chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: More headache; On the left arm between the elbow and shoulder a very blue with circle bruise was noted; hot flushes; chills; very high fever around 103F; fatigue; cold/a little bit chilly; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold/a little bit chilly), HOT FLUSH (hot flushes), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (More headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) for Headache, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CIMICIFUGA RACEMOSA ROOT, GLYCINE MAX EXTRACT (BLACK COHOSH & SOY ISOFLAVONES) and PANTOPRAZOLE for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (cold/a little bit chilly) and FATIGUE (fatigue). On 03-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (very high fever around 103F). On 16-Feb-2021, the patient experienced HOT FLUSH (hot flushes). On 04-May-2021, the patient experienced HEADACHE (More headache) and CONTUSION (On the left arm between the elbow and shoulder a very blue with circle bruise was noted). At the time of the report, NASOPHARYNGITIS (cold/a little bit chilly), HOT FLUSH (hot flushes), CHILLS (chills), FATIGUE (fatigue), HEADACHE (More headache), PYREXIA (very high fever around 103F) and CONTUSION (On the left arm between the elbow and shoulder a very blue with circle bruise was noted) 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.   Treatment details were :Took Tylenol for fever, icepack for headache and consulted Gynecologist for hot flushes and was prescribed with Black cohosh 540 mg capsule once a day   This case was linked to US-MODERNATX, INC.-MOD-2021-109635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109635:Original Case : MOD-2021-109635
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: body aches; jolt/shocking pains all over body.; soreness in arm of injection site; headache; fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (soreness in arm of injection site), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and MYALGIA (jolt/shocking pains all over body.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm of injection site), HEADACHE (headache) and FATIGUE (fatigue). On 20-Apr-2021, the patient experienced MYALGIA (body aches) and MYALGIA (jolt/shocking pains all over body.). At the time of the report, VACCINATION SITE PAIN (soreness in arm of injection site), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and MYALGIA (jolt/shocking pains all over body.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea from constipation relieving tea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea from constipation relieving tea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Constipation. Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER), NAPROXEN, LEVOTHYROXINE, LOSARTAN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID (VIT C) and MECLIZINE [MECLOZINE] for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIARRHOEA (diarrhea from constipation relieving tea). At the time of the report, DIARRHOEA (diarrhea from constipation relieving tea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (body ache) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-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) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (nausea) and MYALGIA (body ache). At the time of the report, NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable. No concomitant medication wee reported. No treatment medication were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash pruritic, Skin discolouration, Urticaria, Vaccination site erythema
Clinical narrative: red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist; itchy hives on legs,itchy hives on torso,itchy hives on wrist; (left) arm "almost black and blue"; (left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange; Vaccination site pain; red (left) arm "a bit larger than an orange"; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange"), URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange"). 11-Mar-2021, the patient experienced SKIN DISCOLOURATION ((left) arm "almost black and blue"). On an unknown date, the patient experienced URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist). On 25-Mar-2021, PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange") and SKIN DISCOLOURATION ((left) arm "almost black and blue") had resolved. At the time of the report, URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist) outcome was unknown. Not Provided          Concomitant medications include cortisone (topical) and Antihistamines. Treatment information was not provided.   This case was linked to MOD-2021-109666 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist; itchy hives on legs,itchy hives on torso,itchy hives on wrist; (left) arm "almost black and blue"; (left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange; Vaccination site pain; red (left) arm "a bit larger than an orange"; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange"), URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange"). 11-Mar-2021, the patient experienced SKIN DISCOLOURATION ((left) arm "almost black and blue"). On an unknown date, the patient experienced URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist). On 25-Mar-2021, PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange") and SKIN DISCOLOURATION ((left) arm "almost black and blue") had resolved. At the time of the report, URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist) outcome was unknown. Not Provided          Concomitant medications include cortisone (topical) and Antihistamines. Treatment information was not provided.   This case was linked to MOD-2021-109666 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MIGRAINE (Migraine). On 31-Mar-2021, MIGRAINE (Migraine) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment given included Ibuprofen. Concomitant medications were not provided.   This case was linked to MOD-2021-109707 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nausea
