chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; Headache; Pain at the injection site; Expired vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-367477 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Can not move the left arm; HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the left arm), VACCINATION SITE PAIN (HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 006B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the left arm), VACCINATION SITE PAIN (HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot) and CHILLS (Chills). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the left arm), VACCINATION SITE PAIN (HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot) and CHILLS (Chills) was resolving.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-367625 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received 0.5ml instead of 0.25ml for booster; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 0.5ml instead of 0.25ml for booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 28-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received 0.5ml instead of 0.25ml for booster). On 28-Oct-2021, INCORRECT DOSE ADMINISTERED (Received 0.5ml instead of 0.25ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided   This case was linked to MOD-2021-367420 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: They received 3, 0.5mL doses of the Moderna covid-19 vaccine; 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 ACCIDENTAL OVERDOSE (They received 3, 0.5mL doses of the Moderna covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (They received 3, 0.5mL doses of the Moderna covid-19 vaccine). On 25-Oct-2021, ACCIDENTAL OVERDOSE (They received 3, 0.5mL doses of the Moderna covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 9399001) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-366988, MOD-2021-367774 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Reddish Injection Site after booster shot; Swollen Injection Site after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Reddish Injection Site after booster shot) and VACCINATION SITE SWELLING (Swollen Injection Site after booster shot) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 030L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Injection Site after booster shot) and VACCINATION SITE SWELLING (Swollen Injection Site after booster shot). At the time of the report, VACCINATION SITE ERYTHEMA (Reddish Injection Site after booster shot) and VACCINATION SITE SWELLING (Swollen Injection Site after booster shot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Expired product administered, Swelling
Clinical narrative: Swelling in her shoulder; experienced pain in the armpit of the injection site left arm; wife received an expired Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in her shoulder), EXPIRED PRODUCT ADMINISTERED (wife received an expired Moderna Covid-19 vaccine) and AXILLARY PAIN (experienced pain in the armpit of the injection site left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SWELLING (Swelling in her shoulder) and AXILLARY PAIN (experienced pain in the armpit of the injection site left arm). On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (wife received an expired Moderna Covid-19 vaccine). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (wife received an expired Moderna Covid-19 vaccine) had resolved. At the time of the report, SWELLING (Swelling in her shoulder) and AXILLARY PAIN (experienced pain in the armpit of the injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-367460 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 048B21A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNKNOWN. At the time of the report, HEART RATE INCREASED (Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Heart rate: high (High) Heart rate went above 90 and was at times 120 and it never went below 95.Heart rate was now in the high 80s..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised; received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE NRVV AD26. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26. Concurrent medical conditions included Diabetes and Down's syndrome.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially). On 28-Oct-2021, ACCIDENTAL OVERDOSE (off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 016B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.   Date the vial was initially stored in the refrigerator on 08-Sep-2021 o
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: got the booster dose and was given the full dose.; 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 ACCIDENTAL OVERDOSE (got the booster dose and was given the full 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got the booster dose and was given the full dose.). At the time of the report, ACCIDENTAL OVERDOSE (got the booster dose and was given the full dose.) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis
Clinical narrative: trouble hearing out of the right ear for probably 3 weeks; increased head ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (trouble hearing out of the right ear for probably 3 weeks) and HEADACHE (increased head ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPOACUSIS (trouble hearing out of the right ear for probably 3 weeks) and HEADACHE (increased head ache). At the time of the report, HYPOACUSIS (trouble hearing out of the right ear for probably 3 weeks) and HEADACHE (increased head ache) had resolved.            concomitant medications were provided. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pruritus, Injection site swelling
Clinical narrative: the injection site is about the size of a 50 cent piece; injection site is itchy; got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (the injection site is about the size of a 50 cent piece), INJECTION SITE PRURITUS (injection site is itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021). On an unknown date, the patient experienced INJECTION SITE SWELLING (the injection site is about the size of a 50 cent piece) and INJECTION SITE PRURITUS (injection site is itchy). On 11-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021) had resolved. At the time of the report, INJECTION SITE SWELLING (the injection site is about the size of a 50 cent piece) and INJECTION SITE PRURITUS (injection site is itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-364292, MOD-2021-367502 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Illness, Pyrexia, Viral infection
