chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: itching arm; big red welp in the area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (big red welp in the area of the shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (big red welp in the area of the shot). At the time of the report, PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (big red welp in the area of the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Hydrocortisone cream
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: expired vaccine used; this time pulled a Pfizer vial and gave that; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and EXTRA DOSE ADMINISTERED (this time pulled a Pfizer vial and gave that) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and EXTRA DOSE ADMINISTERED (this time pulled a Pfizer vial and gave that). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and EXTRA DOSE ADMINISTERED (this time pulled a Pfizer vial and gave that) 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 concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product complaint
Clinical narrative: needle came apart while vaccine was being administered; Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT COMPLAINT (needle came apart while vaccine was being administered) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT COMPLAINT (needle came apart while vaccine was being administered) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL). On 24-Apr-2021, PRODUCT COMPLAINT (needle came apart while vaccine was being administered) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in invalid dose SRL) 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.   Concomitant medication was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-089574 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089574:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash, Skin discolouration
Clinical narrative: Skin discoloration; Shingle; Pain on his lower left side close to his torso; Rash on his lower left side close to his torso; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Skin discoloration), HERPES ZOSTER (Shingle), PAIN (Pain on his lower left side close to his torso) and RASH (Rash on his lower left side close to his torso) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin discoloration), HERPES ZOSTER (Shingle), PAIN (Pain on his lower left side close to his torso) and RASH (Rash on his lower left side close to his torso). On 27-Mar-2021, PAIN (Pain on his lower left side close to his torso) and RASH (Rash on his lower left side close to his torso) had resolved. On 29-Mar-2021, HERPES ZOSTER (Shingle) had resolved. On 23-Apr-2021, SKIN DISCOLOURATION (Skin discoloration) 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.   Concomitant medication was not reported. Treatment medication included Valtrex.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anal haemorrhage, Tremor
Clinical narrative: stomach cramps; pink stain on toilet paper; experienced jolt upon administration; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), ANAL HAEMORRHAGE (pink stain on toilet paper) and TREMOR (experienced jolt upon administration) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0476214) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (The allergy was not specified.).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), ANAL HAEMORRHAGE (pink stain on toilet paper) and TREMOR (experienced jolt upon administration). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), ANAL HAEMORRHAGE (pink stain on toilet paper) and TREMOR (experienced jolt upon administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was reported to be on an unspecified concomitant medication for an unknown indication.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Head discomfort, Headache, Heart rate, Heart rate increased
Clinical narrative: really bad ringing in ears (tinnitus); whole ear system is swollen; heartrate to 125; hyperacusis; pressure in upper mouth; neck spasm; headaches/pulsating and pounding in the back of head; pressure headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (really bad ringing in ears (tinnitus)), EAR SWELLING (whole ear system is swollen), HEAD DISCOMFORT (pressure headaches), HEART RATE INCREASED (heartrate to 125) and HYPERACUSIS (hyperacusis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus. Previously administered products included for Product used for unknown indication: Atorvastatin (ears worse). Past adverse reactions to the above products included Ear disorder with Atorvastatin. Concurrent medical conditions included Allergy, Sinusitis, Asthma and Tendonitis. Concomitant products included ALPRAZOLAM (XANAX) for Sleep difficult, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (pressure headaches). On 30-Apr-2021, the patient experienced HEART RATE INCREASED (heartrate to 125), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth), MUSCLE SPASMS (neck spasm) and HEADACHE (headaches/pulsating and pounding in the back of head). On an unknown date, the patient experienced TINNITUS (really bad ringing in ears (tinnitus)) and EAR SWELLING (whole ear system is swollen). The patient was treated with PREDNISONE for