chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with Covid-19) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Diabetic.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2023, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient was fully vaccinated. Patient had primary series vaccines and booster vaccines and were all Pfizer except, one of them was Moderna.  It was reported that patient had not received any prior vaccinations (within 4 weeks). Patient went to Emergency room, was diagnosed with Covid there. Patient was diagnosed with Covid on 27 March 2023, prior to taking the Paxlovid.  It was reported that the patient was not sure if she should do something about taking more pills. Finished the regimen of pills. Was not sure where to go from there.  Patient felt like got everything, got really sick. Patient was sicker than a dog, followed all the rules, done everything, still got sick. Patient was taking some medications as concomitant products/medical conditions and was told to stop taking one while on Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2023-718675 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2023: Live follow up received that contains non significant information, quality complaint number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718675:Husband case
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness
Clinical narrative: she lost her eyesight after getting the Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (she lost her eyesight after getting the Moderna shot) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (she lost her eyesight after getting the Moderna shot) (seriousness criteria disability and medically significant). At the time of the report, BLINDNESS (she lost her eyesight after getting the Moderna shot) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    No treatment medications were reported.  Company comment: This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected serious (disability, medically significant) event of Blindness, unknown time after receiving a dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that she lost her eyesight after getting the Moderna shot. No further information was available for medical review. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: Impaired work ability, Insomnia, Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Itching all over the body, has not subsided-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Started the night of the shot per patient. Patient states that itching is all over; tingling all over. This itching and tingling has caused him to lose his job. His head is "going to explode" from the itching.
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Needle issue
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: The patient's skin and muscle were a little tough and when my intern went to adminster the vaccine the needle bent a little and was not able to admnister the vaccine.  I drew up a new dose with the vanish point needle and syringe and admnistered the vaccine to the patient.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Blood pressure increased, Ear discomfort, Headache, Hypertension, Tinnitus
Clinical narrative: Systemic: Pressure in ears-Severe, Systemic: Headache-Mild, Systemic: Hypertension-Severe, Systemic: Tinnitus-Severe, Additional Details: After receiving Prevnar 20 and Boostrix immunizations, the patient started to experience a lot of pressure in one side of her ear and some tinnitus.  Her blood pressure shot up as well.  She ended up having to go to the emergency.  She is feeling better now but still has some pressure in ear.  She is seeing her PCP on Monday.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Chills, Cognitive disorder, Confusional state, Disorientation
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Disorientation-Severe, Additional Details: Patient experienced loss of cognitave ability, severe chills, disorientation. Went to hospital where he was ruled out for sepsis, congestive heart failure. ER doctors decided it was an allergic reaction to Shingrix.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Disorientation-Severe, Additional Details: Patient experienced loss of cognitave ability, severe chills, disorientation. Went to hospital where he was ruled out for sepsis, congestive heart failure. ER doctors decided it was an allergic reaction to Shingrix.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breech presentation, COVID-19, Caesarean section, Maternal exposure before pregnancy, Refusal of treatment by patient
Clinical narrative: dISCHARGE SUMMARY " Admitting Diagnosis: IUP at 39+ wks, Breech presentation, COVID+, religious preference - declines blood products   Reasons for Admission:  Scheduled C/S   Prenatal Procedures: U/S x 3   Intrapartum Procedures: PLTCS   Postpartum Procedures: None   Postpartum/Operative Complications: None   Newborn Data: Female   Discharge Diagnosis: Term Pregnancy-Delivered COVID+"
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Ultrasound foetal
Clinical narrative: dISCHARGE SUMMARY " Admitting Diagnosis: IUP at 39+ wks, Breech presentation, COVID+, religious preference - declines blood products   Reasons for Admission:  Scheduled C/S   Prenatal Procedures: U/S x 3   Intrapartum Procedures: PLTCS   Postpartum Procedures: None   Postpartum/Operative Complications: None   Newborn Data: Female   Discharge Diagnosis: Term Pregnancy-Delivered COVID+"
