chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity
Clinical narrative: arm soreness; chills; weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), CHILLS (chills) and ASTHENIA (weakness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), CHILLS (chills) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (arm soreness), CHILLS (chills) and ASTHENIA (weakness) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD21-046339 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Soreness in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness in shoulder) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Soreness in shoulder). At the time of the report, ARTHRALGIA (Soreness in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Bed rest, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Hot & Cold Feeling; Sweating; Fever 102 F; Swollen Lymph nodes Armpit; Joint Pain; Stomach hurt Severely; Could not get out of bed; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold Feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever 102 F), LYMPHADENOPATHY (Swollen Lymph nodes Armpit) and ARTHRALGIA (Joint Pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold Feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever 102 F), LYMPHADENOPATHY (Swollen Lymph nodes Armpit), ARTHRALGIA (Joint Pain), ABDOMINAL PAIN UPPER (Stomach hurt Severely) and BED REST (Could not get out of bed). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold Feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever 102 F), LYMPHADENOPATHY (Swollen Lymph nodes Armpit), ARTHRALGIA (Joint Pain), ABDOMINAL PAIN UPPER (Stomach hurt Severely) and BED REST (Could not get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The treatment medication was Unknown.   This case was linked to MOD-2021-066952 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Hot & Cold Feeling; Sweating; Fever 102 F; Swollen Lymph nodes Armpit; Joint Pain; Stomach hurt Severely; Could not get out of bed; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold Feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever 102 F), LYMPHADENOPATHY (Swollen Lymph nodes Armpit) and ARTHRALGIA (Joint Pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold Feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever 102 F), LYMPHADENOPATHY (Swollen Lymph nodes Armpit), ARTHRALGIA (Joint Pain), ABDOMINAL PAIN UPPER (Stomach hurt Severely) and BED REST (Could not get out of bed). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold Feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever 102 F), LYMPHADENOPATHY (Swollen Lymph nodes Armpit), ARTHRALGIA (Joint Pain), ABDOMINAL PAIN UPPER (Stomach hurt Severely) and BED REST (Could not get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The treatment medication was Unknown.   This case was linked to MOD-2021-066952 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal Bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal Bleeding) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 dosage form. On 04-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal Bleeding). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal Bleeding) outcome was unknown.            Patient received treatment for cancer. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eye pain, Headache, Myalgia
Clinical narrative: Body ache, pain all over; Swollen arm; jaws were hurting; Eyes were hurting; Back Pain; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache, pain all over), PERIPHERAL SWELLING (Swollen arm), PAIN IN JAW (jaws were hurting), EYE PAIN (Eyes were hurting) and BACK PAIN (Back Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Body ache, pain all over), PERIPHERAL SWELLING (Swollen arm), PAIN IN JAW (jaws were hurting), EYE PAIN (Eyes were hurting), BACK PAIN (Back Pain), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, MYALGIA (Body ache, pain all over), PERIPHERAL SWELLING (Swollen arm), PAIN IN JAW (jaws were hurting), EYE PAIN (Eyes were hurting), BACK PAIN (Back Pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Peripheral swelling
Clinical narrative: Body ache, pain all over; Swollen arm; jaws were hurting; Eyes were hurting; Back Pain; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache, pain all over), PERIPHERAL SWELLING (Swollen arm), PAIN IN JAW (jaws were hurting), EYE PAIN (Eyes were hurting) and BACK PAIN (Back Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Body ache, pain all over), PERIPHERAL SWELLING (Swollen arm), PAIN IN JAW (jaws were hurting), EYE PAIN (Eyes were hurting), BACK PAIN (Back Pain), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, MYALGIA (Body ache, pain all over), PERIPHERAL SWELLING (Swollen arm), PAIN IN JAW (jaws were hurting), EYE PAIN (Eyes were hurting), BACK PAIN (Back Pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Syringe issue
Clinical narrative: Syringe broke; Full dose immediately in other arm; This spontaneous case was reported by a physician and describes the occurrence of SYRINGE ISSUE (Syringe broke) and ACCIDENTAL OVERDOSE (Full dose immediately in other arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYRINGE ISSUE (Syringe broke) and ACCIDENTAL OVERDOSE (Full dose immediately in other arm). At the time of the report, SYRINGE ISSUE (Syringe broke) and ACCIDENTAL OVERDOSE (Full dose immediately in other arm) had resolved. 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of syringe issue and accidental overdose for mRNA-1273, lot # 029A21A with no associated AEs.; Sender's Comments: This report refers to a case of syringe issue and accidental overdose for mRNA-1273, lot # 029A21A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: swelling in her arm; It's very hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her arm) and FEELING HOT (It's very hot to touch) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling in her arm) and FEELING HOT (It's very hot to touch). At the time of the report, PERIPHERAL SWELLING (swelling in her arm) and FEELING HOT (It's very hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Outside 42 day period; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside 42 day period) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside 42 day period). On 07-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside 42 day period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Immunized a 17-year-old with Moderna; A spontaneous report  was received from a nurse concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 03 Mar 2021, the patient received their dose of mRNA-1273 (Batch Number: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  Director of nursing reported a medication error, on 03 Mar 2021, immunized a 17-year-old patient with Moderna.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.  On 03 Mar 2021, the outcome of the event, immunized a 17-year-old with Moderna was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 022M20A) with no associated AEs reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administred to 17 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administred to 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administred to 17 year old). On 02-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administred to 17 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Swelling, Vaccination site induration, Vaccination site pain
