chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Influenza like illness, Migraine
Clinical narrative: felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out; felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out; flu-sick from head to toe; Migraine; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), ILLNESS (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), INFLUENZA LIKE ILLNESS (flu-sick from head to toe), MIGRAINE (Migraine) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-sick from head to toe), MIGRAINE (Migraine), HEADACHE (Headache) and NAUSEA (nausea). On 14-May-2021, the patient experienced DIARRHOEA (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out) and ILLNESS (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), ILLNESS (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), INFLUENZA LIKE ILLNESS (flu-sick from head to toe), MIGRAINE (Migraine), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out; felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out; flu-sick from head to toe; Migraine; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), ILLNESS (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), INFLUENZA LIKE ILLNESS (flu-sick from head to toe), MIGRAINE (Migraine) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-sick from head to toe), MIGRAINE (Migraine), HEADACHE (Headache) and NAUSEA (nausea). On 14-May-2021, the patient experienced DIARRHOEA (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out) and ILLNESS (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), ILLNESS (felt sick sick sick and had a severe episode of diarrhea where she felt all flushed out), INFLUENZA LIKE ILLNESS (flu-sick from head to toe), MIGRAINE (Migraine), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: area of injection still has pain; redness; swollen; when area pressed it is painful/painful initially; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (area of injection still has pain), INJECTION SITE ERYTHEMA (redness), INJECTION SITE SWELLING (swollen) and PAIN (when area pressed it is painful/painful initially) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (area of injection still has pain), INJECTION SITE ERYTHEMA (redness), INJECTION SITE SWELLING (swollen) and PAIN (when area pressed it is painful/painful initially). On 16-Apr-2021, INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swollen) had resolved. At the time of the report, INJECTION SITE PAIN (area of injection still has pain) and PAIN (when area pressed it is painful/painful initially) 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.   No concomitant medications were provided.  Treatment details were unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently vaccinated a 17 year old because of miscommunication.;This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently vaccinated a 17 year old because of miscommunication.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045D21A) for COVID-19 vaccination.  No medical history was provided by the reporter.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently vaccinated a 17 year old because of miscommunication.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently vaccinated a 17 year old because of miscommunication.) outcome was unknown. 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.   concomitant medications include birth control pills
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: High temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) 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 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 PYREXIA (High temperature). At the time of the report, PYREXIA (High temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.         No concomitant products were reported.  No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest pain, Feeling abnormal, Headache
Clinical narrative: My chest is achy; my lungs are achy; I have a headache; I have foggy brain; my abdomen is achy; sweating profusely; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating; weakness; difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), HYPERHIDROSIS (sweating), ASTHENIA (weakness), INSOMNIA (difficulty sleeping) and PAIN (body aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating), ASTHENIA (weakness) and INSOMNIA (difficulty sleeping). On 12-May-2021, the patient experienced PAIN (body aches) and MYALGIA (random deep body pains, they would come & rapidly disappeared). On 13-May-2021, the patient experienced HYPERHIDROSIS (sweating profusely) and ASTHENIA (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), PULMONARY PAIN (my lungs are achy), HEADACHE (I have a headache), FEELING ABNORMAL (I have foggy brain) and ABDOMINAL PAIN (my abdomen is achy). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), HYPERHIDROSIS (sweating), ASTHENIA (weakness), INSOMNIA (difficulty sleeping), PAIN (body aches), HYPERHIDROSIS (sweating profusely), ASTHENIA (I was super exhausted), CHEST PAIN (My chest is achy), PULMONARY PAIN (my lungs are achy), HEADACHE (I have a headache), FEELING ABNORMAL (I have foggy brain), ABDOMINAL PAIN (my abdomen is achy) and MYALGIA (random deep body pains, they would come & rapidly disappeared) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    This case was linked to MOD-2021-132119 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Myalgia, Pain, Pulmonary pain
