chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nerve damage, Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: hurt around the injection site; Injection site was red and puffed up; Injection site was red and puffed up; site remains hot; muscle is still tender when she moves it; She thinks they might have hit a nerve with the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up), VACCINATION SITE SWELLING (Injection site was red and puffed up), VACCINATION SITE WARMTH (site remains hot) and MYALGIA (muscle is still tender when she moves it) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up), VACCINATION SITE SWELLING (Injection site was red and puffed up), VACCINATION SITE WARMTH (site remains hot), MYALGIA (muscle is still tender when she moves it) and INJECTION SITE NERVE DAMAGE (She thinks they might have hit a nerve with the injection). On 24-Feb-2021, VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up) and VACCINATION SITE SWELLING (Injection site was red and puffed up) had resolved. At the time of the report, VACCINATION SITE WARMTH (site remains hot), MYALGIA (muscle is still tender when she moves it) and INJECTION SITE NERVE DAMAGE (She thinks they might have hit a nerve with the injection) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: hurt around the injection site; Injection site was red and puffed up; Injection site was red and puffed up; site remains hot; muscle is still tender when she moves it; She thinks they might have hit a nerve with the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up), VACCINATION SITE SWELLING (Injection site was red and puffed up), VACCINATION SITE WARMTH (site remains hot) and MYALGIA (muscle is still tender when she moves it) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up), VACCINATION SITE SWELLING (Injection site was red and puffed up), VACCINATION SITE WARMTH (site remains hot), MYALGIA (muscle is still tender when she moves it) and INJECTION SITE NERVE DAMAGE (She thinks they might have hit a nerve with the injection). On 24-Feb-2021, VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up) and VACCINATION SITE SWELLING (Injection site was red and puffed up) had resolved. At the time of the report, VACCINATION SITE WARMTH (site remains hot), MYALGIA (muscle is still tender when she moves it) and INJECTION SITE NERVE DAMAGE (She thinks they might have hit a nerve with the injection) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced COVID-19 (COVID positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID positive) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired as heck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired as heck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in jaw. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Pain in jaw.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt tired as heck). At the time of the report, FATIGUE (Felt tired as heck) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-044328 (E2B Linked Report).; Sender's Comments:  MOD21-044328:Crosslinked
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: thrown up; fever; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VOMITING (thrown up), PYREXIA (fever) and CHILLS (chills) 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 26-Feb-2021, the patient experienced VOMITING (thrown up), PYREXIA (fever) and CHILLS (chills). At the time of the report, VOMITING (thrown up), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Asthenia, Blood glucose increased, Confusional state, Decreased appetite
Clinical narrative: Had no mobility; Fell to the floor; Very weak; Little confused; No apetite; High blood sugar; Agitated; Restless; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused) and DECREASED APPETITE (No apetite) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL (ZESTRIL), METFORMIN HYDROCHLORIDE (METFORMIN ER), GLIMEPIRIDE (AMARYL), GABAPENTIN 100MG (GABARONE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LEUPROLIDE [LEUPRORELIN], ENZALUTAMIDE (XTANDI), ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused), DECREASED APPETITE (No apetite), BLOOD GLUCOSE INCREASED (High blood sugar), AGITATION (Agitated) and RESTLESSNESS (Restless). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused), DECREASED APPETITE (No apetite), BLOOD GLUCOSE INCREASED (High blood sugar), AGITATION (Agitated), RESTLESSNESS (Restless) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included hot and cold compresses.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Mobility decreased, Restlessness, Vaccination site pain
