chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 44 days between doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days between doses) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days between doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days between doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021 and does not contain any new information
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes zoster reaction after vaccination with Moderna COVID-19 vaccine; 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 HERPES ZOSTER (herpes zoster reaction after vaccination with Moderna COVID-19 vaccine) 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 HERPES ZOSTER (herpes zoster reaction after vaccination with Moderna COVID-19 vaccine). At the time of the report, HERPES ZOSTER (herpes zoster reaction after vaccination with Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Swelling
Clinical narrative: swollen; pain in arm at backside of arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PAIN IN EXTREMITY (pain in arm at backside of arm) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced SWELLING (swollen), PAIN IN EXTREMITY (pain in arm at backside of arm) and HEADACHE (headache). At the time of the report, SWELLING (swollen), PAIN IN EXTREMITY (pain in arm at backside of arm) and HEADACHE (headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Tongue discolouration
Clinical narrative: funny taste; tongue is blue; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (funny taste) and TONGUE DISCOLOURATION (tongue is blue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was reported.     On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced TASTE DISORDER (funny taste) and TONGUE DISCOLOURATION (tongue is blue). At the time of the report, TASTE DISORDER (funny taste) and TONGUE DISCOLOURATION (tongue is blue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: "It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles."; "Having lots of pain."; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN ("Having lots of pain.") and HERPES ZOSTER ("It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles.") in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN ("Having lots of pain."). On 06-Apr-2021, the patient experienced HERPES ZOSTER ("It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles."). The patient was treated with PREDNISONE at a dose of 50 mg; ACYCLOVIR [ACICLOVIR] at a dose of 800 mg and HYDROCODONE at a dose of hydrocodone pain pills to help relieve side effects. At the time of the report, PAIN ("Having lots of pain.") and HERPES ZOSTER ("It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles.") outcome was unknown. Not Provided          No Relevant concomitant medications was reported
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported The case is cross linked to MOD21-080147  and MOD21-080185   This case was linked to MOD21-080185 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Event updated; Sender's Comments:  MOD21-080185:Wife's case
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction at vaccination site, after second dose of the vaccine), PRURITUS (Started itching right away) and VACCINATION SITE ERYTHEMA (A hot redness of the size of an orange) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.  No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Started itching right away) and VACCINATION SITE ERYTHEMA (A hot redness of the size of an orange). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction at vaccination site, after second dose of the vaccine). On 02-Mar-2021, PRURITUS (Started itching right away) had resolved. At the time of the report, ALLERGY TO VACCINE (Allergic reaction at vaccination site, after second dose of the vaccine) and VACCINATION SITE ERYTHEMA (A hot redness of the size of an orange) had resolved. On 25 Feb 2021, the patient received second dose of Moderna Covid-19 vaccine and experienced an allergic reaction in the injection site and the reaction was a hot redness of the size of an orange.  The patient also reported that they also experienced itching which lasted for 5 days. The patient recovered after 3 weeks. Concomitant medication reported also included Blood pressure drugs. No treatment medications were the by the patient. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-085317 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 26 May 2021 contains patient demographics, additional event information, and event date.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-085317.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza
Clinical narrative: developed shingles; felt like she had the flu after injection; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles) and INFLUENZA (felt like she had the flu after injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 HERPES ZOSTER (developed shingles) and INFLUENZA (felt like she had the flu after injection). At the time of the report, HERPES ZOSTER (developed shingles) and INFLUENZA (felt like she had the flu after injection) outcome was unknown. Not Provided      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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Dyspnoea, Headache
Clinical narrative: seriously stiff muscles that compromised her breathing; back muscles were hurting so bad along with her shoulder blades that she could not sleep; back muscles were hurting so bad along with her shoulder blades that she could not sleep; back muscles were hurting so bad along with her shoulder blades that she could not sleep; seriously stiff muscles that compromised her breathing; lost her appetite; headaches that lasted for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DYSPNOEA (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite), INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep) and BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite) and HEADACHE (headaches that lasted for 3 days). On 19-Apr-2021, the patient experienced INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep). On an unknown date, the patient experienced DYSPNOEA (seriously stiff muscles that compromised her breathing), BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) and ARTHRALGIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep). On 19-Apr-2021, HEADACHE (headaches that lasted for 3 days) outcome was unknown. On 22-Apr-2021, MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite) and INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep) had resolved. At the time of the report, DYSPNOEA (seriously stiff muscles that compromised her breathing) and BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  Treatment information include Aspirin
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness
Clinical narrative: seriously stiff muscles that compromised her breathing; back muscles were hurting so bad along with her shoulder blades that she could not sleep; back muscles were hurting so bad along with her shoulder blades that she could not sleep; back muscles were hurting so bad along with her shoulder blades that she could not sleep; seriously stiff muscles that compromised her breathing; lost her appetite; headaches that lasted for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DYSPNOEA (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite), INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep) and BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite) and HEADACHE (headaches that lasted for 3 days). On 19-Apr-2021, the patient experienced INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep). On an unknown date, the patient experienced DYSPNOEA (seriously stiff muscles that compromised her breathing), BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) and ARTHRALGIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep). On 19-Apr-2021, HEADACHE (headaches that lasted for 3 days) outcome was unknown. On 22-Apr-2021, MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite) and INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep) had resolved. At the time of the report, DYSPNOEA (seriously stiff muscles that compromised her breathing) and BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  Treatment information include Aspirin
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Tinnitus
Clinical narrative: feeling sick; sore arm; dull ringing in the ear; a lot of headaches; This spontaneous case was reported by an other caregiver and describes the occurrence of MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), TINNITUS (dull ringing in the ear) and HEADACHE (a lot of headaches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 44B21A and 13B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), TINNITUS (dull ringing in the ear) and HEADACHE (a lot of headaches). At the time of the report, MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), TINNITUS (dull ringing in the ear) and HEADACHE (a lot of headaches) outcome was unknown. Unknown          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Myalgia
Clinical narrative: Muscle pain; Feels arthritis has worsen since taking the vaccine; Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Feels arthritis has worsen since taking the vaccine), ARTHRALGIA (Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain) and MYALGIA (Muscle pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Thyroid disorder and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ARTHRITIS (Feels arthritis has worsen since taking the vaccine) and ARTHRALGIA (Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain). On 24-Mar-2021, the patient experienced MYALGIA (Muscle pain). The patient was treated with PREDNISONE for Joint pain, at a dose of 1 dosage form and HYDROXYCHLOROQUINE ongoing since an unknown date for Joint pain, at a dose of 200 milligram. At the time of the report, ARTHRITIS (Feels arthritis has worsen since taking the vaccine) outcome was unknown and ARTHRALGIA (Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain) and MYALGIA (Muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Muscle and Joint pain occurred again on 7-Apr-2021 and 22-Apr-2021.   Dosage of Prednisone (treatment) was taken as 2X20 milligram tablet per day for next 7 days, then 1X20 milligram tablet per day for next 7 days, then again 1X10 milligram tablet per day for next 7 days, then 2X5 milligram tablet per day for next 7 days and then 1X5 milligrams and half 2 and half milligram tablet per day for next 14 days. If the pain did not go away then, 7 and half milligram.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant Follow up appended for AE Contact Update On 27-Jul-2021: Significant follow up appended to AER, event. concomitant medications updated
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the 2nd dose <21 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose <21 days) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 23-Jun-2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose <21 days). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose <21 days) had resolved. 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 concomitants were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non significant Follow up received on 26-may-2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Eye irritation, Fatigue
Clinical narrative: is dizzy; don't fell well; without appetite; very "tired"; fever; body aches; fever did not drop below 100.4/100.2; headache; burning eyes; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), DIZZINESS (is dizzy), MALAISE (don't fell well) and DECREASED APPETITE (without appetite) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), HEADACHE (headache), PYREXIA (fever), MYALGIA (body aches) and PYREXIA (fever did not drop below 100.4/100.2). On 22-Apr-2021, the patient experienced DIZZINESS (is dizzy), MALAISE (don't fell well), DECREASED APPETITE (without appetite) and FATIGUE (very "tired"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), DIZZINESS (is dizzy), MALAISE (don't fell well), DECREASED APPETITE (without appetite), HEADACHE (headache), FATIGUE (very "tired"), PYREXIA (fever), MYALGIA (body aches) and PYREXIA (fever did not drop below 100.4/100.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: is dizzy; don't fell well; without appetite; very "tired"; fever; body aches; fever did not drop below 100.4/100.2; headache; burning eyes; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), DIZZINESS (is dizzy), MALAISE (don't fell well) and DECREASED APPETITE (without appetite) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), HEADACHE (headache), PYREXIA (fever), MYALGIA (body aches) and PYREXIA (fever did not drop below 100.4/100.2). On 22-Apr-2021, the patient experienced DIZZINESS (is dizzy), MALAISE (don't fell well), DECREASED APPETITE (without appetite) and FATIGUE (very "tired"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), DIZZINESS (is dizzy), MALAISE (don't fell well), DECREASED APPETITE (without appetite), HEADACHE (headache), FATIGUE (very "tired"), PYREXIA (fever), MYALGIA (body aches) and PYREXIA (fever did not drop below 100.4/100.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: Really adverse side effects; woke her up at night; arm was extremely painful, could hardly lift it; chills; fever from 98-101; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Really adverse side effects), SLEEP DISORDER (woke her up at night), MYALGIA (arm was extremely painful, could hardly lift it), CHILLS (chills) and PYREXIA (fever from 98-101) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000621a) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included METOPROLOL and WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ADVERSE EVENT (Really adverse side effects), SLEEP DISORDER (woke her up at night), MYALGIA (arm was extremely painful, could hardly lift it), CHILLS (chills) and PYREXIA (fever from 98-101). At the time of the report, ADVERSE EVENT (Really adverse side effects), SLEEP DISORDER (woke her up at night), MYALGIA (arm was extremely painful, could hardly lift it), CHILLS (chills) and PYREXIA (fever from 98-101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain in lower left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in lower left side) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain in lower left side). At the time of the report, PAIN (pain in lower left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Migraine, Nasal congestion
Clinical narrative: about to get a migraine; stuffy nose; runny eyes; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (about to get a migraine), NASAL CONGESTION (stuffy nose) and LACRIMATION INCREASED (runny eyes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced MIGRAINE (about to get a migraine), NASAL CONGESTION (stuffy nose) and LACRIMATION INCREASED (runny eyes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MIGRAINE (about to get a migraine), NASAL CONGESTION (stuffy nose) and LACRIMATION INCREASED (runny eyes) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications reported.  Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nasal congestion, Oropharyngeal pain
Clinical narrative: Cold; Sore throat; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) 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 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced FEELING COLD (Cold), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion). At the time of the report, FEELING COLD (Cold), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24 May 2021 included patient demographics.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Arm is sore; Headache; Muscle pain, arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and MYALGIA (Muscle pain, arm is sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, Levothroxine and OMEPRAZOLE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and MYALGIA (Muscle pain, arm is sore). At the time of the report, PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced NIGHT SWEATS (night sweats). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Mar-2021, NIGHT SWEATS (night sweats) had resolved. Not Provided          Concomitant products included Blood pressure medicine.Treatment medication included Tylenol. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-085406 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Heart rate increased
Clinical narrative: rapid heartrate; metallic taste in her mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid heartrate) and DYSGEUSIA (metallic taste in her mouth) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (rapid heartrate) and DYSGEUSIA (metallic taste in her mouth). On 02-Jan-2021, HEART RATE INCREASED (rapid heartrate) and DYSGEUSIA (metallic taste in her mouth) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Treatment information was not provided.    This case was linked to MOD-2021-085398 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Headache, Vision blurred, Vomiting
Clinical narrative: had really bad headache; he was in bed all day, no energy; no energy.still lacking energy; still having blurriness; throwing up all night (vomiting) after second dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (he was in bed all day, no energy), ASTHENIA (no energy.still lacking energy), VISION BLURRED (still having blurriness), VOMITING (throwing up all night (vomiting) after second dose) and HEADACHE (had really bad headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No current or past medical history was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BEDRIDDEN (he was in bed all day, no energy), ASTHENIA (no energy.still lacking energy), VISION BLURRED (still having blurriness), VOMITING (throwing up all night (vomiting) after second dose) and HEADACHE (had really bad headache). On 09-Apr-2021, BEDRIDDEN (he was in bed all day, no energy), ASTHENIA (no energy.still lacking energy), VOMITING (throwing up all night (vomiting) after second dose) and HEADACHE (had really bad headache) had resolved. At the time of the report, VISION BLURRED (still having blurriness) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter   This case was linked to MOD21-080147, MOD21-080185 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up attempt in 22-Apr-2021 in there the reporter mention about the 2nd dose and add so many events like really bad headache, he was in bed all day, no energy, blurriness and lacking energy.The patients have recovered from the events  "he was throwing up all night".; Sender's Comments:  MOD21-080147:1st dose MOD21-080185:wife's case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Condition aggravated, Confusional state, Feeling abnormal, Headache
