chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Product dose omission issue, Pyrexia, Rhinorrhoea
Clinical narrative: migraine headache; sleep apnea; incontinence in going to bathroom.; Depression; Runny nose; cough; She didn't get 2nd dose due to all these side effects; chills; fatigue; body aches; fever; muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL and VITAMIN D2 for an unknown indication.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced MUSCLE SPASMS (muscle spasms), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever). On an unknown date, the patient experienced MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression), RHINORRHOEA (Runny nose), COUGH (cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get 2nd dose due to all these side effects). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression), RHINORRHOEA (Runny nose), MUSCLE SPASMS (muscle spasms), COUGH (cough), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She didn't get 2nd dose due to all these side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drugs included
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome, Urinary incontinence
Clinical narrative: migraine headache; sleep apnea; incontinence in going to bathroom.; Depression; Runny nose; cough; She didn't get 2nd dose due to all these side effects; chills; fatigue; body aches; fever; muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL and VITAMIN D2 for an unknown indication.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced MUSCLE SPASMS (muscle spasms), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever). On an unknown date, the patient experienced MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression), RHINORRHOEA (Runny nose), COUGH (cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get 2nd dose due to all these side effects). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression), RHINORRHOEA (Runny nose), MUSCLE SPASMS (muscle spasms), COUGH (cough), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She didn't get 2nd dose due to all these side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drugs included
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse events are rare; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse events are rare) 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 VACCINATION COMPLICATION (Adverse events are rare). At the time of the report, VACCINATION COMPLICATION (Adverse events are rare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medicine,treatment and Medical history were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII.   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, 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 VACCINATION COMPLICATION (vaccination adverse event). At the time of the report, VACCINATION COMPLICATION (vaccination adverse event) outcome was unknown. Not Provided          No information about concomitant and treatment medication was provided by reporter.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old received the Moderna COVID-19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna COVID-19 vaccine) in a 17-year-old patient of an unknown 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna COVID-19 vaccine) 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 treatment drugs included no concomitant drugs included
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13-year-old received the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old received the Moderna COVID-19 vaccine) in a 13-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old received the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13-year-old received the Moderna COVID-19 vaccine) had resolved.        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.   No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Swelling
Clinical narrative: Big Ole Knot (bigger than a quarter/golf ball size); Can feel the heat from it (the knot); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Big Ole Knot (bigger than a quarter/golf ball size)) and FEELING HOT (Can feel the heat from it (the knot)) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced SWELLING (Big Ole Knot (bigger than a quarter/golf ball size)) and FEELING HOT (Can feel the heat from it (the knot)). At the time of the report, SWELLING (Big Ole Knot (bigger than a quarter/golf ball size)) and FEELING HOT (Can feel the heat from it (the knot)) 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.   No treatment drugs included No concomitant drugs included
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Pain in extremity, Superficial vein prominence, Vascular pain
Clinical narrative: Pain is getting to her left leg to the back; Left leg is hurting more and more; Numbness in hands/feels as if everything is numb; Veins from knee down are sticking out; Veins are sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands/feels as if everything is numb), SUPERFICIAL VEIN PROMINENCE (Veins from knee down are sticking out), VASCULAR PAIN (Veins are sore), BACK PAIN (Pain is getting to her left leg to the back) and PAIN IN EXTREMITY (Left leg is hurting more and more) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in hands/feels as if everything is numb), SUPERFICIAL VEIN PROMINENCE (Veins from knee down are sticking out) and VASCULAR PAIN (Veins are sore). On an unknown date, the patient experienced BACK PAIN (Pain is getting to her left leg to the back) and PAIN IN EXTREMITY (Left leg is hurting more and more). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in hands/feels as if everything is numb), SUPERFICIAL VEIN PROMINENCE (Veins from knee down are sticking out), VASCULAR PAIN (Veins are sore), BACK PAIN (Pain is getting to her left leg to the back) and PAIN IN EXTREMITY (Left leg is hurting more and more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: It started to be sore; Arm was swollen; Arm was red; Arm was hot/ hot skin; Arm was itching; Numbness; Tingling; Arm was burning; Arm was sore; Slight headache; Rash around area where i got the jab/ larger rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), SKIN WARM (Arm was hot/ hot skin), PRURITUS (Arm was itching) and HYPOAESTHESIA (Numbness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Anxiety, Crohn's since August 1984, Drug allergy (rash, itchy, hives) and Drug allergy (rash, itchy, burning, threw up, throat closed up, bumps hives). Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, ENTYVIO for Crohn's.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), SKIN WARM (Arm was hot/ hot skin), PRURITUS (Arm was itching), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), BURNING SENSATION (Arm was burning), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Slight headache) and VACCINATION SITE RASH (Rash around area where i got the jab/ larger rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (It started to be sore). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC) from 14-Jul-2021 to 20-Jul-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (Benadryl) from 13-Jul-2021 to 20-Jul-2021 for Adverse reaction, at an unspecified dose and frequency; SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOPRIM) from 15-Jul-2021 to 16-Jul-2021 for Adverse reaction, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN) 14-Jul-2021 for Adverse reaction, at an unspecified dose and frequency. On 20-Jul-2021, PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), SKIN WARM (Arm was hot/ hot skin), PRURITUS (Arm was itching), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), BURNING SENSATION (Arm was burning), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Slight headache) and VACCINATION SITE RASH (Rash around area where i got the jab/ larger rash) had resolved. At the time of the report, VACCINATION SITE PAIN (It started to be sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: significant follow up- patient medical history, concomitant medications, treatment details and event onset, end date, outcome of events. On 29-Jul-2021: Photos attached.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest discomfort, Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: chest had a heaviness about it; sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting; coughed up sputum, big pieces of it; legs are weak; sometimes lose balance; feel horrible/never been the same; my whole body is not working right; fatigued; muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest had a heaviness about it), NEURALGIA (sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting), PRODUCTIVE COUGH (coughed up sputum, big pieces of it), MUSCULAR WEAKNESS (legs are weak) and BALANCE DISORDER (sometimes lose balance) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-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 CHEST DISCOMFORT (chest had a heaviness about it), NEURALGIA (sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting), PRODUCTIVE COUGH (coughed up sputum, big pieces of it), MUSCULAR WEAKNESS (legs are weak), BALANCE DISORDER (sometimes lose balance), FEELING ABNORMAL (feel horrible/never been the same), MOBILITY DECREASED (my whole body is not working right), FATIGUE (fatigued) and MYALGIA (muscles hurt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (chest had a heaviness about it), NEURALGIA (sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting), MUSCULAR WEAKNESS (legs are weak), BALANCE DISORDER (sometimes lose balance), FEELING ABNORMAL (feel horrible/never been the same), MOBILITY DECREASED (my whole body is not working right), FATIGUE (fatigued) and MYALGIA (muscles hurt) had not resolved and PRODUCTIVE COUGH (coughed up sputum, big pieces of it) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  concomitant medications were reported.  It was reported that she did not received the second dose. She stated she did not have any fever. She went to the doctor on 05-May-2021 and blood test was performed (results not provided).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and contained no new information. Patient stated via email that she could not provide the information on the ADR form. On 03-Sep-2021: Non-significant Follow up received included Fax number.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Neuralgia, Productive cough
Clinical narrative: chest had a heaviness about it; sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting; coughed up sputum, big pieces of it; legs are weak; sometimes lose balance; feel horrible/never been the same; my whole body is not working right; fatigued; muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest had a heaviness about it), NEURALGIA (sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting), PRODUCTIVE COUGH (coughed up sputum, big pieces of it), MUSCULAR WEAKNESS (legs are weak) and BALANCE DISORDER (sometimes lose balance) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-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 CHEST DISCOMFORT (chest had a heaviness about it), NEURALGIA (sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting), PRODUCTIVE COUGH (coughed up sputum, big pieces of it), MUSCULAR WEAKNESS (legs are weak), BALANCE DISORDER (sometimes lose balance), FEELING ABNORMAL (feel horrible/never been the same), MOBILITY DECREASED (my whole body is not working right), FATIGUE (fatigued) and MYALGIA (muscles hurt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (chest had a heaviness about it), NEURALGIA (sharp nerve pains in my arms, legs, and feet/stabbing pains/nerves are hurting), MUSCULAR WEAKNESS (legs are weak), BALANCE DISORDER (sometimes lose balance), FEELING ABNORMAL (feel horrible/never been the same), MOBILITY DECREASED (my whole body is not working right), FATIGUE (fatigued) and MYALGIA (muscles hurt) had not resolved and PRODUCTIVE COUGH (coughed up sputum, big pieces of it) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  concomitant medications were reported.  It was reported that she did not received the second dose. She stated she did not have any fever. She went to the doctor on 05-May-2021 and blood test was performed (results not provided).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and contained no new information. Patient stated via email that she could not provide the information on the ADR form. On 03-Sep-2021: Non-significant Follow up received included Fax number.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No patient details were provided. No medical history was provided. No relevant laboratory data was provided.     