chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Product storage error, Pyrexia
Clinical narrative: Body ache; Chills; Fever; Second dose was stored incorrectly; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and PRODUCT STORAGE ERROR (Second dose was stored incorrectly) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and PRODUCT STORAGE ERROR (Second dose was stored incorrectly). On 02-Apr-2021, PRODUCT STORAGE ERROR (Second dose was stored incorrectly) had resolved. On 03-Apr-2021, MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: she wobbles; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (she wobbles) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced GAIT DISTURBANCE (she wobbles). At the time of the report, GAIT DISTURBANCE (she wobbles) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.  It was reported that patient required MRI as she wobbled.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080185 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Foot fracture
Clinical narrative: fractured her foot; Caller fell and fractured her foot; This spontaneous case was reported by a consumer and describes the occurrence of FOOT FRACTURE (fractured her foot) and FALL (Caller fell and fractured her foot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), ROPINIROLE HYDROCHLORIDE (REQUIP), OXYBUTYNIN, ALPRAZOLAM (XANAX), PREDNISONE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced FOOT FRACTURE (fractured her foot) and FALL (Caller fell and fractured her foot). At the time of the report, FOOT FRACTURE (fractured her foot) had not resolved and FALL (Caller fell and fractured her foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: no new information
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache, Hypopnoea, Myalgia
Clinical narrative: Entire body got swollen; Weird dizziness; Felt warm; Llittle bit of a headache; Achy body; Shallow breathing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOPNOEA (Shallow breathing), SWELLING (Entire body got swollen), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm) and PAIN IN EXTREMITY (Sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergies to food additives and preservatives) and Vitamin D deficiency.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 03-Apr-2021, the patient experienced HYPOPNOEA (Shallow breathing), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm), HEADACHE (Llittle bit of a headache) and MYALGIA (Achy body). On 08-Apr-2021, the patient experienced SWELLING (Entire body got swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and Manual therapy (Rubbed all the lymph areas and that calmed the swelling down) for Swelling. On 16-Apr-2021, HYPOPNOEA (Shallow breathing), SWELLING (Entire body got swollen), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm), PAIN IN EXTREMITY (Sore arm), HEADACHE (Llittle bit of a headache) and MYALGIA (Achy body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Entire body got swollen; Weird dizziness; Felt warm; Llittle bit of a headache; Achy body; Shallow breathing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOPNOEA (Shallow breathing), SWELLING (Entire body got swollen), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm) and PAIN IN EXTREMITY (Sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergies to food additives and preservatives) and Vitamin D deficiency.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 03-Apr-2021, the patient experienced HYPOPNOEA (Shallow breathing), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm), HEADACHE (Llittle bit of a headache) and MYALGIA (Achy body). On 08-Apr-2021, the patient experienced SWELLING (Entire body got swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and Manual therapy (Rubbed all the lymph areas and that calmed the swelling down) for Swelling. On 16-Apr-2021, HYPOPNOEA (Shallow breathing), SWELLING (Entire body got swollen), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm), PAIN IN EXTREMITY (Sore arm), HEADACHE (Llittle bit of a headache) and MYALGIA (Achy body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus, Skin warm, Vaccination site rash
Clinical narrative: Itch; Warm to touch; Soreness and ache; COVID arm rash; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch), SKIN WARM (Warm to touch), PAIN (Soreness and ache), VACCINATION SITE RASH (COVID arm rash) and FATIGUE (Tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 09-Apr-2021, the patient experienced PRURITUS (Itch), SKIN WARM (Warm to touch), PAIN (Soreness and ache), VACCINATION SITE RASH (COVID arm rash) and FATIGUE (Tired). At the time of the report, PRURITUS (Itch), SKIN WARM (Warm to touch), PAIN (Soreness and ache), VACCINATION SITE RASH (COVID arm rash) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the COVID arm rash included cortisone cream.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Irritability, Lethargy, Tinnitus
Clinical narrative: Not feeling great; Ringing in left ear mostly; "It's annoying, not detrimental"; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling great), TINNITUS (Ringing in left ear mostly), IRRITABILITY ("It's annoying, not detrimental") and LETHARGY (Lethargic) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling great), TINNITUS (Ringing in left ear mostly), IRRITABILITY ("It's annoying, not detrimental") and LETHARGY (Lethargic). On 22-Mar-2021, FEELING ABNORMAL (Not feeling great) and LETHARGY (Lethargic) had resolved. At the time of the report, TINNITUS (Ringing in left ear mostly) had not resolved and IRRITABILITY ("It's annoying, not detrimental") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Thyroid medication.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090168:crosslinked
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear pain, Fatigue, Headache
Clinical narrative: Head Hurt when Coughing; Inner Ear Hurt; Fatigue; Muscle Aches; Mild Chills (After Second Vaccine); Mild sore injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Mild Chills (After Second Vaccine)), HEADACHE (Headache), EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild sore injection site). On 14-Apr-2021, the patient experienced CHILLS (Mild Chills (After Second Vaccine)). On 15-Apr-2021, the patient experienced EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches). On 16-Apr-2021, the patient experienced COUGH (Head Hurt when Coughing). On 18-Mar-2021, VACCINATION SITE PAIN (Mild sore injection site) had resolved. On 16-Apr-2021, HEADACHE (Headache), EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches) had resolved. On 17-Apr-2021, CHILLS (Mild Chills (After Second Vaccine)) and COUGH (Head Hurt when Coughing) had resolved. Not Provided          Treatment included Tylenol   This case was linked to MOD-2021-080321 (E2B Linked Report).; Sender's Comments:  MOD-2021-080321:Second dose of vaccine case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Head Hurt when Coughing; Inner Ear Hurt; Fatigue; Muscle Aches; Mild Chills (After Second Vaccine); Mild sore injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Mild Chills (After Second Vaccine)), HEADACHE (Headache), EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild sore injection site). On 14-Apr-2021, the patient experienced CHILLS (Mild Chills (After Second Vaccine)). On 15-Apr-2021, the patient experienced EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches). On 16-Apr-2021, the patient experienced COUGH (Head Hurt when Coughing). On 18-Mar-2021, VACCINATION SITE PAIN (Mild sore injection site) had resolved. On 16-Apr-2021, HEADACHE (Headache), EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches) had resolved. On 17-Apr-2021, CHILLS (Mild Chills (After Second Vaccine)) and COUGH (Head Hurt when Coughing) had resolved. Not Provided          Treatment included Tylenol   This case was linked to MOD-2021-080321 (E2B Linked Report).; Sender's Comments:  MOD-2021-080321:Second dose of vaccine case
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Musculoskeletal chest pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: hard to sleep; right arm sore; left side near his ribs started hurting; pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle; stiff neck; pain returned and it started to radiate from his left arm into his neck down his shoulder on the; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the), INSOMNIA (hard to sleep), PAIN IN EXTREMITY (right arm sore) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 032b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site hurt). On 17-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the). On 19-Mar-2021, the patient experienced ARTHRALGIA (pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (right arm sore) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting). On an unknown date, the patient experienced INSOMNIA (hard to sleep). On 17-Mar-2021, VACCINATION SITE PAIN (injection site hurt) had resolved. On 19-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved. At the time of the report, NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the), PAIN IN EXTREMITY (right arm sore) and ARTHRALGIA (pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle) had resolved and INSOMNIA (hard to sleep) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting) outcome was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: hard to sleep; right arm sore; left side near his ribs started hurting; pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle; stiff neck; pain returned and it started to radiate from his left arm into his neck down his shoulder on the; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the), INSOMNIA (hard to sleep), PAIN IN EXTREMITY (right arm sore) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 032b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site hurt). On 17-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the). On 19-Mar-2021, the patient experienced ARTHRALGIA (pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (right arm sore) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting). On an unknown date, the patient experienced INSOMNIA (hard to sleep). On 17-Mar-2021, VACCINATION SITE PAIN (injection site hurt) had resolved. On 19-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved. At the time of the report, NECK PAIN (pain returned and it started to radiate from his left arm into his neck down his shoulder on the), PAIN IN EXTREMITY (right arm sore) and ARTHRALGIA (pain returned and it started to radiate from his left arm into his neck down his shoulder on the inside near his spine following the muscle) had resolved and INSOMNIA (hard to sleep) and MUSCULOSKELETAL CHEST PAIN (left side near his ribs started hurting) outcome was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site hot to the touch after 1st dose; Injection site itchy after 1st dose; Injection site red after 1st dose; Injection site swollen after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) outcome was unknown and VACCINATION SITE SWELLING (Injection site swollen after 1st dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided Treatment product  included Cold compress.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: Under right arm lymph nodes became swollen and tender; Headaches which came and went; Fatigue; Mildly sore injection site.; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Under right arm lymph nodes became swollen and tender), HEADACHE (Headaches which came and went), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mildly sore injection site.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mildly sore injection site.). On 27-Mar-2021, the patient experienced LYMPHADENOPATHY (Under right arm lymph nodes became swollen and tender), HEADACHE (Headaches which came and went) and FATIGUE (Fatigue). At the time of the report, LYMPHADENOPATHY (Under right arm lymph nodes became swollen and tender), HEADACHE (Headaches which came and went), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mildly sore injection site.