chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: symptom of pleurisy with intense sharp stabbing pain over the right chest area; achy all over; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (symptom of pleurisy with intense sharp stabbing pain over the right chest area) and PAIN (achy all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (symptom of pleurisy with intense sharp stabbing pain over the right chest area) and PAIN (achy all over). At the time of the report, CHEST PAIN (symptom of pleurisy with intense sharp stabbing pain over the right chest area) and PAIN (achy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient tested positive for COVID after the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID after the first dose of the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID after the first dose of the vaccine). At the time of the report, COVID-19 (Patient tested positive for COVID after the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Oral candidiasis, Pain, Pain in extremity
Clinical narrative: headaches; big tongue; thrush on the tongue; stomach pain; body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain) and PAIN (body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain), PAIN (body aches) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain), PAIN (body aches) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: headaches; big tongue; thrush on the tongue; stomach pain; body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain) and PAIN (body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain), PAIN (body aches) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (headaches), SWOLLEN TONGUE (big tongue), ORAL CANDIDIASIS (thrush on the tongue), ABDOMINAL PAIN UPPER (stomach pain), PAIN (body aches) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, General symptom, Headache, Illness
Clinical narrative: redness; itchy; very severe headache; sore throat; dizziness; muscle aches; fever of 103 F; felt sicker after getting the vaccine; symptoms have improved but are not completely gone; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (very severe headache), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), MYALGIA (muscle aches) and PYREXIA (fever of 103 F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 HEADACHE (very severe headache), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), MYALGIA (muscle aches), PYREXIA (fever of 103 F), ILLNESS (felt sicker after getting the vaccine) and GENERAL SYMPTOM (symptoms have improved but are not completely gone). On an unknown date, the patient experienced ERYTHEMA (redness) and PRURITUS (itchy). At the time of the report, HEADACHE (very severe headache), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), MYALGIA (muscle aches), PYREXIA (fever of 103 F), ILLNESS (felt sicker after getting the vaccine), GENERAL SYMPTOM (symptoms have improved but are not completely gone), ERYTHEMA (redness) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: redness; itchy; very severe headache; sore throat; dizziness; muscle aches; fever of 103 F; felt sicker after getting the vaccine; symptoms have improved but are not completely gone; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (very severe headache), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), MYALGIA (muscle aches) and PYREXIA (fever of 103 F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 HEADACHE (very severe headache), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), MYALGIA (muscle aches), PYREXIA (fever of 103 F), ILLNESS (felt sicker after getting the vaccine) and GENERAL SYMPTOM (symptoms have improved but are not completely gone). On an unknown date, the patient experienced ERYTHEMA (redness) and PRURITUS (itchy). At the time of the report, HEADACHE (very severe headache), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), MYALGIA (muscle aches), PYREXIA (fever of 103 F), ILLNESS (felt sicker after getting the vaccine), GENERAL SYMPTOM (symptoms have improved but are not completely gone), ERYTHEMA (redness) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19
Clinical narrative: Bronchitis; Tested Positive for Covid-19; A spontaneous report was received from a consumer concerning a male patient of unspecified age who was administered Moderna's COVID-19 vaccine and experienced bronchitis and tested positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025520A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.    On 30-JAN-2021, the patient experienced bronchitis and tested positive for COVID-19. He was prescribed azithromycin, methylpred and benzonatate. He reports no other side effects.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events of bronchitis and tested positive for COVID-19 was unknown.; Reporter's Comments: Based on the available information the Moderna's COVID-19 vaccine does not contain a virus, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizziness; sweat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HYPERHIDROSIS (sweat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness) and HYPERHIDROSIS (sweat). At the time of the report, DIZZINESS (Dizziness) and HYPERHIDROSIS (sweat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Palpitations
Clinical narrative: Soreness at injection site; dizzy; Heart raced; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PALPITATIONS (Heart raced) and INJECTION SITE PAIN (Soreness at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, METFORMIN, ATORVASTATIN, LOSARTAN and HYDROCHLOROTHIAZIDE.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (dizzy) and PALPITATIONS (Heart raced). On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection site). On 15-Feb-2021, INJECTION SITE PAIN (Soreness at injection site) had resolved. At the time of the report, DIZZINESS (dizzy) and PALPITATIONS (Heart raced) 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.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hot flush, Rash
