chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster administered less than 6 months apart from the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6 months apart from the second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6 months apart from the second dose). On 09-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6 months apart from the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Vaccination site induration
Clinical narrative: a red rash pinkish rash; Sore arm / It is very sore; Big knot on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a red rash pinkish rash), PAIN IN EXTREMITY (Sore arm / It is very sore) and VACCINATION SITE INDURATION (Big knot on the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced RASH ERYTHEMATOUS (a red rash pinkish rash), PAIN IN EXTREMITY (Sore arm / It is very sore) and VACCINATION SITE INDURATION (Big knot on the arm). At the time of the report, RASH ERYTHEMATOUS (a red rash pinkish rash), PAIN IN EXTREMITY (Sore arm / It is very sore) and VACCINATION SITE INDURATION (Big knot on the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: received Moderna booster dose(half dose); This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (received Moderna booster dose(half dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Knee deformity (Bad knees) and Immunocompromised.    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 UNDERDOSE (received Moderna booster dose(half dose)). On 08-Nov-2021, UNDERDOSE (received Moderna booster dose(half dose)) had resolved.            No concomitant medications were reported.   Treatment information was not provided.    Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 Doses administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient. It was reported that vials were taken out of freezer on 27Oct2021. Vials were thawed and administered on the same day and vials were stored properly, no temperature excursions involved.   This case was linked to MOD-2021-380857, MOD-2021-380858 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inflammation, Neuralgia, Therapeutic response unexpected
Clinical narrative: Few of her nodes inflamed; Less brain fog; Less neuropathic pain; Energy level increased/Like something has awaken in her immune system/Able to do household work/Feeling demonstrably better/Able to do things that she has not been able to do in 4 to 6 years; This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (Few of her nodes inflamed), FEELING ABNORMAL (Less brain fog), NEURALGIA (Less neuropathic pain) and THERAPEUTIC RESPONSE UNEXPECTED (Energy level increased/Like something has awaken in her immune system/Able to do household work/Feeling demonstrably better/Able to do things that she has not been able to do in 4 to 6 years) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A, 019B21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Bedridden (Bedbound) and Housebound. Concurrent medical conditions included Myalgic encephalomyelitis, Connective tissue disorder, Immunodeficiency, IgM decreased (Lack of IgM), Neuropathy peripheral (Hardly any peripheral nerve left,severe amount of autoneuropathy) and Activities of daily living impaired.   On 06-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 26-Aug-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 INFLAMMATION (Few of her nodes inflamed), FEELING ABNORMAL (Less brain fog), NEURALGIA (Less neuropathic pain) and THERAPEUTIC RESPONSE UNEXPECTED (Energy level increased/Like something has awaken in her immune system/Able to do household work/Feeling demonstrably better/Able to do things that she has not been able to do in 4 to 6 years). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Few of her nodes inflamed), FEELING ABNORMAL (Less brain fog), NEURALGIA (Less neuropathic pain) and THERAPEUTIC RESPONSE UNEXPECTED (Energy level increased/Like something has awaken in her immune system/Able to do household work/Feeling demonstrably better/Able to do things that she has not been able to do in 4 to 6 years) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient has lived with been very heal for 40  years ,still very active but last two years she has been chair bound and not been able to do many activities associated with daily living. Patient has been debilitated with ME.   This case was linked to MOD-2021-380837 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Contusion, Erythema, Fatigue
Clinical narrative: did not have full movement could not close his hand; red,The whole back of his hand was red; Right hand was swollen , swollen the other day (right hand); chills,terrible chill,terrible, terrible, terrible chills; achy all over; hands were tingly,  could not close his hand; felt like it (hands) was bruised; exhaustion; headache; fever; Reaction hit that night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand) and ERYTHEMA (red,The whole back of his hand was red) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 012A21A and 13M20A) 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 LEVOTHYROXINE and TADALAFIL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction hit that night). On 05-Nov-2021, the patient experienced MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), FATIGUE (exhaustion), HEADACHE (headache) and PYREXIA (fever). On 06-Nov-2021, the patient experienced CHILLS (chills,terrible chill,terrible, terrible, terrible chills). On an unknown date, the patient experienced HYPOKINESIA (did not have full movement could not close his hand), ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)). On 09-Nov-2021, ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)) had resolved. At the time of the report, MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand), FATIGUE (exhaustion), HEADACHE (headache), PYREXIA (fever) and VACCINATION COMPLICATION (Reaction hit that night) outcome was unknown and CHILLS (chills,terrible chill,terrible, terrible, terrible chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 99.4 (High) temp 99.4high.         No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Myalgia, Paraesthesia, Peripheral swelling
