chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Night sweats, Pain, Pain in extremity
Clinical narrative: Feeling sick; Fever; Really bad headache; Arm hurts a lot; Aching all over; Woke up with up with sweat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts a lot), MALAISE (Feeling sick), PAIN (Aching all over), NIGHT SWEATS (Woke up with up with sweat) and HEADACHE (Really bad headache) in a 78-year-old female 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 information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts a lot), PAIN (Aching all over) and NIGHT SWEATS (Woke up with up with sweat). On 26-Feb-2021, the patient experienced HEADACHE (Really bad headache). On an unknown date, the patient experienced MALAISE (Feeling sick) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts a lot), MALAISE (Feeling sick), PAIN (Aching all over), NIGHT SWEATS (Woke up with up with sweat), HEADACHE (Really bad headache) and PYREXIA (Fever) outcome was unknown.            Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling sick; Fever; Really bad headache; Arm hurts a lot; Aching all over; Woke up with up with sweat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts a lot), MALAISE (Feeling sick), PAIN (Aching all over), NIGHT SWEATS (Woke up with up with sweat) and HEADACHE (Really bad headache) in a 78-year-old female 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 information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts a lot), PAIN (Aching all over) and NIGHT SWEATS (Woke up with up with sweat). On 26-Feb-2021, the patient experienced HEADACHE (Really bad headache). On an unknown date, the patient experienced MALAISE (Feeling sick) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts a lot), MALAISE (Feeling sick), PAIN (Aching all over), NIGHT SWEATS (Woke up with up with sweat), HEADACHE (Really bad headache) and PYREXIA (Fever) outcome was unknown.            Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Arm pain; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included IBUPROFEN for an unknown indication.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Delayed injection site pain; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Delayed injection site pain) and PERIPHERAL SWELLING (Swollen arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Delayed injection site pain) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, INJECTION SITE PAIN (Delayed injection site pain) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: red spot; Itchy rash; Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine), RASH ERYTHEMATOUS (red spot) and RASH PRURITIC (Itchy rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M204) for COVID-19 vaccination.     The patient's past medical history included Ulcerative colitis in 1984. Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy (Adhesives), Diabetes (Diabetes Type 1) since 12-Feb-1978, Hashimoto's disease in 1995, Hypertension in 2010 and Osteoporosis in 2019. Concomitant products included MESALAZINE (ASACOL) for Colitis ulcerative, INSULIN LISPRO (HUMALOG) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, LISINOPRIL for Hypertension, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, ATORVASTATIN CALCIUM (LIPITOR), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3), CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red spot) and RASH PRURITIC (Itchy rash). At the time of the report, PRURITUS (Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine), RASH ERYTHEMATOUS (red spot) and RASH PRURITIC (Itchy rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medicine      Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient demographics is updated.Patient medical history is updated.Concomitant product information is updated. Outcome of the event is updated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: injection site hardness/sore; Aches and pain; Nausea; Headache; Feels like has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Feels like has a temperature) and VACCINATION SITE PAIN (injection site hardness/sore) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive (Late October/early November).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Aches and pain), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Feels like has a temperature). On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site hardness/sore). At the time of the report, MYALGIA (Aches and pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Feels like has a temperature) and VACCINATION SITE PAIN (injection site hardness/sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Fatigue, Glycosylated haemoglobin increased, Myalgia
Clinical narrative: muscle ache; severe joint pain; severe fatigue; joint ache; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle ache), ARTHRALGIA (joint ache), RASH (rash) and ARTHRALGIA (severe joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Demoral allergy was reported). Concomitant products included TESTOSTERONE (FORTESTA) and COLESEVELAM HCL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FATIGUE (fatigue). On 02-Feb-2021, the patient experienced ARTHRALGIA (joint ache) and RASH (rash). On 09-Feb-2021, the patient experienced MYALGIA (muscle ache), ARTHRALGIA (severe joint pain) and FATIGUE (severe fatigue). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle ache) and RASH (rash) had not resolved and ARTHRALGIA (joint ache), ARTHRALGIA (severe joint pain) and FATIGUE (severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood glucose: (High) High and high (High) high. On 09-Feb-2021, Glycosylated haemoglobin increased (6.3-7.8): increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       traeatment medication Triamcinlone Cream for Rash.,rednisone were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-026992 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: added concomitant medication, patient demographic. event, historical condition ,lab data, treatement medication; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026992:cross link
