chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swelling in lymph node located under left armpit; pain in lymph node located under left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in lymph node located under left armpit) and LYMPH NODE PAIN (pain in lymph node located under left armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling in lymph node located under left armpit) and LYMPH NODE PAIN (pain in lymph node located under left armpit). At the time of the report, LYMPHADENOPATHY (swelling in lymph node located under left armpit) and LYMPH NODE PAIN (pain in lymph node located under left armpit) outcome was unknown. Not Provided          No concomitant medication was reported. The treatment information was unknown. Patient got booster on Monday in my left shoulder.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Oral herpes, Pyrexia
Clinical narrative: cold sores; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; muscle soreness; joint pain; fever, 101.5°F, very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sores), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sores), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Rheumatologist recommended to stop taking biologicals when getting the vaccine.   This case was linked to MOD-2021-390501, MOD-2021-390502 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Lymphadenopathy, Myalgia, Odynophagia
Clinical narrative: cold sores; it was painful to swallow; fever, 101.5°F, very low grade fever; muscle soreness/ minor soreness; joint pain; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores), ODYNOPHAGIA (it was painful to swallow), PYREXIA (fever, 101.5°F, very low grade fever), MYALGIA (muscle soreness/ minor soreness) and ARTHRALGIA (joint pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sores), ODYNOPHAGIA (it was painful to swallow), PYREXIA (fever, 101.5°F, very low grade fever), MYALGIA (muscle soreness/ minor soreness), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, ORAL HERPES (cold sores), PYREXIA (fever, 101.5°F, very low grade fever) and MYALGIA (muscle soreness/ minor soreness) had not resolved and ODYNOPHAGIA (it was painful to swallow), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5°f (High) fever 101.5°F.         Patient reported that his Rheumatologist recommended to stop taking biologicals when getting the vaccine.     This case was linked to MOD-2021-390501, MOD-2021-390480 (Patient Link).   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia
Clinical narrative: cold sores; it was painful to swallow; fever, 101.5°F, very low grade fever; muscle soreness/ minor soreness; joint pain; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores), ODYNOPHAGIA (it was painful to swallow), PYREXIA (fever, 101.5°F, very low grade fever), MYALGIA (muscle soreness/ minor soreness) and ARTHRALGIA (joint pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sores), ODYNOPHAGIA (it was painful to swallow), PYREXIA (fever, 101.5°F, very low grade fever), MYALGIA (muscle soreness/ minor soreness), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, ORAL HERPES (cold sores), PYREXIA (fever, 101.5°F, very low grade fever) and MYALGIA (muscle soreness/ minor soreness) had not resolved and ODYNOPHAGIA (it was painful to swallow), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5°f (High) fever 101.5°F.         Patient reported that his Rheumatologist recommended to stop taking biologicals when getting the vaccine.     This case was linked to MOD-2021-390501, MOD-2021-390480 (Patient Link).   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm turned and stayed real red for about 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned and stayed real red for about 2 weeks) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Arm turned and stayed real red for about 2 weeks). At the time of the report, ERYTHEMA (Arm turned and stayed real red for about 2 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-390656 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Patient was admitted in the hospital; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Patient was admitted in the hospital) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced HOSPITALISATION (Patient was admitted in the hospital) (seriousness criterion hospitalization). The patient was hospitalized on 06-Nov-2021 due to HOSPITALISATION. At the time of the report, HOSPITALISATION (Patient was admitted in the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was scheduled to take second dose on 06 Nov 2021 but he stayed in the hospital for a week for another condition that the caller mentioned it was unrelated to the vaccine. No treatment information was provided.  Company comment This case concerns a 26 year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Hospitalisation. The event occurred approximately 19 days after the first dose of mRNA-1273 vaccine. The reporter stated the patient has hospitalised a week for another condition that was unrelated to the vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The event was considered unrelated to the vaccine per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 26 year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Hospitalisation. The event occurred approximately 19 days after the first dose of mRNA-1273 vaccine. The reporter stated the patient has hospitalised a week for another condition that was unrelated to the vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The event was considered unrelated to the vaccine per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rhinorrhoea
Clinical narrative: nose keeps running; 100.2 degrees F fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose keeps running) and PYREXIA (100.2 degrees F fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RHINORRHOEA (nose keeps running) and PYREXIA (100.2 degrees F fever). At the time of the report, RHINORRHOEA (nose keeps running) and PYREXIA (100.2 degrees F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 100.2 (High) 100.2 degrees F fever.         No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Swelling, hardness and redness at left arm injection site; Had a headache all day yesterday; Redness at left arm injection site; Hardness at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling, hardness and redness at left arm injection site), HEADACHE (Had a headache all day yesterday), VACCINATION SITE ERYTHEMA (Redness at left arm injection site) and VACCINATION SITE INDURATION (Hardness at left arm injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling, hardness and redness at left arm injection site), HEADACHE (Had a headache all day yesterday), VACCINATION SITE ERYTHEMA (Redness at left arm injection site) and VACCINATION SITE INDURATION (Hardness at left arm injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling, hardness and redness at left arm injection site), HEADACHE (Had a headache all day yesterday), VACCINATION SITE ERYTHEMA (Redness at left arm injection site) and VACCINATION SITE INDURATION (Hardness at left arm injection site) outcome was unknown.            Concomitant medications were not reported.  Treatment details were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: lower back felt like it was breaking; severe nausea [after second dose]; fever; chills; aches and pains all over my body; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back felt like it was breaking), NAUSEA (severe nausea [after second dose]), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back felt like it was breaking), NAUSEA (severe nausea [after second dose]), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body). At the time of the report, BACK PAIN (lower back felt like it was breaking), NAUSEA (severe nausea [after second dose]), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) outcome was unknown.            Patient reported that her all vaccination doses were given in her deltoid.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-390522, MOD-2021-390664 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspepsia, Myalgia, Pyrexia
