chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Skin lesion
Clinical narrative: about 4 days after I received the first shot of vaccine the red spots returnedover my body; the spots and skin lesions re-appeared; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (about 4 days after I received the first shot of vaccine the red spots returnedover my body) and SKIN LESION (the spots and skin lesions re-appeared) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis (Had about 10years ago; The spots and lesions disappeared for the past 6 years; ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (about 4 days after I received the first shot of vaccine the red spots returnedover my body) and SKIN LESION (the spots and skin lesions re-appeared). At the time of the report, RASH MACULAR (about 4 days after I received the first shot of vaccine the red spots returnedover my body) and SKIN LESION (the spots and skin lesions re-appeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment information  was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added Medical History - Psoriasis; Added Dose number-- 1; Added Event - Skin lesion;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pruritus, Rash
Clinical narrative: (Rash on front of legs) Itching/Right Elbow itching/Left Elbow Itching; Rash on the front of legs; Chills Really Bad for 2 days; "No Good"; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS ((Rash on front of legs) Itching/Right Elbow itching/Left Elbow Itching), RASH (Rash on the front of legs), CHILLS (Chills Really Bad for 2 days) and MALAISE ("No Good") in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C1A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced CHILLS (Chills Really Bad for 2 days) and MALAISE ("No Good"). On 13-Jun-2021, the patient experienced PRURITUS ((Rash on front of legs) Itching/Right Elbow itching/Left Elbow Itching) and RASH (Rash on the front of legs). The patient was treated with IBUPROFEN ongoing from 11-Jun-2021 at a dose of 1 dosage form and LORATADINE (CLARITIN [LORATADINE]) ongoing from 14-Jun-2021 at a dose of 10 mg. On 13-Jun-2021, CHILLS (Chills Really Bad for 2 days) had resolved. On 15-Jun-2021, PRURITUS ((Rash on front of legs) Itching/Right Elbow itching/Left Elbow Itching) had resolved. At the time of the report, RASH (Rash on the front of legs) had not resolved and MALAISE ("No Good") outcome was unknown.            No concomitant medication were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-221984 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was administered 7 days earlier; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered 7 days earlier) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered 7 days earlier). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered 7 days earlier) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) 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 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) outcome was unknown.            No concomitant medications reported. Patient reported blood in urine started the day after the second dose was administered.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) 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 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 PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine had been out of the fridge for 18 hours; vaccine had been out of the fridge for 18 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine had been out of the fridge for 18 hours) and PRODUCT STORAGE ERROR (vaccine had been out of the fridge for 18 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine had been out of the fridge for 18 hours) and PRODUCT STORAGE ERROR (vaccine had been out of the fridge for 18 hours). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccine had been out of the fridge for 18 hours) and PRODUCT STORAGE ERROR (vaccine had been out of the fridge for 18 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  It was reported that the Moderna COVID-19 Vaccine was left at room temperature at 02:58 PM on 14Jun2021 and then administered to three individuals on 15un2021. No patient information was provided other than this was the first dose for two patients and the second dose for one patient.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received and contains no new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itched around the site of the injection after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itched around the site of the injection after the first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PRURITUS (itched around the site of the injection after the first dose). At the time of the report, VACCINATION SITE PRURITUS (itched around the site of the injection after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: have not received the second dose of the Moderna vaccine yet, and is now day 42; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (have not received the second dose of the Moderna vaccine yet, and is now day 42) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received the second dose of the Moderna vaccine yet, and is now day 42). At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received the second dose of the Moderna vaccine yet, and is now day 42) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: have not received the second dose of the Moderna vaccine yet, and is now day 42; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (have not received the second dose of the Moderna vaccine yet, and is now day 42) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (have not received the second dose of the Moderna vaccine yet, and is now day 42). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (have not received the second dose of the Moderna vaccine yet, and is now day 42) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of lymphadenopathy (swollen cervical lymph node on the right-side of neck) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (swollen cervical lymph node on the right-side of neck). At the time of the report, lymphadenopathy (swollen cervical lymph node on the right-side of neck) outcome:  unknown. Action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Consent for follow-up accepted. This case linked to MOD-2021-222025 (patient link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Nasopharyngitis, Oral discomfort