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 07-Mar-2021 and the estimated date of delivery was 19-Dec-2021. On 26-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient talked to her primary care physicians who recommended delaying the second dose of the vaccine until the second trimester of the Pregnancy . Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of MEDICATION ERROR (about 300 people received a vaccine after an excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical history 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 MEDICATION ERROR (about 300 people received a vaccine after an excursion). At the time of the report, MEDICATION ERROR (about 300 people received a vaccine after an excursion) 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. No Concomitant  information was  provided. No Treatment information was  provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: his arm swollen; bleeding in the injection site; his arm hurting a lot; weakness; fever; chills; nausea; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness) and PYREXIA (fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (constant headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (constant headache) outcome was unknown.            No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant FU - Email address provided; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080260:crosslinked
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site haemorrhage
Clinical narrative: his arm swollen; bleeding in the injection site; his arm hurting a lot; weakness; fever; chills; nausea; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness) and PYREXIA (fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (constant headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (constant headache) outcome was unknown.            No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant FU - Email address provided; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080260:crosslinked
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia, Injection site pain
Clinical narrative: immediately collapsed; she couldn't feel her feet and her feet felt numb; immediately collapsed; she couldn't feel her feet and her feet felt numb; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (immediately collapsed; she couldn't feel her feet and her feet felt numb), FALL (immediately collapsed; she couldn't feel her feet and her feet felt numb) and INJECTION SITE PAIN (injection site pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 15-Apr-2021, the patient experienced HYPOAESTHESIA (immediately collapsed; she couldn't feel her feet and her feet felt numb) and FALL (immediately collapsed; she couldn't feel her feet and her feet felt numb). On 14-Apr-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, HYPOAESTHESIA (immediately collapsed; she couldn't feel her feet and her feet felt numb) and FALL (immediately collapsed; she couldn't feel her feet and her feet felt numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-080418 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080418:Crosslinked
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear pain, Fatigue, Feeling abnormal
Clinical narrative: Head Hurt when Coughing; Inner Ear Hurt; Muscle aches; Fatigue; headache/when coughed her Head hurt; felt like she was Ran Over by a Truck; Mild Chills (After Second Vaccine).; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was Ran Over by a Truck), COUGH (Head Hurt when Coughing), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches) and CHILLS (Mild Chills (After Second Vaccine).) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Mild Chills (After Second Vaccine).). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (felt like she was Ran Over by a Truck), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches), FATIGUE (Fatigue) and HEADACHE (headache/when coughed her Head hurt). On 16-Apr-2021, the patient experienced COUGH (Head Hurt when Coughing). On 16-Apr-2021, FEELING ABNORMAL (felt like she was Ran Over by a Truck), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches) and FATIGUE (Fatigue) had resolved. On 17-Apr-2021, COUGH (Head Hurt when Coughing), CHILLS (Mild Chills (After Second Vaccine).) and HEADACHE (headache/when coughed her Head hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment for the events was taken with Tylenol.   This case was linked to MOD-2021-080312 (E2B Linked Report).; Sender's Comments:  MOD-2021-080312:First dose of vaccine case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Head Hurt when Coughing; Inner Ear Hurt; Muscle aches; Fatigue; headache/when coughed her Head hurt; felt like she was Ran Over by a Truck; Mild Chills (After Second Vaccine).; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was Ran Over by a Truck), COUGH (Head Hurt when Coughing), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches) and CHILLS (Mild Chills (After Second Vaccine).) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Mild Chills (After Second Vaccine).). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (felt like she was Ran Over by a Truck), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches), FATIGUE (Fatigue) and HEADACHE (headache/when coughed her Head hurt). On 16-Apr-2021, the patient experienced COUGH (Head Hurt when Coughing). On 16-Apr-2021, FEELING ABNORMAL (felt like she was Ran Over by a Truck), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches) and FATIGUE (Fatigue) had resolved. On 17-Apr-2021, COUGH (Head Hurt when Coughing), CHILLS (Mild Chills (After Second Vaccine).) and HEADACHE (headache/when coughed her Head hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment for the events was taken with Tylenol.   