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: muscle ache; severe joint pain; severe fatigue; joint ache; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle ache), ARTHRALGIA (joint ache), RASH (rash) and ARTHRALGIA (severe joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Demoral allergy was reported). Concomitant products included TESTOSTERONE (FORTESTA) and COLESEVELAM HCL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FATIGUE (fatigue). On 02-Feb-2021, the patient experienced ARTHRALGIA (joint ache) and RASH (rash). On 09-Feb-2021, the patient experienced MYALGIA (muscle ache), ARTHRALGIA (severe joint pain) and FATIGUE (severe fatigue). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle ache) and RASH (rash) had not resolved and ARTHRALGIA (joint ache), ARTHRALGIA (severe joint pain) and FATIGUE (severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood glucose: (High) High and high (High) high. On 09-Feb-2021, Glycosylated haemoglobin increased (6.3-7.8): increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       traeatment medication Triamcinlone Cream for Rash.,rednisone were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-026992 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: added concomitant medication, patient demographic. event, historical condition ,lab data, treatement medication; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026992:cross link
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dysphagia, Insomnia
Clinical narrative: No sleep for two days; severe cold; chills; coughing; cant eat; having trouble swallowing; fever; A spontaneous report was received from a consumer concerning a 86 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events no sleep for 2 days/insomnia, severe cold/nasopharyngitis, chills, coughing, cant eat/decreased appetite, having trouble swallowing/dysphagia, fever/pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) No sleep for 2 days, Severe cold, Chills, Coughing, Cant eat, Having trouble swallowing, Fever.  Treatment details included Patient have been taking Zical since reactions started.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), no sleep for 2 days/insomnia, severe cold/nasopharyngitis, chills, coughing, cant eat/decreased appetite, having trouble swallowing/dysphagia, fever/pyrexia  was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: No sleep for two days; severe cold; chills; coughing; cant eat; having trouble swallowing; fever; A spontaneous report was received from a consumer concerning a 86 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events no sleep for 2 days/insomnia, severe cold/nasopharyngitis, chills, coughing, cant eat/decreased appetite, having trouble swallowing/dysphagia, fever/pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) No sleep for 2 days, Severe cold, Chills, Coughing, Cant eat, Having trouble swallowing, Fever.  Treatment details included Patient have been taking Zical since reactions started.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), no sleep for 2 days/insomnia, severe cold/nasopharyngitis, chills, coughing, cant eat/decreased appetite, having trouble swallowing/dysphagia, fever/pyrexia  was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Migraine, Myalgia
Clinical narrative: Headache (congested heavy)/migraine; Itchy left arm; Chills; Joint left side pain; Muscle left side pain; Very very tired; Swollen left arm; A spontaneous report was received from a 64 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed headache (congested, heavy)/migraine, chills, joint left side pain, muscle left side pain, very very tired, swollen left arm, and itchy left arm.  The patient's medical history was not provided. Concomitant medications, known to have been used by the patient within two weeks prior to the event, included vitamins.  On 18-FEB-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19-FEB-2021, the patient developed headache (congested, heavy)/migraine, chills, joint left side pain, muscle left side pain, very very tired, swollen left arm, and itchy left arm. Treatment included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of headache (congested, heavy)/migraine was not resolved and outcomes of chills, joint left side pain, muscle left side pain, very very tired, swollen left arm, and Itchy left arm were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Headache (congested heavy)/migraine; Itchy left arm; Chills; Joint left side pain; Muscle left side pain; Very very tired; Swollen left arm; A spontaneous report was received from a 64 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed headache (congested, heavy)/migraine, chills, joint left side pain, muscle left side pain, very very tired, swollen left arm, and itchy left arm.  The patient's medical history was not provided. Concomitant medications, known to have been used by the patient within two weeks prior to the event, included vitamins.  On 18-FEB-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19-FEB-2021, the patient developed headache (congested, heavy)/migraine, chills, joint left side pain, muscle left side pain, very very tired, swollen left arm, and itchy left arm. Treatment included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of headache (congested, heavy)/migraine was not resolved and outcomes of chills, joint left side pain, muscle left side pain, very very tired, swollen left arm, and Itchy left arm were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Eye pruritus, Feeling hot, Nasal congestion
Clinical narrative: itching on different parts of her body; short of breath; wheezing; right arm had swelling; congested; nose started running; eye turned red; like coming up with a cold; eye itched; warm sensation; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body) and DYSPNOEA (short of breath) 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.     Concomitant products included CETIRIZINE HCL for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING HOT (warm sensation) and DIZZINESS (dizzy). On 02-Feb-2021, the patient experienced EYE PRURITUS (eye itched), NASOPHARYNGITIS (like coming up with a cold) and OCULAR HYPERAEMIA (eye turned red). On an unknown date, the patient experienced PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested) and RHINORRHOEA (nose started running). At the time of the report, FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested), NASOPHARYNGITIS (like coming up with a cold), RHINORRHOEA (nose started running) and OCULAR HYPERAEMIA (eye turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Ocular hyperaemia, Peripheral swelling, Pruritus, Rhinorrhoea
Clinical narrative: itching on different parts of her body; short of breath; wheezing; right arm had swelling; congested; nose started running; eye turned red; like coming up with a cold; eye itched; warm sensation; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body) and DYSPNOEA (short of breath) 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.     Concomitant products included CETIRIZINE HCL for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING HOT (warm sensation) and DIZZINESS (dizzy). On 02-Feb-2021, the patient experienced EYE PRURITUS (eye itched), NASOPHARYNGITIS (like coming up with a cold) and OCULAR HYPERAEMIA (eye turned red). On an unknown date, the patient experienced PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested) and RHINORRHOEA (nose started running). At the time of the report, FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested), NASOPHARYNGITIS (like coming up with a cold), RHINORRHOEA (nose started running) and OCULAR HYPERAEMIA (eye turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: itching on different parts of her body; short of breath; wheezing; right arm had swelling; congested; nose started running; eye turned red; like coming up with a cold; eye itched; warm sensation; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body) and DYSPNOEA (short of breath) 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.     Concomitant products included CETIRIZINE HCL for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING HOT (warm sensation) and DIZZINESS (dizzy). On 02-Feb-2021, the patient experienced EYE PRURITUS (eye itched), NASOPHARYNGITIS (like coming up with a cold) and OCULAR HYPERAEMIA (eye turned red). On an unknown date, the patient experienced PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested) and RHINORRHOEA (nose started running). At the time of the report, FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested), NASOPHARYNGITIS (like coming up with a cold), RHINORRHOEA (nose started running) and OCULAR HYPERAEMIA (eye turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Every muscle started aching; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Every muscle started aching) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Allergic to Lisinopril).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Every muscle started aching) and PYREXIA (Fever). At the time of the report, MYALGIA (Every muscle started aching) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bed rest, Body temperature, Chills, Dizziness
Clinical narrative: Severe flu symptoms; Bed rest for 4 days and could not go to work; Weak; Dizziness; Chills; Nausea; Vomiting; headache; Lowgrade fever; Body aches; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weak) and DIZZINESS (Dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], CURCUMIN and UBIDECARENONE (COQ 10) for an unknown indication.    On 20-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced MYALGIA (Body aches). On 27-Jan-2021, the patient experienced INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), ASTHENIA (Weak), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 01-Feb-2021, INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever) had resolved. On 02-Feb-2021, DIZZINESS (Dizziness) had resolved. On 04-Feb-2021, ASTHENIA (Weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7 F. On 28-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient demographic details updated. Lab data added. 2 nd dose details added. Concomitant medications added.New events added. The outcome of the event (s) changed from unknown to recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Myalgia, Nausea, Pain in extremity
Clinical narrative: Severe flu symptoms; Bed rest for 4 days and could not go to work; Weak; Dizziness; Chills; Nausea; Vomiting; headache; Lowgrade fever; Body aches; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weak) and DIZZINESS (Dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], CURCUMIN and UBIDECARENONE (COQ 10) for an unknown indication.    On 20-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced MYALGIA (Body aches). On 27-Jan-2021, the patient experienced INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), ASTHENIA (Weak), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 01-Feb-2021, INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever) had resolved. On 02-Feb-2021, DIZZINESS (Dizziness) had resolved. On 04-Feb-2021, ASTHENIA (Weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7 F. On 28-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient demographic details updated. Lab data added. 2 nd dose details added. Concomitant medications added.New events added. The outcome of the event (s) changed from unknown to recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe flu symptoms; Bed rest for 4 days and could not go to work; Weak; Dizziness; Chills; Nausea; Vomiting; headache; Lowgrade fever; Body aches; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weak) and DIZZINESS (Dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], CURCUMIN and UBIDECARENONE (COQ 10) for an unknown indication.    On 20-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced MYALGIA (Body aches). On 27-Jan-2021, the patient experienced INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), ASTHENIA (Weak), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 01-Feb-2021, INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever) had resolved. On 02-Feb-2021, DIZZINESS (Dizziness) had resolved. On 04-Feb-2021, ASTHENIA (Weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7 F. On 28-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient demographic details updated. Lab data added. 2 nd dose details added. Concomitant medications added.New events added. The outcome of the event (s) changed from unknown to recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and; Patient had itchiness all over her body in the late afternoon few hours after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient had itchiness all over her body in the late afternoon few hours after the vaccination) and RASH PRURITIC (Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Patient had itchiness all over her body in the late afternoon few hours after the vaccination). On 18-Feb-2021, the patient experienced RASH PRURITIC (Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and). At the time of the report, PRURITUS (Patient had itchiness all over her body in the late afternoon few hours after the vaccination) and RASH PRURITIC (Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site urticaria
Clinical narrative: HIves at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (HIves at injection site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (HIves at injection site) and HEADACHE (Headache). At the time of the report, INJECTION SITE URTICARIA (HIves at injection site) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The age range of the patient was provided as 28-35 years.  No treatment information was provided.  No concomitant medications was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site was itchy; Injection site was swollen; Round red rash around the injection site; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE RASH (Round red rash around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE RASH (Round red rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE RASH (Round red rash around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Weight decreased
Clinical narrative: has lost pounds , which is something difficult for her; can´t get herself around /feel she drag herself; feeling some fatigue that went worst /usually have some fatigue but not like the one she has been experiencing after the shot /still have the fatigue; could not sleep or eat for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep or eat for 2 days), WEIGHT DECREASED (has lost pounds , which is something difficult for her), FEELING ABNORMAL (can´t get herself around /feel she drag herself) and FATIGUE (feeling some fatigue that went worst /usually have some fatigue but not like the one she has been experiencing after the shot /still have the fatigue) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (Had a stroke 3 years ago).    On 02-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 INSOMNIA (could not sleep or eat for 2 days) and FATIGUE (feeling some fatigue that went worst /usually have some fatigue but not like the one she has been experiencing after the shot /still have the fatigue). On 09-Feb-2021, the patient experienced WEIGHT DECREASED (has lost pounds , which is something difficult for her) and FEELING ABNORMAL (can´t get herself around /feel she drag herself). On 06-Feb-2021, INSOMNIA (could not sleep or eat for 2 days) had resolved. At the time of the report, WEIGHT DECREASED (has lost pounds , which is something difficult for her), FEELING ABNORMAL (can´t get herself around /feel she drag herself) and FATIGUE (feeling some fatigue that went worst /usually have some fatigue but not like the one she has been experiencing after the shot /still have the fatigue) 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.   Concomitant product include pill for blood thinner.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22 Apr 2021 included no new information and patient denied further follow up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Body temperature, Pain
Clinical narrative: Lost taste; Lost smell; Back aches/Achy; 99.8 fever; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant are provided.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain). On 09-Feb-2021, AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 99.8 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs included diabetes medicines and blood pressure medicine. No treatment medication information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lost taste; Lost smell; Back aches/Achy; 99.8 fever; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant are provided.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain). On 09-Feb-2021, AGEUSIA (Lost taste), ANOSMIA (Lost smell), PAIN (Back aches/Achy), PYREXIA (99.8 fever) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 99.8 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs included diabetes medicines and blood pressure medicine. No treatment medication information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: A red raised circle the size of a quarter, it was warm to touch; A red raised circle the size of a quarter; A red raised circle the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A red raised circle the size of a quarter, it was warm to touch), VACCINATION SITE ERYTHEMA (A red raised circle the size of a quarter) and VACCINATION SITE RASH (A red raised circle the size of a quarter) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic reaction to Dupixent injection).  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (A red raised circle the size of a quarter, it was warm to touch), VACCINATION SITE ERYTHEMA (A red raised circle the size of a quarter) and VACCINATION SITE RASH (A red raised circle the size of a quarter). At the time of the report, VACCINATION SITE WARMTH (A red raised circle the size of a quarter, it was warm to touch), VACCINATION SITE ERYTHEMA (A red raised circle the size of a quarter) and VACCINATION SITE RASH (A red raised circle the size of a quarter) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Throat irritation
Clinical narrative: Got a cold; Throat is kind of hoarse right now; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Got a cold) and THROAT IRRITATION (Throat is kind of hoarse right now) 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) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced NASOPHARYNGITIS (Got a cold) and THROAT IRRITATION (Throat is kind of hoarse right now).   At the time of the report, NASOPHARYNGITIS (Got a cold) and THROAT IRRITATION (Throat is kind of hoarse right now) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on her right upper limb), FATIGUE (Tired), HEADACHE (Headache) and ARTHRALGIA (Pain on right shoulder blade) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on her right upper limb), FATIGUE (Tired) and HEADACHE (Headache). 23-Feb-2021, the patient experienced ARTHRALGIA (Pain on right shoulder blade). At the time of the report, VACCINATION SITE PAIN (Pain on her right upper limb), FATIGUE (Tired), HEADACHE (Headache) and ARTHRALGIA (Pain on right shoulder blade) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.