chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after receiving Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after receiving Moderna COVID-19 vaccine). At the time of the report, FATIGUE (Fatigue after receiving Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Vaccination site pruritus; red, swollen, hot, bubbly, and itchy rash around her site of injection; Vaccination site erythema; fatigue; swollen arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, PAIN, VACCINATION SITE PRURITUS, FATIGUE, and VACCINATION SITE SWELLING in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 19-Apr-2021, the patient experienced PERIPHERAL SWELLING, PAIN, and FATIGUE. On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING and VACCINATION SITE ERYTHEMA. At the time of the report, PERIPHERAL SWELLING, PAIN, VACCINATION SITE PRURITUS, FATIGUE, VACCINATION SITE SWELLING, and VACCINATION SITE ERYTHEMA outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Vaccination site pruritus; red, swollen, hot, bubbly, and itchy rash around her site of injection; Vaccination site erythema; fatigue; swollen arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, PAIN, VACCINATION SITE PRURITUS, FATIGUE, and VACCINATION SITE SWELLING in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 19-Apr-2021, the patient experienced PERIPHERAL SWELLING, PAIN, and FATIGUE. On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING and VACCINATION SITE ERYTHEMA. At the time of the report, PERIPHERAL SWELLING, PAIN, VACCINATION SITE PRURITUS, FATIGUE, VACCINATION SITE SWELLING, and VACCINATION SITE ERYTHEMA outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: "egg" swelling, left upper arm/large egg shaped bump on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION ("egg" swelling, left upper arm/large egg shaped bump on arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CLONAZEPAM, PRAMIPEXOLE, GABAPENTIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE INDURATION ("egg" swelling, left upper arm/large egg shaped bump on arm). On 31-Jan-2021, VACCINATION SITE INDURATION ("egg" swelling, left upper arm/large egg shaped bump on arm) had resolved.        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.   This case was linked to MOD-2021-094972.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient stated that she only experienced one event
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. No concomitant medication or treatment information reported. This case linked to MOD-2021-038692 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia
Clinical narrative: was so sick; brutal headache; chills; aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was so sick), HEADACHE (brutal headache), CHILLS (chills) and MYALGIA (aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ILLNESS (was so sick), HEADACHE (brutal headache), CHILLS (chills) and MYALGIA (aches). At the time of the report, ILLNESS (was so sick), HEADACHE (brutal headache), CHILLS (chills) and MYALGIA (aches) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: COVID-19; chills; headache; Nasal Congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION, COVID-19 (COVID-19), CHILLS, and HEADACHE in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN BASAGLAR, LEXAPRO, and ACYCLOVIR for an unknown indication.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced NASAL CONGESTION. On 19-Apr-2021, the patient experienced CHILLS and HEADACHE. On 20-Apr-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with TYLENOL at an unspecified dose and frequency and DAYQUIL at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION, COVID-19 (COVID-19), CHILLS, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: Positive COVID.         Concomitant included Novolog and Birth Control Pill were noted.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: Small cough; Fever of 102 and 103; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Small cough), PYREXIA (Fever of 102 and 103) and FATIGUE (Fatigue) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced COUGH (Small cough), PYREXIA (Fever of 102 and 103) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COUGH (Small cough), PYREXIA (Fever of 102 and 103) and FATIGUE (Fatigue) had not resolved.            No concomitant product use was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR-Follow up received on 28-May-2021 and contains email address.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: arm stiff; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS and MYALGIA in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (arm stiff) and MYALGIA. The patient was treated with ALEVE at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS and MYALGIA outcome was unknown.            No concomitant medications provided.   Reporter did not allow further contact.