Clinical narrative: lower back felt like it was breaking; inside my stomach felt really hot [after third dose], burning; fever; chills; aches and pains all over my body; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back felt like it was breaking), DYSPEPSIA (inside my stomach felt really hot [after third dose], burning), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back felt like it was breaking), DYSPEPSIA (inside my stomach felt really hot [after third dose], burning), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body). At the time of the report, BACK PAIN (lower back felt like it was breaking), DYSPEPSIA (inside my stomach felt really hot [after third dose], burning), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) outcome was unknown.            No Concomitant medication was provided.  No treatment medication was provided.  Company comment: This case concerns a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected events of back pain, dyspepsia and non-serious expected events of pyrexia, chills and myalgia. The events occurred  on unknown date after third dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-390522, MOD-2021-390656 (Patient Link).; Sender's Comments: This case concerns a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected events of back pain, dyspepsia and non-serious expected events of pyrexia, chills and myalgia. The events occurred  on unknown date after third dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Vaccination site erythema
Clinical narrative: got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow; is tender to  touch; have some fatigue, but so far no fever; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow), INJECTION SITE PAIN (is tender to  touch) and FATIGUE (have some fatigue, but so far no fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow), INJECTION SITE PAIN (is tender to  touch) and FATIGUE (have some fatigue, but so far no fever). At the time of the report, VACCINATION SITE ERYTHEMA (got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow), INJECTION SITE PAIN (is tender to  touch) and FATIGUE (have some fatigue, but so far no fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 027b21a) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021). On 08-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021) had resolved.            Concomitant medication includes medication for her thyroid No treatment medications provided by the reporter. This case concerns a 64-year-old female patient, with no relevant medical history, who experienced the non-serious event of inappropriate schedule of product administration. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The patient received second dose 4 months after the first dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-390783 (Patient Link).; Sender's Comments: This case concerns a 64-year-old female patient, with no relevant medical history, who experienced the non-serious event of inappropriate schedule of product administration. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The patient received second dose 4 months after the first dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.  This is a spontaneous case concerning a 74-year-old patient of unknown gender with no relevant medical history, who experienced the non serious event of expired product administered. The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 4 days past the expiration date with lot number 047B21A. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old patient of unknown gender with no relevant medical history, who experienced the non serious event of expired product administered. The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 4 days past the expiration date with lot number 047B21A. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medications were provided. This case concerns a 72-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 72-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.; Sender's Comments: This case concerns a 73-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the third day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experience adverse event.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. There was no product quality issues.  Company comment- This case concerns a 77-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a 77-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Unfortunately we did use this beyond the use date of 10/9/21.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experience adverse event.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Mammogram
Clinical narrative: One arm has lymphedema; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHOEDEMA (One arm has lymphedema) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Breast cancer.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced LYMPHOEDEMA (One arm has lymphedema). At the time of the report, LYMPHOEDEMA (One arm has lymphedema) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: positive (Positive) False positive result.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The reporter stated that other arm gave a false positive result on the mammogram whenever she got the first 2 doses due to the covid vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received included 3rd dose details  of Moderna vaccine..
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Unfortunately we did use this beyond the use date of 10/9/21.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.  This is a case of Expired Product Administered concerning a 73-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 73-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Pain in extremity, Vaccination site induration, Vaccination site mass
Clinical narrative: feels hard (at injection site); left arm became sore; lumpy at injection site/ puffy at the injection site; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), PAIN IN EXTREMITY (left arm became sore), VACCINATION SITE MASS (lumpy at injection site/ puffy at the injection site) and VACCINATION SITE INDURATION (feels hard (at injection site)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 10-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (left arm became sore) and VACCINATION SITE MASS (lumpy at injection site/ puffy at the injection site). On 17-Nov-2021, the patient experienced VACCINATION SITE INDURATION (feels hard (at injection site)). On 14-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm became sore), VACCINATION SITE MASS (lumpy at injection site/ puffy at the injection site) and VACCINATION SITE INDURATION (feels hard (at injection site)) outcome was unknown.            Patient stated that she takes other medications and Concomitant medication details were not provided. Treatment information was not provided. Patient had no known drug or food allergies.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. This case concerns a 63-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 63-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Oropharyngeal pain
Clinical narrative: experiencing a sore throat; experiencing a cough; experiencing a voice change; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (experiencing a sore throat), COUGH (experiencing a cough) and DYSPHONIA (experiencing a voice change) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (experiencing a sore throat), COUGH (experiencing a cough) and DYSPHONIA (experiencing a voice change). At the time of the report, OROPHARYNGEAL PAIN (experiencing a sore throat), COUGH (experiencing a cough) and DYSPHONIA (experiencing a voice change) had not resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.; Sender's Comments: This case concerns a patient, unknown age and gender,  with no known medical history, who experienced the non-serious, unexpected events of oropharyngeal pain, cough, and dysphonia. The events occurred  on unknown date after third dose of mRNA 1273 vaccine. The patient reports sore throat, voice change and cough that is ongoing as of receipt of the report.The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.