This case was linked to MOD-2021-080312 (E2B Linked Report).; Sender's Comments:  MOD-2021-080312:First dose of vaccine case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: hardness at the injection site; swelling at the injection site; redness (dark pink) at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness (dark pink) at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Blood pressure fluctuation.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness (dark pink) at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness (dark pink) at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was provided with blood pressure medication and supplements as concomitant medication.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Stabbing pain in arm during 1st dose; 1st dose more painful than other shots; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Stabbing pain in arm during 1st dose) and VACCINATION SITE PAIN (1st dose more painful than other shots) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) for COVID-19 vaccination.     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 experienced PAIN IN EXTREMITY (Stabbing pain in arm during 1st dose) and VACCINATION SITE PAIN (1st dose more painful than other shots). At the time of the report, PAIN IN EXTREMITY (Stabbing pain in arm during 1st dose) and VACCINATION SITE PAIN (1st dose more painful than other shots) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports not having excessive bleeding after the 1st dose.   Concomitant product use was not provided by the reporter.    Treatment ice pack for pain.   This case was linked to MOD-2021-148615 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006321A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN (Soreness). The patient was treated with MELOXICAM at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (Soreness) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.    This case was linked to MOD-2021-080291, MOD-2021-080302 (E2B Linked Report).; Sender's Comments:  MOD-2021-080291:1st dose of fiance MOD-2021-080302:2nd dose of fiance
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Pyrexia, Vaccination site pain
Clinical narrative: Shortness of breath; Felt like when patient had COVID19 Virus; Knot at injection site; Fever; Chills; Injected arm was very sore; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), COVID-19 (Felt like when patient had COVID19 Virus), VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in January 2021.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Injected arm was very sore). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) and COVID-19 (Felt like when patient had COVID19 Virus). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), COVID-19 (Felt like when patient had COVID19 Virus), VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Injected arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant products used for Hypertension ,Hyperlipidemia and Thyroid however the product information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Shortness of breath; Felt like when patient had COVID19 Virus; Knot at injection site; Fever; Chills; Injected arm was very sore; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), COVID-19 (Felt like when patient had COVID19 Virus), VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in January 2021.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Injected arm was very sore). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) and COVID-19 (Felt like when patient had COVID19 Virus). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), COVID-19 (Felt like when patient had COVID19 Virus), VACCINATION SITE REACTION (Knot at injection site), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Injected arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant products used for Hypertension ,Hyperlipidemia and Thyroid however the product information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It's hot to touch; A bump at the injection site; A redness at the injection site, 5 inches long and 2 inches depth; Dizziness; Stomachaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomachaches), VACCINATION SITE WARMTH (It's hot to touch), VACCINATION SITE SWELLING (A bump at the injection site) and VACCINATION SITE ERYTHEMA (A redness at the injection site, 5 inches long and 2 inches depth) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomachaches). On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (It's hot to touch), VACCINATION SITE SWELLING (A bump at the injection site) and VACCINATION SITE ERYTHEMA (A redness at the injection site, 5 inches long and 2 inches depth). On 11-Apr-2021, DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomachaches) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's hot to touch), VACCINATION SITE SWELLING (A bump at the injection site) and VACCINATION SITE ERYTHEMA (A redness at the injection site, 5 inches long and 2 inches depth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hypersomnia, Pain
Clinical narrative: Can not get the 2nd shot; difficulty breathing upon minimal exertion; pain everywhere; fatigue (slept for 5 days); chills; fatigue (slept for 5 days); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot), DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)), CHILLS (chills) and FATIGUE (fatigue (slept for 5 days)). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot) had resolved and DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)), CHILLS (chills) and FATIGUE (fatigue (slept for 5 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to MOD-2021-079973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Event added. On 31-Jul-2021: Follow-up information included no new information. On 04-Aug-2021: Follow-up information included no new information.