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Chest X-ray abnormal, Exposure to communicable disease, Increased bronchial secretion, Lung opacity
Clinical narrative: Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient is a 19-year-old female with past medical history of Rett syndrome, asthma, GERD and chronic tube feeding.  She presented for chief complaint of increased pulmonary secretions and vomiting.  Patient had been tested positive on home testing for COVID earlier that day after being exposed to a sick family member.  On presentation vitals are notable for temperature 100.1°.  Labs notable for positive COVID test.  Chest x-ray was notable for bilateral perihilar opacities.  Patient was admitted initially satting well on room air but had desaturations later in her stay and was therefore started on remdesivir and Decadron for treatment of COVID.  Patient required aggressive pulmonary hygiene throughout her stay.  Nausea vomiting and increased secretions improved and patient was restarted back on to work home tube feeding formula.  Patient was weaned off oxygen requirements and will be discharged home under the care of her mother
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Nausea, Oxygen saturation decreased, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient is a 19-year-old female with past medical history of Rett syndrome, asthma, GERD and chronic tube feeding.  She presented for chief complaint of increased pulmonary secretions and vomiting.  Patient had been tested positive on home testing for COVID earlier that day after being exposed to a sick family member.  On presentation vitals are notable for temperature 100.1°.  Labs notable for positive COVID test.  Chest x-ray was notable for bilateral perihilar opacities.  Patient was admitted initially satting well on room air but had desaturations later in her stay and was therefore started on remdesivir and Decadron for treatment of COVID.  Patient required aggressive pulmonary hygiene throughout her stay.  Nausea vomiting and increased secretions improved and patient was restarted back on to work home tube feeding formula.  Patient was weaned off oxygen requirements and will be discharged home under the care of her mother
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aggression, Asthenia, COVID-19, Confusional state, Hypoxia
Clinical narrative: Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient is a 90-year-old male with history of coronary artery disease, basal cell carcinoma of the nose presented from facility emergency department.  Presented for decreased energy weakness and confusion.  Workup notable for hypoxia presentation, viral testing COVID positive.  Patient was combative and confused on presentation this improved following high-flow oxygen.  She was started on Decadron for COVID treatment family refused remdesivir.  Family declined further aggressive care or imaging.  Oxygen gross or titrated down to room air prior to discharge home.
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient is a 90-year-old male with history of coronary artery disease, basal cell carcinoma of the nose presented from facility emergency department.  Presented for decreased energy weakness and confusion.  Workup notable for hypoxia presentation, viral testing COVID positive.  Patient was combative and confused on presentation this improved following high-flow oxygen.  She was started on Decadron for COVID treatment family refused remdesivir.  Family declined further aggressive care or imaging.  Oxygen gross or titrated down to room air prior to discharge home.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood culture negative, COVID-19, Chemotherapy, Chest X-ray normal
Clinical narrative: Brief Summary of Hospital Stay:  Patient is under treatment for Large cell lymphoma, extranodal and solid organ sites with Malignant neoplasm of overlapping sites of stomach leading to chronic Epigastric pain, Early satiety, Weight loss.  On routine lab testing he was found to have Pancytopenia due to antineoplastic chemotherapy, including Chemotherapy induced neutropenia.  He had a very low grade fever so was instructed to come to the hospital.  He was found have both COVID-19 and Rhinovirus infections.  He is not dyspneic or hypoxic. No acute findings on chest film. In addition to neutropenia, he has further immunosuppression as he is On prednisone therapy so completred three day course of REMDESIVIR. He was also empirically started on VANCOMYCIN and CEFEPIME but blood cultures were negative at 72 hours so antibiotics discontinued.   Oncology recommended starting FILGRASTIM and his ANC rose to 1500 prior to discharge.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Early satiety, Gastric cancer, Immunosuppression, Laboratory test abnormal, Lymphoma
Clinical narrative: Brief Summary of Hospital Stay:  Patient is under treatment for Large cell lymphoma, extranodal and solid organ sites with Malignant neoplasm of overlapping sites of stomach leading to chronic Epigastric pain, Early satiety, Weight loss.  On routine lab testing he was found to have Pancytopenia due to antineoplastic chemotherapy, including Chemotherapy induced neutropenia.  He had a very low grade fever so was instructed to come to the hospital.  He was found have both COVID-19 and Rhinovirus infections.  He is not dyspneic or hypoxic. No acute findings on chest film. In addition to neutropenia, he has further immunosuppression as he is On prednisone therapy so completred three day course of REMDESIVIR. He was also empirically started on VANCOMYCIN and CEFEPIME but blood cultures were negative at 72 hours so antibiotics discontinued.   Oncology recommended starting FILGRASTIM and his ANC rose to 1500 prior to discharge.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neutropenia, Pancytopenia, Pyrexia, Rhinovirus infection, SARS-CoV-2 test positive
