chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Vomiting
Clinical narrative: "Felt like my heart went out of my chest"; Joint Pain; vomiting; Chills; Fatigue; headache; Muscle pain; arm swollen and itch (Left); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS ("Felt like my heart went out of my chest"), ARTHRALGIA (Joint Pain), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PALPITATIONS ("Felt like my heart went out of my chest"), ARTHRALGIA (Joint Pain), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and INJECTION SITE SWELLING (arm swollen and itch (Left)). At the time of the report, PALPITATIONS ("Felt like my heart went out of my chest"), ARTHRALGIA (Joint Pain), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and INJECTION SITE SWELLING (arm swollen and itch (Left)) 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 concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Non-Significant Follow-up
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: big red circle on injection side; itchy injection side; sore on the injected arm; hurting too bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (big red circle on injection side), VACCINATION SITE PRURITUS (itchy injection side), VACCINATION SITE PAIN (sore on the injected arm) and PAIN IN EXTREMITY (hurting too bad) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for an unknown indication.     The patient's past medical history included No adverse drug reaction.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (big red circle on injection side), VACCINATION SITE PRURITUS (itchy injection side), VACCINATION SITE PAIN (sore on the injected arm) and PAIN IN EXTREMITY (hurting too bad). At the time of the report, VACCINATION SITE ERYTHEMA (big red circle on injection side), VACCINATION SITE PRURITUS (itchy injection side), VACCINATION SITE PAIN (sore on the injected arm) and PAIN IN EXTREMITY (hurting too bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cautery to nose, Epistaxis, Myalgia
Clinical narrative: Muscle soreness; Bleeding; Cauterization on the nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bleeding nose), CAUTERY TO NOSE (Cauterization on the nose), MYALGIA (Muscle soreness) and in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (No recorded medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding) and CAUTERY TO NOSE (Cauterization on the nose). On an unknown date, the patient experienced MYALGIA (Muscle soreness) and ARTHRALGIA (Soreness on the legs and knees). At the time of the report, HAEMORRHAGE (Bleeding), CAUTERY TO NOSE (Cauterization on the nose), MYALGIA (Muscle soreness) and ARTHRALGIA (Soreness on the legs and knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included vaseline saline spray.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: pain in the armpit; swelling in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain in the armpit) and PERIPHERAL SWELLING (swelling in the armpit) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AXILLARY PAIN (pain in the armpit) and PERIPHERAL SWELLING (swelling in the armpit). At the time of the report, AXILLARY PAIN (pain in the armpit) and PERIPHERAL SWELLING (swelling in the armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fatigue; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (Fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MOMETASONE FUROATE (NASONEX), OMEPRAZOLE, METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATENOLOL for an unknown indication.    On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, FATIGUE (fatigue) had resolved and HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            Treatment medication includes Antibiotics
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Vomiting; dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Spike in blood pressure), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swelling of lymph node groin) and PAIN (body ache all over and joint, muscle) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 BLOOD PRESSURE INCREASED (Spike in blood pressure), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swelling of lymph node groin), PAIN (body ache all over and joint, muscle), BLOOD GLUCOSE INCREASED (high glucose), DIZZINESS (dizziness) and HYPOTENSION (hypotension).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: improvement in cognitive function/ improvement in memory function; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (improvement in cognitive function/ improvement in memory function) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improvement in cognitive function/ improvement in memory function). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improvement in cognitive function/ improvement in memory function) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.  Patient received both the doses of Moderna vaccine and almost one week later showed improvement in cognitive function and with memory as well.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Limb discomfort
Clinical narrative: pulling sensation on right arm and right leg; sick; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (pulling sensation on right arm and right leg), ILLNESS (sick), FATIGUE (tired) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 031M20) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (sick), FATIGUE (tired) and HEADACHE (headache). On 27-Mar-2021, the patient experienced LIMB DISCOMFORT (pulling sensation on right arm and right leg). On 28-Mar-2021, LIMB DISCOMFORT (pulling sensation on right arm and right leg), ILLNESS (sick), FATIGUE (tired) and HEADACHE (headache) had resolved.            Concomitant product details was not provided by the reporter. Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Initial Additional-1 document Containing AE information reported for husband; Sender's Comments: 1st dose
