chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site papule, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Oval, bright-red, bumpy rash 2x3 in diameter; Itching near site of rash; Oval, bright-red, bumpy rash 2x3 in diameter; Oval, bright-red, bumpy rash 2x3 in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAPULE (Oval, bright-red, bumpy rash 2x3 in diameter), VACCINATION SITE PRURITUS (Itching near site of rash), VACCINATION SITE RASH (Oval, bright-red, bumpy rash 2x3 in diameter) and VACCINATION SITE ERYTHEMA (Oval, bright-red, bumpy rash 2x3 in diameter) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAPULE (Oval, bright-red, bumpy rash 2x3 in diameter), VACCINATION SITE PRURITUS (Itching near site of rash), VACCINATION SITE RASH (Oval, bright-red, bumpy rash 2x3 in diameter) and VACCINATION SITE ERYTHEMA (Oval, bright-red, bumpy rash 2x3 in diameter). On 13-Mar-2021, VACCINATION SITE PAPULE (Oval, bright-red, bumpy rash 2x3 in diameter), VACCINATION SITE RASH (Oval, bright-red, bumpy rash 2x3 in diameter) and VACCINATION SITE ERYTHEMA (Oval, bright-red, bumpy rash 2x3 in diameter) had resolved. On 17-Mar-2021, VACCINATION SITE PRURITUS (Itching near site of rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: 3inches of swelling in arm; Arm began to ache dully every day/ sharp in the arm again; The pain is causing them to sleep poorly; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (3inches of swelling in arm), PAIN IN EXTREMITY (Arm began to ache dully every day/ sharp in the arm again) and INSOMNIA (The pain is causing them to sleep poorly) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-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 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm began to ache dully every day/ sharp in the arm again) and INSOMNIA (The pain is causing them to sleep poorly). On an unknown date, the patient experienced PERIPHERAL SWELLING (3inches of swelling in arm). At the time of the report, PERIPHERAL SWELLING (3inches of swelling in arm), PAIN IN EXTREMITY (Arm began to ache dully every day/ sharp in the arm again) and INSOMNIA (The pain is causing them to sleep poorly) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeling cold, Headache
Clinical narrative: Woke up he felt he could not move, ¨i though i was going to die ¨; freezing; could not move, ¨i though i was going to die; pain in the arm of the injection; chills; fever up to 101F; very bad headache; lost of appetite,; This spontaneous case was reported by a consumer and describes the occurrence of Immobility(Woke up he felt he could not move) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Appetite lost on 17-Mar-2021, Headache on 18-Mar-2021, Chills on 18-Mar-2021, Freezing phenomenon on 18-Mar-2021, Fever on 18-Mar-2021, Pain in arm of the injection on 18-Mar-2021 and Movements reduced on 18-Mar-2021.  Concomitant products included Blood pressure medication, Cholesterol medication, Thyroid medication, Liver medication and Methadone.   On 17-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Moderna COVID-19 Vaccine batch #: 047A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 18-Mar-2021, the patient experienced Woke up he felt he could not move, HEADACHE (very bad headache), CHILLS (chills), FEELING COLD (freezing), PYREXIA (fever up to 101F), VACCINATION SITE PAIN (pain in the arm of the injection), MOBILITY DECREASED (could not move, ¨I though I was going to die) and DECREASED APPETITE ( lost of appetite). Treatment information was not provided.   At the time of the report, (Woke up he felt he could not move) is gone,  loss of appetite is coming back on 19-Mar-2021. The outcome of the events headache, chills, freezing, fever up to 101F, pain in arm of the injection, and woke up he felt he could not move was unknown. The outcome of the event appetite loss was resolved. Action taken with mRNA-1273 in response to the events was not provided.; Reporter'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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052642:Crosslinked case
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Immobile, Mobility decreased, Pyrexia, Vaccination site pain
Clinical narrative: Woke up he felt he could not move, ¨i though i was going to die ¨; freezing; could not move, ¨i though i was going to die; pain in the arm of the injection; chills; fever up to 101F; very bad headache; lost of appetite,; This spontaneous case was reported by a consumer and describes the occurrence of Immobility(Woke up he felt he could not move) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Appetite lost on 17-Mar-2021, Headache on 18-Mar-2021, Chills on 18-Mar-2021, Freezing phenomenon on 18-Mar-2021, Fever on 18-Mar-2021, Pain in arm of the injection on 18-Mar-2021 and Movements reduced on 18-Mar-2021.  Concomitant products included Blood pressure medication, Cholesterol medication, Thyroid medication, Liver medication and Methadone.   On 17-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Moderna COVID-19 Vaccine batch #: 047A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 18-Mar-2021, the patient experienced Woke up he felt he could not move, HEADACHE (very bad headache), CHILLS (chills), FEELING COLD (freezing), PYREXIA (fever up to 101F), VACCINATION SITE PAIN (pain in the arm of the injection), MOBILITY DECREASED (could not move, ¨I though I was going to die) and DECREASED APPETITE ( lost of appetite). Treatment information was not provided.   At the time of the report, (Woke up he felt he could not move) is gone,  loss of appetite is coming back on 19-Mar-2021. The outcome of the events headache, chills, freezing, fever up to 101F, pain in arm of the injection, and woke up he felt he could not move was unknown. The outcome of the event appetite loss was resolved. Action taken with mRNA-1273 in response to the events was not provided.; Reporter'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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052642:Crosslinked case
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Influenza
Clinical narrative: Swollen arm; Felt like I had a flu; Felt extreme thirst; Painful arm; dizziness; Fever; Nausea; Headache; Sore arm, Body Ache; Chills; Tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), INFLUENZA (Felt like I had a flu), THIRST (Felt extreme thirst) and VACCINATION SITE SWELLING (Swollen arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023MLDA and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder. Concurrent medical conditions included Latex allergy, Adhesive tape allergy, Type 2 diabetes mellitus and Thyroidectomy. Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) for Supplementation therapy, LEVOTHYROXINE for Thyroidectomy, METFORMIN for Type 2 diabetes mellitus, VITAMIN B COMPLEX and VITAMIN C [ASCORBIC ACID] for Vitamin supplementation.   On 25-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), THIRST (Felt extreme thirst), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Sore arm, Body Ache), CHILLS (Chills) and FATIGUE (Tired). On 20-Mar-2021, the patient experienced INFLUENZA (Felt like I had a flu). On 20-Mar-2021 at 8:00 AM, the patient experienced VACCINATION SITE SWELLING (Swollen arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 22-Mar-2021, VACCINATION SITE SWELLING (Swollen arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), INFLUENZA (Felt like I had a flu), THIRST (Felt extreme thirst), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Sore arm, Body Ache), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up information was received from the initial reporter: Patient's race, height and weight were added. Concomitant medications and event influenza  were added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Swollen arm; Felt like I had a flu; Felt extreme thirst; Painful arm; dizziness; Fever; Nausea; Headache; Sore arm, Body Ache; Chills; Tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), INFLUENZA (Felt like I had a flu), THIRST (Felt extreme thirst) and VACCINATION SITE SWELLING (Swollen arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023MLDA and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder. Concurrent medical conditions included Latex allergy, Adhesive tape allergy, Type 2 diabetes mellitus and Thyroidectomy. Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) for Supplementation therapy, LEVOTHYROXINE for Thyroidectomy, METFORMIN for Type 2 diabetes mellitus, VITAMIN B COMPLEX and VITAMIN C [ASCORBIC ACID] for Vitamin supplementation.   On 25-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), THIRST (Felt extreme thirst), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Sore arm, Body Ache), CHILLS (Chills) and FATIGUE (Tired). On 20-Mar-2021, the patient experienced INFLUENZA (Felt like I had a flu). On 20-Mar-2021 at 8:00 AM, the patient experienced VACCINATION SITE SWELLING (Swollen arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 22-Mar-2021, VACCINATION SITE SWELLING (Swollen arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), INFLUENZA (Felt like I had a flu), THIRST (Felt extreme thirst), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Sore arm, Body Ache), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up information was received from the initial reporter: Patient's race, height and weight were added. Concomitant medications and event influenza  were added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Vaccination site swelling
Clinical narrative: Swollen arm; Felt like I had a flu; Felt extreme thirst; Painful arm; dizziness; Fever; Nausea; Headache; Sore arm, Body Ache; Chills; Tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), INFLUENZA (Felt like I had a flu), THIRST (Felt extreme thirst) and VACCINATION SITE SWELLING (Swollen arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023MLDA and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder. Concurrent medical conditions included Latex allergy, Adhesive tape allergy, Type 2 diabetes mellitus and Thyroidectomy. Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) for Supplementation therapy, LEVOTHYROXINE for Thyroidectomy, METFORMIN for Type 2 diabetes mellitus, VITAMIN B COMPLEX and VITAMIN C [ASCORBIC ACID] for Vitamin supplementation.   On 25-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), THIRST (Felt extreme thirst), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Sore arm, Body Ache), CHILLS (Chills) and FATIGUE (Tired). On 20-Mar-2021, the patient experienced INFLUENZA (Felt like I had a flu). On 20-Mar-2021 at 8:00 AM, the patient experienced VACCINATION SITE SWELLING (Swollen arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 22-Mar-2021, VACCINATION SITE SWELLING (Swollen arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm), DIZZINESS (dizziness), INFLUENZA (Felt like I had a flu), THIRST (Felt extreme thirst), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Sore arm, Body Ache), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up information was received from the initial reporter: Patient's race, height and weight were added. Concomitant medications and event influenza  were added.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; headache; Chills; Body ache; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L28) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 03-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (fatigue). At the time of the report, PYREXIA (Fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (fatigue) had resolved. Not Provided      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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Sore left arm; Redness around injection site; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PRURITUS (Itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received 4 doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 4 doses of the Moderna COVID 19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 4 doses of the Moderna COVID 19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Received 4 doses of the Moderna COVID 19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 was not applicable. Concomitant and treatment medication was not provided.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19; Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) and OFF LABEL USE (Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and OFF LABEL USE (Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies). At the time of the report, COVID-19 (COVID-19) outcome was unknown and OFF LABEL USE (Missed his second dose/ told by his HCP he did not need to take the second dose because he has antibodies) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: 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.   No concomitant medications were provided. Treatment medications were unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Arm hurts; Hot; Hard; Red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE ERYTHEMA (Red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: received meningitis vaccine within 10 days of receiving moderna covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (received meningitis vaccine within 10 days of receiving moderna covid 19 vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG INTERACTION (received meningitis vaccine within 10 days of receiving moderna covid 19 vaccine). At the time of the report, DRUG INTERACTION (received meningitis vaccine within 10 days of receiving moderna covid 19 vaccine) 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.   ? No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pain, Pain in extremity
Clinical narrative: Diarrhea; Stomach cramps; It was really hard to close left hand - can now close it but with a lot of pain; Little bit of pain throughout my system/Pain; Siick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN IN EXTREMITY (It was really hard to close left hand - can now close it but with a lot of pain), PAIN (Little bit of pain throughout my system/Pain) and NAUSEA (Siick to my stomach) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA), METHOTREXATE, DULOXETINE and FOLIC ACID for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN IN EXTREMITY (It was really hard to close left hand - can now close it but with a lot of pain), PAIN (Little bit of pain throughout my system/Pain) and NAUSEA (Siick to my stomach). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN IN EXTREMITY (It was really hard to close left hand - can now close it but with a lot of pain), PAIN (Little bit of pain throughout my system/Pain) and NAUSEA (Siick to my stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthralgia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 ARTHRALGIA (Arthralgia). At the time of the report, ARTHRALGIA (Arthralgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medication was not reported. The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: report contained no new information
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Ventricular extrasystoles
Clinical narrative: Mild numbness on the left side of their chin and lip; Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine; Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPOAESTHESIA (Mild numbness on the left side of their chin and lip), VENTRICULAR EXTRASYSTOLES (Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine) and HYPOAESTHESIA (Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Premature ventricular contractions.   On 10-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) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 10-Mar-2021, the patient experienced HYPOAESTHESIA (Mild numbness on the left side of their chin and lip), VENTRICULAR EXTRASYSTOLES (Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine) and HYPOAESTHESIA (Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. At the time of the report, HYPOAESTHESIA (Mild numbness on the left side of their chin and lip) had resolved, VENTRICULAR EXTRASYSTOLES (Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine) had not resolved and HYPOAESTHESIA (Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-052750 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash around her arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH (Rash around her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (Rash around her arm). At the time of the report, RASH (Rash around her arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details provided. Treatment details include antibiotics.   This case was linked to MOD-2021-115468 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09-May-2021 included event details.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood sodium, Glycosylated haemoglobin, Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 300042698 and 3000489) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Vision loss (Lost eye sight on the right one.) since 1967, Cataract operation (Cataract surgery of left eye) in 2013 and Bypass surgery. Concurrent medical conditions included Diabetes since 2003. Concomitant products included INSULIN, METFORMIN HYDROCHLORIDE (SIOFOR), SULODEXIDE (VESSEL DUE), ROSUVASTATIN CALCIUM (CRESTOR), GLICLAZIDE (DIAPREL), FENOFIBRATE (LIPANTHYL) and ACETYLSALICYLIC ACID (ASPIRIN CARDIO) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: Normal. On an unknown date, Blood sodium: Normal. On an unknown date, Glycosylated haemoglobin: (High) 11.3 Higher than normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications include, Resveratrol, Vitamin C, Multivitamin, Milgamma N, Actovegin, Thioctic acid.  On an unknown date, laboratory data include tomography, optic nerve echography, eye fundus examination, result unknown. On 12 Mar 2021 had an angiotomography, result unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Urinary incontinence
Clinical narrative: Urinary incontinence; Joint pain; Muscle Pain; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle Pain), CHILLS (Severe chills) and URINARY INCONTINENCE (Urinary incontinence) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), MYALGIA (Muscle Pain) and CHILLS (Severe chills). On 11-Mar-2021, the patient experienced URINARY INCONTINENCE (Urinary incontinence). At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle Pain), CHILLS (Severe chills) and URINARY INCONTINENCE (Urinary incontinence) outcome was unknown.            She did not receive treatment for her symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Oropharyngeal pain, Product dose omission issue, Rhinorrhoea, Sinusitis
Clinical narrative: upset stomach; sore throat; Runny nose; Sinusitis; missed dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), SINUSITIS (Sinusitis) and PRODUCT DOSE OMISSION ISSUE (missed dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 12-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), SINUSITIS (Sinusitis) and PRODUCT DOSE OMISSION ISSUE (missed dose). On 12-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and OROPHARYNGEAL PAIN (sore throat) was resolving and RHINORRHOEA (Runny nose) and SINUSITIS (Sinusitis) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient taking sinus medicine to treat. No concomitant medication were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm is just starting to hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm is just starting to hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, High cholesterol and Kidney stone (started an unknown antibiotic for a pre-planned kidney stone procedure.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm is just starting to hurt). At the time of the report, PAIN IN EXTREMITY (Left arm is just starting to hurt) outcome was unknown.            No treatment information was provided. Concomitant medications included unspecified blood pressure medication, an unspecified statin to treat high cholesterol and unknown antibiotic for pre-planned outpatient kidney stone procedure on 12 Feb 2021.   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.   This case was linked to MOD-2021-030996 (Patient Link).; 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: Vaccination site rash
Clinical narrative: Vaccination site rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 VACCINATION SITE RASH (Vaccination site rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (Vaccination site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Benadryl. Patient developed a red splotchy rash on her skin within the 30 minute window frame of patient observation.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Feeling abnormal, Hypoaesthesia, Ventricular extrasystoles
Clinical narrative: history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine; mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening; painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,; patient was feeling uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine), HYPOAESTHESIA (mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening), FACIAL PAIN (painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,) and FEELING ABNORMAL (patient was feeling uncomfortable) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 17-Mar-2021, the patient experienced HYPOAESTHESIA (mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening), FACIAL PAIN (painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,) and FEELING ABNORMAL (patient was feeling uncomfortable). On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine). On 19-Mar-2021, FACIAL PAIN (painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,) had resolved. At the time of the report, VENTRICULAR EXTRASYSTOLES (history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine) and HYPOAESTHESIA (mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening) had not resolved and FEELING ABNORMAL (patient was feeling uncomfortable) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.   The patient took ibuprofen and loratadine for treatment of symptoms which provided temporary relief.   This case was linked to MOD-2021-052734 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: F/U 1:  No new information was received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Pyrexia
Clinical narrative: Cold Sweats; Fever; This spontaneous case was reported by a nurse and describes the occurrence of COLD SWEAT (Cold Sweats) and PYREXIA (Fever) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 03-Feb-2021, the patient experienced COLD SWEAT (Cold Sweats) and PYREXIA (Fever). On 06-Feb-2021, COLD SWEAT (Cold Sweats) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (received vaccine after temperature excursion) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (received vaccine after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (received vaccine after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Energy increased, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Her appetite was down; little red spot and itching to touch on injection site; little red spot and itching to touch on injection site; felt big boost of energy; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (felt big boost of energy), DECREASED APPETITE (Her appetite was down), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ENERGY INCREASED (felt big boost of energy), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site). On an unknown date, the patient experienced DECREASED APPETITE (Her appetite was down). At the time of the report, ENERGY INCREASED (felt big boost of energy), DECREASED APPETITE (Her appetite was down), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant  medications were provided. The treatment information was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Taste disorder
Clinical narrative: perceived odors; taste became more acute; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (8-10 years ago, a patient lost his sense of smell because he had a surgery where some polyps in his nose had to be removed, and where the septum was straightened.). Concomitant products included MONTELUKAST, CANNABIS and ALBUTEROL SULFATE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute). At the time of the report, ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Oestrogen receptor assay, Pregnancy test, Ultrasound uterus
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. uu3A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Nov-2020 and the estimated date of delivery was 06-Sep-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 10-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Genetic test: normal (normal) Normal. On an unknown date, Oestrogen receptor assay: normal (normal) Normal. On an unknown date, Ultrasound uterus: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Pre-natal VIT. Treatment medications were unknown.