chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Insomnia, Muscle spasms, Pain in extremity, Vaccination site paraesthesia
Clinical narrative: cramps; When I hit my hand I have a strange pain; I could not sleep; Dominant upper arm; Something like numbness of right hand/When I go to sleep, I wake up because my arm goes numb,as if the blood isn't circulating; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I could not sleep), ADVERSE EVENT (Dominant upper arm), VACCINATION SITE PARAESTHESIA (Something like numbness of right hand/When I go to sleep, I wake up because my arm goes numb,as if the blood isn't circulating), MUSCLE SPASMS (cramps) and PAIN IN EXTREMITY (When I hit my hand I have a strange pain) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007BZ1A and 0021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021 at 12:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INSOMNIA (I could not sleep), ADVERSE EVENT (Dominant upper arm) and VACCINATION SITE PARAESTHESIA (Something like numbness of right hand/When I go to sleep, I wake up because my arm goes numb,as if the blood isn't circulating). On an unknown date, the patient experienced MUSCLE SPASMS (cramps) and PAIN IN EXTREMITY (When I hit my hand I have a strange pain). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date for Numbness in hand and Insomnia, at a dose of 2 tablets PO OD and IBUPROFEN (ADVIL [IBUPROFEN]) (oral) ongoing since an unknown date for Numbness and Sleep problem, at a dose of 2 tablets PO OD. At the time of the report, INSOMNIA (I could not sleep), ADVERSE EVENT (Dominant upper arm), VACCINATION SITE PARAESTHESIA (Something like numbness of right hand/When I go to sleep, I wake up because my arm goes numb,as if the blood isn't circulating), MUSCLE SPASMS (cramps) and PAIN IN EXTREMITY (When I hit my hand I have a strange pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitent medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: FU received patient demographics updated and new events were added On 05-Jul-2021: Translated Follow-up form received and important information was translated
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: Ringing in both ears; Dizziness; Headache; Nauseas; Trouble sleeping; Chills; Tiredness; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), INSOMNIA (Trouble sleeping), TINNITUS (Ringing in both ears), DIZZINESS (Dizziness) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 0381421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation, Stroke (mini stroke in 1998) in 1998 and Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Eliquis), Drug allergy (Xarelto), Drug allergy (Omeprazole), Drug allergy (Amiodarone) and Drug allergy (Pantoprazole).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Trouble sleeping), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas). On 26-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Apr-2021, the patient experienced TINNITUS (Ringing in both ears). The patient was treated with WARFARIN at a dose of 1 dosage form and LAMOTRIGINE at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm hurt), INSOMNIA (Trouble sleeping), TINNITUS (Ringing in both ears), DIZZINESS (Dizziness), CHILLS (Chills), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseas) outcome was unknown.            This case was linked to MOD-2021-091984 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Tinnitus
Clinical narrative: Ringing in both ears; Dizziness; Headache; Nauseas; Trouble sleeping; Chills; Tiredness; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), INSOMNIA (Trouble sleeping), TINNITUS (Ringing in both ears), DIZZINESS (Dizziness) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 0381421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation, Stroke (mini stroke in 1998) in 1998 and Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Eliquis), Drug allergy (Xarelto), Drug allergy (Omeprazole), Drug allergy (Amiodarone) and Drug allergy (Pantoprazole).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Trouble sleeping), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas). On 26-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Apr-2021, the patient experienced TINNITUS (Ringing in both ears). The patient was treated with WARFARIN at a dose of 1 dosage form and LAMOTRIGINE at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm hurt), INSOMNIA (Trouble sleeping), TINNITUS (Ringing in both ears), DIZZINESS (Dizziness), CHILLS (Chills), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseas) outcome was unknown.            This case was linked to MOD-2021-091984 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Inappropriate schedule of product administration, Rash, Skin odour abnormal
Clinical narrative: rashes all across the chest; Armpit painful; armpits got really red; Swollen armpits,first started in right armpit and then to left armpit; smelly; received 2nd dose 41 days later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later), ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and RASH (rashes all across the chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0426204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later). On 08-Mar-2021, the patient experienced ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and AXILLARY PAIN (Armpit painful). On an unknown date, the patient experienced RASH (rashes all across the chest). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later) had resolved. On 17-Mar-2021, ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and AXILLARY PAIN (Armpit painful) had resolved. At the time of the report, RASH (rashes all across the chest) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: rashes all across the chest; Armpit painful; armpits got really red; Swollen armpits,first started in right armpit and then to left armpit; smelly; received 2nd dose 41 days later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later), ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and RASH (rashes all across the chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0426204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later). On 08-Mar-2021, the patient experienced ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and AXILLARY PAIN (Armpit painful). On an unknown date, the patient experienced RASH (rashes all across the chest). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later) had resolved. On 17-Mar-2021, ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and AXILLARY PAIN (Armpit painful) had resolved. At the time of the report, RASH (rashes all across the chest) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Lymphadenopathy, Myalgia, Swelling
