chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: red blood blisters raised on her stomach; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (red blood blisters raised on her stomach) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BLISTER (red blood blisters raised on her stomach). At the time of the report, BLISTER (red blood blisters raised on her stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data :  blood tests done along with the platelets count  No concomitant product reported by the reporter No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-05-2021,contains non-significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; very bad diarrhea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (very bad diarrhea), PYREXIA (fever) and CHILLS (chills) in a 69-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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (very bad diarrhea), PYREXIA (fever) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPRIN) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (very bad diarrhea), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Seasonal allergy
Clinical narrative: she has a cold; seasonal allergies; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she has a cold) and SEASONAL ALLERGY (seasonal allergies) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Meniere's disease and Seasonal allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced NASOPHARYNGITIS (she has a cold) and SEASONAL ALLERGY (seasonal allergies). At the time of the report, NASOPHARYNGITIS (she has a cold) and SEASONAL ALLERGY (seasonal allergies) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose past 36 day mark; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 day mark) 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) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 day mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 day mark) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications are not provided.  No treatment information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiving the second shot after 13 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving the second shot after 13 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving the second shot after 13 days). On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving the second shot after 13 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported no adverse events after the dose administration.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Vaccination complication
Clinical narrative: Mild side effect; Around 6 am they noticed a water blister on the left knuckle and around 10:15 am they got another one on the right knuckle. Both are pretty big in size, and Patient states it is hard to work; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Around 6 am they noticed a water blister on the left knuckle and around 10:15 am they got another one on the right knuckle. Both are pretty big in size, and Patient states it is hard to work) and VACCINATION COMPLICATION (Mild side effect) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, AMLODIPINE and LISINOPRIL for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced BLISTER (Around 6 am they noticed a water blister on the left knuckle and around 10:15 am they got another one on the right knuckle. Both are pretty big in size, and Patient states it is hard to work). On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild side effect). At the time of the report, BLISTER (Around 6 am they noticed a water blister on the left knuckle and around 10:15 am they got another one on the right knuckle. Both are pretty big in size, and Patient states it is hard to work) and VACCINATION COMPLICATION (Mild side effect) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No treatment medication were reported.   This case was linked to MOD21-070766 (E2B Linked Report).; Sender's Comments:  MOD21-070766:Crosslink
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue
Clinical narrative: loss of taste; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of AGEUSIA (loss of taste) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) 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 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: circular redness around site with no pain, minimal swelling; circular redness around site with no pain, minimal swelling; chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE SWELLING (circular redness around site with no pain, minimal swelling) and INJECTION SITE ERYTHEMA (circular redness around site with no pain, minimal swelling) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 03-Apr-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 05-Apr-2021, the patient experienced INJECTION SITE SWELLING (circular redness around site with no pain, minimal swelling) and INJECTION SITE ERYTHEMA (circular redness around site with no pain, minimal swelling). On 04-Apr-2021, CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, INJECTION SITE SWELLING (circular redness around site with no pain, minimal swelling) and INJECTION SITE ERYTHEMA (circular redness around site with no pain, minimal swelling) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-068983 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068983:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Sensation of foreign body
