound, it was recommended that I have a gallbladder removal. The surgeon stated I had a very large gallstone.
Age: 1.25
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 0.92
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Neck pain
Clinical narrative: I began to feel more extreme pain in my knee, ankle, shoulder, and neck. In course of getting treatment for prior back pain, I received a cortisone shot and the pain in my knee, ankle, shoulder, and neck increased.  At present pain is rated as being sometimes, and sometimes ranging up to 7.  Pain has been steady and getting worse in neck and shoulders.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose, Cold sweat, Electrocardiogram, Headache, Nausea
Clinical narrative: CLIENT COMPLAINED OF NAUSEA, HEADACHE,  PALE CLAMMY SKIN COLD TO TOUCH, SLEEPY.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Somnolence
Clinical narrative: CLIENT COMPLAINED OF NAUSEA, HEADACHE,  PALE CLAMMY SKIN COLD TO TOUCH, SLEEPY.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Shortly after receiving the post laceration TdaP booster, the patient notice itching at the site of injection. I noted  wheals localized to the deltoid area of the left UE. We applied ice and ordered antihistamines.  The following day, he returned for a recheck. This morning (05/19/2023) he had fading wheals, but new  swelling without redness, warmth, tenderness and painful UE ROM above expected post vaccine.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX that had undergone temperature excursion was administered to patient; This spontaneous report was received from an other health care professional referring to 14-month-old male patient.  On 16-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) (lot #W006412, expiration date 23-FEB-2024) (dose not reported) intramuscularly in right thigh.  On 20-JAN-2023, the administered dose had temperature excursion range of -14 degree Celsius to -10 degree Celsius for 1 hour (Product storage error). No additional adverse event reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869: US-009507513-2304USA007889: US-009507513-2304USA007931:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: rash all over the body; This spontaneous report was received from a physician via company representative and referred to a 15-year-old patient 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 an unknown date in 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (anatomical location, strength, dose, route, lot number, and expiration date were not reported) for prophylaxis.  On an unknown date in 2022, the patient developed rash all over the body after receiving a dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The rash went away the next day.  The causality between the event and the suspect vaccine was considered unknown.