Tinnitus, at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE (NASACORT) at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency and IPRATROPIUM BROMIDE at a dose of Nasal spray. On 30-Apr-2021, HEAD DISCOMFORT (pressure headaches) outcome was unknown. At the time of the report, TINNITUS (really bad ringing in ears (tinnitus)) had not resolved and EAR SWELLING (whole ear system is swollen), HEART RATE INCREASED (heartrate to 125), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth), MUSCLE SPASMS (neck spasm) and HEADACHE (headaches/pulsating and pounding in the back of head) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 125 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Prednisone and vit D are used as treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received from the initial reporter: Patient's medical history, Concomitant medications, treatment medication and new events were added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Muscle spasms, Oral pain, Tinnitus
Clinical narrative: really bad ringing in ears (tinnitus); whole ear system is swollen; heartrate to 125; hyperacusis; pressure in upper mouth; neck spasm; headaches/pulsating and pounding in the back of head; pressure headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (really bad ringing in ears (tinnitus)), EAR SWELLING (whole ear system is swollen), HEAD DISCOMFORT (pressure headaches), HEART RATE INCREASED (heartrate to 125) and HYPERACUSIS (hyperacusis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus. Previously administered products included for Product used for unknown indication: Atorvastatin (ears worse). Past adverse reactions to the above products included Ear disorder with Atorvastatin. Concurrent medical conditions included Allergy, Sinusitis, Asthma and Tendonitis. Concomitant products included ALPRAZOLAM (XANAX) for Sleep difficult, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (pressure headaches). On 30-Apr-2021, the patient experienced HEART RATE INCREASED (heartrate to 125), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth), MUSCLE SPASMS (neck spasm) and HEADACHE (headaches/pulsating and pounding in the back of head). On an unknown date, the patient experienced TINNITUS (really bad ringing in ears (tinnitus)) and EAR SWELLING (whole ear system is swollen). The patient was treated with PREDNISONE for Tinnitus, at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE (NASACORT) at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency and IPRATROPIUM BROMIDE at a dose of Nasal spray. On 30-Apr-2021, HEAD DISCOMFORT (pressure headaches) outcome was unknown. At the time of the report, TINNITUS (really bad ringing in ears (tinnitus)) had not resolved and EAR SWELLING (whole ear system is swollen), HEART RATE INCREASED (heartrate to 125), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth), MUSCLE SPASMS (neck spasm) and HEADACHE (headaches/pulsating and pounding in the back of head) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 125 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Prednisone and vit D are used as treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received from the initial reporter: Patient's medical history, Concomitant medications, treatment medication and new events were added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: feel pain at the inject site/muscle pain in injection site; body pain/body aches; flu like symptoms; headaches like a migraine; fever of 101.4 F/updated fever of 101.9; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (feel pain at the inject site/muscle pain in injection site), MYALGIA (body pain/body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headaches like a migraine) and PYREXIA (fever of 101.4 F/updated fever of 101.9) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Epilepsy. Concomitant products included OXCARBAZEPINE, CITALOPRAM, LAMOTRIGINE, GABAPENTIN and LORATADINE (CLARITINE) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (feel pain at the inject site/muscle pain in injection site), MYALGIA (body pain/body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headaches like a migraine) and PYREXIA (fever of 101.4 F/updated fever of 101.9). At the time of the report, VACCINATION SITE PAIN (feel pain at the inject site/muscle pain in injection site), MYALGIA (body pain/body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headaches like a migraine) and PYREXIA (fever of 101.4 F/updated fever of 101.9) outcome was unknown. 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.   Other concomitant medications include Prenatal vitamins. No treatment reported
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm very swollen; Redness on arm; Itchiness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm very swollen), ERYTHEMA (Redness on arm) and PRURITUS (Itchiness on arm) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm very swollen), ERYTHEMA (Redness on arm) and PRURITUS (Itchiness on arm). At the time of the report, PERIPHERAL SWELLING (Arm very swollen), ERYTHEMA (Redness on arm) and PRURITUS (Itchiness on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included Thyroid medication for an unknown indication.Treatment medication was not provided.