Clinical narrative: did not have full movement could not close his hand; red,The whole back of his hand was red; Right hand was swollen , swollen the other day (right hand); chills,terrible chill,terrible, terrible, terrible chills; achy all over; hands were tingly,  could not close his hand; felt like it (hands) was bruised; exhaustion; headache; fever; Reaction hit that night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand) and ERYTHEMA (red,The whole back of his hand was red) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 012A21A and 13M20A) 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 LEVOTHYROXINE and TADALAFIL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction hit that night). On 05-Nov-2021, the patient experienced MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), FATIGUE (exhaustion), HEADACHE (headache) and PYREXIA (fever). On 06-Nov-2021, the patient experienced CHILLS (chills,terrible chill,terrible, terrible, terrible chills). On an unknown date, the patient experienced HYPOKINESIA (did not have full movement could not close his hand), ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)). On 09-Nov-2021, ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)) had resolved. At the time of the report, MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand), FATIGUE (exhaustion), HEADACHE (headache), PYREXIA (fever) and VACCINATION COMPLICATION (Reaction hit that night) outcome was unknown and CHILLS (chills,terrible chill,terrible, terrible, terrible chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 99.4 (High) temp 99.4high.         No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: did not have full movement could not close his hand; red,The whole back of his hand was red; Right hand was swollen , swollen the other day (right hand); chills,terrible chill,terrible, terrible, terrible chills; achy all over; hands were tingly,  could not close his hand; felt like it (hands) was bruised; exhaustion; headache; fever; Reaction hit that night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand) and ERYTHEMA (red,The whole back of his hand was red) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 012A21A and 13M20A) 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 LEVOTHYROXINE and TADALAFIL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction hit that night). On 05-Nov-2021, the patient experienced MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), FATIGUE (exhaustion), HEADACHE (headache) and PYREXIA (fever). On 06-Nov-2021, the patient experienced CHILLS (chills,terrible chill,terrible, terrible, terrible chills). On an unknown date, the patient experienced HYPOKINESIA (did not have full movement could not close his hand), ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)). On 09-Nov-2021, ERYTHEMA (red,The whole back of his hand was red) and PERIPHERAL SWELLING (Right hand was swollen , swollen the other day (right hand)) had resolved. At the time of the report, MYALGIA (achy all over), PARAESTHESIA (hands were tingly,  could not close his hand), CONTUSION (felt like it (hands) was bruised), HYPOKINESIA (did not have full movement could not close his hand), FATIGUE (exhaustion), HEADACHE (headache), PYREXIA (fever) and VACCINATION COMPLICATION (Reaction hit that night) outcome was unknown and CHILLS (chills,terrible chill,terrible, terrible, terrible chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 99.4 (High) temp 99.4high.         No treatment medications were provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 Doses administered past the expiration date/5 doses were administered (all booster doses of 0.25 ml) from expired vials; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date/5 doses were administered (all booster doses of 0.25 ml) from expired vials) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date/5 doses were administered (all booster doses of 0.25 ml) from expired vials). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date/5 doses were administered (all booster doses of 0.25 ml) from expired vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.  Vials were taken out of freezer on 27 Oct 2021. Vials were thawed and administered on the same day. Vials were stored properly, no temperature excursions involved.   This case was linked to MOD-2021-380859, MOD-2021-380858, MOD-2021-380834, MOD-2021-380860 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses were administered (all booster doses of 0.25 ml) from expired vials; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered (all booster doses of 0.25 ml) from expired vials) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered (all booster doses of 0.25 ml) from expired vials). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered (all booster doses of 0.25 ml) from expired vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No Treatment information was provided by the reporter.  It was reported that Vials were taken out of freezer on 27Oct2021. Vials were thawed and administered on the same day.Vials were stored properly, no temperature excursions involved.   This case was linked to MOD-2021-380859, MOD-2021-380860, MOD-2021-380834, MOD-2021-380857 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered past the expiration date) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered past the expiration date). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses administered past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 27-Oct-2021, the vials were taken out of freezer and were thawed and administered on the same day. Vials were stored properly, and no temperature excursion issue was involved with the vials.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 Doses administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Doses administered past the expiration date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-380857 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My wife got very sick in late October; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (My wife got very sick in late October) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced ILLNESS (My wife got very sick in late October). At the time of the report, ILLNESS (My wife got very sick in late October) outcome was unknown.            Patient is getting tested for Covid-19. No concomitant medication were provided. No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received and contains NNI.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Pyrexia