Clinical narrative: Brief Summary of Hospital Stay:  Patient is under treatment for Large cell lymphoma, extranodal and solid organ sites with Malignant neoplasm of overlapping sites of stomach leading to chronic Epigastric pain, Early satiety, Weight loss.  On routine lab testing he was found to have Pancytopenia due to antineoplastic chemotherapy, including Chemotherapy induced neutropenia.  He had a very low grade fever so was instructed to come to the hospital.  He was found have both COVID-19 and Rhinovirus infections.  He is not dyspneic or hypoxic. No acute findings on chest film. In addition to neutropenia, he has further immunosuppression as he is On prednisone therapy so completred three day course of REMDESIVIR. He was also empirically started on VANCOMYCIN and CEFEPIME but blood cultures were negative at 72 hours so antibiotics discontinued.   Oncology recommended starting FILGRASTIM and his ANC rose to 1500 prior to discharge.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Brief Summary of Hospital Stay:  Patient is under treatment for Large cell lymphoma, extranodal and solid organ sites with Malignant neoplasm of overlapping sites of stomach leading to chronic Epigastric pain, Early satiety, Weight loss.  On routine lab testing he was found to have Pancytopenia due to antineoplastic chemotherapy, including Chemotherapy induced neutropenia.  He had a very low grade fever so was instructed to come to the hospital.  He was found have both COVID-19 and Rhinovirus infections.  He is not dyspneic or hypoxic. No acute findings on chest film. In addition to neutropenia, he has further immunosuppression as he is On prednisone therapy so completred three day course of REMDESIVIR. He was also empirically started on VANCOMYCIN and CEFEPIME but blood cultures were negative at 72 hours so antibiotics discontinued.   Oncology recommended starting FILGRASTIM and his ANC rose to 1500 prior to discharge.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Reason for Admission: 31 YO female with history of Rett's syndrome, seizure disorder, GERD, vitamin d deficiency, neurogenic bladder, chronic constipation, who was brought in due to symptoms of labored breathing with cough and fever since yesterday.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for bacterial left-sided pneumonia, what appears to be an incidental COVID 19 infection   weaned of oxygen, is being discharged on room     COVID-19 virus infection with hypoxia   - confirmed by rapid test   - symptomatic with cough, fever, hypoxia   - no known sick contacts   - prednisone po initiated in ED   -  antibiotics initiated in ED given result of CT chest suggestive of consolidation in left lung   - symptoms likely Covid-19 related, no leukocytosis  Given CT findings of complete whiteout of the left lung, this could be consolidation or aspiration causing collapse, would treat with IV Rocephin and IV doxycycline for now   - PCT is normal at 0.05, streptococcal and Legionella you urine antigens are also negative   - met parameters for Covid-19 treatment ( hypoxia requiring supplemental O2) > change prednisone to decadron po, remdesevir    - breathing treatments with albuterol nebulizer    - droplet precautions    - cough relief    - O2 per protocol 4/8 suggestion of pleural fluid, was reviewed with interventional radiologist Dr., not sufficient to need thoracentesis 4/9 chest x-ray does mention of moderate pleural effusion, will attempt to do thoracentesis tomorrow   4/10 3rd day of the discharge repeat chest x-ray shows significant improvement and bruit small amount of pleural effusion Active Problems:   With consideration of aspiration high on the list, speech therapy consult was made the modified the diet further patient to have follow-up VFSS as outpatient after being followed by about patient's speech therapy   Rett's syndrome   - neurology following out pt    - wheelchair-bound   - up to chair or wheelchair with 2 assists        Seizure disorder (HCC)   - stable, no recent seizure episode   - on phenobarb, continue   - last phenobarb level therapeutic on 3/23/23   - seizure precautions     Chronic constipation   - increased fibers and fluids   - prn laxative     Asthma   - stable, continue with albuterol neb tx while inpateint     GERD (gastroesophageal reflux disease)   - stable, on PPI, continue   Issues Requiring Follow Up: (Who, what, when, and how communicated?)   diet initiation of NDD Level 1 (purees) with nectar-thick liquids via single sips Follow-up with speech pathologist
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Gastrooesophageal reflux disease, Hypoxia, Legionella test, Lung consolidation
