chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Moderna vaccine was mistakenly taken instead of Flu vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna vaccine was mistakenly taken instead of Flu vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna vaccine was mistakenly taken instead of Flu vaccine). On 28-Apr-2021, WRONG PRODUCT ADMINISTERED (Moderna vaccine was mistakenly taken instead of Flu vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he did not had any reactions to the two doses . No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 and Reporter information updated, Suspect vaccine dosing details were updated and Patient course of events were added din narrative
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Nausea, Pallor
Clinical narrative: Pale; Blood pressure dropped; Dizziness; Nauseaus; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (Pale), BLOOD PRESSURE DECREASED (Blood pressure dropped), DIZZINESS (Dizziness) and NAUSEA (Nauseaus) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) 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) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PALLOR (Pale), BLOOD PRESSURE DECREASED (Blood pressure dropped), DIZZINESS (Dizziness) and NAUSEA (Nauseaus). At the time of the report, PALLOR (Pale), BLOOD PRESSURE DECREASED (Blood pressure dropped), DIZZINESS (Dizziness) and NAUSEA (Nauseaus) 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 medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Hip discomfort after receiving Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    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 MUSCULOSKELETAL DISCOMFORT (Hip discomfort after receiving Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Hip discomfort after receiving Moderna vaccine). The patient was treated with DENOSUMAB (PROLIA) for Osteoporosis, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Hip discomfort after receiving Moderna vaccine) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Other treatment given included Steroid pack.   This case was linked to MOD-2021-095168, MOD-2021-095133 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Headache, Vision blurred
Clinical narrative: Knot on the back like the size of a golf ball; Headache; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), CYST (Knot on the back like the size of a golf ball) and HEADACHE (Headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007B21A) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL MYCLIC) for Arthritis, CARVEDILOL for Blood pressure high, SEMAGLUTIDE (OZEMPIC) for Diabetes, TRAZODONE HCL for Sleeplessness, MELOXICAM, EMPAGLIFLOZIN (JARDIANCE), FUROSEMIDE, ACETAMINOPHEN, FOLIC ACID, AMLODIPINE BESYLATE, HYDROXYZINE HCL, VITAMIN D3, LISINOPRIL and METFORMIN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VISION BLURRED (Blurry vision) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced CYST (Knot on the back like the size of a golf ball). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurry vision), CYST (Knot on the back like the size of a golf ball) and HEADACHE (Headache) outcome was unknown. Not Provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: It was itchy; A red rash starting from the injection site; A red rash starting from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was itchy), VACCINATION SITE ERYTHEMA (A red rash starting from the injection site) and VACCINATION SITE RASH (A red rash starting from the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (It was itchy), VACCINATION SITE ERYTHEMA (A red rash starting from the injection site) and VACCINATION SITE RASH (A red rash starting from the injection site). On 22-Apr-2021, VACCINATION SITE PRURITUS (It was itchy), VACCINATION SITE ERYTHEMA (A red rash starting from the injection site) and VACCINATION SITE RASH (A red rash starting from the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (tiredness). On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, PANTOPRAZOLE, METOPROLOL and AMITRIPTYLINE for an unknown indication.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Concomitant medications included statin Treatment medication included antibiotics and steroid injection
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: interchange of vaccine products; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5; This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-095384, US-MODERNATX, INC.-MOD-2021-095367, US-MODERNATX, INC.-MOD-2021-095200, US-MODERNATX, INC.-MOD-2021-095633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095384: US-MODERNATX, INC.-MOD-2021-095367: US-MODERNATX, INC.-MOD-2021-095200: US-MODERNATX, INC.-MOD-2021-095633:
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 10 patients receive vaccine after temperature excursion reaching 68 degrees F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (10 patients receive vaccine after temperature excursion reaching 68 degrees F) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients receive vaccine after temperature excursion reaching 68 degrees F). At the time of the report, PRODUCT STORAGE ERROR (10 patients receive vaccine after temperature excursion reaching 68 degrees F) had resolved. 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.   No Treatment medications were provided No  Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-JUNE-2021, included no new information
