chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional underdose
Clinical narrative: A spontaneous report was received from a consumer concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced intentional under dose.  The patient's medical history, as provided by the reporter, included cancer. Concomitant medications reported included acetylsalicylic acid and diabetic medication. The patient  is overweight but, doesn't know exact weight.  On 02 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) for prophylaxis of COVID-19 infection.   The patient had cancer in the past, and got 75% dosage. The reporter mentioned that the healthcare professional said it was the protocol to give 75% dosage to patient that previously had cancer.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was considered as recovered on 02 Mar 2021.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Throat irritation, Vaccination site bruising, Vaccination site mass
Clinical narrative: Tired; Huge purple birth mark with a lump; Had a scratchy throat; Huge purple birth mark with a lump; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), VACCINATION SITE BRUISING (Huge purple birth mark with a lump), THROAT IRRITATION (Had a scratchy throat) and VACCINATION SITE MASS (Huge purple birth mark with a lump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Tired), VACCINATION SITE BRUISING (Huge purple birth mark with a lump), THROAT IRRITATION (Had a scratchy throat) and VACCINATION SITE MASS (Huge purple birth mark with a lump). At the time of the report, FATIGUE (Tired), VACCINATION SITE BRUISING (Huge purple birth mark with a lump), THROAT IRRITATION (Had a scratchy throat) and VACCINATION SITE MASS (Huge purple birth mark with a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    This case was linked to MOD-2021-057778 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: body aches; flu-like symptoms; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included RIVAROXABAN (XARELTO), METOPROLOL, AMIODARONE HYDROCHLORIDE (AMIDARONE), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN AND HYDROCHLOROTHIAZIDE) and LEVOTHYROXINE for an unknown indication.    On 27-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills). At the time of the report, PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he didn't take any treatment for his symptoms as he was on so many other medications
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: arm is slightly tender; shivering uncontrollably; temperature of 104 degrees, then 101 degrees, then 99.8 degrees, then 100 degrees Fahrenheit; felt the vaccine going into her arm; arm was sore when raised above head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt the vaccine going into her arm), PAIN IN EXTREMITY (arm was sore when raised above head), CHILLS (shivering uncontrollably), PYREXIA (temperature of 104 degrees, then 101 degrees, then 99.8 degrees, then 100 degrees Fahrenheit) and TENDERNESS (arm is slightly tender) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FEELING ABNORMAL (felt the vaccine going into her arm) and PAIN IN EXTREMITY (arm was sore when raised above head). On 27-Feb-2021, the patient experienced CHILLS (shivering uncontrollably) and PYREXIA (temperature of 104 degrees, then 101 degrees, then 99.8 degrees, then 100 degrees Fahrenheit). On 02-Mar-2021, the patient experienced TENDERNESS (arm is slightly tender). At the time of the report, FEELING ABNORMAL (felt the vaccine going into her arm), PAIN IN EXTREMITY (arm was sore when raised above head), CHILLS (shivering uncontrollably), PYREXIA (temperature of 104 degrees, then 101 degrees, then 99.8 degrees, then 100 degrees Fahrenheit) and TENDERNESS (arm is slightly tender) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: a couple of times the head was sweating; the right arm is Swollen as an orange size in diameter; just don't feel good; joints are hurting; thinks it's breaking a fever; head aches; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (a couple of times the head was sweating), PERIPHERAL SWELLING (the right arm is Swollen as an orange size in diameter), MALAISE (just don't feel good), ARTHRALGIA (joints are hurting) and PYREXIA (thinks it's breaking a fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient told that she got COVID in December and was in quarantine 10 days until Dec 28th.) in December 2020. Concurrent medical conditions included Allergy (The patient mentioned a history of allergies(unspecified)).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced HYPERHIDROSIS (a couple of times the head was sweating), PERIPHERAL SWELLING (the right arm is Swollen as an orange size in diameter), MALAISE (just don't feel good), ARTHRALGIA (joints are hurting), PYREXIA (thinks it's breaking a fever), HEADACHE (head aches) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (a couple of times the head was sweating), PERIPHERAL SWELLING (the right arm is Swollen as an orange size in diameter), MALAISE (just don't feel good), ARTHRALGIA (joints are hurting), PYREXIA (thinks it's breaking a fever), HEADACHE (head aches), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: a couple of times the head was sweating; the right arm is Swollen as an orange size in diameter; just don't feel good; joints are hurting; thinks it's breaking a fever; head aches; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (a couple of times the head was sweating), PERIPHERAL SWELLING (the right arm is Swollen as an orange size in diameter), MALAISE (just don't feel good), ARTHRALGIA (joints are hurting) and PYREXIA (thinks it's breaking a fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient told that she got COVID in December and was in quarantine 10 days until Dec 28th.) in December 2020. Concurrent medical conditions included Allergy (The patient mentioned a history of allergies(unspecified)).