Clinical narrative: she had something viral most of September, had fever; Caller states she had something viral most of September, had fever, head and eye pain; "I got very sick a week ago"; Caller states she had something viral most of September, had fever, head and eye pain/massive top of head headache; she had something viral most of September, had fever; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (she had something viral most of September, had fever), EYE PAIN (Caller states she had something viral most of September, had fever, head and eye pain), ILLNESS ("I got very sick a week ago"), HEADACHE (Caller states she had something viral most of September, had fever, head and eye pain/massive top of head headache) and PYREXIA (she had something viral most of September, had 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.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (she had something viral most of September, had fever), EYE PAIN (Caller states she had something viral most of September, had fever, head and eye pain), ILLNESS ("I got very sick a week ago"), HEADACHE (Caller states she had something viral most of September, had fever, head and eye pain/massive top of head headache) and PYREXIA (she had something viral most of September, had fever). At the time of the report, VIRAL INFECTION (she had something viral most of September, had fever), EYE PAIN (Caller states she had something viral most of September, had fever, head and eye pain), HEADACHE (Caller states she had something viral most of September, had fever, head and eye pain/massive top of head headache) and PYREXIA (she had something viral most of September, had fever) outcome was unknown and ILLNESS ("I got very sick a week ago") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received treatment 2 antibiotics and she tried to be holistic.  The patient States nothing showed up on x-ray and CT scan.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over; Pain was really bad for 3 days, I couldn't get out of bed; My feet hurt all summer; Was nauseated; She had headaches; Had a fever of 104 F; She used a Decadron taper once & it helped with the pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated) and HEADACHE (She had headaches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Trigeminal neuralgia (for 7 years.), Fibromyalgia (For Years) and Chronic migraine (for 20 years).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated), HEADACHE (She had headaches), PYREXIA (Had a fever of 104 F) and ARTHRALGIA (She used a Decadron taper once & it helped with the pain in the joints). The patient was treated with DEXAMETHASONE ACETATE (DECADRON A) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated), HEADACHE (She had headaches), PYREXIA (Had a fever of 104 F) and ARTHRALGIA (She used a Decadron taper once & it helped with the pain in the joints) outcome was unknown.            A couple of weeks ago it felt like she had shards of glass in her eye.  No Concomitants product was reported.   This case was linked to MOD-2021-367302 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over; Pain was really bad for 3 days, I couldn't get out of bed; My feet hurt all summer; Was nauseated; She had headaches; Had a fever of 104 F; She used a Decadron taper once & it helped with the pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated) and HEADACHE (She had headaches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Trigeminal neuralgia (for 7 years.), Fibromyalgia (For Years) and Chronic migraine (for 20 years).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated), HEADACHE (She had headaches), PYREXIA (Had a fever of 104 F) and ARTHRALGIA (She used a Decadron taper once & it helped with the pain in the joints). The patient was treated with DEXAMETHASONE ACETATE (DECADRON A) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated), HEADACHE (She had headaches), PYREXIA (Had a fever of 104 F) and ARTHRALGIA (She used a Decadron taper once & it helped with the pain in the joints) outcome was unknown.            A couple of weeks ago it felt like she had shards of glass in her eye.  No Concomitants product was reported.   This case was linked to MOD-2021-367302 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Urticaria, Vaccination site erythema
Clinical narrative: Kind of like a welt; Rash on parts of her body on her back; red spot at injection site, 3-4 inches in diameter; Headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Kind of like a welt), RASH (Rash on parts of her body on her back), VACCINATION SITE ERYTHEMA (red spot at injection site, 3-4 inches in diameter) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091F21A, 02AL20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, SERTRALINE, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced URTICARIA (Kind of like a welt), RASH (Rash on parts of her body on her back), VACCINATION SITE ERYTHEMA (red spot at injection site, 3-4 inches in diameter) and HEADACHE (Headache). The patient was treated with XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 27-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (Kind of like a welt), RASH (Rash on parts of her body on her back) and VACCINATION SITE ERYTHEMA (red spot at injection site, 3-4 inches in diameter) had not resolved.            This case was linked to MOD-2021-367396, MOD-2021-367552.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache in the back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache in the back of the head) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, SERTRALINE, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Mild headache in the back of the head). The patient was treated with XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Mild headache in the back of the head) outcome was unknown.            This case was linked to MOD-2021-367396, MOD-2021-367550 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: became violently sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (became violently sick) 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 ILLNESS (became violently sick). At the time of the report, ILLNESS (became violently sick) outcome was unknown.        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.   Concomitant drugs were not reported. Treatment medications were not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity, Palpitations
Clinical narrative: Heart rate was 92; Sore arm/Sore got worse in the night/Felt achy; Heart started pounding/Heart was racing/Heart racing was this morning; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started pounding/Heart was racing/Heart racing was this morning), HEART RATE INCREASED (Heart rate was 92) and PAIN IN EXTREMITY (Sore arm/Sore got worse in the night/Felt achy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 077C21B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Heart rate high. Concomitant products included IRBESARTAN (AVAPRO) for Blood pressure, PROPRANOLOL for Heart rate high.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced PALPITATIONS (Heart started pounding/Heart was racing/Heart racing was this morning) and PAIN IN EXTREMITY (Sore arm/Sore got worse in the night/Felt achy). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate was 92). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart started pounding/Heart was racing/Heart racing was this morning), HEART RATE INCREASED (Heart rate was 92) and PAIN IN EXTREMITY (Sore arm/Sore got worse in the night/Felt achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Heart rate: 92 (High) heart rate was 92.         Patient experienced increased heart rate 20 years ago and was taking propranolol for the increased heart rate .
