chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dysstasia, Illness
Clinical narrative: Patient wakes up in the morning, sometimes during night also due to ringing sound in ears; patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears; cannot sleep well; Weakness; Dizziness; 6 hours later started with pain in the arm; Couldn't stand; Patient was sick for 2-3 days; Increased fever, tmeperature/fever; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness) and DIZZINESS (Dizziness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (6 hours later started with pain in the arm), DYSSTASIA (Couldn't stand), ILLNESS (Patient was sick for 2-3 days), PYREXIA (Increased fever, tmeperature/fever) and ARTHRALGIA (Knee pain). On an unknown date, the patient experienced TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness) and DIZZINESS (Dizziness). The patient was treated with ACETAMINOPHEN for Pyrexia, at a dose of 1 dosage form. On 02-Mar-2021, DYSSTASIA (Couldn't stand) and PYREXIA (Increased fever, tmeperature/fever) outcome was unknown. At the time of the report, TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN IN EXTREMITY (6 hours later started with pain in the arm), ILLNESS (Patient was sick for 2-3 days) and ARTHRALGIA (Knee pain) outcome was unknown.            No concomitant medications were provided.     Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Contact details, event details were added.; Sender's Comments: na
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Performance status decreased, Pyrexia, Tinnitus
Clinical narrative: Patient wakes up in the morning, sometimes during night also due to ringing sound in ears; patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears; cannot sleep well; Weakness; Dizziness; 6 hours later started with pain in the arm; Couldn't stand; Patient was sick for 2-3 days; Increased fever, tmeperature/fever; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness) and DIZZINESS (Dizziness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (6 hours later started with pain in the arm), DYSSTASIA (Couldn't stand), ILLNESS (Patient was sick for 2-3 days), PYREXIA (Increased fever, tmeperature/fever) and ARTHRALGIA (Knee pain). On an unknown date, the patient experienced TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness) and DIZZINESS (Dizziness). The patient was treated with ACETAMINOPHEN for Pyrexia, at a dose of 1 dosage form. On 02-Mar-2021, DYSSTASIA (Couldn't stand) and PYREXIA (Increased fever, tmeperature/fever) outcome was unknown. At the time of the report, TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN IN EXTREMITY (6 hours later started with pain in the arm), ILLNESS (Patient was sick for 2-3 days) and ARTHRALGIA (Knee pain) outcome was unknown.            No concomitant medications were provided.     Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Contact details, event details were added.; Sender's Comments: na
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fracture since an unknown date.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.            Patient reported she is on a lot of medicine for fractures in her back and other conditions, therefore she was not sure if the vaccine caused the reactions. Patient did not see her provider about the symptoms, she just talked with the nurse. Patient said she only took her normal medication and nothing extra to manage the symptoms.   This case was linked to MOD-2021-064252 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Secound shot was not as severe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Secound shot was not as severe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030b21a and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema (from childhood, reported as worsening cuts on fingers), Degenerative bone disease (Started in 2015. Undergoing physiotherapy for pain), Drug allergy (codeine), Drug allergy (Bacitracin), Blood pressure high and Hypothyroidism. Concomitant products included LOSARTAN for Blood pressure high, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Secound shot was not as severe). On 20-Apr-2021, VACCINATION COMPLICATION (Secound shot was not as severe) had resolved.            Treatment of the events were not reported.   This case was linked to MOD-2021-054508, MOD-2021-135260 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Vaccination complication
Clinical narrative: Felt really, really awful; felt like I was going to die; Suffering from the effects of many discomforts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt really, really awful; felt like I was going to die) and DISCOMFORT (Suffering from the effects of many discomforts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Active lupus).    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 COMPLICATION (Felt really, really awful; felt like I was going to die) and DISCOMFORT (Suffering from the effects of many discomforts). At the time of the report, VACCINATION COMPLICATION (Felt really, really awful; felt like I was going to die) and DISCOMFORT (Suffering from the effects of many discomforts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Translation received on 17-MAY-2021 contains significant information: Added medical history and adverse events.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Took 1st dose of Moderna vaccine on 06Feb2021 and was inquiring as to whether or not he would need to staqrt the series over; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Took 1st dose of Moderna vaccine on 06Feb2021 and was inquiring as to whether or not he would need to staqrt the series over) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-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 PRODUCT DOSE OMISSION ISSUE (Took 1st dose of Moderna vaccine on 06Feb2021 and was inquiring as to whether or not he would need to staqrt the series over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Took 1st dose of Moderna vaccine on 06Feb2021 and was inquiring as to whether or not he would need to staqrt the series over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: No new Information was provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever like 100.2 F; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever like 100.2 F) and MYALGIA (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever like 100.2 F) and MYALGIA (Body aches). On 21-Feb-2021, CHILLS (Chills), PYREXIA (Fever like 100.2 F) and MYALGIA (Body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient underwent unspecified surgery in her left arm in the past. Concomitant medications were not reported. No treatments were taken  by the patient because she was allergic to Tylenol, so she took it easy and put cold compress in her head.     This case was linked to MOD-2021-135394 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Discoloured vomit, Fear of death, Vaccination complication
Clinical narrative: nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed; multiple side effects; I am going to die; I cant even type; I am throwing up with a green color right now; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed), FEAR OF DEATH (I am going to die), ASTHENIA (I cant even type), DISCOLOURED VOMIT (I am throwing up with a green color right now) and VACCINATION COMPLICATION (multiple side effects) 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) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced FEAR OF DEATH (I am going to die), ASTHENIA (I cant even type) and DISCOLOURED VOMIT (I am throwing up with a green color right now). On an unknown date, the patient experienced DIARRHOEA (nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed) and VACCINATION COMPLICATION (multiple side effects). At the time of the report, DIARRHOEA (nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed), FEAR OF DEATH (I am going to die), ASTHENIA (I cant even type), DISCOLOURED VOMIT (I am throwing up with a green color right now) and VACCINATION COMPLICATION (multiple side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication details was provided. No treatment medication details was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reactions were less than the reactions after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions were less than the reactions after the 1st vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 VACCINATION COMPLICATION (Reactions were less than the reactions after the 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Reactions were less than the reactions after the 1st vaccine) outcome was unknown.            Concomitant product information was not provided.  Treatment information was not provided.  After dose 1 was taken patient experienced the event- sore arm and itching but after dose 2 patient stated that the reactions were less than the reactions after the 1st vaccine.   This case was linked to MOD-2021-044350 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: The vaccine was exposed to sunlight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 039B21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included PRAVASTATIN for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight). On 11-May-2021, POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported receiving the second dose of the Moderna COVID-19 vaccine on 11-May-2021, 10 minutes prior to reporting. As of the time when he called in, he had not experienced any side effects. When he received the second dose, the vaccination provider had a box of syringes ready to go in the sunlight, and was opening and closing the box to get a syringe out under the sun. The patient received both doses of the vaccine at a fire department parking lot, through the county health department.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Somnolence, Vaccination site urticaria
Clinical narrative: very sleepy; Tired all the time; Raised, red welt at site of the shot about the size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), VACCINATION SITE URTICARIA (Raised, red welt at site of the shot about the size of an egg) and FATIGUE (Tired all the time) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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 VACCINATION SITE URTICARIA (Raised, red welt at site of the shot about the size of an egg). On an unknown date, the patient experienced SOMNOLENCE (very sleepy) and FATIGUE (Tired all the time). At the time of the report, SOMNOLENCE (very sleepy), VACCINATION SITE URTICARIA (Raised, red welt at site of the shot about the size of an egg) and FATIGUE (Tired all the time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood test: unknown (Inconclusive) blood labs drawn today 05MAY2021 for testing..         Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.    This case was linked to MOD-2021-044371 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: follow-up information include:Event updated(Fatigue)Lab data was added On 20-Jun-2021: event added
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Melanocytic naevus, Myalgia, Nausea
Clinical narrative: Port wine birthmark has faded to almost gone; Port wine birthmark has faded to almost gone; Bad struggled to sleep; Pain in upper arm that radiate to back; Fever; Headache; Bodyache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MELANOCYTIC NAEVUS (Port wine birthmark has faded to almost gone), BACK PAIN (Pain in upper arm that radiate to back), SLEEP DISORDER (Bad struggled to sleep), THERAPEUTIC RESPONSE UNEXPECTED (Port wine birthmark has faded to almost gone) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine since 1990. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for Discomfort in joints, ESTRADIOL for Hormone replacement therapy, MULTIVITAMIN [VITAMINS NOS] for Multi-vitamin maintenance, CALCIUM for Supplementation therapy.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-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 MELANOCYTIC NAEVUS (Port wine birthmark has faded to almost gone), BACK PAIN (Pain in upper arm that radiate to back), SLEEP DISORDER (Bad struggled to sleep), THERAPEUTIC RESPONSE UNEXPECTED (Port wine birthmark has faded to almost gone), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Bodyache) and NAUSEA (Nausea). At the time of the report, MELANOCYTIC NAEVUS (Port wine birthmark has faded to almost gone), BACK PAIN (Pain in upper arm that radiate to back), THERAPEUTIC RESPONSE UNEXPECTED (Port wine birthmark has faded to almost gone), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Bodyache) and NAUSEA (Nausea) had resolved and SLEEP DISORDER (Bad struggled to sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (1-10): 8 (abnormal) 8.         Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-065652 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pyrexia, Sleep disorder, Therapeutic response unexpected