Clinical narrative: could not lift arm or move it; swollen lymph node on the base of neck; excruciating pain and throbbing to her left arm; left hand, shoulder and neck are slightly swellen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (left hand, shoulder and neck are slightly swellen), INJECTED LIMB MOBILITY DECREASED (could not lift arm or move it), LYMPHADENOPATHY (swollen lymph node on the base of neck) and MYALGIA (excruciating pain and throbbing to her left arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced SWELLING (left hand, shoulder and neck are slightly swellen) and MYALGIA (excruciating pain and throbbing to her left arm). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (could not lift arm or move it) and LYMPHADENOPATHY (swollen lymph node on the base of neck). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING (left hand, shoulder and neck are slightly swellen), INJECTED LIMB MOBILITY DECREASED (could not lift arm or move it), LYMPHADENOPATHY (swollen lymph node on the base of neck) and MYALGIA (excruciating pain and throbbing to her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that they went to the doctor who said that she had a swollen lymph node on the base of neck. After the first vaccination, the left arm where vaccinated was more swollen than right arm. She could not lift arm or move it for weeks. After second shot, she just experienced a slight pinch at site. The doctor thought for the more severe adverse arm event that perhaps the shot went into the Bursa.  No concomitant details were provided Treatment details include Motrin   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: TCR received.. events updated
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness at the site of the injection; red patch around the area where they inserted the needle; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection), VACCINATION SITE ERYTHEMA (red patch around the area where they inserted the needle) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection), VACCINATION SITE ERYTHEMA (red patch around the area where they inserted the needle) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. On 31-Mar-2021, HEADACHE (headache) had resolved. On 02-Apr-2021, VACCINATION SITE PAIN (soreness at the site of the injection) and VACCINATION SITE ERYTHEMA (red patch around the area where they inserted the needle) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment taken was Motrin  no any concomitant drug was given in SD
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Excruciating back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Excruciating back pain) in a 50-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 PAROXETINE, METFORMIN, LISINOPRIL, AMLODIPINE, GABAPENTIN, ATORVASTATIN and INSULIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced BACK PAIN (Excruciating back pain). The patient was treated with NAPROXEN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Excruciating back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath, difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath, difficulty breathing) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CLONAZEPAM (KLONOPIN), PAROXETINE HYDROCHLORIDE (PAROXETIN +PHARMA) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced DYSPNOEA (shortness of breath, difficulty breathing). At the time of the report, DYSPNOEA (shortness of breath, difficulty breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2021-092184 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-092184:Dose1
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Sweats; Feels like flu; Very tired; Fevers; Joint pains; Muscle aches in her neck; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Feels like flu), FATIGUE (Very tired), NAUSEA (Nausea) and PYREXIA (Fevers) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 NAUSEA (Nausea). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Feels like flu), FATIGUE (Very tired), PYREXIA (Fevers), ARTHRALGIA (Joint pains), MYALGIA (Muscle aches in her neck) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Feels like flu), FATIGUE (Very tired), NAUSEA (Nausea), PYREXIA (Fevers), ARTHRALGIA (Joint pains), MYALGIA (Muscle aches in her neck) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Sweats; Feels like flu; Very tired; Fevers; Joint pains; Muscle aches in her neck; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Feels like flu), FATIGUE (Very tired), NAUSEA (Nausea) and PYREXIA (Fevers) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 NAUSEA (Nausea). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Feels like flu), FATIGUE (Very tired), PYREXIA (Fevers), ARTHRALGIA (Joint pains), MYALGIA (Muscle aches in her neck) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Feels like flu), FATIGUE (Very tired), NAUSEA (Nausea), PYREXIA (Fevers), ARTHRALGIA (Joint pains), MYALGIA (Muscle aches in her neck) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling well). At the time of the report, VACCINATION COMPLICATION (Not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitants was not reported. no known treatment reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Tinnitus