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced HYPERHIDROSIS (a couple of times the head was sweating), PERIPHERAL SWELLING (the right arm is Swollen as an orange size in diameter), MALAISE (just don't feel good), ARTHRALGIA (joints are hurting), PYREXIA (thinks it's breaking a fever), HEADACHE (head aches) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (a couple of times the head was sweating), PERIPHERAL SWELLING (the right arm is Swollen as an orange size in diameter), MALAISE (just don't feel good), ARTHRALGIA (joints are hurting), PYREXIA (thinks it's breaking a fever), HEADACHE (head aches), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Her close up vision has gotten progressively worse; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (Her close up vision has gotten progressively worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (The patient has myasthenia gravis that just affects her eyes. for treating that disease, she gets infusions every 28 days, and the day before getting the vaccine, she received one.). Concomitant products included FLUTICASONE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Her close up vision has gotten progressively worse). The patient was treated with OMEPRAZOLE at a dose of UNK dosage form and ALPRAZOLAM at a dose of UNK dosage form. At the time of the report, VISUAL IMPAIRMENT (Her close up vision has gotten progressively worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: severe vomiting episodes; severe stomach cramping and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (severe vomiting episodes) and ABDOMINAL PAIN UPPER (severe stomach cramping and pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VOMITING (severe vomiting episodes) and ABDOMINAL PAIN UPPER (severe stomach cramping and pains). On 01-Mar-2021, VOMITING (severe vomiting episodes) and ABDOMINAL PAIN UPPER (severe stomach cramping and pains) had resolved.            No concomitant medication reported  No treatment information was provided    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Her arm has a very round circle that is red; Itchy; A little sore; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm has a very round circle that is red), PRURITUS (Itchy), PAIN (A little sore) and SWELLING (Swollen) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Her arm has a very round circle that is red), PRURITUS (Itchy), PAIN (A little sore) and SWELLING (Swollen). At the time of the report, ERYTHEMA (Her arm has a very round circle that is red), PRURITUS (Itchy), PAIN (A little sore) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: didn't get good sleep last night; tired; lethargic; loose bowel movements; hot; sweating; restless at night; mild headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), DIARRHOEA (loose bowel movements), FEELING HOT (hot) and HYPERHIDROSIS (sweating) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Type 2 diabetes mellitus and Heart disease, unspecified. Concomitant products included BEMPEDOIC ACID for Cholesterol, LEVOTHYROXINE, RAMIPRIL, CARVEDILOL, AMLODIPINE, AMIODARONE, WARFARIN, METFORMIN, INSULIN DEGLUDEC (TRESIBA), NITROGLYCERIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Feb-2021, the patient experienced HEADACHE (mild headache). On 01-Mar-2021, the patient experienced LETHARGY (lethargic), DIARRHOEA (loose bowel movements), FEELING HOT (hot), HYPERHIDROSIS (sweating) and POOR QUALITY SLEEP (restless at night). On 02-Mar-2021, the patient experienced SLEEP DISORDER (didn't get good sleep last night) and FATIGUE (tired). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 02-Mar-2021, DIARRHOEA (loose bowel movements), FEELING HOT (hot), HYPERHIDROSIS (sweating), POOR QUALITY SLEEP (restless at night) and HEADACHE (mild headache) had resolved. At the time of the report, LETHARGY (lethargic), SLEEP DISORDER (didn't get good sleep last night) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Significant followup received on 01-MAY-2021. Reporter information, Patient demographical information, relevant medical history and 2nd dose of vaccine information were updated. On 13-Jul-2021: Follow up received on 13-JUL-2021.and contain no new information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Poor quality sleep, Sleep disorder
Clinical narrative: didn't get good sleep last night; tired; lethargic; loose bowel movements; hot; sweating; restless at night; mild headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), DIARRHOEA (loose bowel movements), FEELING HOT (hot) and HYPERHIDROSIS (sweating) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Type 2 diabetes mellitus and Heart disease, unspecified. Concomitant products included BEMPEDOIC ACID for Cholesterol, LEVOTHYROXINE, RAMIPRIL, CARVEDILOL, AMLODIPINE, AMIODARONE, WARFARIN, METFORMIN, INSULIN DEGLUDEC (TRESIBA), NITROGLYCERIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Feb-2021, the patient experienced HEADACHE (mild headache). On 01-Mar-2021, the patient experienced LETHARGY (lethargic), DIARRHOEA (loose bowel movements), FEELING HOT (hot), HYPERHIDROSIS (sweating) and POOR QUALITY SLEEP (restless at night). On 02-Mar-2021, the patient experienced SLEEP DISORDER (didn't get good sleep last night) and FATIGUE (tired). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 02-Mar-2021, DIARRHOEA (loose bowel movements), FEELING HOT (hot), HYPERHIDROSIS (sweating), POOR QUALITY SLEEP (restless at night) and HEADACHE (mild headache) had resolved. At the time of the report, LETHARGY (lethargic), SLEEP DISORDER (didn't get good sleep last night) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Significant followup received on 01-MAY-2021. Reporter information, Patient demographical information, relevant medical history and 2nd dose of vaccine information were updated. On 13-Jul-2021: Follow up received on 13-JUL-2021.and contain no new information.