chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Dyspnoea, Pain, Pyrexia
Clinical narrative: Side effects; Breathing problem; Massive body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Side effects), DYSPNOEA (Breathing problem), PAIN (Massive body aches) and PYREXIA (Fever) 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 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 DRUG REACTION (Side effects), DYSPNOEA (Breathing problem), PAIN (Massive body aches) and PYREXIA (Fever). At the time of the report, ADVERSE DRUG REACTION (Side effects) outcome was unknown and DYSPNOEA (Breathing problem), PAIN (Massive body aches) and PYREXIA (Fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Pain is specified as body aches.  Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information received on 07-MAY-2021, Events fever, breathing problem, massive body aches were added
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: has pain under his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (has pain under his arm) 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 14-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 PAIN IN EXTREMITY (has pain under his arm). At the time of the report, PAIN IN EXTREMITY (has pain under his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: a couple side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (a couple side effects) 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 REACTION (a couple side effects). At the time of the report, ADVERSE REACTION (a couple side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment information was not provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Diarrhoea, Rash pruritic, Vaccination site swelling
Clinical narrative: Itchy rash on her left arm that extended from the injection site down to her elbow; injection site swollen; Elevated cholesterol; Diarrhea; Vomitting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD CHOLESTEROL INCREASED (Elevated cholesterol), DIARRHOEA (Diarrhea), VOMITING (Vomitting), RASH PRURITIC (Itchy rash on her left arm that extended from the injection site down to her elbow) and VACCINATION SITE SWELLING (injection site swollen) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 BLOOD CHOLESTEROL INCREASED (Elevated cholesterol). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomitting), RASH PRURITIC (Itchy rash on her left arm that extended from the injection site down to her elbow) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, BLOOD CHOLESTEROL INCREASED (Elevated cholesterol) and VACCINATION SITE SWELLING (injection site swollen) outcome was unknown, DIARRHOEA (Diarrhea) and VOMITING (Vomitting) had resolved and RASH PRURITIC (Itchy rash on her left arm that extended from the injection site down to her elbow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood cholesterol: elevated High.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    The age of patient was 86 years. No relevant concomitant medications were reported. Treatment information included anti-itch cream and atorvastatin.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Itchy rash on her left arm that extended from the injection site down to her elbow; injection site swollen; Elevated cholesterol; Diarrhea; Vomitting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD CHOLESTEROL INCREASED (Elevated cholesterol), DIARRHOEA (Diarrhea), VOMITING (Vomitting), RASH PRURITIC (Itchy rash on her left arm that extended from the injection site down to her elbow) and VACCINATION SITE SWELLING (injection site swollen) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 BLOOD CHOLESTEROL INCREASED (Elevated cholesterol). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomitting), RASH PRURITIC (Itchy rash on her left arm that extended from the injection site down to her elbow) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, BLOOD CHOLESTEROL INCREASED (Elevated cholesterol) and VACCINATION SITE SWELLING (injection site swollen) outcome was unknown, DIARRHOEA (Diarrhea) and VOMITING (Vomitting) had resolved and RASH PRURITIC (Itchy rash on her left arm that extended from the injection site down to her elbow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood cholesterol: elevated High.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    The age of patient was 86 years. No relevant concomitant medications were reported. Treatment information included anti-itch cream and atorvastatin.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Pruritus, Rash morbilliform, Rash pruritic