Clinical narrative: Reason for Admission: 31 YO female with history of Rett's syndrome, seizure disorder, GERD, vitamin d deficiency, neurogenic bladder, chronic constipation, who was brought in due to symptoms of labored breathing with cough and fever since yesterday.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for bacterial left-sided pneumonia, what appears to be an incidental COVID 19 infection   weaned of oxygen, is being discharged on room     COVID-19 virus infection with hypoxia   - confirmed by rapid test   - symptomatic with cough, fever, hypoxia   - no known sick contacts   - prednisone po initiated in ED   -  antibiotics initiated in ED given result of CT chest suggestive of consolidation in left lung   - symptoms likely Covid-19 related, no leukocytosis  Given CT findings of complete whiteout of the left lung, this could be consolidation or aspiration causing collapse, would treat with IV Rocephin and IV doxycycline for now   - PCT is normal at 0.05, streptococcal and Legionella you urine antigens are also negative   - met parameters for Covid-19 treatment ( hypoxia requiring supplemental O2) > change prednisone to decadron po, remdesevir    - breathing treatments with albuterol nebulizer    - droplet precautions    - cough relief    - O2 per protocol 4/8 suggestion of pleural fluid, was reviewed with interventional radiologist Dr., not sufficient to need thoracentesis 4/9 chest x-ray does mention of moderate pleural effusion, will attempt to do thoracentesis tomorrow   4/10 3rd day of the discharge repeat chest x-ray shows significant improvement and bruit small amount of pleural effusion Active Problems:   With consideration of aspiration high on the list, speech therapy consult was made the modified the diet further patient to have follow-up VFSS as outpatient after being followed by about patient's speech therapy   Rett's syndrome   - neurology following out pt    - wheelchair-bound   - up to chair or wheelchair with 2 assists        Seizure disorder (HCC)   - stable, no recent seizure episode   - on phenobarb, continue   - last phenobarb level therapeutic on 3/23/23   - seizure precautions     Chronic constipation   - increased fibers and fluids   - prn laxative     Asthma   - stable, continue with albuterol neb tx while inpateint     GERD (gastroesophageal reflux disease)   - stable, on PPI, continue   Issues Requiring Follow Up: (Who, what, when, and how communicated?)   diet initiation of NDD Level 1 (purees) with nectar-thick liquids via single sips Follow-up with speech pathologist
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Pneumonia bacterial, Procalcitonin normal, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Reason for Admission: 31 YO female with history of Rett's syndrome, seizure disorder, GERD, vitamin d deficiency, neurogenic bladder, chronic constipation, who was brought in due to symptoms of labored breathing with cough and fever since yesterday.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for bacterial left-sided pneumonia, what appears to be an incidental COVID 19 infection   weaned of oxygen, is being discharged on room     COVID-19 virus infection with hypoxia   - confirmed by rapid test   - symptomatic with cough, fever, hypoxia   - no known sick contacts   - prednisone po initiated in ED   -  antibiotics initiated in ED given result of CT chest suggestive of consolidation in left lung   - symptoms likely Covid-19 related, no leukocytosis  Given CT findings of complete whiteout of the left lung, this could be consolidation or aspiration causing collapse, would treat with IV Rocephin and IV doxycycline for now   - PCT is normal at 0.05, streptococcal and Legionella you urine antigens are also negative   - met parameters for Covid-19 treatment ( hypoxia requiring supplemental O2) > change prednisone to decadron po, remdesevir    - breathing treatments with albuterol nebulizer    - droplet precautions    - cough relief    - O2 per protocol 4/8 suggestion of pleural fluid, was reviewed with interventional radiologist Dr., not sufficient to need thoracentesis 4/9 chest x-ray does mention of moderate pleural effusion, will attempt to do thoracentesis tomorrow   4/10 3rd day of the discharge repeat chest x-ray shows significant improvement and bruit small amount of pleural effusion Active Problems:   With consideration of aspiration high on the list, speech therapy consult was made the modified the diet further patient to have follow-up VFSS as outpatient after being followed by about patient's speech therapy   Rett's syndrome   - neurology following out pt    - wheelchair-bound   - up to chair or wheelchair with 2 assists        Seizure disorder (HCC)   - stable, no recent seizure episode   - on phenobarb, continue   - last phenobarb level therapeutic on 3/23/23   - seizure precautions     Chronic constipation   - increased fibers and fluids   - prn laxative     Asthma   - stable, continue with albuterol neb tx while inpateint     GERD (gastroesophageal reflux disease)   - stable, on PPI, continue   Issues Requiring Follow Up: (Who, what, when, and how communicated?)   diet initiation of NDD Level 1 (purees) with nectar-thick liquids via single sips Follow-up with speech pathologist
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test negative, Urine analysis normal
