chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Leukopenia, Liver function test, Osteomyelitis, Pain
Clinical narrative: Narrative:  Patient is a resident of the nursing home since 11/1/22 - short rehab admission. 01/2/23 - Pt spiked fever overnight 1/1-1/2 = 100.8 and report of cough, congestion (couple of days), and runny nose. Isolation and Signs/Symptoms Assessment following exposure to a confirmed case with a communicable pathogen. Pt admitted to hospital medical floor on 1/2/23 d/t agency institutional policy. Upon admission to medical floor: Pt admits to cough (non productive, started within 24 hours), congestion, fatigue, chills. Pt denies CP, SOB, abd pain, N/V/D. Principal diagnosis (Reason for admission after study) = 1. acute mild COVID infection; 2. acute osteomyelitis of the left foot/TMA on 12/8/22. Additional diagnosis include: 3. PAD - 10/19/2022 S/P Angioplasty; Hx Stents x 2 4. ESRD on HD 5. Diabetes Mellitus, Type 2: 6. HTN: 7. HD: 8. H/O Stroke: 9. GERD: 10. Chronic PTSD: 11. Leukocytopenia: 12. Constipation: HOSPITAL COURSE: Hemodynamically stable. Patient remains with asymptomatic COVID on resp isolation until 1/13/22. 10 day resp isolation from 1/2/23. Pt is returning further tx at nursing home for continued care for mgmt of acute osteo of the left foot/ s/p TMA on 12/8/22. 1. Acute Mild Covid Infection: - Hemodynamically, remains asymptomatic on RA. Resp Isolation will be completed as of today. Continue with the plan for the patient to be transferred back to nursing home to continue hyperbaric treatment s/p TMA 2/2 to VRE. 2. Acute Osteomyelitis of the Left Foot/TMA on 12/8/22: - Followed by ID - Pt is on IV dapto/cefepime until 2/7/23. Pt received abtx with HD sessions - T/TH/S. CPK and LFTs monitored closely 2/2 to pt being on dapto - CPK has stayed elevated but essentially unchanged. Pt denies any muscle pain, chest pain, sob or general discomfort. - See #1 for plan of care for d/c status - Related hx: 10/20/2022 S/P amputation of left hallux 10/15/2022 S/P Left foot sichemia with gangrene of hallux - Ct supportive care, monitoring, prn pain med (lortab 5/325 mg daily prn)and wound/dsg care by WCN. - Ct hyperbaric treatment w/ wound vac as per vascular surgery - Ct monitoring screening labs with PRN supplementation CHRONIC MEDICAL CONDITIONS 3. PAD - 10/19/2022 S/P Angioplasty cont apixiban, asa, gabapentin. Hx Stents x 2 4. ESRD on HD - managed by renal - tu/thus/sat 5. Diabetes Mellitus, Type 2: Ct 32 units glargine qhs and 9 units aspart with meals. ssi - <10 units use noted. 6. HTN: Ct amlodipine 10 mgpo daily 7. HD: Ct to hold lipitor held due to being on dapto/ drug interaction 8. hx of stroke on asa and doac 9. GERD: Ct Prilosec 10. Chronic PTSD: Ct on prozosin 4mg po 11. Leukocytopenia: RESOLVED 12. Constipation: Ct miralax daily, s/p 1 dose of Senna Patient discharged back to nursing home on 1/13/23.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral arterial occlusive disease, Peripheral ischaemia, Post-traumatic stress disorder, Pyrexia, Respiratory tract congestion
Clinical narrative: Narrative:  Patient is a resident of the nursing home since 11/1/22 - short rehab admission. 01/2/23 - Pt spiked fever overnight 1/1-1/2 = 100.8 and report of cough, congestion (couple of days), and runny nose. Isolation and Signs/Symptoms Assessment following exposure to a confirmed case with a communicable pathogen. Pt admitted to hospital medical floor on 1/2/23 d/t agency institutional policy. Upon admission to medical floor: Pt admits to cough (non productive, started within 24 hours), congestion, fatigue, chills. Pt denies CP, SOB, abd pain, N/V/D. Principal diagnosis (Reason for admission after study) = 1. acute mild COVID infection; 2. acute osteomyelitis of the left foot/TMA on 12/8/22. Additional diagnosis include: 3. PAD - 10/19/2022 S/P Angioplasty; Hx Stents x 2 4. ESRD on HD 5. Diabetes Mellitus, Type 2: 6. HTN: 7. HD: 8. H/O Stroke: 9. GERD: 10. Chronic PTSD: 11. Leukocytopenia: 12. Constipation: HOSPITAL COURSE: Hemodynamically stable. Patient remains with asymptomatic COVID on resp isolation until 1/13/22. 