chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: arm still sore underneath injection site; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm still sore underneath injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 19-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm still sore underneath injection site). On 21-Apr-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, VACCINATION SITE PAIN (arm still sore underneath injection site) had not resolved. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Concomitant medications also included Vitamins and Supplements. Treatment information was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry skin, Erythema, Nausea
Clinical narrative: Might be hives; Rough; Redness; Dizziness; Swollen neck; swollen face; Reddish rash all over her body warm and slightly raised,upperbody rash; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Might be hives), DRY SKIN (Rough), ERYTHEMA (Redness), DIZZINESS (Dizziness) and SWELLING (Swollen neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, LUTEIN;VITAMINS NOS and FISH OIL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (Might be hives), DRY SKIN (Rough), ERYTHEMA (Redness), DIZZINESS (Dizziness), SWELLING (Swollen neck), SWELLING FACE (swollen face), RASH (Reddish rash all over her body warm and slightly raised,upperbody rash), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 27-Apr-2021, URTICARIA (Might be hives), ERYTHEMA (Redness), DIZZINESS (Dizziness), SWELLING (Swollen neck), SWELLING FACE (swollen face), RASH (Reddish rash all over her body warm and slightly raised,upperbody rash), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, DRY SKIN (Rough) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that her skin felt like sandpaper when the rash subsided, which was rough. She stated that one and a half month later of receiving the second moderna vaccine, her skin felt normal and heat from hot shower seemed to make her skin feel rough.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Updated patient demographics, event term rash with upper body rash. event outcome for all events to recovered/resolved.Added new events (dry skin, fever, chills, dizziness, swollen neck and face), concomitant medication atorvastatin.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling, Swelling face, Urticaria
Clinical narrative: Might be hives; Rough; Redness; Dizziness; Swollen neck; swollen face; Reddish rash all over her body warm and slightly raised,upperbody rash; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Might be hives), DRY SKIN (Rough), ERYTHEMA (Redness), DIZZINESS (Dizziness) and SWELLING (Swollen neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, LUTEIN;VITAMINS NOS and FISH OIL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (Might be hives), DRY SKIN (Rough), ERYTHEMA (Redness), DIZZINESS (Dizziness), SWELLING (Swollen neck), SWELLING FACE (swollen face), RASH (Reddish rash all over her body warm and slightly raised,upperbody rash), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 27-Apr-2021, URTICARIA (Might be hives), ERYTHEMA (Redness), DIZZINESS (Dizziness), SWELLING (Swollen neck), SWELLING FACE (swollen face), RASH (Reddish rash all over her body warm and slightly raised,upperbody rash), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, DRY SKIN (Rough) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that her skin felt like sandpaper when the rash subsided, which was rough. She stated that one and a half month later of receiving the second moderna vaccine, her skin felt normal and heat from hot shower seemed to make her skin feel rough.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Updated patient demographics, event term rash with upper body rash. event outcome for all events to recovered/resolved.Added new events (dry skin, fever, chills, dizziness, swollen neck and face), concomitant medication atorvastatin.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: Fever/102 degree Fahrenheit; Headache; Nausea; Loss of appetite; Body ache; Very bad chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite) and MYALGIA (Body ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body ache) and CHILLS (Very bad chills). At the time of the report, PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body ache) and CHILLS (Very bad chills) outcome was unknown.            treatment to the events not reported. nurse advised patient to drink plenty of water to keep hydrated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever/102 degree Fahrenheit; Headache; Nausea; Loss of appetite; Body ache; Very bad chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite) and MYALGIA (Body ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body ache) and CHILLS (Very bad chills). At the time of the report, PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body ache) and CHILLS (Very bad chills) outcome was unknown.            treatment to the events not reported. nurse advised patient to drink plenty of water to keep hydrated.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: diarrhea; abdominal pain; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal pain). At the time of the report, DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain
Clinical narrative: sore throat; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089560, US-MODERNATX, INC.-MOD-2021-089565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089560: US-MODERNATX, INC.-MOD-2021-089565:Crossed linked
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: >35 days from first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose) had resolved. 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.   No concomitant medications are provided. treatment to the events not reported. patient has  not yet received a second dose due to personal reasons.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dysentery
Clinical narrative: dysentery, feels like I'm having a colonoscopy; a little disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (dysentery, feels like I'm having a colonoscopy) and DISORIENTATION (a little disoriented) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included ALPRAZOLAM (XANAX) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced DYSENTERY (dysentery, feels like I'm having a colonoscopy) and DISORIENTATION (a little disoriented). At the time of the report, DYSENTERY (dysentery, feels like I'm having a colonoscopy) and DISORIENTATION (a little disoriented) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported taking migraine medications. No product name was given. No treatment information for the events was reported.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history reported.     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19 positive after first dose; 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 COVID-19 (Covid-19 positive after first dose) 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 COVID-19 (Covid-19 positive after first dose). At the time of the report, COVID-19 (Covid-19 positive after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications information was provided.  No treatment medications information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non significant follow-up received and.denied further follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: difficulty breathing, shortness of breath; weakness; Coughing; felling tired; Nose dripping like she is going to get sick; headache; arm pain three hours after the injection; difficulties moving of right arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (arm pain three hours after the injection), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulties moving of right arm), DYSPNOEA (difficulty breathing, shortness of breath) and ASTHENIA (weakness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (arm pain three hours after the injection) and VACCINATION SITE MOVEMENT IMPAIRMENT (difficulties moving of right arm). On 19-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing, shortness of breath), ASTHENIA (weakness), COUGH (Coughing), FATIGUE (felling tired) and RHINORRHOEA (Nose dripping like she is going to get sick). The patient was treated with ACETAMINOPHEN (oral) at a dose of 500 milligram twice a day. At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (arm pain three hours after the injection), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulties moving of right arm), DYSPNOEA (difficulty breathing, shortness of breath), ASTHENIA (weakness), COUGH (Coughing), FATIGUE (felling tired) and RHINORRHOEA (Nose dripping like she is going to get sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include iron supplements and multivitamins .
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: difficulty breathing, shortness of breath; weakness; Coughing; felling tired; Nose dripping like she is going to get sick; headache; arm pain three hours after the injection; difficulties moving of right arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (arm pain three hours after the injection), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulties moving of right arm), DYSPNOEA (difficulty breathing, shortness of breath) and ASTHENIA (weakness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (arm pain three hours after the injection) and VACCINATION SITE MOVEMENT IMPAIRMENT (difficulties moving of right arm). On 19-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing, shortness of breath), ASTHENIA (weakness), COUGH (Coughing), FATIGUE (felling tired) and RHINORRHOEA (Nose dripping like she is going to get sick). The patient was treated with ACETAMINOPHEN (oral) at a dose of 500 milligram twice a day. At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (arm pain three hours after the injection), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulties moving of right arm), DYSPNOEA (difficulty breathing, shortness of breath), ASTHENIA (weakness), COUGH (Coughing), FATIGUE (felling tired) and RHINORRHOEA (Nose dripping like she is going to get sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include iron supplements and multivitamins .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Migraine, Myalgia
