chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Neck pain
Clinical narrative: Afraid/ very scary; Confused; Heart began to beat very, very fast; Felt cold; Pain in her neck; Chills; Body hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (Afraid/ very scary), CONFUSIONAL STATE (Confused), HEART RATE INCREASED (Heart began to beat very, very fast), NASOPHARYNGITIS (Felt cold) and NECK PAIN (Pain in her neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced FEAR (Afraid/ very scary), CONFUSIONAL STATE (Confused), HEART RATE INCREASED (Heart began to beat very, very fast), NASOPHARYNGITIS (Felt cold), NECK PAIN (Pain in her neck), CHILLS (Chills) and MYALGIA (Body hurt). The patient was treated with MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency. On 10-May-2021, CONFUSIONAL STATE (Confused), HEART RATE INCREASED (Heart began to beat very, very fast), NASOPHARYNGITIS (Felt cold), NECK PAIN (Pain in her neck), CHILLS (Chills) and MYALGIA (Body hurt) had resolved. At the time of the report, FEAR (Afraid/ very scary) 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.   Concomitant product use was not provided by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: One unpunctured vial for 23 hours and he administered one dose to one patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One unpunctured vial for 23 hours and he administered one dose to one patient.) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One unpunctured vial for 23 hours and he administered one dose to one patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One unpunctured vial for 23 hours and he administered one dose to one patient.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Vaginal haemorrhage
Clinical narrative: on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period; cramps; headache; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period), MUSCLE SPASMS (cramps) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included IUD embedded.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VAGINAL HAEMORRHAGE (on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period), MUSCLE SPASMS (cramps) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 17-May-2021, VAGINAL HAEMORRHAGE (on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period) had resolved. At the time of the report, MUSCLE SPASMS (cramps) and HEADACHE (headache) had not resolved.            No concomitant medications were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Benign lymph node neoplasm, Computerised tomogram, Feeling abnormal, Swelling, Ultrasound scan
Clinical narrative: multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck; feels big tumors moving in the left neck; left upper arm was swelling; couldn't move left arm; had a huge swelling in her neck (left side); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm), SWELLING (had a huge swelling in her neck (left side)), BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck), FEELING ABNORMAL (feels big tumors moving in the left neck) and VACCINATION SITE SWELLING (left upper arm was swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm   ), SWELLING (had a huge swelling in her neck (left side)) and VACCINATION SITE SWELLING (left upper arm was swelling). On 17-May-2021, the patient experienced FEELING ABNORMAL (feels big tumors moving in the left neck). On an unknown date, the patient experienced BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm   ), SWELLING (had a huge swelling in her neck (left side)), BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck), FEELING ABNORMAL (feels big tumors moving in the left neck) and VACCINATION SITE SWELLING (left upper arm was swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) ct scan which has confirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck.. On an unknown date, Ultrasound scan: abnormal (abnormal) sonogram and ct scan which has confirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck and abnormal (abnormal) Ultrasound of left neck showed multiple tumors in lymph node.         No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU : email received in that she states that I obtained a sona gram and ct scan which hasconfirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck; feels big tumors moving in the left neck; left upper arm was swelling; couldn't move left arm; had a huge swelling in her neck (left side); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm), SWELLING (had a huge swelling in her neck (left side)), BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck), FEELING ABNORMAL (feels big tumors moving in the left neck) and VACCINATION SITE SWELLING (left upper arm was swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm   ), SWELLING (had a huge swelling in her neck (left side)) and VACCINATION SITE SWELLING (left upper arm was swelling). On 17-May-2021, the patient experienced FEELING ABNORMAL (feels big tumors moving in the left neck). On an unknown date, the patient experienced BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm   ), SWELLING (had a huge swelling in her neck (left side)), BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck), FEELING ABNORMAL (feels big tumors moving in the left neck) and VACCINATION SITE SWELLING (left upper arm was swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) ct scan which has confirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck.. On an unknown date, Ultrasound scan: abnormal (abnormal) sonogram and ct scan which has confirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck and abnormal (abnormal) Ultrasound of left neck showed multiple tumors in lymph node.         