Clinical narrative: Flu-like symptom; Had ringing in her ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptom) and TINNITUS (Had ringing in her ears) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044BZIA and 040AZiA) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptom) and TINNITUS (Had ringing in her ears). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptom) and TINNITUS (Had ringing in her ears) outcome was unknown.            No concomitant medications were reported. The patient had not undergone any treatment.   Action taken with mRNA-1273 in response to the events were not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Fatigue, Joint swelling, Pain in extremity
Clinical narrative: Interior parts of both elbows were swollen; Intense pain in the legs; Swollen lymph nodes in the injection arm; Intense pain in the breast; Intense pain in the forearm up to finger; At night has tingling sensation in the body; Pain in the interior part of the knees; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast) and PAIN IN EXTREMITY (Intense pain in the forearm up to finger) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast), PAIN IN EXTREMITY (Intense pain in the forearm up to finger), PARAESTHESIA (At night has tingling sensation in the body), ARTHRALGIA (Pain in the interior part of the knees) and FATIGUE (Feels tired). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast), PAIN IN EXTREMITY (Intense pain in the forearm up to finger), PARAESTHESIA (At night has tingling sensation in the body), ARTHRALGIA (Pain in the interior part of the knees) and FATIGUE (Feels tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-092103 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site lymphadenopathy
Clinical narrative: Interior parts of both elbows were swollen; Intense pain in the legs; Swollen lymph nodes in the injection arm; Intense pain in the breast; Intense pain in the forearm up to finger; At night has tingling sensation in the body; Pain in the interior part of the knees; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast) and PAIN IN EXTREMITY (Intense pain in the forearm up to finger) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast), PAIN IN EXTREMITY (Intense pain in the forearm up to finger), PARAESTHESIA (At night has tingling sensation in the body), ARTHRALGIA (Pain in the interior part of the knees) and FATIGUE (Feels tired). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast), PAIN IN EXTREMITY (Intense pain in the forearm up to finger), PARAESTHESIA (At night has tingling sensation in the body), ARTHRALGIA (Pain in the interior part of the knees) and FATIGUE (Feels tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-092103 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: bad adverse reactions of the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bad adverse reactions of the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ADVERSE REACTION (bad adverse reactions of the first dose). At the time of the report, ADVERSE REACTION (bad adverse reactions of the first dose) outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump above right collar bone; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump above right collar bone ) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Apr-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Apr-2021, the patient experienced AXILLARY MASS (lump above right collar bone ). At the time of the report, AXILLARY MASS (lump above right collar bone ) outcome was unknown. Not Provided          Concomitant Atorvastatin
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hectic Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (hectic Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (hectic Tinnitus). At the time of the report, TINNITUS (hectic Tinnitus) outcome was unknown. Not Provided          No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-092206 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: patient's right arm is extremely numb and the numbness rates as a 7 out of 10; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (patient's right arm is extremely numb and the numbness rates as a 7 out of 10) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced HYPOAESTHESIA (patient's right arm is extremely numb and the numbness rates as a 7 out of 10). At the time of the report, HYPOAESTHESIA (patient's right arm is extremely numb and the numbness rates as a 7 out of 10) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and PAIN IN EXTREMITY (pain in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (fever) and PAIN IN EXTREMITY (pain in her arm). At the time of the report, PYREXIA (fever) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-092478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092478:wife case
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: hot at the injections site; ACHY; INFLAMED AT INJECTION SITE; Itchy at injection site; RED AT INJECTION SITE; Achy; Tired; FEET AND HANDS REAL COLD; feels light headed; 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 DIZZINESS (feels light headed), PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), INJECTION SITE WARMTH (hot at the injections site), PAIN (ACHY) and INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), PAIN (ACHY), INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), MYALGIA (Achy) and FATIGUE (Tired). In April 2021, the patient experienced DIZZINESS (feels light headed). On 24-Apr-2021, the patient experienced INJECTION SITE WARMTH (hot at the injections site). On 15-Apr-2021, PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), PAIN (ACHY), INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE), INJECTION SITE PRURITUS (Itchy at injection site), MYALGIA (Achy) and FATIGUE (Tired) had resolved, INJECTION SITE ERYTHEMA (RED AT INJECTION SITE) outcome was unknown. At the time of the report, DIZZINESS (feels light headed) and INJECTION SITE WARMTH (hot at the injections site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain, Peripheral coldness