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Intentional product use issue, Type IV hypersensitivity reaction, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: she may have had an allergic reaction the shot; Greater than 35 days between Moderna Covid-19 vaccinations; Covid Arm; And it is itchy progressively moving down her arm; she noticed a welt on her at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (she may have had an allergic reaction the shot), TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations), VACCINATION SITE PRURITUS (And it is itchy progressively moving down her arm) and VACCINATION SITE URTICARIA (she noticed a welt on her at the site of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 VACCINATION SITE PRURITUS (And it is itchy progressively moving down her arm) and VACCINATION SITE URTICARIA (she noticed a welt on her at the site of injection). On 29-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid Arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (she may have had an allergic reaction the shot) and INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations). At the time of the report, ALLERGY TO VACCINE (she may have had an allergic reaction the shot), TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), VACCINATION SITE PRURITUS (And it is itchy progressively moving down her arm) and VACCINATION SITE URTICARIA (she noticed a welt on her at the site of injection) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.  Treatment details included Cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains added event - Delayed type hypersensitivity and Intentional deviation from dosage regimen added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pruritus, Vaccination site rash, Vaccination site scar, Vaccination site warmth
Clinical narrative: had a reaction; raised (spot) on her injection site and her chest; itchy (spot) on her injection site and her chest; warm (spot) on her injection site and her chest; spot on her injection site and her chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy (spot) on her injection site and her chest), VACCINATION SITE WARMTH (warm (spot) on her injection site and her chest), VACCINATION SITE SCAR (spot on her injection site and her chest), VACCINATION COMPLICATION (had a reaction) and VACCINATION SITE RASH (raised (spot) on her injection site and her chest) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy (spot) on her injection site and her chest), VACCINATION SITE WARMTH (warm (spot) on her injection site and her chest), VACCINATION SITE SCAR (spot on her injection site and her chest) and VACCINATION SITE RASH (raised (spot) on her injection site and her chest). On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction). At the time of the report, VACCINATION SITE PRURITUS (itchy (spot) on her injection site and her chest), VACCINATION SITE WARMTH (warm (spot) on her injection site and her chest), VACCINATION SITE SCAR (spot on her injection site and her chest), VACCINATION COMPLICATION (had a reaction) and VACCINATION SITE RASH (raised (spot) on her injection site and her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include dexamethasone and ice.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Stress, Tachycardia, Vertigo
Clinical narrative: Stress response from the vaccine; Vertigo; Tachycardia; Dizziness; Weakness; This spontaneous case was reported by a physician and describes the occurrence of TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness), ASTHENIA (Weakness), VERTIGO (Vertigo) and STRESS (Stress response from the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness) and ASTHENIA (Weakness). On 28-Mar-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced STRESS (Stress response from the vaccine). At the time of the report, TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness), ASTHENIA (Weakness), VERTIGO (Vertigo) and STRESS (Stress response from the vaccine) 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.   Products known to have been used by the patient, within two weeks prior to the event, included steroid dose.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on contains non-significant information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Speech disorder, Swollen tongue
Clinical narrative: Tongue was swollen; It even affected her speech; Discomfort in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in arm), SWOLLEN TONGUE (Tongue was swollen) and SPEECH DISORDER (It even affected her speech) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Discomfort in arm). On 28-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue was swollen) and SPEECH DISORDER (It even affected her speech). At the time of the report, LIMB DISCOMFORT (Discomfort in arm), SWOLLEN TONGUE (Tongue was swollen) and SPEECH DISORDER (It even affected her speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. Treatment information included Zyrtec, which softened the effect.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is hurting a little bit; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm is hurting a little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVONORGESTREL (MIRENA) for an unknown indication.    On 25-Mar-2021, the patient received eleventh dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is hurting a little bit). At the time of the report, PAIN IN EXTREMITY (arm is hurting a little bit) 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 treatment information was 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 event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional dose omission, Pruritus, Rash vesicular
Clinical narrative: Didn't get 2nd shot under advice of pharmacist & doctor; itch on my arms; Red blistering rash under both arms and between legs & torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itch on my arms), RASH VESICULAR (Red blistering rash under both arms and between legs & torso) and INTENTIONAL DOSE OMISSION (Didn't get 2nd shot under advice of pharmacist & doctor) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     no specified medical history was reported.  Concurrent medical conditions included Lung cancer since 05-Feb-2020, Diabetes, Blood pressure fluctuation and Prostate cancer. Concomitant products included ENALAPRIL and ATENOLOL for Blood pressure management, METFORMIN, GLYBURIDE and SAXAGLIPTIN HYDROCHLORIDE (ONGLYZA [SAXAGLIPTIN HYDROCHLORIDE]) for Diabetes, TAMSULOSIN for Prostate cancer.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (itch on my arms) and RASH VESICULAR (Red blistering rash under both arms and between legs & torso). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Didn't get 2nd shot under advice of pharmacist & doctor). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of unknown. On 19-Mar-2021, PRURITUS (itch on my arms) and RASH VESICULAR (Red blistering rash under both arms and between legs & torso) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Didn't get 2nd shot under advice of pharmacist & doctor) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment medications of the patient included Benedryl.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Lot No. of the vaccine was provided. On 17-May-2021: Completed ADR, concomitant medications added, additional event information, outcome of previous events updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Vaccination site pain
