chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it; Left side of the neck is stiff; Left  arm is sore weak  and heavy; Her left arm is heavy; Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful; ongoing left arm injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy) and PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccination (has received the flu shot in left arm). Past adverse reactions to the above products included No adverse event with Flu vaccination.   On 23-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy), PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) and VACCINATION SITE PAIN (ongoing left arm injection site pain). At the time of the report, HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy), PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) and VACCINATION SITE PAIN (ongoing left arm injection site pain) outcome was unknown.            Patient has received both doses of the Moderna COVID-19 vaccine and states that she had a booster appointment but has not gone due to fear of becoming paralyzed in arm.   No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant Follow-up Appended events added
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (muscle aches in legs after second vaccine) and chills in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037A211B and 011A21A) for COVID-19 immunization. No medical history reported. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient experienced myalgia (muscle aches in legs after second vaccine) and chills. At the time of the report, myalgia (muscle aches in legs after second vaccine) and chills outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-395800 (patient link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 19-Nov-2021 an open vial was found in the refrigerator, Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured. Patients after 05-Nov-2021 were potentially getting their doses from vials punctured longer than 12 hours ago. Concomitant medication use was not reported. Treatment information was not reported..   This case was linked to MOD-2021-395851 (E2B Linked Report).; Sender's Comments:  MOD-2021-395851:Second patient case
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102.6 / it went higher) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PYREXIA (Fever of 102.6 / it went higher). At the time of the report, PYREXIA (Fever of 102.6 / it went higher) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 102.6 (High) 102.6 fever.         Concomitant drugs were not reported.  Treatment medications were not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Illness, Nausea
Clinical narrative: Shortness of breath; Got really sick on it/was constantly getting sick all day; Headache; Nausea/like a fire hose all over the house from one bathroom to another bathroom; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ILLNESS (Got really sick on it/was constantly getting sick all day), HEADACHE (Headache) and NAUSEA (Nausea/like a fire hose all over the house from one bathroom to another bathroom) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-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 DYSPNOEA (Shortness of breath), ILLNESS (Got really sick on it/was constantly getting sick all day), HEADACHE (Headache) and NAUSEA (Nausea/like a fire hose all over the house from one bathroom to another bathroom). At the time of the report, DYSPNOEA (Shortness of breath), ILLNESS (Got really sick on it/was constantly getting sick all day), HEADACHE (Headache) and NAUSEA (Nausea/like a fire hose all over the house from one bathroom to another bathroom) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant medications details were not reported by the reporter.  Treatment medication included unspecified pills to help with the nausea.  Patient took second dose on 17 May 2021 and did not experience any events. Patient's Moderna booster was on 17-Nov-2021.   This case was linked to MOD-2021-395817.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: less than 6 months from the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 6 months from the second dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third 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 (less than 6 months from the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 6 months from the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-395807 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Headache, Iridocyclitis, Malaise, Nausea
Clinical narrative: Iridocyclitis; malaise; inflammation of eye; nausea; horrible headache; This spontaneous case was reported by a physician and describes the occurrence of IRIDOCYCLITIS (Iridocyclitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE and PRAVASTATIN for an unknown indication.   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IRIDOCYCLITIS (Iridocyclitis) (seriousness criterion medically significant), MALAISE (malaise), EYE INFLAMMATION (inflammation of eye), NAUSEA (nausea) and HEADACHE (horrible headache). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and PREDNISOLONE ACETATE (PRED FORTE) for Adverse event, at an unspecified dose and frequency. At the time of the report, IRIDOCYCLITIS (Iridocyclitis), MALAISE (malaise), EYE INFLAMMATION (inflammation of eye), NAUSEA (nausea) and HEADACHE (horrible headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date lab data was performed CT Scan. The patient experienced eye pain as a result of iridocyclitis. Company Comment : This case concerns a 75-year-old, female patient with no medical history, who experienced the unexpected event of iridocyclitis along with other non serious events. The event occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was not applicable, as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 75-year-old, female patient with no medical history, who experienced the unexpected event of iridocyclitis along with other non serious events. The event occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was not applicable, as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have 2 neighbors, they both got very sick after getting the Moderna shot.; 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 ILLNESS (I have 2 neighbors, they both got very sick after getting the Moderna shot.