chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Hot and cold; Swelling in abdomen; Swelling in her abdomen, ankles, and feet; Swelling in her abdomen, ankles, and feet; Exhaustion; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ABDOMINAL DISTENSION (Swelling in abdomen), JOINT SWELLING (Swelling in her abdomen, ankles, and feet), PERIPHERAL SWELLING (Swelling in her abdomen, ankles, and feet) and FATIGUE (Exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension and Thyroid disorder NOS.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ABDOMINAL DISTENSION (Swelling in abdomen), JOINT SWELLING (Swelling in her abdomen, ankles, and feet), PERIPHERAL SWELLING (Swelling in her abdomen, ankles, and feet), FATIGUE (Exhaustion) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ABDOMINAL DISTENSION (Swelling in abdomen), JOINT SWELLING (Swelling in her abdomen, ankles, and feet), PERIPHERAL SWELLING (Swelling in her abdomen, ankles, and feet), FATIGUE (Exhaustion) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included diabetes medication,blood pressure medication and thyroid medication (dose recently increased). No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Musculoskeletal stiffness, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Shoulder got tight; Shoulder got swollen; Where he got the injection is warm; Where he got the injection is itchy; Red dot where he got the injection; Where he got the injection that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy) and VACCINATION SITE ERYTHEMA (Red dot where he got the injection) in a male patient of an unknown age 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy), VACCINATION SITE ERYTHEMA (Red dot where he got the injection) and VACCINATION SITE SWELLING (Where he got the injection that is swollen). At the time of the report, MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy), VACCINATION SITE ERYTHEMA (Red dot where he got the injection) and VACCINATION SITE SWELLING (Where he got the injection that is swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment included ice.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Shoulder got tight; Shoulder got swollen; Where he got the injection is warm; Where he got the injection is itchy; Red dot where he got the injection; Where he got the injection that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy) and VACCINATION SITE ERYTHEMA (Red dot where he got the injection) in a male patient of an unknown age 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy), VACCINATION SITE ERYTHEMA (Red dot where he got the injection) and VACCINATION SITE SWELLING (Where he got the injection that is swollen). At the time of the report, MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy), VACCINATION SITE ERYTHEMA (Red dot where he got the injection) and VACCINATION SITE SWELLING (Where he got the injection that is swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment included ice.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some of the vaccine leaked while administering; Syringe connection issue; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Some of the vaccine leaked while administering) and DEVICE CONNECTION ISSUE (Syringe connection issue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced UNDERDOSE (Some of the vaccine leaked while administering) and DEVICE CONNECTION ISSUE (Syringe connection issue). On 31-Mar-2021, UNDERDOSE (Some of the vaccine leaked while administering) and DEVICE CONNECTION ISSUE (Syringe connection issue) had resolved. Not Provided      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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Nightmare
Clinical narrative: nightmare; insomnia; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmare), INSOMNIA (insomnia) and ARTHRALGIA (joint pain) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHTMARE (nightmare), INSOMNIA (insomnia) and ARTHRALGIA (joint pain). At the time of the report, NIGHTMARE (nightmare), INSOMNIA (insomnia) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-135246, MOD-2021-135246 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Action taken was updated to unknown as the events were related to the first dose of the vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain, Vaccination site rash
Clinical narrative: Pain in Arm; painful headache; fatigued; swelling; rash; pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain), the first episode of VACCINATION SITE SWELLING (swelling), the second episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (pain) and the first episode of VACCINATION SITE SWELLING (swelling). On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (rash). On an unknown date, the patient experienced the second episode of VACCINATION SITE SWELLING (swelling). On 27-Feb-2021, VACCINATION SITE PAIN (pain) had resolved. At the time of the report, VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain), the first episode of VACCINATION SITE SWELLING (swelling), the second episode of VACCINATION SITE SWELLING (swelling), VACCINATION SITE RASH (rash) and PAIN IN EXTREMITY (Pain in Arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain) and the first episode of VACCINATION SITE SWELLING (swelling). On 04-Mar-2021, the patient experienced the second episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in Arm), HEADACHE (painful headache) and FATIGUE (fatigued). On 27-Feb-2021, VACCINATION SITE PAIN (pain) had resolved. On 26-Mar-2021, PAIN IN EXTREMITY (Pain in Arm) had resolved. At the time of the report, last episode of VACCINATION SITE SWELLING (swelling), VACCINATION SITE RASH (rash), HEADACHE (painful headache) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment Received
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Pain in Arm; painful headache; fatigued; swelling; rash; pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain), the first episode of VACCINATION SITE SWELLING (swelling), the second episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (pain) and the first episode of VACCINATION SITE SWELLING (swelling). On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (rash). On an unknown date, the patient experienced the second episode of VACCINATION SITE SWELLING (swelling). On 27-Feb-2021, VACCINATION SITE PAIN (pain) had resolved. At the time of the report, VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain), the first episode of VACCINATION SITE SWELLING (swelling), the second episode of VACCINATION SITE SWELLING (swelling), VACCINATION SITE RASH (rash) and PAIN IN EXTREMITY (Pain in Arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain) and the first episode of VACCINATION SITE SWELLING (swelling). On 04-Mar-2021, the patient experienced the second episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in Arm), HEADACHE (painful headache) and FATIGUE (fatigued). On 27-Feb-2021, VACCINATION SITE PAIN (pain) had resolved. On 26-Mar-2021, PAIN IN EXTREMITY (Pain in Arm) had resolved. At the time of the report, last episode of VACCINATION SITE SWELLING (swelling), VACCINATION SITE RASH (rash), HEADACHE (painful headache) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment Received
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Urticaria
Clinical narrative: It started hurting and it was a litlte red; It is red; Hot to the touch; Itchy with a rash like hives; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It started hurting and it was a litlte red), ERYTHEMA (It is red), FEELING HOT (Hot to the touch), URTICARIA (Itchy with a rash like hives) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concomitant products included DIGOXIN (DOGOXINE) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (It started hurting and it was a litlte red), ERYTHEMA (It is red), FEELING HOT (Hot to the touch), URTICARIA (Itchy with a rash like hives) and PRURITUS (Itchy). The patient was treated with ALCOHOL at an unspecified dose and frequency. At the time of the report, PAIN (It started hurting and it was a litlte red), ERYTHEMA (It is red), FEELING HOT (Hot to the touch), URTICARIA (Itchy with a rash like hives) and PRURITUS (Itchy) had resolved.            Concomitant products also included blood thinners. Treatment medication included cold water application. She also treated it with rubbing alcohol compress a few times a day. The symptoms lasted 5-6 days and then went away.   This case was linked to US-MODERNATX, INC.-MOD-2021-064215 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Live follow up was received on 13-May-2021 and updated event onset date and event outcome, added event, and treatment.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064215:Case for first dose
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 31-May-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Internal review on 26-Jul-2021 resulted in updates to the pregnancy information. On 15-Jul-2021: Follow up received on included no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, Vaccination site swelling, Vertigo
Clinical narrative: Feverish; Vaccination site swelling; Arm was slightly sore; The room was spinning; His eyes were very slow at focusing; Felt crappy; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was slightly sore), VERTIGO (The room was spinning), VISION BLURRED (His eyes were very slow at focusing), MALAISE (Felt crappy) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 30-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was slightly sore), VERTIGO (The room was spinning), VISION BLURRED (His eyes were very slow at focusing) and MALAISE (Felt crappy). On 31-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On 31-Mar-2021 at 6:30 AM, the patient experienced PYREXIA (Feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (Arm was slightly sore), VERTIGO (The room was spinning), VISION BLURRED (His eyes were very slow at focusing), MALAISE (Felt crappy), VACCINATION SITE SWELLING (Vaccination site swelling) and PYREXIA (Feverish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-064216 (E2B Linked Report).; Sender's Comments:  MOD-2021-064216:1st dose case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Feverish; Vaccination site swelling; Arm was slightly sore; The room was spinning; His eyes were very slow at focusing; Felt crappy; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was slightly sore), VERTIGO (The room was spinning), VISION BLURRED (His eyes were very slow at focusing), MALAISE (Felt crappy) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 30-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was slightly sore), VERTIGO (The room was spinning), VISION BLURRED (His eyes were very slow at focusing) and MALAISE (Felt crappy). On 31-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On 31-Mar-2021 at 6:30 AM, the patient experienced PYREXIA (Feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (Arm was slightly sore), VERTIGO (The room was spinning), VISION BLURRED (His eyes were very slow at focusing), MALAISE (Felt crappy), VACCINATION SITE SWELLING (Vaccination site swelling) and PYREXIA (Feverish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-064216 (E2B Linked Report).; Sender's Comments:  MOD-2021-064216:1st dose case
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash erythematous, Rash macular, Swelling, Swelling face
Clinical narrative: 2 little brown spots; red rash on top of the swollen part under the left eye; a swelling started on her right side of her face; her whole head felt hot; she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (a swelling started on her right side of her face), FEELING HOT (her whole head felt hot), SWELLING (she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye), RASH ERYTHEMATOUS (red rash on top of the swollen part under the left eye) and RASH MACULAR (2 little brown spots) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 041C20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, VITAMIN D3, CELECOXIB, LISINOPRIL and SIMVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING (she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye). On 26-Mar-2021, the patient experienced SWELLING FACE (a swelling started on her right side of her face), FEELING HOT (her whole head felt hot) and RASH ERYTHEMATOUS (red rash on top of the swollen part under the left eye). On an unknown date, the patient experienced RASH MACULAR (2 little brown spots). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash, Facial swelling and Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (a swelling started on her right side of her face), FEELING HOT (her whole head felt hot), RASH ERYTHEMATOUS (red rash on top of the swollen part under the left eye) and RASH MACULAR (2 little brown spots) had resolved and SWELLING (she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye) had not resolved.            Treatment information include allergy OTC medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Except of event swelling all other events outcome updated to resolved. On 29-Jun-2021: No new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling in her left upper arm at the injection site; Pain and swelling in her left upper arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Pain and swelling in her left upper arm at the injection site) and VACCINATION SITE PAIN (Pain and swelling in her left upper arm at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included FUROSEMIDE and LISINOPRIL for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Pain and swelling in her left upper arm at the injection site) and VACCINATION SITE PAIN (Pain and swelling in her left upper arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Pain and swelling in her left upper arm at the injection site) and VACCINATION SITE PAIN (Pain and swelling in her left upper arm at the injection site) outcome was unknown.            Relevant concomitant medications also included cholesterol pills (she did not provide name). Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Formication, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: tingling in the arms; Cold feet; Pain in the legs; Numbness in the arms; Feeling that something is walking on the leg; Fatigue; Pain in her body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the arms), PERIPHERAL COLDNESS (Cold feet), PAIN IN EXTREMITY (Pain in the legs), HYPOAESTHESIA (Numbness in the arms) and FORMICATION (Feeling that something is walking on the leg) in a female patient of an unknown age 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 Fibromyalgia in December 2020.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PARAESTHESIA (tingling in the arms), PERIPHERAL COLDNESS (Cold feet), PAIN IN EXTREMITY (Pain in the legs), HYPOAESTHESIA (Numbness in the arms), FORMICATION (Feeling that something is walking on the leg), FATIGUE (Fatigue) and MYALGIA (Pain in her body). At the time of the report, PARAESTHESIA (tingling in the arms), PERIPHERAL COLDNESS (Cold feet), PAIN IN EXTREMITY (Pain in the legs), HYPOAESTHESIA (Numbness in the arms), FORMICATION (Feeling that something is walking on the leg), FATIGUE (Fatigue) and MYALGIA (Pain in her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: tingling in the arms; Cold feet; Pain in the legs; Numbness in the arms; Feeling that something is walking on the leg; Fatigue; Pain in her body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the arms), PERIPHERAL COLDNESS (Cold feet), PAIN IN EXTREMITY (Pain in the legs), HYPOAESTHESIA (Numbness in the arms) and FORMICATION (Feeling that something is walking on the leg) in a female patient of an unknown age 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 Fibromyalgia in December 2020.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PARAESTHESIA (tingling in the arms), PERIPHERAL COLDNESS (Cold feet), PAIN IN EXTREMITY (Pain in the legs), HYPOAESTHESIA (Numbness in the arms), FORMICATION (Feeling that something is walking on the leg), FATIGUE (Fatigue) and MYALGIA (Pain in her body). At the time of the report, PARAESTHESIA (tingling in the arms), PERIPHERAL COLDNESS (Cold feet), PAIN IN EXTREMITY (Pain in the legs), HYPOAESTHESIA (Numbness in the arms), FORMICATION (Feeling that something is walking on the leg), FATIGUE (Fatigue) and MYALGIA (Pain in her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A little itch after first dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AQ1A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (A little itch after first dose). At the time of the report, PRURITUS (A little itch after first dose) outcome was unknown. Not Provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitants were not provided. Treatments were not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-064273 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-064273:Crosslinked case dose 2.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 29-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 29-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  The patient's estimated date of conception was 10-Dec-2020.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: ADR and consent form
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Illness, Rash, Vaccination site pruritus
Clinical narrative: got really sick; Bronchitis; rash around and under her arms; itching around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), ILLNESS (got really sick), RASH (rash around and under her arms) and VACCINATION SITE PRURITUS (itching around the site of injection) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced RASH (rash around and under her arms) and VACCINATION SITE PRURITUS (itching around the site of injection). On 27-Jan-2021, the patient experienced BRONCHITIS (Bronchitis). On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, BRONCHITIS (Bronchitis), ILLNESS (got really sick), RASH (rash around and under her arms) and VACCINATION SITE PRURITUS (itching around the site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.   But for the event of Intentional Product Issue there  were no reported AE's noted.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Little soreness). At the time of the report, PAIN IN EXTREMITY (Little soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications also included high blood pressure medication and cholesterol medication. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-066997 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066997:Second dose
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: Body ache; fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM); Headache; Chills; Nausea; Sore arm (injection site); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body ache), PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body ache), PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm (injection site)). On 31-Mar-2021, PAIN (Body ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm (injection site)) had resolved. At the time of the report, PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (High) Temperature taken at 4:00 PM - 99.4F and 100.8 (High) Temperature taken at 5:00 PM - 100.8 F.     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. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-064232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064232:Case created for events after first dose of Moderna Vaccine