Clinical narrative: allergic reaction; SWELLING; arm is really hot; It's very hard; rash; size of a baseball/it's like a circunference; arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard) and RASH (rash) in a 67-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurt really bad). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard), RASH (rash) and VACCINATION SITE SWELLING (size of a baseball/it's like a circunference). On 01-Mar-2021, VACCINATION SITE PAIN (arm hurt really bad) outcome was unknown. At the time of the report, HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard), RASH (rash) and VACCINATION SITE SWELLING (size of a baseball/it's like a circunference) 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 relevant concomitant medications reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: allergic reaction; SWELLING; arm is really hot; It's very hard; rash; size of a baseball/it's like a circunference; arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard) and RASH (rash) in a 67-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurt really bad). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard), RASH (rash) and VACCINATION SITE SWELLING (size of a baseball/it's like a circunference). On 01-Mar-2021, VACCINATION SITE PAIN (arm hurt really bad) outcome was unknown. At the time of the report, HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard), RASH (rash) and VACCINATION SITE SWELLING (size of a baseball/it's like a circunference) 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 relevant concomitant medications reported.  No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives on upper torso; Severe itching; Bumps; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on upper torso), PRURITUS (Severe itching) and SWELLING (Bumps) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (Hives on upper torso), PRURITUS (Severe itching) and SWELLING (Bumps). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives on upper torso), PRURITUS (Severe itching) and SWELLING (Bumps) outcome was unknown. Visited ER  due to the event. Event took 5 days to go away and came back after 5 days.  Was given Med dose pack and Acetaminophen.  After returning again to ER, he was given steroid and stronger acetaminophen.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Other relevant treatment included Med dose pack,Steroid.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Pyrexia, Rash macular
Clinical narrative: muscle pain in back; fever; chills; red blotches; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), MYALGIA (muscle pain in back) and PYREXIA (fever) in a female patient of an unknown age 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 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 23-Feb-2021, the patient experienced MYALGIA (muscle pain in back). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 25-Feb-2021, MYALGIA (muscle pain in back) had resolved. At the time of the report, RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to MOD-2021-024801 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: muscle pain in back; fever; chills; red blotches; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), MYALGIA (muscle pain in back) and PYREXIA (fever) in a female patient of an unknown age 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 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 23-Feb-2021, the patient experienced MYALGIA (muscle pain in back). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 25-Feb-2021, MYALGIA (muscle pain in back) had resolved. At the time of the report, RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to MOD-2021-024801 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Very hot and uncomfortable ear for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Very hot and uncomfortable ear for 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (Very hot and uncomfortable ear for 24 hours). At the time of the report, EAR DISCOMFORT (Very hot and uncomfortable ear for 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Diarrhea; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) 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 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 DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: STARTED SWEATING PROFUSELY; CHILLS; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (STARTED SWEATING PROFUSELY), CHILLS (CHILLS) and PYREXIA (FEVER) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERHIDROSIS (STARTED SWEATING PROFUSELY), CHILLS (CHILLS) and PYREXIA (FEVER). At the time of the report, HYPERHIDROSIS (STARTED SWEATING PROFUSELY), CHILLS (CHILLS) and PYREXIA (FEVER) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: Red rash, more like a welt around it; Red rash, more like a welt around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Red rash, more like a welt around it) and VACCINATION SITE RASH (Red rash, more like a welt around it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Red rash, more like a welt around it) and VACCINATION SITE RASH (Red rash, more like a welt around it). At the time of the report, VACCINATION SITE URTICARIA (Red rash, more like a welt around it) and VACCINATION SITE RASH (Red rash, more like a welt around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-May-2021 included no new information; the patient did not consent to further follow-up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: HIVES; itching; redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (HIVES), PRURITUS (itching) and ERYTHEMA (redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (HIVES), PRURITUS (itching) and ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, URTICARIA (HIVES), PRURITUS (itching) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: corrected email added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Feels like an egg; It's warm; Swollen arm; It's itchy; It's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Feels like an egg), VACCINATION SITE WARMTH (It's warm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE PAIN (It's sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Neuropathy and High cholesterol.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Feels like an egg), VACCINATION SITE WARMTH (It's warm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE PAIN (It's sore). At the time of the report, VACCINATION SITE INDURATION (Feels like an egg), VACCINATION SITE WARMTH (It's warm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE PAIN (It's sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include thyroid, neuropathy, and cholesterol medication, not otherwise specified. Treatment details not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm felt like someone took a bat & hit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm felt like someone took a bat & hit) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm felt like someone took a bat & hit). At the time of the report, VACCINATION SITE PAIN (My arm felt like someone took a bat & hit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea after receiving the first dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NAUSEA (Nausea after receiving the first dose). At the time of the report, NAUSEA (Nausea after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hangover, Pyrexia