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced ILLNESS (I have 2 neighbors, they both got very sick after getting the Moderna shot.). At the time of the report, ILLNESS (I have 2 neighbors, they both got very sick after getting the Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395763, MOD-2021-395776, MOD-2021-395777 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal
Clinical narrative: feeling bad; clear cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (clear cough) and FEELING ABNORMAL (feeling bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COUGH (clear cough). On 21-Nov-2021, the patient experienced FEELING ABNORMAL (feeling bad). At the time of the report, COUGH (clear cough) had not resolved and FEELING ABNORMAL (feeling bad) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient was scheduled to take 3rd dose on 22-Nov-2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have side effects to the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have side effects to the first 2 doses) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's disease, Thyroid disorder and Immunocompromised.    On 23-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 VACCINATION COMPLICATION (have side effects to the first 2 doses). At the time of the report, VACCINATION COMPLICATION (have side effects to the first 2 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient reported, she was on a lot of medications, but did not specify which ones. Treatment drug information was not given   This case was linked to MOD-2021-395759, MOD-2021-395849.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have side effects to the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have side effects to the first 2 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Sjogren's disease and Thyroid disorder.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have side effects to the first 2 doses). At the time of the report, VACCINATION COMPLICATION (have side effects to the first 2 doses) outcome was unknown.            The patient reported, she was on a lot of medications, but did not specify which ones.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395848, MOD-2021-395759 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Potentially got the dose from a vial punctured longer than 12 hours ago; More than 36 days after the first dose receiving the second dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose receiving the second dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose receiving the second dose). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose receiving the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild GI upset after first shot; Mild diarrhea after first shot; Sore Injected arm after first shot; Swollen Injected arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Mild GI upset after first shot), DIARRHOEA (Mild diarrhea after first shot), VACCINATION SITE PAIN (Sore Injected arm after first shot) and VACCINATION SITE SWELLING (Swollen Injected arm after first shot) in a 59-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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Mild GI upset after first shot), DIARRHOEA (Mild diarrhea after first shot), VACCINATION SITE PAIN (Sore Injected arm after first shot) and VACCINATION SITE SWELLING (Swollen Injected arm after first shot). On 20-Apr-2021, ABDOMINAL DISCOMFORT (Mild GI upset after first shot), DIARRHOEA (Mild diarrhea after first shot), VACCINATION SITE PAIN (Sore Injected arm after first shot) and VACCINATION SITE SWELLING (Swollen Injected arm after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-396447, MOD-2021-396448, MOD-2021-395897 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient got a booster dose instead of a third dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient got a booster dose instead of a third dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 006B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (patient got a booster dose instead of a third dose). On 20-Nov-2021, ACCIDENTAL UNDERDOSE (patient got a booster dose instead of a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included immunosuppressive agents.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Limb discomfort, Vaccination site pain
Clinical narrative: Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit; Move the arm and stickiness; Little bit of chills; Arm sore; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit), LIMB DISCOMFORT (Move the arm and stickiness), CHILLS (Little bit of chills), VACCINATION SITE PAIN (Arm sore) and HEADACHE (Slight headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 036A21A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Pain in thigh (In September or October.) and Leg operation in January 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Anticoagulant therapy.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BURNING SENSATION (Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit), LIMB DISCOMFORT (Move the arm and stickiness), CHILLS (Little bit of chills), VACCINATION SITE PAIN (Arm sore) and HEADACHE (Slight headache). At the time of the report, BURNING SENSATION (Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit) and HEADACHE (Slight headache) had resolved and LIMB DISCOMFORT (Move the arm and stickiness), CHILLS (Little bit of chills) and VACCINATION SITE PAIN (Arm sore) outcome was unknown.            