Clinical narrative: Heightened Anxiety; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Heightened Anxiety) and VACCINATION SITE PAIN (Pain at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM and HYDROCORTISONE (HUMERA) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 14-Mar-2021, the patient experienced ANXIETY (Heightened Anxiety). On 14-Mar-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, ANXIETY (Heightened Anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment details were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Nausea, Pain
Clinical narrative: I just don´t feel good (after second dose); very itchy (after first dose and second dose); chills (after first dose)/ chills (after second dose); nausea (after first dose)/ nausea (after second dose); fever 101.7 (after first dose)/ fever 101.7 (after Second dose); Very bad pain in my stomach in the right side (after first dose and second dose); dry heave(after first dose)/ dry heave(after second dose); achy (after first dose)/ achy (after second dose); This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Very bad pain in my stomach in the right side (after first dose and second dose)), RETCHING (dry heave(after first dose)/ dry heave(after second dose)), PAIN (achy (after first dose)/ achy (after second dose)), FEELING ABNORMAL (I just don´t feel good (after second dose)) and PRURITUS (very itchy (after first dose and second dose)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O14M2OA and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-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 ABDOMINAL PAIN UPPER (Very bad pain in my stomach in the right side (after first dose and second dose)), RETCHING (dry heave(after first dose)/ dry heave(after second dose)), PAIN (achy (after first dose)/ achy (after second dose)), PRURITUS (very itchy (after first dose and second dose)), CHILLS (chills (after first dose)/ chills (after second dose)), NAUSEA (nausea (after first dose)/ nausea (after second dose)) and PYREXIA (fever 101.7 (after first dose)/ fever 101.7 (after Second dose)). On an unknown date, the patient experienced FEELING ABNORMAL (I just don´t feel good (after second dose)). At the time of the report, ABDOMINAL PAIN UPPER (Very bad pain in my stomach in the right side (after first dose and second dose)), RETCHING (dry heave(after first dose)/ dry heave(after second dose)), PAIN (achy (after first dose)/ achy (after second dose)), FEELING ABNORMAL (I just don´t feel good (after second dose)), PRURITUS (very itchy (after first dose and second dose)), CHILLS (chills (after first dose)/ chills (after second dose)), NAUSEA (nausea (after first dose)/ nausea (after second dose)) and PYREXIA (fever 101.7 (after first dose)/ fever 101.7 (after Second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Retching
Clinical narrative: I just don´t feel good (after second dose); very itchy (after first dose and second dose); chills (after first dose)/ chills (after second dose); nausea (after first dose)/ nausea (after second dose); fever 101.7 (after first dose)/ fever 101.7 (after Second dose); Very bad pain in my stomach in the right side (after first dose and second dose); dry heave(after first dose)/ dry heave(after second dose); achy (after first dose)/ achy (after second dose); This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Very bad pain in my stomach in the right side (after first dose and second dose)), RETCHING (dry heave(after first dose)/ dry heave(after second dose)), PAIN (achy (after first dose)/ achy (after second dose)), FEELING ABNORMAL (I just don´t feel good (after second dose)) and PRURITUS (very itchy (after first dose and second dose)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O14M2OA and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-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 ABDOMINAL PAIN UPPER (Very bad pain in my stomach in the right side (after first dose and second dose)), RETCHING (dry heave(after first dose)/ dry heave(after second dose)), PAIN (achy (after first dose)/ achy (after second dose)), PRURITUS (very itchy (after first dose and second dose)), CHILLS (chills (after first dose)/ chills (after second dose)), NAUSEA (nausea (after first dose)/ nausea (after second dose)) and PYREXIA (fever 101.7 (after first dose)/ fever 101.7 (after Second dose)). On an unknown date, the patient experienced FEELING ABNORMAL (I just don´t feel good (after second dose)). At the time of the report, ABDOMINAL PAIN UPPER (Very bad pain in my stomach in the right side (after first dose and second dose)), RETCHING (dry heave(after first dose)/ dry heave(after second dose)), PAIN (achy (after first dose)/ achy (after second dose)), FEELING ABNORMAL (I just don´t feel good (after second dose)), PRURITUS (very itchy (after first dose and second dose)), CHILLS (chills (after first dose)/ chills (after second dose)), NAUSEA (nausea (after first dose)/ nausea (after second dose)) and PYREXIA (fever 101.7 (after first dose)/ fever 101.7 (after Second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chills in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 8, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 10, 2021, patient experienced chills. On Mar 11, 2021, chills resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment information provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: lost feeling in face; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and HYPOAESTHESIA (lost feeling in face) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and HYPOAESTHESIA (lost feeling in face). At the time of the report, PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and HYPOAESTHESIA (lost feeling in face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment details include, ibuprofen.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Inability to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Inability to sleep) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dementia, Blood pressure high and Diabetes. Concomitant products included LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). At the time of the report, INSOMNIA (Inability to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
