chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Lymph node pain, Pain in extremity
Clinical narrative: Lymph nodes on one side hurt a lot; Arm got sore; Got tired about an hour; Slept a long while; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph nodes on one side, painful), PAIN IN EXTREMITY (Arm sore), FATIGUE, and HYPERSOMNIA in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (Lymph nodes on one side), PAIN IN EXTREMITY (Arm sore), FATIGUE, and HYPERSOMNIA. At the time of the report, LYMPH NODE PAIN, PAIN IN EXTREMITY (Arm got sore), FATIGUE, and HYPERSOMNIA had resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-026446.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Pruritus, Urinary tract infection
Clinical narrative: itchy; knee arthropathy; UTI; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itchy), URINARY TRACT INFECTION (UTI) and ARTHROPATHY (knee arthropathy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. In January 2021, the patient experienced URINARY TRACT INFECTION (UTI). On an unknown date, the patient experienced PRURITUS (itchy) and ARTHROPATHY (knee arthropathy). At the time of the report, PRURITUS (itchy) had resolved and URINARY TRACT INFECTION (UTI) and ARTHROPATHY (knee arthropathy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-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 an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (Tiredness). At the time of the report, HEADACHE (headache) and FATIGUE (Tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event were not applicable.  Treatment information was not provided. Concomitant medication were not provided.   This case was linked to MOD-2021-029693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Followup added on 10-june-2021,upated with new events.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: pain in arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA injection for Plaque psoriasis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started HUMIRA (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm). At the time of the report, PAIN IN EXTREMITY (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 considered PAIN IN EXTREMITY (arm) to be probably related.    No concomitant medications were reported. Moderna COVID-19 Vaccine was administered on an unknown date in 2021.  No treatment drugs were reported.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional document received on 24 May 2021 had no new information. On 20-Jul-2021: Follow up received on 20 Jul 2021 contains no new information.
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hot flush
Clinical narrative: Felt warm flushed after covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of HOT FLUSH (Felt warm flushed after covid-19 vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA for Crohn's disease.    No medical history was provided by reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and HUMIRA (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HOT FLUSH. At the time of the report, HOT FLUSH 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 considered HOT FLUSH to be possibly related.    No concomitant medications reported by investigator. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No new information was received.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus
Clinical narrative: generalized itching; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RINVOQ for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RINVOQ (Oral) at an unspecified dose. On 01-Apr-2021, the patient experienced PRURITUS. On 13-Apr-2021, PRURITUS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Additional information received on 03 Jun 2021 had no new information. On 27-Jul-2021: Follow-up contains No New Information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: less intense itching; milder reaction- painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS and VACCINATION SITE PAIN in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PRURITUS and VACCINATION SITE PAIN outcome was unknown.            Concomitants include air Shield Immunity Support Gummies once daily start date 03-01-2021. Treatment include hydrocortisone cream.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-025504.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast mass, Chills, Dizziness, Feeling cold
Clinical narrative: Arm pain; Shingles on torso and leg; Lump in breast; Joint pain; Throw up; Headache; Chills; Nausea; Whole body felt hot; Felt faint; Extremely cold for next 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, and Arm pain in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease (In 2002), Anxiety (in 2001) and Blood pressure (in 2001). Concomitant products included LEXAPRO for Anxiety, METOPROLOL for Anxiety and Blood pressure high, SYNTHROID for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced Whole body felt hot, Felt faint, and Extremely cold for next 30 hours. 18-Feb-2021, the patient experienced Joint pain, Throwing up, Headache, Chills, and Nausea. On 06-Mar-2021, the patient experienced Lump in breast. On 18-Apr-2021, the patient experienced Shingles on torso and leg. On an unknown date, the patient experienced Arm pain. At the time of the report, Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, Arm pain, Lump in breast, Joint pain, Throwing up, Headache, Chills, and Nausea outcome was unknown.            Treatment information was not provided by the reporter.    This case was linked to MOD-2021-014748.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Herpes zoster, Nausea, Pain in extremity
Clinical narrative: Arm pain; Shingles on torso and leg; Lump in breast; Joint pain; Throw up; Headache; Chills; Nausea; Whole body felt hot; Felt faint; Extremely cold for next 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, and Arm pain in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease (In 2002), Anxiety (in 2001) and Blood pressure (in 2001). Concomitant products included LEXAPRO for Anxiety, METOPROLOL for Anxiety and Blood pressure high, SYNTHROID for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced Whole body felt hot, Felt faint, and Extremely cold for next 30 hours. 18-Feb-2021, the patient experienced Joint pain, Throwing up, Headache, Chills, and Nausea. On 06-Mar-2021, the patient experienced Lump in breast. On 18-Apr-2021, the patient experienced Shingles on torso and leg. On an unknown date, the patient experienced Arm pain. At the time of the report, Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, Arm pain, Lump in breast, Joint pain, Throwing up, Headache, Chills, and Nausea outcome was unknown.            