Clinical narrative: Had no mobility; Fell to the floor; Very weak; Little confused; No apetite; High blood sugar; Agitated; Restless; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused) and DECREASED APPETITE (No apetite) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL (ZESTRIL), METFORMIN HYDROCHLORIDE (METFORMIN ER), GLIMEPIRIDE (AMARYL), GABAPENTIN 100MG (GABARONE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LEUPROLIDE [LEUPRORELIN], ENZALUTAMIDE (XTANDI), ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused), DECREASED APPETITE (No apetite), BLOOD GLUCOSE INCREASED (High blood sugar), AGITATION (Agitated) and RESTLESSNESS (Restless). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused), DECREASED APPETITE (No apetite), BLOOD GLUCOSE INCREASED (High blood sugar), AGITATION (Agitated), RESTLESSNESS (Restless) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included hot and cold compresses.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: lightheaded; Hypertension; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (lightheaded) and HYPERTENSION (Hypertension) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension aggravated since an unknown date. Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021 at 4:27 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021 at 4:34 PM, the patient experienced DIZZINESS (lightheaded) and HYPERTENSION (Hypertension). On 27-Feb-2021, DIZZINESS (lightheaded) had resolved. At the time of the report, HYPERTENSION (Hypertension) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood pressure measurement (120-80 mmHg): 189/120 mmHg (High) 10 minutes later 180/90 and after sometime 175/80..     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 10-May-2021: The follow-up document received were patient initials, dosage information, age, race, allergies, concomitant medication and event stop date was updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia, Tendon discomfort
Clinical narrative: Right Achilles Tendon began to hurt badly; Low dull headache; Malaise; Fevers; Felt "achy"; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Low dull headache), MALAISE (Malaise), PYREXIA (Fevers), PAIN (Felt "achy") and TENDON DISCOMFORT (Right Achilles Tendon began to hurt badly) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was reported  by the reporter.  Concomitant products included DISULFIRAM, RIFAMPIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 25-Feb-2021, the patient experienced HEADACHE (Low dull headache), MALAISE (Malaise), PYREXIA (Fevers) and PAIN (Felt "achy"). On 26-Feb-2021, the patient experienced TENDON DISCOMFORT (Right Achilles Tendon began to hurt badly). On 03-Mar-2021, TENDON DISCOMFORT (Right Achilles Tendon began to hurt badly) had resolved. At the time of the report, HEADACHE (Low dull headache), MALAISE (Malaise), PYREXIA (Fevers) and PAIN (Felt "achy") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: A big rash at the injection site about 3-inches in diameter; A little itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (A big rash at the injection site about 3-inches in diameter) and INJECTION SITE PRURITUS (A little itchy) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE RASH (A big rash at the injection site about 3-inches in diameter) and INJECTION SITE PRURITUS (A little itchy). At the time of the report, INJECTION SITE RASH (A big rash at the injection site about 3-inches in diameter) and INJECTION SITE PRURITUS (A little itchy) outcome was unknown.        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.   No relevant concomitant medications were reported.   No treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Progesterone, Ultrasound abdomen
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 28-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039KZ0A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 10-Feb-2019, Abortion (spontaneous abortion) in March 2018 and Alcoholic (once every 3-4 months). Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).   On 06-Jan-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) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Progesterone: low (Low) Low. On an unknown date, Ultrasound abdomen: normal (normal) Normal  (done between the 2 doses).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Low progesterone levels(before vaccine administration). The date of positive pregnancy test was 04-Oct-2020. No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Feeling hot, Pruritus, Skin reaction
Clinical narrative: A big red patch on her upper arm, left arm, near the injection site; Very, very red and itchy; Felt very hot and warm to the touch; Like a skin reaction; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (A big red patch on her upper arm, left arm, near the injection site), PRURITUS (Very, very red and itchy), FEELING HOT (Felt very hot and warm to the touch), SKIN REACTION (Like a skin reaction) and DISCOMFORT (Uncomfortable) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.    Co-suspect product included non-company product cream for an unknown indication.    No medical history is provided and concomitant drugs are provided.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started cream (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (A big red patch on her upper arm, left arm, near the injection site), PRURITUS (Very, very red and itchy), FEELING HOT (Felt very hot and warm to the touch), SKIN REACTION (Like a skin reaction) and DISCOMFORT (Uncomfortable). At the time of the report, ERYTHEMA (A big red patch on her upper arm, left arm, near the injection site), PRURITUS (Very, very red and itchy), FEELING HOT (Felt very hot and warm to the touch), SKIN REACTION (Like a skin reaction) and DISCOMFORT (Uncomfortable) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Additional Information-NNI