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Body ache; fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM); Headache; Chills; Nausea; Sore arm (injection site); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body ache), PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body ache), PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm (injection site)). On 31-Mar-2021, PAIN (Body ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm (injection site)) had resolved. At the time of the report, PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (High) Temperature taken at 4:00 PM - 99.4F and 100.8 (High) Temperature taken at 5:00 PM - 100.8 F.     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. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-064232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064232:Case created for events after first dose of Moderna Vaccine
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Thirst
Clinical narrative: Extreme thirst; Migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Extreme thirst) and MIGRAINE (Migraine headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date. Concomitant products included KETOROLAC TROMETHAMINE (TORADOL) for Migraine.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced THIRST (Extreme thirst) and MIGRAINE (Migraine headache). On 30-Mar-2021, THIRST (Extreme thirst) had resolved. At the time of the report, MIGRAINE (Migraine headache) outcome was unknown.            No treatment medication was provided for the events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash itches; Rash on her torso (below her breast, stomach, and all over back); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her torso (below her breast, stomach, and all over back)) and RASH PRURITIC (Rash itches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Rash on her torso (below her breast, stomach, and all over back)) and RASH PRURITIC (Rash itches). At the time of the report, RASH (Rash on her torso (below her breast, stomach, and all over back)) and RASH PRURITIC (Rash itches) outcome was unknown. Not Provided          Concomitants were not provided.  Treatments were not provided.   This case was linked to MOD21-066731 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-066731:Link to Dose 1 with argus ID MOD-2021-064265
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema
Clinical narrative: Rash and itching near the shot; Red; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash and itching near the shot) and VACCINATION SITE ERYTHEMA (Red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and AMLODIPINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced RASH PRURITIC (Rash and itching near the shot) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, RASH PRURITIC (Rash and itching near the shot) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07-Jul-2021 contains Non significant information of updated contact details
Sex: M
Vaccine: COVID19
Symptoms: Infection, Pyrexia, White blood cell count, White blood cell count increased
Clinical narrative: Wife reports her husband developed an infection like 19 days after receiving the vaccine; high white blood count; Fevers; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Wife reports her husband developed an infection like 19 days after receiving the vaccine), WHITE BLOOD CELL COUNT INCREASED (high white blood count) and PYREXIA (Fevers) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Quadriplegic infantile cerebral palsy (for 8 years).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INFECTION (Wife reports her husband developed an infection like 19 days after receiving the vaccine), WHITE BLOOD CELL COUNT INCREASED (high white blood count) and PYREXIA (Fevers). At the time of the report, INFECTION (Wife reports her husband developed an infection like 19 days after receiving the vaccine), WHITE BLOOD CELL COUNT INCREASED (high white blood count) and PYREXIA (Fevers) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, White blood cell count: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The 2nd dose is scheduled to take place tomorrow.She reports that he was on antibiotics his doctor prescribed for him after he got out of the hospital for a month back om the 23JAN2021; and his wife reports that when his first dose was administered to him from the vaccine; that was the last day that he took the antibiotics. He was on antibiotics at the home. She said that he hasn't been on any antibiotics since 01MAR2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vertigo
Clinical narrative: weakness in the right arm; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in the right arm) and VERTIGO (vertigo) in a 71-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 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 ASTHENIA (weakness in the right arm) and VERTIGO (vertigo). At the time of the report, ASTHENIA (weakness in the right arm) outcome was unknown and VERTIGO (vertigo) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-064977 (E2B Linked Report).; Sender's Comments:  MOD21-064977:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Contusion, Insomnia, Lethargy, Neck pain
Clinical narrative: 2 bruises on the arm which showed a round thing; Body was lethargic; Kept misplacing her things; Couldn't sleep for 3days/2nights; Neck pain but was just a little bit now; Swollen tongue; Raw mouth; Throat burning; Gums were peeling; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (2 bruises on the arm which showed a round thing), STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling) and LETHARGY (Body was lethargic) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling) and SWOLLEN TONGUE (Swollen tongue). On an unknown date, the patient experienced CONTUSION (2 bruises on the arm which showed a round thing), LETHARGY (Body was lethargic), AMNESIA (Kept misplacing her things), INSOMNIA (Couldn't sleep for 3days/2nights) and NECK PAIN (Neck pain but was just a little bit now). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (2 bruises on the arm which showed a round thing), STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling), LETHARGY (Body was lethargic), AMNESIA (Kept misplacing her things), INSOMNIA (Couldn't sleep for 3days/2nights), NECK PAIN (Neck pain but was just a little bit now) and SWOLLEN TONGUE (Swollen tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.