she got a surgery on Nov2019 and in Jan2020 got a leg surgery (right leg) product of a clot for the previous surgery.  Since the surgery she tales a full aspirin, 325mg and Excedrin 250mg to make the blood thinner.   This case was linked to MOD-2021-395886 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Malaise after 2nd dose; Joint Pain after 2nd dose; Tired after 2nd dose; Nausea; Fever (unmeasured); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise after 2nd dose), ARTHRALGIA (Joint Pain after 2nd dose), FATIGUE (Tired after 2nd dose), NAUSEA (Nausea) and PYREXIA (Fever (unmeasured)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced MALAISE (Malaise after 2nd dose), ARTHRALGIA (Joint Pain after 2nd dose), FATIGUE (Tired after 2nd dose) and NAUSEA (Nausea). 13-May-2021, the patient experienced PYREXIA (Fever (unmeasured)). On 14-May-2021, MALAISE (Malaise after 2nd dose), ARTHRALGIA (Joint Pain after 2nd dose), FATIGUE (Tired after 2nd dose), NAUSEA (Nausea) and PYREXIA (Fever (unmeasured)) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient after the 2nd dose had fever (unmeasured), nausea, joint pain, tired and malaise for 1.5days.   This case was linked to MOD-2021-395910, MOD-2021-395855 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Little soreness on the area of the injection; Warm to touch; Area of the injection got sore again/pain; Note of redness; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (Area of the injection got sore again/pain), VACCINATION SITE ERYTHEMA (Note of redness) and VACCINATION SITE PAIN (Little soreness on the area of the injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE PAIN (Little soreness on the area of the injection). In November 2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (Area of the injection got sore again/pain) and VACCINATION SITE ERYTHEMA (Note of redness). On 15-Nov-2021, VACCINATION SITE PAIN (Little soreness on the area of the injection) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (Area of the injection got sore again/pain) and VACCINATION SITE ERYTHEMA (Note of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that soreness went away on 4th day and reappeared on 8th -9th day. Patient started experiencing by 8th-9th day there was note of redness and warm to touch and pain on the area of the injection.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positve.         No concomitant medications were reported. Treatment included Regeneron IV monoclonal antibodies  This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history, who experienced the unexpected, non serious event of SARS-CoV-2 test positive. The patient received 2 doses of mRNA-1273 (dose 1: 2 March 2021, dose 2: 30 March 2021) with appropriate dosage interval of 28 days. The event SARS-CoV-2 test positive exact occurrence unknown but stated that the event occurred after receiving the primary series of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history, who experienced the unexpected, non serious event of SARS-CoV-2 test positive. The patient received 2 doses of mRNA-1273 (dose 1: 2 March 2021, dose 2: 30 March 2021) with appropriate dosage interval of 28 days. The event SARS-CoV-2 test positive exact occurrence unknown but stated that the event occurred after receiving the primary series of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pyrexia
Clinical narrative: Fever (unmeasured); Nausea; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (unmeasured)), NAUSEA (Nausea) and ARTHRALGIA (Joint Pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 034C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PYREXIA (Fever (unmeasured)), NAUSEA (Nausea) and ARTHRALGIA (Joint Pain). At the time of the report, PYREXIA (Fever (unmeasured)), NAUSEA (Nausea) and ARTHRALGIA (Joint Pain) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-395897 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Sore arm; Severe headache, headache was bad enough where the patient stated in the bed all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Severe headache, headache was bad enough where the patient stated in the bed all day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROGESTERONE, ESTRADIOL (ESTROGEN) and TESTOSTERONE for an unknown indication.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Severe headache, headache was bad enough where the patient stated in the bed all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Severe headache, headache was bad enough where the patient stated in the bed all day) outcome was unknown.            The patient reported that the side effects from the second dose were not as bad  as after the first dose . The treatment with Tylenol did not help the patient and the patient was not sick as bad either like the first time.   This case was linked to US-MODERNATX, INC.-MOD-2021-142441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142441:Dose 1
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: brain fog; Extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog) and FATIGUE (Extreme exhaustion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Sleep problem.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (brain fog) and FATIGUE (Extreme exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency and ZINC for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fog) and FATIGUE (Extreme exhaustion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were supplements and vitamins. Treatment also included lots of fluids and rest.   This case was linked to MOD-2021-395717, MOD-2021-395927 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Illness, Influenza like illness, Pyrexia