10 day resp isolation from 1/2/23. Pt is returning further tx at nursing home for continued care for mgmt of acute osteo of the left foot/ s/p TMA on 12/8/22. 1. Acute Mild Covid Infection: - Hemodynamically, remains asymptomatic on RA. Resp Isolation will be completed as of today. Continue with the plan for the patient to be transferred back to nursing home to continue hyperbaric treatment s/p TMA 2/2 to VRE. 2. Acute Osteomyelitis of the Left Foot/TMA on 12/8/22: - Followed by ID - Pt is on IV dapto/cefepime until 2/7/23. Pt received abtx with HD sessions - T/TH/S. CPK and LFTs monitored closely 2/2 to pt being on dapto - CPK has stayed elevated but essentially unchanged. Pt denies any muscle pain, chest pain, sob or general discomfort. - See #1 for plan of care for d/c status - Related hx: 10/20/2022 S/P amputation of left hallux 10/15/2022 S/P Left foot sichemia with gangrene of hallux - Ct supportive care, monitoring, prn pain med (lortab 5/325 mg daily prn)and wound/dsg care by WCN. - Ct hyperbaric treatment w/ wound vac as per vascular surgery - Ct monitoring screening labs with PRN supplementation CHRONIC MEDICAL CONDITIONS 3. PAD - 10/19/2022 S/P Angioplasty cont apixiban, asa, gabapentin. Hx Stents x 2 4. ESRD on HD - managed by renal - tu/thus/sat 5. Diabetes Mellitus, Type 2: Ct 32 units glargine qhs and 9 units aspart with meals. ssi - <10 units use noted. 6. HTN: Ct amlodipine 10 mgpo daily 7. HD: Ct to hold lipitor held due to being on dapto/ drug interaction 8. hx of stroke on asa and doac 9. GERD: Ct Prilosec 10. Chronic PTSD: Ct on prozosin 4mg po 11. Leukocytopenia: RESOLVED 12. Constipation: Ct miralax daily, s/p 1 dose of Senna Patient discharged back to nursing home on 1/13/23.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Toe amputation, Type 2 diabetes mellitus, Wound
Clinical narrative: Narrative:  Patient is a resident of the nursing home since 11/1/22 - short rehab admission. 01/2/23 - Pt spiked fever overnight 1/1-1/2 = 100.8 and report of cough, congestion (couple of days), and runny nose. Isolation and Signs/Symptoms Assessment following exposure to a confirmed case with a communicable pathogen. Pt admitted to hospital medical floor on 1/2/23 d/t agency institutional policy. Upon admission to medical floor: Pt admits to cough (non productive, started within 24 hours), congestion, fatigue, chills. Pt denies CP, SOB, abd pain, N/V/D. Principal diagnosis (Reason for admission after study) = 1. acute mild COVID infection; 2. acute osteomyelitis of the left foot/TMA on 12/8/22. Additional diagnosis include: 3. PAD - 10/19/2022 S/P Angioplasty; Hx Stents x 2 4. ESRD on HD 5. Diabetes Mellitus, Type 2: 6. HTN: 7. HD: 8. H/O Stroke: 9. GERD: 10. Chronic PTSD: 11. Leukocytopenia: 12. Constipation: HOSPITAL COURSE: Hemodynamically stable. Patient remains with asymptomatic COVID on resp isolation until 1/13/22. 10 day resp isolation from 1/2/23. Pt is returning further tx at nursing home for continued care for mgmt of acute osteo of the left foot/ s/p TMA on 12/8/22. 