chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: Dizziness; Sweaty; Ringing in ears; Head pressure; Shaky; Headache; Tired; right arm hurting; pain has shifted to the elbow; felt nauseas; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure) and TREMOR (Shaky) in a 33-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure), TREMOR (Shaky), HEADACHE (Headache), FATIGUE (Tired), MYALGIA (right arm hurting), ARTHRALGIA (pain has shifted to the elbow) and NAUSEA (felt nauseas). At the time of the report, DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure), TREMOR (Shaky), HEADACHE (Headache), FATIGUE (Tired), MYALGIA (right arm hurting), ARTHRALGIA (pain has shifted to the elbow) and NAUSEA (felt nauseas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided Action taken with mRNA-1273 in response to the event was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Non significant follow up accepted on 28-05-21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Tinnitus, Tremor
Clinical narrative: Dizziness; Sweaty; Ringing in ears; Head pressure; Shaky; Headache; Tired; right arm hurting; pain has shifted to the elbow; felt nauseas; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure) and TREMOR (Shaky) in a 33-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure), TREMOR (Shaky), HEADACHE (Headache), FATIGUE (Tired), MYALGIA (right arm hurting), ARTHRALGIA (pain has shifted to the elbow) and NAUSEA (felt nauseas). At the time of the report, DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure), TREMOR (Shaky), HEADACHE (Headache), FATIGUE (Tired), MYALGIA (right arm hurting), ARTHRALGIA (pain has shifted to the elbow) and NAUSEA (felt nauseas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided Action taken with mRNA-1273 in response to the event was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Non significant follow up accepted on 28-05-21
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Body temperature: 99.9 degrees fahrenheit (High) High.         No concomitant medication provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24-MAY-2021.TCR: email obtained
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Swollen tongue, Tinnitus, Urticaria, Vaccination site reaction
Clinical narrative: anxiety; tinnitus in my left ear, tinnitus spread to both ears; a quarter-sized red welt appeared; Covid Arm; tongue felt swollen; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in my left ear, tinnitus spread to both ears), SWOLLEN TONGUE (tongue felt swollen), ANXIETY (anxiety), URTICARIA (a quarter-sized red welt appeared) and VACCINATION SITE REACTION (Covid Arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ACETAMINOPHEN for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWOLLEN TONGUE (tongue felt swollen). On 01-Apr-2021, the patient experienced URTICARIA (a quarter-sized red welt appeared) and VACCINATION SITE REACTION (Covid Arm). On 07-Apr-2021, the patient experienced TINNITUS (tinnitus in my left ear, tinnitus spread to both ears). On 21-Apr-2021, the patient experienced ANXIETY (anxiety). On 05-Apr-2021, URTICARIA (a quarter-sized red welt appeared) had resolved. At the time of the report, TINNITUS (tinnitus in my left ear, tinnitus spread to both ears) had not resolved and SWOLLEN TONGUE (tongue felt swollen), ANXIETY (anxiety) and VACCINATION SITE REACTION (Covid Arm) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-089166 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021: contains No New Information. On 19-Jul-2021: Follow up received on 19 Jul 2021 contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089166:First Dose
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Visual impairment
Clinical narrative: Shingles on right breast; Headache; Trouble focusing eyes; This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (Trouble focusing eyes), HERPES ZOSTER (Shingles on right breast) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Trouble focusing eyes), HERPES ZOSTER (Shingles on right breast) and HEADACHE (Headache). At the time of the report, VISUAL IMPAIRMENT (Trouble focusing eyes) and HEADACHE (Headache) had resolved and HERPES ZOSTER (Shingles on right breast) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to urgent care on 21-Apr-2021 after developing shingles on the right breast on an unknown date. The patient was prescribed valacyclovir 1 gram three times a day.   This case was linked to MOD-2021-089181 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on her arm after getting 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash on her arm after getting 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on her arm after getting 1st dose). At the time of the report, VACCINATION SITE RASH (Rash on her arm after getting 1st dose) outcome was unknown. 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle brachial index, Arthralgia, Hypokinesia, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Pain in leg; It's hard to get up; Sore and cramping in her toes; flu like symptoms; Can't do dusting and simple activities that require bending; Bending down has become difficult; Hurting backs of my legs; pain in hips; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in leg), HYPOKINESIA (It's hard to get up), MUSCLE SPASMS (Sore and cramping in her toes), INFLUENZA LIKE ILLNESS (flu like symptoms) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do dusting and simple activities that require bending) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in leg), HYPOKINESIA (It's hard to get up), MUSCLE SPASMS (Sore and cramping in her toes), INFLUENZA LIKE ILLNESS (flu like symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do dusting and simple activities that require bending), MOVEMENT DISORDER (Bending down has become difficult), PAIN IN EXTREMITY (Hurting backs of my legs) and ARTHRALGIA (pain in hips). At the time of the report, PAIN IN EXTREMITY (Pain in leg), HYPOKINESIA (It's hard to get up), MUSCLE SPASMS (Sore and cramping in her toes), INFLUENZA LIKE ILLNESS (flu like symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do dusting and simple activities that require bending), MOVEMENT DISORDER (Bending down has become difficult), PAIN IN EXTREMITY (Hurting backs of my legs) and ARTHRALGIA (pain in hips) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ankle brachial index: high (High) High.         The patient is on five different medication for her preexisting medical condition which she did not share. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscle spasms, Pain in extremity
Clinical narrative: Pain in leg; It's hard to get up; Sore and cramping in her toes; flu like symptoms; Can't do dusting and simple activities that require bending; Bending down has become difficult; Hurting backs of my legs; pain in hips; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in leg), HYPOKINESIA (It's hard to get up), MUSCLE SPASMS (Sore and cramping in her toes), INFLUENZA LIKE ILLNESS (flu like symptoms) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do dusting and simple activities that require bending) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in leg), HYPOKINESIA (It's hard to get up), MUSCLE SPASMS (Sore and cramping in her toes), INFLUENZA LIKE ILLNESS (flu like symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do dusting and simple activities that require bending), MOVEMENT DISORDER (Bending down has become difficult), PAIN IN EXTREMITY (Hurting backs of my legs) and ARTHRALGIA (pain in hips). At the time of the report, PAIN IN EXTREMITY (Pain in leg), HYPOKINESIA (It's hard to get up), MUSCLE SPASMS (Sore and cramping in her toes), INFLUENZA LIKE ILLNESS (flu like symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do dusting and simple activities that require bending), MOVEMENT DISORDER (Bending down has become difficult), PAIN IN EXTREMITY (Hurting backs of my legs) and ARTHRALGIA (pain in hips) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ankle brachial index: high (High) High.         The patient is on five different medication for her preexisting medical condition which she did not share. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia, Vomiting
Clinical narrative: vomiting (only once); lower back pain; fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), PYREXIA (fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit), CHILLS (chills) and VOMITING (vomiting (only once)) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M1A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced BACK PAIN (lower back pain), PYREXIA (fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit) and CHILLS (chills). On an unknown date, the patient experienced VOMITING (vomiting (only once)). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at a dose of 25 mg. At the time of the report, BACK PAIN (lower back pain), PYREXIA (fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit), CHILLS (chills) and VOMITING (vomiting (only once)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication included pills.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received and contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever all night; body aches all night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever all night) and MYALGIA (body aches all night) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (fever all night) and MYALGIA (body aches all night). At the time of the report, PYREXIA (fever all night) and MYALGIA (body aches all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medication was reported.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; Headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-081017, US-MODERNATX, INC.-MOD-2021-089197, US-MODERNATX, INC.-MOD-2021-089084 (E2B Linked Report).; Sender's Comments:  MOD21-081017: US-MODERNATX, INC.-MOD-2021-089197: US-MODERNATX, INC.-MOD-2021-089084:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Joint swelling, Salivary hypersecretion
Clinical narrative: right eye was swollen; toes swollen; mouth full of water from jaw and throat and taste of medicine on her mouth."; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (mouth full of water from jaw and throat and taste of medicine on her mouth."), EYE SWELLING (right eye was swollen) and JOINT SWELLING (toes swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (mouth full of water from jaw and throat and taste of medicine on her mouth."). On 22-Apr-2021, the patient experienced EYE SWELLING (right eye was swollen) and JOINT SWELLING (toes swollen). At the time of the report, SALIVARY HYPERSECRETION (mouth full of water from jaw and throat and taste of medicine on her mouth."), EYE SWELLING (right eye was swollen) and JOINT SWELLING (toes swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided Patient applied warm water to her swollen right eye.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: NNI