Age: 0.42
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pyrexia
Clinical narrative: developed a fever that kept climbing; breastfed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (developed a fever that kept climbing) and EXPOSURE VIA BREAST MILK (breastfed) in a 5-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with PYREXIA (developed a fever that kept climbing) and EXPOSURE VIA BREAST MILK (breastfed). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, PYREXIA (developed a fever that kept climbing) and EXPOSURE VIA BREAST MILK (breastfed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089747 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089747:case for daughter
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (bump that itched - at injection site), VACCINATION SITE SWELLING (raised bump - at injection site), VACCINATION SITE ERYTHEMA (red bump- at injection site) and VACCINATION SITE PAIN (painful bump- at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (bump that itched - at injection site), VACCINATION SITE SWELLING (raised bump - at injection site), VACCINATION SITE ERYTHEMA (red bump- at injection site) and VACCINATION SITE PAIN (painful bump- at injection site). At the time of the report, VACCINATION SITE PRURITUS (bump that itched - at injection site), VACCINATION SITE SWELLING (raised bump - at injection site), VACCINATION SITE ERYTHEMA (red bump- at injection site) and VACCINATION SITE PAIN (painful bump- at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-089618 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness, Vaccination site movement impairment
Clinical narrative: tenderness to his arm; arm swollen; Cannot even move his arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness to his arm), PERIPHERAL SWELLING (arm swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot even move his arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048821A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TENDERNESS (tenderness to his arm), PERIPHERAL SWELLING (arm swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot even move his arm). At the time of the report, TENDERNESS (tenderness to his arm), PERIPHERAL SWELLING (arm swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot even move his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications were  reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: form attached
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Nausea; exhausted, no energy; no energy; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FATIGUE (exhausted, no energy) and ASTHENIA (no energy) in a 48-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, the patient experienced NAUSEA (Nausea), FATIGUE (exhausted, no energy) and ASTHENIA (no energy). At the time of the report, NAUSEA (Nausea), FATIGUE (exhausted, no energy) and ASTHENIA (no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant no treatment medication included.   This case was linked to US-MODERNATX, INC.-MOD-2021-089048, US-MODERNATX, INC.-MOD-2021-089362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up report received on 27-May-2021 contains No New Information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089048:patient 1 US-MODERNATX, INC.-MOD-2021-089362:patient 2
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Oral mucosal erythema, Product dose omission issue, Pruritus, Rash
Clinical narrative: Delayed the 2nd dose until 09May2021; crazy itching; bad rash on body,bad rash on head,bad rash on chest,bad rash on waist,bad rash on arms,bad rash on back, bad rash on body; bad rash on leg; cannot sleep; red dots on roof of her mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (crazy itching), RASH (bad rash on body,bad rash on head,bad rash on chest,bad rash on waist,bad rash on arms,bad rash on back, bad rash on body), RASH (bad rash on leg), INSOMNIA (cannot sleep) and ORAL MUCOSAL ERYTHEMA (red dots on roof of her mouth) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Milk allergy, Food allergy (codfish) and Food allergy (Had a small rash on wrist, didn't think anything of it.) since 03-Mar-2021.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (crazy itching), RASH (bad rash on body,bad rash on head,bad rash on chest,bad rash on waist,bad rash on arms,bad rash on back, bad rash on body), RASH (bad rash on leg), INSOMNIA (cannot sleep) and ORAL MUCOSAL ERYTHEMA (red dots on roof of her mouth). On 23-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delayed the 2nd dose until 09May2021). At the time of the report, PRURITUS (crazy itching), RASH (bad rash on body,bad rash on head,bad rash on chest,bad rash on waist,bad rash on arms,bad rash on back, bad rash on body), RASH (bad rash on leg), INSOMNIA (cannot sleep), ORAL MUCOSAL ERYTHEMA (red dots on roof of her mouth) and PRODUCT DOSE OMISSION ISSUE (Delayed the 2nd dose until 09May2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Limb discomfort, Malaise
