chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pain in extremity
Clinical narrative: arm hurting; allergic reaction; tired; a little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), HYPERSENSITIVITY (allergic reaction), FATIGUE (tired) and FATIGUE (a little bit of fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), HYPERSENSITIVITY (allergic reaction), FATIGUE (tired) and FATIGUE (a little bit of fatigue). At the time of the report, PAIN IN EXTREMITY (arm hurting), HYPERSENSITIVITY (allergic reaction), FATIGUE (tired) and FATIGUE (a little bit of fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not provided by the reporter. Treinformation were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips
Clinical narrative: Chapped lips; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Chapped lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (Chapped lips). At the time of the report, CHAPPED LIPS (Chapped lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.NO treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114465, MOD21-088065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114465:Patient case MOD21-088065:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Both hand tingle; Both hands "get sleepy" (numbness); Left arm hurts and burns; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Both hand tingle), HYPOAESTHESIA (Both hands "get sleepy" (numbness)), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE PAIN (Left arm hurts and burns) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-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 VACCINATION SITE ERYTHEMA (Red at injection site). On 19-Apr-2021, the patient experienced PARAESTHESIA (Both hand tingle), HYPOAESTHESIA (Both hands "get sleepy" (numbness)) and VACCINATION SITE PAIN (Left arm hurts and burns). At the time of the report, PARAESTHESIA (Both hand tingle), HYPOAESTHESIA (Both hands "get sleepy" (numbness)), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE PAIN (Left arm hurts and burns) 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of constant headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch#  041C21A) for COVID-19 immunization. No medical history reported. On Apr 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 11, 2021, patient experienced constant headache. At the time of the report, constant headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications provided. Treatment: Tylenol and cranial work taken to alleviate the symptoms experienced.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Off label use
Clinical narrative: Given 3rd shot accidentally; 3rd shot accidentally; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Given 3rd shot accidentally) and ACCIDENTAL OVERDOSE (3rd shot accidentally) in a 97-year-old female patient 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 07-May-2021, the patient experienced OFF LABEL USE (Given 3rd shot accidentally) and ACCIDENTAL OVERDOSE (3rd shot accidentally). On 07-May-2021, OFF LABEL USE (Given 3rd shot accidentally) and ACCIDENTAL OVERDOSE (3rd shot accidentally) outcome was unknown. Not Provided          No concomitant medication were reported. No treatment information was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced FATIGUE (felt tired). At the time of the report, FATIGUE (felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: My arm still hurts; difficulty raising his right arm over shoulder level / I still can't raise it past my shoulder without it hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising his right arm over shoulder level / I still can't raise it past my shoulder without it hurting) and PAIN IN EXTREMITY (My arm still hurts) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), LOSARTAN, ATORVASTATIN and MELOXICAM for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising his right arm over shoulder level / I still can't raise it past my shoulder without it hurting). On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm still hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising his right arm over shoulder level / I still can't raise it past my shoulder without it hurting) and PAIN IN EXTREMITY (My arm still hurts) had not resolved.            .   This case was linked to MOD-2021-114349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: significant information. added event arm hurts, Updated event outcome.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: breathing difficulty; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Blood test- negative. On an unknown date, Computerised tomogram: negative (Negative) Computerised tomogram-negative. On an unknown date, Electrocardiogram: negative (Negative) Electrocardiogram-negative. On an unknown date, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 tested 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.   No concomitant medications were mentioned. Treatment medication reported includes Albuterol and Flovent inhaler ,Prednisone and singulair. He will have stress test and pulmonary tests week.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: breathing difficulty; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Blood test- negative. On an unknown date, Computerised tomogram: negative (Negative) Computerised tomogram-negative. On an unknown date, Electrocardiogram: negative (Negative) Electrocardiogram-negative. On an unknown date, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 tested 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.   No concomitant medications were mentioned. Treatment medication reported includes Albuterol and Flovent inhaler ,Prednisone and singulair. He will have stress test and pulmonary tests week.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on back, close to left neck, and a little to the right; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back, close to left neck, and a little to the right) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH (Rash on back, close to left neck, and a little to the right). At the time of the report, RASH (Rash on back, close to left neck, and a little to the right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information  was provided.   This case was linked to MOD-2021-114508 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Unexperienced nursing student gave Pfizer vaccine to Moderna patient; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Unexperienced nursing student gave Pfizer vaccine to Moderna patient) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Unexperienced nursing student gave Pfizer vaccine to Moderna patient). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Unexperienced nursing student gave Pfizer vaccine to Moderna patient) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria, Vaccination site reaction