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Experienced severe pain in her calve; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced severe pain in her calve) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Experienced severe pain in her calve). At the time of the report, PAIN IN EXTREMITY (Experienced severe pain in her calve) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac stress test, Chest pain, Dyspnoea, Gait inability
Clinical narrative: Could barely walk; had zero energy; Had hard time breathing; Sweating profusely; Had chest pain; This spontaneous case was reported by an other caregiver and describes the occurrence of GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mast cell activation syndrome.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain). At the time of the report, GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The symptoms were still going on, and the doctors has instructed her not to take the second vaccine. patient  has mast cell activation disease and takes 19 medication, but does know the names of the medication.  Treatment: Patient was given Aspirin but did not help.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Could barely walk; had zero energy; Had hard time breathing; Sweating profusely; Had chest pain; This spontaneous case was reported by an other caregiver and describes the occurrence of GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mast cell activation syndrome.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain). At the time of the report, GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The symptoms were still going on, and the doctors has instructed her not to take the second vaccine. patient  has mast cell activation disease and takes 19 medication, but does know the names of the medication.  Treatment: Patient was given Aspirin but did not help.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Chills, Dizziness
Clinical narrative: weak; dizzy/light headed; felt like her husband had a Covid again; nauseated; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated) and PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UBIDECARENONE (Q10) for Heart failure.    The patient's past medical history included COVID-19 rapid POC test positive on 05-Feb-2021. Concurrent medical conditions included Drug allergy (Librium), Drug allergy (stern) and Drug allergy (losartan). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), INSULIN, HYDROCHLOROTHIAZIDE, INSULIN ASPART (NOVOLOG), SOTALOL HYDROCHLORIDE (SOTALOL AF [SOTALOL HYDROCHLORIDE]), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), CLOPIDOGREL BISULFATE (PLAVIX) and UBIDECARENONE (COENZYME) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UBIDECARENONE (Q10) (unknown route) 200 mg once a day. On 23-Apr-2021, the patient experienced ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 tablets. At the time of the report, ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101.5 (Inconclusive) 101.5 degrees F.     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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: weak; dizzy/light headed; felt like her husband had a Covid again; nauseated; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated) and PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UBIDECARENONE (Q10) for Heart failure.    The patient's past medical history included COVID-19 rapid POC test positive on 05-Feb-2021. Concurrent medical conditions included Drug allergy (Librium), Drug allergy (stern) and Drug allergy (losartan). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), INSULIN, HYDROCHLOROTHIAZIDE, INSULIN ASPART (NOVOLOG), SOTALOL HYDROCHLORIDE (SOTALOL AF [SOTALOL HYDROCHLORIDE]), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), CLOPIDOGREL BISULFATE (PLAVIX) and UBIDECARENONE (COENZYME) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UBIDECARENONE (Q10) (unknown route) 200 mg once a day. On 23-Apr-2021, the patient experienced ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 tablets. At the time of the report, ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101.5 (Inconclusive) 101.5 degrees F.     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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache
Clinical narrative: cold sweating; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweating), CHILLS (chills) and HEADACHE (headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COLD SWEAT (cold sweating), CHILLS (chills) and HEADACHE (headache). On 24-Apr-2021, COLD SWEAT (cold sweating), CHILLS (chills) and HEADACHE (headache) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-089050, MOD-2021-089055, MOD-2021-089063 (E2B Linked Report).; Sender's Comments:  MOD-2021-089050:husband case MOD-2021-089055:wife 1st dosage MOD-2021-089063:wife 2nd dosage case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Headache, Pain in extremity