1. Acute Mild Covid Infection: - Hemodynamically, remains asymptomatic on RA. Resp Isolation will be completed as of today. Continue with the plan for the patient to be transferred back to nursing home to continue hyperbaric treatment s/p TMA 2/2 to VRE. 2. Acute Osteomyelitis of the Left Foot/TMA on 12/8/22: - Followed by ID - Pt is on IV dapto/cefepime until 2/7/23. Pt received abtx with HD sessions - T/TH/S. CPK and LFTs monitored closely 2/2 to pt being on dapto - CPK has stayed elevated but essentially unchanged. Pt denies any muscle pain, chest pain, sob or general discomfort. - See #1 for plan of care for d/c status - Related hx: 10/20/2022 S/P amputation of left hallux 10/15/2022 S/P Left foot sichemia with gangrene of hallux - Ct supportive care, monitoring, prn pain med (lortab 5/325 mg daily prn)and wound/dsg care by WCN. - Ct hyperbaric treatment w/ wound vac as per vascular surgery - Ct monitoring screening labs with PRN supplementation CHRONIC MEDICAL CONDITIONS 3. PAD - 10/19/2022 S/P Angioplasty cont apixiban, asa, gabapentin. Hx Stents x 2 4. ESRD on HD - managed by renal - tu/thus/sat 5. Diabetes Mellitus, Type 2: Ct 32 units glargine qhs and 9 units aspart with meals. ssi - <10 units use noted. 6. HTN: Ct amlodipine 10 mgpo daily 7. HD: Ct to hold lipitor held due to being on dapto/ drug interaction 8. hx of stroke on asa and doac 9. GERD: Ct Prilosec 10. Chronic PTSD: Ct on prozosin 4mg po 11. Leukocytopenia: RESOLVED 12. Constipation: Ct miralax daily, s/p 1 dose of Senna Patient discharged back to nursing home on 1/13/23.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Wound closure, Wound treatment
Clinical narrative: Narrative:  Patient is a resident of the nursing home since 11/1/22 - short rehab admission. 01/2/23 - Pt spiked fever overnight 1/1-1/2 = 100.8 and report of cough, congestion (couple of days), and runny nose. Isolation and Signs/Symptoms Assessment following exposure to a confirmed case with a communicable pathogen. Pt admitted to hospital medical floor on 1/2/23 d/t agency institutional policy. Upon admission to medical floor: Pt admits to cough (non productive, started within 24 hours), congestion, fatigue, chills. Pt denies CP, SOB, abd pain, N/V/D. Principal diagnosis (Reason for admission after study) = 1. acute mild COVID infection; 2. acute osteomyelitis of the left foot/TMA on 12/8/22. Additional diagnosis include: 3. PAD - 10/19/2022 S/P Angioplasty; Hx Stents x 2 4. ESRD on HD 5. Diabetes Mellitus, Type 2: 6. HTN: 7. HD: 8. H/O Stroke: 9. GERD: 10. Chronic PTSD: 11. Leukocytopenia: 12. Constipation: HOSPITAL COURSE: Hemodynamically stable. Patient remains with asymptomatic COVID on resp isolation until 1/13/22. 10 day resp isolation from 1/2/23. Pt is returning further tx at nursing home for continued care for mgmt of acute osteo of the left foot/ s/p TMA on 12/8/22. 1. Acute Mild Covid Infection: - Hemodynamically, remains asymptomatic on RA. Resp Isolation will be completed as of today. Continue with the plan for the patient to be transferred back to nursing home to continue hyperbaric treatment s/p TMA 2/2 to VRE. 2. Acute Osteomyelitis of the Left Foot/TMA on 12/8/22: - Followed by ID - Pt is on IV dapto/cefepime until 2/7/23. Pt received abtx with HD sessions - T/TH/S. CPK and LFTs monitored closely 2/2 to pt being on dapto - CPK has stayed elevated but essentially unchanged. Pt denies any muscle pain, chest pain, sob or general discomfort. - See #1 for plan of care for d/c status - Related hx: 10/20/2022 S/P amputation of left hallux 10/15/2022 S/P Left foot sichemia with gangrene of hallux - Ct supportive care, monitoring, prn pain med (lortab 5/325 mg daily prn)and wound/dsg care by WCN. - Ct hyperbaric treatment w/ wound vac as per vascular surgery - Ct monitoring screening labs with PRN supplementation CHRONIC MEDICAL CONDITIONS 3. PAD - 10/19/2022 S/P Angioplasty cont apixiban, asa, gabapentin. Hx Stents x 2 4. ESRD on HD - managed by renal - tu/thus/sat 5. Diabetes Mellitus, Type 2: Ct 32 units glargine qhs and 9 units aspart with meals. ssi - <10 units use noted. 6. HTN: Ct amlodipine 10 mgpo daily 7. HD: Ct to hold lipitor held due to being on dapto/ drug interaction 8. hx of stroke on asa and doac 9. GERD: Ct Prilosec 10. Chronic PTSD: Ct on prozosin 4mg po 11. Leukocytopenia: RESOLVED 12. Constipation: Ct miralax daily, s/p 1 dose of Senna Patient discharged back to nursing home on 1/13/23.