Age: 0.25
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding with her 3 month old baby; This spontaneous case was reported by an other caregiver and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding with her 3 month old baby) in a 3-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Immunocompromised and Cholangitis.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No medical history reported.).    On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding with her 3 month old baby). On 27-Mar-2021, EXPOSURE VIA BREAST MILK (Breastfeeding with her 3 month old baby) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-060390 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Intentional product use issue, Myalgia
Clinical narrative: balance issues; couldn't think straight,; dry heaves; red itchy rash in her upper tarsal; red itchy rash in her upper tarsal; Patient didn't have the second vaccine yet; dizziness; muscle aches; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Artificial sweetener intolerance and Food allergy.    On 23-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 CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet). At the time of the report, CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-May-2021: added new adverse events, suspect vaccine details (batch number).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash erythematous, Rash pruritic, Retching
Clinical narrative: balance issues; couldn't think straight,; dry heaves; red itchy rash in her upper tarsal; red itchy rash in her upper tarsal; Patient didn't have the second vaccine yet; dizziness; muscle aches; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Artificial sweetener intolerance and Food allergy.    On 23-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 CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet). At the time of the report, CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-May-2021: added new adverse events, suspect vaccine details (batch number).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: balance issues; couldn't think straight,; dry heaves; red itchy rash in her upper tarsal; red itchy rash in her upper tarsal; Patient didn't have the second vaccine yet; dizziness; muscle aches; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Artificial sweetener intolerance and Food allergy.    On 23-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 CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet). At the time of the report, CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-May-2021: added new adverse events, suspect vaccine details (batch number).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: red dots all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red dots all over body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exposure to poison ivy on 13-Mar-2021.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH (red dots all over body). The patient was treated with PREDNISONE for Adverse event, at a dose of 5 day regimen. At the time of the report, RASH (red dots all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient was reported to be exposed to poison ivy on 13-MAR-2021 (2 days prior to the first dose of vaccine) and developed small patches of red blisters on their hand.  Then on 17-MAR-2021 after the first dose of vaccination, the patient developed red dots all over their body and was treated in urgent care with a steroid injection and prescribed a 5 day regimen of prednisone.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to 17 yr old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 17 yr old patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 17 yr old patient). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 17 yr old patient) 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 for the event was provided.  This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site red; injection site itchy; chills; felt very tired; injection site very sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (felt very tired), VACCINATION SITE PAIN (injection site very sore), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (felt very tired) and VACCINATION SITE PAIN (injection site very sore). On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy). On 25-Mar-2021, CHILLS (chills), FATIGUE (felt very tired) and VACCINATION SITE PAIN (injection site very sore) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Illness, Influenza like illness, Sinusitis
Clinical narrative: Flu like symptoms; Stomachache; Sinus infection; Diarrhea; Throwing up; Sick for a week; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), SINUSITIS (Sinus infection), DIARRHOEA (Diarrhea) and ILLNESS (Sick for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-1900, the patient experienced ILLNESS (Sick for a week). On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), SINUSITIS (Sinus infection), DIARRHOEA (Diarrhea) and VOMITING (Throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), SINUSITIS (Sinus infection), DIARRHOEA (Diarrhea), ILLNESS (Sick for a week) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment details not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu like symptoms; Stomachache; Sinus infection; Diarrhea; Throwing up; Sick for a week; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), SINUSITIS (Sinus infection), DIARRHOEA (Diarrhea) and ILLNESS (Sick for a week) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-1900, the patient experienced ILLNESS (Sick for a week). On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), SINUSITIS (Sinus infection), DIARRHOEA (Diarrhea) and VOMITING (Throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), SINUSITIS (Sinus infection), DIARRHOEA (Diarrhea), ILLNESS (Sick for a week) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment details not provided.