chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: pain in the arm; headache; a lot of sneezing; I think I have flu; a lot of snot; a lot of cough; body ache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough) and VACCINATION SITE PAIN (pain in the arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (very tired) and MYALGIA (body ache). On 03-May-2021, the patient experienced SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough), VACCINATION SITE PAIN (pain in the arm), FATIGUE (very tired), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported included medication for blood pressure, cholesterol and medication used for sleep. 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Pyrexia
Clinical narrative: felt dizzy whenever she would bend over; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (felt dizzy whenever she would bend over) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever). On 29-Apr-2021, the patient experienced DIZZINESS POSTURAL (felt dizzy whenever she would bend over). On 29-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, DIZZINESS POSTURAL (felt dizzy whenever she would bend over) had not resolved.            Concomitant medications were not provided. Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 12 year girl received first dose of vaccine as Off label; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year girl received first dose of vaccine as Off label) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year girl received first dose of vaccine as Off label). On 04-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year girl received first dose of vaccine as Off label) 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 treatment information provided.  No concomitant medications reported by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Pain in left arm; Weakness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) and ASTHENIA (Weakness in left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm) and ASTHENIA (Weakness in left arm). At the time of the report, PAIN IN EXTREMITY (Pain in left arm) and ASTHENIA (Weakness in left arm) 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 medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-138367 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  The patient was asking if he can get the second dose on 17-May-2021, 47th day after the 1st dose. The pharmacist asking if he can get the second dose past 42 days and mentioned she was not comfortable giving the patient giving his 2nd dose as it is five days past 42 days after 1st dose. The Pharmacist declined to give any of the patient details, his first dose details.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dizziness, Headache, Hypersensitivity, Sinusitis
Clinical narrative: "allergy type reactions"; "sinus infections"; "dizziness"; "broke out in lesions on his skin"; "some adverse events"; "headaches"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin") and ADVERSE EVENT ("some adverse events") in a male 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 was provided by the reporter.     In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin"), ADVERSE EVENT ("some adverse events") and HEADACHE ("headaches"). At the time of the report, HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin"), ADVERSE EVENT ("some adverse events") and HEADACHE ("headaches") outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: "allergy type reactions"; "sinus infections"; "dizziness"; "broke out in lesions on his skin"; "some adverse events"; "headaches"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin") and ADVERSE EVENT ("some adverse events") in a male 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 was provided by the reporter.     In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin"), ADVERSE EVENT ("some adverse events") and HEADACHE ("headaches"). At the time of the report, HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin"), ADVERSE EVENT ("some adverse events") and HEADACHE ("headaches") outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Magnet sticking at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Magnet sticking at the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Magnet sticking at the injection site). At the time of the report, VACCINATION SITE REACTION (Magnet sticking at the injection site) 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.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information received on 17-Jun-2021, contains no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain in extremity, Swelling
Clinical narrative: Sore arm that was hard and swelled up; Sore arm that was hard and swelled up; sore arm that was hard and swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm that was hard and swelled up), SWELLING (Sore arm that was hard and swelled up) and INDURATION (sore arm that was hard and swelled up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-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 that was hard and swelled up), SWELLING (Sore arm that was hard and swelled up) and INDURATION (sore arm that was hard and swelled up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm that was hard and swelled up), SWELLING (Sore arm that was hard and swelled up) and INDURATION (sore arm that was hard and swelled up) outcome was unknown.            No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache) 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) had not 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.    Concomitant and treatment medications were not provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pityriasis rosea, Rash, Rash pruritic
Clinical narrative: Pityriasis Rosea; rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity; rash, which they did not take seriously, that looked like a patch on right hand, chest ,back; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis Rosea), PAIN (little pain), RASH PRURITIC (rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity) and RASH (rash, which they did not take seriously, that looked like a patch on right hand, chest ,back) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN (little pain). On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis Rosea), RASH PRURITIC (rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity) and RASH (rash, which they did not take seriously, that looked like a patch on right hand, chest ,back). The patient was treated with TRIAMCINOLONE at a dose of 0.1 % and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PITYRIASIS ROSEA (Pityriasis Rosea), PAIN (little pain), RASH PRURITIC (rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity) and RASH (rash, which they did not take seriously, that looked like a patch on right hand, chest ,back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator Treatment medications provided by the reporter included Triamcinolone 0.1 % prescribed by dermatologist, started 17MAY2021 in the morning . Prescriber (telemedicine) recommended to use for 2 weeks. Benadryl - 17MAY2021 in the morning.