Age: 93.0
Sex: M
Vaccine: FLUX
Symptoms: Ataxia, Hyporeflexia
Clinical narrative: Narrative:  The patient presented to the ED with ataxia and decreased reflexes.  The patient or caregiver refer he was administered a influenza vaccines outside the facility about two weeks before the ED visit. There is no evidence of vaccine administration outside facility.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Narrative:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Narrative:  Patient developed rash on right arm, states that is where he received the vaccine though it is documented he received it on left arm. Being reported to RN one month post vaccination. RN observes rash on right deltoid. No treatment was given, patient was educated he could use benadryl OTC if needed and to refrain from scratching it. No further issues noted.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative: NONE REPRTED
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 94.0
Sex: M
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case belongs to adult patient 5 of the 17 adult patients reported.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received on 19-Jan-2023, no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.).    No concomitant medication was provided.  Treatment medication was not provided by the reporter.  This case was reported for patient 9th out of 17 adults patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: No new information was provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses after the 30 day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses after the 30 day) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses after the 30 day). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses after the 30 day) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses after the 30 day).    Concomitant and treatment medication information was not reported.  Date and Time of Last Administration was reported as 17-Jan-2023.  This case is created for 7th Patient out of 17 Adult patients   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received and contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses).    No concomitant medication was provided.  Treatment medication was not provided by the reporter.  This case was reported for patient 8th out of 17 adults patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case belonged to adult patient 4 out of 17 patients described by the reporter.  Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received and contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.).    This case belongs to adult patient 12 of the 17 adult patients reported.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received on 19-Jan-2023, no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.).    This case belongs to adult patient 17 of the 17 adult patients reported.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received on 19-Jan-2023, no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 2/18/21 Lot# 010M20A;  Moderna 3/18/21 Lot# 037K20A;
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Delivery, Exposure during pregnancy, Premature labour, SARS-CoV-2 test positive
Clinical narrative: 01/15/22 presents to Birth Center Triage for "contractions" "SVD (spontaneous vaginal delivery)""39w2d".  No significant PMH.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, Premature labour, SARS-CoV-2 test positive
Clinical narrative: 01/15/22 presents to Birth Center Triage for "Contractions" "38w6d". PMHx of "HSV"
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Clear cell endometrial carcinoma, Endometrial cancer stage III, Laboratory test abnormal, Postmenopausal haemorrhage, Surgery
Clinical narrative: A few months after receiving my final dose of the pfizer vax I started having post menopausal bleeding which turned out to be endometrial cancer -clear cell carcinoma stage 3 - this is not hereditary.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient received Janssen 1 day after receiving Pfizer Vaccine
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: pain at the site of injection-Medium
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: pain at the site of injection-Medium
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Pruritus, Rash, Skin reaction
Clinical narrative: ; This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "I am not happy about it"; RASH ERYTHEMATOUS (non-serious) with onset 2022, outcome "unknown", described as "I got a rash that was from my thigh line to my knee cap with total red flared up with bumpy and itchy and skin coming off of that"; SKIN REACTION (non-serious) with onset 2022, outcome "unknown"; SCAB (non-serious) with onset 2022, outcome "unknown", described as "even though my flared up went away I have these scabs on my skin"; BURNING SENSATION (non-serious) with onset 2022, outcome "unknown", described as "inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SCAR (non-serious) with onset 2022, outcome "unknown", described as "left pigmentation of a scar of burnt of scabby flat scar skin and off and on burning"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "skin was itching very badly/inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SKIN HYPERPIGMENTATION (non-serious) with onset 2022, outcome "unknown", described as "thigh patches to my knee patches of scabby, scaly, burn kind of looking skin not burnt but what you call it hyperpigmentation skin; it is white like a ghost and then there is some dots".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling abnormal, Pruritus, Rash erythematous, Scab
Clinical narrative: ; This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "I am not happy about it"; RASH ERYTHEMATOUS (non-serious) with onset 2022, outcome "unknown", described as "I got a rash that was from my thigh line to my knee cap with total red flared up with bumpy and itchy and skin coming off of that"; SKIN REACTION (non-serious) with onset 2022, outcome "unknown"; SCAB (non-serious) with onset 2022, outcome "unknown", described as "even though my flared up went away I have these scabs on my skin"; BURNING SENSATION (non-serious) with onset 2022, outcome "unknown", described as "inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SCAR (non-serious) with onset 2022, outcome "unknown", described as "left pigmentation of a scar of burnt of scabby flat scar skin and off and on burning"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "skin was itching very badly/inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SKIN HYPERPIGMENTATION (non-serious) with onset 2022, outcome "unknown", described as "thigh patches to my knee patches of scabby, scaly, burn kind of looking skin not burnt but what you call it hyperpigmentation skin; it is white like a ghost and then there is some dots".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Scar, Skin hyperpigmentation, Skin reaction
Clinical narrative: ; This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "I am not happy about it"; RASH ERYTHEMATOUS (non-serious) with onset 2022, outcome "unknown", described as "I got a rash that was from my thigh line to my knee cap with total red flared up with bumpy and itchy and skin coming off of that"; SKIN REACTION (non-serious) with onset 2022, outcome "unknown"; SCAB (non-serious) with onset 2022, outcome "unknown", described as "even though my flared up went away I have these scabs on my skin"; BURNING SENSATION (non-serious) with onset 2022, outcome "unknown", described as "inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SCAR (non-serious) with onset 2022, outcome "unknown", described as "left pigmentation of a scar of burnt of scabby flat scar skin and off and on burning"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "skin was itching very badly/inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SKIN HYPERPIGMENTATION (non-serious) with onset 2022, outcome "unknown", described as "thigh patches to my knee patches of scabby, scaly, burn kind of looking skin not burnt but what you call it hyperpigmentation skin; it is white like a ghost and then there is some dots".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Expired product administered; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 06-JAN-2023, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) thimerosal free (RECOMBIVAX HB) intramuscular injection (lot number U019135 has been verified to be valid; expiration date reported and established as 22-NOV-2022) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse event had occurred.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; HCP reported an expired dose of RECOMBIVAX HB was administered to a patient.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.     On 13-DEC-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (expired product administered), lot # T032918, expiration date 12-NOV-2022, 0.5 milliliter for prophylaxis (route not reported). The licensed practical nurse confirmed that the vaccine had no prior temperature excursions. No additional adverse event or product quality complaint were reported.