Clinical narrative: Sore arm; COVID arm; Hives on arms, hands, and back of achilleas tendon; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID arm) and URTICARIA (Hives on arms, hands, and back of achilleas tendon) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID arm) and URTICARIA (Hives on arms, hands, and back of achilleas tendon). On 01-Apr-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID arm) and URTICARIA (Hives on arms, hands, and back of achilleas tendon) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information provided.   This case was linked to MOD21-087942 (E2B Linked Report). This case was linked to MOD-2021-114519 (Patient Link).; Sender's Comments:  MOD21-087942:First dose case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Pallor, Swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Lips started turning white and started looking pale; Swelling of other arm (not arm where vaccine was administered), swelling of both legs; Swelling the size of a small baseball at injection site; Itching at injection site; Hot all around the injection area; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (Lips started turning white and started looking pale), SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Previous COPD symptoms have been getting better since second dose.), Diabetes, Insomnia, Heart disorder, Cholesterol and Migraine. Concomitant products included ARFORMOTEROL TARTRATE (BROVANA) and ALBUTEROL [SALBUTAMOL] for COPD, ALIROCUMAB (PRALUENT) for Cholesterol, METFORMIN for Diabetes, METOPROLOL for Heart disorder, ZIPRASIDONE for Insomnia, ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) and SUMATRIPTAN for Migraine, NITROGLYCERIN, ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ESCITALOPRAM, ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PALLOR (Lips started turning white and started looking pale), SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area). On 05-May-2021, PALLOR (Lips started turning white and started looking pale) had resolved. At the time of the report, SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Liver function test: high (High) Higher levels of alkaline in liver..         Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Lips started turning white and started looking pale; Swelling of other arm (not arm where vaccine was administered), swelling of both legs; Swelling the size of a small baseball at injection site; Itching at injection site; Hot all around the injection area; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (Lips started turning white and started looking pale), SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Previous COPD symptoms have been getting better since second dose.), Diabetes, Insomnia, Heart disorder, Cholesterol and Migraine. Concomitant products included ARFORMOTEROL TARTRATE (BROVANA) and ALBUTEROL [SALBUTAMOL] for COPD, ALIROCUMAB (PRALUENT) for Cholesterol, METFORMIN for Diabetes, METOPROLOL for Heart disorder, ZIPRASIDONE for Insomnia, ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) and SUMATRIPTAN for Migraine, NITROGLYCERIN, ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ESCITALOPRAM, ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PALLOR (Lips started turning white and started looking pale), SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area). On 05-May-2021, PALLOR (Lips started turning white and started looking pale) had resolved. At the time of the report, SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Liver function test: high (High) Higher levels of alkaline in liver..         Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Erythema, Rash, Throat tightness
Clinical narrative: panty line down to my knee cap and my neck so red now; tightness of the throat; over the body rash; the symptoms are back to my legs, arm, in the palm; the symptoms are back to hands; chest pain; tightness of the chest again; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness of the chest again), ERYTHEMA (panty line down to my knee cap and my neck so red now), THROAT TIGHTNESS (tightness of the throat) and RASH (over the body rash) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and lot#016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness of the chest again), THROAT TIGHTNESS (tightness of the throat), RASH (over the body rash), RASH (the symptoms are back to my legs, arm, in the palm) and RASH (the symptoms are back to hands). On 09-May-2021, the patient experienced ERYTHEMA (panty line down to my knee cap and my neck so red now). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness of the chest again), ERYTHEMA (panty line down to my knee cap and my neck so red now), THROAT TIGHTNESS (tightness of the throat), RASH (over the body rash), RASH (the symptoms are back to my legs, arm, in the palm) and RASH (the symptoms are back to hands) outcome was unknown. Not Provided
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on back, close to left neck, and a little to the right; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back, close to left neck, and a little to the right) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history provided).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced RASH (Rash on back, close to left neck, and a little to the right). At the time of the report, RASH (Rash on back, close to left neck, and a little to the right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114500 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on both arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on both arms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CYANOCOBALAMIN (VIT B12) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on both arms). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain on both arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include: hydrating drinks, eating bland diet   This case was linked to US-MODERNATX, INC.-MOD-2021-114516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114516:dose 2