Clinical narrative: arm sore; arm is burning and hot; arm is burning and hot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), BURNING SENSATION (arm is burning and hot), FEELING HOT (arm is burning and hot) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 (arm sore), BURNING SENSATION (arm is burning and hot), FEELING HOT (arm is burning and hot) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (arm sore), BURNING SENSATION (arm is burning and hot), FEELING HOT (arm is burning and hot) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the Ear post vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in the Ear post vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in the Ear post vaccination). At the time of the report, TINNITUS (Ringing in the Ear post vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided by reported. Treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089095 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089095:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site reaction
Clinical narrative: COVID arm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and PRURITUS (Itchy) 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.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm) and PRURITUS (Itchy). At the time of the report, VACCINATION SITE REACTION (COVID arm) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Possible
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Limb discomfort, Nausea
Clinical narrative: I feel like hot garbage; my feet are heavy; fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and; chills; nausea"; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (I feel like hot garbage), LIMB DISCOMFORT (my feet are heavy), PYREXIA (fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and), CHILLS (chills) and NAUSEA (nausea") in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced FEELING HOT (I feel like hot garbage), LIMB DISCOMFORT (my feet are heavy), PYREXIA (fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and), CHILLS (chills), NAUSEA (nausea") and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, FEELING HOT (I feel like hot garbage), LIMB DISCOMFORT (my feet are heavy), PYREXIA (fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and), CHILLS (chills), NAUSEA (nausea") and HEADACHE (headache) outcome was unknown.            Concomitant medications include blood pressure medication, water pill and vitamin  Upon internal review on 4-Aug-21, the age was corrected to 54 years.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I feel like hot garbage; my feet are heavy; fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and; chills; nausea"; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (I feel like hot garbage), LIMB DISCOMFORT (my feet are heavy), PYREXIA (fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and), CHILLS (chills) and NAUSEA (nausea") in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced FEELING HOT (I feel like hot garbage), LIMB DISCOMFORT (my feet are heavy), PYREXIA (fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and), CHILLS (chills), NAUSEA (nausea") and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, FEELING HOT (I feel like hot garbage), LIMB DISCOMFORT (my feet are heavy), PYREXIA (fever that started at 23Apr2021 at 2am. Temperature has been up and down, highest 101 and), CHILLS (chills), NAUSEA (nausea") and HEADACHE (headache) outcome was unknown.            Concomitant medications include blood pressure medication, water pill and vitamin  Upon internal review on 4-Aug-21, the age was corrected to 54 years.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; CYANOCOBALAMIN (VIT B12) at an unspecified dose and frequency and ASCORBIC ACID (VIT C) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   This case was linked to US-MODERNATX, INC.-MOD-2021-089253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089253:1st Dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: hives on hand that spread to rest of body; itching; The rash spread to the rest of her body; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives on hand that spread to rest of body), PRURITUS (itching) and RASH (The rash spread to the rest of her body) in a 64-year-old female 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (hives on hand that spread to rest of body), PRURITUS (itching) and RASH (The rash spread to the rest of her body). On 19-Mar-2021, URTICARIA (hives on hand that spread to rest of body) had resolved. At the time of the report, PRURITUS (itching) outcome was unknown and RASH (The rash spread to the rest of her body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain at the top of his index figure; injection site pain; left wrist; left elbow; pain in left arm; radiating pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain), PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (left wrist), PAIN (radiating pain) and ARTHRALGIA (left elbow) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain), PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (left wrist), PAIN (radiating pain) and ARTHRALGIA (left elbow). On an unknown date, the patient experienced PAIN (Pain at the top of his index figure). At the time of the report, VACCINATION SITE PAIN (injection site pain), PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (left wrist), PAIN (radiating pain) and ARTHRALGIA (left elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Hyperhidrosis, Influenza like illness, Oral herpes