Clinical narrative: Discomfort in arm; Fever; Fatigue / tiredness; Nausea that are increasing; Patient feels that she is decaying with the days; Not felt well; Body aches; Constant tingling in the body; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in arm), FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches) and PARAESTHESIA (Constant tingling in the body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D37D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Discomfort in arm) and PYREXIA (Fever). In April 2021, the patient experienced FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches), PARAESTHESIA (Constant tingling in the body), DIZZINESS (Dizziness), FATIGUE (Fatigue / tiredness) and NAUSEA (Nausea that are increasing). The patient was treated with ACETAMINOPHEN on 09-Apr-2021 for Fever, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Discomfort in arm), FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches), PARAESTHESIA (Constant tingling in the body), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue / tiredness) and NAUSEA (Nausea that are increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: Discomfort in arm; Fever; Fatigue / tiredness; Nausea that are increasing; Patient feels that she is decaying with the days; Not felt well; Body aches; Constant tingling in the body; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in arm), FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches) and PARAESTHESIA (Constant tingling in the body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D37D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Discomfort in arm) and PYREXIA (Fever). In April 2021, the patient experienced FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches), PARAESTHESIA (Constant tingling in the body), DIZZINESS (Dizziness), FATIGUE (Fatigue / tiredness) and NAUSEA (Nausea that are increasing). The patient was treated with ACETAMINOPHEN on 09-Apr-2021 for Fever, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Discomfort in arm), FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches), PARAESTHESIA (Constant tingling in the body), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue / tiredness) and NAUSEA (Nausea that are increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Pain on forearm; Headache; swelling in axilla and next to collarbone; Fever; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on forearm), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN and METFORMIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and LYMPHADENOPATHY (swelling in axilla and next to collarbone). On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain on forearm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 24-Apr-2021 at an unspecified dose and frequency. On 24-Apr-2021, PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on forearm), HEADACHE (Headache) and LYMPHADENOPATHY (swelling in axilla and next to collarbone) 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain on forearm; Headache; swelling in axilla and next to collarbone; Fever; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on forearm), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN and METFORMIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and LYMPHADENOPATHY (swelling in axilla and next to collarbone). On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain on forearm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 24-Apr-2021 at an unspecified dose and frequency. On 24-Apr-2021, PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on forearm), HEADACHE (Headache) and LYMPHADENOPATHY (swelling in axilla and next to collarbone) 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.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Not Able to Sleep for 1 Night post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not Able to Sleep for 1 Night post vaccination) in a 90-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Not Able to Sleep for 1 Night post vaccination). At the time of the report, INSOMNIA (Not Able to Sleep for 1 Night post vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-083018, US-MODERNATX, INC.-MOD-2021-089630 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083018:Crosslinked case US-MODERNATX, INC.-MOD-2021-089630:Crosslinked case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast cyst, Pain in extremity
Clinical narrative: Cyst breast; Back pain; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain ), PAIN IN EXTREMITY (Pain in arm ) and BREAST CYST (Cyst breast) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Back pain ) and PAIN IN EXTREMITY (Pain in arm ). On an unknown date, the patient experienced BREAST CYST (Cyst breast). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back pain ), PAIN IN EXTREMITY (Pain in arm ) and BREAST CYST (Cyst breast) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided.   This case was linked to MOD-2021-089637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: On 03-JUN-2021 follow up was received, patient's demographics were added. New events were added.; 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: Asthma, Local reaction
Clinical narrative: local site reaction was much better with the second dose; Asthma; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (Asthma) and LOCAL REACTION (local site reaction was much better with the second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis since 15-Sep-1005, Breast cancer since 01-Mar-2006 and Depression since 01-Feb-2000. Concomitant products included ESCITALOPRAM for Depression, INTERFERON BETA-1A (REBIF) for Multiple sclerosis.   On 16-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ASTHMA (Asthma). On an unknown date, the patient experienced LOCAL REACTION (local site reaction was much better with the second dose). At the time of the report, ASTHMA (Asthma) and LOCAL REACTION (local site reaction was much better with the second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatments were reported.   This case was linked to MOD-2021-029847 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Aches and pains; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains) and FATIGUE (extreme fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Aches and pains) and FATIGUE (extreme fatigue). At the time of the report, PAIN (Aches and pains) and FATIGUE (extreme fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Asthma medications and low-dose budesonide for an unknown indication. Treatment medication included Tylenol.   This case was linked to MOD-2021-089533 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye swelling, Headache, Lymphadenopathy, Pain