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dysstasia, Glycosylated haemoglobin, Metabolic function test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a tad bit sore), DIZZINESS (real dizzy), VISION BLURRED (eyes were blurry) and DYSSTASIA (hardly stand up) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus (Type-II Diabetic). On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm was a tad bit sore). On 12-May-2021, the patient experienced DIZZINESS (real dizzy), VISION BLURRED (eyes were blurry) and DYSSTASIA (hardly stand up). On 12-May-2021, VISION BLURRED (eyes were blurry) and DYSSTASIA (hardly stand up) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a tad bit sore) had resolved and DIZZINESS (real dizzy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood test: normal (normal) normal. On 04-May-2021, Glycosylated haemoglobin: normal (normal) normal. On 04-May-2021, Metabolic function test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medicines usage was not provided by the reporter. No Treatment medicines were reported
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a tad bit sore), DIZZINESS (real dizzy), VISION BLURRED (eyes were blurry) and DYSSTASIA (hardly stand up) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus (Type-II Diabetic). On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm was a tad bit sore). On 12-May-2021, the patient experienced DIZZINESS (real dizzy), VISION BLURRED (eyes were blurry) and DYSSTASIA (hardly stand up). On 12-May-2021, VISION BLURRED (eyes were blurry) and DYSSTASIA (hardly stand up) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a tad bit sore) had resolved and DIZZINESS (real dizzy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood test: normal (normal) normal. On 04-May-2021, Glycosylated haemoglobin: normal (normal) normal. On 04-May-2021, Metabolic function test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medicines usage was not provided by the reporter. No Treatment medicines were reported
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Illness, Nausea
Clinical narrative: felt sick, shaky; feeling hot; intermittent nausea; Shaky; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick, shaky), FEELING HOT (feeling hot), NAUSEA (intermittent nausea), HEADACHE (Headache) and CHILLS (Shaky) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Shingles on 16-Apr-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (Headache). On 14-May-2021, the patient experienced ILLNESS (felt sick, shaky), FEELING HOT (feeling hot), NAUSEA (intermittent nausea) and CHILLS (Shaky). At the time of the report, ILLNESS (felt sick, shaky), FEELING HOT (feeling hot), NAUSEA (intermittent nausea), HEADACHE (Headache) and CHILLS (Shaky) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUN-2021: Contain Non significant information On 16-Jul-2021: Follow up received on 16-JUL-2021: Events outcome was updated to recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm for a few days after first dose of Moderna COVID-19 Vaccine; tired for a few days after first dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a few days after first dose of Moderna COVID-19 Vaccine) and FATIGUE (tired for a few days after first dose of Moderna COVID-19 Vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a few days after first dose of Moderna COVID-19 Vaccine) and FATIGUE (tired for a few days after first dose of Moderna COVID-19 Vaccine). On 26-Mar-2021, PAIN IN EXTREMITY (sore arm for a few days after first dose of Moderna COVID-19 Vaccine) and FATIGUE (tired for a few days after first dose of Moderna COVID-19 Vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia. Concomitant products included PREDNISONE for Polymyalgia.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tiredness) had resolved.            Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Impaired work ability, Pain in extremity, Presyncope
Clinical narrative: Feels like she's going to pass out after 1st dose; Dizziness with walking after 1st dose/Really bad dizziness after 1st dose; Trouble breathing after 1st dose; Vertigo after the 1st dose; she can't work because of the dizziness; Arm sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose) and IMPAIRED WORK ABILITY (she can't work because of the dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack, Vertigo and Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetes.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose), IMPAIRED WORK ABILITY (she can't work because of the dizziness) and PAIN IN EXTREMITY (Arm sore after the 1st dose). At the time of the report, PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose), IMPAIRED WORK ABILITY (she can't work because of the dizziness) and PAIN IN EXTREMITY (Arm sore after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed a medicine for vertigo but patient did not know if she wanted to take it. The patient was taking a medication for ear infection (not specified). The patient was due for her second dose on 20-May-2021 and was thinking about not getting it.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received updated reporter contact details.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Feels like she's going to pass out after 1st dose; Dizziness with walking after 1st dose/Really bad dizziness after 1st dose; Trouble breathing after 1st dose; Vertigo after the 1st dose; she can't work because of the dizziness; Arm sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose) and IMPAIRED WORK ABILITY (she can't work because of the dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack, Vertigo and Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetes.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose), IMPAIRED WORK ABILITY (she can't work because of the dizziness) and PAIN IN EXTREMITY (Arm sore after the 1st dose). At the time of the report, PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose), IMPAIRED WORK ABILITY (she can't work because of the dizziness) and PAIN IN EXTREMITY (Arm sore after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed a medicine for vertigo but patient did not know if she wanted to take it. The patient was taking a medication for ear infection (not specified). The patient was due for her second dose on 20-May-2021 and was thinking about not getting it.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received updated reporter contact details.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Myalgia, Pyrexia