Treatment information was not provided by the reporter.    This case was linked to MOD-2021-014748.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Arm pain; Shingles on torso and leg; Lump in breast; Joint pain; Throw up; Headache; Chills; Nausea; Whole body felt hot; Felt faint; Extremely cold for next 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, and Arm pain in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease (In 2002), Anxiety (in 2001) and Blood pressure (in 2001). Concomitant products included LEXAPRO for Anxiety, METOPROLOL for Anxiety and Blood pressure high, SYNTHROID for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced Whole body felt hot, Felt faint, and Extremely cold for next 30 hours. 18-Feb-2021, the patient experienced Joint pain, Throwing up, Headache, Chills, and Nausea. On 06-Mar-2021, the patient experienced Lump in breast. On 18-Apr-2021, the patient experienced Shingles on torso and leg. On an unknown date, the patient experienced Arm pain. At the time of the report, Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, Arm pain, Lump in breast, Joint pain, Throwing up, Headache, Chills, and Nausea outcome was unknown.            Treatment information was not provided by the reporter.    This case was linked to MOD-2021-014748.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pyrexia
Clinical narrative: hard time walking; Muscle aches so bad that they had a hard time walking; Fever; 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 hard time walking, Muscle aches so bad that they had a hard time walking, and Fever in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced hard time walking, Muscle aches so bad that they had a hard time walking, and Fever. At the time of the report, hard time walking, Muscle aches so bad that they had a hard time walking, and Fever outcome was unknown.            No concomitant medications and treatment medication were reported.  The reporter stated two doctors that she knows just had a sore arm from the first dose but after the second dose they had fever and muscle aches so bad that they had a hard time walking.   This case was linked to MOD-2021-019765.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE. At the time of the report, FATIGUE outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment medicines were reported.   This case was linked to US-MODERNATX, INC-MOD-2021-098529, US-MODERNATX, INC-MOD-2021-098517; Sender's Comments:  US-MODERNATX, INC-MOD-2021-098517: cross linked case US-MODERNATX, INC-MOD-2021-098529: Cross linked case
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient has not received her second dose past 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received her second dose past 42 days) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received her second dose past 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received her second dose past 42 days) outcome was unknown. Not Provided      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 product use was not provided by the reporter. Treatment information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red arm worsened over a day; Itchy arm worsened over a day; Swollen arm that worsend over a day; Arm sore for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore for two days), VACCINATION SITE ERYTHEMA (Red arm worsened over a day), VACCINATION SITE PRURITUS (Itchy arm worsened over a day) and VACCINATION SITE SWELLING (Swollen arm that worsend over a day) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm sore for two days). On 27-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red arm worsened over a day), VACCINATION SITE PRURITUS (Itchy arm worsened over a day) and VACCINATION SITE SWELLING (Swollen arm that worsend over a day). On 22-Apr-2021, VACCINATION SITE PAIN (Arm sore for two days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red arm worsened over a day), VACCINATION SITE PRURITUS (Itchy arm worsened over a day) and VACCINATION SITE SWELLING (Swollen arm that worsend over a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information provided as, the patient used an antiitch cream that did not help.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and HUMIRA (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN. At the time of the report, PAIN 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.   Suspect drug is HUMIRA solution for injection in pre-filled pen.  Concomitant drugs not reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above included on 28-May-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injected arm was itchy; Injected arm was painful; Injected arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injected arm was itchy), INJECTION SITE PAIN (Injected arm was painful) and INJECTION SITE SWELLING (Injected arm was swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Injected arm was itchy), INJECTION SITE PAIN (Injected arm was painful) and INJECTION SITE SWELLING (Injected arm was swollen). At the time of the report, INJECTION SITE PRURITUS (Injected arm was itchy), INJECTION SITE PAIN (Injected arm was painful) and INJECTION SITE SWELLING (Injected arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medicines were reported. No Treatment information reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Feels hot and cold; Injected arm is stiff; headache; Body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (hot and cold), MUSCULOSKELETAL STIFFNESS (Injected arm is stiff), HEADACHE, and MYALGIA in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0481A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), MUSCULOSKELETAL STIFFNESS (Injected arm is stiff), HEADACHE, and MYALGIA. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), MUSCULOSKELETAL STIFFNESS (Injected arm is stiff), HEADACHE, and MYALGIA outcome was unknown.            No concomitant and treatment medications were provided. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-097518.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm pain; Arm swelling; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Arm pain) and INJECTION SITE SWELLING (Arm swelling) 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 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Arm pain) and INJECTION SITE SWELLING (Arm swelling). At the time of the report, INJECTION SITE PAIN (Arm pain) and INJECTION SITE SWELLING (Arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Rash, Rash pruritic, Skin lesion, Sleep disorder