No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU : email received in that she states that I obtained a sona gram and ct scan which hasconfirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Vaccine Leaked out of the Left Deltoid Muscle; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Vaccine Leaked out of the Left Deltoid Muscle) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced UNDERDOSE (Vaccine Leaked out of the Left Deltoid Muscle). On 11-May-2021, UNDERDOSE (Vaccine Leaked out of the Left Deltoid Muscle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  It was reported that a couple of drops leaked or may be half of the vaccine (0.25ml) leaked out of the deltoid muscle of left arm. Concomitant medications were not provided. Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Eye pain, Headache, Migraine
Clinical narrative: She still has headache that comes and goes; She ended up being in hospital for few hours dehydration; She had nausea  next day; Pain in shoulder; Within 1/2 hour, she started with migraine that lasted for 3 weeks.; She had pain in neck; She had pain in her left eye that started within few hours; Her injected(left) arm was sore and achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.), NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy) and DEHYDRATION (She ended up being in hospital for few hours dehydration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Asthma. Concomitant products included RIZATRIPTAN, ONDANSETRON (ZOFRAN [ONDANSETRON]), VITAMIN B NOS and VITAMIN D NOS for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Apr-2021, the patient experienced MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.), NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy) and ARTHRALGIA (Pain in shoulder). On 21-Apr-2021, the patient experienced NAUSEA (She had nausea  next day). On 27-Apr-2021, the patient experienced DEHYDRATION (She ended up being in hospital for few hours dehydration). On an unknown date, the patient experienced HEADACHE (She still has headache that comes and goes). On 11-May-2021, MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.) had resolved. At the time of the report, NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy), DEHYDRATION (She ended up being in hospital for few hours dehydration), NAUSEA (She had nausea  next day), ARTHRALGIA (Pain in shoulder) and HEADACHE (She still has headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use also included anti-depressant and asthma medicine.  Treatment information also included muscle relaxer and anti-nausea medicine.  Patient ended up being in hospital for dehydration and migraine management one week after receiving the first dose. She was in hospital for few hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity
Clinical narrative: She still has headache that comes and goes; She ended up being in hospital for few hours dehydration; She had nausea  next day; Pain in shoulder; Within 1/2 hour, she started with migraine that lasted for 3 weeks.; She had pain in neck; She had pain in her left eye that started within few hours; Her injected(left) arm was sore and achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.), NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy) and DEHYDRATION (She ended up being in hospital for few hours dehydration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Asthma. Concomitant products included RIZATRIPTAN, ONDANSETRON (ZOFRAN [ONDANSETRON]), VITAMIN B NOS and VITAMIN D NOS for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Apr-2021, the patient experienced MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.), NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy) and ARTHRALGIA (Pain in shoulder). On 21-Apr-2021, the patient experienced NAUSEA (She had nausea  next day). On 27-Apr-2021, the patient experienced DEHYDRATION (She ended up being in hospital for few hours dehydration). On an unknown date, the patient experienced HEADACHE (She still has headache that comes and goes). On 11-May-2021, MIGRAINE (Within 1/2 hour, she started with migraine that lasted for 3 weeks.) had resolved. At the time of the report, NECK PAIN (She had pain in neck), EYE PAIN (She had pain in her left eye that started within few hours), PAIN IN EXTREMITY (Her injected(left) arm was sore and achy), DEHYDRATION (She ended up being in hospital for few hours dehydration), NAUSEA (She had nausea  next day), ARTHRALGIA (Pain in shoulder) and HEADACHE (She still has headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use also included anti-depressant and asthma medicine.  Treatment information also included muscle relaxer and anti-nausea medicine.  Patient ended up being in hospital for dehydration and migraine management one week after receiving the first dose. She was in hospital for few hours.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Not taken her 2nd dose yet,vaccine beyond the 42 days at this point; Symptoms of COVID-19,Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Symptoms of COVID-19,Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Not taken her 2nd dose yet,vaccine beyond the 42 days at this point) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form(s). On 07-Apr-2021, the patient experienced COVID-19 (Symptoms of COVID-19,Tested positive for COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not taken her 2nd dose yet,vaccine beyond the 42 days at this point). At the time of the report, COVID-19 (Symptoms of COVID-19,Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Not taken her 2nd dose yet,vaccine beyond the 42 days at this point) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Cough, Ear pain, Eye colour change
Clinical narrative: Sore throat; Pink eye; Ear pain; COVID tongue; Was very sick; Coughing; >35 days since first dose of vaccination has passed; Not feeling good; Had pain in arm for weeks; Body aches; Bronchitis; Had respiratory problems; COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat) and EYE COLOR CHANGE (Pink eye) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), OROPHARYNGEAL PAIN (Sore throat), EYE COLOR CHANGE (Pink eye), EAR PAIN (Ear pain), GLOSSODYNIA (COVID tongue), ILLNESS (Was very sick), COUGH (Coughing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days since first dose of vaccination has passed), VACCINATION COMPLICATION (Not feeling good), VACCINATION SITE PAIN (Had pain in arm for weeks) and MYALGIA (Body aches). The patient was treated with ZINC ongoing since an unknown date at a dose of 1 dosage form; VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at a dose of 1 dosage form; VIT D [VITAMIN D NOS] ongoing since an unknown date at a dose of 1 dosage form; IRON ongoing since an unknown date at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE for Coughing and Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat), EYE COLOR CHANGE (Pink eye), EAR PAIN (Ear pain), GLOSSODYNIA (COVID tongue), ILLNESS (Was very sick), COUGH (Coughing), VACCINATION COMPLICATION (Not feeling good), VACCINATION SITE PAIN (Had pain in arm for weeks) and MYALGIA (Body aches) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days since first dose of vaccination has passed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications of the patient included, blood pressure and cholesterol medications. No treatment medications provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Illness, Inappropriate schedule of product administration, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat; Pink eye; Ear pain; COVID tongue; Was very sick; Coughing; >35 days since first dose of vaccination has passed; Not feeling good; Had pain in arm for weeks; Body aches; Bronchitis; Had respiratory problems; COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat) and EYE COLOR CHANGE (Pink eye) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), OROPHARYNGEAL PAIN (Sore throat), EYE COLOR CHANGE (Pink eye), EAR PAIN (Ear pain), GLOSSODYNIA (COVID tongue), ILLNESS (Was very sick), COUGH (Coughing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days since first dose of vaccination has passed), VACCINATION COMPLICATION (Not feeling good), VACCINATION SITE PAIN (Had pain in arm for weeks) and MYALGIA (Body aches). The patient was treated with ZINC ongoing since an unknown date at a dose of 1 dosage form; VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at a dose of 1 dosage form; VIT D [VITAMIN D NOS] ongoing since an unknown date at a dose of 1 dosage form; IRON ongoing since an unknown date at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE for Coughing and Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat), EYE COLOR CHANGE (Pink eye), EAR PAIN (Ear pain), GLOSSODYNIA (COVID tongue), ILLNESS (Was very sick), COUGH (Coughing), VACCINATION COMPLICATION (Not feeling good), VACCINATION SITE PAIN (Had pain in arm for weeks) and MYALGIA (Body aches) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days since first dose of vaccination has passed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications of the patient included, blood pressure and cholesterol medications. No treatment medications provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test, Vaccination complication, Vaccination site pain
Clinical narrative: Sore throat; Pink eye; Ear pain; COVID tongue; Was very sick; Coughing; >35 days since first dose of vaccination has passed; Not feeling good; Had pain in arm for weeks; Body aches; Bronchitis; Had respiratory problems; COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat) and EYE COLOR CHANGE (Pink eye) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), OROPHARYNGEAL PAIN (Sore throat), EYE COLOR CHANGE (Pink eye), EAR PAIN (Ear pain), GLOSSODYNIA (COVID tongue), ILLNESS (Was very sick), COUGH (Coughing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days since first dose of vaccination has passed), VACCINATION COMPLICATION (Not feeling good), VACCINATION SITE PAIN (Had pain in arm for weeks) and MYALGIA (Body aches). The patient was treated with ZINC ongoing since an unknown date at a dose of 1 dosage form; VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at a dose of 1 dosage form; VIT D [VITAMIN D NOS] ongoing since an unknown date at a dose of 1 dosage form; IRON ongoing since an unknown date at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE for Coughing and Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis), RESPIRATORY DISORDER (Had respiratory problems), COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat), EYE COLOR CHANGE (Pink eye), EAR PAIN (Ear pain), GLOSSODYNIA (COVID tongue), ILLNESS (Was very sick), COUGH (Coughing), VACCINATION COMPLICATION (Not feeling good), VACCINATION SITE PAIN (Had pain in arm for weeks) and MYALGIA (Body aches) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days since first dose of vaccination has passed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications of the patient included, blood pressure and cholesterol medications. No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site reaction
Clinical narrative: Mild injection site reaction; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Mild injection site reaction) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included CARVEDILOL (COREG) and RAMIPRIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE REACTION (Mild injection site reaction) and PAIN IN EXTREMITY (Sore arm). On 24-Jan-2021, VACCINATION SITE REACTION (Mild injection site reaction) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-137763 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination site erythema
Clinical narrative: arm sore; arm stiff; arm red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), MUSCULOSKELETAL STIFFNESS (arm stiff) and VACCINATION SITE ERYTHEMA (arm red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), MUSCULOSKELETAL STIFFNESS (arm stiff) and VACCINATION SITE ERYTHEMA (arm red). At the time of the report, PAIN IN EXTREMITY (arm sore), MUSCULOSKELETAL STIFFNESS (arm stiff) and VACCINATION SITE ERYTHEMA (arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD21-091000, US-MODERNATX, INC.-MOD-2021-137978, MOD21-091050 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-may-2021 does not contain any new information; Sender's Comments:  MOD21-091000: US-MODERNATX, INC.-MOD-2021-137978: MOD21-091050:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Muscle spasms
Clinical narrative: Diarrhoea; Muscle spasms; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), MUSCLE SPASMS (Muscle spasms) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), MUSCLE SPASMS (Muscle spasms) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhoea), MUSCLE SPASMS (Muscle spasms) and FATIGUE (Fatigue) had resolved.            No concomitant medication were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-039838 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Vaccination site pain; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A2LA and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue). On 31-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant medications were not reported and treatment included applying ice to left arm.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pruritus
Clinical narrative: some itching at the injection site; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (some itching at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a and 022L0N/D) for COVID-19 vaccination.     The patient's past medical history included Itching.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (some itching at the injection site). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE PRURITUS (some itching at the injection site) had resolved. Unknown          No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-023895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Itching added to med history, Event outcome updated
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Head ache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) 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 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Head ache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and HEADACHE (Head ache) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Excessive eye blinking, Heart rate irregular, Peripheral coldness
Clinical narrative: a lot more irregular heart beats; couldn't catch my breath; arm (felt) was ice cold; trouble breathing; eyes got "blinky-eyed" / couldn't keep eyes open; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (arm (felt) was ice cold), DYSPNOEA (trouble breathing), EXCESSIVE EYE BLINKING (eyes got "blinky-eyed" / couldn't keep eyes open), HEART RATE IRREGULAR (a lot more irregular heart beats) and DYSPNOEA (couldn't catch my breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Irregular pulse, Coronary artery disease, Osteoarthritis and High cholesterol. Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, ACETYLSALICYLIC ACID (ASPRIN) and ATORVASTATIN for an unknown indication, FAMOTIDINE.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PERIPHERAL COLDNESS (arm (felt) was ice cold), DYSPNOEA (trouble breathing), EXCESSIVE EYE BLINKING (eyes got "blinky-eyed" / couldn't keep eyes open), HEART RATE IRREGULAR (a lot more irregular heart beats) and DYSPNOEA (couldn't catch my breath). At the time of the report, PERIPHERAL COLDNESS (arm (felt) was ice cold), DYSPNOEA (trouble breathing), EXCESSIVE EYE BLINKING (eyes got "blinky-eyed" / couldn't keep eyes open), HEART RATE IRREGULAR (a lot more irregular heart beats) and DYSPNOEA (couldn't catch my breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included Novalin N and Novalin R. Patient states her blood sugar (A1C) went up. Was at 9.2 (before shot) and then went up 9.8 (done by CBC) reported a couple weeks after the shot. Patient states she is supposed to get second dose on 26May2021 but is hesitant. Patient states she's notice that she has been having "a lot more irregular heart beats" at night. Patient states she think was doing fine until getting the vaccine.  Treatment information was unknown.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received her first dose at age of seventeen; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received her first dose at age of seventeen) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received her first dose at age of seventeen). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received her first dose at age of seventeen) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient filled her birthday incorrect when she received her first dose of Moderna COVID 19 Vaccine. no concomitant medications were reported. Treatment medicines were not included Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: NNI
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: some dripped down his arm. It was 2 big drops.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (some dripped down his arm. It was 2 big drops.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced UNDERDOSE (some dripped down his arm. It was 2 big drops.). On 17-May-2021, UNDERDOSE (some dripped down his arm. It was 2 big drops.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: He also got shingles after his Moderna vaccine.; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (He also got shingles after his Moderna vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced HERPES ZOSTER (He also got shingles after his Moderna vaccine.). At the time of the report, HERPES ZOSTER (He also got shingles after his Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment details were provided. patient priest got shingles after his Moderna Covid-19 vaccine on 17-may-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-137922, US-MODERNATX, INC.-MOD-2021-138184 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137922:Same reporter US-MODERNATX, INC.-MOD-2021-138184:Same reporter, different patient
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), PAIN (Pain, in morning next day it was really bad), RASH (Rash all over around neck, chest, breast) and MYALGIA (I had muscle ache, in morning next day it was really bad) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) 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 PAIN (Pain, in morning next day it was really bad), MYALGIA (I had muscle ache, in morning next day it was really bad) and ARTHRALGIA (I had joint pain, in morning next day it was really bad). On 14-May-2021, the patient experienced ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), HEADACHE (I had headache), PYREXIA (Fever 100 F) and NAUSEA (Nausea). On 15-May-2021, the patient experienced RASH (Rash all over around neck, chest, breast). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), PAIN (Pain, in morning next day it was really bad), RASH (Rash all over around neck, chest, breast), MYALGIA (I had muscle ache, in morning next day it was really bad), HEADACHE (I had headache), ARTHRALGIA (I had joint pain, in morning next day it was really bad), PYREXIA (Fever 100 F) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 test, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), PAIN (Pain, in morning next day it was really bad), RASH (Rash all over around neck, chest, breast) and MYALGIA (I had muscle ache, in morning next day it was really bad) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) 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 PAIN (Pain, in morning next day it was really bad), MYALGIA (I had muscle ache, in morning next day it was really bad) and ARTHRALGIA (I had joint pain, in morning next day it was really bad). On 14-May-2021, the patient experienced ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), HEADACHE (I had headache), PYREXIA (Fever 100 F) and NAUSEA (Nausea). On 15-May-2021, the patient experienced RASH (Rash all over around neck, chest, breast). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), PAIN (Pain, in morning next day it was really bad), RASH (Rash all over around neck, chest, breast), MYALGIA (I had muscle ache, in morning next day it was really bad), HEADACHE (I had headache), ARTHRALGIA (I had joint pain, in morning next day it was really bad), PYREXIA (Fever 100 F) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.