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Wrong technique in product usage process
Clinical narrative: vaccine was injected to my bone; Arm is very Sore all the time; Severe Pain in her Left Shoulder; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine was injected to my bone), PAIN IN EXTREMITY (Arm is very Sore all the time) and ARTHRALGIA (Severe Pain in her Left Shoulder) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine was injected to my bone), PAIN IN EXTREMITY (Arm is very Sore all the time) and ARTHRALGIA (Severe Pain in her Left Shoulder). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine was injected to my bone) had resolved and PAIN IN EXTREMITY (Arm is very Sore all the time) and ARTHRALGIA (Severe Pain in her Left Shoulder) outcome was unknown.            No concomitant medications Provided by the reporter. No treatment medications provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vertigo
Clinical narrative: vertigo; dizziness in the head; off balance type things; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness in the head) and BALANCE DISORDER (off balance type things) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-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 VERTIGO (vertigo), DIZZINESS (dizziness in the head) and BALANCE DISORDER (off balance type things). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness in the head) and BALANCE DISORDER (off balance type things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: Dizziness; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 016M20A,) for COVID-19 vaccination.     Concurrent medical conditions included Partial seizures since June 1970. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE SPRINKLE) for Partial seizures, CLORAZEPATE DIPOTASSIUM (TRANXENE) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Jan-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment drugs were reported.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Patient details was updated. Medical history date was updated.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) outcome was unknown. Not Provided          No Concomitant medications provided No treatment information provided
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Missed second dose and was beyond day 36; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed second dose and was beyond day 36) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Defibrillator/pacemaker insertion (The patient is using Defibrillator in his chest.).    On 15-Mar-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 INTENTIONAL PRODUCT USE ISSUE (Missed second dose and was beyond day 36). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed second dose and was beyond day 36) had resolved. 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.   The patient is under medication for diabetes. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received, TCR form  attached does not contain any  information
Sex: U
Vaccine: COVID19
Symptoms: Gout, Pain
Clinical narrative: gout; electrical radiation went up her leg\ waking up to right toe being in excruciating pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GOUT (gout) and PAIN (electrical radiation went up her leg\ waking up to right toe being in excruciating pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (gout) and PAIN (electrical radiation went up her leg\ waking up to right toe being in excruciating pain). At the time of the report, GOUT (gout) and PAIN (electrical radiation went up her leg\ waking up to right toe being in excruciating pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment products were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-096435 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-096435:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects as being "typical"; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects as being "typical") 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 ADVERSE EVENT (side effects as being "typical"). At the time of the report, ADVERSE EVENT (side effects as being "typical") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095793 (E2B Linked Report). This case was linked to MOD-2021-095403 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095793:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiff body; Worried about clotting; Achy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff body), COAGULOPATHY (Worried about clotting) and MYALGIA (Achy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff body), COAGULOPATHY (Worried about clotting) and MYALGIA (Achy). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff body), COAGULOPATHY (Worried about clotting) and MYALGIA (Achy) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Malaise, Nausea, Pain, Swelling