Clinical narrative: she had some amount of lesions; lesions; rash; Thought I had poison ivy; Itchy rash all over my body from head to toe, front to back; Woke up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Thought I had poison ivy), RASH PRURITIC (Itchy rash all over my body from head to toe, front to back), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions) and SKIN LESION in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid atrophy, Type 2 diabetes mellitus and Hypercholesterolemia. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid atrophy, METFORMIN for Type 2 diabetes mellitus, and VITAMIN B and VITAMIN D for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DERMATITIS CONTACT (Thought I had poison ivy), RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) and SLEEP DISORDER (Woke up in the middle of the night). On an unknown date, the patient experienced ULCER (she had some amount of lesions), SKIN LESION and RASH. On 01-May-2021, RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) and RASH (rash) had resolved. At the time of the report, DERMATITIS CONTACT (Thought I had poison ivy), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions) and SKIN LESION 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 considered RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) to be possibly related. No further causality assessments were provided for DERMATITIS CONTACT (Thought I had poison ivy), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions), and SKIN LESION (lesions).    Patient washed the area and states she applied disinfectant for relief. The patient developed itchy spots on arms. On day 11 rash was on trunk and extremities. The patient denied SOB or difficulty swallowing and after a few days resolved. The patient was advised to use over the counter cream for pruritus and the therapy is for symptomatic relief.   This case was linked to MOD-2021-097574.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 and does not contain any new information On 08-Jun-2021: follow up received on 08-JUN-2021 Contains patient demographic details was updated. Medical history was added. Dose 1 details updated. Vaccination facility information added. Concomitant medications added. Events was updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ulcer
Clinical narrative: she had some amount of lesions; lesions; rash; Thought I had poison ivy; Itchy rash all over my body from head to toe, front to back; Woke up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Thought I had poison ivy), RASH PRURITIC (Itchy rash all over my body from head to toe, front to back), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions) and SKIN LESION in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid atrophy, Type 2 diabetes mellitus and Hypercholesterolemia. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid atrophy, METFORMIN for Type 2 diabetes mellitus, and VITAMIN B and VITAMIN D for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DERMATITIS CONTACT (Thought I had poison ivy), RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) and SLEEP DISORDER (Woke up in the middle of the night). On an unknown date, the patient experienced ULCER (she had some amount of lesions), SKIN LESION and RASH. On 01-May-2021, RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) and RASH (rash) had resolved. At the time of the report, DERMATITIS CONTACT (Thought I had poison ivy), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions) and SKIN LESION 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 considered RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) to be possibly related. No further causality assessments were provided for DERMATITIS CONTACT (Thought I had poison ivy), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions), and SKIN LESION (lesions).    Patient washed the area and states she applied disinfectant for relief. The patient developed itchy spots on arms. On day 11 rash was on trunk and extremities. The patient denied SOB or difficulty swallowing and after a few days resolved. The patient was advised to use over the counter cream for pruritus and the therapy is for symptomatic relief.   This case was linked to MOD-2021-097574.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 and does not contain any new information On 08-Jun-2021: follow up received on 08-JUN-2021 Contains patient demographic details was updated. Medical history was added. Dose 1 details updated. Vaccination facility information added. Concomitant medications added. Events was updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown and CHILLS (Chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy right now / itchy spots on arms and legs; Same rash all over head, to toe, front to back / rash was on trunck and extremitis; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy right now / itchy spots on arms and legs) and RASH (Same rash all over head, to toe, front to back / rash was on trunck and extremitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 17-Jul-2018, Thyroid atrophy, Type 2 diabetes mellitus and Hypercholesterolemia. Concomitant products included LEVOTHYROXINE for Atrophy thyroid, AMLODIPINE and LISINOPRIL for Hypertension, METFORMIN for Type 2 diabetes mellitus, VITAMIN B NOS and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced RASH (Same rash all over head, to toe, front to back / rash was on trunck and extremitis). On 28-Apr-2021, the patient experienced PRURITUS (Itchy right now / itchy spots on arms and legs). On 01-May-2021, PRURITUS (Itchy right now / itchy spots on arms and legs) and RASH (Same rash all over head, to toe, front to back / rash was on trunck and extremitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided include, patient washed the area and applied disinfectant for relief. The patient was advised to use over the counter cream for pruritus and the therapy is symptomatic relief.   This case was linked to US-MODERNATX, INC.-MOD-2021-097567 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up received on 28-Apr-2021: concomitant medications, past medical history, event details and outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097567:Dose 1
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: just mild pain in her left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (just mild pain in her left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031k20A and 039K20A) for COVID-19 vaccination.     No Medical history Information was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 04-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (just mild pain in her left arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, INJECTION SITE PAIN (just mild pain in her left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up received and Updated patient demographic details,Concomitant drug is added, Updated Second dose details On 21-Jul-2021: Follow up received and contains Significant information Event, Address updated; Sender's Comments:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Dizziness, Pain in extremity, Pruritus
