chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: unstable blood pressure; bruised left finger/ bruised right arm; pink eye; hyperventilated; rosacea; hives; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives), CONTUSION (bruised left finger/ bruised right arm), ROSACEA (rosacea), EYE COLOUR CHANGE (pink eye) and HYPERVENTILATION (hyperventilated) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Drug allergy (Severe allergic reactions to Cefaclor 10 years ago causing near death). Concurrent medical conditions included Blood pressure high, COPD, Arthritis (RA, psoriatic), Osteoporosis (Osteoporosis of hip) and Spinal pain (chronic spinal pain).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VOMITING (vomiting). On 10-Apr-2021, the patient experienced URTICARIA (hives). On 13-Apr-2021, the patient experienced ROSACEA (rosacea). On 16-Apr-2021, the patient experienced EYE COLOUR CHANGE (pink eye) and HYPERVENTILATION (hyperventilated). On 06-May-2021, the patient experienced CONTUSION (bruised left finger/ bruised right arm). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (unstable blood pressure). At the time of the report, URTICARIA (hives), CONTUSION (bruised left finger/ bruised right arm), ROSACEA (rosacea), EYE COLOUR CHANGE (pink eye), HYPERVENTILATION (hyperventilated), BLOOD PRESSURE ABNORMAL (unstable blood pressure) and VOMITING (vomiting) 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 Relevant concomitant medications was reported. Treatment information included administration of Decadron injection on 13-Apr-2021 and 16-Apr-2021 for severe allergic reactions.
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fibromyalgia
Clinical narrative: increased fibromyalgia; lack of endurance, decreased exercise; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (increased fibromyalgia) and EXERCISE TOLERANCE DECREASED (lack of endurance, decreased exercise) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FIBROMYALGIA (increased fibromyalgia) and EXERCISE TOLERANCE DECREASED (lack of endurance, decreased exercise). At the time of the report, FIBROMYALGIA (increased fibromyalgia) had not resolved and EXERCISE TOLERANCE DECREASED (lack of endurance, decreased exercise) outcome was unknown.            She had severe lack of endurance  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient history of Fibromyalgia is a strong confounder.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient history of Fibromyalgia is a strong confounder.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Oropharyngeal pain, Psoriasis, Rash papular
Clinical narrative: Psoriasis; swollen lymph nodes  in neck,ears,face, clavicle; Sore throat; body covered in bumps head to toe; swallowing difficult; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RASH PAPULAR (body covered in bumps head to toe), DYSPHAGIA (swallowing difficult), PSORIASIS (Psoriasis) and LYMPHADENOPATHY (swollen lymph nodes  in neck,ears,face, clavicle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 06-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) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 16-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RASH PAPULAR (body covered in bumps head to toe), DYSPHAGIA (swallowing difficult) and LYMPHADENOPATHY (swollen lymph nodes  in neck,ears,face, clavicle). On an unknown date, the patient experienced PSORIASIS (Psoriasis). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RASH PAPULAR (body covered in bumps head to toe), DYSPHAGIA (swallowing difficult), PSORIASIS (Psoriasis) and LYMPHADENOPATHY (swollen lymph nodes  in neck,ears,face, clavicle) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Pharyngeal swelling, Pulmonary function test decreased, Swollen tongue
Clinical narrative: pulse rate high; throat and tongue swelling; throat and tongue swelling; decreased lung function; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat and tongue swelling), SWOLLEN TONGUE (throat and tongue swelling), PULMONARY FUNCTION TEST DECREASED (decreased lung function), DYSPNOEA (shortness of breath) and HEART RATE INCREASED (pulse rate high) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB (ACTEMRA), PANTOPRAZOLE, METHOTREXATE and PREDNISONE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PHARYNGEAL SWELLING (throat and tongue swelling) and SWOLLEN TONGUE (throat and tongue swelling). In April 2021, the patient experienced PULMONARY FUNCTION TEST DECREASED (decreased lung function) and DYSPNOEA (shortness of breath). On 05-May-2021, the patient experienced HEART RATE INCREASED (pulse rate high). On 14-Apr-2021, PHARYNGEAL SWELLING (throat and tongue swelling) and SWOLLEN TONGUE (throat and tongue swelling) had resolved. At the time of the report, PULMONARY FUNCTION TEST DECREASED (decreased lung function) outcome was unknown and DYSPNOEA (shortness of breath) and HEART RATE INCREASED (pulse rate high) had not resolved.            No treatment medication was reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood gases, Chest discomfort, Chills, Dyspnoea, Headache
Clinical narrative: felt like she had pneumonia; felt like panic attacks; heart would skip a beat; gasping for breath; low grade fever; chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath) and PYREXIA (low grade fever) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood gases: low (Low) had low blood oxygen levels.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, she went to a doctor, and started treatment with an antibiotic. On another future, unknown date, she went to different doctor, who confirmed that she had low blood oxygen levels that continued into Apr-2021.  Very limited information regarding this event/s has been provided at this time.  Further information is not expected as the patient has declined follow-up.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information is not expected as the patient has declined follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Pyrexia
Clinical narrative: felt like she had pneumonia; felt like panic attacks; heart would skip a beat; gasping for breath; low grade fever; chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath) and PYREXIA (low grade fever) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood gases: low (Low) had low blood oxygen levels.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, she went to a doctor, and started treatment with an antibiotic. On another future, unknown date, she went to different doctor, who confirmed that she had low blood oxygen levels that continued into Apr-2021.  Very limited information regarding this event/s has been provided at this time.  Further information is not expected as the patient has declined follow-up.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information is not expected as the patient has declined follow-up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 23-Mar-2021, PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided   This case was linked to MOD-2021-039179 (Linked Report). This case was linked to MOD21-086779, MOD-2021-039179 (Patient Link).; Sender's Comments:  MOD-2021-039179:1st Dose
Sex: U
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: need second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (need second shot) 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 an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (need second shot). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (need second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days; Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days; 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days) and PRODUCT STORAGE ERROR (Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days) and PRODUCT STORAGE ERROR (Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days) and PRODUCT STORAGE ERROR (Patients administered with vaccine refrigerated temperature at 2° to 8°C longer than 30 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse used her two fingers down firm massage technique in injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 008B21-2A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse used her two fingers down firm massage technique in injection site). On 03-May-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse used her two fingers down firm massage technique in injection site) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient concerned that after second shot the nurse used her two fingers down firm massage technique in injection site. The patient reported that, she had concerns of effectiveness of second injection as she read that due to big size of mRNA the rubbing of injection site can destroy the vaccine. Concomitant medications were not reported. No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Eye pruritus, Eye swelling, Lip swelling, Rhinorrhoea
Clinical narrative: allergic reaction; eyes swollen shut; eye itching; lips swollen; nose did not stop running; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction), EYE SWELLING (eyes swollen shut), EYE PRURITUS (eye itching), LIP SWELLING (lips swollen) and RHINORRHEA (nose did not stop running) in a 63-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO VACCINE (allergic reaction), EYE SWELLING (eyes swollen shut), EYE PRURITUS (eye itching), LIP SWELLING (lips swollen) and RHINORRHEA (nose did not stop running). At the time of the report, ALLERGY TO VACCINE (allergic reaction) outcome was unknown and EYE SWELLING (eyes swollen shut), EYE PRURITUS (eye itching), LIP SWELLING (lips swollen) and RHINORRHEA (nose did not stop running) had resolved. Not Provided          Treatment medication included prednisone for allergic reaction.   This case was linked to US-MODERNATX, INC.-MOD-2021-089104 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089104:cross link
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: Lethargy; Body aches; Chills/shivers; Low grade fever; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN (Body aches), CHILLS (Chills/shivers), PYREXIA (Low grade fever) and INJECTION SITE PAIN (Injection site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021 at 5:30 AM, the patient experienced LETHARGY (Lethargy). 09-Apr-2021 at 5:30 AM, the patient experienced PAIN (Body aches), CHILLS (Chills/shivers), PYREXIA (Low grade fever) and INJECTION SITE PAIN (Injection site pain). On 10-Apr-2021, LETHARGY (Lethargy), PAIN (Body aches), CHILLS (Chills/shivers), PYREXIA (Low grade fever) and INJECTION SITE PAIN (Injection site pain) had resolved.            Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information received on 07-MAY-2021, Updated new event Lethargy and outcome of the event low-grade fever as resolved. Added concomitant medications.