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bedridden, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Confined to bed; Loose bowel movements; Feverish; Weak, tired; nauseous; GI upset; Muscle twitching; Tinnitus; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Tinnitus), ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching) and BEDRIDDEN (Confined to bed) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic kidney disease. Concomitant products included ESTROGENS CONJUGATED (PREMARIN), VITAMIN D3, VITAMIN B12 NOS and MAGNESIUM OXIDE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 07-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 16-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching), PYREXIA (Feverish), FATIGUE (Weak, tired) and NAUSEA (nauseous). On 19-Apr-2021, the patient experienced DIARRHOEA (Loose bowel movements). On 27-Apr-2021, the patient experienced BEDRIDDEN (Confined to bed). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Tinnitus), ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching), BEDRIDDEN (Confined to bed), DIARRHOEA (Loose bowel movements), PYREXIA (Feverish), FATIGUE (Weak, tired) and NAUSEA (nauseous) had not resolved.            Treatment was not provided. Patient used Vitamin B2, Turmeric as a Concomitant medication.   This case was linked to MOD-2021-060221 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Nausea, Pyrexia, Tinnitus
Clinical narrative: Confined to bed; Loose bowel movements; Feverish; Weak, tired; nauseous; GI upset; Muscle twitching; Tinnitus; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Tinnitus), ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching) and BEDRIDDEN (Confined to bed) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic kidney disease. Concomitant products included ESTROGENS CONJUGATED (PREMARIN), VITAMIN D3, VITAMIN B12 NOS and MAGNESIUM OXIDE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 07-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 16-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching), PYREXIA (Feverish), FATIGUE (Weak, tired) and NAUSEA (nauseous). On 19-Apr-2021, the patient experienced DIARRHOEA (Loose bowel movements). On 27-Apr-2021, the patient experienced BEDRIDDEN (Confined to bed). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Tinnitus), ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching), BEDRIDDEN (Confined to bed), DIARRHOEA (Loose bowel movements), PYREXIA (Feverish), FATIGUE (Weak, tired) and NAUSEA (nauseous) had not resolved.            Treatment was not provided. Patient used Vitamin B2, Turmeric as a Concomitant medication.   This case was linked to MOD-2021-060221 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head, Migraine with aura
Clinical narrative: headache with aura; Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode; Fourth episode headache; 3 episodes of vision headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE WITH AURA (headache with aura), HEADACHE (3 episodes of vision headaches), HEADACHE (Fourth episode headache) and HEADACHE (Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (diladid) and Penicillin allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 09-Nov-1991 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CYANOCOBALAMIN (VIT B 12), PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS] and CALCIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (3 episodes of vision headaches). On 08-Apr-2021, the patient experienced HEADACHE (Fourth episode headache). On 13-Apr-2021, the patient experienced HEADACHE (Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode). On an unknown date, the patient experienced MIGRAINE WITH AURA (headache with aura). On 27-Feb-2021, HEADACHE (3 episodes of vision headaches) had resolved. On 08-Apr-2021, HEADACHE (Fourth episode headache) had resolved. On 13-Apr-2021, HEADACHE (Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode) had resolved. At the time of the report, MIGRAINE WITH AURA (headache with aura) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Magnetic resonance imaging head: normal (normal) normal.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Date of vaccine, and event information updated.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pallor, Swelling
Clinical narrative: left 1st, 2nd toes were red and swollen; left 1st, 2nd toes were red and swollen; left 1st, 2nd, and 3rd toes that blanched more easily; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING (left 1st, 2nd toes were red and swollen), ERYTHEMA (left 1st, 2nd toes were red and swollen) and PALLOR (left 1st, 2nd, and 3rd toes that blanched more easily) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Raynauds. Concurrent medical conditions included Penicillin allergy and Hypertension since 05-Jul-1980. Concomitant products included VITAMIN D3 from 04-Jan-2019 to an unknown date for Immune imbalance, VITAMINS NOS (DAILY MULTIVITAMIN) from 09-Jan-1980 to an unknown date for Vitamin supplementation.   On 14-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced SWELLING (left 1st, 2nd toes were red and swollen) and ERYTHEMA (left 1st, 2nd toes were red and swollen). 11-Mar-2021, the patient experienced PALLOR (left 1st, 2nd, and 3rd toes that blanched more easily). On 17-Apr-2021, SWELLING (left 1st, 2nd toes were red and swollen) and ERYTHEMA (left 1st, 2nd toes were red and swollen) had resolved. At the time of the report, PALLOR (left 1st, 2nd, and 3rd toes that blanched more easily) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's dermatologist recommended clotrimazole on 11mar2021. Her podiatrist changed treatment to triamcinolone 0.1% ointment, "that was helpful."
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Night sweats, Pain in extremity, Vaccination site erythema
Clinical narrative: night sweats; hot for 6days; arm felt achy; achy; tired; a red spot the size of a baseball below the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (hot for 6days), PAIN IN EXTREMITY (arm felt achy), MYALGIA (achy) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D 3), GABAPENTIN, OMEPRAZOLE, BIOTIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (hot for 6days), PAIN IN EXTREMITY (arm felt achy), MYALGIA (achy), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (a red spot the size of a baseball below the injection site). At the time of the report, NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (hot for 6days), PAIN IN EXTREMITY (arm felt achy), MYALGIA (achy), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (a red spot the size of a baseball below the injection site) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: night sweats; hot for 6days; arm felt achy; achy; tired; a red spot the size of a baseball below the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (hot for 6days), PAIN IN EXTREMITY (arm felt achy), MYALGIA (achy) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D 3), GABAPENTIN, OMEPRAZOLE, BIOTIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (hot for 6days), PAIN IN EXTREMITY (arm felt achy), MYALGIA (achy), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (a red spot the size of a baseball below the injection site). At the time of the report, NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (hot for 6days), PAIN IN EXTREMITY (arm felt achy), MYALGIA (achy), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (a red spot the size of a baseball below the injection site) 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Sleep disorder
Clinical narrative: vivid dreams every single day; Disrupting sleep pattern; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (vivid dreams every single day) and SLEEP DISORDER (Disrupting sleep pattern) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Factor V Leiden thrombophilia and Stokes Adams syndrome. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) and CEFIXIME (GENIXIME) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (vivid dreams every single day) and SLEEP DISORDER (Disrupting sleep pattern). At the time of the report, ABNORMAL DREAMS (vivid dreams every single day) and SLEEP DISORDER (Disrupting sleep pattern) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-009257 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-009257:case for first dose
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Peed on my pants; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Peed on my pants) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B2114) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient is on Blood pressure medication).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced URINARY INCONTINENCE (Peed on my pants). On 26-Apr-2021, URINARY INCONTINENCE (Peed on my pants) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was a Speaker and reported that they received the 1st dose of the Moderna vaccine on 08-Apr-2021 and had their 2nd dose on 26-Apr-2021. The patient reported that when they went to have their 2nd dose appointment, they peed on their pants and had to go to the bathroom and lost their appointment. The patient wanted to reschedule their 2nd dose appointment.   Reportedly, the patient had no side effects post receiving the first dose of Moderna vaccine.  Concomitant medication used included blood pressure medication and 5 other pills which was unknown to patient. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site rash
Clinical narrative: mild joint pains; rash on injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE RASH (rash on injection site) and ARTHRALGIA (mild joint pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on injection site) and ARTHRALGIA (mild joint pains). At the time of the report, VACCINATION SITE RASH (rash on injection site) had resolved and ARTHRALGIA (mild joint pains) had not resolved.            No concomitant and treatment medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-020514 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Slight sore arm for a short duration; Administered vaccine to a 17-year-old patient; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm for a short duration) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 17-year-old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced PAIN IN EXTREMITY (Slight sore arm for a short duration) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 17-year-old patient). On 23-Dec-2020, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 17-year-old patient) had resolved. At the time of the report, PAIN IN EXTREMITY (Slight sore arm for a short duration) had resolved.        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 medications were not provided. The patient did not receive any treatment medications.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Neck pain, Neuralgia, Pyrexia