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Pain; Body really sore; Super tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MYALGIA (Body really sore) and FATIGUE (Super tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Pain), MYALGIA (Body really sore) and FATIGUE (Super tired). At the time of the report, PAIN (Pain), MYALGIA (Body really sore) and FATIGUE (Super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  Concomitant medications were not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Pyrexia
Clinical narrative: muscle weakness in legs and shoulders; chills; high temperature all night (around 104°F); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in legs and shoulders), CHILLS (chills) and PYREXIA (high temperature all night (around 104°F)) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) 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) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness in legs and shoulders), CHILLS (chills) and PYREXIA (high temperature all night (around 104°F)). On 04-Feb-2021, CHILLS (chills) and PYREXIA (high temperature all night (around 104°F)) had resolved. At the time of the report, MUSCULAR WEAKNESS (muscle weakness in legs and shoulders) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include High blood pressure medication and  Thyroid medication.   This case was linked to MOD-2021-034338 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Minimum fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) outcome was unknown.            No relevant concomitant medications were reported.    No treatment information 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 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Minimum fatigue) outcome was unknown.            No relevant concomitant medications were reported.    No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication
Clinical narrative: some kind of reaction; nausea; 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 NAUSEA (nausea) and ADVERSE REACTION (some kind of reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea) and ADVERSE REACTION (some kind of reaction). At the time of the report, NAUSEA (nausea) and ADVERSE REACTION (some kind of reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Musculoskeletal stiffness
Clinical narrative: Minor ache in bones, mainly in knees and ankle; stiffness in my arm around the shot area; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Minor ache in bones, mainly in knees and ankle) and MUSCULOSKELETAL STIFFNESS (stiffness in my arm around the shot area) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 immunisation.     Concurrent medical conditions included Hypertension, Diabetes and Hyperlipidemia. Concomitant products included AMLODIPINE for Blood pressure abnormal, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, ACETYLSALICYLIC ACID (ASPIRINE), GABAPENTIN, LEVOTHYROXINE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) and DULAGLUTIDE (TRULICITY).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced BONE PAIN (Minor ache in bones, mainly in knees and ankle) and MUSCULOSKELETAL STIFFNESS (stiffness in my arm around the shot area). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, BONE PAIN (Minor ache in bones, mainly in knees and ankle) and MUSCULOSKELETAL STIFFNESS (stiffness in my arm around the shot area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitantly, patient was taking one med agent that could not get it right: 0.5 mg two twice a week.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, Swelling face
Clinical narrative: Hot temperature on the face; Lower lip became puffy; Right side of face became puffy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Hot temperature on the face), LIP SWELLING (Lower lip became puffy) and SWELLING FACE (Right side of face became puffy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 431M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Drug allergy (Diflucan). Concomitant products included PROBIOTIC 10, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Hot temperature on the face), LIP SWELLING (Lower lip became puffy) and SWELLING FACE (Right side of face became puffy). At the time of the report, PYREXIA (Hot temperature on the face) outcome was unknown and LIP SWELLING (Lower lip became puffy) and SWELLING FACE (Right side of face became puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment related information has been reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm was red; amazingly tired; arm hurt so bad; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (amazingly tired), PAIN IN EXTREMITY (arm hurt so bad), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (arm was red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included LEVETIRACETAM (KEPPRA XR), CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), CYANOCOBALAMIN (VITAMIN B12 AAA) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    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 FATIGUE (amazingly tired), PAIN IN EXTREMITY (arm hurt so bad) and VACCINATION SITE PAIN (injection site pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm was red). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. On 01-Mar-2021, VACCINATION SITE PAIN (injection site pain) outcome was unknown. At the time of the report, FATIGUE (amazingly tired), PAIN IN EXTREMITY (arm hurt so bad) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034074 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-034074:same reporter, different patient and event