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site induration, Vaccination site streaking
Clinical narrative: Streak of about 4-5inches long/leading toward the inner part of my body; red lump about an inch and a half round/ It's hard; She also had a 99 degree temperature, but it's really 97 most of time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (Streak of about 4-5inches long/leading toward the inner part of my body), PYREXIA (She also had a 99 degree temperature, but it's really 97 most of time) and VACCINATION SITE INDURATION (red lump about an inch and a half round/ It's hard) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F214, 041L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE STREAKING (Streak of about 4-5inches long/leading toward the inner part of my body), PYREXIA (She also had a 99 degree temperature, but it's really 97 most of time) and VACCINATION SITE INDURATION (red lump about an inch and a half round/ It's hard). At the time of the report, VACCINATION SITE STREAKING (Streak of about 4-5inches long/leading toward the inner part of my body), PYREXIA (She also had a 99 degree temperature, but it's really 97 most of time) and VACCINATION SITE INDURATION (red lump about an inch and a half round/ It's hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Body temperature: 99 degree (High) 99 degree but it's really 97 most of time..         Treatment Included The patient reports using an ice pack on her arm.  No concomitant medication was reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Tenderness in his arm for a day for first two shots; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness in his arm for a day for first two shots) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 04R20A and H062E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and DOXAZOSIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE PAIN (Tenderness in his arm for a day for first two shots). At the time of the report, INJECTION SITE PAIN (Tenderness in his arm for a day for first two shots) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment Medications details were provided.   This case was linked to MOD-2021-367613, MOD-2021-367614.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Cough, Dyspnoea, Fatigue
Clinical narrative: shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath; constant cough; post COVID syndrome; no strength; a lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath), COUGH (constant cough), POST-ACUTE COVID-19 SYNDROME (post COVID syndrome), ASTHENIA (no strength) and FATIGUE (a lot of fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Blood pressure, ATORVASTATIN for an unknown indication.    On 28-Sep-2021 at 5:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced DYSPNOEA (shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath), COUGH (constant cough), POST-ACUTE COVID-19 SYNDROME (post COVID syndrome), ASTHENIA (no strength) and FATIGUE (a lot of fatigue). The patient was treated with PREDNISONE for Adverse event, at a dose of 10 mg, Taper; GUAIFENESIN (BREONESIN) for Adverse event, at a dose of Breo inhaler and UMECLIDINIUM BROMIDE (INCRUSE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath), COUGH (constant cough), POST-ACUTE COVID-19 SYNDROME (post COVID syndrome), ASTHENIA (no strength) and FATIGUE (a lot of fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Chest X-ray: normal (normal) chest X-ray that came back clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a CT scan on 29-Oct-2021. All events started after one week of vaccination.   This case was linked to MOD-2021-235169.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath; constant cough; post COVID syndrome; no strength; a lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath), COUGH (constant cough), POST-ACUTE COVID-19 SYNDROME (post COVID syndrome), ASTHENIA (no strength) and FATIGUE (a lot of fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Blood pressure, ATORVASTATIN for an unknown indication.    On 28-Sep-2021 at 5:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced DYSPNOEA (shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath), COUGH (constant cough), POST-ACUTE COVID-19 SYNDROME (post COVID syndrome), ASTHENIA (no strength) and FATIGUE (a lot of fatigue). The patient was treated with PREDNISONE for Adverse event, at a dose of 10 mg, Taper; GUAIFENESIN (BREONESIN) for Adverse event, at a dose of Breo inhaler and UMECLIDINIUM BROMIDE (INCRUSE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath (worse than after the 2nd dose)/if she keeps talking, she runs out of breath), COUGH (constant cough), POST-ACUTE COVID-19 SYNDROME (post COVID syndrome), ASTHENIA (no strength) and FATIGUE (a lot of fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Chest X-ray: normal (normal) chest X-ray that came back clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a CT scan on 29-Oct-2021. All events started after one week of vaccination.   This case was linked to MOD-2021-235169.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: She felt weak; Didn't felt great; Sore arm; Felt really tired for three days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She felt weak), FEELING ABNORMAL (Didn't felt great), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt really tired for three days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS (Thyroid). Concomitant products included THYROID (ARMOUR THYROID) for Thyroid disorder NOS.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced ASTHENIA (She felt weak), FEELING ABNORMAL (Didn't felt great), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt really tired for three days). On 06-Aug-2021, ASTHENIA (She felt weak), FEELING ABNORMAL (Didn't felt great), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt really tired for three days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.    This case was linked to MOD-2021-367647 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided.  No medical information was provided by the reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Insomnia, Myalgia
Clinical narrative: hard time sleep, slept really badly; has sinus; has fever 99.6F; chills; nausea; achy around neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. H062E21A and 04R20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included LEVOTHYROXINE and DOXAZOSIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills), NAUSEA (nausea), MYALGIA (achy around neck) and HEADACHE (headache). At the time of the report, INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills), NAUSEA (nausea), MYALGIA (achy around neck) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (Inconclusive) 99.6F.         No treatment medications were reported.  Case is non-serious (lack of evidence of seriousness for all the events from a regulatory or clinical standpoint) and does not include any AESI event after correcting the coding of the event initially captured as "hypersomnia" to a more specific one according to source document. In consequence, no CC is required for this case".   This case was linked to MOD-2021-367613, MOD-2021-367566 (Patient Link).