Clinical narrative: Burning throat; Burning mouth; Bad taste in the mouth; "feel like a head cold"; Flu like feeling; Fatigue; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth), NASOPHARYNGITIS ("feel like a head cold") and INFLUENZA LIKE ILLNESS (Flu like feeling) in a 72-year-old female 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 Ringing in ears in 2020. Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness). On an unknown date, the patient experienced THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold"). At the time of the report, THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold") outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold") to be not related. No further causality assessments were provided for INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness).    Additional concomitant medications included unspecified BP medications.  No treatment was received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Throat irritation
Clinical narrative: Burning throat; Burning mouth; Bad taste in the mouth; "feel like a head cold"; Flu like feeling; Fatigue; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth), NASOPHARYNGITIS ("feel like a head cold") and INFLUENZA LIKE ILLNESS (Flu like feeling) in a 72-year-old female 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 Ringing in ears in 2020. Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness). On an unknown date, the patient experienced THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold"). At the time of the report, THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold") outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold") to be not related. No further causality assessments were provided for INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness).    Additional concomitant medications included unspecified BP medications.  No treatment was received.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia oral, Paraesthesia
Clinical narrative: numbness around her mouth; tingling and burning in feet, tingling and burning in legs, tingling and burning in hands; tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness around her mouth), BURNING SENSATION (tingling and burning in feet, tingling and burning in legs, tingling and burning in hands) and PARAESTHESIA (tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands) 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 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HYPOAESTHESIA ORAL (numbness around her mouth), BURNING SENSATION (tingling and burning in feet, tingling and burning in legs, tingling and burning in hands) and PARAESTHESIA (tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands). At the time of the report, HYPOAESTHESIA ORAL (numbness around her mouth), BURNING SENSATION (tingling and burning in feet, tingling and burning in legs, tingling and burning in hands) and PARAESTHESIA (tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine within 3 weeks of receiving the first one; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine within 3 weeks of receiving the first one) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine within 3 weeks of receiving the first one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine within 3 weeks of receiving the first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     The patient was administered with the second dose of vaccine within 3 weeks of receiving the first one.  No concomitant medication was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen cervical lymph node on my left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen cervical lymph node on my left side) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen cervical lymph node on my left side). At the time of the report, LYMPHADENOPATHY (Swollen cervical lymph node on my left side) outcome was unknown.            Lab work was done and was normal and unspecified antigen testing was performed(results are unknown).  No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-222001 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (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 provided.    On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of Took 2 advils. At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature: 100 (Inconclusive) 100.         No concomitant medication information provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Really tired; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired) and VACCINATION SITE PAIN (Arm hurt) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Really tired) and VACCINATION SITE PAIN (Arm hurt). At the time of the report, FATIGUE (Really tired) and VACCINATION SITE PAIN (Arm hurt) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was included. No treatment drug details was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. No relevant concomitant medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: complaining of pain in her arm still; 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 PAIN IN EXTREMITY (complaining of pain in her arm still) 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 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 PAIN IN EXTREMITY (complaining of pain in her arm still). At the time of the report, PAIN IN EXTREMITY (complaining of pain in her arm still) had not resolved.            Reporter reported that their grafther received his 2nd shot back in April  No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Injection site left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore Injection site left arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Injection site left arm). At the time of the report, VACCINATION SITE PAIN (Sore Injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Pain in extremity
Clinical narrative: Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine; Sore arm/Had typical sore arm at injection site; Light body aches and sniffles started about 10-12 hours after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine), PAIN IN EXTREMITY (Sore arm/Had typical sore arm at injection site) and PAIN (Light body aches and sniffles started about 10-12 hours after second vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOLOC) for GERD.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced DYSGEUSIA (Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine), PAIN IN EXTREMITY (Sore arm/Had typical sore arm at injection site) and PAIN (Light body aches and sniffles started about 10-12 hours after second vaccine). On 16-Jun-2021, DYSGEUSIA (Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine) and PAIN (Light body aches and sniffles started about 10-12 hours after second vaccine) had resolved. On 21-Jun-2021, PAIN IN EXTREMITY (Sore arm/Had typical sore arm at injection site) had resolved.            No treatment information was reported Had similar reaction with previous flu Vaccination   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Event details, Concomitant medication, Other medical history and patient demographics updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Bump on my skin; 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 VACCINATION SITE RASH (Bump on my skin) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Bump on my skin). At the time of the report, VACCINATION SITE RASH (Bump on my skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: Patient got diagnosed with COVID after first shot; Patient missed the recommended interval between two doses; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got diagnosed with COVID after first shot) and PRODUCT DOSE OMISSION ISSUE (Patient missed the recommended interval between two doses) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient got diagnosed with COVID after first shot) and PRODUCT DOSE OMISSION ISSUE (Patient missed the recommended interval between two doses). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got diagnosed with COVID after first shot) and PRODUCT DOSE OMISSION ISSUE (Patient missed the recommended interval between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had received Monoclonal antibodies & had to wait for 90 days for the second shot.  No concomitant medication information was provided.   No treatment information was given.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Facial pain, Fatigue, Feeding disorder, Nausea
Clinical narrative: Couldn't eat or drink; Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away; Cheek had skin falling off; Fever; Nausea; Joints hurt; Couldn't get off couch for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 experienced FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Joints hurt) and FATIGUE (Couldn't get off couch for 48 hours). At the time of the report, FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Joints hurt) and FATIGUE (Couldn't get off couch for 48 hours) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.         Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: follow up received Additional information added on 15-JUN-2021 and added new event.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: Couldn't eat or drink; Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away; Cheek had skin falling off; Fever; Nausea; Joints hurt; Couldn't get off couch for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 experienced FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Joints hurt) and FATIGUE (Couldn't get off couch for 48 hours). At the time of the report, FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Joints hurt) and FATIGUE (Couldn't get off couch for 48 hours) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.         Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: follow up received Additional information added on 15-JUN-2021 and added new event.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Nausea
Clinical narrative: Swollen lymph nodes to the left side of body; nauseous; increased pain in joints and muscles; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes to the left side of body), NAUSEA (nauseous) and ARTHRALGIA (increased pain in joints and muscles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes to the left side of body), NAUSEA (nauseous) and ARTHRALGIA (increased pain in joints and muscles). On 15-Jun-2021, NAUSEA (nauseous) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes to the left side of body) had not resolved and ARTHRALGIA (increased pain in joints and muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were mentioned. No treatment details were reported. Swollen lymph nodes on the left side of her body  became more pronounced after the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: might have a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (might have a UTI) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (might have a UTI). At the time of the report, URINARY TRACT INFECTION (might have a UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was supposed to get the second dose on Thursday morning. No concomitant medications were reported. No treatment medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fibromyalgia, Lymphadenopathy, Mass, Nausea
Clinical narrative: Pain/pain all over body; Nausea; Swollen glands in both sides of the jaw/swollen lymph node; Arthritis; Fibromyalgia; Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh) and PAIN (Pain/pain all over body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Pain/pain all over body). In June 2021, the patient experienced LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh) and NAUSEA (Nausea). At the time of the report, LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh), PAIN (Pain/pain all over body) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications and medical history details are not provided by the Reporter.  No treatment information is provided.   The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.   This case was linked to MOD-2021-222076 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-Jun-2021 included additional events
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain/pain all over body; Nausea; Swollen glands in both sides of the jaw/swollen lymph node; Arthritis; Fibromyalgia; Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh) and PAIN (Pain/pain all over body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Pain/pain all over body). In June 2021, the patient experienced LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh) and NAUSEA (Nausea). At the time of the report, LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh), PAIN (Pain/pain all over body) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications and medical history details are not provided by the Reporter.  No treatment information is provided.   The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.   This case was linked to MOD-2021-222076 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-Jun-2021 included additional events
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site pain; swelling or lump at the injection site (left arm); Hardness at the injection site; could not raise left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (swelling or lump at the injection site (left arm)), JOINT RANGE OF MOTION DECREASED (could not raise left arm) and VACCINATION SITE INDURATION (Hardness at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, Gabiscon advance and Famotodine for Reflux gastritis, Levothyroxine 25 mcg for Thyroid disorder, Vitamin D for an unknown indication.   On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (swelling or lump at the injection site (left arm)), JOINT RANGE OF MOTION DECREASED (could not raise left arm) and VACCINATION SITE INDURATION (Hardness at the injection site). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (swelling or lump at the injection site (left arm)), JOINT RANGE OF MOTION DECREASED (could not raise left arm) and VACCINATION SITE INDURATION (Hardness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.