Clinical narrative: hot at the injections site; ACHY; INFLAMED AT INJECTION SITE; Itchy at injection site; RED AT INJECTION SITE; Achy; Tired; FEET AND HANDS REAL COLD; feels light headed; 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 DIZZINESS (feels light headed), PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), INJECTION SITE WARMTH (hot at the injections site), PAIN (ACHY) and INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), PAIN (ACHY), INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), MYALGIA (Achy) and FATIGUE (Tired). In April 2021, the patient experienced DIZZINESS (feels light headed). On 24-Apr-2021, the patient experienced INJECTION SITE WARMTH (hot at the injections site). On 15-Apr-2021, PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), PAIN (ACHY), INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE), INJECTION SITE PRURITUS (Itchy at injection site), MYALGIA (Achy) and FATIGUE (Tired) had resolved, INJECTION SITE ERYTHEMA (RED AT INJECTION SITE) outcome was unknown. At the time of the report, DIZZINESS (feels light headed) and INJECTION SITE WARMTH (hot at the injections site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Experienced soreness in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Experienced soreness in injected arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Experienced soreness in injected arm). At the time of the report, MYALGIA (Experienced soreness in injected arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Feeling hot, Myalgia
Clinical narrative: swelling in arm; Diarrhoea; hot to the touch / hot; big red spot on arm; Itchy; Nausea; whole body aches / arm sore to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Asthma and Heart disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm), PRURITUS (Itchy), NAUSEA (Nausea), MYALGIA (whole body aches / arm sore to the touch) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm), PRURITUS (Itchy), NAUSEA (Nausea), MYALGIA (whole body aches / arm sore to the touch) and CHILLS (chills) outcome was unknown.            No concomitant medications reported by investigator.  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus
Clinical narrative: swelling in arm; Diarrhoea; hot to the touch / hot; big red spot on arm; Itchy; Nausea; whole body aches / arm sore to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Asthma and Heart disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm), PRURITUS (Itchy), NAUSEA (Nausea), MYALGIA (whole body aches / arm sore to the touch) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling in arm), DIARRHOEA (Diarrhoea), FEELING HOT (hot to the touch / hot), ERYTHEMA (big red spot on arm), PRURITUS (Itchy), NAUSEA (Nausea), MYALGIA (whole body aches / arm sore to the touch) and CHILLS (chills) outcome was unknown.            No concomitant medications reported by investigator.  No treatment medications provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: breathing harder; limitation of daily activities; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing harder) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (limitation of daily activities) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CLONAZEPAM (KLONOPIN), PAROXETINE HYDROCHLORIDE (PAROXETIN +PHARMA) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DYSPNOEA (breathing harder) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (limitation of daily activities). At the time of the report, DYSPNOEA (breathing harder) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (limitation of daily activities) outcome was unknown. Not Provided          Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-092161 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092161:Dose1
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BODY TEMPERATURE INCREASED (feeling as sick as a dog with temperature) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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 27-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 DIARRHOEA (Diarrhea), BODY TEMPERATURE INCREASED (feeling as sick as a dog with temperature) and VOMITING (vomiting). At the time of the report, DIARRHOEA (Diarrhea), BODY TEMPERATURE INCREASED (feeling as sick as a dog with temperature) and VOMITING (vomiting) outcome was unknown.            no concomitant  medication was listed.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: inadvertently administered 1ml instead of .5ml; 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 ACCIDENTAL OVERDOSE (inadvertently administered 1ml instead of .5ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     no medical history was reported.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered 1ml instead of .5ml). At the time of the report, ACCIDENTAL OVERDOSE (inadvertently administered 1ml instead of .5ml) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-092554 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092554:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: raised area patch at injection site; a week later that was slightly red; Vaccination site itched; injection site soreness / hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (raised area patch at injection site), VACCINATION SITE ERYTHEMA (a week later that was slightly red), VACCINATION SITE PRURITUS (Vaccination site itched) and VACCINATION SITE PAIN (injection site soreness / hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Cataract operation in December 2019. Concurrent medical conditions included Glaucoma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), EZETIMIBE and TRAVOPROST (TRAVATAN Z) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-1948, the patient experienced VACCINATION SITE PAIN (injection site soreness / hurt). On 18-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (raised area patch at injection site), VACCINATION SITE ERYTHEMA (a week later that was slightly red) and VACCINATION SITE PRURITUS (Vaccination site itched). At the time of the report, VACCINATION SITE INFLAMMATION (raised area patch at injection site), VACCINATION SITE ERYTHEMA (a week later that was slightly red), VACCINATION SITE PRURITUS (Vaccination site itched) and VACCINATION SITE PAIN (injection site soreness / hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she was has to take Travatan Z for her increased intraocular pressure.  Treatment medicines were not reported.