chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the left side of her face went numb for an hour or so, she could not feel her cheek), NECK PAIN (pain shot up into her neck), PAIN IN EXTREMITY (a bit of a sore arm, by afternoon really started to hurt) and HEADACHE (a bit of a headache (mainly on the left side)) in a 59-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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (a bit of a sore arm, by afternoon really started to hurt). On 09-Jan-2021, the patient experienced HYPOAESTHESIA (the left side of her face went numb for an hour or so, she could not feel her cheek), NECK PAIN (pain shot up into her neck) and HEADACHE (a bit of a headache (mainly on the left side)). The patient was treated with IBUPROFEN on 09-Jan-2021 for Headache, at an unspecified dose and frequency. On 09-Jan-2021, HYPOAESTHESIA (the left side of her face went numb for an hour or so, she could not feel her cheek), PAIN IN EXTREMITY (a bit of a sore arm, by afternoon really started to hurt) and HEADACHE (a bit of a headache (mainly on the left side)) had resolved. At the time of the report, NECK PAIN (pain shot up into her neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash around the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the site of the injection) 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 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash around the site of the injection). At the time of the report, VACCINATION SITE RASH (Rash around the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Influenza, Pain in extremity
Clinical narrative: pain right arm; pain in the back; pain in the chest; feels like flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain right arm), BACK PAIN (pain in the back), CHEST PAIN (pain in the chest) and INFLUENZA (feels like flu) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain right arm), BACK PAIN (pain in the back), CHEST PAIN (pain in the chest) and INFLUENZA (feels like flu). At the time of the report, PAIN IN EXTREMITY (pain right arm), BACK PAIN (pain in the back), CHEST PAIN (pain in the chest) and INFLUENZA (feels like flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy), pain in extremity (tiresome in the legs), vaccination site pain (soreness on the injection site), fatigue (tired, tiresome in legs) and headache in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Jan 22, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 22, 2021, patient experienced vaccination site pain (soreness on the injection site). On Jan 28, 2021, patient experienced fatigue (tired, tiresome in legs), headache and pyrexia (running a temperature). On Feb 1, 2021, patient experienced pain in extremity (tiresome in the legs). On Feb 2, 2021, patient experienced dizziness (dizzy). The patient treated with Tylenol (paracetamol) on Jan 28, 2021 for headache and increased body temperature (unspecified dose and frequency). On Jan 23, 2021, vaccination site pain (soreness on the injection site) resolved. On Jan 28, 2021, headache and pyrexia (running a temperature) resolved. At the time of the report, dizziness (dizzy), pain in extremity (tiresome in the legs) and fatigue (tired, tiresome in legs) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 intramuscular: unknown. No concomitant medications reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy), pain in extremity (tiresome in the legs), vaccination site pain (soreness on the injection site), fatigue (tired, tiresome in legs) and headache in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Jan 22, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 22, 2021, patient experienced vaccination site pain (soreness on the injection site). On Jan 28, 2021, patient experienced fatigue (tired, tiresome in legs), headache and pyrexia (running a temperature). On Feb 1, 2021, patient experienced pain in extremity (tiresome in the legs). On Feb 2, 2021, patient experienced dizziness (dizzy). The patient treated with Tylenol (paracetamol) on Jan 28, 2021 for headache and increased body temperature (unspecified dose and frequency). On Jan 23, 2021, vaccination site pain (soreness on the injection site) resolved. On Jan 28, 2021, headache and pyrexia (running a temperature) resolved. At the time of the report, dizziness (dizzy), pain in extremity (tiresome in the legs) and fatigue (tired, tiresome in legs) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 intramuscular: unknown. No concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Ringing on his ears; Tingling like pins and needles all over his body; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body). At the time of the report, TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information 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 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body). At the time of the report, TINNITUS (Ringing on his ears) and PARAESTHESIA (Tingling like pins and needles all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information 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 the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It has an oval area extremely warm and hot to the touch; It has an oval area and it itches; Injection site was becoming swollen; Injection site was becoming red and it has an oval area extremely red; Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It has an oval area extremely warm and hot to the touch), VACCINATION SITE INDURATION (Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide), VACCINATION SITE PRURITUS (It has an oval area and it itches), VACCINATION SITE SWELLING (Injection site was becoming swollen) and VACCINATION SITE ERYTHEMA (Injection site was becoming red and it has an oval area extremely red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE, FOLIC ACID, PANTOPRAZOLE, FEBUXOSTAT, METOPROLOL, SERTRALINE and TRAMADOL for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide) and VACCINATION SITE ERYTHEMA (Injection site was becoming red and it has an oval area extremely red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It has an oval area extremely warm and hot to the touch), VACCINATION SITE PRURITUS (It has an oval area and it itches) and VACCINATION SITE SWELLING (Injection site was becoming swollen). At the time of the report, VACCINATION SITE WARMTH (It has an oval area extremely warm and hot to the touch), VACCINATION SITE INDURATION (Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide), VACCINATION SITE PRURITUS (It has an oval area and it itches), VACCINATION SITE SWELLING (Injection site was becoming swollen) and VACCINATION SITE ERYTHEMA (Injection site was becoming red and it has an oval area extremely red) 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 were reported.; Sender's Comments: Based on the current available information which includes a 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.  Injection site redness, Injection site induration, injection site pruritus and injection site swelling are consistent with the known safety profile of mRNA-1273 vaccine.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Aches and Pain throughout her body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Aches and Pain throughout her body) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2OA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 20-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 PYREXIA (Fever) and MYALGIA (Aches and Pain throughout her body). At the time of the report, PYREXIA (Fever) had not resolved and MYALGIA (Aches and Pain throughout her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  Advanced age is a confounder for the event of myalgia.; 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.  Advanced age is a confounder for the event of myalgia.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fluid retention, Musculoskeletal stiffness, Myalgia, Peripheral swelling
Clinical narrative: when I lifts her hand up I can fill the fluid going back down my arm; swelling never goes down fully but certain periods of the day it does go down, the morning is when im usually really swollen, muscles are stiff and hard to close the han; achiness in joints; muscle pain; hands have swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands have swollen), FLUID RETENTION (when I lifts her hand up I can fill the fluid going back down my arm), MUSCULOSKELETAL STIFFNESS (swelling never goes down fully but certain periods of the day it does go down, the morning is when im usually really swollen, muscles are stiff and hard to close the han), ARTHRALGIA (achiness in joints) and MYALGIA (muscle pain) in a 72-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 22-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 PERIPHERAL SWELLING (hands have swollen), ARTHRALGIA (achiness in joints) and MYALGIA (muscle pain). On an unknown date, the patient experienced FLUID RETENTION (when I lifts her hand up I can fill the fluid going back down my arm) and MUSCULOSKELETAL STIFFNESS (swelling never goes down fully but certain periods of the day it does go down, the morning is when im usually really swollen, muscles are stiff and hard to close the han). At the time of the report, PERIPHERAL SWELLING (hands have swollen), FLUID RETENTION (when I lifts her hand up I can fill the fluid going back down my arm), MUSCULOSKELETAL STIFFNESS (swelling never goes down fully but certain periods of the day it does go down, the morning is when im usually really swollen, muscles are stiff and hard to close the han), ARTHRALGIA (achiness in joints) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Joint swelling, Pain
Clinical narrative: shoulder tender; shoulder swollen; shaking arms and legs; shoulder red; aches and pains; fever 102ºF; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen), TREMOR (shaking arms and legs), ERYTHEMA (shoulder red) and PAIN (aches and pains) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (They had COVID back in March (in late March), and they were very sick with it: fever, chills, aches and pains.) in March 2020. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) 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 30-Dec-2020, the patient experienced TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen), TREMOR (shaking arms and legs), ERYTHEMA (shoulder red), PAIN (aches and pains), PYREXIA (fever 102ºF) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 03-Jan-2021, TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen) and ERYTHEMA (shoulder red) had resolved. At the time of the report, TREMOR (shaking arms and legs) and CHILLS (chills) had resolved and PAIN (aches and pains) and PYREXIA (fever 102ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 102 (High) Degree F.     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.   Patient who is also a physician reported , he tested for COVID in their office both with the swabs and the quick read and 15 minutes test,  and also tested for antibodies several times since then. Obviously had the IgG but still has the IgM does not know whether it's from past infection or for being exposed pretty much on a daily basis from patients populations.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Tremor
Clinical narrative: shoulder tender; shoulder swollen; shaking arms and legs; shoulder red; aches and pains; fever 102ºF; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen), TREMOR (shaking arms and legs), ERYTHEMA (shoulder red) and PAIN (aches and pains) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (They had COVID back in March (in late March), and they were very sick with it: fever, chills, aches and pains.) in March 2020. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) 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 30-Dec-2020, the patient experienced TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen), TREMOR (shaking arms and legs), ERYTHEMA (shoulder red), PAIN (aches and pains), PYREXIA (fever 102ºF) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 03-Jan-2021, TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen) and ERYTHEMA (shoulder red) had resolved. At the time of the report, TREMOR (shaking arms and legs) and CHILLS (chills) had resolved and PAIN (aches and pains) and PYREXIA (fever 102ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 102 (High) Degree F.     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.   Patient who is also a physician reported , he tested for COVID in their office both with the swabs and the quick read and 15 minutes test,  and also tested for antibodies several times since then. Obviously had the IgG but still has the IgM does not know whether it's from past infection or for being exposed pretty much on a daily basis from patients populations.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Weakness; Sore arm; Body aches , pain everywhere; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), PAIN (Body aches , pain everywhere), HEADACHE (Headache) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), PAIN (Body aches , pain everywhere), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), PAIN (Body aches , pain everywhere), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever of 101.5°F) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     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 24-Jan-2021, the patient experienced CHILLS (chills). On 25-Jan-2021, the patient experienced PYREXIA (fever of 101.5°F) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 26-Jan-2021, CHILLS (chills), PYREXIA (fever of 101.5°F) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101.5 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: feels sick; earache; neck is rigid; sore at the injection site; horrible headache; fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (feels sick), EAR PAIN (earache), MUSCULOSKELETAL STIFFNESS (neck is rigid), INJECTION SITE PAIN (sore at the injection site) and HEADACHE (horrible headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DOCUSATE SODIUM (COLACE), MACROGOL 3350 (MIRALAX) and PROBIOTICS NOS for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (feels sick), EAR PAIN (earache), MUSCULOSKELETAL STIFFNESS (neck is rigid), INJECTION SITE PAIN (sore at the injection site), HEADACHE (horrible headache) and PYREXIA (fever). At the time of the report, VACCINATION COMPLICATION (feels sick), EAR PAIN (earache), MUSCULOSKELETAL STIFFNESS (neck is rigid), INJECTION SITE PAIN (sore at the injection site), HEADACHE (horrible headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feels sick; earache; neck is rigid; sore at the injection site; horrible headache; fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (feels sick), EAR PAIN (earache), MUSCULOSKELETAL STIFFNESS (neck is rigid), INJECTION SITE PAIN (sore at the injection site) and HEADACHE (horrible headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DOCUSATE SODIUM (COLACE), MACROGOL 3350 (MIRALAX) and PROBIOTICS NOS for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (feels sick), EAR PAIN (earache), MUSCULOSKELETAL STIFFNESS (neck is rigid), INJECTION SITE PAIN (sore at the injection site), HEADACHE (horrible headache) and PYREXIA (fever). At the time of the report, VACCINATION COMPLICATION (feels sick), EAR PAIN (earache), MUSCULOSKELETAL STIFFNESS (neck is rigid), INJECTION SITE PAIN (sore at the injection site), HEADACHE (horrible headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He had COVID-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He had COVID-19 after vaccination) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included GUSELKUMAB (TREMFYA), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (He had COVID-19 after vaccination). On 24-Jan-2021, COVID-19 (He had COVID-19 after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: covid-19 Positive. On 24-Jan-2021, SARS-CoV-2 test: covid-19 Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was treated for Covid-19 infection with Regeneron Monoclonal antibody, intravenously on 20Jan2021
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain in extremity, Vaccination site erythema
Clinical narrative: delayed reaction arm red spot; delayed reaction severe itching; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (delayed reaction arm red spot), INJECTION SITE PRURITUS (delayed reaction severe itching) and PAIN IN EXTREMITY (arm pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-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 VACCINATION SITE ERYTHEMA (delayed reaction arm red spot), INJECTION SITE PRURITUS (delayed reaction severe itching) and PAIN IN EXTREMITY (arm pain). At the time of the report, VACCINATION SITE ERYTHEMA (delayed reaction arm red spot), INJECTION SITE PRURITUS (delayed reaction severe itching) and PAIN IN EXTREMITY (arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Mild Soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild Soreness) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-24) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (Mild Soreness) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Headache, at an unspecified dose and frequency. At the time of the report, PAIN (Mild Soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) 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 ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hot flush, Myalgia, Pain in extremity, Vaccination site erythema
Clinical narrative: Joint pain; Muscle pain; More hot flashes than usual; Red area underneath the injection site; Arm was sore; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced joint pain, muscle pain, more hot flashes than usual, red area underneath the injection site and sore arm.  The patient's medical history included hot flashes. Relevant concomitant medications included Estrogen for hot flashes(since 20 years).  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly on her left arm, for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced sore arm and lasted for few days. On an unknown date,she also started to have joint andcmuscle pain. She stated that she usually had hot flashes, but that approximately a week and a half later from getting the vaccine, she seemed to have a lot more and that feeling lasted for a couple of days. Also, underneath the injection site, there was a little red area. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s) joint pain, muscle pain, more hot flashes than usual, red area underneath the injection site and sore arm were Unknown.; 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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION 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.     No Medical History information was reported.    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 VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruise; 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 CONTUSION (bruise) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise). At the time of the report, CONTUSION (bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Sore Arm; Bleeding on the injection site immediately after injection; Rush of warmth from upper chest going to his head; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced little bleeding on the injection site immediately after injection, rush of warmth from upper chest going to his head and sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 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 in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced little bleeding on the injection site immediately after injection and rush of warmth from upper chest going to his head. On 29 Jan 2021, the patient experienced the events sore arm.  No lab data was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  On 28 Jan 2021 the outcome of events bleeding on the injection site immediately after injection and rush of warmth from upper chest going to his head- was resolved. The outcome of event-sore arm -was considered to be unknown.; 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. Further information has been requested
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site for 2 days and nothing more; A spontaneous report ( was received from a Consumer concerning a 59-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at the injection site for two days.  The patient's medical history was not provided. Concomitant medications reported included metformin for diabetes and lisinopril for blood pressure.  On 25 Jan 2021, prior to the onset of the event the patient received their dose of mRNA-1273 (Batch Number: 00420A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced pain at the injection site for 2 days and nothing more.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event pain at the injection site for 2 days was not reported.   The outcome of the event pain at the injection site for 2 days was considered resolved (for 2 days) on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red large circle around the injection site), CONTUSION (Bruise), INJECTION SITE PRURITUS (injection site Itching) and INJECTION SITE WARMTH (Injection site hot to the touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, OMEPRAZOLE and LOFEXIDINE 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 INJECTION SITE ERYTHEMA (Red large circle around the injection site), CONTUSION (Bruise), INJECTION SITE PRURITUS (injection site Itching) and INJECTION SITE WARMTH (Injection site hot to the touch). At the time of the report, INJECTION SITE ERYTHEMA (Red large circle around the injection site), CONTUSION (Bruise), INJECTION SITE PRURITUS (injection site Itching) and INJECTION SITE WARMTH (Injection site hot to the touch) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Hydrocortisone
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: Lethargic; FELT HORRIBLE; fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), FEELING ABNORMAL (FELT HORRIBLE) and PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced LETHARGY (Lethargic), FEELING ABNORMAL (FELT HORRIBLE) and PYREXIA (fever). At the time of the report, LETHARGY (Lethargic), FEELING ABNORMAL (FELT HORRIBLE) and PYREXIA (fever) had resolved.            No relevant concomitant medications were reported.  The patient had second dose of Moderna on an unspecified date and had no adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: No adverse reaction after the second dose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Body temperature 102°F; Temperature ranging between 99.8°F and 99.2 °F; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BODY TEMPERATURE INCREASED (Body temperature 102°F) and BODY TEMPERATURE INCREASED (Temperature ranging between 99.8°F and 99.2 °F) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Body temperature 102°F) and BODY TEMPERATURE INCREASED (Temperature ranging between 99.8°F and 99.2 °F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Body temperature 102°F) and BODY TEMPERATURE INCREASED (Temperature ranging between 99.8°F and 99.2 °F) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 102*F, 99.8*F, 99.2*F.     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: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nausea
Clinical narrative: Pain behind eyes; Headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pain behind eyes), HEADACHE (Headaches) and NAUSEA (nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057620A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), OXYBUTYNIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-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 EYE PAIN (Pain behind eyes), HEADACHE (Headaches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, EYE PAIN (Pain behind eyes), HEADACHE (Headaches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feeling light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling light headed) in a 78-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 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 DIZZINESS (Feeling light headed). At the time of the report, DIZZINESS (Feeling light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chills, Dizziness, Fatigue
Clinical narrative: faint, cold/clammy, and sweating.; dizziness; blood pressure changes; chills; fatigue that would come and go; severe itching on both her forearms.; lips on the inside of her mouth swelled up on one side; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (lips on the inside of her mouth swelled up on one side), PRURITUS (severe itching on both her forearms.), FATIGUE (fatigue that would come and go), CHILLS (chills) and DIZZINESS (dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 MOUTH SWELLING (lips on the inside of her mouth swelled up on one side). On 22-Jan-2021, the patient experienced PRURITUS (severe itching on both her forearms.). On 23-Jan-2021, the patient experienced FATIGUE (fatigue that would come and go). On 31-Jan-2021, the patient experienced CHILLS (chills). On 02-Feb-2021, the patient experienced DIZZINESS (dizziness) and BLOOD PRESSURE ABNORMAL (blood pressure changes). On an unknown date, the patient experienced NASOPHARYNGITIS (faint, cold/clammy, and sweating.). The patient was treated with CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC PLUS) for Itching, at an unspecified dose and frequency. At the time of the report, MOUTH SWELLING (lips on the inside of her mouth swelled up on one side), PRURITUS (severe itching on both her forearms.), FATIGUE (fatigue that would come and go), CHILLS (chills), DIZZINESS (dizziness), BLOOD PRESSURE ABNORMAL (blood pressure changes) and NASOPHARYNGITIS (faint, cold/clammy, and sweating.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Blood pressure measurement: 61/45, 71/49, 107/64, 109/65, 82/53, 71/53.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.