Clinical narrative: itching; being uncomfortable; arm was sore; dizziness for a week, severe for 3 to 4 days; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), DIZZINESS (dizziness for a week, severe for 3 to 4 days), ASTHENIA (Weakness), PRURITUS (itching) and DISCOMFORT (being uncomfortable) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Blood pressure, FENOFIBRATE for Cholesterol.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), DIZZINESS (dizziness for a week, severe for 3 to 4 days) and ASTHENIA (Weakness). On an unknown date, the patient experienced PRURITUS (itching) and DISCOMFORT (being uncomfortable). On 19-Jan-2021, PAIN IN EXTREMITY (arm was sore), DIZZINESS (dizziness for a week, severe for 3 to 4 days) and ASTHENIA (Weakness) had resolved. At the time of the report, PRURITUS (itching) and DISCOMFORT (being uncomfortable) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication were provided   concomitants were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: email  updated. patient information updated .vaccine information updated and event verbatim were updated
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Pain in extremity
Clinical narrative: Norming feeling; Extreme pain in arm; Loss of complete function of epsilateral arm; 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 HYPOAESTHESIA (Norming feeling), PAIN IN EXTREMITY (arm), and HYPOKINESIA (Loss of complete function of epsilateral arm) 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 HYPOAESTHESIA (Norming feeling), PAIN IN EXTREMITY and HYPOKINESIA (Loss of complete function of epsilateral arm). At the time of the report, HYPOAESTHESIA (Norming feeling), PAIN IN EXTREMITY (arm) and HYPOKINESIA (Loss of complete function of epsilateral arm) 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.   No concomitant medication was reported.  The treatment information was not given.   This case was linked to MOD21-083908, MOD-2021-097544, MOD-2021-097588.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: FEVER; Full body soreness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), MYALGIA (Full body soreness) and INJECTION SITE PAIN (injection site pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 12-Mar-2021, the patient experienced PYREXIA (FEVER) and MYALGIA (Full body soreness). On 13-Mar-2021, PYREXIA (FEVER) and MYALGIA (Full body soreness) had resolved. At the time of the report, INJECTION SITE PAIN (injection site pain) had not resolved. Not Provided          concomitant medication was not reported treatment information was not provided Action taken with mRNA-1273 in response to the event was not applicable. No further fu needed as per patient.  Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: TCR document attached: event outcome and event updated
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Fever; Headache; Vaccination site swelling; injection site redness; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, PYREXIA, HEADACHE, VACCINATION SITE SWELLING, and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Pyrexia: 98 degree - 102 degree (High) Fever.         No concomitant medication was reported.  No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 24-Mar-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100 (High) 100 F.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-030563 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Underdose
Clinical narrative: She did not receive the full dose; The needle was not screwed in all the way and some of the dose leaked out.; The needle was not screwed in all the way and some of the dose leaked out.; This case was received via an unknown source no reference has been entered for a health authority on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of not receiving the full dose, the needle was not screwed in all the way and some of the dose leaked out, and the needle was not screwed in all the way and some of the dose leaked out in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced not receive the full dose, the needle was not screwed in all the way and some of the dose leaked out, and the needle was not screwed in all the way and some of the dose leaked out. On 28-Apr-2021, She did not receive the full dose, the needle was not screwed in all the way and some of the dose leaked out, and the needle was not screwed in all the way and some of the dose leaked out had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment for the events were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: pains; fever; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (pains), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pains), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, PAIN (pains), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs were not provided,  Concomitant medicines were not included,  Action taken with mRNA-1273 in response to the event was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eating disorder, Fatigue, Headache
Clinical narrative: couldn't sleep for 2 days because I sleep on my left side; vomiting; chills; Fatigue; joint pain; headaches; still having nausea; haven't eaten in two days; This spontaneous case was reported by a consumer and describes the occurrence of haven't eaten in two days, couldn't sleep for 2 days because I sleep on my left side, vomiting, chills, and Fatigue in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was Provided by Reporter.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced EATING DISORDER (haven't eaten in two days), VOMITING, CHILLS, FATIGUE, ARTHRALGIA (joint pain), HEADACHE, and NAUSEA. On an unknown date, the patient experienced SLEEP DISORDER (couldn't sleep for 2 days because I sleep on my left side). The patient was treated with ZOFRAN at an unspecified dose and frequency. At the time of the report, EATING DISORDER (haven't eaten in two days), SLEEP DISORDER (couldn't sleep for 2 days), VOMITING, CHILLS, FATIGUE, ARTHRALGIA (joint pain), HEADACHE, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   concomitant medications are not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: The TCR form received does not contain any new information.