Clinical narrative: extremely migraine; muscle aches from head to tow; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (extremely migraine), MYALGIA (muscle aches from head to tow) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced MIGRAINE (extremely migraine), MYALGIA (muscle aches from head to tow) and NAUSEA (nausea). At the time of the report, MIGRAINE (extremely migraine), MYALGIA (muscle aches from head to tow) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine liquid spilled during the administration; Vaccine liquid spilled during the administration; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine liquid spilled during the administration) and DEVICE CONNECTION ISSUE (Vaccine liquid spilled during the administration) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced UNDERDOSE (Vaccine liquid spilled during the administration) and DEVICE CONNECTION ISSUE (Vaccine liquid spilled during the administration). On 05-May-2021, UNDERDOSE (Vaccine liquid spilled during the administration) and DEVICE CONNECTION ISSUE (Vaccine liquid spilled during the administration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Bedridden, Chills, Decreased appetite
Clinical narrative: Stomach pain; Back pain; Diarrhea; Low appetite; Was in bed for two days; He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite) and BEDRIDDEN (Was in bed for two days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite), BEDRIDDEN (Was in bed for two days), PRODUCT DOSE OMISSION ISSUE (He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite), BEDRIDDEN (Was in bed for two days), PRODUCT DOSE OMISSION ISSUE (He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Product dose omission issue
Clinical narrative: Stomach pain; Back pain; Diarrhea; Low appetite; Was in bed for two days; He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite) and BEDRIDDEN (Was in bed for two days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite), BEDRIDDEN (Was in bed for two days), PRODUCT DOSE OMISSION ISSUE (He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIARRHEA (Diarrhea), DECREASED APPETITE (Low appetite), BEDRIDDEN (Was in bed for two days), PRODUCT DOSE OMISSION ISSUE (He wanted to know after passing 42 days is it worth to receive the 2nd dose and can he still get that.) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days have passed and received 2nd dose after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and received 2nd dose after 1st dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and received 2nd dose after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and received 2nd dose after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced MIGRAINE (Migraine). On 31-Mar-2021, MIGRAINE (Migraine) had resolved. Unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant details were provided. Treatment details include Ibuprofen. This case was linked to MOD-2021-109690.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on his legs, knees, wrists, stomach, arms, head and "butt"; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on his legs, knees, wrists, stomach, arms, head and "butt") in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001f21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced RASH PRURITIC (itchy rash on his legs, knees, wrists, stomach, arms, head and "butt"). At the time of the report, RASH PRURITIC (itchy rash on his legs, knees, wrists, stomach, arms, head and "butt") 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.   Upon internal review on 04-Aug-2021, age units was updated to years.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness in muscles; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness in muscles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE, EZETIMIBE (ZETIA), OMEPRAZOLE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and USTEKINUMAB (STELARA).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (soreness in muscles). On 02-Apr-2021, MYALGIA (soreness in muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-109734 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Nausea, Pain
Clinical narrative: slept for 4 days constantly; sore arm; body aches and pain; mild fever of 100 degrees; bad headache; milder nausea; incredibily tired; didn't feel like she was going to die from this second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea), FATIGUE (incredibily tired) and THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, PROPRANOLOL, LEVOTHYROXINE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and MAGNESIUM for an unknown indication.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-May-2021, the patient experienced HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea), FATIGUE (incredibily tired) and THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine).   The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   On 03-May-2021, THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine) had resolved. On 06-May-2021, HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea) and FATIGUE (incredibily tired) had resolved.       This case was linked to MOD-2021-072645 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Therapeutic response unexpected
Clinical narrative: slept for 4 days constantly; sore arm; body aches and pain; mild fever of 100 degrees; bad headache; milder nausea; incredibily tired; didn't feel like she was going to die from this second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea), FATIGUE (incredibily tired) and THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, PROPRANOLOL, LEVOTHYROXINE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and MAGNESIUM for an unknown indication.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-May-2021, the patient experienced HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea), FATIGUE (incredibily tired) and THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine).   The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   On 03-May-2021, THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine) had resolved. On 06-May-2021, HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea) and FATIGUE (incredibily tired) had resolved.       This case was linked to MOD-2021-072645 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Pain in extremity, Pyrexia
Clinical narrative: pain in foot; Fever; shortness of breath; cough; Pain in head; Vomiting; Rash all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough) and HEADACHE (Pain in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) 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 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough), HEADACHE (Pain in head), VOMITING (Vomiting) and RASH (Rash all over). At the time of the report, PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough), HEADACHE (Pain in head) and VOMITING (Vomiting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114889 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: pain in foot; Fever; shortness of breath; cough; Pain in head; Vomiting; Rash all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough) and HEADACHE (Pain in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) 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 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough), HEADACHE (Pain in head), VOMITING (Vomiting) and RASH (Rash all over). At the time of the report, PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough), HEADACHE (Pain in head) and VOMITING (Vomiting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114889 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of the Moderna Covid-19 vaccine greater than 42 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna Covid-19 vaccine greater than 42 days after the 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna Covid-19 vaccine greater than 42 days after the first dose). 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Head discomfort, Hot flush, Neuritis, Otorrhoea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash) and tinnitus (ringing in the ear) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Previously administered products included for an unreported indication: hepatitis and typhoid vaccine. No concomitant medication reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 31, 2021, patient experienced head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash), tinnitus (ringing in the ear) and otorrhea (fluid in the ear). At the time of the report, head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash), tinnitus (ringing in the ear) and otorrhea (fluid in the ear) outcome: unknown. Treatment medication included Aleve. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash) and tinnitus (ringing in the ear) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Previously administered products included for an unreported indication: hepatitis and typhoid vaccine. No concomitant medication reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 31, 2021, patient experienced head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash), tinnitus (ringing in the ear) and otorrhea (fluid in the ear). At the time of the report, head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash), tinnitus (ringing in the ear) and otorrhea (fluid in the ear) outcome: unknown. Treatment medication included Aleve. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Tinnitus
Clinical narrative: my tinnitus has gotten worse; I have higher blood pressure; continuous headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (my tinnitus has gotten worse), BLOOD PRESSURE INCREASED (I have higher blood pressure) and HEADACHE (continuous headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced TINNITUS (my tinnitus has gotten worse), BLOOD PRESSURE INCREASED (I have higher blood pressure) and HEADACHE (continuous headaches). At the time of the report, TINNITUS (my tinnitus has gotten worse), BLOOD PRESSURE INCREASED (I have higher blood pressure) and HEADACHE (continuous headaches) had resolved. Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Pain, Somnolence
Clinical narrative: weak; slept on and off all day; nauseous; super tired; achy - Soreness; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), PAIN (achy - Soreness), SOMNOLENCE (slept on and off all day), NAUSEA (nauseous) and FATIGUE (super tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Multiple concomitant medications are reported, but no historical medical condition is reported.).   On 30-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 27-Apr-2021, the patient experienced PAIN (achy - Soreness) and FATIGUE (super tired). On 28-Apr-2021, the patient experienced ASTHENIA (weak), SOMNOLENCE (slept on and off all day) and NAUSEA (nauseous). On 29-Apr-2021, ASTHENIA (weak), PAIN (achy - Soreness), SOMNOLENCE (slept on and off all day), NAUSEA (nauseous) and FATIGUE (super tired) had resolved.            No treatment medication was reported.   This case was linked to MOD-2021-109711 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I am pregnant and I took the vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and I took the vaccine) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and I took the vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and I took the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Visual impairment
Clinical narrative: Eyes have been burning burning badly since she has received the vaccine; Having difficulty with her vision; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes have been burning burning badly since she has received the vaccine) and VISUAL IMPAIRMENT (Having difficulty with her vision) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Food allergy. Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, LEVOTHYROXINE, CARVEDILOL, ROSUVASTATIN, CALCITRIOL, MORPHINE and VITAMINS NOS for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EYE IRRITATION (Eyes have been burning burning badly since she has received the vaccine) and VISUAL IMPAIRMENT (Having difficulty with her vision). At the time of the report, EYE IRRITATION (Eyes have been burning burning badly since she has received the vaccine) and VISUAL IMPAIRMENT (Having difficulty with her vision) had not resolved.            Other concomitant medications included: OTC vitamins The patient reported that she was having a lot of trouble to the point that she was having difficulty with her vision. She was not sure if this was due to the vaccine. Treatment for the events included: Eye drops.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Feeling abnormal, Gait disturbance
Clinical narrative: really sick for 3 days; arthritic issues/arthritis in right knee; feet feel weak; feet feel strange; pain in right calf; pain is jumpy sometimes from knee to ankle and calf; severe muscle fatigue; When she walks it feels like she has climbed for six hours on a mountain; left hand has begun to feel weak; joint issues; joint pain in right knee; pain in right ankle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (really sick for 3 days), ARTHRITIS (arthritic issues/arthritis in right knee), ASTHENIA (feet feel weak), FEELING ABNORMAL (feet feel strange) and PAIN IN EXTREMITY (pain in right calf) 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.     The patient's past medical history included Colectomy and Ileostomy. Concurrent medical conditions included Guillain-Barre syndrome.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient experienced ILLNESS (really sick for 3 days), ARTHRITIS (arthritic issues/arthritis in right knee), ASTHENIA (feet feel weak), FEELING ABNORMAL (feet feel strange), PAIN IN EXTREMITY (pain in right calf), PAIN (pain is jumpy sometimes from knee to ankle and calf), MUSCLE FATIGUE (severe muscle fatigue), GAIT DISTURBANCE (When she walks it feels like she has climbed for six hours on a mountain), MUSCULAR WEAKNESS (left hand has begun to feel weak), ARTHRALGIA (joint issues), ARTHRALGIA (joint pain in right knee) and ARTHRALGIA (pain in right ankle). At the time of the report, ILLNESS (really sick for 3 days), ARTHRITIS (arthritic issues/arthritis in right knee), ASTHENIA (feet feel weak), FEELING ABNORMAL (feet feel strange), PAIN IN EXTREMITY (pain in right calf), PAIN (pain is jumpy sometimes from knee to ankle and calf), MUSCLE FATIGUE (severe muscle fatigue), GAIT DISTURBANCE (When she walks it feels like she has climbed for six hours on a mountain), MUSCULAR WEAKNESS (left hand has begun to feel weak), ARTHRALGIA (joint issues), ARTHRALGIA (joint pain in right knee) and ARTHRALGIA (pain in right ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle fatigue, Muscular weakness, Pain, Pain in extremity
Clinical narrative: really sick for 3 days; arthritic issues/arthritis in right knee; feet feel weak; feet feel strange; pain in right calf; pain is jumpy sometimes from knee to ankle and calf; severe muscle fatigue; When she walks it feels like she has climbed for six hours on a mountain; left hand has begun to feel weak; joint issues; joint pain in right knee; pain in right ankle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (really sick for 3 days), ARTHRITIS (arthritic issues/arthritis in right knee), ASTHENIA (feet feel weak), FEELING ABNORMAL (feet feel strange) and PAIN IN EXTREMITY (pain in right calf) 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.     The patient's past medical history included Colectomy and Ileostomy. Concurrent medical conditions included Guillain-Barre syndrome.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient experienced ILLNESS (really sick for 3 days), ARTHRITIS (arthritic issues/arthritis in right knee), ASTHENIA (feet feel weak), FEELING ABNORMAL (feet feel strange), PAIN IN EXTREMITY (pain in right calf), PAIN (pain is jumpy sometimes from knee to ankle and calf), MUSCLE FATIGUE (severe muscle fatigue), GAIT DISTURBANCE (When she walks it feels like she has climbed for six hours on a mountain), MUSCULAR WEAKNESS (left hand has begun to feel weak), ARTHRALGIA (joint issues), ARTHRALGIA (joint pain in right knee) and ARTHRALGIA (pain in right ankle). At the time of the report, ILLNESS (really sick for 3 days), ARTHRITIS (arthritic issues/arthritis in right knee), ASTHENIA (feet feel weak), FEELING ABNORMAL (feet feel strange), PAIN IN EXTREMITY (pain in right calf), PAIN (pain is jumpy sometimes from knee to ankle and calf), MUSCLE FATIGUE (severe muscle fatigue), GAIT DISTURBANCE (When she walks it feels like she has climbed for six hours on a mountain), MUSCULAR WEAKNESS (left hand has begun to feel weak), ARTHRALGIA (joint issues), ARTHRALGIA (joint pain in right knee) and ARTHRALGIA (pain in right ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Vision blurred
Clinical narrative: Left sore arm; dizziness; Right eye blurriness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left sore arm), DIZZINESS (dizziness), VISION BLURRED (Right eye blurriness) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (Left sore arm), DIZZINESS (dizziness), VISION BLURRED (Right eye blurriness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Left sore arm), DIZZINESS (dizziness), VISION BLURRED (Right eye blurriness) and HEADACHE (Headache) 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Micturition urgency, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION URGENCY (urinary urgency/has an intense urge to urinate, but barely excretes anything when she goes to the restroom), PAIN (pain), DIZZINESS (light headedness), CHILLS (chills) and PYREXIA (fever) in a 54-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 ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) for Hormone replacement therapy.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MICTURITION URGENCY (urinary urgency/has an intense urge to urinate, but barely excretes anything when she goes to the restroom), PAIN (pain), DIZZINESS (light headedness), CHILLS (chills) and PYREXIA (fever). At the time of the report, MICTURITION URGENCY (urinary urgency/has an intense urge to urinate, but barely excretes anything when she goes to the restroom), PAIN (pain), DIZZINESS (light headedness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol, 4 pills.