Clinical narrative: Shaking; Migraine; Raised bumpy are on the injection site dime size; felt like passing out; Nausea; Rash like the map of africa; Hives; Warm on the injection site; injection site reactions as redness; Soreness on the left arm, arm is painful and sore; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like passing out), URTICARIA (Hives), TREMOR (Shaking), MIGRAINE (Migraine) and INJECTION SITE MASS (Raised bumpy are on the injection site dime size) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2015 and Breast cancer in 2016. Concurrent medical conditions included Drug allergy (Allergic to Percocet .).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced URTICARIA (Hives), INJECTION SITE WARMTH (Warm on the injection site), INJECTION SITE ERYTHEMA (injection site reactions as redness), MYALGIA (Soreness on the left arm, arm is painful and sore) and RASH (Rash like the map of africa). On 23-Apr-2021, the patient experienced PRESYNCOPE (felt like passing out), TREMOR (Shaking), MIGRAINE (Migraine), INJECTION SITE MASS (Raised bumpy are on the injection site dime size) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (felt like passing out), URTICARIA (Hives), TREMOR (Shaking), MIGRAINE (Migraine), INJECTION SITE MASS (Raised bumpy are on the injection site dime size), INJECTION SITE WARMTH (Warm on the injection site), INJECTION SITE ERYTHEMA (injection site reactions as redness), MYALGIA (Soreness on the left arm, arm is painful and sore), NAUSEA (Nausea) and RASH (Rash like the map of africa) 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 Relevant concomitant medications was reported. 4 surgeries for Breast Cancer in 2015 and 2016.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Rash, Tremor, Urticaria
Clinical narrative: Shaking; Migraine; Raised bumpy are on the injection site dime size; felt like passing out; Nausea; Rash like the map of africa; Hives; Warm on the injection site; injection site reactions as redness; Soreness on the left arm, arm is painful and sore; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like passing out), URTICARIA (Hives), TREMOR (Shaking), MIGRAINE (Migraine) and INJECTION SITE MASS (Raised bumpy are on the injection site dime size) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2015 and Breast cancer in 2016. Concurrent medical conditions included Drug allergy (Allergic to Percocet .).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced URTICARIA (Hives), INJECTION SITE WARMTH (Warm on the injection site), INJECTION SITE ERYTHEMA (injection site reactions as redness), MYALGIA (Soreness on the left arm, arm is painful and sore) and RASH (Rash like the map of africa). On 23-Apr-2021, the patient experienced PRESYNCOPE (felt like passing out), TREMOR (Shaking), MIGRAINE (Migraine), INJECTION SITE MASS (Raised bumpy are on the injection site dime size) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (felt like passing out), URTICARIA (Hives), TREMOR (Shaking), MIGRAINE (Migraine), INJECTION SITE MASS (Raised bumpy are on the injection site dime size), INJECTION SITE WARMTH (Warm on the injection site), INJECTION SITE ERYTHEMA (injection site reactions as redness), MYALGIA (Soreness on the left arm, arm is painful and sore), NAUSEA (Nausea) and RASH (Rash like the map of africa) 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 Relevant concomitant medications was reported. 4 surgeries for Breast Cancer in 2015 and 2016.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Hundreds of pin pricks (rash) all over arms and chest going all the way down to navel and outside of throat; Burning all over her chest/hit with a swarm of insects; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Hundreds of pin pricks (rash) all over arms and chest going all the way down to navel and outside of throat) and BURNING SENSATION (Burning all over her chest/hit with a swarm of insects) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN B12 NOS, VITAMIN D [VITAMIN D NOS] and VITAMIN B COMPLEX (B COMPLEX (B50)) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced RASH (Hundreds of pin pricks (rash) all over arms and chest going all the way down to navel and outside of throat) and BURNING SENSATION (Burning all over her chest/hit with a swarm of insects). The patient was treated with HYDROXYZINE HCL from 04-Apr-2021 to 14-Apr-2021 at a dose of 25 milligram once a day; PREDNISONE from 04-Apr-2021 to 11-Apr-2021 at a dose of 20 milligram once a day; FAMOTIDINE from 04-Apr-2021 to 11-May-2021 at a dose of 40 milligram once a day and ALPRAZOLAM (ATARAX [ALPRAZOLAM]) at an unspecified dose and frequency. On 15-Mar-2021, RASH (Hundreds of pin pricks (rash) all over arms and chest going all the way down to navel and outside of throat) had resolved. At the time of the report, BURNING SENSATION (Burning all over her chest/hit with a swarm of insects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-089508 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Afollow up received on 02-jun-2021,patient demographic details updated, concomitant medication updated, vaccine lot numbers, AE outcome updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; feeling tired; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy. Concomitant products included VITAMIN D3 and FISH OIL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg; METHYLPREDNISOLONE at a dose of 16 mg and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 650 mg. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired) 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.   This case was linked to MOD-2021-089522 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days); She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) and VACCINATION SITE INDURATION (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medication history was provided.     On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) and VACCINATION SITE INDURATION (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)). At the time of the report, VACCINATION SITE ERYTHEMA (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) and VACCINATION SITE INDURATION (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) 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 use was not reported. Treatment information was not provided.   This case was linked to MOD-2021-021836 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded. On 28-May-2021: Non Significant Followup
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Somnolence
Clinical narrative: sore left arm after first dose; drowsiness after first dose; dizziness after first dose; headaches for four days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after first dose), SOMNOLENCE (drowsiness after first dose), DIZZINESS (dizziness after first dose) and HEADACHE (headaches for four days after first dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, OMEPRAZOLE, GABAPENTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, VIT D [VITAMIN D NOS] and ASCORBIC ACID (VIT C) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm after first dose), SOMNOLENCE (drowsiness after first dose), DIZZINESS (dizziness after first dose) and HEADACHE (headaches for four days after first dose). On 06-Mar-2021, HEADACHE (headaches for four days after first dose) had resolved. On 06-Apr-2021, PAIN IN EXTREMITY (sore left arm after first dose), SOMNOLENCE (drowsiness after first dose) and DIZZINESS (dizziness after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information  was provided by the reporter.   This case was linked to MOD-2021-089507 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Nasal congestion
Clinical narrative: congestion; cough; itchy throat; chills; Fever; felt that she can't breath; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (felt that she can't breath), NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 2:30 PM, the patient experienced FATIGUE (felt tired). On 23-Apr-2021 at 9:00 PM, the patient experienced DYSPNOEA (felt that she can't breath). On 24-Apr-2021, the patient experienced NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat), CHILLS (chills) and PYREXIA (Fever). At the time of the report, DYSPNOEA (felt that she can't breath), NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat), CHILLS (chills), PYREXIA (Fever) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included Benadryl.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: congestion; cough; itchy throat; chills; Fever; felt that she can't breath; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (felt that she can't breath), NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 2:30 PM, the patient experienced FATIGUE (felt tired). On 23-Apr-2021 at 9:00 PM, the patient experienced DYSPNOEA (felt that she can't breath). On 24-Apr-2021, the patient experienced NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat), CHILLS (chills) and PYREXIA (Fever). At the time of the report, DYSPNOEA (felt that she can't breath), NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat), CHILLS (chills), PYREXIA (Fever) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included Benadryl.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sclerosis multiple.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced TREMOR (Tremors). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors) 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 include vitamins. The treatment included Steroid (did not know name).   This case was linked to MOD-2021-089481 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: Bloated/ bump on his stomach like a  squishy ball with something inside; Tender, bothering while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloated/ bump on his stomach like a  squishy ball with something inside) and ABDOMINAL PAIN UPPER (Tender, bothering while sleeping) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ABDOMINAL DISTENSION (Bloated/ bump on his stomach like a  squishy ball with something inside) and ABDOMINAL PAIN UPPER (Tender, bothering while sleeping). At the time of the report, ABDOMINAL DISTENSION (Bloated/ bump on his stomach like a  squishy ball with something inside) and ABDOMINAL PAIN UPPER (Tender, bothering while sleeping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Bloating; diarrhea; I feel terrible; "I feel hard to breathing well"; 2lb weight gain; Arm pain with numbness; Arm pain with numbness; "Feels like a block of cement"; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well") and WEIGHT INCREASED (2lb weight gain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 646B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well"), WEIGHT INCREASED (2lb weight gain), PAIN IN EXTREMITY (Arm pain with numbness), HYPOAESTHESIA (Arm pain with numbness), DYSPNOEA ("Feels like a block of cement") and HEADACHE (headaches). At the time of the report, ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well"), WEIGHT INCREASED (2lb weight gain), PAIN IN EXTREMITY (Arm pain with numbness), HYPOAESTHESIA (Arm pain with numbness), DYSPNOEA ("Feels like a block of cement") and HEADACHE (headaches) outcome was unknown. Not Provided          No concomitant medications reported by investigator. Advil and Aleeve used as a Treatment Medication.   This case was linked to MOD-2021-089492 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Weight increased
Clinical narrative: Bloating; diarrhea; I feel terrible; "I feel hard to breathing well"; 2lb weight gain; Arm pain with numbness; Arm pain with numbness; "Feels like a block of cement"; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well") and WEIGHT INCREASED (2lb weight gain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 646B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well"), WEIGHT INCREASED (2lb weight gain), PAIN IN EXTREMITY (Arm pain with numbness), HYPOAESTHESIA (Arm pain with numbness), DYSPNOEA ("Feels like a block of cement") and HEADACHE (headaches). At the time of the report, ABDOMINAL DISTENSION (Bloating), DIARRHOEA (diarrhea), FEELING ABNORMAL (I feel terrible), DYSPNOEA ("I feel hard to breathing well"), WEIGHT INCREASED (2lb weight gain), PAIN IN EXTREMITY (Arm pain with numbness), HYPOAESTHESIA (Arm pain with numbness), DYSPNOEA ("Feels like a block of cement") and HEADACHE (headaches) outcome was unknown. Not Provided          No concomitant medications reported by investigator. Advil and Aleeve used as a Treatment Medication.   This case was linked to MOD-2021-089492 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia, Tremor
Clinical narrative: Tingling in the feet; Tremor in hands; Cramping in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the feet), TREMOR (Tremor in hands) and MUSCLE SPASMS (Cramping in her legs) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008621-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PARAESTHESIA (Tingling in the feet), TREMOR (Tremor in hands) and MUSCLE SPASMS (Cramping in her legs). At the time of the report, PARAESTHESIA (Tingling in the feet), TREMOR (Tremor in hands) and MUSCLE SPASMS (Cramping in her legs) had not resolved. 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.   no concomitant medications are provided. treatment to the events not reported. patient want to know if she can received the second dose as scheduled  despite the ongoing symptoms on 24-apr-2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: burning rash; After 8 days new rash like hives on face and neck; touches it and it burns; This spontaneous case was reported by a consumer and describes the occurrence of RASH (burning rash), URTICARIA (After 8 days new rash like hives on face and neck) and BURNING SENSATION (touches it and it burns) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 027A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and VITAMIN D NOS for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced URTICARIA (After 8 days new rash like hives on face and neck) and BURNING SENSATION (touches it and it burns). On an unknown date, the patient experienced RASH (burning rash). The patient was treated with PREDNISONE from 04-Apr-2021 to 11-Apr-2021 at a dose of 20 mg once a day; FAMOTIDINE from 04-Apr-2021 to 11-Apr-2021 at a dose of 40 mg once a day and HYDROXYZINE (ATARAX [HYDROXYZINE]) from 04-Apr-2021 to 14-Apr-2021 at an unspecified dose and frequency. At the time of the report, RASH (burning rash), URTICARIA (After 8 days new rash like hives on face and neck) and BURNING SENSATION (touches it and it burns) 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.   Other concomitant medication included Sarno, Benadryl.   This case was linked to MOD-2021-089496 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up was received  Vaccine lot numbers, patient  info, concomitant products, AE outcome was added
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: soreness in her arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) and FATIGUE (tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (soreness in her arm) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received: No significant information was found.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089523:Cross linked with Dose 2