Clinical narrative: A heavy head; Feverish; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (A heavy head), PYREXIA (Feverish) and HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (light heart attack  years ago) and Stent placement (a heart stent). Previously administered products included for Product used for unknown indication: AstraZeneca Covisheild on 20-Mar-2021 and AstraZeneca Covisheild on 04-May-2021. Past adverse reactions to the above products included No adverse event with AstraZeneca Covisheild and AstraZeneca Covisheild. Concurrent medical conditions included Type II diabetes mellitus.    On 05-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 HEAD DISCOMFORT (A heavy head), PYREXIA (Feverish) and HEADACHE (Headache). At the time of the report, HEAD DISCOMFORT (A heavy head), PYREXIA (Feverish) and HEADACHE (Headache) had not resolved.      It was reported that  patient  has been getting feverish with a heavy head and headache those go away after about 5 hours then come back after another 3 hours. No relevant concomitant medications was reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient did not feel well for 2 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient did not feel well for 2 days after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (Patient did not feel well for 2 days after first shot). On 10-Feb-2021, MALAISE (Patient did not feel well for 2 days after first shot) had resolved.            No concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-381277 (Patient Link).   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Inappropriate schedule of product administration, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Beyond 35 days for 2nd dose; The swelling as its throbbing; skin is being stretched; Sore throat; Coughing; Difficulty swallowing; Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and DYSPHAGIA (Difficulty swallowing) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), DYSPHAGIA (Difficulty swallowing) and LYMPHADENOPATHY (Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). At the time of the report, PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), DYSPHAGIA (Difficulty swallowing) and LYMPHADENOPATHY (Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved.            Treatment medication was not provided.  Concomitant medication was not provided.  Patient was worried and panicking while patient called to report the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin tightness
Clinical narrative: Beyond 35 days for 2nd dose; The swelling as its throbbing; skin is being stretched; Sore throat; Coughing; Difficulty swallowing; Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and DYSPHAGIA (Difficulty swallowing) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), DYSPHAGIA (Difficulty swallowing) and LYMPHADENOPATHY (Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). At the time of the report, PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), DYSPHAGIA (Difficulty swallowing) and LYMPHADENOPATHY (Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved.            Treatment medication was not provided.  Concomitant medication was not provided.  Patient was worried and panicking while patient called to report the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Atrophic vulvovaginitis, Chills, Dizziness, Fatigue, Loss of consciousness
Clinical narrative: sometimes blackouts; vaginal atrophy; lots of dizziness; runny nose; really bad fatigue; lots of muscle aches; chills; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (sometimes blackouts) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 LOSS OF CONSCIOUSNESS (sometimes blackouts) (seriousness criterion medically significant), ATROPHIC VULVOVAGINITIS (vaginal atrophy), DIZZINESS (lots of dizziness), RHINORRHOEA (runny nose), FATIGUE (really bad fatigue), MYALGIA (lots of muscle aches) and CHILLS (chills). At the time of the report, LOSS OF CONSCIOUSNESS (sometimes blackouts), ATROPHIC VULVOVAGINITIS (vaginal atrophy), DIZZINESS (lots of dizziness), RHINORRHOEA (runny nose), FATIGUE (really bad fatigue), MYALGIA (lots of muscle aches) and CHILLS (chills) outcome 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.  Company Comment : This case concerns a 40-year old, female subject with no relevant medical history, who experienced the serious unexpected event of loss of consciousness and other non-serious expected/unexpected events. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 40-year old, female subject with no relevant medical history, who experienced the serious unexpected event of loss of consciousness and other non-serious expected/unexpected events. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rhinorrhoea
Clinical narrative: sometimes blackouts; vaginal atrophy; lots of dizziness; runny nose; really bad fatigue; lots of muscle aches; chills; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (sometimes blackouts) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 LOSS OF CONSCIOUSNESS (sometimes blackouts) (seriousness criterion medically significant), ATROPHIC VULVOVAGINITIS (vaginal atrophy), DIZZINESS (lots of dizziness), RHINORRHOEA (runny nose), FATIGUE (really bad fatigue), MYALGIA (lots of muscle aches) and CHILLS (chills). At the time of the report, LOSS OF CONSCIOUSNESS (sometimes blackouts), ATROPHIC VULVOVAGINITIS (vaginal atrophy), DIZZINESS (lots of dizziness), RHINORRHOEA (runny nose), FATIGUE (really bad fatigue), MYALGIA (lots of muscle aches) and CHILLS (chills) outcome 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.  Company Comment : This case concerns a 40-year old, female subject with no relevant medical history, who experienced the serious unexpected event of loss of consciousness and other non-serious expected/unexpected events. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 40-year old, female subject with no relevant medical history, who experienced the serious unexpected event of loss of consciousness and other non-serious expected/unexpected events. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast swelling, Breast tenderness, Lymphadenopathy, Swelling
Clinical narrative: Area of the injection hot; Area around her collarbone was tender; Area around her collarbone was swollen; Area around her left breast was tender; Area around her left breast was swollen; Golf ball sized swelling on her left armpit; Tender, sharp pain on her left armpit; Area of the injection red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender) and BREAST SWELLING (Area around her left breast was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 026L20T(?) and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender), BREAST SWELLING (Area around her left breast was swollen), LYMPHADENOPATHY (Golf ball sized swelling on her left armpit), AXILLARY PAIN (Tender, sharp pain on her left armpit) and VACCINATION SITE ERYTHEMA (Area of the injection red). At the time of the report, VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender), BREAST SWELLING (Area around her left breast was swollen), LYMPHADENOPATHY (Golf ball sized swelling on her left armpit), AXILLARY PAIN (Tender, sharp pain on her left armpit) and VACCINATION SITE ERYTHEMA (Area of the injection red) was resolving.            No concomitant medications were reported.  No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Area of the injection hot; Area around her collarbone was tender; Area around her collarbone was swollen; Area around her left breast was tender; Area around her left breast was swollen; Golf ball sized swelling on her left armpit; Tender, sharp pain on her left armpit; Area of the injection red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender) and BREAST SWELLING (Area around her left breast was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 026L20T(?) and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender), BREAST SWELLING (Area around her left breast was swollen), LYMPHADENOPATHY (Golf ball sized swelling on her left armpit), AXILLARY PAIN (Tender, sharp pain on her left armpit) and VACCINATION SITE ERYTHEMA (Area of the injection red). At the time of the report, VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender), BREAST SWELLING (Area around her left breast was swollen), LYMPHADENOPATHY (Golf ball sized swelling on her left armpit), AXILLARY PAIN (Tender, sharp pain on her left armpit) and VACCINATION SITE ERYTHEMA (Area of the injection red) was resolving.            No concomitant medications were reported.  No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Stiff arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff arm) and VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff arm) and VACCINATION SITE PAIN (Sore arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff arm) and VACCINATION SITE PAIN (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and medication information provided.   No treatment information provided.  The more patient  used the arm the better it got.   This case was linked to MOD-2021-380920 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Stiff injected arm after 2nd vaccine; Sore injected arm after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff injected arm after 2nd vaccine) and INJECTION SITE PAIN (Sore injected arm after 2nd vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff injected arm after 2nd vaccine) and INJECTION SITE PAIN (Sore injected arm after 2nd vaccine). On 15-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff injected arm after 2nd vaccine) and INJECTION SITE PAIN (Sore injected arm after 2nd vaccine) had resolved.            No concomitant medication was provided. No treatment information was provided.  Patient reported that the more she used the arm the better it got.   This case was linked to MOD-2021-380909, MOD-2021-380909 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site nodule
Clinical narrative: At injection site there is a bump; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (At injection site there is a bump) and HEADACHE (Slight headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU SHOT (2 weeks ago in the same arm where booster vaccine given.) in October 2021. Past adverse reactions to the above products included No adverse event with FLU SHOT.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first 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 09-Nov-2021, the patient experienced VACCINATION SITE NODULE (At injection site there is a bump) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE NODULE (At injection site there is a bump) and HEADACHE (Slight headache) had not resolved.            No concomitant medications were reported.   No treatment information was reported.    Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; Tested positive for COVID-19/only had fatigue/Feels a little weak; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (Tested positive for COVID-19/only had fatigue/Feels a little weak) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (Tested positive for COVID-19/only had fatigue/Feels a little weak). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown and COVID-19 (Tested positive for COVID-19/only had fatigue/Feels a little weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No concomitant medications were reported No treatment medications were reported.  The patient had symptoms of COVID only a couple of days earlier to the diagnosis date and currently feels a little bit weak, otherwise almost recovered.  This case concerns a 88-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, Drug ineffective was captured. The event occurred approximately 8 months after the second dose of mRNA- 1273 vaccine with an appropriate schedule of vaccination (window between doses 26 days). The disease was mild, clinical manifestations were fatigue and asthenia. The rechallenge is not applicable due to the nature of the event . It is noted that patient´s age is a risk factor for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 88-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, Drug ineffective was captured. The event occurred approximately 8 months after the second dose of mRNA- 1273 vaccine with an appropriate schedule of vaccination (window between doses 26 days). The disease was mild, clinical manifestations were fatigue and asthenia. The rechallenge is not applicable due to the nature of the event . It is noted that patient´s age is a risk factor for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.