Clinical narrative: swollen lymph nodes below her ears; her head hurt; a real red abrasive looking rash on her head; a scab that is healing right on her waterline; painful; broke out in a rash and it got real bad, it was miserable and horrible; her ears still hurt; eyes swelled close; a red rash that turned to lesions and there was pus in it.; This spontaneous case was reported by a physician and describes the occurrence of EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), RASH ERYTHEMATOUS (a real red abrasive looking rash on her head) and SCAB (a scab that is healing right on her waterline) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), SCAB (a scab that is healing right on her waterline), PAIN (painful) and RASH (broke out in a rash and it got real bad, it was miserable and horrible). On 18-Apr-2021, the patient experienced RASH ERYTHEMATOUS (a real red abrasive looking rash on her head) and HEADACHE (her head hurt). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes below her ears). The patient was treated with HYDROXYZINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), RASH ERYTHEMATOUS (a real red abrasive looking rash on her head), SCAB (a scab that is healing right on her waterline), PAIN (painful), RASH (broke out in a rash and it got real bad, it was miserable and horrible), LYMPHADENOPATHY (swollen lymph nodes below her ears) and HEADACHE (her head hurt) 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 were reported.  Treatment medication also include pain pill, and fresh eye solution.   This case was linked to US-MODERNATX, INC.-MOD-2021-089663 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089663:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Scab, Skin lesion
Clinical narrative: swollen lymph nodes below her ears; her head hurt; a real red abrasive looking rash on her head; a scab that is healing right on her waterline; painful; broke out in a rash and it got real bad, it was miserable and horrible; her ears still hurt; eyes swelled close; a red rash that turned to lesions and there was pus in it.; This spontaneous case was reported by a physician and describes the occurrence of EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), RASH ERYTHEMATOUS (a real red abrasive looking rash on her head) and SCAB (a scab that is healing right on her waterline) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), SCAB (a scab that is healing right on her waterline), PAIN (painful) and RASH (broke out in a rash and it got real bad, it was miserable and horrible). On 18-Apr-2021, the patient experienced RASH ERYTHEMATOUS (a real red abrasive looking rash on her head) and HEADACHE (her head hurt). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes below her ears). The patient was treated with HYDROXYZINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, EAR PAIN (her ears still hurt), EYE SWELLING (eyes swelled close), SKIN LESION (a red rash that turned to lesions and there was pus in it.), RASH ERYTHEMATOUS (a real red abrasive looking rash on her head), SCAB (a scab that is healing right on her waterline), PAIN (painful), RASH (broke out in a rash and it got real bad, it was miserable and horrible), LYMPHADENOPATHY (swollen lymph nodes below her ears) and HEADACHE (her head hurt) 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 were reported.  Treatment medication also include pain pill, and fresh eye solution.   This case was linked to US-MODERNATX, INC.-MOD-2021-089663 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089663:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: became very sleepy, slept 3 days during the day for quite a long time; right leg felt like small stings for about 8 to 10 minutes; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (became very sleepy, slept 3 days during the day for quite a long time) and PAIN IN EXTREMITY (right leg felt like small stings for about 8 to 10 minutes) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003BB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 SOMNOLENCE (became very sleepy, slept 3 days during the day for quite a long time) and PAIN IN EXTREMITY (right leg felt like small stings for about 8 to 10 minutes). On 25-Mar-2021, SOMNOLENCE (became very sleepy, slept 3 days during the day for quite a long time) and PAIN IN EXTREMITY (right leg felt like small stings for about 8 to 10 minutes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details pertained to the events were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089638 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089638:Second Dose Case
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever (99 to 100°F); Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (99 to 100°F)) and HEADACHE (Headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VENLAFAXINE for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (Fever (99 to 100°F)) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever (99 to 100°F)) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: arm soreness; 16-year-old received the Moderna vaccine instead of the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine instead of the Pfizer vaccine) and PAIN IN EXTREMITY (arm soreness) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine instead of the Pfizer vaccine). On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 30-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine instead of the Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter