chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain
Clinical narrative: Now still when I go to sleep I get a weird sensation in my throat when I shallow that is not normal, like raspy in my throat; About 3 days after the first dose, my mouth felt weird; my mouth tasted like I was going to get a cold, then it tasted like medicine; joint pain, mostly in the knees; when I go for a walk my right knee get sore; I felt fatigue for one day; My injection site are was sore, It felt like it had been ran over by a truck, that lasted for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Now still when I go to sleep I get a weird sensation in my throat when I shallow that is not normal, like raspy in my throat), FEELING ABNORMAL (About 3 days after the first dose, my mouth felt weird), TASTE DISORDER (my mouth tasted like I was going to get a cold, then it tasted like medicine), ARTHRALGIA (joint pain, mostly in the knees) and MYALGIA (when I go for a walk my right knee get sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ARTHRALGIA (joint pain, mostly in the knees), MYALGIA (when I go for a walk my right knee get sore), FATIGUE (I felt fatigue for one day) and VACCINATION SITE PAIN (My injection site are was sore, It felt like it had been ran over by a truck, that lasted for 10 days). On 25-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Now still when I go to sleep I get a weird sensation in my throat when I shallow that is not normal, like raspy in my throat), FEELING ABNORMAL (About 3 days after the first dose, my mouth felt weird) and TASTE DISORDER (my mouth tasted like I was going to get a cold, then it tasted like medicine). On 23-Apr-2021, FATIGUE (I felt fatigue for one day) had resolved. On 01-May-2021, VACCINATION SITE PAIN (My injection site are was sore, It felt like it had been ran over by a truck, that lasted for 10 days) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (Now still when I go to sleep I get a weird sensation in my throat when I shallow that is not normal, like raspy in my throat), FEELING ABNORMAL (About 3 days after the first dose, my mouth felt weird), TASTE DISORDER (my mouth tasted like I was going to get a cold, then it tasted like medicine), ARTHRALGIA (joint pain, mostly in the knees) and MYALGIA (when I go for a walk my right knee get sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   This case was linked to MOD-2021-162187 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient became positive for Covid after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient became positive for Covid after 1st dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-May-2021, the patient experienced COVID-19 (Patient became positive for Covid after 1st dose). At the time of the report, COVID-19 (Patient became positive for Covid after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Illness, Product dose omission issue, Pyrexia
Clinical narrative: Very winded; Sick; I didn't get my 2nd dose yet.; Feverous; She was tired; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Very winded), ILLNESS (Sick), PRODUCT DOSE OMISSION ISSUE (I didn't get my 2nd dose yet.), PYREXIA (Feverous) and FATIGUE (She was tired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Very winded), ILLNESS (Sick), PRODUCT DOSE OMISSION ISSUE (I didn't get my 2nd dose yet.), PYREXIA (Feverous) and FATIGUE (She was tired). At the time of the report, DYSPNOEA (Very winded), ILLNESS (Sick), PRODUCT DOSE OMISSION ISSUE (I didn't get my 2nd dose yet.), PYREXIA (Feverous) and FATIGUE (She was tired) 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.   The concomitant medications were not reported. The treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Fever 103 F; Aching all over; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 103 F) and MYALGIA (Aching all over) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-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 22-May-2021, the patient experienced PYREXIA (Fever 103 F) and MYALGIA (Aching all over). In 2021, PYREXIA (Fever 103 F) and MYALGIA (Aching all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 103 f (High) 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment information provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Telephone Contact Report was received and the event outcomes were updated.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Insomnia
Clinical narrative: insomnia; also have chills; soreness at injection site; 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 INSOMNIA (insomnia), CHILLS (also have chills) and INJECTION SITE PAIN (soreness at injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (insomnia), CHILLS (also have chills) and INJECTION SITE PAIN (soreness at injection site). At the time of the report, INSOMNIA (insomnia), CHILLS (also have chills) and INJECTION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache for 3 hours; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for 3 hours) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included DICLOFENAC POTASSIUM for Pain in hip, METFORMIN, CLOPIDOGREL, METOPROLOL SUCCINATE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), SIMVASTATIN, MELOXICAM and METHOCARBAMOL for an unknown indication, SERTRALINE HYDROCHLORIDE (SERTRALINE HCL).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache for 3 hours) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 milligram. On 19-Feb-2021, HEADACHE (Headache for 3 hours) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to INC.-MOD-2021-162334 (E2B Linked Report). This case was linked to MOD-2021-162161 (Patient Link).; Sender's Comments: INC.-MOD-2021-162334:Crosslink
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Burning sensation, Erythema, Pruritus, Skin lesion
Clinical narrative: hormonal acne; Skin lesions on torso mostly on back; burning sensation to her face and torso; itching localised; redness/erythema local; hives/urtricaria local; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN LESION (Skin lesions on torso mostly on back), BURNING SENSATION (burning sensation to her face and torso), PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local). On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN LESION (Skin lesions on torso mostly on back) and BURNING SENSATION (burning sensation to her face and torso). On an unknown date, the patient experienced ACNE (hormonal acne). On 15-May-2021, BURNING SENSATION (burning sensation to her face and torso) had resolved. On 18-May-2021, PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local) had resolved. On 21-May-2021, SKIN LESION (Skin lesions on torso mostly on back) had resolved. At the time of the report, ACNE (hormonal acne) 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 considered PRURITUS (itching localised), ERYTHEMA (redness/erythema local), URTICARIA (hives/urtricaria local) and ACNE (hormonal acne) to be possibly related. No further causality assessments were provided for SKIN LESION (Skin lesions on torso mostly on back) and BURNING SENSATION (burning sensation to her face and torso).    No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided patient ethnicity, additional events, suspect dosage details and reporter causality.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hormonal acne; Skin lesions on torso mostly on back; burning sensation to her face and torso; itching localised; redness/erythema local; hives/urtricaria local; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN LESION (Skin lesions on torso mostly on back), BURNING SENSATION (burning sensation to her face and torso), PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local). On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN LESION (Skin lesions on torso mostly on back) and BURNING SENSATION (burning sensation to her face and torso). On an unknown date, the patient experienced ACNE (hormonal acne). On 15-May-2021, BURNING SENSATION (burning sensation to her face and torso) had resolved. On 18-May-2021, PRURITUS (itching localised), ERYTHEMA (redness/erythema local) and URTICARIA (hives/urtricaria local) had resolved. On 21-May-2021, SKIN LESION (Skin lesions on torso mostly on back) had resolved. At the time of the report, ACNE (hormonal acne) 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 considered PRURITUS (itching localised), ERYTHEMA (redness/erythema local), URTICARIA (hives/urtricaria local) and ACNE (hormonal acne) to be possibly related. No further causality assessments were provided for SKIN LESION (Skin lesions on torso mostly on back) and BURNING SENSATION (burning sensation to her face and torso).    No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided patient ethnicity, additional events, suspect dosage details and reporter causality.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Injection site swelling, Rash erythematous
Clinical narrative: Developed a red rash in right shoulder; Swelling in right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Developed a red rash in right shoulder) and INJECTION SITE SWELLING (Swelling in right shoulder) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Developed a red rash in right shoulder) and INJECTION SITE SWELLING (Swelling in right shoulder). At the time of the report, RASH ERYTHEMATOUS (Developed a red rash in right shoulder) and INJECTION SITE SWELLING (Swelling in right shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood pressure measurement: 199/96 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-162176, US-MODERNATX, INC.-MOD-2021-162133, US-MODERNATX, INC.-MOD-2021-162267, US-MODERNATX, INC.-MOD-2021-162303 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: NNI received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162176: US-MODERNATX, INC.-MOD-2021-162133: US-MODERNATX, INC.-MOD-2021-162303: US-MODERNATX, INC.-MOD-2021-162267:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Chest discomfort, Chills, Dizziness
Clinical narrative: Pain all over; Felt like a truck sat on their chest; Anxiety; Back Pain/Pain in lower back; Could only get from bed to bathroom (limited mobility); Felt stung during second vaccine dose administration; Low grade fever; Chills; Headache; Tiredness; Dizzy/Lightheaded; Arm was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back) and MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch) and FATIGUE (Tiredness). On 20-May-2021, the patient experienced PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 21-May-2021, PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (Back Pain/Pain in lower back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Mobility decreased, Pain
Clinical narrative: Pain all over; Felt like a truck sat on their chest; Anxiety; Back Pain/Pain in lower back; Could only get from bed to bathroom (limited mobility); Felt stung during second vaccine dose administration; Low grade fever; Chills; Headache; Tiredness; Dizzy/Lightheaded; Arm was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back) and MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch) and FATIGUE (Tiredness). On 20-May-2021, the patient experienced PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 21-May-2021, PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (Back Pain/Pain in lower back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site warmth
Clinical narrative: Pain all over; Felt like a truck sat on their chest; Anxiety; Back Pain/Pain in lower back; Could only get from bed to bathroom (limited mobility); Felt stung during second vaccine dose administration; Low grade fever; Chills; Headache; Tiredness; Dizzy/Lightheaded; Arm was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back) and MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch) and FATIGUE (Tiredness). On 20-May-2021, the patient experienced PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 21-May-2021, PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (Back Pain/Pain in lower back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Extreme tiredness; mucus in her throat but nothing comes up; Developed a cough 2 hours after vaccine; Lightheadedness; Little bit of shortness of breath from coughing; Hurts chest when I cough; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (mucus in her throat but nothing comes up), COUGH (Developed a cough 2 hours after vaccine), DIZZINESS (Lightheadedness), DYSPNOEA (Little bit of shortness of breath from coughing) and CHEST PAIN (Hurts chest when I cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Estrace vaginal cream for an unknown indication.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (mucus in her throat but nothing comes up), COUGH (Developed a cough 2 hours after vaccine), DIZZINESS (Lightheadedness), DYSPNOEA (Little bit of shortness of breath from coughing), CHEST PAIN (Hurts chest when I cough), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Extreme tiredness). At the time of the report, THROAT IRRITATION (mucus in her throat but nothing comes up), COUGH (Developed a cough 2 hours after vaccine), DIZZINESS (Lightheadedness), DYSPNOEA (Little bit of shortness of breath from coughing), CHEST PAIN (Hurts chest when I cough), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Throat irritation
Clinical narrative: Extreme tiredness; mucus in her throat but nothing comes up; Developed a cough 2 hours after vaccine; Lightheadedness; Little bit of shortness of breath from coughing; Hurts chest when I cough; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (mucus in her throat but nothing comes up), COUGH (Developed a cough 2 hours after vaccine), DIZZINESS (Lightheadedness), DYSPNOEA (Little bit of shortness of breath from coughing) and CHEST PAIN (Hurts chest when I cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Estrace vaginal cream for an unknown indication.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (mucus in her throat but nothing comes up), COUGH (Developed a cough 2 hours after vaccine), DIZZINESS (Lightheadedness), DYSPNOEA (Little bit of shortness of breath from coughing), CHEST PAIN (Hurts chest when I cough), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Extreme tiredness). At the time of the report, THROAT IRRITATION (mucus in her throat but nothing comes up), COUGH (Developed a cough 2 hours after vaccine), DIZZINESS (Lightheadedness), DYSPNOEA (Little bit of shortness of breath from coughing), CHEST PAIN (Hurts chest when I cough), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Inappropriate schedule of product administration
Clinical narrative: received Johnson and Johnson vaccine after receiving Moderna; interval of both vaccines is only 11 days; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (received Johnson and Johnson vaccine after receiving Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of both vaccines is only 11 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced COVID-19 IMMUNISATION (received Johnson and Johnson vaccine after receiving Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of both vaccines is only 11 days). On 10-May-2021, COVID-19 IMMUNISATION (received Johnson and Johnson vaccine after receiving Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of both vaccines is only 11 days) 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pulmonary pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Lung pain), HEADACHE (Headache) and CHILLS (Chills again) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Pain in hip. Concomitant products included DICLOFENAC POTASSIUM for Pain in hip, METFORMIN, CLOPIDOGREL, METOPROLOL SUCCINATE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), SIMVASTATIN, MELOXICAM, METHOCARBAMOL and SERTRALINE HCL for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PULMONARY PAIN (Lung pain), HEADACHE (Headache) and CHILLS (Chills again). The patient was treated with ACETAMINOPHEN (oral) for Headache, Chills and Lung pain, at a dose of 650 milligram every four hours. At the time of the report, PULMONARY PAIN (Lung pain), HEADACHE (Headache) and CHILLS (Chills again) had resolved.    This case was linked to MOD-2021-162150.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Only received half the dose; Patient pulled away and only half the dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Only received half the dose) and DEVICE CONNECTION ISSUE (Patient pulled away and only half the dose was administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced UNDERDOSE (Only received half the dose) and DEVICE CONNECTION ISSUE (Patient pulled away and only half the dose was administered). At the time of the report, UNDERDOSE (Only received half the dose) and DEVICE CONNECTION ISSUE (Patient pulled away and only half the dose was administered) 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.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: first dose 4/23, second dose 7/22; 4 weeks pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (4 weeks pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 4/23, second dose 7/22) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (4 weeks pregnant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 4/23, second dose 7/22). On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (4 weeks pregnant) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 4/23, second dose 7/22) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave second dose 5 days sooner than recommendation; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave second dose 5 days sooner than recommendation) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Not provided and 027C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave second dose 5 days sooner than recommendation). On 20-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave second dose 5 days sooner than recommendation) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Drug dose details updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine).   On 21-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-093500, MOD21-093559, MOD21-093561, MOD21-093562, MOD21-093563, US-MODERNATX, INC.-MOD-2021-162156, US-MODERNATX, INC.-MOD-2021-162267, US-MODERNATX, INC.-MOD-2021-162303 (E2B Linked Report).; Sender's Comments:  MOD21-093500: MOD21-093559: MOD21-093561: MOD21-093562: MOD21-093563: US-MODERNATX, INC.-MOD-2021-162156: US-MODERNATX, INC.-MOD-2021-162267: US-MODERNATX, INC.-MOD-2021-162303:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Mobility decreased, Pain, Vaccination site pain
Clinical narrative: Pain all over body; Swelling on left arm; unable to lift arm; Dizziness while doing yard work; Pain on left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over body), VACCINATION SITE SWELLING (Swelling on left arm), MOBILITY DECREASED (unable to lift arm), DIZZINESS (Dizziness while doing yard work) and VACCINATION SITE PAIN (Pain on left arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0441321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-May-2021, the patient experienced PAIN (Pain all over body), VACCINATION SITE SWELLING (Swelling on left arm), MOBILITY DECREASED (unable to lift arm), DIZZINESS (Dizziness while doing yard work), VACCINATION SITE PAIN (Pain on left arm) and HEADACHE (headache).   The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (Pain all over body), VACCINATION SITE SWELLING (Swelling on left arm), MOBILITY DECREASED (unable to lift arm), DIZZINESS (Dizziness while doing yard work), VACCINATION SITE PAIN (Pain on left arm) and HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Pain all over body; Swelling on left arm; unable to lift arm; Dizziness while doing yard work; Pain on left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over body), VACCINATION SITE SWELLING (Swelling on left arm), MOBILITY DECREASED (unable to lift arm), DIZZINESS (Dizziness while doing yard work) and VACCINATION SITE PAIN (Pain on left arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0441321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-May-2021, the patient experienced PAIN (Pain all over body), VACCINATION SITE SWELLING (Swelling on left arm), MOBILITY DECREASED (unable to lift arm), DIZZINESS (Dizziness while doing yard work), VACCINATION SITE PAIN (Pain on left arm) and HEADACHE (headache).   The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (Pain all over body), VACCINATION SITE SWELLING (Swelling on left arm), MOBILITY DECREASED (unable to lift arm), DIZZINESS (Dizziness while doing yard work), VACCINATION SITE PAIN (Pain on left arm) and HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, SARS-CoV-2 test, Upper-airway cough syndrome
Clinical narrative: Tested positive for COVID-19; Post-nasal drip sensation; Cough; Chills that were almost unnoticeable; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), UPPER-AIRWAY COUGH SYNDROME (Post-nasal drip sensation), COUGH (Cough) and CHILLS (Chills that were almost unnoticeable) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post-nasal drip sensation), COUGH (Cough) and CHILLS (Chills that were almost unnoticeable). On 21-May-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved and UPPER-AIRWAY COUGH SYNDROME (Post-nasal drip sensation), COUGH (Cough) and CHILLS (Chills that were almost unnoticeable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 via a rapid test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication provided include Top Care Allergy Medication, daily. Treatment provided also include Top Care Allergy Medication.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: patient has not received 2nd injection after 42 days; slight soreness in arm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (slight soreness in arm) and PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd injection after 42 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (slight soreness in arm). On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd injection after 42 days).   On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd injection after 42 days) had resolved. At the time of the report, VACCINATION SITE PAIN (slight soreness in 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.   Patient on psoriasis medication but does not know the name. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Fatigue, Gait disturbance, Somnolence
Clinical narrative: was a little tired.; very hard to walk; went to sit on the toilet, I slid right off, fell on the floor; so weak; groggy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (very hard to walk), FALL (went to sit on the toilet, I slid right off, fell on the floor), ASTHENIA (so weak), SOMNOLENCE (groggy) and FATIGUE (was a little tired.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m21a and 040a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (ambicillin (ampicillin) allergy) and Drug allergy (zanax Xanax) allergy). Concomitant products included LORAZEPAM (ATIVAN) from 13-Aug-2012 to an unknown date, GABAPENTIN from 13-May-2012 to an unknown date and QUETIAPINE from 04-Apr-2018 to an unknown date for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) from 05-Dec-2000 to an unknown date for Cholesterol.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (very hard to walk), FALL (went to sit on the toilet, I slid right off, fell on the floor), ASTHENIA (so weak) and SOMNOLENCE (groggy). On 05-Mar-2021, the patient experienced FATIGUE (was a little tired.). On 05-Mar-2021, GAIT DISTURBANCE (very hard to walk), FALL (went to sit on the toilet, I slid right off, fell on the floor), ASTHENIA (so weak) and SOMNOLENCE (groggy) had resolved. At the time of the report, FATIGUE (was a little tired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   This case was linked to MOD-2021-162197 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: ADR form uploaded. Added patient demographics, race, ethnicity, medical history, concomitant medications and a new event (fatigue).
Sex: U
Vaccine: COVID19
Symptoms: Joint stiffness, Myalgia, Pain in extremity
Clinical narrative: painful leg pain; joint stiffness; muscle ache; 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 (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   In March 2021, the patient experienced PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache). At the time of the report, PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-162185 (Patient Link).