Clinical narrative: Delayed adverse effets; Feeling fatigue/very tired all the time; Just a bad feeling/Don't feel right; Feels hungover all the time; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time), VACCINATION COMPLICATION (Delayed adverse effets), FATIGUE (Feeling fatigue/very tired all the time) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry mouth. Concomitant products included CEVIMELINE for Dry mouth, BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX), LAMOTRIGINE (LAMICTAL), ASA, ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, HCTZ, MULTIVITAMIN [VITAMINS NOS], GABAPENTIN, VITAMIN D [VITAMIN D NOS], ALENDRONATE SODIUM (FOSAMAX) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time) and FATIGUE (Feeling fatigue/very tired all the time). On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed adverse effets). At the time of the report, FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time), VACCINATION COMPLICATION (Delayed adverse effets), FATIGUE (Feeling fatigue/very tired all the time), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol for fever and chills   This case was linked to MOD-2021-036845 (E2B Linked Report).; Sender's Comments:  MOD-2021-036845:Same reporter, different patient and event
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Delayed adverse effets; Feeling fatigue/very tired all the time; Just a bad feeling/Don't feel right; Feels hungover all the time; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time), VACCINATION COMPLICATION (Delayed adverse effets), FATIGUE (Feeling fatigue/very tired all the time) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry mouth. Concomitant products included CEVIMELINE for Dry mouth, BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX), LAMOTRIGINE (LAMICTAL), ASA, ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, HCTZ, MULTIVITAMIN [VITAMINS NOS], GABAPENTIN, VITAMIN D [VITAMIN D NOS], ALENDRONATE SODIUM (FOSAMAX) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time) and FATIGUE (Feeling fatigue/very tired all the time). On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed adverse effets). At the time of the report, FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time), VACCINATION COMPLICATION (Delayed adverse effets), FATIGUE (Feeling fatigue/very tired all the time), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol for fever and chills   This case was linked to MOD-2021-036845 (E2B Linked Report).; Sender's Comments:  MOD-2021-036845:Same reporter, different patient and event
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: itching; burning; rash all over his back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SKIN BURNING SENSATION (burning) and RASH (rash all over his back) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02920A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), SKIN BURNING SENSATION (burning) and RASH (rash all over his back). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching) and SKIN BURNING SENSATION (burning) outcome was unknown and RASH (rash all over his back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included Pain cream.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event outcome updated to recovered for rash.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bad Rash all over the body) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (Bad Rash all over the body). At the time of the report, RASH (Bad Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Infection prophylaxis, Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swollen; Rubbed alcohol before receiving the vaccine; Itching; Sore; Red; Pain; Stinging; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), INFECTION PROPHYLAXIS (Rubbed alcohol before receiving the vaccine), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Sore) and VACCINATION SITE ERYTHEMA (Red) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 AMLODIPINE, OMEPRAZOLE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) and DEXAMETHASONE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen), INFECTION PROPHYLAXIS (Rubbed alcohol before receiving the vaccine), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Sore), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Pain) and VACCINATION SITE PAIN (Stinging). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Swollen), INFECTION PROPHYLAXIS (Rubbed alcohol before receiving the vaccine), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Sore), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Pain) and VACCINATION SITE PAIN (Stinging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other relevant medication history included vitamins and OTC meds.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait disturbance, Headache
Clinical narrative: Could not walk after receiving the second dose; Felt dizzy after receiving the second dose; Had no stability after receiving the second dose; Headaches after receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk after receiving the second dose), DIZZINESS (Felt dizzy after receiving the second dose), BALANCE DISORDER (Had no stability after receiving the second dose) and HEADACHE (Headaches after receiving the second dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced GAIT DISTURBANCE (Could not walk after receiving the second dose), DIZZINESS (Felt dizzy after receiving the second dose), BALANCE DISORDER (Had no stability after receiving the second dose) and HEADACHE (Headaches after receiving the second dose). At the time of the report, GAIT DISTURBANCE (Could not walk after receiving the second dose), DIZZINESS (Felt dizzy after receiving the second dose), BALANCE DISORDER (Had no stability after receiving the second dose) and HEADACHE (Headaches after receiving the second dose) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-036491 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; body aches; terrible headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (terrible headache), CHILLS (chills) and MYALGIA (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Penicillin allergy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 28-Jan-2021, the patient experienced HEADACHE (terrible headache). On an unknown date, the patient experienced CHILLS (chills) and MYALGIA (body aches). At the time of the report, HEADACHE (terrible headache), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.