chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Pain; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and MYALGIA (Achiness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A71A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Pain) and MYALGIA (Achiness). At the time of the report, PAIN (Pain) and MYALGIA (Achiness) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Headache, Hypoaesthesia oral
Clinical narrative: Face started to swell; Lips still tingly.; Lips became numb; Had itchy feeling in my throat; Shortness of breath; Nausea; Headache; Body chills; Aches everywhere; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face started to swell), PARAESTHESIA ORAL (Lips still tingly.), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat) and DIARRHOEA (Diarrhea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 DIARRHOEA (Diarrhea), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills) and MYALGIA (Aches everywhere). On 27-Mar-2021, the patient experienced SWELLING FACE (Face started to swell), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat) and DYSPNOEA (Shortness of breath). 27-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lips still tingly.). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face started to swell), PARAESTHESIA ORAL (Lips still tingly.), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills) and MYALGIA (Aches everywhere) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065332 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065332:Cross-linked with first dose
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Paraesthesia oral, Swelling face, Throat irritation
Clinical narrative: Face started to swell; Lips still tingly.; Lips became numb; Had itchy feeling in my throat; Shortness of breath; Nausea; Headache; Body chills; Aches everywhere; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face started to swell), PARAESTHESIA ORAL (Lips still tingly.), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat) and DIARRHOEA (Diarrhea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 DIARRHOEA (Diarrhea), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills) and MYALGIA (Aches everywhere). On 27-Mar-2021, the patient experienced SWELLING FACE (Face started to swell), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat) and DYSPNOEA (Shortness of breath). 27-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lips still tingly.). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face started to swell), PARAESTHESIA ORAL (Lips still tingly.), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills) and MYALGIA (Aches everywhere) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065332 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065332:Cross-linked with first dose
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 virus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid-19 virus ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (covid-19 virus ). At the time of the report, COVID-19 (covid-19 virus ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment medication was provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Cough, Headache
Clinical narrative: bone started aching badly; coughing; head started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone started aching badly), COUGH (coughing) and HEADACHE (head started to hurt) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (bone started aching badly), COUGH (coughing) and HEADACHE (head started to hurt). At the time of the report, BONE PAIN (bone started aching badly), COUGH (coughing) and HEADACHE (head started to hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product preparation issue, Wrong technique in product usage process
Clinical narrative: vaccine had been put into the syringe the night before and thus it was considered null and void; first dose not guaranteed as valid; Got administered with total 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine had been put into the syringe the night before and thus it was considered null and void), PRODUCT PREPARATION ISSUE (first dose not guaranteed as valid) and OFF LABEL USE (Got administered with total 3 doses) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine had been put into the syringe the night before and thus it was considered null and void), PRODUCT PREPARATION ISSUE (first dose not guaranteed as valid) and OFF LABEL USE (Got administered with total 3 doses). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine had been put into the syringe the night before and thus it was considered null and void), PRODUCT PREPARATION ISSUE (first dose not guaranteed as valid) and OFF LABEL USE (Got administered with total 3 doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment details were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded. On 28-Jun-2021: Patient height and weight updated and mentioned second dose received after 1 month
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pyrexia
Clinical narrative: shortness of breath; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HEADACHE (headache) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure Medication for an unknown indication.    On 16-Feb-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 DYSPNOEA (shortness of breath), HEADACHE (headache) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
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 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment History was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Muscle spasms, Pyrexia
Clinical narrative: Diarrhea; Cramps; Sweating; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), HYPERHIDROSIS (Sweating) and PYREXIA (Low grade fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), HYPERHIDROSIS (Sweating) and PYREXIA (Low grade fever). At the time of the report, DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), HYPERHIDROSIS (Sweating) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Fatigue, Influenza like illness, Myalgia
Clinical narrative: flu like illness; Dry mouth; Feverish; Joint Soreness; Fatigue; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness) and FATIGUE (Fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness), FATIGUE (Fatigue) and MYALGIA (Aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness), FATIGUE (Fatigue) and MYALGIA (Aches) outcome was unknown.            No relevant concomitant medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like illness; Dry mouth; Feverish; Joint Soreness; Fatigue; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness) and FATIGUE (Fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness), FATIGUE (Fatigue) and MYALGIA (Aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness), FATIGUE (Fatigue) and MYALGIA (Aches) outcome was unknown.            No relevant concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: stomach pains; weakness; Stayed in bed all day; fever; chill; headache; achiness; Arm was sore/pain in arm; she felt worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore/pain in arm), FEELING ABNORMAL (she felt worse), ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness) and SOMNOLENCE (Stayed in bed all day) in a 58-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.     The patient's past medical history included COVID-19 in July 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/pain in arm) and FEELING ABNORMAL (she felt worse). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness), SOMNOLENCE (Stayed in bed all day), PYREXIA (fever), CHILLS (chill), HEADACHE (headache) and MYALGIA (achiness). At the time of the report, PAIN IN EXTREMITY (Arm was sore/pain in arm), FEELING ABNORMAL (she felt worse), ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness), SOMNOLENCE (Stayed in bed all day), PYREXIA (fever), CHILLS (chill), HEADACHE (headache) and MYALGIA (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: stomach pains; weakness; Stayed in bed all day; fever; chill; headache; achiness; Arm was sore/pain in arm; she felt worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore/pain in arm), FEELING ABNORMAL (she felt worse), ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness) and SOMNOLENCE (Stayed in bed all day) in a 58-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.     The patient's past medical history included COVID-19 in July 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/pain in arm) and FEELING ABNORMAL (she felt worse). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness), SOMNOLENCE (Stayed in bed all day), PYREXIA (fever), CHILLS (chill), HEADACHE (headache) and MYALGIA (achiness). At the time of the report, PAIN IN EXTREMITY (Arm was sore/pain in arm), FEELING ABNORMAL (she felt worse), ABDOMINAL PAIN UPPER (stomach pains), ASTHENIA (weakness), SOMNOLENCE (Stayed in bed all day), PYREXIA (fever), CHILLS (chill), HEADACHE (headache) and MYALGIA (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Weakness; Dizziness; Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was given for the events reported.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .; 14 years of age and received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years of age and received the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) in a 14-year-old patient of an unknown 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years of age and received the Moderna vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .). On 22-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years of age and received the Moderna vaccine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This report refers to a case of Product administered to patient of inappropriate age and Inappropriate schedule of product administration,  for mRNA-1273, lot # unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age and Inappropriate schedule of product administration,  for mRNA-1273, lot # unknown,  with no associated AEs.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Blood pressure increased, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Foggy; Really hot; Hot flushes; Weird dreams; Fatigued, tired; A little nauseated; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams) and FATIGUE (Fatigued, tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams), FATIGUE (Fatigued, tired), NAUSEA (A little nauseated) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams), FATIGUE (Fatigued, tired), NAUSEA (A little nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure increased: other (High) Increased blood pressure.         Concomitant medications included normal blood pressure medication and a diuretic. The patient did not receive any treatment. 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Pyrexia
Clinical narrative: Foggy; Really hot; Hot flushes; Weird dreams; Fatigued, tired; A little nauseated; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams) and FATIGUE (Fatigued, tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams), FATIGUE (Fatigued, tired), NAUSEA (A little nauseated) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams), FATIGUE (Fatigued, tired), NAUSEA (A little nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure increased: other (High) Increased blood pressure.         Concomitant medications included normal blood pressure medication and a diuretic. The patient did not receive any treatment. 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound abdomen
Clinical narrative: vaccination during pregnancy 33 weeks; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccination during pregnancy 33 weeks) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 016C21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Aug-2020 to an unknown date for an unknown indication.   On 31-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Aug-2020 and the estimated date of delivery was 19-May-2021. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (vaccination during pregnancy 33 weeks). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 31-Mar-2021, EXPOSURE DURING PREGNANCY (vaccination during pregnancy 33 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: unknown (Positive) Positive. On an unknown date, Ultrasound abdomen: unknown (Inconclusive) Unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients Estimated date of Conception is 01-SEP-2021.  Treatment medicines were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13-May-2021 updated reporter details, updated patient demographics, relevant lab tests, concomitant medicines, pregnancy details, 2nd dose details, vaccine facility details
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.     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 PAIN (pain) and CHILLS (Chills). At the time of the report, PAIN (pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Pyrexia, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (site is warm to touch), FEELING ABNORMAL (felt washed out), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site) and VACCINATION SITE SWELLING (my arm is swollen at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006BUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (felt washed out). On 24-Mar-2021, the patient experienced PYREXIA (fever of 99.4) and FATIGUE (felt fatigued/tired). On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site) and VACCINATION SITE SWELLING (my arm is swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (site is warm to touch), FEELING ABNORMAL (felt washed out), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site), VACCINATION SITE SWELLING (my arm is swollen at injection site), PYREXIA (fever of 99.4) and FATIGUE (felt fatigued/tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (Inconclusive) fever of 99.4. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (site is warm to touch), FEELING ABNORMAL (felt washed out), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site) and VACCINATION SITE SWELLING (my arm is swollen at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006BUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (felt washed out). On 24-Mar-2021, the patient experienced PYREXIA (fever of 99.4) and FATIGUE (felt fatigued/tired). On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site) and VACCINATION SITE SWELLING (my arm is swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (site is warm to touch), FEELING ABNORMAL (felt washed out), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site), VACCINATION SITE SWELLING (my arm is swollen at injection site), PYREXIA (fever of 99.4) and FATIGUE (felt fatigued/tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (Inconclusive) fever of 99.4. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination site swelling