Clinical narrative: Port wine birthmark has faded to almost gone; Port wine birthmark has faded to almost gone; Bad struggled to sleep; Pain in upper arm that radiate to back; Fever; Headache; Bodyache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MELANOCYTIC NAEVUS (Port wine birthmark has faded to almost gone), BACK PAIN (Pain in upper arm that radiate to back), SLEEP DISORDER (Bad struggled to sleep), THERAPEUTIC RESPONSE UNEXPECTED (Port wine birthmark has faded to almost gone) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine since 1990. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for Discomfort in joints, ESTRADIOL for Hormone replacement therapy, MULTIVITAMIN [VITAMINS NOS] for Multi-vitamin maintenance, CALCIUM for Supplementation therapy.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-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 MELANOCYTIC NAEVUS (Port wine birthmark has faded to almost gone), BACK PAIN (Pain in upper arm that radiate to back), SLEEP DISORDER (Bad struggled to sleep), THERAPEUTIC RESPONSE UNEXPECTED (Port wine birthmark has faded to almost gone), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Bodyache) and NAUSEA (Nausea). At the time of the report, MELANOCYTIC NAEVUS (Port wine birthmark has faded to almost gone), BACK PAIN (Pain in upper arm that radiate to back), THERAPEUTIC RESPONSE UNEXPECTED (Port wine birthmark has faded to almost gone), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Bodyache) and NAUSEA (Nausea) had resolved and SLEEP DISORDER (Bad struggled to sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (1-10): 8 (abnormal) 8.         Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-065652 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bedridden, Eye pain, Fatigue
Clinical narrative: Loss of weight; Orbs around my eyes hurt; In bed almost 3 days; loss of taste; Loss of smell; Fever; Overwhelming Fatigue; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste) and ANOSMIA (Loss of smell) in a 76-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.     The patient's past medical history included COVID-19 from 03-Feb-2021 to 23-Feb-2021 and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Drug allergy, Diabetes, Drug allergy, Drug allergy and Drug allergy. Concomitant products included RIVAROXABAN (XARELTO), METFORMIN HCL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), GLYBURIDE, SIMVASTATIN, METOPROLOL TARTRATE, FERROUS SULFATE (SLOW FE), COLECALCIFEROL (D3), LEVOCARNITINE HYDROCHLORIDE, UBIDECARENONE (Q10 + L-CARNITINE), ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, VITAMIN B COMPLEX and CANNABIDIOL (CBD OIL) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), FATIGUE (Overwhelming Fatigue), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), FATIGUE (Overwhelming Fatigue), HEADACHE (Headache) and MYALGIA (Body aches) had not resolved.             Treatment medication was not reported.   This case was linked to MOD-2021-052125 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Weight decreased
Clinical narrative: Loss of weight; Orbs around my eyes hurt; In bed almost 3 days; loss of taste; Loss of smell; Fever; Overwhelming Fatigue; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste) and ANOSMIA (Loss of smell) in a 76-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.     The patient's past medical history included COVID-19 from 03-Feb-2021 to 23-Feb-2021 and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Drug allergy, Diabetes, Drug allergy, Drug allergy and Drug allergy. Concomitant products included RIVAROXABAN (XARELTO), METFORMIN HCL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), GLYBURIDE, SIMVASTATIN, METOPROLOL TARTRATE, FERROUS SULFATE (SLOW FE), COLECALCIFEROL (D3), LEVOCARNITINE HYDROCHLORIDE, UBIDECARENONE (Q10 + L-CARNITINE), ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, VITAMIN B COMPLEX and CANNABIDIOL (CBD OIL) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), FATIGUE (Overwhelming Fatigue), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, WEIGHT DECREASED (Loss of weight), EYE PAIN (Orbs around my eyes hurt), BEDRIDDEN (In bed almost 3 days), AGEUSIA (loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), FATIGUE (Overwhelming Fatigue), HEADACHE (Headache) and MYALGIA (Body aches) had not resolved.             Treatment medication was not reported.   This case was linked to MOD-2021-052125 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left, non-dominant arm in which he received the dose began hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left, non-dominant arm in which he received the dose began hurting) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Previously administered products included for Headache: ASPIRIN [ACETYLSALICYLIC ACID].    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Left, non-dominant arm in which he received the dose began hurting). On 11-Feb-2021, VACCINATION SITE PAIN (Left, non-dominant arm in which he received the dose began hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-040327 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Vaccination complication
Clinical narrative: really really sick; extremely high fever; joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really really sick), PYREXIA (extremely high fever), ARTHRALGIA (joint pain) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (really really sick), PYREXIA (extremely high fever), ARTHRALGIA (joint pain) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (really really sick), PYREXIA (extremely high fever), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown.            The  concomitant medications on use were not provided.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: only really tired and continued to be tired even through the 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (only really tired and continued to be tired even through the 2nd vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 028Az1A) for COVID-19 vaccination.     The patient's past medical history included Nausea and Fever.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced FATIGUE (only really tired and continued to be tired even through the 2nd vaccine). At the time of the report, FATIGUE (only really tired and continued to be tired even through the 2nd vaccine) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter.   This case was linked to MOD-2021-136663, MOD-2021-042717 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction
Clinical narrative: Potential AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Potential AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Potential AE). At the time of the report, ADVERSE DRUG REACTION (Potential AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Mass
Clinical narrative: lump; fever; draining headache; chills; muscle aches; joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump), PYREXIA (fever), HEADACHE (draining headache), CHILLS (chills) and ARTHRALGIA (joint pain) in a female patient of an unknown age 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MASS (lump), PYREXIA (fever), HEADACHE (draining headache), CHILLS (chills), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, MASS (lump), PYREXIA (fever), HEADACHE (draining headache), CHILLS (chills), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown.            The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.    This case was linked to MOD-2021-066157 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: lump; fever; draining headache; chills; muscle aches; joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump), PYREXIA (fever), HEADACHE (draining headache), CHILLS (chills) and ARTHRALGIA (joint pain) in a female patient of an unknown age 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MASS (lump), PYREXIA (fever), HEADACHE (draining headache), CHILLS (chills), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, MASS (lump), PYREXIA (fever), HEADACHE (draining headache), CHILLS (chills), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown.            The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.    This case was linked to MOD-2021-066157 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-042718 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up appended- added  reporter's address, date of birth, date of administration and batch number of first dose, second dose details.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021; he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Fall in January 2021.   On 27-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received Moderna vaccine on 12-feb-2021,  find out that he did receive pfizer covid vaccine on 27-jan-2021) had resolved.            Concomitant medication and treatment drug were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Tinnitus, Vaccination site swelling
Clinical narrative: Heart racing; Tinnitus; Dizziness; Cantaloupe sized injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), TINNITUS (Tinnitus), DIZZINESS (Dizziness) and VACCINATION SITE SWELLING (Cantaloupe sized injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 041C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PALPITATIONS (Heart racing), TINNITUS (Tinnitus), DIZZINESS (Dizziness) and VACCINATION SITE SWELLING (Cantaloupe sized injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-May-2021, PALPITATIONS (Heart racing) and VACCINATION SITE SWELLING (Cantaloupe sized injection site) had resolved. At the time of the report, TINNITUS (Tinnitus) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-137496 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Tinnitus
Clinical narrative: Dizziness; Tinnitus; Confusion; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), TINNITUS (Tinnitus) and CONFUSIONAL STATE (Confusion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced DIZZINESS (Dizziness), TINNITUS (Tinnitus) and CONFUSIONAL STATE (Confusion). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), TINNITUS (Tinnitus) and CONFUSIONAL STATE (Confusion) outcome was unknown.            Concomitant medication information was not provided.     This case was linked to MOD-2021-137462 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of the vaccine administered after day 36 from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine administered after day 36 from the first dose) in a 31-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) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine administered after day 36 from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine administered after day 36 from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient has not received  the second dose at the scheduled time because he moved; and his second dose was within the time frame when the pharmacist was not accepting walk-ins so the patient did not try to come in.  Action taken with mRNA-1273 with respect to events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash behind knee; This spontaneous case was reported by an other caregiver and describes the occurrence of RASH (Rash behind knee) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash behind knee). At the time of the report, RASH (Rash behind knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-138739 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138739:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fear, Heart rate increased, Myalgia
Clinical narrative: Afraid/ very scary; Confused; Heart began to beat very, very fast; Felt cold; Pain in her neck; Chills; Body hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (Afraid/ very scary), CONFUSIONAL STATE (Confused), HEART RATE INCREASED (Heart began to beat very, very fast), NASOPHARYNGITIS (Felt cold) and NECK PAIN (Pain in her neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced FEAR (Afraid/ very scary), CONFUSIONAL STATE (Confused), HEART RATE INCREASED (Heart began to beat very, very fast), NASOPHARYNGITIS (Felt cold), NECK PAIN (Pain in her neck), CHILLS (Chills) and MYALGIA (Body hurt). The patient was treated with MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency. On 10-May-2021, CONFUSIONAL STATE (Confused), HEART RATE INCREASED (Heart began to beat very, very fast), NASOPHARYNGITIS (Felt cold), NECK PAIN (Pain in her neck), CHILLS (Chills) and MYALGIA (Body hurt) had resolved. At the time of the report, FEAR (Afraid/ very scary) 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 product use was not provided by the reporter.