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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Up to 50 patients given 1st or 2nd doses 1-45 days after vaccine had been stored in liquid state at appropriate temperature for 30 days; Expired vaccine used; 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 PRODUCT STORAGE ERROR (Up to 50 patients given 1st or 2nd doses 1-45 days after vaccine had been stored in liquid state at appropriate temperature for 30 days) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Up to 50 patients given 1st or 2nd doses 1-45 days after vaccine had been stored in liquid state at appropriate temperature for 30 days) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (Up to 50 patients given 1st or 2nd doses 1-45 days after vaccine had been stored in liquid state at appropriate temperature for 30 days) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.   Batch/Lot numbers provided for unknown patients were: .14 doses of lot# 047A21A 20May2021, 32 doses of lot # 009C21A 22 May2021, 20 doses of lot# 009C21A 25 May2021, 11 doses of lot# 009C21A 28 May2021, 6 doses of lot# 006B21A 11 Jun 2021, 1 dose of lot# 047A21A 23 Jun 2021, 3 doses of lot# 009C21A 10Jul 2021, 5 doses of lot# 006B21A 13Jul 2021  No concomitant medication was reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received on 23 Jul 2021: Updated iNarrative reference Batch numbers. On 02-Aug-2021: Follow-up information received on 03-Aug-2021, contains non-significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Dizziness; fatigue; low grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (fatigue), PYREXIA (low grade fever) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 014C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: HERPES SIMPLEX 1 VACCINE;HERPES SIMPLEX 2 VACCINE (50 MCG/0.5ML) on 05-Apr-2021. Concurrent medical conditions included Depression, Anxiety, Genital herpes and Vulvodynia. Concomitant products included CLONAZEPAM for Anxiety, ESCITALOPRAM and SERTRALINE HCL for Depression, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes genital, GABAPENTIN for Vulvodynia.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (fatigue), PYREXIA (low grade fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (Dizziness), FATIGUE (fatigue), PYREXIA (low grade fever) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-116582 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inappropriate schedule of product administration, Rash, Rash erythematous, Urticaria
Clinical narrative: Red rash; hot; hives are much worse; rashes in front of her legs, rashes from her knee up; Patient received the second dose of the vaccine more than 36 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot), URTICARIA (hives are much worse), RASH (rashes in front of her legs, rashes from her knee up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days from the first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, AMLODIPINE, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE and MELATONIN (MELATONINA) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-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 RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot), URTICARIA (hives are much worse), RASH (rashes in front of her legs, rashes from her knee up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days from the first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot), URTICARIA (hives are much worse) and RASH (rashes in front of her legs, rashes from her knee up) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking medication for blood pressure and thyroid.  On 3-February-2021 patient starts treatment with Steroids unknown dosage and stopped use on 10-February-2021.On 16-February-2021 patient starts to use antihistamines unknown dosage daily for treatment.   This case was linked to MOD-2021-017845 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Product dose omission issue, Vaccination complication
Clinical narrative: experiencing side effects; flu like symptoms; not feeling very good; Patient might not receive the second dose of the vaccine or might receive it more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing side effects), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (not feeling very good) and PRODUCT DOSE OMISSION ISSUE (Patient might not receive the second dose of the vaccine or might receive it more than 36 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 VACCINATION COMPLICATION (experiencing side effects), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (not feeling very good) and PRODUCT DOSE OMISSION ISSUE (Patient might not receive the second dose of the vaccine or might receive it more than 36 days). At the time of the report, VACCINATION COMPLICATION (experiencing side effects), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (not feeling very good) and PRODUCT DOSE OMISSION ISSUE (Patient might not receive the second dose of the vaccine or might receive it more than 36 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 99.7F fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (99.7F fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    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 PYREXIA (99.7F fever). At the time of the report, PYREXIA (99.7F fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Caller did not receive second Moderna Dose in the series (56 days since receiving first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller did not receive second Moderna Dose in the series (56 days since receiving first dose)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blindness, one eye (Left eye) and Heart disorder (Heart issues).    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller did not receive second Moderna Dose in the series (56 days since receiving first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller did not receive second Moderna Dose in the series (56 days since receiving first dose)) 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.   No concomitant medication information were provided. No treatment information were provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient passed  83 days without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient passed  83 days without receiving the second dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient passed  83 days without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient passed  83 days without receiving the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Cough, Ear pain