Clinical narrative: Got abundant(6-8) cold sores in her mouth; Flu like symptoms; Sweating profusely; No appetite could only eat couple of bite; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating profusely), DECREASED APPETITE (No appetite could only eat couple of bite) and ORAL HERPES (Got abundant(6-8) cold sores in her mouth) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included NAPROXEN for an unknown indication.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating profusely) and DECREASED APPETITE (No appetite could only eat couple of bite). On 25-Apr-2021, the patient experienced ORAL HERPES (Got abundant(6-8) cold sores in her mouth). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating profusely), DECREASED APPETITE (No appetite could only eat couple of bite) and ORAL HERPES (Got abundant(6-8) cold sores in her mouth) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Hypersomnia, Oxygen saturation increased, Somnolence
Clinical narrative: Chest is really heavy; Oxygen saturation level is going down to 93. It oscillates between 93-96% and it is normally higher; Slept most of the day; Tired; Felt groggy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt groggy), FATIGUE (Tired), CHEST DISCOMFORT (Chest is really heavy), OXYGEN SATURATION INCREASED (Oxygen saturation level is going down to 93. It oscillates between 93-96% and it is normally higher) and HYPERSOMNIA (Slept most of the day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (Felt groggy), FATIGUE (Tired) and HYPERSOMNIA (Slept most of the day). On 24-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest is really heavy). On an unknown date, the patient experienced OXYGEN SATURATION INCREASED (Oxygen saturation level is going down to 93. It oscillates between 93-96% and it is normally higher). At the time of the report, SOMNOLENCE (Felt groggy), FATIGUE (Tired), CHEST DISCOMFORT (Chest is really heavy) and HYPERSOMNIA (Slept most of the day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: did not feel comfortable; headache in the right side/stood up ok with the headache/headache got worse when the patient laid down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel comfortable) and HEADACHE (headache in the right side/stood up ok with the headache/headache got worse when the patient laid down) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included CARBIDOPA, LEVODOPA (SINEMET) for Parkinson's disease.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FEELING ABNORMAL (did not feel comfortable) and HEADACHE (headache in the right side/stood up ok with the headache/headache got worse when the patient laid down). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel comfortable) and HEADACHE (headache in the right side/stood up ok with the headache/headache got worse when the patient laid down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication:Sinemet 25/100mg, 1 tablet 3 times a day
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Computerised tomogram, Dyspnoea
Clinical narrative: pressure in my chest; Shortness of breathe; rash; fever; headache; This spontaneous case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (pressure in my chest), DYSPNOEA (Shortness of breathe), RASH (rash), PYREXIA (fever) and HEADACHE (headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Ventricular contractions premature on 01-Jan-2015. Concurrent medical conditions included Penicillin allergy. Concomitant products included FLINTSTONES MULTIVITAMINS WITH IRON from 01-Jan-2000 to an unknown date, PROBIOTICS NOS from 01-Jan-2019 to an unknown date and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) from 01-Jan-2019 to an unknown date 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 11-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (headache). On 21-Apr-2021, the patient experienced CHEST DISCOMFORT (pressure in my chest), DYSPNOEA (Shortness of breathe), RASH (rash) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Apr-2021, HEADACHE (headache) had resolved. On 22-Apr-2021, PYREXIA (fever) had resolved. On 25-Apr-2021, DYSPNOEA (Shortness of breathe) had resolved. At the time of the report, CHEST DISCOMFORT (pressure in my chest) and RASH (rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 100.4 (High) 100.4. On 22-Apr-2021, Heart rate: 90-150 (High) Increase 90-150 beats per minute. On 23-Apr-2021, Blood pressure measurement: 128/71 mmHg (High) high. On 23-Apr-2021, Body temperature: 97.5 (High) 97.5. On 23-Apr-2021, Computerised tomogram: abnormal (abnormal) there was a 0.5 cm ground glass optical left.. On 23-Apr-2021, Heart rate: 91 (High) 91 beats per minute. On 23-Apr-2021, Respiratory rate: 18 breaths per minute (abnormal) 18.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In the ER, patient received a CT chest which showed glass opacities.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: update reporter, patient details, lab data, additional event (shortness of breath) and events outcome.