Clinical narrative: was delirious; got  real real sick; felt like having the flu; fever; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (was delirious), ILLNESS (got  real real sick), INFLUENZA LIKE ILLNESS (felt like having the flu) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DELIRIUM (was delirious), ILLNESS (got  real real sick), INFLUENZA LIKE ILLNESS (felt like having the flu) and PYREXIA (fever). On 19-Apr-2021, DELIRIUM (was delirious), ILLNESS (got  real real sick), INFLUENZA LIKE ILLNESS (felt like having the flu) and PYREXIA (fever) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-395960 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: some patients experienced tachycardia; 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 TACHYCARDIA (some patients experienced tachycardia) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (some patients experienced tachycardia). At the time of the report, TACHYCARDIA (some patients experienced tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: they got cold chills; Nausea; a little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (they got cold chills), NAUSEA (Nausea) and HEADACHE (a little bit of a headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Diabetes.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced CHILLS (they got cold chills), NAUSEA (Nausea) and HEADACHE (a little bit of a headache). At the time of the report, CHILLS (they got cold chills), NAUSEA (Nausea) and HEADACHE (a little bit of a headache) outcome was unknown.            Patient is having chemotherapy.  Concomitant products included BP Medication and Diabetes medication.  No treatment was reported by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported. No Treatment informations were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cold sweat, Fatigue, Feeling abnormal
Clinical narrative: Still feels not right; Hot sweats; Back ache; Cold sweats; Migraines; Fever; Horrible headache; Muscle ache/horrible aching; Joint pain; Extreme fatigue; A tiny bit of nausea but no vomiting; She felt like she was going through menopause again but worse; Worst flu she has ever had; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (She felt like she was going through menopause again but worse), FEELING ABNORMAL (Still feels not right), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache) and COLD SWEAT (Cold sweats) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 039B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA (Worst flu she has ever had). On 15-Nov-2021, the patient experienced MENOPAUSE (She felt like she was going through menopause again but worse), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache), COLD SWEAT (Cold sweats), MIGRAINE (Migraines), PYREXIA (Fever), HEADACHE (Horrible headache), MYALGIA (Muscle ache/horrible aching), ARTHRALGIA (Joint pain), FATIGUE (Extreme fatigue) and NAUSEA (A tiny bit of nausea but no vomiting). On 22-Nov-2021, the patient experienced FEELING ABNORMAL (Still feels not right). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Nov-2021, INFLUENZA (Worst flu she has ever had) had resolved. At the time of the report, MENOPAUSE (She felt like she was going through menopause again but worse), FEELING ABNORMAL (Still feels not right), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache), COLD SWEAT (Cold sweats), MIGRAINE (Migraines), PYREXIA (Fever), HEADACHE (Horrible headache), MYALGIA (Muscle ache/horrible aching), ARTHRALGIA (Joint pain), FATIGUE (Extreme fatigue) and NAUSEA (A tiny bit of nausea but no vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the following the booster dose of the vaccine, the day after receiving the shot was not so bad.   This case was linked to MOD-2021-395936, MOD-2021-395951 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Influenza, Menopause, Migraine
Clinical narrative: Still feels not right; Hot sweats; Back ache; Cold sweats; Migraines; Fever; Horrible headache; Muscle ache/horrible aching; Joint pain; Extreme fatigue; A tiny bit of nausea but no vomiting; She felt like she was going through menopause again but worse; Worst flu she has ever had; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (She felt like she was going through menopause again but worse), FEELING ABNORMAL (Still feels not right), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache) and COLD SWEAT (Cold sweats) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 039B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA (Worst flu she has ever had). On 15-Nov-2021, the patient experienced MENOPAUSE (She felt like she was going through menopause again but worse), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache), COLD SWEAT (Cold sweats), MIGRAINE (Migraines), PYREXIA (Fever), HEADACHE (Horrible headache), MYALGIA (Muscle ache/horrible aching), ARTHRALGIA (Joint pain), FATIGUE (Extreme fatigue) and NAUSEA (A tiny bit of nausea but no vomiting). On 22-Nov-2021, the patient experienced FEELING ABNORMAL (Still feels not right). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Nov-2021, INFLUENZA (Worst flu she has ever had) had resolved. At the time of the report, MENOPAUSE (She felt like she was going through menopause again but worse), FEELING ABNORMAL (Still feels not right), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache), COLD SWEAT (Cold sweats), MIGRAINE (Migraines), PYREXIA (Fever), HEADACHE (Horrible headache), MYALGIA (Muscle ache/horrible aching), ARTHRALGIA (Joint pain), FATIGUE (Extreme fatigue) and NAUSEA (A tiny bit of nausea but no vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the following the booster dose of the vaccine, the day after receiving the shot was not so bad.   This case was linked to MOD-2021-395936, MOD-2021-395951 (Patient Link).