chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, 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 PAIN (Soreness at injection site). At the time of the report, INJECTION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender'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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site warmth, Nausea, Pyrexia, Vaccination site erythema
Clinical narrative: Fever; Nausea; Fatigue; Redness at injection site; Itchiness at the site of injection; Tender at the site injection; Warm to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection), INJECTION SITE WARMTH (Warm to the touch at injection site) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection) and INJECTION SITE WARMTH (Warm to the touch at injection site). On 01-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection), INJECTION SITE WARMTH (Warm to the touch at injection site), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  The treatment Medication was Tylenol.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Fever; Nausea; Fatigue; Redness at injection site; Itchiness at the site of injection; Tender at the site injection; Warm to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection), INJECTION SITE WARMTH (Warm to the touch at injection site) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection) and INJECTION SITE WARMTH (Warm to the touch at injection site). On 01-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection), INJECTION SITE WARMTH (Warm to the touch at injection site), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  The treatment Medication was Tylenol.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Big red square at the site of the injection; Injection site was swollen and was terribly itchy; Injection site was terribly itchy; Pain at the injection site; A spontaneous report was received from a consumer concerning herself ,a 72-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at the injection site, big red square at the site of the injection, injection site was swollen and was terribly itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023LwA) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the pain at the injection site.  On 23 Jan 2021, the patient experienced big red square at the site of the injection, injection site was swollen and was terribly itchy.  Treatment details included Ice, Advil, Benadryl.  Action taken with mRNA-1273 in response to the events was unknown.   On 26 Jan 2021 the outcome of big red square at the site of the injection, injection site swollen was resolved.  The outcome of pain at the injection site was unknown and for injection site was terribly itchy was not recovered.; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Malaise, Pruritus, Skin burning sensation, Vaccination site erythema
Clinical narrative: Kind of itchy all over my body; Warm; Injection site was very itchy; Red welt with a white center about 2.5 inches, oval shaped; Nose skin burned; Red spots on either side of nose; Injection site was swollen; Felt a little crummy; A little redness at the injection site/injection site was very red, about 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), MALAISE (Felt a little crummy), PRURITUS (Kind of itchy all over my body) and VACCINATION SITE WARMTH (Warm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (Felt a little crummy) and VACCINATION SITE ERYTHEMA (A little redness at the injection site/injection site was very red, about 3 inches in diameter). On 25-Jan-2021, the patient experienced SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Injection site was very itchy), VACCINATION SITE URTICARIA (Red welt with a white center about 2.5 inches, oval shaped) and VACCINATION SITE SWELLING (Injection site was swollen). On 26-Jan-2021, the patient experienced PRURITUS (Kind of itchy all over my body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Jan-2021, MALAISE (Felt a little crummy) had resolved. At the time of the report, SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Injection site was very itchy), VACCINATION SITE ERYTHEMA (A little redness at the injection site/injection site was very red, about 3 inches in diameter) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown, PRURITUS (Kind of itchy all over my body) had not resolved and VACCINATION SITE URTICARIA (Red welt with a white center about 2.5 inches, oval shaped) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had had 2 red spots on either side of her nose. The one on the left side of her nose was the size of a penny and the one on the right side was the size of the quarter and burned.   Treatment using fluorouracil/calcipotriene 5%/.005% cream was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow Up received and contains  non-significant information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Kind of itchy all over my body; Warm; Injection site was very itchy; Red welt with a white center about 2.5 inches, oval shaped; Nose skin burned; Red spots on either side of nose; Injection site was swollen; Felt a little crummy; A little redness at the injection site/injection site was very red, about 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), MALAISE (Felt a little crummy), PRURITUS (Kind of itchy all over my body) and VACCINATION SITE WARMTH (Warm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (Felt a little crummy) and VACCINATION SITE ERYTHEMA (A little redness at the injection site/injection site was very red, about 3 inches in diameter). On 25-Jan-2021, the patient experienced SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Injection site was very itchy), VACCINATION SITE URTICARIA (Red welt with a white center about 2.5 inches, oval shaped) and VACCINATION SITE SWELLING (Injection