Clinical narrative: itchy rash on torso, neck, ears, back and down back of thighs; itchy rash on torso; itchy rash on neck; itchy rash down back of thighs; itchy rash on back; received doses 2 weeks apart; little red dots under the injection site; rash that looks likes measles and chicken pox; cant sleep; cant wear clothes as it makes her itch/Severe itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on torso, neck, ears, back and down back of thighs), RASH PRURITIC (itchy rash on torso), RASH PRURITIC (itchy rash on neck), RASH PRURITIC (itchy rash down back of thighs) and RASH PRURITIC (itchy rash on back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 RIVAROXABAN (XARELTO), AMLODIPINE, AMIODARONE, VITAMIN D3, CYANOCOBALAMIN (B12-VITAMIIN), BIOTIN, METOPROLOL TARTRATE and SODIUM BICARBONATE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, 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 RASH MORBILLIFORM (rash that looks likes measles and chicken pox), INSOMNIA (cant sleep) and PRURITUS (cant wear clothes as it makes her itch/Severe itching). On an unknown date, the patient experienced RASH PRURITIC (itchy rash on torso, neck, ears, back and down back of thighs), RASH PRURITIC (itchy rash on torso), RASH PRURITIC (itchy rash on neck), RASH PRURITIC (itchy rash down back of thighs), RASH PRURITIC (itchy rash on back), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received doses 2 weeks apart) and VACCINATION SITE RASH (little red dots under the injection site). At the time of the report, RASH PRURITIC (itchy rash on torso, neck, ears, back and down back of thighs), RASH PRURITIC (itchy rash on torso), RASH PRURITIC (itchy rash on neck), RASH PRURITIC (itchy rash down back of thighs), RASH PRURITIC (itchy rash on back), RASH MORBILLIFORM (rash that looks likes measles and chicken pox), INSOMNIA (cant sleep), PRURITUS (cant wear clothes as it makes her itch/Severe itching) and VACCINATION SITE RASH (little red dots under the injection site) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received doses 2 weeks apart) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060259 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Rash pruritic, Rash morbilliform, Insomnia, Pruritus events added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060259:first dose
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: itchy rash on torso, neck, ears, back and down back of thighs; itchy rash on torso; itchy rash on neck; itchy rash down back of thighs; itchy rash on back; received doses 2 weeks apart; little red dots under the injection site; rash that looks likes measles and chicken pox; cant sleep; cant wear clothes as it makes her itch/Severe itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on torso, neck, ears, back and down back of thighs), RASH PRURITIC (itchy rash on torso), RASH PRURITIC (itchy rash on neck), RASH PRURITIC (itchy rash down back of thighs) and RASH PRURITIC (itchy rash on back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 RIVAROXABAN (XARELTO), AMLODIPINE, AMIODARONE, VITAMIN D3, CYANOCOBALAMIN (B12-VITAMIIN), BIOTIN, METOPROLOL TARTRATE and SODIUM BICARBONATE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, 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 RASH MORBILLIFORM (rash that looks likes measles and chicken pox), INSOMNIA (cant sleep) and PRURITUS (cant wear clothes as it makes her itch/Severe itching). On an unknown date, the patient experienced RASH PRURITIC (itchy rash on torso, neck, ears, back and down back of thighs), RASH PRURITIC (itchy rash on torso), RASH PRURITIC (itchy rash on neck), RASH PRURITIC (itchy rash down back of thighs), RASH PRURITIC (itchy rash on back), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received doses 2 weeks apart) and VACCINATION SITE RASH (little red dots under the injection site). At the time of the report, RASH PRURITIC (itchy rash on torso, neck, ears, back and down back of thighs), RASH PRURITIC (itchy rash on torso), RASH PRURITIC (itchy rash on neck), RASH PRURITIC (itchy rash down back of thighs), RASH PRURITIC (itchy rash on back), RASH MORBILLIFORM (rash that looks likes measles and chicken pox), INSOMNIA (cant sleep), PRURITUS (cant wear clothes as it makes her itch/Severe itching) and VACCINATION SITE RASH (little red dots under the injection site) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received doses 2 weeks apart) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060259 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Rash pruritic, Rash morbilliform, Insomnia, Pruritus events added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060259:first dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Nausea, Vomiting
Clinical narrative: So sick/ I became sick sick sick; feeling cold; feeling tired; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (So sick/ I became sick sick sick), CHILLS (feeling cold), FATIGUE (feeling tired), NAUSEA (nausea) and VOMITING (vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-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 14-Apr-2021, the patient experienced CHILLS (feeling cold), FATIGUE (feeling tired), NAUSEA (nausea) and VOMITING (vomiting). On an unknown date, the patient experienced ILLNESS (So sick/ I became sick sick sick). At the time of the report, ILLNESS (So sick/ I became sick sick sick), CHILLS (feeling cold), FATIGUE (feeling tired), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.            No concomitant medications were provided.  On follow-up, the patient reported that she was so sick. Her health care provider sent her to urgent care. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 4-AUG-202, Event has been added.  Amended dosage regimen from initial version. On 05-Aug-2021: Follow-up information received email address updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her upper arm ache for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her upper arm ache for a day and a half) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TRAMADOL and SUMATRIPTAN for Migraine, POTASSIUM, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and MOMETASONA [MOMETASONE] for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced VACCINATION SITE PAIN (Her upper arm ache for a day and a half). On 23-Dec-2020, VACCINATION SITE PAIN (Her upper arm ache for a day and a half) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-076762 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizzy) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Swelling and pain; Swelling and pain; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Swelling and pain), VACCINATION SITE SWELLING (Swelling and pain), CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches) and NAUSEA (Chills, soreness on her arm, nausea, headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Swelling and pain), VACCINATION SITE SWELLING (Swelling and pain), CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches), NAUSEA (Chills, soreness on her arm, nausea, headaches) and HEADACHE (Chills, soreness on her arm, nausea, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2021, CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches), NAUSEA (Chills, soreness on her arm, nausea, headaches) and HEADACHE (Chills, soreness on her arm, nausea, headaches) had resolved. At the time of the report, VACCINATION SITE PAIN (Swelling and pain) and VACCINATION SITE SWELLING (Swelling and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included cholesterol medication and thyroid medication.  The patient stopped taking regular medications.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling and pain; Swelling and pain; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Swelling and pain), VACCINATION SITE SWELLING (Swelling and pain), CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches) and NAUSEA (Chills, soreness on her arm, nausea, headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Swelling and pain), VACCINATION SITE SWELLING (Swelling and pain), CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches), NAUSEA (Chills, soreness on her arm, nausea, headaches) and HEADACHE (Chills, soreness on her arm, nausea, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2021, CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches), NAUSEA (Chills, soreness on her arm, nausea, headaches) and HEADACHE (Chills, soreness on her arm, nausea, headaches) had resolved. At the time of the report, VACCINATION SITE PAIN (Swelling and pain) and VACCINATION SITE SWELLING (Swelling and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included cholesterol medication and thyroid medication.  The patient stopped taking regular medications.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Palpitations, Somnolence
Clinical narrative: heart palpitations; left earache; slept; Felt tired; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), SOMNOLENCE (slept), EAR PAIN (left earache), HEADACHE (bad headaches) and FATIGUE (Felt tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL, HCTZ, OXYBUTYNIN, PROGESTERONE, DOCUSATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE and PRAVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (bad headaches). On 05-Apr-2021, the patient experienced SOMNOLENCE (slept) and FATIGUE (Felt tired). On 07-Apr-2021, the patient experienced EAR PAIN (left earache). On 08-Apr-2021, the patient experienced PALPITATIONS (heart palpitations). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, EAR PAIN (left earache) had resolved. At the time of the report, PALPITATIONS (heart palpitations), SOMNOLENCE (slept), HEADACHE (bad headaches) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-076726 (E2B Linked Report).; Sender's Comments:  MOD-2021-076726:Second dose of vaccine case.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TRAMADOL and SUMATRIPTAN for Migraine, POTASSIUM, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and MOMETASONA [MOMETASONE] for an unknown indication.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-076700 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076700:MOD-2021-076700 Case for dose 1
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Tenderness in her left arm; Lymph node swelling in her neck on her left side; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in her left arm) and LYMPHADENOPATHY (Lymph node swelling in her neck on her left side) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 10-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 TENDERNESS (Tenderness in her left arm) and LYMPHADENOPATHY (Lymph node swelling in her neck on her left side). At the time of the report, TENDERNESS (Tenderness in her left arm) and LYMPHADENOPATHY (Lymph node swelling in her neck on her left side) outcome was unknown.            The patient's medical history was not provided.  No relevant concomitant medications were reported. Treatment information included Tylenol.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain, Vomiting
Clinical narrative: diarrhea; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (vomiting) and VACCINATION SITE PAIN (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (vomiting) and VACCINATION SITE PAIN (sore arm). On 16-Mar-2021, DIARRHOEA (diarrhea), VOMITING (vomiting) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site mass, Vaccination site pain
Clinical narrative: pain all over the body; small bump below the left arm; mild headache; left arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain all over the body), VACCINATION SITE MASS (small bump below the left arm), HEADACHE (mild headache) and VACCINATION SITE PAIN (left arm soreness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (pain all over the body), VACCINATION SITE MASS (small bump below the left arm), HEADACHE (mild headache) and VACCINATION SITE PAIN (left arm soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (pain all over the body), VACCINATION SITE MASS (small bump below the left arm), HEADACHE (mild headache) and VACCINATION SITE PAIN (left arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication consisted of Triglyceride medications and Diabetic medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-076682 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076682:case for dose 1
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Body aches after 2nd dose; Felt bad after the 2nd dose; Chills after 2nd dose; Fatigue after 2nd dose; May have had a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches after 2nd dose), FEELING ABNORMAL (Felt bad after the 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (May have had a fever after the 2nd dose) in a 20-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches after 2nd dose), FEELING ABNORMAL (Felt bad after the 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (May have had a fever after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches after 2nd dose), FEELING ABNORMAL (Felt bad after the 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (May have had a fever after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Discomfort, Influenza like illness, Lethargy
Clinical narrative: flu-like symptoms; lethargic; uncomfortable; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), DISCOMFORT (uncomfortable) and ABDOMINAL DISCOMFORT (upset stomach) 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), DISCOMFORT (uncomfortable) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), DISCOMFORT (uncomfortable) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm (second injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm (second injection)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm (second injection)). At the time of the report, VACCINATION SITE PAIN (sore arm (second injection)) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-076831, MOD-2021-077197, US-MODERNATX, INC.-MOD-2021-077211 (E2B Linked Report).; Sender's Comments:  MOD-2021-076831:Same reporter MOD-2021-077197:Same reporter US-MODERNATX, INC.-MOD-2021-077211:Same reporter
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Chills, Pyrexia, Sleep disorder
Clinical narrative: "15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."; " Felt wired and couldn't sleep at all."; " I was wheezing and I thought something is wrong or different than normal."; "My allergies are apposite from normal, Bronchial."; "I got chills"; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."), SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), ASTHMA ("My allergies are apposite from normal, Bronchial.") and CHILLS ("I got chills") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (states that her seasonal allergies are normally nasal and sinus related. After receiving the vaccine "My allergies are apposite from normal, Bronchial.). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 08-Apr-2021, the patient experienced CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."), SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), ASTHMA ("My allergies are apposite from normal, Bronchial."), CHILLS ("I got chills") and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (KENALOG 40) at an unspecified dose and frequency. On 08-Apr-2021, CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up.") had resolved. On 14-Apr-2021, SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), CHILLS ("I got chills") and PYREXIA (fever) had resolved. At the time of the report, ASTHMA ("My allergies are apposite from normal, Bronchial.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: "15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."; " Felt wired and couldn't sleep at all."; " I was wheezing and I thought something is wrong or different than normal."; "My allergies are apposite from normal, Bronchial."; "I got chills"; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."), SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), ASTHMA ("My allergies are apposite from normal, Bronchial.") and CHILLS ("I got chills") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (states that her seasonal allergies are normally nasal and sinus related. After receiving the vaccine "My allergies are apposite from normal, Bronchial.). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 08-Apr-2021, the patient experienced CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."), SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), ASTHMA ("My allergies are apposite from normal, Bronchial."), CHILLS ("I got chills") and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (KENALOG 40) at an unspecified dose and frequency. On 08-Apr-2021, CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up.") had resolved. On 14-Apr-2021, SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), CHILLS ("I got chills") and PYREXIA (fever) had resolved. At the time of the report, ASTHMA ("My allergies are apposite from normal, Bronchial.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pain, Vaccination site pain
Clinical narrative: Sore Injection Site; Chills; Body aches; Painful Breathing after Second Vaccine (Chest hurts on deep breathing); Pain Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DYSPNOEA (Painful Breathing after Second Vaccine (Chest hurts on deep breathing)), VACCINATION SITE PAIN (Pain Left Arm), VACCINATION SITE PAIN (Sore Injection Site) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain Left Arm). On 13-Apr-2021, the patient experienced PAIN (Body aches), DYSPNOEA (Painful Breathing after Second Vaccine (Chest hurts on deep breathing)) and CHILLS (Chills). On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). At the time of the report, PAIN (Body aches), DYSPNOEA (Painful Breathing after Second Vaccine (Chest hurts on deep breathing)), VACCINATION SITE PAIN (Pain Left Arm), VACCINATION SITE PAIN (Sore Injection Site) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076754 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076754:
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Electrocardiogram, Fatigue, Palpitations
Clinical narrative: Heart palpitations are off and on; Left earache; Felt tired and slept; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations are off and on), EAR PAIN (Left earache) and FATIGUE (Felt tired and slept) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Palpitations in 2009 and Heart valve replacement in 2009. Concurrent medical conditions included Hypertension (under control), Diabetes (under control) and High cholesterol. Concomitant products included VERAPAMIL, HCTZ, OXYBUTYNIN, PROGESTERONE, DOCUSATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE and PRAVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced FATIGUE (Felt tired and slept). On 07-Apr-2021, the patient experienced EAR PAIN (Left earache). On 08-Apr-2021, the patient experienced PALPITATIONS (Heart palpitations are off and on). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart palpitations are off and on) had not resolved, EAR PAIN (Left earache) had resolved and FATIGUE (Felt tired and slept) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Electrocardiogram: abnormal Cardiologist "saw something" on EKG so patient scheduled to have an echocardiogram (unknown date).         This case was linked to MOD-2021-076706 (E2B Linked Report).; Sender's Comments:  MOD-2021-076706:First dose of vaccine case
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Decreased appetite, Diarrhoea, Feeling cold, Fluid retention
Clinical narrative: Uncontrollable and constant diarrhea; Both legs to knees severely swollen with retention of fluid; bloating in his stomach/constant bloating in stomach; Both legs to knees severely swollen with retention of fluid; Has no appetite; Sleepy all the time; Feels very cold and shaky; Feels very cold and shaky; Vaccine changed his taste of foods; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid) and DECREASED APPETITE (Has no appetite) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid), DECREASED APPETITE (Has no appetite), SOMNOLENCE (Sleepy all the time), FEELING COLD (Feels very cold and shaky), TREMOR (Feels very cold and shaky) and TASTE DISORDER (Vaccine changed his taste of foods). At the time of the report, DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid), DECREASED APPETITE (Has no appetite), SOMNOLENCE (Sleepy all the time), FEELING COLD (Feels very cold and shaky), TREMOR (Feels very cold and shaky) and TASTE DISORDER (Vaccine changed his taste of foods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence, Taste disorder, Tremor
Clinical narrative: Uncontrollable and constant diarrhea; Both legs to knees severely swollen with retention of fluid; bloating in his stomach/constant bloating in stomach; Both legs to knees severely swollen with retention of fluid; Has no appetite; Sleepy all the time; Feels very cold and shaky; Feels very cold and shaky; Vaccine changed his taste of foods; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid) and DECREASED APPETITE (Has no appetite) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid), DECREASED APPETITE (Has no appetite), SOMNOLENCE (Sleepy all the time), FEELING COLD (Feels very cold and shaky), TREMOR (Feels very cold and shaky) and TASTE DISORDER (Vaccine changed his taste of foods). At the time of the report, DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid), DECREASED APPETITE (Has no appetite), SOMNOLENCE (Sleepy all the time), FEELING COLD (Feels very cold and shaky), TREMOR (Feels very cold and shaky) and TASTE DISORDER (Vaccine changed his taste of foods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.