Clinical narrative: Little bit of red/ another red blotchy area in the muscle where vaccination was adminstered; Little bit of itchiness; kind of like a rash; little red bump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Little bit of red/ another red blotchy area in the muscle where vaccination was adminstered), PRURITUS (Little bit of itchiness), RASH (kind of like a rash) and VACCINATION SITE SWELLING (little red bump) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (Little bit of itchiness), RASH (kind of like a rash) and VACCINATION SITE SWELLING (little red bump). On 01-Apr-2021, the patient experienced ERYTHEMA (Little bit of red/ another red blotchy area in the muscle where vaccination was adminstered). At the time of the report, ERYTHEMA (Little bit of red/ another red blotchy area in the muscle where vaccination was adminstered), PRURITUS (Little bit of itchiness), RASH (kind of like a rash) and VACCINATION SITE SWELLING (little red bump) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.  Patient was treated with antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added vaccine second dose and its event details, treatment information and updated outcome of the events.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccination after 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination after 36 days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination after 36 days). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination after 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, lot # 013A21A, with no associated AEs.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: "COVID arm"; arm swollen red and achy, bump at injection site; arm swollen red and achy, bump at injection site; fatigue; fever 100.7; arm swollen red and achy, bump at injection site; arm swollen red and achy, bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue) and PYREXIA (fever 100.7) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue), PYREXIA (fever 100.7), INJECTION SITE SWELLING (arm swollen red and achy, bump at injection site) and INJECTION SITE ERYTHEMA (arm swollen red and achy, bump at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue), PYREXIA (fever 100.7), INJECTION SITE SWELLING (arm swollen red and achy, bump at injection site) and INJECTION SITE ERYTHEMA (arm swollen red and achy, bump at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: inconclusive (Inconclusive) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Type IV hypersensitivity reaction, Vaccination site pain
Clinical narrative: "COVID arm"; arm swollen red and achy, bump at injection site; arm swollen red and achy, bump at injection site; fatigue; fever 100.7; arm swollen red and achy, bump at injection site; arm swollen red and achy, bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue) and PYREXIA (fever 100.7) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue), PYREXIA (fever 100.7), INJECTION SITE SWELLING (arm swollen red and achy, bump at injection site) and INJECTION SITE ERYTHEMA (arm swollen red and achy, bump at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue), PYREXIA (fever 100.7), INJECTION SITE SWELLING (arm swollen red and achy, bump at injection site) and INJECTION SITE ERYTHEMA (arm swollen red and achy, bump at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: inconclusive (Inconclusive) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: stuffy nose; COVID positive; chills; cough; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), SARS-COV-2 TEST POSITIVE (COVID positive), HEADACHE (headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Weight loss. Concomitant products included AMOXICILLIN for Scratch, METFORMIN for Weight loss, ROSUVASTATIN, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) and LEVOTHYROXINE for an unknown indication.    On 27-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 COUGH (cough) and HEADACHE (headache). On 30-Mar-2021, the patient experienced CHILLS (chills). On 31-Mar-2021, the patient experienced NASAL CONGESTION (stuffy nose) and SARS-COV-2 TEST POSITIVE (COVID positive). The patient was treated with IBUPROFEN (ADVIL ULTRA [IBUPROFEN]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. On 01-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), SARS-COV-2 TEST POSITIVE (COVID positive) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) positive for COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: stuffy nose; COVID positive; chills; cough; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), SARS-COV-2 TEST POSITIVE (COVID positive), HEADACHE (headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Weight loss. Concomitant products included AMOXICILLIN for Scratch, METFORMIN for Weight loss, ROSUVASTATIN, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) and LEVOTHYROXINE for an unknown indication.    On 27-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 COUGH (cough) and HEADACHE (headache). On 30-Mar-2021, the patient experienced CHILLS (chills). On 31-Mar-2021, the patient experienced NASAL CONGESTION (stuffy nose) and SARS-COV-2 TEST POSITIVE (COVID positive). The patient was treated with IBUPROFEN (ADVIL ULTRA [IBUPROFEN]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. On 01-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), SARS-COV-2 TEST POSITIVE (COVID positive) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) positive for COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm for couple of days; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for couple of days) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0D1B21A) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for couple of days) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (sore arm for couple of days) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment was not provided no concomitant medications were provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Paraesthesia
Clinical narrative: pins and needles in my hands; very strong and painful left shoulder and it went up my shoulder blade and up to my neck then; headache in the back of my head and it was going down my neck; chills the first two days; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in my hands), ARTHRALGIA (very strong and painful left shoulder and it went up my shoulder blade and up to my neck then), HEADACHE (headache in the back of my head and it was going down my neck) and CHILLS (chills the first two days) in a 73-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 26-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 CHILLS (chills the first two days). On 27-Mar-2021, the patient experienced ARTHRALGIA (very strong and painful left shoulder and it went up my shoulder blade and up to my neck then) and HEADACHE (headache in the back of my head and it was going down my neck). On 28-Mar-2021, the patient experienced PARAESTHESIA (pins and needles in my hands). At the time of the report, PARAESTHESIA (pins and needles in my hands), ARTHRALGIA (very strong and painful left shoulder and it went up my shoulder blade and up to my neck then), HEADACHE (headache in the back of my head and it was going down my neck) and CHILLS (chills the first two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.