site was swollen). On 26-Jan-2021, the patient experienced PRURITUS (Kind of itchy all over my body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Jan-2021, MALAISE (Felt a little crummy) had resolved. At the time of the report, SKIN BURNING SENSATION (Nose skin burned), ERYTHEMA (Red spots on either side of nose), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Injection site was very itchy), VACCINATION SITE ERYTHEMA (A little redness at the injection site/injection site was very red, about 3 inches in diameter) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown, PRURITUS (Kind of itchy all over my body) had not resolved and VACCINATION SITE URTICARIA (Red welt with a white center about 2.5 inches, oval shaped) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had had 2 red spots on either side of her nose. The one on the left side of her nose was the size of a penny and the one on the right side was the size of the quarter and burned.   Treatment using fluorouracil/calcipotriene 5%/.005% cream was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow Up received and contains  non-significant information
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Chills; Tiredness; Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (Chills) and FATIGUE (Tiredness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) 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 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 31-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Advil
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm swelling continued; Injection site red; Injection site Itchy; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling continued), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE ERYTHEMA (Injection site red) 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 PERIPHERAL SWELLING (Arm swelling continued), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, PERIPHERAL SWELLING (Arm swelling continued), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE ERYTHEMA (Injection site red) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment in: Ice, and Benadryl for redness.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: At the injection site it got itchy; At the injection site it got swollen; At the injection site it got red; At the injection site it got very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (At the injection site it got itchy), VACCINATION SITE SWELLING (At the injection site it got swollen), VACCINATION SITE ERYTHEMA (At the injection site it got red) and VACCINATION SITE PAIN (At the injection site it got very painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 24-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 VACCINATION SITE PRURITUS (At the injection site it got itchy), VACCINATION SITE SWELLING (At the injection site it got swollen), VACCINATION SITE ERYTHEMA (At the injection site it got red) and VACCINATION SITE PAIN (At the injection site it got very painful). At the time of the report, VACCINATION SITE PRURITUS (At the injection site it got itchy), VACCINATION SITE SWELLING (At the injection site it got swollen), VACCINATION SITE ERYTHEMA (At the injection site it got red) and VACCINATION SITE PAIN (At the injection site it got very painful) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. Treatment for the events included cortisone cream.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: fever; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 100 degree Fahrenheit. On an unknown date, Body temperature: 99.1 degree Fahrenheit.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The concomitant medications were not provided.  Tylenol brought his fever down to 99.1 degrees F.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Fever; Chills; Nausea; Cramping pain all over body; Swollen red large circle around the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Cramping pain all over body) and VACCINATION SITE SWELLING (Swollen red large circle around the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (Fever). 26-Jan-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Cramping pain all over body) and VACCINATION SITE SWELLING (Swollen red large circle around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Cramping pain all over body) and VACCINATION SITE SWELLING (Swollen red large circle around the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which includes a strong  temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  All events are consistent with the established safety profile of mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: redness like the size of silver dollar; itching at injection site; hard to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness like the size of silver dollar), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE INDURATION (hard to the touch at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness like the size of silver dollar), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE INDURATION (hard to the touch at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness like the size of silver dollar), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE INDURATION (hard to the touch at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Nasopharyngitis
Clinical narrative: Cough; Diarrhea; Cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DIARRHOEA (Diarrhea) and NASOPHARYNGITIS (Cold) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COUGH (Cough), DIARRHOEA (Diarrhea) and NASOPHARYNGITIS (Cold). At the time of the report, COUGH (Cough), DIARRHOEA (Diarrhea) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unspecified blood pressure medication.  No treatment information provided.; Sender'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: Headache, Hypersensitivity, Sinusitis
Clinical narrative: Allergy; Sinusitis; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Allergy), SINUSITIS (Sinusitis) 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy), SINUSITIS (Sinusitis) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Allergy), SINUSITIS (Sinusitis) 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.   No Concomitant Medications were  provided by Reporter No Treatment Medications were  provided by Reporter   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: TCR report : Additional events added. She don't want further follow-ups
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Mouth haemorrhage
Clinical narrative: mouth bleeding; nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH HAEMORRHAGE (mouth bleeding) and EPISTAXIS (nose bleeding) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 27-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 MOUTH HAEMORRHAGE (mouth bleeding) and EPISTAXIS (nose bleeding). On 02-Feb-2021, MOUTH HAEMORRHAGE (mouth bleeding) and EPISTAXIS (nose bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Arm pain/Arm pain felt like needle pricks; injection site feels tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain/Arm pain felt like needle pricks) and VACCINATION SITE PAIN (injection site feels tender) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain/Arm pain felt like needle pricks). In January 2021, the patient experienced VACCINATION SITE PAIN (injection site feels tender). At the time of the report, PAIN IN EXTREMITY (Arm pain/Arm pain felt like needle pricks) and VACCINATION SITE PAIN (injection site feels tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: very itchy left arm; symptoms appeared again, i have swollen, red arm; symptoms appeared again, i have swollen, red arm; Hurted really really bad; Swollen left arm; Red left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE PAIN (Hurted really really bad), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE ERYTHEMA (Red left arm) and VACCINATION SITE SWELLING (symptoms appeared again, i have swollen, red arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O32L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Hurted really really bad), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE ERYTHEMA (Red left arm). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE SWELLING (symptoms appeared again, i have swollen, red arm) and VACCINATION SITE ERYTHEMA (symptoms appeared again, i have swollen, red arm). On 25-Jan-2021, VACCINATION SITE PAIN (Hurted really really bad), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE ERYTHEMA (Red left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE SWELLING (symptoms appeared again, i have swollen, red arm) and VACCINATION SITE ERYTHEMA (symptoms appeared again, i have swollen, red arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included Thyroid medication for unknown indication.  The patient not taking any medication as a corrective treatment.  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.   Reporter did not allow further contact; Sender'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: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: body aches; Developed side effects including, fatigue; Joint pain; headache; bad chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), FATIGUE (Developed side effects including, fatigue), ARTHRALGIA (Joint pain), HEADACHE (headache) and CHILLS (bad chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   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 PAIN (body aches), FATIGUE (Developed side effects including, fatigue), ARTHRALGIA (Joint pain), HEADACHE (headache) and CHILLS (bad chills). At the time of the report, PAIN (body aches), FATIGUE (Developed side effects including, fatigue), ARTHRALGIA (Joint pain), HEADACHE (headache) and CHILLS (bad chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication was reported. No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: body aches; headache; pain at the injection site; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (body aches), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue). At the time of the report, PAIN (body aches), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Chills, Fatigue, Myalgia
Clinical narrative: aches; chills; upset stomach; fatigue; temperature 100.5; it feels like i have covid; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (aches), CHILLS (chills), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue) and PYREXIA (temperature 100.5) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches), CHILLS (chills), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), PYREXIA (temperature 100.5) and COVID-19 (it feels like i have covid). At the time of the report, MYALGIA (aches), CHILLS (chills), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), PYREXIA (temperature 100.5) and COVID-19 (it feels like i have covid) 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 reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: aches; chills; upset stomach; fatigue; temperature 100.5; it feels like i have covid; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (aches), CHILLS (chills), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue) and PYREXIA (temperature 100.5) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches), CHILLS (chills), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), PYREXIA (temperature 100.5) and COVID-19 (it feels like i have covid). At the time of the report, MYALGIA (aches), CHILLS (chills), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), PYREXIA (temperature 100.5) and COVID-19 (it feels like i have covid) 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 reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection area is red, raised, warm, and itchy; injection area is red, raised, warm, and itchy; injection area is red, raised, warm, and itchy; injection area is red, raised, warm, and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection area is red, raised, warm, and itchy), VACCINATION SITE PRURITUS (injection area is red, raised, warm, and itchy), VACCINATION SITE ERYTHEMA (injection area is red, raised, warm, and itchy) and VACCINATION SITE SWELLING (injection area is red, raised, warm, and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (injection area is red, raised, warm, and itchy), VACCINATION SITE PRURITUS (injection area is red, raised, warm, and itchy), VACCINATION SITE ERYTHEMA (injection area is red, raised, warm, and itchy) and VACCINATION SITE SWELLING (injection area is red, raised, warm, and itchy). At the time of the report, VACCINATION SITE WARMTH (injection area is red, raised, warm, and itchy), VACCINATION SITE PRURITUS (injection area is red, raised, warm, and itchy), VACCINATION SITE ERYTHEMA (injection area is red, raised, warm, and itchy) and VACCINATION SITE SWELLING (injection area is red, raised, warm, and itchy) had not resolved.        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 medication reported.  No treatment information provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: 3pm patient woke up due to lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (3pm patient woke up due to lower back pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced BACK PAIN (3pm patient woke up due to lower back pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (3pm patient woke up due to lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Heating pad since 26Jan2021; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise
Clinical narrative: not eating; feels sickly right now; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels sickly right now) and DECREASED APPETITE (not eating) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), MELATONIN and ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (feels sickly right now). On an unknown date, the patient experienced DECREASED APPETITE (not eating). At the time of the report, MALAISE (feels sickly right now) and DECREASED APPETITE (not eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: Her arm started to swell; Her arm became red; She had severe fatigue; She wasn't feeling well; Her arm started to hurt again; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt), PAIN IN EXTREMITY (Her arm started to hurt again), MALAISE (She wasn't feeling well), PERIPHERAL SWELLING (Her arm started to swell) and VACCINATION SITE ERYTHEMA (Her arm became red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes since an unknown date.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt).   On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm started to hurt again). On 25-Jan-2021, the patient experienced MALAISE (She wasn't feeling well).   On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Her arm started to swell), VACCINATION SITE ERYTHEMA (Her arm became red) and FATIGUE (She had severe fatigue).   At the time of the report, PAIN IN EXTREMITY (Her arm hurt) had resolved and PAIN IN EXTREMITY (Her arm started to hurt again), MALAISE (She wasn't feeling well), PERIPHERAL SWELLING (Her arm started to swell), VACCINATION SITE ERYTHEMA (Her arm became red) and FATIGUE (She had severe fatigue) 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after receiving the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for covid after receiving the first dose of the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid after receiving the first dose of the vaccine). The patient was treated with Monoclonal antibody treatment (MONOCLONAL ANTIBODIES) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid after receiving the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Patient had COVID positive test results after receiving the first dose of the Moderna Covid-19 Vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: muscle pain; fatigue; headache; nausea; 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 MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Could hardly lift my arm; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Could hardly lift my arm), CHILLS (Chills) and VACCINATION SITE PAIN (Arm soreness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Could hardly lift my arm), CHILLS (Chills) and VACCINATION SITE PAIN (Arm soreness). At the time of the report, INJECTED LIMB MOBILITY DECREASED (Could hardly lift my arm), CHILLS (Chills) and VACCINATION SITE PAIN (Arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: pain at injection site; redness at injection site; rash started from injection site down towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE RASH (m rash started from injection site down towards elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included LETROZOL, ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), ALPRAZOLAM (XANAX) and TEMAZEPAM for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE RASH (m rash started from injection site down towards elbow). On an unknown date, the patient experienced INJECTION SITE PAIN (pain at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). On 31-Jan-2021, INJECTION SITE RASH (m rash started from injection site down towards elbow) outcome was unknown. At the time of the report, INJECTION SITE PAIN (pain at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Vaccination site pain
Clinical narrative: Cough; fatigue; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COUGH (Cough), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up received on 10-JUL-2021.event outcomes updated.