chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Ached all over; Fatigue; Fever of 102 degrees F; Chills; Head hurt; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees F), CHILLS (Chills) and HEADACHE (Head hurt) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Ached all over), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees F), CHILLS (Chills), HEADACHE (Head hurt) and VOMITING (Threw up). At the time of the report, PAIN (Ached all over), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees F), CHILLS (Chills), HEADACHE (Head hurt) and VOMITING (Threw up) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 (High) 102 degrees F.         No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   This case was linked to MOD21-064660, MOD21-064762 (E2B Linked Report). This case was linked to MOD-2021-061138 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  MOD21-064660: MOD21-064762:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Ached all over; Fatigue; Fever of 102 degrees F; Chills; Head hurt; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees F), CHILLS (Chills) and HEADACHE (Head hurt) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Ached all over), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees F), CHILLS (Chills), HEADACHE (Head hurt) and VOMITING (Threw up). At the time of the report, PAIN (Ached all over), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees F), CHILLS (Chills), HEADACHE (Head hurt) and VOMITING (Threw up) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 (High) 102 degrees F.         No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   This case was linked to MOD21-064660, MOD21-064762 (E2B Linked Report). This case was linked to MOD-2021-061138 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  MOD21-064660: MOD21-064762:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Low level fatigue; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (Low level fatigue ) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FATIGUE (Low level fatigue ). At the time of the report, FATIGUE (Low level fatigue ) outcome was unknown. Not Provided          Concomitant product use was not provided  by the reporter.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2021-060412 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-060412:dose 2 (crosslink)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Parosmia, Vaccination site erythema, Vaccination site scar
Clinical narrative: arm from second dose still has a mark; smell of pin burning sensation; hair loss; seven days later, redness in area, not as bad as the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (arm from second dose still has a mark), PAROSMIA (smell of pin burning sensation), ALOPECIA (hair loss) and VACCINATION SITE ERYTHEMA (seven days later, redness in area, not as bad as the first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAR (arm from second dose still has a mark), PAROSMIA (smell of pin burning sensation), ALOPECIA (hair loss) and VACCINATION SITE ERYTHEMA (seven days later, redness in area, not as bad as the first dose). At the time of the report, VACCINATION SITE SCAR (arm from second dose still has a mark), PAROSMIA (smell of pin burning sensation), ALOPECIA (hair loss) and VACCINATION SITE ERYTHEMA (seven days later, redness in area, not as bad as the first dose) outcome was unknown.            This case was linked to MOD-2021-034899 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: Patient got PCR Covid test positive after completing 2 doses.; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got PCR Covid test positive after completing 2 doses.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient got PCR Covid test positive after completing 2 doses.). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got PCR Covid test positive after completing 2 doses.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) positive.     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.      Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chest discomfort, Diarrhoea, Limb discomfort
Clinical narrative: upset stomach; arm bothered her; itchy; heart rate is up; loose stool; felt like some someone was sitting on her chest; fever of 99 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up) and DIARRHOEA (loose stool) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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 CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LANSOPRAZOLE (PREVACID), ZOLMITRIPTAN (ZOMIG), FAMOTIDINE (PEPCID AC), ATENOLOL, LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST and FLUTICASONE FUROATE (ARNUITY ELLIPTA) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up), DIARRHOEA (loose stool), CHEST DISCOMFORT (felt like some someone was sitting on her chest) and PYREXIA (fever of 99 degrees Fahrenheit). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and LANSOPRAZOLE (PREVACID) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up), DIARRHOEA (loose stool), CHEST DISCOMFORT (felt like some someone was sitting on her chest) and PYREXIA (fever of 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 99 (High) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Pyrexia
Clinical narrative: upset stomach; arm bothered her; itchy; heart rate is up; loose stool; felt like some someone was sitting on her chest; fever of 99 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up) and DIARRHOEA (loose stool) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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 CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LANSOPRAZOLE (PREVACID), ZOLMITRIPTAN (ZOMIG), FAMOTIDINE (PEPCID AC), ATENOLOL, LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST and FLUTICASONE FUROATE (ARNUITY ELLIPTA) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up), DIARRHOEA (loose stool), CHEST DISCOMFORT (felt like some someone was sitting on her chest) and PYREXIA (fever of 99 degrees Fahrenheit). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and LANSOPRAZOLE (PREVACID) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up), DIARRHOEA (loose stool), CHEST DISCOMFORT (felt like some someone was sitting on her chest) and PYREXIA (fever of 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 99 (High) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Skin discolouration, Vaccination site pain
Clinical narrative: Changes to the color of skin in both arms; Breast feeding; Little pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Changes to the color of skin in both arms), EXPOSURE VIA BREAST MILK (Breast feeding) and VACCINATION SITE PAIN (Little pain in the arm of injection) in a 36-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.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SKIN DISCOLOURATION (Changes to the color of skin in both arms), EXPOSURE VIA BREAST MILK (Breast feeding) and VACCINATION SITE PAIN (Little pain in the arm of injection). At the time of the report, SKIN DISCOLOURATION (Changes to the color of skin in both arms), EXPOSURE VIA BREAST MILK (Breast feeding) and VACCINATION SITE PAIN (Little pain in the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060428 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site pain, Skin sensitisation, Swelling, Urticaria
Clinical narrative: Can't even let anything touch that; Today I have two isolated hives; Raised; Severe reaction that day; Itchy; Red; Injection  site was hurting; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives), SWELLING (Raised), ADVERSE REACTION (Severe reaction that day) and VACCINATION SITE PRURITUS (Itchy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, SEGESTERONE ACETATE (ANNOVERA) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE REACTION (Severe reaction that day), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Injection  site was hurting). On 29-Mar-2021, the patient experienced SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives) and SWELLING (Raised). At the time of the report, SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives), SWELLING (Raised), ADVERSE REACTION (Severe reaction that day), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Injection  site was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication Annovera ring  was reported.   Treatment for the itchy, injection site burning included Steroid cream.  Action taken with mRNA-1273 in response to the event was unknown
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Can't even let anything touch that; Today I have two isolated hives; Raised; Severe reaction that day; Itchy; Red; Injection  site was hurting; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives), SWELLING (Raised), ADVERSE REACTION (Severe reaction that day) and VACCINATION SITE PRURITUS (Itchy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, SEGESTERONE ACETATE (ANNOVERA) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE REACTION (Severe reaction that day), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Injection  site was hurting). On 29-Mar-2021, the patient experienced SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives) and SWELLING (Raised). At the time of the report, SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives), SWELLING (Raised), ADVERSE REACTION (Severe reaction that day), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Injection  site was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication Annovera ring  was reported.   Treatment for the itchy, injection site burning included Steroid cream.  Action taken with mRNA-1273 in response to the event was unknown
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Tinnitus, Vomiting
Clinical narrative: Buzzing in the ear; diarrhea; headache; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Buzzing in the ear), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) 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 COVID-19 in December 2020.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced TINNITUS (Buzzing in the ear), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, TINNITUS (Buzzing in the ear), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Second dose was reportedly added.
Age: 75.0
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 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (had pseudo relapse so I couldn't use my legs and arm).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at a dose of 8 mg. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          Concomitant product use was not provided by the reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060436 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact information updated, NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060436:2nd dose case
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Influenza like illness, Malaise
Clinical narrative: Flu like symptoms; side effects consisted of full physical and mental demise.; effects consisted of full physical and mental demise.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (side effects consisted of full physical and mental demise.) and EMOTIONAL DISTRESS (effects consisted of full physical and mental demise.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (side effects consisted of full physical and mental demise.) and EMOTIONAL DISTRESS (effects consisted of full physical and mental demise.). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and MALAISE (side effects consisted of full physical and mental demise.) and EMOTIONAL DISTRESS (effects consisted of full physical and mental demise.) outcome was unknown. Not Provided          Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD21-065042 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26 May 2021 and included new events and the description of the events.; Sender's Comments:  MOD21-065042:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID 19 vaccine given to 16 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine given to 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine given to 16 year old). On 29-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine given to 16 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-Jun-2021 contain no new information. On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.Contact information was updated.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 016B21A) with no associated AEs reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain, Pain in extremity
Clinical narrative: Arm a bit sore; Armpit starting to get very hard; pain getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a bit sore), INDURATION (Armpit starting to get very hard) and PAIN (pain getting worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm a bit sore), INDURATION (Armpit starting to get very hard) and PAIN (pain getting worse). At the time of the report, PAIN IN EXTREMITY (Arm a bit sore), INDURATION (Armpit starting to get very hard) and PAIN (pain getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant and treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Headache, Pruritus, Rash, Rash erythematous
Clinical narrative: Headache; Deep red rash on the crease of her right arm by the elbow; Soreness under the breast; Itching; Rash spreading to her neck, chest, breast; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RASH ERYTHEMATOUS (Deep red rash on the crease of her right arm by the elbow), BREAST PAIN (Soreness under the breast), PRURITUS (Itching) and RASH (Rash spreading to her neck, chest, breast) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache), RASH ERYTHEMATOUS (Deep red rash on the crease of her right arm by the elbow), BREAST PAIN (Soreness under the breast), PRURITUS (Itching) and RASH (Rash spreading to her neck, chest, breast). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form; Cortisone cream at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), RASH ERYTHEMATOUS (Deep red rash on the crease of her right arm by the elbow), BREAST PAIN (Soreness under the breast), PRURITUS (Itching) and RASH (Rash spreading to her neck, chest, breast) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment meds: Advil, Cortisone cream, Benadryl.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced COVID-19 (Tested positive for covid). The patient was treated with ALBUTEROL [SALBUTAMOL] for COVID-19, at an unspecified dose and frequency; IBUPROFEN for COVID-19, at an unspecified dose and frequency; ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) for COVID-19, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for COVID-19, at an unspecified dose and frequency and ZINC PHOSPHATE for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Consumer reported second Moderna COVID-19 Vaccine dose was received. No further information was provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Pruritus
Clinical narrative: Itchiness on the face, the eyebrows, under their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin; Annoying; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchiness on the face, the eyebrows, under their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin) and IRRITABILITY (Annoying) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 PRURITUS (Itchiness on the face, the eyebrows, under their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin) and IRRITABILITY (Annoying). At the time of the report, PRURITUS (Itchiness on the face, the eyebrows, under their eyes, it is all over their face, around their lips and mouth, from the forehead, down to the chin) and IRRITABILITY (Annoying) 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 details included unspecified antihistamine.   This case was linked to MOD-2021-060454 (E2B Linked Report).; Sender's Comments:  MOD-2021-060454:case (No patient identifier)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I'm dizzy /very slight at first; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I'm dizzy /very slight at first) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (I'm dizzy /very slight at first). At the time of the report, DIZZINESS (I'm dizzy /very slight at first) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Flu like symptoms; Sick; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and ILLNESS (Sick) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and ILLNESS (Sick). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and ILLNESS (Sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.  Patient reported that there were and are still, adverse effects. Patient states that the side effects are not "Flu-like", as stated in the initial report. Patient is undergoing therapy for cognitive decline which occurred(along with a host of other side effects) 30-45 minutes after the 2nd shot of Moderna.   This case was linked to MOD21-065042, MOD21-065091 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: email follow up received on 07-jul-2021: Please note follow also added to MOD-2021-061188, possible NNI; 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.   MOD21-065042: MOD21-065091:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site rash, Myalgia
Clinical narrative: rash at the injection site; slept a lot,; chills; nausea; fatigue; body aches; headache; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) 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 information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and MYALGIA (sore arm). On 22-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache), MYALGIA (sore arm) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: rash at the injection site; slept a lot,; chills; nausea; fatigue; body aches; headache; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) 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 information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and MYALGIA (sore arm). On 22-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache), MYALGIA (sore arm) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
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 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN and METOPROLOL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM). At the time of the report, PAIN IN EXTREMITY (SORE ARM) outcome was unknown. Not Provided          No treatment information was provided.   This case was linked to MOD-2021-065167 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.1ml of the liquid was left over in the syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (0.1ml of the liquid was left over in the syringe) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.1ml of the liquid was left over in the syringe). At the time of the report, ACCIDENTAL UNDERDOSE (0.1ml of the liquid was left over in the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: A small allergic reaction at the injection site; Itches a lot at the injection site; A little red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (A small allergic reaction at the injection site), VACCINATION SITE PRURITUS (Itches a lot at the injection site) and VACCINATION SITE ERYTHEMA (A little red at the injection site) 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 29-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 VACCINATION SITE REACTION (A small allergic reaction at the injection site), VACCINATION SITE PRURITUS (Itches a lot at the injection site) and VACCINATION SITE ERYTHEMA (A little red at the injection site). At the time of the report, VACCINATION SITE REACTION (A small allergic reaction at the injection site), VACCINATION SITE PRURITUS (Itches a lot at the injection site) and VACCINATION SITE ERYTHEMA (A little red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were provided    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin discolouration, Skin warm
Clinical narrative: itchy rash; a large hot itchy rash purple and red; large hot itchy rash purple and red; large hot itchy rash purple and red; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (itchy rash), SKIN DISCOLOURATION (a large hot itchy rash purple and red), SKIN WARM (large hot itchy rash purple and red) and RASH ERYTHEMATOUS (large hot itchy rash purple and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH PRURITIC (itchy rash), SKIN DISCOLOURATION (a large hot itchy rash purple and red), SKIN WARM (large hot itchy rash purple and red) and RASH ERYTHEMATOUS (large hot itchy rash purple and red). At the time of the report, RASH PRURITIC (itchy rash), SKIN DISCOLOURATION (a large hot itchy rash purple and red), SKIN WARM (large hot itchy rash purple and red) and RASH ERYTHEMATOUS (large hot itchy rash purple and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID19 virus; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID19 virus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 (Tested positive for COVID19 virus). At the time of the report, COVID-19 (Tested positive for COVID19 virus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Severe migraine all week; Just red; Fist-size, hard lump at injection site; Itches when touched; Lump is raised around the edges; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Fist-size, hard lump at injection site), MIGRAINE (Severe migraine all week), VACCINATION SITE PRURITUS (Itches when touched), VACCINATION SITE SWELLING (Lump is raised around the edges) and VACCINATION SITE ERYTHEMA (Just red) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.    On 22-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 MASS (Fist-size, hard lump at injection site), VACCINATION SITE PRURITUS (Itches when touched) and VACCINATION SITE SWELLING (Lump is raised around the edges). On an unknown date, the patient experienced MIGRAINE (Severe migraine all week) and VACCINATION SITE ERYTHEMA (Just red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Fist-size, hard lump at injection site), MIGRAINE (Severe migraine all week), VACCINATION SITE PRURITUS (Itches when touched), VACCINATION SITE SWELLING (Lump is raised around the edges) and VACCINATION SITE ERYTHEMA (Just red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient used ice pack.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; extremely soreness at injection site; body aches; pain; 101 fever,; red area around breast bone; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain) and PYREXIA (101 fever,) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain), PYREXIA (101 fever,), ERYTHEMA (red area around breast bone) and FATIGUE (fatigue). On 25-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain), PYREXIA (101 fever,), ERYTHEMA (red area around breast bone) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.     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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: flu like symptoms; extremely soreness at injection site; body aches; pain; 101 fever,; red area around breast bone; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain) and PYREXIA (101 fever,) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain), PYREXIA (101 fever,), ERYTHEMA (red area around breast bone) and FATIGUE (fatigue). On 25-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain), PYREXIA (101 fever,), ERYTHEMA (red area around breast bone) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.     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.