Clinical narrative: dizziness; lump in her throat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and SENSATION OF FOREIGN BODY (lump in her throat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and SENSATION OF FOREIGN BODY (lump in her throat). On 13-Mar-2021, SENSATION OF FOREIGN BODY (lump in her throat) had resolved. At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included  Zyrtec
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Musculoskeletal discomfort
Clinical narrative: After shot, that Saturday, my back went out; I was having trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (After shot, that Saturday, my back went out) and GAIT DISTURBANCE (I was having trouble walking) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O31120A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (After shot, that Saturday, my back went out) and GAIT DISTURBANCE (I was having trouble walking). At the time of the report, MUSCULOSKELETAL DISCOMFORT (After shot, that Saturday, my back went out) 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever with temperature readings of 99.8 F and 101.2 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever with temperature readings of 99.8 F and 101.2 F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-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 06-Apr-2021, the patient experienced PYREXIA (Fever with temperature readings of 99.8 F and 101.2 F). At the time of the report, PYREXIA (Fever with temperature readings of 99.8 F and 101.2 F) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment details included Tylenol.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Chills, Joint swelling
Clinical narrative: all body was shaking; joint started to hurt; every joint in her body and all inflammation; can visibly see joint inflame; weakness is really bad; rash on her chest; shoulder, hands, ankles, knees, elbow, joint, neck is very painful; all joint pain; body swollen; face is huge, very swollen; hands, arms, everything is swollen; chills so bad; tounge is swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt) and ARTHRITIS (every joint in her body and all inflammation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Apr-2021, the patient experienced SWOLLEN TONGUE (tounge is swelling). On an unknown date, the patient experienced CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt), ARTHRITIS (every joint in her body and all inflammation), JOINT SWELLING (can visibly see joint inflame), ASTHENIA (weakness is really bad), RASH (rash on her chest), ARTHRALGIA (shoulder, hands, ankles, knees, elbow, joint, neck is very painful), ARTHRALGIA (all joint pain), SWELLING (body swollen), SWELLING FACE (face is huge, very swollen) and PERIPHERAL SWELLING (hands, arms, everything is swollen). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt), ARTHRITIS (every joint in her body and all inflammation), JOINT SWELLING (can visibly see joint inflame), ASTHENIA (weakness is really bad), RASH (rash on her chest), ARTHRALGIA (shoulder, hands, ankles, knees, elbow, joint, neck is very painful), ARTHRALGIA (all joint pain), SWELLING (body swollen), SWELLING FACE (face is huge, very swollen), PERIPHERAL SWELLING (hands, arms, everything is swollen) and SWOLLEN TONGUE (tounge is swelling) outcome was unknown.            concomitant medication: Osteoarthritis medicine ( once a week) and medication for allergy.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: event added
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash, Swelling, Swelling face
Clinical narrative: all body was shaking; joint started to hurt; every joint in her body and all inflammation; can visibly see joint inflame; weakness is really bad; rash on her chest; shoulder, hands, ankles, knees, elbow, joint, neck is very painful; all joint pain; body swollen; face is huge, very swollen; hands, arms, everything is swollen; chills so bad; tounge is swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt) and ARTHRITIS (every joint in her body and all inflammation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Apr-2021, the patient experienced SWOLLEN TONGUE (tounge is swelling). On an unknown date, the patient experienced CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt), ARTHRITIS (every joint in her body and all inflammation), JOINT SWELLING (can visibly see joint inflame), ASTHENIA (weakness is really bad), RASH (rash on her chest), ARTHRALGIA (shoulder, hands, ankles, knees, elbow, joint, neck is very painful), ARTHRALGIA (all joint pain), SWELLING (body swollen), SWELLING FACE (face is huge, very swollen) and PERIPHERAL SWELLING (hands, arms, everything is swollen). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt), ARTHRITIS (every joint in her body and all inflammation), JOINT SWELLING (can visibly see joint inflame), ASTHENIA (weakness is really bad), RASH (rash on her chest), ARTHRALGIA (shoulder, hands, ankles, knees, elbow, joint, neck is very painful), ARTHRALGIA (all joint pain), SWELLING (body swollen), SWELLING FACE (face is huge, very swollen), PERIPHERAL SWELLING (hands, arms, everything is swollen) and SWOLLEN TONGUE (tounge is swelling) outcome was unknown.            concomitant medication: Osteoarthritis medicine ( once a week) and medication for allergy.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: event added
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tremor
Clinical narrative: all body was shaking; joint started to hurt; every joint in her body and all inflammation; can visibly see joint inflame; weakness is really bad; rash on her chest; shoulder, hands, ankles, knees, elbow, joint, neck is very painful; all joint pain; body swollen; face is huge, very swollen; hands, arms, everything is swollen; chills so bad; tounge is swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt) and ARTHRITIS (every joint in her body and all inflammation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Apr-2021, the patient experienced SWOLLEN TONGUE (tounge is swelling). On an unknown date, the patient experienced CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt), ARTHRITIS (every joint in her body and all inflammation), JOINT SWELLING (can visibly see joint inflame), ASTHENIA (weakness is really bad), RASH (rash on her chest), ARTHRALGIA (shoulder, hands, ankles, knees, elbow, joint, neck is very painful), ARTHRALGIA (all joint pain), SWELLING (body swollen), SWELLING FACE (face is huge, very swollen) and PERIPHERAL SWELLING (hands, arms, everything is swollen). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills so bad), TREMOR (all body was shaking), ARTHRALGIA (joint started to hurt), ARTHRITIS (every joint in her body and all inflammation), JOINT SWELLING (can visibly see joint inflame), ASTHENIA (weakness is really bad), RASH (rash on her chest), ARTHRALGIA (shoulder, hands, ankles, knees, elbow, joint, neck is very painful), ARTHRALGIA (all joint pain), SWELLING (body swollen), SWELLING FACE (face is huge, very swollen), PERIPHERAL SWELLING (hands, arms, everything is swollen) and SWOLLEN TONGUE (tounge is swelling) outcome was unknown.            concomitant medication: Osteoarthritis medicine ( once a week) and medication for allergy.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: event added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Malaise, Somnolence, Tremor
Clinical narrative: sleepy; she was tired; At night, she didn't feel well after receiving 1st dose; She was shaking; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (At night, she didn't feel well after receiving 1st dose), TREMOR (She was shaking), SOMNOLENCE (sleepy) and FATIGUE (she was tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (At night, she didn't feel well after receiving 1st dose) and TREMOR (She was shaking). On 16-Mar-2021, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (she was tired). At the time of the report, MALAISE (At night, she didn't feel well after receiving 1st dose), TREMOR (She was shaking), SOMNOLENCE (sleepy) and FATIGUE (she was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 200/100 mmHg (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Contact Information Updated
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She experienced soreness of arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0205L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (She experienced soreness of arm). At the time of the report, VACCINATION SITE PAIN (She experienced soreness of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068579:CROSSLINKED WITH DOSE 2
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: throbbing at the injection site; headache with nausea; Her headache has worsened since 22/Mar/2021; a heavy pressure pain in her forehead; chills; Headache; body aches; Joint pain; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (Headache), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue). 27-Feb-2021, the patient experienced HEADACHE (Headache), HEADACHE (Her headache has worsened since 22/Mar/2021) and HEADACHE (a heavy pressure pain in her forehead). On 22-Mar-2021, the patient experienced NAUSEA (headache with nausea). On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (throbbing at the injection site). On 01-Mar-2021, CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) had resolved. On 06-Apr-2021, VACCINATION SITE PAIN (throbbing at the injection site) had resolved. At the time of the report, HEADACHE (Headache), HEADACHE (Her headache has worsened since 22/Mar/2021) and HEADACHE (a heavy pressure pain in her forehead) had not resolved and NAUSEA (headache with nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included following : Tylenol, Ketorolac 30 mg injection, sumatriptan hydrochloride, Naproxen, Inderal (propranolol).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: throbbing at the injection site; headache with nausea; Her headache has worsened since 22/Mar/2021; a heavy pressure pain in her forehead; chills; Headache; body aches; Joint pain; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (Headache), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue). 27-Feb-2021, the patient experienced HEADACHE (Headache), HEADACHE (Her headache has worsened since 22/Mar/2021) and HEADACHE (a heavy pressure pain in her forehead). On 22-Mar-2021, the patient experienced NAUSEA (headache with nausea). On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (throbbing at the injection site). On 01-Mar-2021, CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) had resolved. On 06-Apr-2021, VACCINATION SITE PAIN (throbbing at the injection site) had resolved. At the time of the report, HEADACHE (Headache), HEADACHE (Her headache has worsened since 22/Mar/2021) and HEADACHE (a heavy pressure pain in her forehead) had not resolved and NAUSEA (headache with nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included following : Tylenol, Ketorolac 30 mg injection, sumatriptan hydrochloride, Naproxen, Inderal (propranolol).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat with yellow mucous; sore throat with yellow mucous; congestion; chills; fever of 102; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SECRETION DISCHARGE (sore throat with yellow mucous), OROPHARYNGEAL PAIN (sore throat with yellow mucous), NASAL CONGESTION (congestion), CHILLS (chills) and PYREXIA (fever of 102) in a 20-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.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (MOTRIN CHILDREN), LORATADINE, DEXTROMETHORPHAN POLISTIREX (ROBITUSSIN 12 HOUR COUGH RELIEF), EUCALYPTUS GLOBULUS OIL, MENTHOL (HALLS) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Apr-2021, the patient experienced SECRETION DISCHARGE (sore throat with yellow mucous), OROPHARYNGEAL PAIN (sore throat with yellow mucous), NASAL CONGESTION (congestion), CHILLS (chills), PYREXIA (fever of 102) and HEADACHE (headache). At the time of the report, SECRETION DISCHARGE (sore throat with yellow mucous), OROPHARYNGEAL PAIN (sore throat with yellow mucous), NASAL CONGESTION (congestion), CHILLS (chills), PYREXIA (fever of 102) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: sore throat with yellow mucous; sore throat with yellow mucous; congestion; chills; fever of 102; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SECRETION DISCHARGE (sore throat with yellow mucous), OROPHARYNGEAL PAIN (sore throat with yellow mucous), NASAL CONGESTION (congestion), CHILLS (chills) and PYREXIA (fever of 102) in a 20-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.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (MOTRIN CHILDREN), LORATADINE, DEXTROMETHORPHAN POLISTIREX (ROBITUSSIN 12 HOUR COUGH RELIEF), EUCALYPTUS GLOBULUS OIL, MENTHOL (HALLS) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Apr-2021, the patient experienced SECRETION DISCHARGE (sore throat with yellow mucous), OROPHARYNGEAL PAIN (sore throat with yellow mucous), NASAL CONGESTION (congestion), CHILLS (chills), PYREXIA (fever of 102) and HEADACHE (headache). At the time of the report, SECRETION DISCHARGE (sore throat with yellow mucous), OROPHARYNGEAL PAIN (sore throat with yellow mucous), NASAL CONGESTION (congestion), CHILLS (chills), PYREXIA (fever of 102) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Inflammation
Clinical narrative: inflamed; hard; red patch in the arm (>2 inches); This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflamed), INDURATION (hard) and ERYTHEMA (red patch in the arm (>2 inches)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INFLAMMATION (inflamed), INDURATION (hard) and ERYTHEMA (red patch in the arm (>2 inches)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflamed), INDURATION (hard) and ERYTHEMA (red patch in the arm (>2 inches)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product : Santrax
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: achy; crummy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achy) and FEELING ABNORMAL (crummy) in an 18-year-old female patient 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.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 06-Apr-2021, the patient experienced PAIN (achy) and FEELING ABNORMAL (crummy). On 13-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PAIN (achy) and FEELING ABNORMAL (crummy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: (Positive) Covid19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Erythema, Headache
Clinical narrative: Rash all over face and right arm; Face looked red; Really bad headache; Flu-like symptoms; Upset stomach; Temperature of 102.5F/ lower temperature in the 100s/ low fever; Felt real achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Upset stomach), ERYTHEMA (Face looked red), RASH (Rash all over face and right arm) and PYREXIA (Temperature of 102.5F/ lower temperature in the 100s/ low fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 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 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Temperature of 102.5F/ lower temperature in the 100s/ low fever), PAIN (Felt real achy) and CHILLS (Chills). On 04-Apr-2021, the patient experienced ERYTHEMA (Face looked red) and HEADACHE (Really bad headache). On 05-Apr-2021, the patient experienced RASH (Rash all over face and right arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Upset stomach), ERYTHEMA (Face looked red), RASH (Rash all over face and right arm), PYREXIA (Temperature of 102.5F/ lower temperature in the 100s/ low fever), PAIN (Felt real achy), CHILLS (Chills) and HEADACHE (Really bad headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 102.5 (Inconclusive) 102.5 F. On 03-Apr-2021, Body temperature: 100 (Low) 100s.         Concomitant product use was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received contains updated information of outcome of the events, updated from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Rash