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Nausea, Pain in extremity, Pruritus
Clinical narrative: Symptoms started last night, around bedtime, been dizzy; Sick to my stomach; Arm is very sore; Back where my ribs are is killing and body is itching me; Nauseas this morning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Symptoms started last night, around bedtime, been dizzy), ILLNESS (Sick to my stomach), PAIN IN EXTREMITY (Arm is very sore), PRURITUS (Back where my ribs are is killing and body is itching me) and NAUSEA (Nauseas this morning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Symptoms started last night, around bedtime, been dizzy), ILLNESS (Sick to my stomach), PAIN IN EXTREMITY (Arm is very sore), PRURITUS (Back where my ribs are is killing and body is itching me) and NAUSEA (Nauseas this morning). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Symptoms started last night, around bedtime, been dizzy), ILLNESS (Sick to my stomach), PAIN IN EXTREMITY (Arm is very sore), PRURITUS (Back where my ribs are is killing and body is itching me) and NAUSEA (Nauseas this morning) 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 relevant concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of erythematous rash (red rash 4 inches across) and pruritic rash (itchy rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007M20A) for COVID-19 immunization. No medical history reported. On Feb 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced erythematous rash (red rash 4 inches across) and pruritic rash (itchy rash). The patient treated with Cortisone at an unspecified dose and frequency. At the time of the report, erythematous rash (red rash 4 inches across) and pruritic rash (itchy rash) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported. Most recent follow-up information incorporated above included: On Jul 21, 2021: Attachment provided. Reporter contact information updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: redness; injection site rash; injection site itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash), VACCINATION SITE PRURITUS (injection site itch) and VACCINATION SITE ERYTHEMA (redness) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE RASH (injection site rash) and VACCINATION SITE PRURITUS (injection site itch). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness). On 01-Feb-2021, VACCINATION SITE RASH (injection site rash) and VACCINATION SITE PRURITUS (injection site itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-033833 (Patient Link).   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia
Clinical narrative: Vaccine exposure during pregnancy; body aches; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Jun-2020 and the estimated date of delivery was 23-Mar-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            Treatment medications were not reported.   This case was linked to MOD-2021-033840 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash after second dose), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site itch) 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 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (injection site rash after second dose), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site itch). At the time of the report, VACCINATION SITE RASH (injection site rash after second dose), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.    Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypertension, Hypoaesthesia, Lip swelling, Pruritus
Clinical narrative: Swelling of the lips; Blood pressure spiked; Half of the face numb; Itching all over; rash all over the body; Metal taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Metal taste), LIP SWELLING (Swelling of the lips), HYPERTENSION (Blood pressure spiked), HYPOAESTHESIA (Half of the face numb) and PRURITUS (Itching all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder since an unknown date. Concomitant products included CARVEDILOL, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CLOPIDOGREL, ATORVASTATIN, ENALAPRIL and FISH OIL for an unknown indication, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DYSGEUSIA (Metal taste). On 27-Feb-2021, the patient experienced LIP SWELLING (Swelling of the lips), HYPERTENSION (Blood pressure spiked), HYPOAESTHESIA (Half of the face numb), PRURITUS (Itching all over) and RASH (rash all over the body). On 26-Feb-2021, DYSGEUSIA (Metal taste) had resolved. On 01-Mar-2021, LIP SWELLING (Swelling of the lips), HYPOAESTHESIA (Half of the face numb) and PRURITUS (Itching all over) had resolved. At the time of the report, HYPERTENSION (Blood pressure spiked) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Swelling of the lips; Blood pressure spiked; Half of the face numb; Itching all over; rash all over the body; Metal taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Metal taste), LIP SWELLING (Swelling of the lips), HYPERTENSION (Blood pressure spiked), HYPOAESTHESIA (Half of the face numb) and PRURITUS (Itching all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder since an unknown date. Concomitant products included CARVEDILOL, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CLOPIDOGREL, ATORVASTATIN, ENALAPRIL and FISH OIL for an unknown indication, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DYSGEUSIA (Metal taste). On 27-Feb-2021, the patient experienced LIP SWELLING (Swelling of the lips), HYPERTENSION (Blood pressure spiked), HYPOAESTHESIA (Half of the face numb), PRURITUS (Itching all over) and RASH (rash all over the body). On 26-Feb-2021, DYSGEUSIA (Metal taste) had resolved. On 01-Mar-2021, LIP SWELLING (Swelling of the lips), HYPOAESTHESIA (Half of the face numb) and PRURITUS (Itching all over) had resolved. At the time of the report, HYPERTENSION (Blood pressure spiked) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Musculoskeletal stiffness, Pain, Peripheral swelling
Clinical narrative: Has not slept; Arm is frozen; Swollen; Pain; Unable to use arm; Pain is terrific; Aching; Shot went too deeply into the muscle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Shot went too deeply into the muscle), INSOMNIA (Has not slept), MUSCULOSKELETAL STIFFNESS (Arm is frozen), PERIPHERAL SWELLING (Swollen) and PAIN (Pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETAMINOPHEN for an unknown indication.   On 03-Mar-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-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Shot went too deeply into the muscle). On an unknown date, the patient experienced INSOMNIA (Has not slept), MUSCULOSKELETAL STIFFNESS (Arm is frozen), PERIPHERAL SWELLING (Swollen), PAIN (Pain), LIMB DISCOMFORT (Unable to use arm), PAIN (Pain is terrific) and PAIN (Aching). On 03-Mar-2021, PRODUCT ADMINISTRATION ERROR (Shot went too deeply into the muscle) had resolved. At the time of the report, INSOMNIA (Has not slept), MUSCULOSKELETAL STIFFNESS (Arm is frozen), PERIPHERAL SWELLING (Swollen), PAIN (Pain), LIMB DISCOMFORT (Unable to use arm), PAIN (Pain is terrific) and PAIN (Aching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-060786 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter contact information updated and verified. Event(Product administration error)updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060786:First dose
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Has not slept; Arm is frozen; Swollen; Pain; Unable to use arm; Pain is terrific; Aching; Shot went too deeply into the muscle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Shot went too deeply into the muscle), INSOMNIA (Has not slept), MUSCULOSKELETAL STIFFNESS (Arm is frozen), PERIPHERAL SWELLING (Swollen) and PAIN (Pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETAMINOPHEN for an unknown indication.   On 03-Mar-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-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Shot went too deeply into the muscle). On an unknown date, the patient experienced INSOMNIA (Has not slept), MUSCULOSKELETAL STIFFNESS (Arm is frozen), PERIPHERAL SWELLING (Swollen), PAIN (Pain), LIMB DISCOMFORT (Unable to use arm), PAIN (Pain is terrific) and PAIN (Aching). On 03-Mar-2021, PRODUCT ADMINISTRATION ERROR (Shot went too deeply into the muscle) had resolved. At the time of the report, INSOMNIA (Has not slept), MUSCULOSKELETAL STIFFNESS (Arm is frozen), PERIPHERAL SWELLING (Swollen), PAIN (Pain), LIMB DISCOMFORT (Unable to use arm), PAIN (Pain is terrific) and PAIN (Aching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-060786 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter contact information updated and verified. Event(Product administration error)updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060786:First dose
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Leaked; Leaked; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Leaked) and UNDERDOSE (Leaked) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M0A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DEVICE CONNECTION ISSUE (Leaked) and UNDERDOSE (Leaked). On 13-Feb-2021, DEVICE CONNECTION ISSUE (Leaked) and UNDERDOSE (Leaked) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment:  This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 012M0A  with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-033788 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Follow up received: Report contained no new information; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 012M0A  with no associated AEs. US-MODERNATX, INC.-MOD-2021-033788: