chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: Sick; Tested positive for Coivd after vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick) and COVID-19 (Tested positive for Coivd after vaccine was given) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Sick) and COVID-19 (Tested positive for Coivd after vaccine was given). At the time of the report, MALAISE (Sick) and COVID-19 (Tested positive for Coivd after vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Nasal congestion, Nausea, Pyrexia
Clinical narrative: congestion; elevated blood pressure; nausea; fever; head ache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION, HYPERTENSION, NAUSEA, PYREXIA, and HEADACHE in a 56-year-old female 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) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION, HYPERTENSION, NAUSEA, PYREXIA, and HEADACHE. At the time of the report, NASAL CONGESTION, HYPERTENSION, NAUSEA, PYREXIA, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medication. Treatment details included paracetamol and did nothing.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperkeratosis, Illness, Myalgia
Clinical narrative: aches and pains in the muscles; aches and pains in the muscles; Fatigue; Chills; soreness at the injection site; hard lump at the injection site; felt sick for two days; bumps in her arm that stayed for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE MASS (hard lump at the injection site), ILLNESS (felt sick for two days) and HYPERKERATOSIS (bumps in her arm that stayed for about a week). On 18-Mar-2021, ILLNESS (felt sick for two days) had resolved. On 22-Mar-2021, HYPERKERATOSIS (bumps in her arm that stayed for about a week) had resolved. At the time of the report, PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE MASS (hard lump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol with Codeine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass, Vaccination site pain
Clinical narrative: aches and pains in the muscles; aches and pains in the muscles; Fatigue; Chills; soreness at the injection site; hard lump at the injection site; felt sick for two days; bumps in her arm that stayed for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE MASS (hard lump at the injection site), ILLNESS (felt sick for two days) and HYPERKERATOSIS (bumps in her arm that stayed for about a week). On 18-Mar-2021, ILLNESS (felt sick for two days) had resolved. On 22-Mar-2021, HYPERKERATOSIS (bumps in her arm that stayed for about a week) had resolved. At the time of the report, PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE MASS (hard lump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol with Codeine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pruritus, Rash erythematous, Retching
Clinical narrative: Scarlet red rash; Itchy; Dry heaving; Diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Scarlet red rash), PRURITUS (Itchy), RETCHING (Dry heaving), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 15-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Scarlet red rash), PRURITUS (Itchy), RETCHING (Dry heaving), DIARRHOEA (Diarrhea) and CHILLS (Chills). At the time of the report, RASH ERYTHEMATOUS (Scarlet red rash), PRURITUS (Itchy), RETCHING (Dry heaving), DIARRHOEA (Diarrhea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included steroids.  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 02-Aug-2021: Follow up received on 2-AUG-2021 and it contain no significant follow-up.; 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: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (symptoms). At the time of the report, ADVERSE EVENT (symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site induration, Joint swelling, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Swollen knee; 10 to 12 bruised lines on left leg; Swelling of injection site; Itchy Injection Site; rash on injection site; Hard at injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen knee), CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE RASH (rash on injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and AMLODIPINE for Blood pressure high, VIT D [VITAMIN D NOS] for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced JOINT SWELLING (Swollen knee), CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE RASH (rash on injection site) and INJECTION SITE INDURATION (Hard at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 03-Mar-2021, CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE RASH (rash on injection site) had resolved with sequelae. At the time of the report, JOINT SWELLING (Swollen knee) and INJECTION SITE INDURATION (Hard at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Physician advised not to take the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information On 11-May-2021: Email address and address of the reporter was added. Age , height, weight of the patient was added. Ethnicity and race of the patient was added. Past medical history was added. concomitant medication was added. Losartan medication description and dose  was added.  Events outcome updated to recovered with sequelae. Treatment drug was added. On 25-Jul-2021: Non-significant follow-up appended
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen knee; 10 to 12 bruised lines on left leg; Swelling of injection site; Itchy Injection Site; rash on injection site; Hard at injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen knee), CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE RASH (rash on injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and AMLODIPINE for Blood pressure high, VIT D [VITAMIN D NOS] for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced JOINT SWELLING (Swollen knee), CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE RASH (rash on injection site) and INJECTION SITE INDURATION (Hard at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 03-Mar-2021, CONTUSION (10 to 12 bruised lines on left leg), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE RASH (rash on injection site) had resolved with sequelae. At the time of the report, JOINT SWELLING (Swollen knee) and INJECTION SITE INDURATION (Hard at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Physician advised not to take the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information On 11-May-2021: Email address and address of the reporter was added. Age , height, weight of the patient was added. Ethnicity and race of the patient was added. Past medical history was added. concomitant medication was added. Losartan medication description and dose  was added.  Events outcome updated to recovered with sequelae. Treatment drug was added. On 25-Jul-2021: Non-significant follow-up appended
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the legs) 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 PAIN IN EXTREMITY (pain in the legs). At the time of the report, PAIN IN EXTREMITY (pain in the legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Muscle spasms, Vaccination site erythema, Vaccination site pain
Clinical narrative: Dizziness; Pain/redness at the site of the injection in left arm; Pain/redness at the site of the injection in left arm; Cramps in both feet; Mild shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (Mild shortness of breath), VACCINATION SITE PAIN (Pain/redness at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Pain/redness at the site of the injection in left arm) and MUSCLE SPASMS (Cramps in both feet) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Mild shortness of breath). On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE PAIN (Pain/redness at the site of the injection in left arm) and VACCINATION SITE ERYTHEMA (Pain/redness at the site of the injection in left arm). 09-Mar-2021, the patient experienced MUSCLE SPASMS (Cramps in both feet). At the time of the report, DIZZINESS (Dizziness), DYSPNOEA (Mild shortness of breath), VACCINATION SITE PAIN (Pain/redness at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Pain/redness at the site of the injection in left arm) and MUSCLE SPASMS (Cramps in both feet) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  treatment for the events included Bananas and Magnesium supplements for muscle cramps in  feet.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Pain in extremity
Clinical narrative: developed a bladder infection; some soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness in her arm) and CYSTITIS (developed a bladder infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection. Concomitant products included SULFAMETHAZINE, INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), METFORMIN, LISINOPRIL and APIXABAN (ELIQUIS) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (some soreness in her arm). On an unknown date, the patient experienced CYSTITIS (developed a bladder infection). At the time of the report, PAIN IN EXTREMITY (some soreness in her arm) and CYSTITIS (developed a bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as antibiotic for bladder infection.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Dry mouth, Dyspnoea
Clinical narrative: difficulty breathing; lost of taste; lost appetite; body aches; runny nose; dry mouth; tongue is sore; she dropped 5 pounds; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), AGEUSIA (lost of taste), DECREASED APPETITE (lost appetite), PAIN (body aches) and RHINORRHOEA (runny nose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-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) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), AGEUSIA (lost of taste), DECREASED APPETITE (lost appetite), PAIN (body aches), RHINORRHOEA (runny nose), DRY MOUTH (dry mouth), GLOSSODYNIA (tongue is sore), WEIGHT DECREASED (she dropped 5 pounds), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, DYSPNOEA (difficulty breathing), AGEUSIA (lost of taste), DECREASED APPETITE (lost appetite), PAIN (body aches), RHINORRHOEA (runny nose), DRY MOUTH (dry mouth), GLOSSODYNIA (tongue is sore), WEIGHT DECREASED (she dropped 5 pounds), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossodynia, Pain, Rhinorrhoea, Weight decreased
Clinical narrative: difficulty breathing; lost of taste; lost appetite; body aches; runny nose; dry mouth; tongue is sore; she dropped 5 pounds; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), AGEUSIA (lost of taste), DECREASED APPETITE (lost appetite), PAIN (body aches) and RHINORRHOEA (runny nose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-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) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), AGEUSIA (lost of taste), DECREASED APPETITE (lost appetite), PAIN (body aches), RHINORRHOEA (runny nose), DRY MOUTH (dry mouth), GLOSSODYNIA (tongue is sore), WEIGHT DECREASED (she dropped 5 pounds), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, DYSPNOEA (difficulty breathing), AGEUSIA (lost of taste), DECREASED APPETITE (lost appetite), PAIN (body aches), RHINORRHOEA (runny nose), DRY MOUTH (dry mouth), GLOSSODYNIA (tongue is sore), WEIGHT DECREASED (she dropped 5 pounds), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: Some of the vaccine (a drop) got on her arm; This spontaneous case was reported by a consumer and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Some of the vaccine (a drop) got on her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 25L20A and 16M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Topical) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (Some of the vaccine (a drop) got on her arm). On 01-Mar-2021, OCCUPATIONAL EXPOSURE TO PRODUCT (Some of the vaccine (a drop) got on her arm) had resolved.            Concomitant product information was not provided. Treatment information was not provided. Patient stated that lot number from the vaccine that got on arm was unknown.   This case was linked to MOD-2021-052911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021. Updated reporter mail ID. On 05-Aug-2021: Follow-up received and confirmed lot numbers.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Disturbance in attention, Dry mouth, Dyspnoea
Clinical narrative: Poor concentration; dropping things (like knife and scissors); Weak; Coughing; Hemorrhoid; No taste of food; Lack of sleep; Dry mouth; Congested; Trouble catching his breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), DRY MOUTH (Dry mouth), HAEMORRHOIDS (Hemorrhoid), HYPOGEUSIA (No taste of food) and INSOMNIA (Lack of sleep) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DRY MOUTH (Dry mouth), HYPOGEUSIA (No taste of food), INSOMNIA (Lack of sleep), DYSPNOEA (Trouble catching his breath) and NASAL CONGESTION (Congested). On 18-Mar-2021, the patient experienced COUGH (Coughing) and HAEMORRHOIDS (Hemorrhoid). On 19-Mar-2021, the patient experienced ASTHENIA (Weak) and MUSCULAR WEAKNESS (dropping things (like knife and scissors)). On 21-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (Poor concentration). On 19-Mar-2021, INSOMNIA (Lack of sleep) had resolved. At the time of the report, COUGH (Coughing), DRY MOUTH (Dry mouth), HAEMORRHOIDS (Hemorrhoid), HYPOGEUSIA (No taste of food), ASTHENIA (Weak), DISTURBANCE IN ATTENTION (Poor concentration), DYSPNOEA (Trouble catching his breath), MUSCULAR WEAKNESS (dropping things (like knife and scissors)) and NASAL CONGESTION (Congested) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-053010 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhoids, Hypogeusia, Insomnia, Muscular weakness, Nasal congestion
Clinical narrative: Poor concentration; dropping things (like knife and scissors); Weak; Coughing; Hemorrhoid; No taste of food; Lack of sleep; Dry mouth; Congested; Trouble catching his breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), DRY MOUTH (Dry mouth), HAEMORRHOIDS (Hemorrhoid), HYPOGEUSIA (No taste of food) and INSOMNIA (Lack of sleep) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DRY MOUTH (Dry mouth), HYPOGEUSIA (No taste of food), INSOMNIA (Lack of sleep), DYSPNOEA (Trouble catching his breath) and NASAL CONGESTION (Congested). On 18-Mar-2021, the patient experienced COUGH (Coughing) and HAEMORRHOIDS (Hemorrhoid). On 19-Mar-2021, the patient experienced ASTHENIA (Weak) and MUSCULAR WEAKNESS (dropping things (like knife and scissors)). On 21-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (Poor concentration). On 19-Mar-2021, INSOMNIA (Lack of sleep) had resolved. At the time of the report, COUGH (Coughing), DRY MOUTH (Dry mouth), HAEMORRHOIDS (Hemorrhoid), HYPOGEUSIA (No taste of food), ASTHENIA (Weak), DISTURBANCE IN ATTENTION (Poor concentration), DYSPNOEA (Trouble catching his breath), MUSCULAR WEAKNESS (dropping things (like knife and scissors)) and NASAL CONGESTION (Congested) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-053010 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Rash, Tachypnoea
Clinical narrative: Eyes puffy; Fast breathing; Rash on arms, legs, back, and face; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (Eyes puffy), TACHYPNOEA (Fast breathing) and RASH (Rash on arms, legs, back, and face) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RASH (Rash on arms, legs, back, and face). On an unknown date, the patient experienced PERIORBITAL SWELLING (Eyes puffy) and TACHYPNOEA (Fast breathing). At the time of the report, PERIORBITAL SWELLING (Eyes puffy), TACHYPNOEA (Fast breathing) and RASH (Rash on arms, legs, back, and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (small welts on their left side of their body close to their armpit), RASH (rash on back) and HYPERSENSITIVITY (allergic reaction) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (small welts on their left side of their body close to their armpit), RASH (rash on back) and HYPERSENSITIVITY (allergic reaction). At the time of the report, URTICARIA (small welts on their left side of their body close to their armpit), RASH (rash on back) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. 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 provided as cetirizine hydrochloride.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        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.   This case was linked to MOD-2021-052992 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia
Clinical narrative: Stomach pain; Diarrhea; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and PYREXIA (Little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and PYREXIA (Little fever). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and PYREXIA (Little fever) outcome was unknown.            no treatment medications were reported concomitants medications were not reported  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-059927, MOD-2021-052899 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Ear pain, Mass, Mouth swelling, Neck pain
Clinical narrative: Ear, neck was hurting; Ear, neck was hurting; Couldn't get face, neck comfortable; Swelling in left side of face from behind ear into jaw; Swelling into the mouth; Throat hurts little bit on left side; Little bump under left ear; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Little bump under left ear), SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth), OROPHARYNGEAL PAIN (Throat hurts little bit on left side) and EAR PAIN (Ear, neck was hurting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE/BENAZEPRIL) for Blood pressure.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the arm). On 19-Mar-2021, the patient experienced MASS (Little bump under left ear). On 20-Mar-2021, the patient experienced SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth) and OROPHARYNGEAL PAIN (Throat hurts little bit on left side). On 21-Mar-2021, the patient experienced EAR PAIN (Ear, neck was hurting), NECK PAIN (Ear, neck was hurting) and DISCOMFORT (Couldn't get face, neck comfortable). At the time of the report, MASS (Little bump under left ear), SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth), OROPHARYNGEAL PAIN (Throat hurts little bit on left side), EAR PAIN (Ear, neck was hurting), NECK PAIN (Ear, neck was hurting), DISCOMFORT (Couldn't get face, neck comfortable) and VACCINATION SITE PAIN (Soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swelling face, Vaccination site pain
Clinical narrative: Ear, neck was hurting; Ear, neck was hurting; Couldn't get face, neck comfortable; Swelling in left side of face from behind ear into jaw; Swelling into the mouth; Throat hurts little bit on left side; Little bump under left ear; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Little bump under left ear), SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth), OROPHARYNGEAL PAIN (Throat hurts little bit on left side) and EAR PAIN (Ear, neck was hurting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE/BENAZEPRIL) for Blood pressure.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the arm). On 19-Mar-2021, the patient experienced MASS (Little bump under left ear). On 20-Mar-2021, the patient experienced SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth) and OROPHARYNGEAL PAIN (Throat hurts little bit on left side). On 21-Mar-2021, the patient experienced EAR PAIN (Ear, neck was hurting), NECK PAIN (Ear, neck was hurting) and DISCOMFORT (Couldn't get face, neck comfortable). At the time of the report, MASS (Little bump under left ear), SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth), OROPHARYNGEAL PAIN (Throat hurts little bit on left side), EAR PAIN (Ear, neck was hurting), NECK PAIN (Ear, neck was hurting), DISCOMFORT (Couldn't get face, neck comfortable) and VACCINATION SITE PAIN (Soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really Sick) and INJECTION SITE ERYTHEMA (Red Ring around Arm) 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 ILLNESS (Really Sick) and INJECTION SITE ERYTHEMA (Red Ring around Arm). At the time of the report, ILLNESS (Really Sick) and INJECTION SITE ERYTHEMA (Red Ring around Arm) outcome was unknown. Not Provided. 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site mass, Injection site pain
Clinical narrative: hard around injection site; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (hard around injection site) and INJECTION SITE PAIN (Injection site soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN DEGLUDEC (TRESIBA) and ANAKINRA (KINERET) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INJECTION SITE MASS (hard around injection site) and INJECTION SITE PAIN (Injection site soreness). At the time of the report, INJECTION SITE MASS (hard around injection site) and INJECTION SITE PAIN (Injection site soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: increased (High) elevated body temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was provided as advil
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Felt sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt sick). At the time of the report, ILLNESS (Felt sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitants medications were not reported no treatment medications were not reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Delusion, Dyspepsia
Clinical narrative: bad reaction; delusions; stomach problems; chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bad reaction), DELUSION (delusions), DYSPEPSIA (stomach problems) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ADVERSE REACTION (bad reaction), DELUSION (delusions), DYSPEPSIA (stomach problems) and CHILLS (chills). On 28-Feb-2021, ADVERSE REACTION (bad reaction), DELUSION (delusions), DYSPEPSIA (stomach problems) and CHILLS (chills) had resolved. Not Provided      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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal cord insertion, Maternal exposure during pregnancy, Placental disorder, Pregnancy test, Subchorionic haematoma
Clinical narrative: subchorionic hematoma; circumvallate placenta; Velamentous cord insertion; Pregnant patient received first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SUBCHORIONIC HAEMATOMA (subchorionic hematoma) and ABNORMAL CORD INSERTION (Velamentous cord insertion) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy loss in 2019. Concurrent medical conditions included Hashimoto's thyroiditis since 1999 and Rheumatoid arthritis since 2018.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 21-May-2021. On 22-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose). On an unknown date, the patient experienced SUBCHORIONIC HAEMATOMA (subchorionic hematoma) (seriousness criterion medically significant), PLACENTAL DISORDER (circumvallate placenta) and ABNORMAL CORD INSERTION (Velamentous cord insertion) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 21-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose) had resolved. At the time of the report, SUBCHORIONIC HAEMATOMA (subchorionic hematoma), PLACENTAL DISORDER (circumvallate placenta) and ABNORMAL CORD INSERTION (Velamentous cord insertion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2020, Pregnancy test: positive (Positive) Positive.         No Concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Significant follow up received, Patient demographics, medical history, previous pregnancy history, maternity medical history, 2nd dose details updated; Sender's Comments: This is a case of product exposure during pregnancy with associated serious AEs of subchorionic hematoma, circumvallate placenta and Velamentous cord insertion. 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. Patient will continue to be contacted for further monitoring of AEs and pregnancy outcome. Events are considered serious as per medical judgment.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: Sore arm; fast heartbeat lasted for 30 mins; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEART RATE INCREASED (fast heartbeat lasted for 30 mins) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Penicillin allergy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEART RATE INCREASED (fast heartbeat lasted for 30 mins). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEART RATE INCREASED (fast heartbeat lasted for 30 mins) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: unknown High.     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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Vaccination site pain
Clinical narrative: very weak; it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot; felt dizzy; lightheaded feeling, if she turns quickly, everything spins; it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING ABNORMAL (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot), DIZZINESS (felt dizzy), DIZZINESS (lightheaded feeling, if she turns quickly, everything spins) and VACCINATION SITE PAIN (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Mar-2021, the patient experienced ASTHENIA (very weak), FEELING ABNORMAL (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot), DIZZINESS (felt dizzy), DIZZINESS (lightheaded feeling, if she turns quickly, everything spins) and VACCINATION SITE PAIN (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot). At the time of the report, ASTHENIA (very weak), FEELING ABNORMAL (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot), DIZZINESS (felt dizzy), DIZZINESS (lightheaded feeling, if she turns quickly, everything spins) and VACCINATION SITE PAIN (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-052972 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site infection, Injection site rash
Clinical narrative: Shingles; pretty serious rash at the injection site; few spots of rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFECTION (few spots of rash at the injection site), INJECTION SITE RASH (pretty serious rash at the injection site) and HERPES ZOSTER (Shingles) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 002A21A) 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 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced INJECTION SITE INFECTION (few spots of rash at the injection site). On 10-Mar-2021, the patient experienced INJECTION SITE RASH (pretty serious rash at the injection site). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, INJECTION SITE INFECTION (few spots of rash at the injection site), INJECTION SITE RASH (pretty serious rash at the injection site) and HERPES ZOSTER (Shingles) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use the product and the start date of the events, a causal relationship cannot be excluded.