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Patient had a gout attack in his right foot; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Patient had a gout attack in his right foot) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout (had gout 6 months ago).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced GOUT (Patient had a gout attack in his right foot). At the time of the report, GOUT (Patient had a gout attack in his right foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment was reported as unspecified gout medicine.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event outcome updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives on her neck; red all over"; Itching all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her neck), ERYTHEMA (red all over") and PRURITUS (Itching all over) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives on her neck), ERYTHEMA (red all over") and PRURITUS (Itching all over). At the time of the report, URTICARIA (Hives on her neck), ERYTHEMA (red all over") and PRURITUS (Itching all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had a vaccine that was applied earlier than the 28 days mark; A spontaneous report was received from a consumer concerning an unspecified-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced second vaccine applied earlier than 28 days after the first one.  The patient's medical history was not provided by the reporter.  No relevant concomitant medications were reported.  On an unspecified date, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient received second vaccine applied earlier than 28 days after the first one.  Lab details was not provided.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, second vaccine applied earlier than 28 days after the first one was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown with no associated AEs.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: red rash; itchiness; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), RASH ERYTHEMATOUS (red rash) and PRURITUS (itchiness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and PRURITUS (itchiness). On 01-Mar-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash) and PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl. Concomitant medication details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site erythema, Tenderness, Vaccination site reaction, Vaccination site swelling
Clinical narrative: difficulty breathing; feeling under the weather and arm was sore; arm was tender, tough to the touch, and hot to the touch; injection site was red/purple; size of a palm; arm swelled up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), TENDERNESS (feeling under the weather and arm was sore), VACCINATION SITE REACTION (arm was tender, tough to the touch, and hot to the touch), VACCINATION SITE SWELLING (arm swelled up) and INJECTION SITE ERYTHEMA (injection site was red/purple; size of a palm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included PARACETAMOL (TYLENOL) for Migraine.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm swelled up). On 06-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site was red/purple; size of a palm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), TENDERNESS (feeling under the weather and arm was sore) and VACCINATION SITE REACTION (arm was tender, tough to the touch, and hot to the touch). On 23-Feb-2021, VACCINATION SITE SWELLING (arm swelled up) had resolved. At the time of the report, DYSPNOEA (difficulty breathing), TENDERNESS (feeling under the weather and arm was sore), VACCINATION SITE REACTION (arm was tender, tough to the touch, and hot to the touch) and INJECTION SITE ERYTHEMA (injection site was red/purple; size of a palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information provided   This case was linked to MOD-2021-030077, MOD-2021-032239, MOD-2021-032129, MOD-2021-032177 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dental paraesthesia, Hypoaesthesia, Paraesthesia oral
Clinical narrative: left side of the face felt numb; teeth tingling; mouth tingling; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (left side of the face felt numb), DENTAL PARAESTHESIA (teeth tingling) and PARAESTHESIA ORAL (mouth tingling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HYPOAESTHESIA (left side of the face felt numb), DENTAL PARAESTHESIA (teeth tingling) and PARAESTHESIA ORAL (mouth tingling). On 26-Feb-2021, HYPOAESTHESIA (left side of the face felt numb), DENTAL PARAESTHESIA (teeth tingling) and PARAESTHESIA ORAL (mouth tingling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: woke up with dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woke up with dizziness) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (woke up with dizziness). At the time of the report, DIZZINESS (woke up with dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: developed shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (developed shortness of breath) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Type 2 diabetes mellitus, Congestive heart failure, Pacemaker insertion (cardiac), Hypertension, Rheumatoid arthritis, Allergy (cortisone allergy) and Allergy (morphine allergy).    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 DYSPNOEA (developed shortness of breath). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (developed shortness of breath) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment was reported as restarted home oxygen and albuterol inhaler and experienced continued shortness of breath. Emergency Medical Services called and evaluated patient. Vitals were stable, no Benadryl or epinephrine were administered. Patient was not transported to the emergency room.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: NO new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Itchy; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and SWELLING (Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D43L20A) 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) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Itchy) and SWELLING (Swollen). At the time of the report, PRURITUS (Itchy) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and SWELLING (Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D43L20A) 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) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Itchy) and SWELLING (Swollen). At the time of the report, PRURITUS (Itchy) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site rash