Clinical narrative: Reason for Admission: 31 YO female with history of Rett's syndrome, seizure disorder, GERD, vitamin d deficiency, neurogenic bladder, chronic constipation, who was brought in due to symptoms of labored breathing with cough and fever since yesterday.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for bacterial left-sided pneumonia, what appears to be an incidental COVID 19 infection   weaned of oxygen, is being discharged on room     COVID-19 virus infection with hypoxia   - confirmed by rapid test   - symptomatic with cough, fever, hypoxia   - no known sick contacts   - prednisone po initiated in ED   -  antibiotics initiated in ED given result of CT chest suggestive of consolidation in left lung   - symptoms likely Covid-19 related, no leukocytosis  Given CT findings of complete whiteout of the left lung, this could be consolidation or aspiration causing collapse, would treat with IV Rocephin and IV doxycycline for now   - PCT is normal at 0.05, streptococcal and Legionella you urine antigens are also negative   - met parameters for Covid-19 treatment ( hypoxia requiring supplemental O2) > change prednisone to decadron po, remdesevir    - breathing treatments with albuterol nebulizer    - droplet precautions    - cough relief    - O2 per protocol 4/8 suggestion of pleural fluid, was reviewed with interventional radiologist Dr., not sufficient to need thoracentesis 4/9 chest x-ray does mention of moderate pleural effusion, will attempt to do thoracentesis tomorrow   4/10 3rd day of the discharge repeat chest x-ray shows significant improvement and bruit small amount of pleural effusion Active Problems:   With consideration of aspiration high on the list, speech therapy consult was made the modified the diet further patient to have follow-up VFSS as outpatient after being followed by about patient's speech therapy   Rett's syndrome   - neurology following out pt    - wheelchair-bound   - up to chair or wheelchair with 2 assists        Seizure disorder (HCC)   - stable, no recent seizure episode   - on phenobarb, continue   - last phenobarb level therapeutic on 3/23/23   - seizure precautions     Chronic constipation   - increased fibers and fluids   - prn laxative     Asthma   - stable, continue with albuterol neb tx while inpateint     GERD (gastroesophageal reflux disease)   - stable, on PPI, continue   Issues Requiring Follow Up: (Who, what, when, and how communicated?)   diet initiation of NDD Level 1 (purees) with nectar-thick liquids via single sips Follow-up with speech pathologist
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patent did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received Moderna COVID-19 vaccine first dose on 09-Dec-2020 with Lot number 011J20A, second dose on 26-Jan-2021 with lot number 029L20A, third dose on 24-Aug-2021 with lot number 014C21A and fourth dose on 04-Apr-2022 with lot number 065K21A.  Treatment medications were not provided.   This case was linked to MOD-2023-719119 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arrhythmia, Asthenia, Back pain, Blood pressure measurement
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, same product, different dose and events.;PR-PFIZER INC-202300150204 same patient, same product, different dose and events.;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Carpal tunnel syndrome, Deep vein thrombosis, Depression, Fatigue
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, same product, different dose and events.;PR-PFIZER INC-202300150204 same patient, same product, different dose and events.;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Hypersensitivity, Hypertension, Hypoaesthesia, Livedo reticularis
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, same product, different dose and events.;PR-PFIZER INC-202300150204 same patient, same product, different dose and events.;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Pyrexia, Rash, Renal failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, same product, different dose and events.;PR-PFIZER INC-202300150204 same patient, same product, different dose and events.;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis, Systemic lupus erythematosus, Thrombosis, Thyroid disorder
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, same product, different dose and events.;PR-PFIZER INC-202300150204 same patient, same product, different dose and events.;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, same product, different dose and events.;PR-PFIZER INC-202300150204 same patient, same product, different dose and events.;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Epiglottitis, Food allergy
Clinical narrative: Epiglottitis; Allergy to grapefruit and chocolate after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EPIGLOTTITIS (disability), outcome "unknown"; FOOD ALLERGY (disability), outcome "unknown", described as "Allergy to grapefruit and chocolate after the first dose".; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, different vaccine dose number and event;PR-PFIZER INC-202300150205 same patient, different vaccine dose number and event;
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic side effects; VAQTA that was inadvertently administered after it's expiration date; This non-valid spontaneous report was received from a certified medical assistant and refers to a patient of unknown age ad gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAR-2023, the patient was inadvertently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007375, expiration date: 16-JAN-2023 (expired product administered), administered for prophylaxis (dose, and route of administration were not provided). The vaccine had not experienced any temperature excursions and no symptomatic side effects were reported for the patient.  This report is non-valid due to lack of the patient's identifiers.  Follow up information recived on 07-APR-2023:  This spontanous report refers to 15-month-old male patient.The patient identifiers were provided. Vaccine administrator was provided.  