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: lot number in registry...compromised;no updated information; two patients received this lot#; 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 POOR QUALITY PRODUCT ADMINISTERED (lot number in registry...compromised;no updated information; two patients received this lot#) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (lot number in registry...compromised;no updated information; two patients received this lot#). On 06-May-2021, POOR QUALITY PRODUCT ADMINISTERED (lot number in registry..compromised;no updated information; two patients received this lot#) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events was not reported. Concomitant medication use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: No new information On 11-Jun-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Ear pain, Facial pain, Headache
Clinical narrative: Intense Daily pressure headaches; L  facial and eye pain; Intense Daily pressure headaches; L  facial and eye pain; L  facial and eye pain; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (Intense Daily pressure headaches), FACIAL PAIN (L  facial and eye pain), EAR PAIN (L  facial and eye pain), CONDITION AGGRAVATED (L  facial and eye pain) and HEADACHE (Intense Daily pressure headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011L20A) for an unknown indication.     Concurrent medical conditions included Drug allergy (Erythromycin, Augmentin, Cefalexin.), Anxiety in February 2019 and Depression in February 2019. Concomitant products included DULOXETINE for Depression, VITAMIN C [ASCORBIC ACID] for Product used for unknown indication, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced FACIAL PAIN (L  facial and eye pain), EAR PAIN (L  facial and eye pain) and HEADACHE (Intense Daily pressure headaches). On 09-Feb-2021, the patient experienced CONDITION AGGRAVATED (Intense Daily pressure headaches) and CONDITION AGGRAVATED (L  facial and eye pain). The patient was treated with SUMATRIPTAN at an unspecified dose and frequency; HYDROCODONE at an unspecified dose and frequency; INDOMETHACIN [INDOMETACIN] at an unspecified dose and frequency; TOPIRAMATE at an unspecified dose and frequency; NORTRIPTYLINE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; LAMOTRIGINE at an unspecified dose and frequency and ACETAZOLAMIDE SODIUM (DIAMOX [ACETAZOLAMIDE SODIUM]) at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Intense Daily pressure headaches), FACIAL PAIN (L  facial and eye pain), EAR PAIN (L  facial and eye pain), CONDITION AGGRAVATED (L  facial and eye pain) and HEADACHE (Intense Daily pressure headaches) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Computerised tomogram: normal. On 14-Feb-2021, Magnetic resonance imaging: (normal) MRI contrast..         This case was linked to MOD-2021-016054, MOD-2021-016054 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Intense Daily pressure headaches; L  facial and eye pain; Intense Daily pressure headaches; L  facial and eye pain; L  facial and eye pain; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (Intense Daily pressure headaches), FACIAL PAIN (L  facial and eye pain), EAR PAIN (L  facial and eye pain), CONDITION AGGRAVATED (L  facial and eye pain) and HEADACHE (Intense Daily pressure headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011L20A) for an unknown indication.     Concurrent medical conditions included Drug allergy (Erythromycin, Augmentin, Cefalexin.), Anxiety in February 2019 and Depression in February 2019. Concomitant products included DULOXETINE for Depression, VITAMIN C [ASCORBIC ACID] for Product used for unknown indication, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced FACIAL PAIN (L  facial and eye pain), EAR PAIN (L  facial and eye pain) and HEADACHE (Intense Daily pressure headaches). On 09-Feb-2021, the patient experienced CONDITION AGGRAVATED (Intense Daily pressure headaches) and CONDITION AGGRAVATED (L  facial and eye pain). The patient was treated with SUMATRIPTAN at an unspecified dose and frequency; HYDROCODONE at an unspecified dose and frequency; INDOMETHACIN [INDOMETACIN] at an unspecified dose and frequency; TOPIRAMATE at an unspecified dose and frequency; NORTRIPTYLINE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; LAMOTRIGINE at an unspecified dose and frequency and ACETAZOLAMIDE SODIUM (DIAMOX [ACETAZOLAMIDE SODIUM]) at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Intense Daily pressure headaches), FACIAL PAIN (L  facial and eye pain), EAR PAIN (L  facial and eye pain), CONDITION AGGRAVATED (L  facial and eye pain) and HEADACHE (Intense Daily pressure headaches) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Computerised tomogram: normal. On 14-Feb-2021, Magnetic resonance imaging: (normal) MRI contrast..         This case was linked to MOD-2021-016054, MOD-2021-016054 (Patient Link).   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypotension, Vaccination site pain