Clinical narrative: Difficulty walking; Fever; chills; Headaches; Muscle pains/body ached all over; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficulty walking), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headaches) and MYALGIA (Muscle pains/body ached all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-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 GAIT DISTURBANCE (Difficulty walking), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headaches) and MYALGIA (Muscle pains/body ached all over). At the time of the report, GAIT DISTURBANCE (Difficulty walking), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headaches) and MYALGIA (Muscle pains/body ached all over) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-138450 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: fever; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.            Concomitant medications were not provided. Treatment medications were not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm in the beginning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in the beginning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm in the beginning). At the time of the report, PAIN IN EXTREMITY (Sore arm in the beginning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-138584 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138584:Husband case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: 3 weeks later he contracted COVID; it has been 90 days since his 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (3 weeks later he contracted COVID) and PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose). On an unknown date, the patient experienced COVID-19 (3 weeks later he contracted COVID). On 11-Feb-2021, PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose) had resolved. At the time of the report, COVID-19 (3 weeks later he contracted COVID) 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 considered COVID-19 (3 weeks later he contracted COVID) and PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose) to be not applicable.    Concomitant information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received. The reporter reported that the patient did not receive vaccination at their covid clinic.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna Covid-19 vaccine after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after beyond use date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 038c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were not provided.   This case was linked to MOD21-091094 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient's race and ethnicity added, second dose details added.; Sender's Comments:  MOD21-091094:Same reporter, different patient
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: shakes; couldn't walk/ "like a drunk person"; severe vertigo "like a drunk person; diarrhea; red bumps at injection site; sweats; steady/solid tinnitus; couldn't sleep; itching injection site; injection site started to swell; chills; vomiting; nausea; exhaution/fatigue; red bumps at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (steady/solid tinnitus), VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site) and HYPERHIDROSIS (sweats) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TINNITUS (steady/solid tinnitus), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site). On 30-Apr-2021, the patient experienced VERTIGO (severe vertigo "like a drunk person), TREMOR (shakes) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person"). On 04-May-2021, VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), TREMOR (shakes), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site) had resolved. At the time of the report, TINNITUS (steady/solid tinnitus) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person") outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Tinnitus, Tremor, Vaccination site erythema
Clinical narrative: shakes; couldn't walk/ "like a drunk person"; severe vertigo "like a drunk person; diarrhea; red bumps at injection site; sweats; steady/solid tinnitus; couldn't sleep; itching injection site; injection site started to swell; chills; vomiting; nausea; exhaution/fatigue; red bumps at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (steady/solid tinnitus), VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site) and HYPERHIDROSIS (sweats) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TINNITUS (steady/solid tinnitus), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site). On 30-Apr-2021, the patient experienced VERTIGO (severe vertigo "like a drunk person), TREMOR (shakes) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person"). On 04-May-2021, VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), TREMOR (shakes), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site) had resolved. At the time of the report, TINNITUS (steady/solid tinnitus) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person") outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site papule, Vaccination site pruritus, Vaccination site swelling, Vertigo, Vomiting
Clinical narrative: shakes; couldn't walk/ "like a drunk person"; severe vertigo "like a drunk person; diarrhea; red bumps at injection site; sweats; steady/solid tinnitus; couldn't sleep; itching injection site; injection site started to swell; chills; vomiting; nausea; exhaution/fatigue; red bumps at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (steady/solid tinnitus), VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site) and HYPERHIDROSIS (sweats) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TINNITUS (steady/solid tinnitus), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site). On 30-Apr-2021, the patient experienced VERTIGO (severe vertigo "like a drunk person), TREMOR (shakes) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person"). On 04-May-2021, VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), TREMOR (shakes), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site) had resolved. At the time of the report, TINNITUS (steady/solid tinnitus) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person") outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Headache, Neck pain
Clinical narrative: aching in the stomach; achy neck; stomach problems; sore arm; headache; achy shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (achy shoulders). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 08-Apr-2021, ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (achy shoulders) had resolved.            No concomitant medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aching in the stomach; achy neck; stomach problems; sore arm; headache; achy shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (achy shoulders). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 08-Apr-2021, ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (achy shoulders) had resolved.            No concomitant medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.