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness from both doses of the vaccine, which lasted only for a day after each shots were given) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 6, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (soreness from both doses of the vaccine, which lasted only for a day after each shots were given). At the time of the report, pain in extremity (soreness from both doses of the vaccine, which lasted only for a day after each shots were given) resolved.  No relevant concomitant medications or treatment information provided. Action taken with mRNA-1273 in response to the events: not applicable. This case linked to MOD-2021-114518 (patient link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Peripheral swelling, Skin irritation
Clinical narrative: the injection site started itching; the injection site started achiness; swelling in arm; 2-3 Inch irritated area; irritated area which was warm to touch; irritated area which was warm to touch and red; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch), ERYTHEMA (irritated area which was warm to touch and red) and VACCINATION SITE PRURITUS (the injection site started itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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 GABAPENTIN, BUPRENORPHINE, ESTRADIOL (ESTROGEN), PROGESTERONE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTIC 10 for an unknown indication.    On 27-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 MYALGIA (arm was very sore). On 05-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch) and ERYTHEMA (irritated area which was warm to touch and red). On 08-May-2021, the patient experienced VACCINATION SITE PRURITUS (the injection site started itching) and VACCINATION SITE PAIN (the injection site started achiness). The patient was treated with NAPROXEN SODIUM for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch), ERYTHEMA (irritated area which was warm to touch and red), VACCINATION SITE PRURITUS (the injection site started itching), VACCINATION SITE PAIN (the injection site started achiness) and MYALGIA (arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: the injection site started itching; the injection site started achiness; swelling in arm; 2-3 Inch irritated area; irritated area which was warm to touch; irritated area which was warm to touch and red; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch), ERYTHEMA (irritated area which was warm to touch and red) and VACCINATION SITE PRURITUS (the injection site started itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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 GABAPENTIN, BUPRENORPHINE, ESTRADIOL (ESTROGEN), PROGESTERONE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTIC 10 for an unknown indication.    On 27-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 MYALGIA (arm was very sore). On 05-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch) and ERYTHEMA (irritated area which was warm to touch and red). On 08-May-2021, the patient experienced VACCINATION SITE PRURITUS (the injection site started itching) and VACCINATION SITE PAIN (the injection site started achiness). The patient was treated with NAPROXEN SODIUM for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in arm), SKIN IRRITATION (2-3 Inch irritated area), FEELING HOT (irritated area which was warm to touch), ERYTHEMA (irritated area which was warm to touch and red), VACCINATION SITE PRURITUS (the injection site started itching), VACCINATION SITE PAIN (the injection site started achiness) and MYALGIA (arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Papule, Peripheral swelling
Clinical narrative: The area got very thick, pretty much the entire circumference of the deltoid was affected; Had some bumps; The area got very red; The area got very hot; Was itchy; Really bad headache; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot) and PRURITUS (Was itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) 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 MULTIVITAMIN [VITAMINS NOS] and PACLITAXEL (PAXEL) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HEADACHE (Really bad headache). On 03-May-2021, the patient experienced PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot) and PRURITUS (Was itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot), PRURITUS (Was itchy) and HEADACHE (Really bad headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-Jun-2021 contains non-significant information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: The area got very thick, pretty much the entire circumference of the deltoid was affected; Had some bumps; The area got very red; The area got very hot; Was itchy; Really bad headache; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot) and PRURITUS (Was itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) 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 MULTIVITAMIN [VITAMINS NOS] and PACLITAXEL (PAXEL) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HEADACHE (Really bad headache). On 03-May-2021, the patient experienced PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot) and PRURITUS (Was itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot), PRURITUS (Was itchy) and HEADACHE (Really bad headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-Jun-2021 contains non-significant information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Appetite disorder, Diarrhoea, Eating disorder, Headache