Clinical narrative: Low Blood Pressure; Site soreness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low Blood Pressure), VACCINATION SITE PAIN (Site soreness) and FATIGUE (Tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Exercise induced asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] and BECLOMETASONE DIPROPIONATE (QVAR) for Exercise induced asthma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPOTENSION (Low Blood Pressure), VACCINATION SITE PAIN (Site soreness) and FATIGUE (Tired). On 04-Feb-2021, VACCINATION SITE PAIN (Site soreness) and FATIGUE (Tired) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: low (Low) Low.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient has increased salt intake to increase the blood pressure.   This case was linked to MOD21-050566 (E2B Linked Report). This case was linked to MOD-2021-116640.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up document received on 07-MAY-2021. Patient's date of birth was verified. It contains no new information.; Sender's Comments:  MOD21-050566.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rotator cuff syndrome, Vaccination site pain
Clinical narrative: Rotator cuff tear; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff tear) and VACCINATION SITE PAIN (Vaccination site pain) 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 LENVATINIB MESILATE (LENVIMA) for an unknown indication.    Concurrent medical conditions included Uterine cancer. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On 04-Feb-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram once a day. On 03-May-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tear) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff tear) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication were provided.   This case was linked to MOD-2021-112220 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initial additional document was received on 07-MAY-2021.It contains identification number and follow up AER number. It contains non significant information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time prolonged
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of prolonged activated partial thromboplastin time (PTT is greater than 200 seconds) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. Concurrent medical conditions included increased blood pressure and vitamin D deficiency. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 13, 2021, patient experienced prolonged activated partial thromboplastin time (PTT is greater than 200 seconds). At the time of the report, prolonged activated partial thromboplastin time (PTT is greater than 200 seconds) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment medications. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Pruritus, Rash
Clinical narrative: A colleague of mine developed the identical reaction (Shingles); Rash; Pain in extremity; itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity), HERPES ZOSTER (A colleague of mine developed the identical reaction (Shingles)), PRURITUS (itchy) and RASH (Rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 03M2OA) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (youngest of 5 aged 4). Concurrent medical conditions included Drug allergy (Allergy to Morphine, 23 years ago broke arm, reportedly had rash and treated with Benadryl).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity) and PRURITUS (itchy). On 16-Mar-2021, the patient experienced RASH (Rash). On 18-Mar-2021, the patient experienced HERPES ZOSTER (A colleague of mine developed the identical reaction (Shingles)). The patient was treated with VALACYCLOVIR [VALACICLOVIR] on 18-Mar-2021 for Nausea, at a dose of UNK, tid; NAPROXEN on 18-Mar-2021 at a dose of UNK, bid; ONDANSETRON for Nausea, at a dose of UNK, q4h and NORTRIPTYLINE for Rash, at a dose of UNK, qhs. On 17-Mar-2021, RASH (Rash) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in extremity) and HERPES ZOSTER (A colleague of mine developed the identical reaction (Shingles)) outcome was unknown and PRURITUS (itchy) had resolved.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported   This case was linked to MOD-2021-053856 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No new information provided about patient (colleague); Sender's Comments:  MOD-2021-053856:Same reporter/different patient
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI-Contact information updated On 07-Jun-2021: patient details were added (age, height, weight, gender),facility was added, medical history was added,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Malaise, Myalgia
Clinical narrative: doesn't feel well; feels terrible/horrible; like the flu; fever; very fatigued; nauseated; arm is sore at injection site; body aches almost like the flu; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (doesn't feel well), FEELING ABNORMAL (feels terrible/horrible), INFLUENZA LIKE ILLNESS (like the flu), PYREXIA (fever) and FATIGUE (very fatigued) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MALAISE (doesn't feel well), FEELING ABNORMAL (feels terrible/horrible), INFLUENZA LIKE ILLNESS (like the flu), PYREXIA (fever), FATIGUE (very fatigued), NAUSEA (nauseated), VACCINATION SITE PAIN (arm is sore at injection site) and MYALGIA (body aches almost like the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, MALAISE (doesn't feel well), FEELING ABNORMAL (feels terrible/horrible), INFLUENZA LIKE ILLNESS (like the flu), PYREXIA (fever), FATIGUE (very fatigued), NAUSEA (nauseated), VACCINATION SITE PAIN (arm is sore at injection site) and MYALGIA (body aches almost like the flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Initial additional document received on 09-JUN-2021 contains no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: doesn't feel well; feels terrible/horrible; like the flu; fever; very fatigued; nauseated; arm is sore at injection site; body aches almost like the flu; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (doesn't feel well), FEELING ABNORMAL (feels terrible/horrible), INFLUENZA LIKE ILLNESS (like the flu), PYREXIA (fever) and FATIGUE (very fatigued) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MALAISE (doesn't feel well), FEELING ABNORMAL (feels terrible/horrible), INFLUENZA LIKE ILLNESS (like the flu), PYREXIA (fever), FATIGUE (very fatigued), NAUSEA (nauseated), VACCINATION SITE PAIN (arm is sore at injection site) and MYALGIA (body aches almost like the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, MALAISE (doesn't feel well), FEELING ABNORMAL (feels terrible/horrible), INFLUENZA LIKE ILLNESS (like the flu), PYREXIA (fever), FATIGUE (very fatigued), NAUSEA (nauseated), VACCINATION SITE PAIN (arm is sore at injection site) and MYALGIA (body aches almost like the flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Initial additional document received on 09-JUN-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (losses about 4 hours of work total between getting both shots and side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (losses about 4 hours of work total between getting both shots and side effects). At the time of the report, ADVERSE DRUG REACTION (losses about 4 hours of work total between getting both shots and side effects) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Feeling abnormal, Feeling cold, Mood altered, Myalgia
Clinical narrative: Sinus infection; Humira citrate free did not work, felt like had not been taken in a while; Felt like body has not had Humira so long; Moody; Muscle ache; Feeling cold; This spontaneous case was reported by a physician and describes the occurrence of SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while), FEELING COLD (Feeling cold), FEELING ABNORMAL (Felt like body has not had Humira so long) and MOOD ALTERED (Moody) in a 31-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 24-Apr-2021, the patient experienced FEELING COLD (Feeling cold). On an unknown date, the patient experienced SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while), FEELING ABNORMAL (Felt like body has not had Humira so long), MOOD ALTERED (Moody) and MYALGIA (Muscle ache). At the time of the report, SINUSITIS (Sinus infection), FEELING COLD (Feeling cold), FEELING ABNORMAL (Felt like body has not had Humira so long) and MOOD ALTERED (Moody) outcome was unknown, DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while) had resolved and MYALGIA (Muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Aleve. The reporter's causality for the event(s) of felt cold, felt like body has not had humira so long, moody, muscle aching, and sinus infection was not provided. The reporter's causality for the event(s) of Humira citrate free did notwork/felt like had not been taken in a while with Humira (Adalimumab) was a reasonable possibility.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinusitis
Clinical narrative: Sinus infection; Humira citrate free did not work, felt like had not been taken in a while; Felt like body has not had Humira so long; Moody; Muscle ache; Feeling cold; This spontaneous case was reported by a physician and describes the occurrence of SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while), FEELING COLD (Feeling cold), FEELING ABNORMAL (Felt like body has not had Humira so long) and MOOD ALTERED (Moody) in a 31-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 24-Apr-2021, the patient experienced FEELING COLD (Feeling cold). On an unknown date, the patient experienced SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while), FEELING ABNORMAL (Felt like body has not had Humira so long), MOOD ALTERED (Moody) and MYALGIA (Muscle ache). At the time of the report, SINUSITIS (Sinus infection), FEELING COLD (Feeling cold), FEELING ABNORMAL (Felt like body has not had Humira so long) and MOOD ALTERED (Moody) outcome was unknown, DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while) had resolved and MYALGIA (Muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Aleve. The reporter's causality for the event(s) of felt cold, felt like body has not had humira so long, moody, muscle aching, and sinus infection was not provided. The reporter's causality for the event(s) of Humira citrate free did notwork/felt like had not been taken in a while with Humira (Adalimumab) was a reasonable possibility.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hangover, Nausea, Pain
Clinical narrative: Hangover; Weakness; Ache; Nauseated; This spontaneous case was reported by a physician and describes the occurrence of HANGOVER (Hangover), ASTHENIA (Weakness), PAIN (Ache) and NAUSEA (Nauseated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HANGOVER (Hangover), ASTHENIA (Weakness), PAIN (Ache) and NAUSEA (Nauseated). At the time of the report, HANGOVER (Hangover), ASTHENIA (Weakness), PAIN (Ache) and NAUSEA (Nauseated) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported by the reporter. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.