Clinical narrative: Fibromyalgia have gone crazy; Arthritis have gone crazy; Excruciating pain in ears; Pain in throat; Sleep apnea is out of control; Headaches; Cough; Fever 105.2 °F; Aches in joints; Aches in muscles; Chills; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears) and OROPHARYNGEAL PAIN (Pain in throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vehicular accident (Have medical issues from a car accident.). Concurrent medical conditions included Arthritis (Arthritis in ear bones.), Sleep apnea, Fibromyalgia and Osteoarthritis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills). On 14-Jul-2021, the patient experienced FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches). The patient was treated with CANNABIDIOL (CBD OIL) for Pain management, at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain management, at an unspecified dose and frequency. On 08-Mar-2021, COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the events were not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fibromyalgia have gone crazy; Arthritis have gone crazy; Excruciating pain in ears; Pain in throat; Sleep apnea is out of control; Headaches; Cough; Fever 105.2 °F; Aches in joints; Aches in muscles; Chills; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears) and OROPHARYNGEAL PAIN (Pain in throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vehicular accident (Have medical issues from a car accident.). Concurrent medical conditions included Arthritis (Arthritis in ear bones.), Sleep apnea, Fibromyalgia and Osteoarthritis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills). On 14-Jul-2021, the patient experienced FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches). The patient was treated with CANNABIDIOL (CBD OIL) for Pain management, at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain management, at an unspecified dose and frequency. On 08-Mar-2021, COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the events were not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: Fibromyalgia have gone crazy; Arthritis have gone crazy; Excruciating pain in ears; Pain in throat; Sleep apnea is out of control; Headaches; Cough; Fever 105.2 °F; Aches in joints; Aches in muscles; Chills; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears) and OROPHARYNGEAL PAIN (Pain in throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vehicular accident (Have medical issues from a car accident.). Concurrent medical conditions included Arthritis (Arthritis in ear bones.), Sleep apnea, Fibromyalgia and Osteoarthritis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills). On 14-Jul-2021, the patient experienced FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches). The patient was treated with CANNABIDIOL (CBD OIL) for Pain management, at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain management, at an unspecified dose and frequency. On 08-Mar-2021, COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the events were not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sickness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness) 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 ILLNESS (sickness). At the time of the report, ILLNESS (sickness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-256795 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Pyrexia, Vaccination complication
Clinical narrative: She still has issues of bouts of coughing; feeling unwell; slight fever; surprisingly the effects were milder, resolved within 24 hours; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (surprisingly the effects were milder, resolved within 24 hours), COUGH (She still has issues of bouts of coughing), MALAISE (feeling unwell) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (surprisingly the effects were milder, resolved within 24 hours), MALAISE (feeling unwell) and PYREXIA (slight fever). an unknown date, the patient experienced COUGH (She still has issues of bouts of coughing). At the time of the report, VACCINATION COMPLICATION (surprisingly the effects were milder, resolved within 24 hours) had resolved and COUGH (She still has issues of bouts of coughing), MALAISE (feeling unwell) and PYREXIA (slight fever) had not resolved.            No concomitant medications reported. The patient was treated with steroids for 1 week after each dose. She also recalled getting a CXR (chest x-ray).   This case was linked to MOD-2021-017375, MOD-2021-256794 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, GABAPENTIN, AMITRIPTYLINE, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-256810.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder pain as like being shot in the back, on the shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain as like being shot in the back, on the shoulder blade) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder pain as like being shot in the back, on the shoulder blade). At the time of the report, ARTHRALGIA (shoulder pain as like being shot in the back, on the shoulder blade) 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.   Concomitant product was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-017375 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Vaccination complication
Clinical narrative: Flu like aches; pain; several were in bed 2-3days/ more severe on second dose (1-2 days in bed); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (several were in bed 2-3days/ more severe on second dose (1-2 days in bed)), INFLUENZA LIKE ILLNESS (Flu like aches) and PAIN (pain) 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 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 VACCINATION COMPLICATION (several were in bed 2-3days/ more severe on second dose (1-2 days in bed)), INFLUENZA LIKE ILLNESS (Flu like aches) and PAIN (pain). At the time of the report, VACCINATION COMPLICATION (several were in bed 2-3days/ more severe on second dose (1-2 days in bed)), INFLUENZA LIKE ILLNESS (Flu like aches) and PAIN (pain) outcome was unknown. Not Provided          No concomitant medication was provided No treatment medication was provided   This case was linked to MOD-2021-256791 (Patient Link).