chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Vaccination site pain
Clinical narrative: hurt so bad; feeling sick like I had COVID; chills; arm was just a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick like I had COVID), PAIN (hurt so bad), VACCINATION SITE PAIN (arm was just a little bit sore) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was just a little bit sore). On 18-Mar-2021, the patient experienced MALAISE (feeling sick like I had COVID) and CHILLS (chills). On an unknown date, the patient experienced PAIN (hurt so bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feeling sick like I had COVID), PAIN (hurt so bad), VACCINATION SITE PAIN (arm was just a little bit sore) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LISINOPRIL, AMLODIPINE, SIMVASTATIN and VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). The patient was treated with CALCIUM CARBONATE (TUMS ANTACID) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: needle detached from the syringe (something faulty happened with the syringe); she is not confident the patient got the full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (needle detached from the syringe (something faulty happened with the syringe)) and UNDERDOSE (she is not confident the patient got the full dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (needle detached from the syringe (something faulty happened with the syringe)) and UNDERDOSE (she is not confident the patient got the full dose). On 19-Apr-2021, DEVICE CONNECTION ISSUE (needle detached from the syringe (something faulty happened with the syringe)) and UNDERDOSE (she is not confident the patient got the full dose) 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 relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: NNI
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: low grade fever 99.8 F; chills; Joint pains; aches; piercing headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (low grade fever 99.8 F), CHILLS (chills), ARTHRALGIA (Joint pains), MYALGIA (aches) and HEADACHE (piercing headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever 99.8 F), CHILLS (chills), ARTHRALGIA (Joint pains), MYALGIA (aches) and HEADACHE (piercing headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; NAPROXEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever 99.8 F), CHILLS (chills), ARTHRALGIA (Joint pains), MYALGIA (aches) and HEADACHE (piercing headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by the reporter.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Chills
Clinical narrative: Lost control of legs/ couldn't get back up off the ground until the next morning; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ATAXIA (Lost control of legs/ couldn't get back up off the ground until the next morning) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CETIRIZINE (ALLERTEC [CETIRIZINE]) from 01-Jan-2015 to an unknown date for Allergy, ALLOPURINOL from 01-Jan-2015 to an unknown date for Blood uric acid, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) from 01-Jan-2020 to an unknown date for Vitamin supplementation.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ATAXIA (Lost control of legs/ couldn't get back up off the ground until the next morning) and CHILLS (Chills). On 12-Mar-2021, ATAXIA (Lost control of legs/ couldn't get back up off the ground until the next morning) had resolved. On 13-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080283 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Added concomitant medications, updated patient demographics and event outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080283:second dose
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Rash pruritic
Clinical narrative: Extremely swollen arm; Itchy blotchy spot; Swollen lymph node on collar bone; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph node on collar bone), PERIPHERAL SWELLING (Extremely swollen arm) and RASH PRURITIC (Itchy blotchy spot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on collar bone). On 19-Apr-2021, the patient experienced PERIPHERAL SWELLING (Extremely swollen arm) and RASH PRURITIC (Itchy blotchy spot). On 14-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on collar bone), PERIPHERAL SWELLING (Extremely swollen arm) and RASH PRURITIC (Itchy blotchy spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness on injection site) and VACCINATION SITE LYMPHADENOPATHY (swelling of lymph glands on same arm of vaccination) 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. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness on injection site) and VACCINATION SITE LYMPHADENOPATHY (swelling of lymph glands on same arm of vaccination). At the time of the report, VACCINATION SITE PAIN (soreness on injection site) outcome was unknown and VACCINATION SITE LYMPHADENOPATHY (swelling of lymph glands on same arm of vaccination) had not resolved. Not Provided  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) swelling of the lymph glands was confirmed to be a side effect from the Moderna COVID-19 Vaccine. Treatment details were not reported. Reporter did not allow further contact.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia
Clinical narrative: Getting weaker; Leg feeling numb; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Getting weaker) and HYPOAESTHESIA (Leg feeling numb) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016BUA and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA (Getting weaker) and HYPOAESTHESIA (Leg feeling numb). At the time of the report, ASTHENIA (Getting weaker) and HYPOAESTHESIA (Leg feeling numb) outcome was unknown. Not Provided          No concomitant medication information was provided No treatment medication information was provided  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Reporter's E -Mail added
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Myalgia, Nausea, Tenderness
Clinical narrative: Bleeding on the arm; soft ball sized lump on my left armpit; It is very very tender; Pain in armpit; shoulder pain; Nausea; Bodyache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding on the arm), VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit) and ARTHRALGIA (shoulder pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit), ARTHRALGIA (shoulder pain), NAUSEA (Nausea) and MYALGIA (Bodyache). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding on the arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding on the arm) outcome was unknown and VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit), ARTHRALGIA (shoulder pain), NAUSEA (Nausea) and MYALGIA (Bodyache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  Treatment information included putting ice on the lump. Physician said not to consider second shot and he did not take his second shot.  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.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up new information received: Event bleeding on the arm and vaccine dose 2 was withdrawn; 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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site mass
Clinical narrative: Bleeding on the arm; soft ball sized lump on my left armpit; It is very very tender; Pain in armpit; shoulder pain; Nausea; Bodyache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding on the arm), VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit) and ARTHRALGIA (shoulder pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit), ARTHRALGIA (shoulder pain), NAUSEA (Nausea) and MYALGIA (Bodyache). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding on the arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding on the arm) outcome was unknown and VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit), ARTHRALGIA (shoulder pain), NAUSEA (Nausea) and MYALGIA (Bodyache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  Treatment information included putting ice on the lump. Physician said not to consider second shot and he did not take his second shot.  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.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up new information received: Event bleeding on the arm and vaccine dose 2 was withdrawn; 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: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt a little bit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (her arm hurt a little bit) 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 (her arm hurt a little bit). At the time of the report, PAIN IN EXTREMITY (her arm hurt a little bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD21-078429, MOD21-078492, MOD21-078496 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up information received on 19-may-2021 contains non-significant information. Reporter mailed "no one has CM initials here".; Sender's Comments:  MOD21-078429:Crosslinked MOD21-078492:Crosslinked MOD21-078496:Crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Potential AE due to delay in receiving 2nd dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-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 PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080243 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm). On 26-Mar-2021, PAIN IN EXTREMITY (soreness in her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Event outcome provided and Second dose details
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Pain
Clinical narrative: she started with swelling of lips; Since last 2 weeks, she started with soreness of body; complaining about shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Since last 2 weeks, she started with soreness of body), DYSPNOEA (complaining about shortness of breath) and LIP SWELLING (she started with swelling of lips) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), DIGOXIN, ISOSORBIDE, LOSARTAN, MAGNESIUM OXIDE, METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (Since last 2 weeks, she started with soreness of body) and DYSPNOEA (complaining about shortness of breath). On 19-Apr-2021, the patient experienced LIP SWELLING (she started with swelling of lips). At the time of the report, PAIN (Since last 2 weeks, she started with soreness of body), DYSPNOEA (complaining about shortness of breath) and LIP SWELLING (she started with swelling of lips) outcome was unknown.            Treatment for the event included Tramadol   This case was linked to US-MODERNATX, INC.-MOD-2021-080250 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080250:1st dose
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Product storage error, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever). On 03-Apr-2021, CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever) had resolved. Not Provided. Concomitant product was not provided by the reporter. Treatment medication was not provided. The Department of Health contacted the reporter that the second dose in which patient got was stored incorrectly and were recommending a third dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Picked up cold last week; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Picked up cold last week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-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 NASOPHARYNGITIS (Picked up cold last week). At the time of the report, NASOPHARYNGITIS (Picked up cold last week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fall
Clinical narrative: patient fell due to his body giving out.; pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of FALL (patient fell due to his body giving out.) and ARTHRALGIA (pain in the joints) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (patient fell due to his body giving out.) and ARTHRALGIA (pain in the joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FALL (patient fell due to his body giving out.) and ARTHRALGIA (pain in the joints) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Blood pressure measurement, Oxygen saturation
Clinical narrative: very mild symptoms after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (very mild symptoms after first dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (very mild symptoms after first dose). At the time of the report, ADVERSE EVENT (very mild symptoms after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (Inconclusive) normal. On an unknown date, Oxygen saturation: normal (Inconclusive) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080212 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080212:second dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product dose omission issue
Clinical narrative: She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever; she is pregnant after receiving 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant after receiving 1st dose) and PRODUCT DOSE OMISSION ISSUE (She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant after receiving 1st dose). On 15-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant after receiving 1st dose) had resolved and PRODUCT DOSE OMISSION ISSUE (She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Parosmia
Clinical narrative: Smelling exhaust fumes; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smelling exhaust fumes) and PAIN (Soreness) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE for Gastric acid increased, SILDENAFIL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAROSMIA (Smelling exhaust fumes) and PAIN (Soreness). The patient was treated with MELOXICAM for Pain, at a dose of UNK dosage form. At the time of the report, PAROSMIA (Smelling exhaust fumes) and PAIN (Soreness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD21-078355 (E2B Linked Report). This case was linked to MOD-2021-080337.; Sender's Comments:  MOD21-078355:Fiance's case
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Dizziness; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DIZZINESS (Dizziness), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) had not resolved.            No concomitant medications reported. no treatment details reported.   This case was linked to MODERNATX, INC.-MOD-2021-080496 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Additional information received on 20-MAY-2021,out come of the event changed from unknown to not recovered.; Sender's Comments:  MODERNATX, INC.-MOD-2021-080496:son case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive after first dose of Moderna covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive after first dose of Moderna covid-19 vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive after first dose of Moderna covid-19 vaccine). At the time of the report, COVID-19 (Tested positive after first dose of Moderna covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs are not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: NNI
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: lying down all day; Her injection site arm couldn't move; Chills; slight fever; body aches; Fatigue; Joint pain; Nauseous; Dizzy/felt just a little dizzy; arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm; arm pain/left arm started to feel sore; difficult sleeping/could hardly sleep; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and FEELING ABNORMAL (lying down all day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (I get east infectiony). Concomitant products included FLUTICASONE for Allergy, VALACYCLOVIR [VALACICLOVIR], ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]), MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and NAUSEA (Nauseous). On 09-Apr-2021, the patient experienced FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Apr-2021, DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), INSOMNIA (difficult sleeping/could hardly sleep), FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), NAUSEA (Nauseous), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain/left arm started to feel sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional Information Received on 24-MAY-2021 Containing Second dose information, Allergy and concomitant drugs updated. On 19-Jul-2021: Non-Significant follow up appended to AER
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Myalgia, Nausea, Pain in extremity
Clinical narrative: lying down all day; Her injection site arm couldn't move; Chills; slight fever; body aches; Fatigue; Joint pain; Nauseous; Dizzy/felt just a little dizzy; arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm; arm pain/left arm started to feel sore; difficult sleeping/could hardly sleep; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and FEELING ABNORMAL (lying down all day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (I get east infectiony). Concomitant products included FLUTICASONE for Allergy, VALACYCLOVIR [VALACICLOVIR], ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]), MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and NAUSEA (Nauseous). On 09-Apr-2021, the patient experienced FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Apr-2021, DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), INSOMNIA (difficult sleeping/could hardly sleep), FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), NAUSEA (Nauseous), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain/left arm started to feel sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional Information Received on 24-MAY-2021 Containing Second dose information, Allergy and concomitant drugs updated. On 19-Jul-2021: Non-Significant follow up appended to AER
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site movement impairment
Clinical narrative: lying down all day; Her injection site arm couldn't move; Chills; slight fever; body aches; Fatigue; Joint pain; Nauseous; Dizzy/felt just a little dizzy; arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm; arm pain/left arm started to feel sore; difficult sleeping/could hardly sleep; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and FEELING ABNORMAL (lying down all day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (I get east infectiony). Concomitant products included FLUTICASONE for Allergy, VALACYCLOVIR [VALACICLOVIR], ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]), MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), PAIN IN EXTREMITY (arm pain/left arm started to feel sore), INSOMNIA (difficult sleeping/could hardly sleep) and NAUSEA (Nauseous). On 09-Apr-2021, the patient experienced FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Apr-2021, DIZZINESS (Dizzy/felt just a little dizzy), LIMB DISCOMFORT (arm felt heavy and hard to lift up/left arm felt so heavy that I can barely lift my arm), INSOMNIA (difficult sleeping/could hardly sleep), FEELING ABNORMAL (lying down all day), VACCINATION SITE MOVEMENT IMPAIRMENT (Her injection site arm couldn't move), CHILLS (Chills), PYREXIA (slight fever), MYALGIA (body aches), NAUSEA (Nauseous), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain/left arm started to feel sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional Information Received on 24-MAY-2021 Containing Second dose information, Allergy and concomitant drugs updated. On 19-Jul-2021: Non-Significant follow up appended to AER
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: arm pain; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and RASH (Rash) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 021B21A) for COVID-19 vaccination.     no medical history was provided by the patient.  The patient's past medical history included Eczema. Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY), METFORMIN, ATORVASTATIN, TESTOSTERONE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), TADALAFIL (CIALIS) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (arm pain) and RASH (Rash) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose). On 22-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided by the reporter.  Patient had taken the first dose of Moderna COVID-19 vaccine in the age of 17, next month the patient turns 18 and wanted to find out if patient is eligible to get 2nd dose or not.  No relevant treatment medication information provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness when gets up and with Movement, Initiating 3 weeks after Second Dose; This spontaneous case was reported by an other caregiver and describes the occurrence of DIZZINESS (Dizziness when gets up and with Movement, Initiating 3 weeks after Second Dose) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness when gets up and with Movement, Initiating 3 weeks after Second Dose). At the time of the report, DIZZINESS (Dizziness when gets up and with Movement, Initiating 3 weeks after Second Dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-080389 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information received on 20-MAY-2021 included additional medical history was added. On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains non-significant information. Patient stated not to contact him.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080389:son case
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE for Gastric pH decreased, MELOXICAM for Pain, SILDENAFIL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No treatment reported   This case was linked to MOD-2021-080291, MOD21-078355 (E2B Linked Report). This case was linked to MOD-2021-080337; Sender's Comments:  MOD-2021-080291:1st dose MOD21-078355:Fiance's case
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pruritus, Purpura, Rash
Clinical narrative: Rash over entire body; itchiness; blisters; rash bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash over entire body), PRURITUS (itchiness), BLISTER (blisters) and PURPURA (rash bleed) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY), METFORMIN, ATORVASTATIN, TESTOSTERONE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), TADALAFIL (CIALIS) and ACETYLSALICYLIC ACID (BAYASPIRIN) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced RASH (Rash over entire body), PRURITUS (itchiness), BLISTER (blisters) and PURPURA (rash bleed). The patient was treated with PREDNISONE at a dose of 1 dosage form and CLOBETASOL at a dose of 1 dosage form. At the time of the report, RASH (Rash over entire body), PRURITUS (itchiness), BLISTER (blisters) and PURPURA (rash bleed) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable. .   This case was linked to MOD-2021-080297 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up information was received on 19-APR-2021. The case was updated and crosslinked to MOD21-078352. Photos of adverse event was attached.