chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Eye irritation, Fluid retention, Hypoaesthesia
Clinical narrative: Lungs felt like they were itching, had retention of fluid all over; Diarrhea/ GI stuff is still going on; Lungs felt like they were itching, had retention of fluid all over; Eyes extremely irritated; Joint pain; Swelling on their shoulder puffy shoulder; Temperature of a 102 ºF; Skin feels odd; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated) and HYPOAESTHESIA (Skin feels odd) in a 60-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 was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPOAESTHESIA (Skin feels odd), SWELLING (Swelling on their shoulder puffy shoulder) and PYREXIA (Temperature of a 102 ºF). On an unknown date, the patient experienced RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated) and ARTHRALGIA (Joint pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated), HYPOAESTHESIA (Skin feels odd), ARTHRALGIA (Joint pain), SWELLING (Swelling on their shoulder puffy shoulder) and PYREXIA (Temperature of a 102 ºF) 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 included Oil cream for shoulder puffing.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract irritation, Swelling
Clinical narrative: Lungs felt like they were itching, had retention of fluid all over; Diarrhea/ GI stuff is still going on; Lungs felt like they were itching, had retention of fluid all over; Eyes extremely irritated; Joint pain; Swelling on their shoulder puffy shoulder; Temperature of a 102 ºF; Skin feels odd; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated) and HYPOAESTHESIA (Skin feels odd) in a 60-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 was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPOAESTHESIA (Skin feels odd), SWELLING (Swelling on their shoulder puffy shoulder) and PYREXIA (Temperature of a 102 ºF). On an unknown date, the patient experienced RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated) and ARTHRALGIA (Joint pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated), HYPOAESTHESIA (Skin feels odd), ARTHRALGIA (Joint pain), SWELLING (Swelling on their shoulder puffy shoulder) and PYREXIA (Temperature of a 102 ºF) 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 included Oil cream for shoulder puffing.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Sore throat; Cough; Loss of taste; Loss of taste and smell; A spontaneous report was received from a Healthcare Professional concerning a 62-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid, sore throat, cough, loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events tested positive for covid, sore throat, cough, loss of taste and smell.  Treatment details included azithromycin medication, OTC medications and allergy medications.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event tested positive for covid, sore throat, cough, loss of taste and smell was not reported.; Reporter's Comments: Based on the information provided, the natural history of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for covid and the product use is assessed as unlikely.  The patient was most likely exposed to the disease prior to vaccination. sore throat, cough, loss of taste and smell. are assessed as due to COVID -19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Sore throat; Cough; Loss of taste; Loss of taste and smell; A spontaneous report was received from a Healthcare Professional concerning a 62-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid, sore throat, cough, loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events tested positive for covid, sore throat, cough, loss of taste and smell.  Treatment details included azithromycin medication, OTC medications and allergy medications.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event tested positive for covid, sore throat, cough, loss of taste and smell was not reported.; Reporter's Comments: Based on the information provided, the natural history of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for covid and the product use is assessed as unlikely.  The patient was most likely exposed to the disease prior to vaccination. sore throat, cough, loss of taste and smell. are assessed as due to COVID -19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Felt dizzy; Very hot to touch; very bright red; sore arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), VACCINATION SITE WARMTH (Very hot to touch), VACCINATION SITE ERYTHEMA (very bright red) and VACCINATION SITE PAIN (sore arm for 2 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included TRAMADOL, LISINOPRIL, HYDROCHLOROTHIAZIDE, ATORVASTATIN, CITALOPRAM, BUSPIRONE and VITAMIN D NOS for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 2 days). On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot to touch) and VACCINATION SITE ERYTHEMA (very bright red). On 06-Feb-2021, the patient experienced DIZZINESS (Felt dizzy). At the time of the report, DIZZINESS (Felt dizzy), VACCINATION SITE WARMTH (Very hot to touch), VACCINATION SITE ERYTHEMA (very bright red) and VACCINATION SITE PAIN (sore arm for 2 days) 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.   Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Raised blood sugar sky high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Raised blood sugar sky high) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Raised blood sugar sky high). The patient was treated with INSULIN INJECTION ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Raised blood sugar sky high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: mg/dl (High) blood glucose raised to 475mg%..     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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased
Clinical narrative: Temperature went down to 94.6 F; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Temperature went down to 94.6 F) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced BODY TEMPERATURE DECREASED (Temperature went down to 94.6 F). On 18-Jan-2021, BODY TEMPERATURE DECREASED (Temperature went down to 94.6 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 94.6 (abnormal) temperature went down to 94.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she's developed shingles; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events developed shingles/Herpes zoster.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unavailable) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) developed shingles.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), developed shingles was not resolved at the time of reporting.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: a big rash at the injection site circular about 2 inches in diameter; a little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness in the arm) and INJECTION SITE RASH (a big rash at the injection site circular about 2 inches in diameter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included METOPROLOL and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (a little soreness in the arm). On 25-Jan-2021, the patient experienced INJECTION SITE RASH (a big rash at the injection site circular about 2 inches in diameter). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date at a dose of UNK dosage form; HYDROCORTISONE (CORTIZONE [HYDROCORTISONE]) ongoing since an unknown date at a dose of UNK dosage form and SERTRALINE HYDROCHLORIDE (SERTAC) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (a little soreness in the arm) and INJECTION SITE RASH (a big rash at the injection site circular about 2 inches in diameter) 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 22-Jan-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Gait inability, Pain
Clinical narrative: loss of appetite; bad cough; aches all over; extreme weakness; could barely move; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (aches all over), ASTHENIA (extreme weakness), GAIT INABILITY (could barely move), COUGH (bad cough) and DECREASED APPETITE (loss of appetite) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (aches all over), ASTHENIA (extreme weakness) and GAIT INABILITY (could barely move). On 20-Jan-2021, the patient experienced COUGH (bad cough). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, PAIN (aches all over), ASTHENIA (extreme weakness), GAIT INABILITY (could barely move), COUGH (bad cough) and DECREASED APPETITE (loss of appetite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 68-year-old male, with PMH of COVID-19, who experienced unexpected events of pain, asthenia, unable to walk, cough, and loss of appetite.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a 68-year-old male, with PMH of COVID-19, who experienced NS unexpected events of pain, asthenia, unable to walk, cough, and loss of appetite.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia
Clinical narrative: every bone in her body hurt; body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in her body hurt) and MYALGIA (body aches all over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, 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 BONE PAIN (every bone in her body hurt) and MYALGIA (body aches all over). At the time of the report, BONE PAIN (every bone in her body hurt) and MYALGIA (body aches all over) outcome was unknown.            Concomitant and Treatment medications were not provided by reporter.   This case was linked to MOD-2021-021146 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 and it contains No new information
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, International normalised ratio increased
Clinical narrative: headache; increase INR of 6.6 recorded; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (increase INR of 6.6 recorded) and HEADACHE (headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included DILTIAZEM, HYDROCHLOROTHIAZIDE, AMLODIPINE, FERROUS SULFATE, K CL, ATORVASTATIN, LEVOTHYROXINE and Calcium Carbonate with Vit D for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INTERNATIONAL NORMALISED RATIO INCREASED (increase INR of 6.6 recorded). On 02-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (increase INR of 6.6 recorded) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: lower back hurt; pain in legs; muscle ache; pain in arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), PAIN IN EXTREMITY (pain in legs), MYALGIA (muscle ache) and BACK PAIN (lower back hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in legs) and MYALGIA (muscle ache). On 03-Feb-2021, the patient experienced BACK PAIN (lower back hurt). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), PAIN IN EXTREMITY (pain in legs), MYALGIA (muscle ache) and BACK PAIN (lower back hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: arm started getting warm; itchy; turned red; swollen from the top of their shoulder down half way into their mid arm; A spontaneous report was received from a healthcare professional concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events started getting warm, it was itchy, it's turned red, swollen from the top of their shoulder down half way into their mid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the event(s) started getting warm, it was itchy, it's turned red, swollen from the top of their shoulder down half way into their mid arm.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), started getting warm, it was itchy, it's turned red, swollen from the top of their shoulder down half way into their mid arm was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: Cracked a molar; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Cracked a molar) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced TOOTH FRACTURE (Cracked a molar). At the time of the report, TOOTH FRACTURE (Cracked a molar) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided    Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Night sweats; Shoulder was sore; Chills; Headache; Fatigue; Body aches; A spontaneous report was received from a Healthcare Professional concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder soreness, chills, dizziness, headaches, fatigued, body aches, and night sweats.   The patient's medical history was not provided. Concomitant medications reported were Rivaroxaban, Omeprazole, Centrum, Vitamins, B12 supplement for drug use for unknown indication.  On 18-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18-Jan-2021, the patient experienced the events shoulder was sore, chills, dizziness, headaches, fatigued, body aches, and night sweats.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   On 19-Jan-2021, the outcome of events, chills, dizziness, headaches, fatigue and body ache was recovered/resolved. On 22-Jan-2021, the outcome of event shoulder soreness was recovered/resolved. The outcome of event night swats was not reported.; 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: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Night sweats
Clinical narrative: Dizziness; Night sweats; Shoulder was sore; Chills; Headache; Fatigue; Body aches; A spontaneous report was received from a Healthcare Professional concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder soreness, chills, dizziness, headaches, fatigued, body aches, and night sweats.   The patient's medical history was not provided. Concomitant medications reported were Rivaroxaban, Omeprazole, Centrum, Vitamins, B12 supplement for drug use for unknown indication.  On 18-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18-Jan-2021, the patient experienced the events shoulder was sore, chills, dizziness, headaches, fatigued, body aches, and night sweats.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   On 19-Jan-2021, the outcome of events, chills, dizziness, headaches, fatigue and body ache was recovered/resolved. On 22-Jan-2021, the outcome of event shoulder soreness was recovered/resolved. The outcome of event night swats was not reported.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: woozy feeling; felt like her head was disconnected from her body; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woozy feeling) and FEELING ABNORMAL (felt like her head was disconnected from her body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced DIZZINESS (woozy feeling) and FEELING ABNORMAL (felt like her head was disconnected from her body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (FARBIVENT) at a dose of 1 dosage form; BECLOMETASONE DIPROPIONATE (QVAR) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 25-Jan-2021, DIZZINESS (woozy feeling) and FEELING ABNORMAL (felt like her head was disconnected from her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-027034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: - No new information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pruritus
Clinical narrative: Itchy Sensation all Over Bod; Redness and numbness of face; Numbness of face; A spontaneous report (United States) was received from a Healthcare Professional concerning a 42-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy sensation all over body/pruritus, redness/erythema and numbness of face/hypoaesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient reported she experienced an itchy sensation all over her body, redness and numbness in her face. She self treated with diphenhydramine. All events seemed to have resolved on 27 Jan 2021.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, itchy sensation all over body/pruritus, redness/erythema and numbness of face/hypoaesthesia, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: extreme pain/Left arm injection site was sore; arm still swollen/Left arm injection site hard and swollen; arm still warm/Left arm injection site hot; sore; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain/Left arm injection site was sore), VACCINATION SITE SWELLING (arm still swollen/Left arm injection site hard and swollen), VACCINATION SITE WARMTH (arm still warm/Left arm injection site hot), MYALGIA (sore) and INJECTION SITE ERYTHEMA (Injection site red) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K0A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (extreme pain/Left arm injection site was sore), VACCINATION SITE SWELLING (arm still swollen/Left arm injection site hard and swollen), VACCINATION SITE WARMTH (arm still warm/Left arm injection site hot), MYALGIA (sore) and INJECTION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE PAIN (extreme pain/Left arm injection site was sore), VACCINATION SITE SWELLING (arm still swollen/Left arm injection site hard and swollen), VACCINATION SITE WARMTH (arm still warm/Left arm injection site hot), MYALGIA (sore) and INJECTION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: No specific follow-up information recorded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cystitis, Discomfort, Nausea, Pain
Clinical narrative: pain right below rib cage in the middle; very uncomfortable; nausea; pain in side; dry heaves; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), PAIN (pain in side), RETCHING (dry heaves), ABDOMINAL PAIN UPPER (pain right below rib cage in the middle) and NAUSEA (nausea) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZVA) 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 TERAZOSIN and FINASTERIDE for Enlarged prostate, AMOXICILLIN for Urinary tract infection, LISINOPRIL for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CYSTITIS (Bladder infection). On 06-Feb-2021, the patient experienced PAIN (pain in side), RETCHING (dry heaves) and NAUSEA (nausea). On 09-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (pain right below rib cage in the middle) and DISCOMFORT (very uncomfortable). The patient was treated with ACETAMINOPHEN;CODEINE ongoing since an unknown date at a dose of one pill 350mg APAP/30 mg. At the time of the report, CYSTITIS (Bladder infection), PAIN (pain in side), RETCHING (dry heaves), ABDOMINAL PAIN UPPER (pain right below rib cage in the middle), NAUSEA (nausea) and DISCOMFORT (very uncomfortable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: A follow up was received on 24-JUN-2021, with no new information
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: pain right below rib cage in the middle; very uncomfortable; nausea; pain in side; dry heaves; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), PAIN (pain in side), RETCHING (dry heaves), ABDOMINAL PAIN UPPER (pain right below rib cage in the middle) and NAUSEA (nausea) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZVA) 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 TERAZOSIN and FINASTERIDE for Enlarged prostate, AMOXICILLIN for Urinary tract infection, LISINOPRIL for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CYSTITIS (Bladder infection). On 06-Feb-2021, the patient experienced PAIN (pain in side), RETCHING (dry heaves) and NAUSEA (nausea). On 09-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (pain right below rib cage in the middle) and DISCOMFORT (very uncomfortable). The patient was treated with ACETAMINOPHEN;CODEINE ongoing since an unknown date at a dose of one pill 350mg APAP/30 mg. At the time of the report, CYSTITIS (Bladder infection), PAIN (pain in side), RETCHING (dry heaves), ABDOMINAL PAIN UPPER (pain right below rib cage in the middle), NAUSEA (nausea) and DISCOMFORT (very uncomfortable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: A follow up was received on 24-JUN-2021, with no new information
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching; lumpy hives all over her body; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (lumpy hives all over her body), URTICARIA (hives) and PRURITUS (itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M201) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for Neck pain, PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), DOXEPIN, MONTELUKAST SODIUM (SINGULAIR) and OMALIZUMAB (XOLAIR) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced URTICARIA (lumpy hives all over her body). On 03-May-2021, the patient experienced URTICARIA (hives) and PRURITUS (itching). At the time of the report, URTICARIA (lumpy hives all over her body), URTICARIA (hives) and PRURITUS (itching) 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.   This case was linked to MOD-2021-024679 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow up received addition of two events hives and itching and addition of concomitant medications
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia
Clinical narrative: face feels like its on fire; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (face feels like its on fire) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     NO Medical History information was reported.  Concomitant products included THYROID (ARMOUR THYROID) and PROGESTERONE for an unknown indication.    On 05-Feb-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING HOT (face feels like its on fire) and PYREXIA (fever). On 05-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, FEELING HOT (face feels like its on fire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (face feels like its on fire) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     NO Medical History information was reported.  Concomitant products included THYROID (ARMOUR THYROID) and PROGESTERONE for an unknown indication.    On 05-Feb-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING HOT (face feels like its on fire) and PYREXIA (fever). On 05-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, FEELING HOT (face feels like its on fire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: pain is also experienced if I try to raise my right arm; pain and burning sensation in right shoulder joint.; Soreness near the injection site; Light pain in the  lower right forearm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Light pain in the  lower right forearm.), INJECTED LIMB MOBILITY DECREASED (pain is also experienced if I try to raise my right arm), ARTHRALGIA (pain and burning sensation in right shoulder joint.) and INJECTION SITE PAIN (Soreness near the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Ankylosing spondylitis on 01-Jan-1975. Concomitant products included NAPROXEN from 02-Feb-2020 to an unknown date and MELOXICAM from 02-Jan-1985 to 25-Feb-2020 for Antiinflammatory therapy, ATORVASTATIN from 02-Jan-1990 to an unknown date for Cholesterol, ASCORBIC ACID (VITAMIN C ACID) from 02-Jan-2000 to an unknown date for Vitamin C supplementation, VITAMIN D3 from 02-Jan-2000 to an unknown date for Vitamin D supplementation.   On 11-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Light pain in the  lower right forearm.) and INJECTION SITE PAIN (Soreness near the injection site). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (pain is also experienced if I try to raise my right arm) and ARTHRALGIA (pain and burning sensation in right shoulder joint.). At the time of the report, PAIN IN EXTREMITY (Light pain in the  lower right forearm.), INJECTED LIMB MOBILITY DECREASED (pain is also experienced if I try to raise my right arm), ARTHRALGIA (pain and burning sensation in right shoulder joint.) and INJECTION SITE PAIN (Soreness near the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: follow-up received on 24-APR-2021 included second dose information,concomitant medications,addition of two new event arthralgia and Injected limb mobility decreased.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Pain in extremity, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: blood pressure was high; headache; itching; sorenessin arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN IN EXTREMITY (sorenessin arm), HYPERTENSION (blood pressure was high) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Tooth implant. Concurrent medical conditions included Hypersensitivity (Sensitive to adhesive.). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), ROSUVASTATIN CALCIUM (CRESTOR), CENTRUM SILVER +50, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ASCORBIC ACID (VITAMIN C FLAVOUR), VITAMIN D3, BIOTIN, FISH OIL, UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and CALCIUM for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (sorenessin arm) and HEADACHE (headache). On 02-Feb-2021, the patient experienced HYPERTENSION (blood pressure was high). On 02-Feb-2021, PRURITUS (itching) and PAIN IN EXTREMITY (sorenessin arm) had resolved. At the time of the report, HYPERTENSION (blood pressure was high) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: negative and negative. On 24-Feb-2021, SARS-CoV-2 antibody test: negative.         Treatment received for the events was not reported. Action taken with mRNA-1273 in response to events was considered unknown.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Contact information updated
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: blood pressure was high; headache; itching; sorenessin arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN IN EXTREMITY (sorenessin arm), HYPERTENSION (blood pressure was high) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Tooth implant. Concurrent medical conditions included Hypersensitivity (Sensitive to adhesive.). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), ROSUVASTATIN CALCIUM (CRESTOR), CENTRUM SILVER +50, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ASCORBIC ACID (VITAMIN C FLAVOUR), VITAMIN D3, BIOTIN, FISH OIL, UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and CALCIUM for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (sorenessin arm) and HEADACHE (headache). On 02-Feb-2021, the patient experienced HYPERTENSION (blood pressure was high). On 02-Feb-2021, PRURITUS (itching) and PAIN IN EXTREMITY (sorenessin arm) had resolved. At the time of the report, HYPERTENSION (blood pressure was high) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: negative and negative. On 24-Feb-2021, SARS-CoV-2 antibody test: negative.         Treatment received for the events was not reported. Action taken with mRNA-1273 in response to events was considered unknown.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Contact information updated