Clinical narrative: My chest is achy; my lungs are achy; I have a headache; I have foggy brain; my abdomen is achy; sweating profusely; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating; weakness; difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), HYPERHIDROSIS (sweating), ASTHENIA (weakness), INSOMNIA (difficulty sleeping) and PAIN (body aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating), ASTHENIA (weakness) and INSOMNIA (difficulty sleeping). On 12-May-2021, the patient experienced PAIN (body aches) and MYALGIA (random deep body pains, they would come & rapidly disappeared). On 13-May-2021, the patient experienced HYPERHIDROSIS (sweating profusely) and ASTHENIA (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), PULMONARY PAIN (my lungs are achy), HEADACHE (I have a headache), FEELING ABNORMAL (I have foggy brain) and ABDOMINAL PAIN (my abdomen is achy). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), HYPERHIDROSIS (sweating), ASTHENIA (weakness), INSOMNIA (difficulty sleeping), PAIN (body aches), HYPERHIDROSIS (sweating profusely), ASTHENIA (I was super exhausted), CHEST PAIN (My chest is achy), PULMONARY PAIN (my lungs are achy), HEADACHE (I have a headache), FEELING ABNORMAL (I have foggy brain), ABDOMINAL PAIN (my abdomen is achy) and MYALGIA (random deep body pains, they would come & rapidly disappeared) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    This case was linked to MOD-2021-132119 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My chest is achy; my lungs are achy; I have a headache; I have foggy brain; my abdomen is achy; sweating profusely; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating; weakness; difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), HYPERHIDROSIS (sweating), ASTHENIA (weakness), INSOMNIA (difficulty sleeping) and PAIN (body aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating), ASTHENIA (weakness) and INSOMNIA (difficulty sleeping). On 12-May-2021, the patient experienced PAIN (body aches) and MYALGIA (random deep body pains, they would come & rapidly disappeared). On 13-May-2021, the patient experienced HYPERHIDROSIS (sweating profusely) and ASTHENIA (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), PULMONARY PAIN (my lungs are achy), HEADACHE (I have a headache), FEELING ABNORMAL (I have foggy brain) and ABDOMINAL PAIN (my abdomen is achy). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), HYPERHIDROSIS (sweating), ASTHENIA (weakness), INSOMNIA (difficulty sleeping), PAIN (body aches), HYPERHIDROSIS (sweating profusely), ASTHENIA (I was super exhausted), CHEST PAIN (My chest is achy), PULMONARY PAIN (my lungs are achy), HEADACHE (I have a headache), FEELING ABNORMAL (I have foggy brain), ABDOMINAL PAIN (my abdomen is achy) and MYALGIA (random deep body pains, they would come & rapidly disappeared) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    This case was linked to MOD-2021-132119 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing
Clinical narrative: felt whole body extremely hot right away/still feels warm; got very flushed; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING HOT (felt whole body extremely hot right away/still feels warm) and FLUSHING (got very flushed) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced FEELING HOT (felt whole body extremely hot right away/still feels warm) and FLUSHING (got very flushed). At the time of the report, FEELING HOT (felt whole body extremely hot right away/still feels warm) and FLUSHING (got very flushed) 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.   No concomitant medication were reported. Treatment included ice pack, water and the patient was laid down.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin burning sensation
Clinical narrative: burning palm-left hand; rash to palm -right hand ( "it's up in the air" ); This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning palm-left hand) and RASH ERYTHEMATOUS (rash to palm -right hand ( "it's up in the air" )) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SKIN BURNING SENSATION (burning palm-left hand) and RASH ERYTHEMATOUS (rash to palm -right hand ( "it's up in the air" )). At the time of the report, SKIN BURNING SENSATION (burning palm-left hand) and RASH ERYTHEMATOUS (rash to palm -right hand ( "it's up in the air" )) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Treatment medication reported includes Calmoseptine ointment
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose) 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.   No concomitant medications was reported.  No treatment details were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient developed Shingles; This spontaneous case was reported by an other caregiver and describes the occurrence of HERPES ZOSTER (Patient developed Shingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #042B21A and 028A21H) 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) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Patient developed Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACICLOVIR RANBAXY) at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Patient developed Shingles) outcome was unknown. Not Provided
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration error to patient <18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error to patient <18 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error to patient <18 years old). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error to patient <18 years old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Significant Follow Up Appended - New event added
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Diabetes, Blood pressure high, Glaucoma, Thyroid disorder, Nervous system disorder and Drug allergy (Allergic to some allergy pills.). Concomitant products included POTASSIUM and METFORMIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included chronic obstructive pulmonary disease medications, diabetes Medications, high blood pressure medications, nerve medication, stomach medication, water medication, thyroid medication, blood thinner medication, eye drops for glaucoma.  Treatment medication was not provided   This case was linked to MOD-2021-132126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received updated outcome of the event.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial was punctured May 7; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was punctured May 7) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021 at 10:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was punctured May 7). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Vial was punctured May 7) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-132324 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Additional information include reporter details updated, patient demographics and second dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132324:Same reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04621A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 28-Apr-2021, CHILLS (chills) and PYREXIA (fever) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Condition aggravated, Pruritus, Swelling, Vaccination complication
Clinical narrative: bumps turned into blisters on arms legs, feet, and ankles; severe itching; bumps turned into sores on arms, legs, feet, and ankles; bumps got progressively worse; bumps on body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bumps on body), CONDITION AGGRAVATED (bumps got progressively worse), PRURITUS (severe itching), VACCINATION COMPLICATION (bumps turned into sores on arms, legs, feet, and ankles) and BLISTER (bumps turned into blisters on arms legs, feet, and ankles) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced SWELLING (bumps on body). On 08-May-2021, the patient experienced CONDITION AGGRAVATED (bumps got progressively worse). On 12-May-2021, the patient experienced PRURITUS (severe itching), VACCINATION COMPLICATION (bumps turned into sores on arms, legs, feet, and ankles) and BLISTER (bumps turned into blisters on arms legs, feet, and ankles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, SWELLING (bumps on body), CONDITION AGGRAVATED (bumps got progressively worse), PRURITUS (severe itching), VACCINATION COMPLICATION (bumps turned into sores on arms, legs, feet, and ankles) and BLISTER (bumps turned into blisters on arms legs, feet, and ankles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details were not provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Malaise, Myalgia
Clinical narrative: Itches started; arm pain,feeling achy; Went upto 103 at one point; hands are freezing; started feeling crappy; body hurts; Chills; Back pain; Knee pain / Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PERIPHERAL COLDNESS (hands are freezing), PRURITUS (Itches started), PAIN IN EXTREMITY (arm pain,feeling achy) and MALAISE (started feeling crappy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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 PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR), BUSPIRONE, PANTOPRAZOLE, FLUOXETINE, FLUOXETINE, ATOMOXETINE, CETIRIZINE and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Knee pain / Joint pain). On 14-May-2021, the patient experienced PERIPHERAL COLDNESS (hands are freezing), MALAISE (started feeling crappy), MYALGIA (body hurts) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (Itches started), PAIN IN EXTREMITY (arm pain,feeling achy) and PYREXIA (Went upto 103 at one point). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PERIPHERAL COLDNESS (hands are freezing), PAIN IN EXTREMITY (arm pain,feeling achy), MALAISE (started feeling crappy), MYALGIA (body hurts), CHILLS (Chills) and ARTHRALGIA (Knee pain / Joint pain) outcome was unknown and PRURITUS (Itches started) and PYREXIA (Went upto 103 at one point) 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.   This case was linked to MOD-2021-221176 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains non-significant information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Pruritus, Pyrexia
Clinical narrative: Itches started; arm pain,feeling achy; Went upto 103 at one point; hands are freezing; started feeling crappy; body hurts; Chills; Back pain; Knee pain / Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PERIPHERAL COLDNESS (hands are freezing), PRURITUS (Itches started), PAIN IN EXTREMITY (arm pain,feeling achy) and MALAISE (started feeling crappy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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 PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR), BUSPIRONE, PANTOPRAZOLE, FLUOXETINE, FLUOXETINE, ATOMOXETINE, CETIRIZINE and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Knee pain / Joint pain). On 14-May-2021, the patient experienced PERIPHERAL COLDNESS (hands are freezing), MALAISE (started feeling crappy), MYALGIA (body hurts) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (Itches started), PAIN IN EXTREMITY (arm pain,feeling achy) and PYREXIA (Went upto 103 at one point). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PERIPHERAL COLDNESS (hands are freezing), PAIN IN EXTREMITY (arm pain,feeling achy), MALAISE (started feeling crappy), MYALGIA (body hurts), CHILLS (Chills) and ARTHRALGIA (Knee pain / Joint pain) outcome was unknown and PRURITUS (Itches started) and PYREXIA (Went upto 103 at one point) 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.   This case was linked to MOD-2021-221176 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: came back later on their lower trunk; vaccination site rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (came back later on their lower trunk) and VACCINATION SITE RASH (vaccination site rash) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (came back later on their lower trunk) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, RASH (came back later on their lower trunk) and VACCINATION SITE RASH (vaccination site rash) 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.   No Relevant concomitant medications was reported.  Treatment information included treated with a steroid.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 Year old received 1st Shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old received 1st Shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old received 1st Shot). On 15-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old received 1st Shot) 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.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest pain, Fatigue, Feeling abnormal
Clinical narrative: My chest is achy; my abdomen is achy; my lungs are achy; I have foggy brain; I have a headache; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating/sweating profusely; weakness; Difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy) and ABDOMINAL PAIN (my abdomen is achy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness) and INSOMNIA (Difficulty sleeping). On 12-May-2021, the patient experienced PAIN (random deep body pains, they would come & rapidly disappeared) and MYALGIA (body aches). On 13-May-2021, the patient experienced FATIGUE (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain) and HEADACHE (I have a headache). At the time of the report, HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain), PAIN (random deep body pains, they would come & rapidly disappeared), MYALGIA (body aches), FATIGUE (I was super exhausted), HEADACHE (I have a headache) and VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.            Action taken with response to the events were not applicable. No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-132103 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Myalgia, Pain
Clinical narrative: My chest is achy; my abdomen is achy; my lungs are achy; I have foggy brain; I have a headache; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating/sweating profusely; weakness; Difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy) and ABDOMINAL PAIN (my abdomen is achy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness) and INSOMNIA (Difficulty sleeping). On 12-May-2021, the patient experienced PAIN (random deep body pains, they would come & rapidly disappeared) and MYALGIA (body aches). On 13-May-2021, the patient experienced FATIGUE (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain) and HEADACHE (I have a headache). At the time of the report, HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain), PAIN (random deep body pains, they would come & rapidly disappeared), MYALGIA (body aches), FATIGUE (I was super exhausted), HEADACHE (I have a headache) and VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.            Action taken with response to the events were not applicable. No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-132103 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain, Vaccination site pain
Clinical narrative: My chest is achy; my abdomen is achy; my lungs are achy; I have foggy brain; I have a headache; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating/sweating profusely; weakness; Difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy) and ABDOMINAL PAIN (my abdomen is achy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness) and INSOMNIA (Difficulty sleeping). On 12-May-2021, the patient experienced PAIN (random deep body pains, they would come & rapidly disappeared) and MYALGIA (body aches). On 13-May-2021, the patient experienced FATIGUE (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain) and HEADACHE (I have a headache). At the time of the report, HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain), PAIN (random deep body pains, they would come & rapidly disappeared), MYALGIA (body aches), FATIGUE (I was super exhausted), HEADACHE (I have a headache) and VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.            Action taken with response to the events were not applicable. No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-132103 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: doses 50 days apart; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021 and was forwarded to Moderna on 14-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C21A) 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) (unknown route) 100 mcg. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication, treatment information provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), METFORMIN for Diabetes mellitus, ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). The patient was treated with IBUPROFEN for Pain in arm, at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Injection site feels hot to touch; Slight redness at injection site; Injection site is itchy; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site feels hot to touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE ERYTHEMA (Slight redness at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM, METFORMIN and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE RASH (Rash at injection site). On 14-May-2021, the patient experienced INJECTION SITE WARMTH (Injection site feels hot to touch) and INJECTION SITE ERYTHEMA (Slight redness at injection site). At the time of the report, INJECTION SITE WARMTH (Injection site feels hot to touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE ERYTHEMA (Slight redness at injection site) outcome was unknown. Not Provided          Concomitant medication includes COPD Medications, Diabetes Medications, HBP Medications,Nerve Medication,Stomach Medication,Water Medication,Thyroid Medication, Blood Thinner Medication. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-132110 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: iintense itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (iintense itching all over body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006C21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (iintense itching all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 30-Apr-2021, PRURITUS (iintense itching all over body) had resolved. Not Provided          No concomitant medications were reported