Sex: F
Vaccine: PNC15, PNC20
Symptoms: Product confusion, Wrong product administered
Clinical narrative: no adverse event; patient was inadvertently given PREVNAR 20 at her local pharmacy when she requested the product VAXNEUVANCE; patient was inadvertently given PREVNAR 20 at her local pharmacy when she requested the product VAXNEUVANCE; This spontaneous report was received from a female consumer of unknown age reporting on herself. On 11-JAN-2023, the patient was inadvertently given pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (dose, route and lot # not reported) when she requested pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). The patient stated she was high risk and she had already been vaccinated with pneumococcal vaccine conj 13v (crm197)) (PREVNAR 13) in the past, but she wanted pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) to be protected against the additional strains. She stated there was a confusion at the pharmacy she went to and they did not think they had pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and did not know what pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was so they gave her the pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) instead (Product confusion, Wrong product administered).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired VAQTA; This spontaneous report has been received from a consumer referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-JAN-2023, the patient has vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) intramuscular Injection (lot #W007382 had been verified to be a valid number; expiration date 16-JAN-2023, and upon internal validation established as the same date) for prophylaxis (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) (expired product administered). No additional adverse events were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA006915:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Autoimmune disorder, Premature menopause
Clinical narrative: Gardasil-induced autoimmune disorder; premature ovarian failure; secondary amenorrhea; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient had no autoimmune diseases prior to vaccination. On 15-FEB-2013, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) following her primary care physician's advice, for the prevention of cancer. On 29-JUN-2016, during a visit to the Clinic, her doctor noted that her last menstrual cycle was in December 2015 and referred her to an endocrinologist. On 28-JUL-2016, the patient was evaluated for secondary amenorrhea. During the evaluation, it was noted that her menses were normally until 8 months ago. She was diagnosed with secondary amenorrhea. On 04-AUG-2016, she returned to the Clinic and was diagnosed with premature ovarian failure. According to the reporter, the patient's Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating injuries, including but not limited to autoimmune disease, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) induced autoimmune disorder (onset date not provided). The outcome of the events was unknown. Causality assessment was considered related.  Upon internal review, the event of autoimmune disorder was considered medically significant.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; a patient was administered a vaccine that was reconstituted with an expired STERILE DILUENT.; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender. The patient's medical history, concomitant medications, previous drug reactions, and allergies were not provided.  On 19-JAN-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 1 dose as prophylaxis (lot number W021740 has been verified to be valid; expiration date reported and established as 10-JUL-2024) (strength, dose, route of administration, and anatomical location were not provided), diluted with an expired sterile diluent (lot number T017425 has been verified to be valid; expiration date reported and established as 22-DEC-2022) (expired product administered). No other adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired lot of PNEUMOVAX 23 / lot expired on 1/8/23 and vaccine was administered on 1/20/23; This spontaneous report was received from a Medical Assistant and refers to a 75 year old male patient. Information regarding the patient's concurrent conditions, pertinent medial history and concomitant medications was not provided.     On 20-JAN-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (Lot # U018309, expiration date 08-JAN-2023), dosage 0.5 ml once, route of administration and anatomical location were not reported for prophylaxis.  No additional adverse events, no product quality complaint (PQC) were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs/no PQCs; HCP reporting that a patient was administered an expired dose of PNEUMOVAX 23 on 01/18/2023. No further information was provided. Consent to contact HCP was provided. No additional AEs/no PQCs.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant medications, previous drug reactions, and allergies were not provided.  On 18-JAN-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection as prophylaxis (lot number U022819 has been verified to be valid; expiration date reported and established as 14-JAN-2023) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects reported; an expired dose of VARIVAX was accidently administered to a patient today, 1/20/23. The vaccine expired on 12/9/22; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 20-JAN-2023 (also reported as "today"), the patient was accidently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), 5 milligram (mg), administered subcutaneously (sq), (lot # T041505, has been verified to be a valid lot number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date reported and upon internal validation established as 09-DEC-2022) for prophylaxis (Expired product administered). An sterile diluent was used to reconstitute the expired vaccine (lot# T018894, has been verified to be a valid lot number for the sterile diluent, expiration date reported and upon internal validation established as 02-MAR-2023).  No adverse side effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm is still red; Arm sore; This case was reported by a consumer and described the occurrence of erythema of extremities in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th January 2023, the patient received Shingles vaccine. On 13th January 2023, 1 days after receiving Shingles vaccine, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter's comment:  The patient received Shingles vaccine and patient arm was still red and sore after the 6th day of getting shingles shot. The symptoms of patient were not treated. The reporter did not consent to follow up.