Clinical narrative: pain; swelling/puffiness; hardness; feeling ill; nauseous without vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), SWELLING (swelling/puffiness), INDURATION (hardness), MALAISE (feeling ill) and NAUSEA (nauseous without vomiting) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (pain), SWELLING (swelling/puffiness), INDURATION (hardness), MALAISE (feeling ill) and NAUSEA (nauseous without vomiting). On 10-Apr-2021, PAIN (pain), SWELLING (swelling/puffiness), INDURATION (hardness), MALAISE (feeling ill) and NAUSEA (nauseous without vomiting) had resolved. 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbness around mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (numbness around mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (numbness around mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Numbness mouth, at an unspecified dose and frequency. On 04-Mar-2021, HYPOAESTHESIA ORAL (numbness around mouth) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medication was not reported.   This case was linked to MOD-2021-024471 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: face swells up at night; itching; severe rashes which looks like measles on her hands, face, and neck.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (severe rashes which looks like measles on her hands, face, and neck.), SWELLING FACE (face swells up at night) and PRURITUS (itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included blood pressure medication for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (severe rashes which looks like measles on her hands, face, and neck.). On an unknown date, the patient experienced SWELLING FACE (face swells up at night) and PRURITUS (itching). At the time of the report, RASH (severe rashes which looks like measles on her hands, face, and neck.), SWELLING FACE (face swells up at night) and PRURITUS (itching) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-094916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-094916:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received 2nd dose of Pfizer, instead of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 2nd dose of Pfizer, instead of Moderna vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31B21A) 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, the patient experienced WRONG PRODUCT ADMINISTERED (Received 2nd dose of Pfizer, instead of Moderna vaccine). On 28-Apr-2021, WRONG PRODUCT ADMINISTERED (Received 2nd dose of Pfizer, instead of Moderna vaccine) had resolved. 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.   No concomitant medications were provided. No treatment details were provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) 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.   The concomitant medication was not provided.  The treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095200, US-MODERNATX, INC.-MOD-2021-095384, US-MODERNATX, INC.-MOD-2021-095302, US-MODERNATX, INC.-MOD-2021-095633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095200:Crosslinked case US-MODERNATX, INC.-MOD-2021-095384: US-MODERNATX, INC.-MOD-2021-095302: US-MODERNATX, INC.-MOD-2021-095633:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm  soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm  soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Injection arm  soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication taken by the patient included blood pressure medication.     This case was linked to US-MODERNATX, INC.-MOD-2021-095295 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095295:2nd dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Headache, Middle ear effusion, Nasal congestion, Off label use
Clinical narrative: Patient was advised to take the second dose outside the window period; her left ear had fluids; Sinus infection; Headache; stuffy nose; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), HEADACHE (Headache), NASAL CONGESTION (stuffy nose), EAR INFECTION (ear infection) and OFF LABEL USE (Patient was advised to take the second dose outside the window period) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced SINUSITIS (Sinus infection), HEADACHE (Headache), NASAL CONGESTION (stuffy nose), EAR INFECTION (ear infection) and MIDDLE EAR EFFUSION (her left ear had fluids). On 28-Apr-2021, the patient experienced OFF LABEL USE (Patient was advised to take the second dose outside the window period). On 23-Apr-2021, SINUSITIS (Sinus infection) and HEADACHE (Headache) had resolved, NASAL CONGESTION (stuffy nose) and EAR INFECTION (ear infection) was resolving, MIDDLE EAR EFFUSION (her left ear had fluids) outcome was unknown. At the time of the report, OFF LABEL USE (Patient was advised to take the second dose outside the window period) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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 medication were not reported  Patient was treated with unspecified antibiotics   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up document received. Added lab data and an event
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis
Clinical narrative: Patient was advised to take the second dose outside the window period; her left ear had fluids; Sinus infection; Headache; stuffy nose; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), HEADACHE (Headache), NASAL CONGESTION (stuffy nose), EAR INFECTION (ear infection) and OFF LABEL USE (Patient was advised to take the second dose outside the window period) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced SINUSITIS (Sinus infection), HEADACHE (Headache), NASAL CONGESTION (stuffy nose), EAR INFECTION (ear infection) and MIDDLE EAR EFFUSION (her left ear had fluids). On 28-Apr-2021, the patient experienced OFF LABEL USE (Patient was advised to take the second dose outside the window period). On 23-Apr-2021, SINUSITIS (Sinus infection) and HEADACHE (Headache) had resolved, NASAL CONGESTION (stuffy nose) and EAR INFECTION (ear infection) was resolving, MIDDLE EAR EFFUSION (her left ear had fluids) outcome was unknown. At the time of the report, OFF LABEL USE (Patient was advised to take the second dose outside the window period) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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 medication were not reported  Patient was treated with unspecified antibiotics   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up document received. Added lab data and an event
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) 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.   No concomitant medication were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-095302, US-MODERNATX, INC.-MOD-2021-095367, US-MODERNATX, INC.-MOD-2021-095633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095302: US-MODERNATX, INC.-MOD-2021-095367: US-MODERNATX, INC.-MOD-2021-095633:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fibromyalgia, Headache, Heart rate, Migraine
Clinical narrative: migraine; fibromyalgia; big red ring around the arm; There was a big red ring around the arm along with swelling as well; stabbing pain on the downside of my left body, down my leg, stayed on the left of my body; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well) and MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21X and 042A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM (LORAZEPAM A) for Anxiety and Sleep disorder, TRAMADOL HYDROCHLORIDE (TRAMADOL [TRAMADOL HYDROCHLORIDE]) for Fibromyalgia.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well), MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well), MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 118/93 (normal) 118/93. On an unknown date, Blood pressure measurement: 115-125/90-95 (normal) 115-125/90-95 and 140-150/115 (High) 140-150/115. On an unknown date, Heart rate: 110 (High) 110.         No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.    This case was linked to MOD-2021-095451 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: No new information was added; Sender's Comments:  MOD-2021-095451:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: migraine; fibromyalgia; big red ring around the arm; There was a big red ring around the arm along with swelling as well; stabbing pain on the downside of my left body, down my leg, stayed on the left of my body; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well) and MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21X and 042A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM (LORAZEPAM A) for Anxiety and Sleep disorder, TRAMADOL HYDROCHLORIDE (TRAMADOL [TRAMADOL HYDROCHLORIDE]) for Fibromyalgia.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well), MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well), MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 118/93 (normal) 118/93. On an unknown date, Blood pressure measurement: 115-125/90-95 (normal) 115-125/90-95 and 140-150/115 (High) 140-150/115. On an unknown date, Heart rate: 110 (High) 110.         No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.    This case was linked to MOD-2021-095451 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: No new information was added; Sender's Comments:  MOD-2021-095451:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Red welt below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Red welt below injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 VACCINATION SITE URTICARIA (Red welt below injection site). At the time of the report, VACCINATION SITE URTICARIA (Red welt below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Myalgia
Clinical narrative: Heavy arm; Sore arm; Dull headache; Extreme fatigue and weakness; Violent Headache for almost 2 months/ Splitting Headache 10/10; Shivering; This spontaneous case was reported by a health care professional and describes the occurrence of LIMB DISCOMFORT (Heavy arm), MYALGIA (Sore arm), HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10), CHILLS (Shivering) and HEADACHE (Dull headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives on 06-Jun-1997. Concomitant products included ALPRAZOLAM (ATARAX [ALPRAZOLAM]) for Hives.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021 at 8:00 PM, the patient experienced HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10) and CHILLS (Shivering). On 26-Jan-2021, the patient experienced FATIGUE (Extreme fatigue and weakness). On 23-Mar-2021, the patient experienced HEADACHE (Dull headache). On an unknown date, the patient experienced LIMB DISCOMFORT (Heavy arm) and MYALGIA (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 23-Mar-2021, HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10) had resolved with sequelae. At the time of the report, LIMB DISCOMFORT (Heavy arm), MYALGIA (Sore arm), CHILLS (Shivering) and FATIGUE (Extreme fatigue and weakness) outcome was unknown and HEADACHE (Dull headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10), CHILLS (Shivering) and HEADACHE (Dull headache) to be related. No further causality assessments were provided for LIMB DISCOMFORT (Heavy arm), MYALGIA (Sore arm) and FATIGUE (Extreme fatigue and weakness).    Action taken with mRNA-1273 in response to the events was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient demographics updated, added relevant history, updated dose 1 and 2 details,added concomitant and treatment drugs, updated event outcomes and added new event Fatigue,dull headache.