Clinical narrative: red rash on right leg behind knee; burning; rash all over her right leg; hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red rash on right leg behind knee), BURNING SENSATION (burning), RASH (rash all over her right leg) and HOT FLUSH (hot) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Stomach discomfort.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced RASH (red rash on right leg behind knee), BURNING SENSATION (burning), RASH (rash all over her right leg) and HOT FLUSH (hot). At the time of the report, RASH (red rash on right leg behind knee), BURNING SENSATION (burning), RASH (rash all over her right leg) and HOT FLUSH (hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Pain in upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper arm) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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) (unknown route) 1 1. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper arm). On 13-Feb-2021, the patient experienced HEADACHE (Headache). On 13-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She took Tylenol on15 Feb 2021 for the arm pain.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after getting first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID after getting first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 SARS-COV-2 TEST POSITIVE (tested positive for COVID after getting first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID after getting first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant Follow up. Reporter first name and address updated
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia
Clinical narrative: Fever; cough; Positive COVID-19 Test; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), COUGH (cough) and COVID-19 (Positive COVID-19 Test) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN and ACETYLSALICYLIC ACID (ASPIRIN) 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 27-Jan-2021, the patient experienced COVID-19 (Positive COVID-19 Test). On an unknown date, the patient experienced PYREXIA (Fever) and COUGH (cough). At the time of the report, PYREXIA (Fever), COUGH (cough) and COVID-19 (Positive COVID-19 Test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: bicep is swelling; light red rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (bicep is swelling) and VACCINATION SITE RASH (light red rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 073L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VACCINATION SITE SWELLING (bicep is swelling) and VACCINATION SITE RASH (light red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (bicep is swelling) and VACCINATION SITE RASH (light red rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that the patient doesn't have any symptoms after his first dose.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-Jun-2021 and included significant information such as new reporter (HCP) was added, Contact details of Primary reporter was updated and details about patient first and second dose were added, Patient age was added and treatment information was added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: sweating; achiness; Feeling sick to her stomach/ stomachache; headache; joint pain; tired; Achiness; Chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), PAIN (Achiness), HYPERHIDROSIS (sweating), PAIN (achiness) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (Achiness), CHILLS (Chills) and PYREXIA (low grade fever). On 15-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), HYPERHIDROSIS (sweating), PAIN (achiness), HEADACHE (headache), ARTHRALGIA (joint pain) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 11-Feb-2021, PAIN (Achiness), CHILLS (Chills) and PYREXIA (low grade fever) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), HYPERHIDROSIS (sweating), PAIN (achiness), HEADACHE (headache), ARTHRALGIA (joint pain) and FATIGUE (tired) was resolving.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information included Address and email.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: sweating; achiness; Feeling sick to her stomach/ stomachache; headache; joint pain; tired; Achiness; Chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), PAIN (Achiness), HYPERHIDROSIS (sweating), PAIN (achiness) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (Achiness), CHILLS (Chills) and PYREXIA (low grade fever). On 15-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), HYPERHIDROSIS (sweating), PAIN (achiness), HEADACHE (headache), ARTHRALGIA (joint pain) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 11-Feb-2021, PAIN (Achiness), CHILLS (Chills) and PYREXIA (low grade fever) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), HYPERHIDROSIS (sweating), PAIN (achiness), HEADACHE (headache), ARTHRALGIA (joint pain) and FATIGUE (tired) was resolving.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information included Address and email.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Was very ill after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very ill after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was very ill after the vaccine). At the time of the report, ILLNESS (Was very ill after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: 2 inch rash at injection site with redness and burning; 2 inch rash at injection site with redness and burning; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE RASH (2 inch rash at injection site with redness and burning) and INJECTION SITE PAIN (2 inch rash at injection site with redness and burning) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness). On 15-Feb-2021, the patient experienced INJECTION SITE RASH (2 inch rash at injection site with redness and burning) and INJECTION SITE PAIN (2 inch rash at injection site with redness and burning). At the time of the report, INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE RASH (2 inch rash at injection site with redness and burning) and INJECTION SITE PAIN (2 inch rash at injection site with redness and burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Pyrexia