Clinical narrative: Neck pain; Pain in nerve endings; weakness; Join pain on the left side of the body; fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), NEURALGIA (Pain in nerve endings), ASTHENIA (weakness), ARTHRALGIA (Join pain on the left side of the body) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery. Concomitant products included GABAPENTIN, OMEPRAZOLE, SIMVASTATIN and VENLAFAXINE for an unknown indication.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced NECK PAIN (Neck pain), NEURALGIA (Pain in nerve endings), ASTHENIA (weakness), ARTHRALGIA (Join pain on the left side of the body) and PYREXIA (fever). At the time of the report, NECK PAIN (Neck pain), NEURALGIA (Pain in nerve endings), ASTHENIA (weakness), ARTHRALGIA (Join pain on the left side of the body) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol and Ibuprofen.  Action taken with response to the events are not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eye contusion, Full blood count, Neutrophil count, Platelet count
Clinical narrative: black eye; This spontaneous case was reported by a physician and describes the occurrence of EYE CONTUSION (black eye) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diarrhea, Sores mouth, Bruise, Cold sore mouth and Black eye. Concurrent medical conditions included Appetite decreased NOS and Weight loss. Concomitant products included ACYCLOVIR [ACICLOVIR] for Cold sore mouth, RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera and Myelofibrosis, LISINOPRIL, CELECOXIB (CELEXA [CELECOXIB]), ROSUVASTATIN, LORAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN LOW), VITAMIN D3, FOLIC ACID, VITAMIN B COMPLEX, PARACETAMOL (TYLENOL EXTRA-STRENGTH), PROBIOTICS NOS and LOVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EYE CONTUSION (black eye). At the time of the report, EYE CONTUSION (black eye) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood test: numbers dropped quite a bit. In March 2021, Neutrophil count: dropped. In March 2021, Platelet count: come up a little bit. On an unknown date, Full blood count: blood counts were okay. On an unknown date, Weight: gained 3.2 pounds and increased from 123 pounds to 130 pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 24-Sep-2019, the patient RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On 15-Mar-2021, the patient experienced EYE CONTUSION (black eye).    This case was linked to US-MODERNATX, INC.-MOD-2021-093449 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-093449:1st dose
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: black eye; This spontaneous case was reported by a physician and describes the occurrence of EYE CONTUSION (black eye) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diarrhea, Sores mouth, Bruise, Cold sore mouth and Black eye. Concurrent medical conditions included Appetite decreased NOS and Weight loss. Concomitant products included ACYCLOVIR [ACICLOVIR] for Cold sore mouth, RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera and Myelofibrosis, LISINOPRIL, CELECOXIB (CELEXA [CELECOXIB]), ROSUVASTATIN, LORAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN LOW), VITAMIN D3, FOLIC ACID, VITAMIN B COMPLEX, PARACETAMOL (TYLENOL EXTRA-STRENGTH), PROBIOTICS NOS and LOVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EYE CONTUSION (black eye). At the time of the report, EYE CONTUSION (black eye) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood test: numbers dropped quite a bit. In March 2021, Neutrophil count: dropped. In March 2021, Platelet count: come up a little bit. On an unknown date, Full blood count: blood counts were okay. On an unknown date, Weight: gained 3.2 pounds and increased from 123 pounds to 130 pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 24-Sep-2019, the patient RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On 15-Mar-2021, the patient experienced EYE CONTUSION (black eye).    This case was linked to US-MODERNATX, INC.-MOD-2021-093449 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-093449:1st dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: bad cough; fever; fatigue; achiness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad cough), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (achiness) in a 40-year-old female 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 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 at an unspecified dose. On an unknown date, the patient experienced COUGH (bad cough), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (achiness). At the time of the report, COUGH (bad cough), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Crosslinked to case MOD21-083038 and MOD21-083112.  No relevant concomitant medications reported. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Illness, Pain, Pyrexia
Clinical narrative: really sick; bad cough; achiness; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), COUGH (bad cough), PAIN (achiness), PYREXIA (fever) and FATIGUE (fatigue) in a 40-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick), COUGH (bad cough), PAIN (achiness), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, ILLNESS (really sick), COUGH (bad cough), PAIN (achiness), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.             No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: fatigue; Headache; Muscle aches; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Feb-2021, FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle aches) 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 products also included birth control pills   This case was linked to MOD-2021-018247 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Hypersomnia