Clinical narrative: Rash all over face and right arm; Face looked red; Really bad headache; Flu-like symptoms; Upset stomach; Temperature of 102.5F/ lower temperature in the 100s/ low fever; Felt real achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Upset stomach), ERYTHEMA (Face looked red), RASH (Rash all over face and right arm) and PYREXIA (Temperature of 102.5F/ lower temperature in the 100s/ low fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 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 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Temperature of 102.5F/ lower temperature in the 100s/ low fever), PAIN (Felt real achy) and CHILLS (Chills). On 04-Apr-2021, the patient experienced ERYTHEMA (Face looked red) and HEADACHE (Really bad headache). On 05-Apr-2021, the patient experienced RASH (Rash all over face and right arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Upset stomach), ERYTHEMA (Face looked red), RASH (Rash all over face and right arm), PYREXIA (Temperature of 102.5F/ lower temperature in the 100s/ low fever), PAIN (Felt real achy), CHILLS (Chills) and HEADACHE (Really bad headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 102.5 (Inconclusive) 102.5 F. On 03-Apr-2021, Body temperature: 100 (Low) 100s.         Concomitant product use was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received contains updated information of outcome of the events, updated from unknown to recovered.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was not 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 WRONG PRODUCT ADMINISTERED (Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine). At the time of the report, WRONG PRODUCT ADMINISTERED (Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine) had resolved. 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pyrexia
Clinical narrative: Symptoms of her arthritis relapsed and flared up.; She experienced fever; She experienced headache.; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms of her arthritis relapsed and flared up.), HEADACHE (She experienced headache.) and PYREXIA (She experienced fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (She experienced headache.). On 27-Jan-2021, the patient experienced PYREXIA (She experienced fever). On 30-Mar-2021, the patient experienced CONDITION AGGRAVATED (Symptoms of her arthritis relapsed and flared up.). The patient was treated with IBUPROFEN for Arthritis, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Symptoms of her arthritis relapsed and flared up.), HEADACHE (She experienced headache.) and PYREXIA (She experienced fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068568 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068568:CROSSLINKED WITH DOSE 1
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: delayed redness on both arms and upper hip; a little swollen; kinda itchy; rash on arm, torso and legs to ackles /hip/  both arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm, torso and legs to ackles /hip/  both arms), ERYTHEMA (delayed redness on both arms and upper hip), SWELLING (a little swollen) and PRURITUS (kinda itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical history was provided by the reporter.     On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced RASH (rash on arm, torso and legs to ackles /hip/  both arms). On 26-Mar-2021, the patient experienced ERYTHEMA (delayed redness on both arms and upper hip), SWELLING (a little swollen) and PRURITUS (kinda itchy). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and BETAMETHASONE DIPROPIONATE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash on arm, torso and legs to ackles /hip/  both arms), ERYTHEMA (delayed redness on both arms and upper hip), SWELLING (a little swollen) and PRURITUS (kinda itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.     Caller received the first vaccine a month ago.  After the first week after the vaccine, caller said she experienced a rash on arm and on upper hip.  Caller said she went to dermatologist.  Caller said dermatologist advised to get the second dose.  Caller said she spoke to a doctor who said that people had this rash.  Caller got her first dose on 24mar21, LOT#018B21A.  Caller said doctor gave her betamethasone dipropionat 0.05 cream, and it was very effective. Caller said she had redness, a little swollen, kinda itchy.  Caller had it on both arms and above the hip.  Caller said she did not get the second dose when she was suppose to but she plans on getting the second dose after talking to moderna.  Caller wanted to know if she should get second dose and whether she will get the rash again.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up appended on 30-April-2021 Added events & events outcome and Treatment details