Clinical narrative: diarrhea; appetite not the same; upset stomach; just started eating meat because it was too hard to get down; bad nausea; headaches that would come and go; vomiting; pain on both arms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down) and MYALGIA (pain on both arms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (pain on both arms). On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down), NAUSEA (bad nausea), HEADACHE (headaches that would come and go) and VOMITING (vomiting). At the time of the report, DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down), MYALGIA (pain on both arms), NAUSEA (bad nausea), HEADACHE (headaches that would come and go) and VOMITING (vomiting) outcome was unknown. Not Provided          Patient was reported to be advised to take OTC generic Dramamine that I take every 24 hours, Gatorade and Pedialyte. Patient was also reported to be taking bland diet.   This case was linked to US-MODERNATX, INC.-MOD-2021-114509 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114509:dose1
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: diarrhea; appetite not the same; upset stomach; just started eating meat because it was too hard to get down; bad nausea; headaches that would come and go; vomiting; pain on both arms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down) and MYALGIA (pain on both arms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (pain on both arms). On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down), NAUSEA (bad nausea), HEADACHE (headaches that would come and go) and VOMITING (vomiting). At the time of the report, DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down), MYALGIA (pain on both arms), NAUSEA (bad nausea), HEADACHE (headaches that would come and go) and VOMITING (vomiting) outcome was unknown. Not Provided          Patient was reported to be advised to take OTC generic Dramamine that I take every 24 hours, Gatorade and Pedialyte. Patient was also reported to be taking bland diet.   This case was linked to US-MODERNATX, INC.-MOD-2021-114509 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114509:dose1
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: m soreness from both doses of the vaccine which lasted only for a day after each shots were; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (m soreness from both doses of the vaccine which lasted only for a day after each shots were) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (m soreness from both doses of the vaccine which lasted only for a day after each shots were). At the time of the report, PAIN IN EXTREMITY (m soreness from both doses of the vaccine which lasted only for a day after each shots were) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD21-087622 (E2B Linked Report). This case was linked to MOD-2021-114511 (Patient Link).; Sender's Comments:  MOD21-087622:Same reporter, different patient
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore injection site left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ACETAMINOPHEN for an unknown indication, LOPERAMIDE HYDROCHLORIDE (IMODIUM).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm) and HEADACHE (headache). On 26-Mar-2021, VACCINATION SITE PAIN (sore injection site left arm) and HEADACHE (headache) had resolved. Not Provided      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 medication included Gatorade, water. Treatment information included Tylenol and Aspirin.   This case was linked to MOD-2021-114526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Nonsignificant Follow up appended On 07-May-2021: Follow up received on 07-05-2021. included information of batch number for suspected product
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Swelling
Clinical narrative: ball formed by the clavicle; pain in her arm; Fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (ball formed by the clavicle), PAIN IN EXTREMITY (pain in her arm), FATIGUE (Fatigue) and MYALGIA (muscle pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. E31B21A and 004621A)) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included birth control pills for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm), FATIGUE (Fatigue) and MYALGIA (muscle pain). On 07-Apr-2021, the patient experienced SWELLING (ball formed by the clavicle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (ball formed by the clavicle), PAIN IN EXTREMITY (pain in her arm), FATIGUE (Fatigue) and MYALGIA (muscle pain) outcome was unknown.            This case was linked to MOD-2021-114543 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema
Clinical narrative: Dry skin on face; Dry skin on hairline to her neck / Dry skin on collar bone; Redness in the area from her neck to collar bone; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin on face), DRY SKIN (Dry skin on hairline to her neck / Dry skin on collar bone) and ERYTHEMA (Redness in the area from her neck to collar bone) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL and HYDROCHLOROTHIAZIDE for Hypertension, POTASSIUM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (Dry skin on face), DRY SKIN (Dry skin on hairline to her neck / Dry skin on collar bone) and ERYTHEMA (Redness in the area from her neck to collar bone). At the time of the report, DRY SKIN (Dry skin on face), DRY SKIN (Dry skin on hairline to her neck / Dry skin on collar bone) and ERYTHEMA (Redness in the area from her neck to collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any medications for skin problems, but used face cream to soothe the affected skin.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: No new information was provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient who got through the initial screening and got the first Moderna vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient who got through the initial screening and got the first Moderna vaccination) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient who got through the initial screening and got the first Moderna vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient who got through the initial screening and got the first Moderna vaccination) 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-2021-114321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114321: