chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment details not provided.  Patient informed that a lot of people online have been reporting vertigo after receiving the vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there; 3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there; Next day morning, she had nodes in her under arm; Under her left arm, there was a node that was painful; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Next day morning, she had nodes in her under arm), LYMPH NODE PAIN (Under her left arm, there was a node that was painful), LYMPHADENOPATHY (3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there) and LYMPH NODE PAIN (3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there) in a female 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 event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) 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 25-Mar-2021, the patient experienced LYMPH NODE PAIN (Under her left arm, there was a node that was painful). On 27-Mar-2021, the patient experienced LYMPHADENOPATHY (3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there). On an unknown date, the patient experienced LYMPH NODE PAIN (Next day morning, she had nodes in her under arm) and LYMPH NODE PAIN (3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there). At the time of the report, LYMPH NODE PAIN (Under her left arm, there was a node that was painful) and LYMPHADENOPATHY (3 days later, she noticed that On the left neck side, there are 3 nodules that are big and still there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain in extremity
Clinical narrative: Sore Arm; upset Stomach; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ABDOMINAL DISCOMFORT (upset Stomach), HEADACHE (Headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), ABDOMINAL DISCOMFORT (upset Stomach), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ABDOMINAL DISCOMFORT (upset Stomach), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060959 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-  MOD-2021-060959:1st dose case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore in the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 29, 2021, patient experienced pain in extremity (sore in the arm). At the time of the report, pain in extremity (sore in the arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE RASH (rash around injection site). At the time of the report, VACCINATION SITE RASH (rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment details were not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Feels a little achy; left arm became sore again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feels a little achy) and VACCINATION SITE PAIN (left arm became sore again) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm became sore again). On 11-Mar-2021, the patient experienced PAIN (Feels a little achy). At the time of the report, PAIN (Feels a little achy) and VACCINATION SITE PAIN (left arm became sore again) outcome was unknown.            No concomitant medications reported.  No treatment medications reported.   This case was linked to MOD-2021-041019 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: COVID-19; The site on her body where she was vaccinated broke out in a rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION SITE RASH (The site on her body where she was vaccinated broke out in a rash) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and VACCINATION SITE RASH (The site on her body where she was vaccinated broke out in a rash). At the time of the report, COVID-19 (COVID-19) and VACCINATION SITE RASH (The site on her body where she was vaccinated broke out in a rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: chills; aches; fever 100.7F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (aches) and PYREXIA (fever 100.7F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 CHILLS (chills), MYALGIA (aches) and PYREXIA (fever 100.7F). On 28-Mar-2021, CHILLS (chills), MYALGIA (aches) and PYREXIA (fever 100.7F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 100.7 (High) 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Peripheral swelling, Vaccination site paraesthesia
Clinical narrative: "Brain fog; Intense fatigue; Joint pain; Tingling on whole arm, injection side; top half of arm doubled in volume; Itching on whole arm, injection side; Swelling of whole arm, injection side; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), FEELING ABNORMAL ("Brain fog), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side) and VACCINATION SITE SWELLING (Swelling of whole arm, injection side) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included CEVIMELINE, PROGESTERONE, ESTRADIOL and TESTOSTERONE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side) and VACCINATION SITE SWELLING (Swelling of whole arm, injection side). On an unknown date, the patient experienced FEELING ABNORMAL ("Brain fog), FATIGUE (Intense fatigue) and ARTHRALGIA (Joint pain). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), FEELING ABNORMAL ("Brain fog), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side), VACCINATION SITE SWELLING (Swelling of whole arm, injection side), FATIGUE (Intense fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment administered: "green tea" No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: The Additional information was received on 16-MAY-2021. Event was added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: "Brain fog; Intense fatigue; Joint pain; Tingling on whole arm, injection side; top half of arm doubled in volume; Itching on whole arm, injection side; Swelling of whole arm, injection side; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), FEELING ABNORMAL ("Brain fog), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side) and VACCINATION SITE SWELLING (Swelling of whole arm, injection side) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included CEVIMELINE, PROGESTERONE, ESTRADIOL and TESTOSTERONE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side) and VACCINATION SITE SWELLING (Swelling of whole arm, injection side). On an unknown date, the patient experienced FEELING ABNORMAL ("Brain fog), FATIGUE (Intense fatigue) and ARTHRALGIA (Joint pain). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling on whole arm, injection side), FEELING ABNORMAL ("Brain fog), PERIPHERAL SWELLING (top half of arm doubled in volume), VACCINATION SITE PRURITUS (Itching on whole arm, injection side), VACCINATION SITE SWELLING (Swelling of whole arm, injection side), FATIGUE (Intense fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment administered: "green tea" No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: The Additional information was received on 16-MAY-2021. Event was added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Thyroid disorder. Concomitant products included DILTIAZEM for Heart disease, unspecified, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 19-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 (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  On 25 Mar 2021, the patient received the second dose mRNA-1273 (Moderna COVID-19 Vaccine).  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-109626 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of COVID-19 (patient diagnosed with COVID-19 five days after 1st dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced COVID-19 (patient diagnosed with COVID-19 five days after 1st dose). At the time of the report, COVID-19 (patient diagnosed with COVID-19 five days after 1st dose) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant product use, treatment information or lab details.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: On left side of neck the lymph nodes were swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (On left side of neck the lymph nodes were swollen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced LYMPHADENOPATHY (On left side of neck the lymph nodes were swollen). At the time of the report, LYMPHADENOPATHY (On left side of neck the lymph nodes were swollen) outcome was unknown.            No concomitant medications were reported. No treatment information was provided. Action taken with respect to mRNA-1273 was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Frostbite, Illness
Clinical narrative: Face knees feet and hands feel frozen; Face knees feet and hands were throbbing/ Face knees feet and hands were aching; Leg was throbbing; No appetite; Felt sick all the time; Sick to the stomach; Diarrhea; Lost 14 lbs; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 14 lbs), FROSTBITE (Face knees feet and hands feel frozen), PAIN IN EXTREMITY (Face knees feet and hands were throbbing/ Face knees feet and hands were aching), PAIN IN EXTREMITY (Leg was throbbing) and DECREASED APPETITE (No appetite) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetic.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WEIGHT DECREASED (Lost 14 lbs). On an unknown date, the patient experienced FROSTBITE (Face knees feet and hands feel frozen), PAIN IN EXTREMITY (Face knees feet and hands were throbbing/ Face knees feet and hands were aching), PAIN IN EXTREMITY (Leg was throbbing), DECREASED APPETITE (No appetite), ILLNESS (Felt sick all the time), ABDOMINAL DISCOMFORT (Sick to the stomach) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WEIGHT DECREASED (Lost 14 lbs), FROSTBITE (Face knees feet and hands feel frozen), PAIN IN EXTREMITY (Face knees feet and hands were throbbing/ Face knees feet and hands were aching), PAIN IN EXTREMITY (Leg was throbbing), DECREASED APPETITE (No appetite), ILLNESS (Felt sick all the time), ABDOMINAL DISCOMFORT (Sick to the stomach) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetic medication. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Weight decreased
Clinical narrative: Face knees feet and hands feel frozen; Face knees feet and hands were throbbing/ Face knees feet and hands were aching; Leg was throbbing; No appetite; Felt sick all the time; Sick to the stomach; Diarrhea; Lost 14 lbs; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 14 lbs), FROSTBITE (Face knees feet and hands feel frozen), PAIN IN EXTREMITY (Face knees feet and hands were throbbing/ Face knees feet and hands were aching), PAIN IN EXTREMITY (Leg was throbbing) and DECREASED APPETITE (No appetite) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetic.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WEIGHT DECREASED (Lost 14 lbs). On an unknown date, the patient experienced FROSTBITE (Face knees feet and hands feel frozen), PAIN IN EXTREMITY (Face knees feet and hands were throbbing/ Face knees feet and hands were aching), PAIN IN EXTREMITY (Leg was throbbing), DECREASED APPETITE (No appetite), ILLNESS (Felt sick all the time), ABDOMINAL DISCOMFORT (Sick to the stomach) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WEIGHT DECREASED (Lost 14 lbs), FROSTBITE (Face knees feet and hands feel frozen), PAIN IN EXTREMITY (Face knees feet and hands were throbbing/ Face knees feet and hands were aching), PAIN IN EXTREMITY (Leg was throbbing), DECREASED APPETITE (No appetite), ILLNESS (Felt sick all the time), ABDOMINAL DISCOMFORT (Sick to the stomach) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetic medication. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: Rash on her two arms, especially on the inside; Her skin looks like an elderly woman's; Itchy, it hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her two arms, especially on the inside), SKIN DISORDER (Her skin looks like an elderly woman's) and PRURITUS (Itchy, it hasn't gone away) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH (Rash on her two arms, especially on the inside), SKIN DISORDER (Her skin looks like an elderly woman's) and PRURITUS (Itchy, it hasn't gone away). At the time of the report, RASH (Rash on her two arms, especially on the inside), SKIN DISORDER (Her skin looks like an elderly woman's) and PRURITUS (Itchy, it hasn't gone away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: heat that come and goes at the injection site; Itchy at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat that come and goes at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat that come and goes at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat that come and goes at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant list.  Treatment was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Felt tiredness; Sore arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and FATIGUE (Felt tiredness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Mar-2021, the patient experienced FATIGUE (Felt tiredness). On 15-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 16-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, FATIGUE (Felt tiredness) outcome was unknown.            First dose received on 25 Feb 2021 and second dose received on 15 Mar 2021, subsequently resulted in the event inappropriate schedule of product administration.  Treatment information was not provided.   This case was linked to MOD-2021-060897 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Feeling cold
Clinical narrative: Loss of apetite; Shivering; Felt very achy all over especially in back and neck; Didn't have the energy to get up; freezing cold, couldn't not get warm enough; Breaking out in sweat; Felt very sick; Headache; Couple of hours later arm starting hurting; Felt a little bit woozy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing cold, couldn't not get warm enough), HYPERHIDROSIS (Breaking out in sweat), MALAISE (Felt very sick), PAIN IN EXTREMITY (Couple of hours later arm starting hurting) and DECREASED APPETITE (Loss of apetite) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Couple of hours later arm starting hurting) and DIZZINESS (Felt a little bit woozy). On 10-Mar-2021, the patient experienced FEELING COLD (freezing cold, couldn't not get warm enough), HYPERHIDROSIS (Breaking out in sweat), MALAISE (Felt very sick), ASTHENIA (Didn't have the energy to get up), HEADACHE (Headache) and MYALGIA (Felt very achy all over especially in back and neck). On an unknown date, the patient experienced DECREASED APPETITE (Loss of apetite) and CHILLS (Shivering). At the time of the report, FEELING COLD (freezing cold, couldn't not get warm enough), HYPERHIDROSIS (Breaking out in sweat), MALAISE (Felt very sick), PAIN IN EXTREMITY (Couple of hours later arm starting hurting), DECREASED APPETITE (Loss of apetite), ASTHENIA (Didn't have the energy to get up), DIZZINESS (Felt a little bit woozy), HEADACHE (Headache), CHILLS (Shivering) and MYALGIA (Felt very achy all over especially in back and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Malaise, Myalgia, Pain in extremity
Clinical narrative: Loss of apetite; Shivering; Felt very achy all over especially in back and neck; Didn't have the energy to get up; freezing cold, couldn't not get warm enough; Breaking out in sweat; Felt very sick; Headache; Couple of hours later arm starting hurting; Felt a little bit woozy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing cold, couldn't not get warm enough), HYPERHIDROSIS (Breaking out in sweat), MALAISE (Felt very sick), PAIN IN EXTREMITY (Couple of hours later arm starting hurting) and DECREASED APPETITE (Loss of apetite) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Couple of hours later arm starting hurting) and DIZZINESS (Felt a little bit woozy). On 10-Mar-2021, the patient experienced FEELING COLD (freezing cold, couldn't not get warm enough), HYPERHIDROSIS (Breaking out in sweat), MALAISE (Felt very sick), ASTHENIA (Didn't have the energy to get up), HEADACHE (Headache) and MYALGIA (Felt very achy all over especially in back and neck). On an unknown date, the patient experienced DECREASED APPETITE (Loss of apetite) and CHILLS (Shivering). At the time of the report, FEELING COLD (freezing cold, couldn't not get warm enough), HYPERHIDROSIS (Breaking out in sweat), MALAISE (Felt very sick), PAIN IN EXTREMITY (Couple of hours later arm starting hurting), DECREASED APPETITE (Loss of apetite), ASTHENIA (Didn't have the energy to get up), DIZZINESS (Felt a little bit woozy), HEADACHE (Headache), CHILLS (Shivering) and MYALGIA (Felt very achy all over especially in back and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Looks like permanent bandaid on arm after 1st shot; Arm swollen after 1st dose; Arm pain after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Looks like permanent bandaid on arm after 1st shot), PERIPHERAL SWELLING (Arm swollen after 1st dose) and PAIN IN EXTREMITY (Arm pain after 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Looks like permanent bandaid on arm after 1st shot), PERIPHERAL SWELLING (Arm swollen after 1st dose) and PAIN IN EXTREMITY (Arm pain after 1st dose). At the time of the report, LIMB DISCOMFORT (Looks like permanent bandaid on arm after 1st shot), PERIPHERAL SWELLING (Arm swollen after 1st dose) and PAIN IN EXTREMITY (Arm pain after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included cream.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Chest pain, Fatigue, Feeling cold
Clinical narrative: Tight throat; she felt very cold; Anxiety; super sick; agitated; sharp pain in the chest; Body pain; very tired; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tight throat), FEELING COLD (she felt very cold), ANXIETY (Anxiety), ILLNESS (super sick) and AGITATION (agitated) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 LEVOTHYROXINE, PROPRANOLOL and LISINOPRIL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced THROAT TIGHTNESS (Tight throat), FEELING COLD (she felt very cold), ANXIETY (Anxiety), ILLNESS (super sick), AGITATION (agitated), CHEST PAIN (sharp pain in the chest), MYALGIA (Body pain) and FATIGUE (very tired). On 27-Mar-2021, CHEST PAIN (sharp pain in the chest) had resolved. At the time of the report, THROAT TIGHTNESS (Tight throat), FEELING COLD (she felt very cold), ANXIETY (Anxiety), ILLNESS (super sick), AGITATION (agitated), MYALGIA (Body pain) and FATIGUE (very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Heart rate: increased (abnormal) she felt a fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported. It was reported that he had the second dose since then and didn't have any events.   This case was linked to MOD-2021-064122 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR was received  Events outcome was updated to recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Illness, Myalgia, Throat tightness
Clinical narrative: Tight throat; she felt very cold; Anxiety; super sick; agitated; sharp pain in the chest; Body pain; very tired; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tight throat), FEELING COLD (she felt very cold), ANXIETY (Anxiety), ILLNESS (super sick) and AGITATION (agitated) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 LEVOTHYROXINE, PROPRANOLOL and LISINOPRIL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced THROAT TIGHTNESS (Tight throat), FEELING COLD (she felt very cold), ANXIETY (Anxiety), ILLNESS (super sick), AGITATION (agitated), CHEST PAIN (sharp pain in the chest), MYALGIA (Body pain) and FATIGUE (very tired). On 27-Mar-2021, CHEST PAIN (sharp pain in the chest) had resolved. At the time of the report, THROAT TIGHTNESS (Tight throat), FEELING COLD (she felt very cold), ANXIETY (Anxiety), ILLNESS (super sick), AGITATION (agitated), MYALGIA (Body pain) and FATIGUE (very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Heart rate: increased (abnormal) she felt a fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported. It was reported that he had the second dose since then and didn't have any events.   This case was linked to MOD-2021-064122 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR was received  Events outcome was updated to recovered.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medications was not reported. Treatment history included Anti-nausea medication .
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on arms, legs, back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on arms, legs, back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 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, the patient experienced RASH PRURITIC (Itchy rash on arms, legs, back). At the time of the report, RASH PRURITIC (Itchy rash on arms, legs, back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were, sleep aide and blood pressure pill.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Back injury
Clinical narrative: injured back; This spontaneous case was reported by a consumer and describes the occurrence of BACK INJURY (injured back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Back injury.    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 BACK INJURY (injured back). At the time of the report, BACK INJURY (injured back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had two blood transfusions after receiving the first dose of vaccine. No treatment medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Skin swelling, Swelling
Clinical narrative: swelling/big oval circle; puffy; warm to touch; injection site became red/its still red spot at injection site/two and quarter in inches/reduce to inch and half; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling/big oval circle), SKIN SWELLING (puffy), FEELING HOT (warm to touch) and INJECTION SITE ERYTHEMA (injection site became red/its still red spot at injection site/two and quarter in inches/reduce to inch and half) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site became red/its still red spot at injection site/two and quarter in inches/reduce to inch and half). On an unknown date, the patient experienced SWELLING (swelling/big oval circle), SKIN SWELLING (puffy) and FEELING HOT (warm to touch). At the time of the report, SWELLING (swelling/big oval circle), SKIN SWELLING (puffy) and FEELING HOT (warm to touch) outcome was unknown and INJECTION SITE ERYTHEMA (injection site became red/its still red spot at injection site/two and quarter in inches/reduce to inch and half) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided. Treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Affected area was swollen and red; Affected area was swollen and red; Intense Itching on the Injection Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Intense Itching on the Injection Arm), VACCINATION SITE ERYTHEMA (Affected area was swollen and red) and VACCINATION SITE SWELLING (Affected area was swollen and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to dried mushroom).   On 16-Mar-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 24-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Intense Itching on the Injection Arm). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Affected area was swollen and red) and VACCINATION SITE SWELLING (Affected area was swollen and red). On 28-Mar-2021, VACCINATION SITE PRURITUS (Intense Itching on the Injection Arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Affected area was swollen and red) and VACCINATION SITE SWELLING (Affected area was swollen and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by the reporter.  No concomitant medication provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13 May 2021 included:Patient demographic details updated, second dose details, relevant medical history details. Event information was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Tremor, Vaccination site rash
Clinical narrative: Congested; Her right arm from Shoulder to Elbow was shaking, Legs were also shaking; Rash on the right Arm Injection Site; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested), TREMOR (Her right arm from Shoulder to Elbow was shaking, Legs were also shaking), VACCINATION SITE RASH (Rash on the right Arm Injection Site), CHILLS (Chills) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced NASAL CONGESTION (Congested), TREMOR (Her right arm from Shoulder to Elbow was shaking, Legs were also shaking), VACCINATION SITE RASH (Rash on the right Arm Injection Site), CHILLS (Chills) and HEADACHE (Headache). On 29-Mar-2021, NASAL CONGESTION (Congested), TREMOR (Her right arm from Shoulder to Elbow was shaking, Legs were also shaking), VACCINATION SITE RASH (Rash on the right Arm Injection Site), CHILLS (Chills) and HEADACHE (Headache) had resolved.            There was no concomitant medication reported. Treatment for the events included bromelain natural supplement (Pineapple driven).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: pain in the Right side of neck extending to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the Right side of neck extending to the shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced NECK PAIN (pain in the Right side of neck extending to the shoulder). At the time of the report, NECK PAIN (pain in the Right side of neck extending to the shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant list.  Treatment included as Tylenol and itch cream.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.