Tis is one of the several cases recived from the same reporter.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: no additional AE; received on 3/21/2023; received on 3/15/2022; This spontaneous report was received from a registered nurse referring to an 84-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-MAR-2023, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 mL, administered for prophylaxis (lot# W019639, expiration date 06-MAY-2024; strength and route were not reported) (extra dose administered), but she had already received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on 15-MAR-2022 (inappropriate schedule of product administration) and 09-MAR-2021 (strength, dose, route, lot #, expiry date, and route of administration were not provided). No additional information was provided. No additional adverse event was reported.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Hormone level abnormal, Menopause
Clinical narrative: She stated that after receiving the first dose "she went into full-on menopause"; This spontaneous report has been received from a 42-year-old female patient, regarding herself. The patient's medical history, concurrent conditions, concomitant therapies and drugs reactions or allergies were not reported.  On 15-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (prevention of human papillomavirus [HPV]) (strength, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided).  On the same date, the patient went into full-on menopause, her hormone levels were tested and found to be at post-menopausal levels, performed by primary care physician (PCP). She was undecided if she would receive the next scheduled dose. The patient sought medical attention, and no received any treatment. At the time of reporting, the outcome of the event menopause was not provided.  The causal relationship between the event menopause and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic side effects; VAQTA that was inadvertently administered after it's expiration date; This non-valid spontaneous report was received from a certified medical assistant and refers to a patient of unknown age ad gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAR-2023, the patient was inadvertently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007375, expiration date: 16-JAN-2023 (expired product administered), administered for prophylaxis (dose, and route of administration were not provided). The vaccine had not experienced any temperature excursions and no symptomatic side effects were reported for the patient.  This report is non-valid due to lack of the patient's identifiers.  Follow up information recived on 07-APR-2023:  This spontanous report refers to 19-month-old male patient.The patient identifiers were provided. Vaccine administrator was provided.  Tis is one of the several cases recived from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Myalgia, Swelling, Vaccination failure
Clinical narrative: Has had breakthrough episode of shingles/Suspected vaccination failure; Has had breakthrough episode of shingles; Muscle aches; Redness; Swelling; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Has had breakthrough episode of shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Has had breakthrough episode of shingles), muscle pain (Verbatim: Muscle aches), erythema (Verbatim: Redness) and swelling (Verbatim: Swelling). The outcome of the vaccination failure was unknown and the outcome of the shingles, muscle pain, erythema and swelling were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, muscle pain, erythema and swelling to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, muscle pain, erythema and swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2023 The case was self-reported by the patient. The patient was over 50 years age. The patient received a dose of Shingles shot and it caused muscle aches, redness, swelling.  The patient said she had breakthrough episode of shingles on her lower back and back of her upper leg. The patient reported that it was always only on one side of her body. The patient asked if Shingrix was a 1x only. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine breakthrough infection
Clinical narrative: Has had breakthrough episode of shingles/Suspected vaccination failure; Has had breakthrough episode of shingles; Muscle aches; Redness; Swelling; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Has had breakthrough episode of shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Has had breakthrough episode of shingles), muscle pain (Verbatim: Muscle aches), erythema (Verbatim: Redness) and swelling (Verbatim: Swelling). The outcome of the vaccination failure was unknown and the outcome of the shingles, muscle pain, erythema and swelling were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, muscle pain, erythema and swelling to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, muscle pain, erythema and swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2023 The case was self-reported by the patient. The patient was over 50 years age. The patient received a dose of Shingles shot and it caused muscle aches, redness, swelling.  The patient said she had breakthrough episode of shingles on her lower back and back of her upper leg. The patient reported that it was always only on one side of her body. The patient asked if Shingrix was a 1x only. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.