chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Erythema, Heart rate
Clinical narrative: Hives all over the body; Itching; Red; Rash; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red), RASH (Rash) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Ovarian cyst, Hymenectomy and Wisdom teeth removal. Concurrent medical conditions included Drug allergy (Codeine phosphate allergy).   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red), RASH (Rash), CHILLS (Chills) and NAUSEA (Nausea). On 26-Feb-2021, URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red) and RASH (Rash) had resolved and CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement (120-80 mmHg): 124/70 mmHg (Inconclusive) Inconclusive. On 26-Feb-2021, Body temperature: inconclusive (Inconclusive) 97.8 degree Fahrenheit. On 26-Feb-2021, Heart rate: inconclusive (Inconclusive) 74 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  Treatment details included triamcinolone acetonide ointment 0.5% and diphenhydramine 50mg.  General examination included no acute distress and clear auscultation bilaterally.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-101914 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021,new events added and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash, Urticaria
Clinical narrative: Hives all over the body; Itching; Red; Rash; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red), RASH (Rash) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Ovarian cyst, Hymenectomy and Wisdom teeth removal. Concurrent medical conditions included Drug allergy (Codeine phosphate allergy).   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red), RASH (Rash), CHILLS (Chills) and NAUSEA (Nausea). On 26-Feb-2021, URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red) and RASH (Rash) had resolved and CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement (120-80 mmHg): 124/70 mmHg (Inconclusive) Inconclusive. On 26-Feb-2021, Body temperature: inconclusive (Inconclusive) 97.8 degree Fahrenheit. On 26-Feb-2021, Heart rate: inconclusive (Inconclusive) 74 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  Treatment details included triamcinolone acetonide ointment 0.5% and diphenhydramine 50mg.  General examination included no acute distress and clear auscultation bilaterally.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-101914 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021,new events added and event outcome updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Decreased appetite, Fatigue
Clinical narrative: little swelling on her forearm; arm was swollen from shoulder to elbow; completely red; Rash goes from vaccine site to 2 inches above elbow; rash at injection site going down to her elbow; left arm felt sore; felt like she was hit by a truck; loss of appetite; whole upper body was sore; fever; shivering; joint pain; fatigue; arm was a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore) and SWELLING (little swelling on her forearm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer since an unknown date and Breast conserving surgery. Concurrent medical conditions included Hypertension, Drug allergy (Allergic to penicillin.) and Drug allergy (Allergic to sulfa drugs.). Concomitant products included LOSARTAN for Hypertension, TAMOXIFEN and ACETAMINOPHEN for an unknown indication.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced AXILLARY PAIN (arm was a little sore).   On 18-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt like she was hit by a truck), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain) and FATIGUE (fatigue).   On 19-Feb-2021, the patient experienced AXILLARY PAIN (left arm felt sore) and INJECTION SITE RASH (rash at injection site going down to her elbow).   On 22-Feb-2021, the patient experienced SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), VACCINATION SITE ERYTHEMA (completely red) and VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow).   At the time of the report, DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore), SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain), INJECTION SITE RASH (rash at injection site going down to her elbow), VACCINATION SITE ERYTHEMA (completely red), VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site rash, Pain, Peripheral swelling, Pyrexia
Clinical narrative: little swelling on her forearm; arm was swollen from shoulder to elbow; completely red; Rash goes from vaccine site to 2 inches above elbow; rash at injection site going down to her elbow; left arm felt sore; felt like she was hit by a truck; loss of appetite; whole upper body was sore; fever; shivering; joint pain; fatigue; arm was a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore) and SWELLING (little swelling on her forearm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer since an unknown date and Breast conserving surgery. Concurrent medical conditions included Hypertension, Drug allergy (Allergic to penicillin.) and Drug allergy (Allergic to sulfa drugs.). Concomitant products included LOSARTAN for Hypertension, TAMOXIFEN and ACETAMINOPHEN for an unknown indication.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced AXILLARY PAIN (arm was a little sore).   On 18-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt like she was hit by a truck), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain) and FATIGUE (fatigue).   On 19-Feb-2021, the patient experienced AXILLARY PAIN (left arm felt sore) and INJECTION SITE RASH (rash at injection site going down to her elbow).   On 22-Feb-2021, the patient experienced SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), VACCINATION SITE ERYTHEMA (completely red) and VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow).   At the time of the report, DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore), SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain), INJECTION SITE RASH (rash at injection site going down to her elbow), VACCINATION SITE ERYTHEMA (completely red), VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site rash
Clinical narrative: little swelling on her forearm; arm was swollen from shoulder to elbow; completely red; Rash goes from vaccine site to 2 inches above elbow; rash at injection site going down to her elbow; left arm felt sore; felt like she was hit by a truck; loss of appetite; whole upper body was sore; fever; shivering; joint pain; fatigue; arm was a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore) and SWELLING (little swelling on her forearm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer since an unknown date and Breast conserving surgery. Concurrent medical conditions included Hypertension, Drug allergy (Allergic to penicillin.) and Drug allergy (Allergic to sulfa drugs.). Concomitant products included LOSARTAN for Hypertension, TAMOXIFEN and ACETAMINOPHEN for an unknown indication.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced AXILLARY PAIN (arm was a little sore).   On 18-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt like she was hit by a truck), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain) and FATIGUE (fatigue).   On 19-Feb-2021, the patient experienced AXILLARY PAIN (left arm felt sore) and INJECTION SITE RASH (rash at injection site going down to her elbow).   On 22-Feb-2021, the patient experienced SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), VACCINATION SITE ERYTHEMA (completely red) and VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow).   At the time of the report, DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore), SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain), INJECTION SITE RASH (rash at injection site going down to her elbow), VACCINATION SITE ERYTHEMA (completely red), VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is nowswollen, red and warm; red; warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site is nowswollen, red and warm), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Drug allergy (Patient is allergic to statins) and Hypertension.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site is nowswollen, red and warm), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm).   At the time of the report, INJECTION SITE SWELLING (Injection site is nowswollen, red and warm), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm) had not resolved. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness in her arm).   At the time of the report, VACCINATION SITE PAIN (soreness in her arm) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Face itchy; L arm Itchy / Face itchy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRURITUS (Face itchy) and INJECTION SITE PRURITUS (L arm Itchy / Face itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Feb-2021, the patient experienced PRURITUS (Face itchy) and INJECTION SITE PRURITUS (L arm Itchy / Face itchy).   At the time of the report, PRURITUS (Face itchy) and INJECTION SITE PRURITUS (L arm Itchy / Face itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Dysuria, Eructation
Clinical narrative: Falling asleep; Feeling extremely weak; Dizziness; Does not feel good; Nausea; Vomiting; stomach pain post vaccination; Burping a lot; Difficulty Urination; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Falling asleep), ASTHENIA (Feeling extremely weak), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Does not feel good) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  Concurrent medical conditions included Diabetes and Sulfonamide allergy. Concomitant products included INSULIN and INSULIN DEGLUDEC (TRESIBA) for Diabetes, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced SOMNOLENCE (Falling asleep), ASTHENIA (Feeling extremely weak), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Does not feel good), NAUSEA (Nausea), VOMITING (Vomiting), ABDOMINAL PAIN UPPER (stomach pain post vaccination), ERUCTATION (Burping a lot) and DYSURIA (Difficulty Urination).   On 06-Feb-2021, SOMNOLENCE (Falling asleep), ASTHENIA (Feeling extremely weak), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Does not feel good), NAUSEA (Nausea), VOMITING (Vomiting), ABDOMINAL PAIN UPPER (stomach pain post vaccination), ERUCTATION (Burping a lot) and DYSURIA (Difficulty Urination) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence, Vaccination complication, Vomiting
Clinical narrative: Falling asleep; Feeling extremely weak; Dizziness; Does not feel good; Nausea; Vomiting; stomach pain post vaccination; Burping a lot; Difficulty Urination; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Falling asleep), ASTHENIA (Feeling extremely weak), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Does not feel good) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  Concurrent medical conditions included Diabetes and Sulfonamide allergy. Concomitant products included INSULIN and INSULIN DEGLUDEC (TRESIBA) for Diabetes, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced SOMNOLENCE (Falling asleep), ASTHENIA (Feeling extremely weak), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Does not feel good), NAUSEA (Nausea), VOMITING (Vomiting), ABDOMINAL PAIN UPPER (stomach pain post vaccination), ERUCTATION (Burping a lot) and DYSURIA (Difficulty Urination).   On 06-Feb-2021, SOMNOLENCE (Falling asleep), ASTHENIA (Feeling extremely weak), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Does not feel good), NAUSEA (Nausea), VOMITING (Vomiting), ABDOMINAL PAIN UPPER (stomach pain post vaccination), ERUCTATION (Burping a lot) and DYSURIA (Difficulty Urination) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site/whole arm became a "big red thing that its hot"; injection site/whole arm became a "big red thing that its hot"; Itching; Injection site/whole arm became a "big red thing that its hot"; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (injection site/whole arm became a "big red thing that its hot"), VACCINATION SITE SWELLING (injection site/whole arm became a "big red thing that its hot"), PRURITUS (Itching) and VACCINATION SITE WARMTH (Injection site/whole arm became a "big red thing that its hot") in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KWA) for COVID-19 vaccination.     The patient's past medical history included Breathing difficult and Heart disease, unspecified. Concurrent medical conditions included Allergic reaction to antibiotics since January 2021.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nausea). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site/whole arm became a "big red thing that its hot"), VACCINATION SITE SWELLING (injection site/whole arm became a "big red thing that its hot"), PRURITUS (Itching) and VACCINATION SITE WARMTH (Injection site/whole arm became a "big red thing that its hot"). At the time of the report, NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (injection site/whole arm became a "big red thing that its hot"), VACCINATION SITE SWELLING (injection site/whole arm became a "big red thing that its hot"), PRURITUS (Itching) and VACCINATION SITE WARMTH (Injection site/whole arm became a "big red thing that its hot") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds provided.  No treatment provided.; 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: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid margin crusting
Clinical narrative: Eye crust; This spontaneous case was reported by a non-health professional and describes the occurrence of EYELID MARGIN CRUSTING (Eye crust) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced EYELID MARGIN CRUSTING (Eye crust). The patient was treated with ERYTHROMYCIN at an unspecified dose and frequency. At the time of the report, EYELID MARGIN CRUSTING (Eye crust) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided No relevant concomitant medications were reported Treatment details included Erythromycin was prescribed but patient did not take at the time of the call.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Malaise
Clinical narrative: warm to touch near injection site; aches and pain; felt sick; arm was painful; Hardness near injection site; itching near injection site; redness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful) and INJECTION SITE INDURATION (Hardness near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful), INJECTION SITE INDURATION (Hardness near injection site), INJECTION SITE PRURITUS (itching near injection site) and INJECTION SITE ERYTHEMA (redness near injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful), INJECTION SITE INDURATION (Hardness near injection site), INJECTION SITE PRURITUS (itching near injection site) and INJECTION SITE ERYTHEMA (redness near injection site) outcome was unknown.            Concomitant medication information included Chemotherapy   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 contains No New Information (NNI)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: warm to touch near injection site; aches and pain; felt sick; arm was painful; Hardness near injection site; itching near injection site; redness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful) and INJECTION SITE INDURATION (Hardness near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful), INJECTION SITE INDURATION (Hardness near injection site), INJECTION SITE PRURITUS (itching near injection site) and INJECTION SITE ERYTHEMA (redness near injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful), INJECTION SITE INDURATION (Hardness near injection site), INJECTION SITE PRURITUS (itching near injection site) and INJECTION SITE ERYTHEMA (redness near injection site) outcome was unknown.            Concomitant medication information included Chemotherapy   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 contains No New Information (NNI)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Pain at injection site; Adverse events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse events) and VACCINATION SITE PAIN (Pain at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Adverse events). On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site).  On 07-Feb-2021, VACCINATION COMPLICATION (Adverse events) and VACCINATION SITE PAIN (Pain at injection site) had resolved.      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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site erythema
Clinical narrative: itchy rash; Red; RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), VACCINATION SITE ERYTHEMA (Red) and RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 18-Feb-2021, the patient experienced RASH PRURITIC (itchy rash), VACCINATION SITE ERYTHEMA (Red) and RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, RASH PRURITIC (itchy rash), VACCINATION SITE ERYTHEMA (Red) and RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Oropharyngeal pain, Pyrexia
Clinical narrative: felt like she had the flu; Fever; slept all day; a little headache; felt tired; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache) and FATIGUE (felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013203A and 030MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), CETIRIZINE, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache), FATIGUE (felt tired) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with AMOXICILLIN for Sore throat, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache), FATIGUE (felt tired) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt like she had the flu; Fever; slept all day; a little headache; felt tired; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache) and FATIGUE (felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013203A and 030MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), CETIRIZINE, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache), FATIGUE (felt tired) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with AMOXICILLIN for Sore throat, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache), FATIGUE (felt tired) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Vaccination site pain
Clinical narrative: Elevated blood pressure; Pain at injection arm; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure), VACCINATION SITE PAIN (Pain at injection arm) and FATIGUE (Fatigue) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection arm) and FATIGUE (Fatigue).   On 27-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure).   The patient was treated with HYDROCHLOROTHIAZIDE for Blood pressure, at an unspecified dose and frequency.   On 23-Jan-2021, VACCINATION SITE PAIN (Pain at injection arm) and FATIGUE (Fatigue) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: 78/131 mmHg Borderline. On 27-Jan-2021, Blood pressure measurement: 102/159 mmHg High.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Pyrexia, Sinusitis
Clinical narrative: Sinus infection; blood coming out of her nose; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), EPISTAXIS (blood coming out of her nose), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills).   On 22-Feb-2021, the patient experienced SINUSITIS (Sinus infection) and EPISTAXIS (blood coming out of her nose).   At the time of the report, SINUSITIS (Sinus infection) and EPISTAXIS (blood coming out of her nose) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had resolved.      No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Mental disorder, Morbid thoughts, Negative thoughts
Clinical narrative: Glimpse of real madness; psychoactive reaction; Negative emotions; Minor aches like you would have with the flu; This spontaneous case was reported by a consumer and describes the occurrence of MORBID THOUGHTS (Glimpse of real madness), MENTAL DISORDER (psychoactive reaction), INFLUENZA LIKE ILLNESS (Minor aches like you would have with the flu) and NEGATIVE THOUGHTS (Negative emotions) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Drug hypersensitivity.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (Minor aches like you would have with the flu). On 10-Feb-2021, the patient experienced MENTAL DISORDER (psychoactive reaction) and NEGATIVE THOUGHTS (Negative emotions).   On an unknown date, the patient experienced MORBID THOUGHTS (Glimpse of real madness).   At the time of the report, MORBID THOUGHTS (Glimpse of real madness), MENTAL DISORDER (psychoactive reaction), INFLUENZA LIKE ILLNESS (Minor aches like you would have with the flu) and NEGATIVE THOUGHTS (Negative emotions) was resolving.      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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Area is hard; Red area all over deltoid/red area around vaccination site; Area is sore; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (Area is hard), VACCINATION SITE ERYTHEMA (Red area all over deltoid/red area around vaccination site) and VACCINATION SITE PAIN (Area is sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Area is hard), VACCINATION SITE ERYTHEMA (Red area all over deltoid/red area around vaccination site) and VACCINATION SITE PAIN (Area is sore).   At the time of the report, VACCINATION SITE INDURATION (Area is hard), VACCINATION SITE ERYTHEMA (Red area all over deltoid/red area around vaccination site) and VACCINATION SITE PAIN (Area is sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Counterfeit product administered
Clinical narrative: The patient believes the 2nd dose was not the real COVID 19 vaccine; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and believes that the second dose was not the real Covid-19 Vaccine (Counterfeit drug administered).   The patient's medical history, as provided by the reporter included cardiomyopathy, hypertension and diabetes. Concomitant medication was not provided by the reporter.  On 18 Jan 2021, the patient received their first of the planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm for prophylaxis of COVID-19 infection. The patient had a mild reaction after the 1st Dose.  On 19 Feb 2021, prior to the onset of the events, the patient received their second of the planned doses of mRNA-1273 (Lot number: 11M20A) in the left arm for prophylaxis of COVID-19 infection. The patient had absolutely no reaction after the 2nd Dose. The patient believes the second Dose was not the real COVID-19 Vaccine.  The patient has reported 2nd dose vial had a red label COVID-19 Vaccine with (#15110911) stamped onto the vial and no Moderna label on the vial. The Patient has pictures of the vial. The Patient thinks the same counterfeit vaccine was administered to at least nine other patients. Patient wanted to receive a real 2nd Dose, so that the patient was protected.  Treatment information for the events was not provided by the reporter.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, second dose was not the real COVID-19 Vaccine was considered resolved on 19 Feb 2021.  Follow-up received on 23 Feb 2021 included, anatomical location, lot# of both the vaccines, expiry Date of the product.; Reporter's Comments: This report refers to a case of Counterfeit product administered for the second dose of mRNA-1273 (Lot number:11M20A) with no associated adverse events.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Itching; Rash on the right arm/ rash pretty cover all the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and VACCINATION SITE RASH (Rash on the right arm/ rash pretty cover all the right arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Asthma and Sulfonamide allergy.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Feb-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE RASH (Rash on the right arm/ rash pretty cover all the right arm).   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PRURITUS (Itching) and VACCINATION SITE RASH (Rash on the right arm/ rash pretty cover all the right arm) had not resolved.      Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 101.7 (High) Patient had a fever of 101.7°F.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: significant / patient feeling well; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Jan-2021, the patient experienced COVID-19 (COVID like symptoms). At the time of the report, COVID-19 (COVID like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ "o or 0" A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 04-Apr-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient is currently taking medication for Heart unison and pre-needles vitamins.