Clinical narrative: headaches and difficulty breathing; everything is blurry visually; head starts pounding; sweating; flu-like symptoms; slept from Wednesday to Friday; feels very tired; headaches and difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERSOMNIA (slept from Wednesday to Friday), FATIGUE (feels very tired) and HEADACHE (headaches and difficulty breathing) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, MAGNESIUM and Vitamin C                                                      taken daily for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERSOMNIA (slept from Wednesday to Friday), FATIGUE (feels very tired), HEADACHE (headaches and difficulty breathing), VISION BLURRED (everything is blurry visually) and HEADACHE (head starts pounding). On 25-Apr-2021, the patient experienced DYSPNOEA (headaches and difficulty breathing). On 23-Apr-2021, HYPERSOMNIA (slept from Wednesday to Friday) had resolved. At the time of the report, HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (feels very tired), HEADACHE (headaches and difficulty breathing), DYSPNOEA (headaches and difficulty breathing), VISION BLURRED (everything is blurry visually) and HEADACHE (head starts pounding) 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vision blurred
Clinical narrative: headaches and difficulty breathing; everything is blurry visually; head starts pounding; sweating; flu-like symptoms; slept from Wednesday to Friday; feels very tired; headaches and difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERSOMNIA (slept from Wednesday to Friday), FATIGUE (feels very tired) and HEADACHE (headaches and difficulty breathing) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, MAGNESIUM and Vitamin C                                                      taken daily for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERSOMNIA (slept from Wednesday to Friday), FATIGUE (feels very tired), HEADACHE (headaches and difficulty breathing), VISION BLURRED (everything is blurry visually) and HEADACHE (head starts pounding). On 25-Apr-2021, the patient experienced DYSPNOEA (headaches and difficulty breathing). On 23-Apr-2021, HYPERSOMNIA (slept from Wednesday to Friday) had resolved. At the time of the report, HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (feels very tired), HEADACHE (headaches and difficulty breathing), DYSPNOEA (headaches and difficulty breathing), VISION BLURRED (everything is blurry visually) and HEADACHE (head starts pounding) 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Felt pain in my arm; Felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt pain in my arm) and ASTHENIA (Felt weak) in an 84-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.  Concomitant products included CARVEDILOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Felt pain in my arm) and ASTHENIA (Felt weak). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 PO OD. At the time of the report, PAIN IN EXTREMITY (Felt pain in my arm) had not resolved and ASTHENIA (Felt weak) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant reported wasVitamins used to treat vision. Treatment involved using ice to relieve the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow-up, Events outcome updated
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Oedema peripheral, Skin discolouration
Clinical narrative: edema in feet and legs; feet color change from bright red, dark red to purple; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (edema in feet and legs) and SKIN DISCOLOURATION (feet color change from bright red, dark red to purple) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema in feet and legs) and SKIN DISCOLOURATION (feet color change from bright red, dark red to purple). The patient was treated with POTASSIUM for Potassium replacement, at an unspecified dose and frequency and LISINOPRIL for Diuretic therapy, at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (edema in feet and legs) and SKIN DISCOLOURATION (feet color change from bright red, dark red to purple) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with response to the events are not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Vertigo; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Vertigo) and PYREXIA (Fever) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter. The patient had no known drug allergies (NKDA) .  Concomitant products included ONE-A-DAY WOMEN'S for Nutritional supplement, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.   On 06-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021 at 6:30 AM, the patient experienced VERTIGO (Vertigo) and PYREXIA (Fever). On 04-Feb-2021 at 10:30 AM, VERTIGO (Vertigo) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-008284 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: body ache; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MYALGIA (body ache) and FATIGUE (tired). At the time of the report, MYALGIA (body ache) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: small knot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (small knot on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 NODULE (small knot on her arm). At the time of the report, NODULE (small knot on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information provided.   This case was linked to MOD-2021-094499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: FU: husband's case info given