Clinical narrative: rash at the site; a little bit of headache; arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash at the site) and HEADACHE (a little bit of headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011CZ0A and 006MZ0A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (a little bit of headache). On 30-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the site). At the time of the report, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash at the site) and HEADACHE (a little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided for first dose events   This case was linked to MOD-2021-057119.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Additional Information received and patient demographics updated
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Hot flush, Illness
Clinical narrative: Sickness; Hot flashes; Nausea; Dizziness; Diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On 10-Feb-2021, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On 10-Feb-2021, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Sickness; Hot flashes; Nausea; Dizziness; Diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On 10-Feb-2021, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On 10-Feb-2021, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Erythema, Feeling hot, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red) and INJECTION SITE PAIN (tender to the touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch) and INJECTION SITE SWELLING (swollen). On an unknown date, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch), INJECTION SITE SWELLING (swollen), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) 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 concomitant medication reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red) and INJECTION SITE PAIN (tender to the touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch) and INJECTION SITE SWELLING (swollen). On an unknown date, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch), INJECTION SITE SWELLING (swollen), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) 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 concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose over 59 days after first one; A spontaneous report, was received from a pharmacist, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and had second dose over 59 days after first one (inappropriate schedule of product administration).   The patient's medical history was not provided. Concomitant medications were not reported.     On 31 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The patient received the first Moderna vaccine on 31 Dec 2020 and didn't get rescheduled for her second dose. Its been 59 or 60 days since the first dose was given to the patient. Treatment information was not provided.    Action taken with second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, second dose over 59 days after first one was considered as recovered.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain
Clinical narrative: Neck Pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain) and FATIGUE (Tiredness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck Pain) and FATIGUE (Tiredness). At the time of the report, NECK PAIN (Neck Pain) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-086154 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021 updated event outcome to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received an incorrectly stored vaccine; A spontaneous report was received from a consumer concerning herself, 70 years old, female patient who received an incorrectly stored vaccine/Product storage error.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received the first of two planned doses of mRNA-1273 (Batch number: 025A21A) on 1 Mar 2021 at unknown injection site for prophylaxis of COVID-19 infection.    The patient received an incorrectly stored vaccine first Moderna vaccine 1 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event received an incorrectly stored vaccine was not reported.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 025A21A  with no associated AEs.; Sender's Comments:  MOD21-041814:Crosslinked same reporter MOD21-041815:Crosslinked same reporter
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety since 2006. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Aug-2020 and the estimated date of delivery was 11-May-2021. On 26-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The cesarean delivery occurred on 06-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 2325 grams (5lbs 2oz). The outcome was reported as Delivered NOS. length-46.99 cm. On 26-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Ultrasound antenatal screen normal: normal (normal) normal. On an unknown date, Pregnancy test: positive (Positive) posiive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided   This case was linked to MOD-2021-265749.   See case MOD-2021-265749 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant follow up: Pregnancy information has updated. Medical history added: Anxiety