Clinical narrative: condition aggravated; Headache; Pressure on brain; Brain fog; Bit confused; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL DISORDER (Pressure on brain), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Bit confused), CONDITION AGGRAVATED (condition aggravated) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to composine), Allergic reaction to analgesics (allergy to acetaminophen), Food allergy (allergy to parsley), Food allergy (allergy to MSG), Vegetable allergy (allergy to cabbage) and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) from 15-Nov-2006 to an unknown date for Hypothyroidism.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBRAL DISORDER (Pressure on brain), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Bit confused) and HEADACHE (Headache). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Head pain, at an unspecified dose and frequency. At the time of the report, CEREBRAL DISORDER (Pressure on brain), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Bit confused) and HEADACHE (Headache) had not resolved and CONDITION AGGRAVATED (condition aggravated) 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.   Lab testes included - MRI was done and result was not provided, ordered an MRV.  Patient was set up with an infusion that was used to treat migraine. Infusion had helped the patient slightly to get out of pain and the pressure.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received: Patient demographics, race, ethnicity, medical history were added. Anatomical location of first dose, concomitant and treatment medication were added. Events outcome was updated from unknown to Not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Has cold; chills; muscle pain; joint pain; Fatigue; headache; fever ( do not know how much); This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever ( do not know how much)). The patient was treated with PARACETAMOL (TYLENOL) on 22-Apr-2021 at a dose of 2 dosage form. At the time of the report, NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever ( do not know how much)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: Has cold; chills; muscle pain; joint pain; Fatigue; headache; fever ( do not know how much); This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever ( do not know how much)). The patient was treated with PARACETAMOL (TYLENOL) on 22-Apr-2021 at a dose of 2 dosage form. At the time of the report, NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever ( do not know how much)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Painful left arm; Big red patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful left arm) and VACCINATION SITE ERYTHEMA (Big red patch at injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red patch at injection site). On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (Painful left arm). At the time of the report, VACCINATION SITE PAIN (Painful left arm) and VACCINATION SITE ERYTHEMA (Big red patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication include birth control. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received and contains no new information. But initial case was submitted without concomitant medication so it becomes significant.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: not yet received their second dose/ missed his second dose because he missed his appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not yet received their second dose/ missed his second dose because he missed his appointment) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not yet received their second dose/ missed his second dose because he missed his appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not yet received their second dose/ missed his second dose because he missed his appointment) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included blood pressure medication No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Denied the second dose, did not receive second shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Denied the second dose, did not receive second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Denied the second dose, did not receive second shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Denied the second dose, did not receive second shot) had resolved. Not Provided          NO CONCOMINANT DRUGS WERE MENTONED. TREATMENT DRUGS WERE NOT USED. LAB DATA WAS NOT GIVEN
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: States the patient never received the second dose and it has now been "4 months" since first dose was administered.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (States the patient never received the second dose and it has now been "4 months" since first dose was administered.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (States the patient never received the second dose and it has now been "4 months" since first dose was administered.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (States the patient never received the second dose and it has now been "4 months" since first dose was administered.) 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up On 25-May-2021: Non significant follow up accepted on 27-05-21 On 26-May-2021: Received 2nd dose after 3 months, no AE