Clinical narrative: really sick; fever (100.7 ºF); a really bad headache (kind of like a migraine); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), PYREXIA (fever (100.7 ºF)) and HEADACHE (a really bad headache (kind of like a migraine)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (a really bad headache (kind of like a migraine)). On 15-Feb-2021, the patient experienced PYREXIA (fever (100.7 ºF)). On an unknown date, the patient experienced ILLNESS (really sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (really sick), PYREXIA (fever (100.7 ºF)) and HEADACHE (a really bad headache (kind of like a migraine)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100.7 (High) 100.7 degree Fahrenheit.         Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: arm is swollen; red with an itchy rash; itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), RASH ERYTHEMATOUS (red with an itchy rash) and RASH PRURITIC (itchy rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Allergy to insect sting and Drug allergy.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen), RASH ERYTHEMATOUS (red with an itchy rash) and RASH PRURITIC (itchy rash). At the time of the report, PERIPHERAL SWELLING (arm is swollen), RASH ERYTHEMATOUS (red with an itchy rash) and RASH PRURITIC (itchy rash) was resolving.            No concomitant medications were reported. No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: some days it bothers and others it doesn't,tired left arm when lifting weight; Left arm is itchy; Left arm burns; red flat stain at the injection site and went bigger and bigger; warm to touch; swollen; sore left arm, left arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm, left arm hurts), INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch), PERIPHERAL SWELLING (swollen) and LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to penicillin). Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm, left arm hurts). On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch) and PERIPHERAL SWELLING (swollen). On an unknown date, the patient experienced LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight), PRURITUS (Left arm is itchy) and BURNING SENSATION (Left arm burns). On 07-Feb-2021, PAIN IN EXTREMITY (sore left arm, left arm hurts) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch), PERIPHERAL SWELLING (swollen), LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight), PRURITUS (Left arm is itchy) and BURNING SENSATION (Left arm burns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient does not received any treatments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: some days it bothers and others it doesn't,tired left arm when lifting weight; Left arm is itchy; Left arm burns; red flat stain at the injection site and went bigger and bigger; warm to touch; swollen; sore left arm, left arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm, left arm hurts), INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch), PERIPHERAL SWELLING (swollen) and LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to penicillin). Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm, left arm hurts). On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch) and PERIPHERAL SWELLING (swollen). On an unknown date, the patient experienced LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight), PRURITUS (Left arm is itchy) and BURNING SENSATION (Left arm burns). On 07-Feb-2021, PAIN IN EXTREMITY (sore left arm, left arm hurts) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch), PERIPHERAL SWELLING (swollen), LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight), PRURITUS (Left arm is itchy) and BURNING SENSATION (Left arm burns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient does not received any treatments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Like an allergy; Little welts; Itchyaround the injection site; Red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Like an allergy), VACCINATION SITE URTICARIA (Little welts), VACCINATION SITE PRURITUS (Itchyaround the injection site) and VACCINATION SITE ERYTHEMA (Red around the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ALLERGY TO VACCINE (Like an allergy), VACCINATION SITE URTICARIA (Little welts), VACCINATION SITE PRURITUS (Itchyaround the injection site) and VACCINATION SITE ERYTHEMA (Red around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Like an allergy), VACCINATION SITE URTICARIA (Little welts), VACCINATION SITE PRURITUS (Itchyaround the injection site) and VACCINATION SITE ERYTHEMA (Red around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Additional information received
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: headache; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). On 16-Feb-2021, HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site urticaria, Vaccination site pain
Clinical narrative: Welt of the size of a lime in the injection site; Red mark; Hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (Welt of the size of a lime in the injection site), INJECTION SITE ERYTHEMA (Red mark) and VACCINATION SITE PAIN (Hurt to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ANTIHISTAMINES for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Welt of the size of a lime in the injection site), INJECTION SITE ERYTHEMA (Red mark) and VACCINATION SITE PAIN (Hurt to touch). On 29-Jan-2021, INJECTION SITE URTICARIA (Welt of the size of a lime in the injection site) and INJECTION SITE ERYTHEMA (Red mark) had resolved. At the time of the report, VACCINATION SITE PAIN (Hurt to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use also included stomach medication. Treatment for the events included Tylenol (acetaminophen) and cold applied on the injection site.   This case was linked to MOD-2021-041652 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Sinus infection; 3 inches of red swelling around the injection site; 3 inches of red swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), VACCINATION SITE SWELLING (3 inches of red swelling around the injection site) and VACCINATION SITE ERYTHEMA (3 inches of red swelling around the injection site) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SINUSITIS (Sinus infection), VACCINATION SITE SWELLING (3 inches of red swelling around the injection site) and VACCINATION SITE ERYTHEMA (3 inches of red swelling around the injection site). At the time of the report, SINUSITIS (Sinus infection), VACCINATION SITE SWELLING (3 inches of red swelling around the injection site) and VACCINATION SITE ERYTHEMA (3 inches of red swelling around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13 JUL 2021 contains change in the outcome. Outcome of the event Sinus infection, Vaccination site swelling and Vaccination site erythema has been updated from Not Recovered to Recovered .
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse effects from the Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse effects from the Moderna dose) 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 ADVERSE EVENT (Adverse effects from the Moderna dose). At the time of the report, ADVERSE EVENT (Adverse effects from the Moderna dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever). At the time of the report, CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and CARVEDILOL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information mentioned that the patient was given Benadryl and an Epi pen if she needed to use it.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary infection; A spontaneous report was received from a Consumer who is a 82 years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary infection (urinary tract infection).  The patient's medical history was not provided. Concomitant medications were not reported.  On 17-Jan-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 006M20A) for prophylaxis of COVID-19 infection.  On an unknown date, the patient was diagnosed with a urinary infection and was treated with ciprofloxacin from 12-Feb-2021 to 15-Feb-2021.  On 16-Feb-2021, after to the onset of the events, the patient received the second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event urinary infection was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm discomfort; Vaccination site eryhtema; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm discomfort), VACCINATION SITE ERYTHEMA (Vaccination site eryhtema) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm discomfort), VACCINATION SITE ERYTHEMA (Vaccination site eryhtema) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, LIMB DISCOMFORT (arm discomfort), VACCINATION SITE ERYTHEMA (Vaccination site eryhtema) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness; Red Spot; Swelling; Sore Arm; Bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Bump), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE ERYTHEMA (Red Spot) and VACCINATION SITE SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included RETINOL, ARGININE HYDROCHLORIDE, IBUPROFEN (ALPAIN [ARGININE HYDROCHLORIDE;IBUPROFEN]), LEVOMEPROMAZINE MALEATE (METHOPRAZINE), DANAZOL and MAGNESIUM for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Bump) and VACCINATION SITE PAIN (Sore Arm). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Spot) and VACCINATION SITE SWELLING (Swelling). The patient was treated with ACETYLSALICYLIC ACID (ASPRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Bump), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE ERYTHEMA (Red Spot) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received. Patient reported she does not want to share email. It contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia, Pyrexia
Clinical narrative: Feeling unwell; fever; body aches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Feeling unwell), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain). On 15-Feb-2021, MALAISE (Feeling unwell), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non significant follow up: Reporter's information has been updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: given a patient a dose that went out instead if the patient's arm; given a patient a dose that went out instead if the patient's arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (given a patient a dose that went out instead if the patient's arm) and UNDERDOSE (given a patient a dose that went out instead if the patient's arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (given a patient a dose that went out instead if the patient's arm) and UNDERDOSE (given a patient a dose that went out instead if the patient's arm). At the time of the report, DEVICE CONNECTION ISSUE (given a patient a dose that went out instead if the patient's arm) and UNDERDOSE (given a patient a dose that went out instead if the patient's arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.