chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: About 3 weeks later, I was diagnosed with Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (About 3 weeks later, I was diagnosed with Covid-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (About 3 weeks later, I was diagnosed with Covid-19). At the time of the report, COVID-19 (About 3 weeks later, I was diagnosed with Covid-19) 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.   No concomitant medications were reported. No treatment medications were reported. Patient was diagnosed with Covid-19 3 weeks after the first dose and 1 week before the second dose. Patient states he still has antibodies and protein spike from the vaccine.; Sender's Comments: This case concerns a  52-year-old, female patient with no relevant medical history, who experienced the unexpected events of COVID-19. The events occurred approximately 3 weeks after the first dose of Spikevax, patient is yet to take the second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event NOS/ Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event NOS/ Possible AE   ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS/ Possible AE   ). At the time of the report, ADVERSE EVENT (Adverse event NOS/ Possible AE   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No Treatment medications reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Seasonal allergy
Clinical narrative: a week or so later her seasonal allergies kicked in; 1st shot on 1May2021; hasn't gotten 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (a week or so later her seasonal allergies kicked in) and PRODUCT DOSE OMISSION ISSUE (1st shot on 1May2021; hasn't gotten 2nd shot) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Food allergy.    On 01-May-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 SEASONAL ALLERGY (a week or so later her seasonal allergies kicked in) and PRODUCT DOSE OMISSION ISSUE (1st shot on 1May2021; hasn't gotten 2nd shot). At the time of the report, SEASONAL ALLERGY (a week or so later her seasonal allergies kicked in) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (1st shot on 1May2021; hasn't gotten 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site reaction
Clinical narrative: Covid arm where her arm swelled up; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Covid arm where her arm swelled up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Covid arm where her arm swelled up). At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Covid arm where her arm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. After her 1st shot patient had muscle and joint pain and after 10 days got Covid arm where her arm swelled up.   This case was linked to MOD-2021-346094.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Loss of personal independence in daily activities, Malaise, Pyrexia
Clinical narrative: not feeling well; BP is 134/112; pulse is 160 lying down.; Loss of personal independence in daily activities; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), BLOOD PRESSURE INCREASED (BP is 134/112), HEART RATE INCREASED (pulse is 160 lying down.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ( Loss of personal independence in daily activities) and PYREXIA (running a fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 019F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-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 MALAISE (not feeling well), BLOOD PRESSURE INCREASED (BP is 134/112), HEART RATE INCREASED (pulse is 160 lying down.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ( Loss of personal independence in daily activities) and PYREXIA (running a fever). At the time of the report, MALAISE (not feeling well), BLOOD PRESSURE INCREASED (BP is 134/112), HEART RATE INCREASED (pulse is 160 lying down.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ( Loss of personal independence in daily activities) and PYREXIA (running a fever) outcome was unknown.            No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-346088 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved. Not Provided          No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-289785 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disseminated intravascular coagulation, Uterine haemorrhage
Clinical narrative: Hemorrhaging from her Fibroids; Diagnosed with DIC; This spontaneous case was reported by an other health care professional and describes the occurrence of UTERINE HAEMORRHAGE (Hemorrhaging from her Fibroids) and DISSEMINATED INTRAVASCULAR COAGULATION (Diagnosed with DIC) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced UTERINE HAEMORRHAGE (Hemorrhaging from her Fibroids) (seriousness criteria hospitalization and medically significant) and DISSEMINATED INTRAVASCULAR COAGULATION (Diagnosed with DIC) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to DISSEMINATED INTRAVASCULAR COAGULATION and UTERINE HAEMORRHAGE. On 08-Feb-2021, UTERINE HAEMORRHAGE (Hemorrhaging from her Fibroids) and DISSEMINATED INTRAVASCULAR COAGULATION (Diagnosed with DIC) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received plasma and blood as a treatment.  This case concerns a 47-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of uterine haemorrhage and disseminated intravascular coagulation. The events occurred 16 days after the first dose of mRNA-1273. The rechallenge was positive. he benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-346425 (Patient Link).; Sender's Comments: This case concerns a 47-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of uterine haemorrhage and disseminated intravascular coagulation. The events occurred 16 days after the first dose of mRNA-1273. The rechallenge was positive. he benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pyrexia, Vaccination complication
Clinical narrative: everyone who got moderna really sick; Normal reaction; chills; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (everyone who got moderna really sick), VACCINATION COMPLICATION (Normal reaction), CHILLS (chills), PYREXIA (fever) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (everyone who got moderna really sick), VACCINATION COMPLICATION (Normal reaction), CHILLS (chills), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, ILLNESS (everyone who got moderna really sick), VACCINATION COMPLICATION (Normal reaction), CHILLS (chills), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medications were reported.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 062e21a) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin mass, Skin warm
Clinical narrative: Redness; Knot in arm; Warm to touch and growing; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (Redness), SKIN MASS (Knot in arm) and SKIN WARM (Warm to touch and growing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SKIN MASS (Knot in arm) and SKIN WARM (Warm to touch and growing). At the time of the report, ERYTHEMA (Redness), SKIN MASS (Knot in arm) and SKIN WARM (Warm to touch and growing) 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 medications was not provided by the reporter Treatment information was not provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Tinnitus, Vaccination site joint inflammation, Vaccination site rash
Clinical narrative: Ringing in the ears after first shot; Metal taste in her mouth  after first shot; Left elbow is growing (Inflamed) after first shot; Left elbow hurting  after first shot; Rash on the vaccination site  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears after first shot), DYSGEUSIA (Metal taste in her mouth  after first shot), VACCINATION SITE JOINT INFLAMMATION (Left elbow is growing (Inflamed) after first shot), ARTHRALGIA (Left elbow hurting  after first shot) and VACCINATION SITE RASH (Rash on the vaccination site  after first shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 019F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced TINNITUS (Ringing in the ears after first shot), DYSGEUSIA (Metal taste in her mouth  after first shot), VACCINATION SITE JOINT INFLAMMATION (Left elbow is growing (Inflamed) after first shot), ARTHRALGIA (Left elbow hurting  after first shot) and VACCINATION SITE RASH (Rash on the vaccination site  after first shot). On 13-Sep-2021, TINNITUS (Ringing in the ears after first shot), DYSGEUSIA (Metal taste in her mouth  after first shot) and VACCINATION SITE RASH (Rash on the vaccination site  after first shot) had resolved. At the time of the report, VACCINATION SITE JOINT INFLAMMATION (Left elbow is growing (Inflamed) after first shot) and ARTHRALGIA (Left elbow hurting  after first shot) 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.   No Concomitant medication was reported. No treatment medications were reported   This case was linked to MOD-2021-346399 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Tenderness, Tinnitus
Clinical narrative: Ringing in the ears after 2nd Shot; Metal taste in the mouth after 2nd Shot; Tender glands under chin & neck after 2nd Shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the ears after 2nd Shot), DYSGEUSIA (Metal taste in the mouth after 2nd Shot) and TENDERNESS (Tender glands under chin & neck after 2nd Shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced TINNITUS (Ringing in the ears after 2nd Shot), DYSGEUSIA (Metal taste in the mouth after 2nd Shot) and TENDERNESS (Tender glands under chin & neck after 2nd Shot). At the time of the report, TINNITUS (Ringing in the ears after 2nd Shot), DYSGEUSIA (Metal taste in the mouth after 2nd Shot) and TENDERNESS (Tender glands under chin & neck after 2nd Shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-346379 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Dyspnoea, Insomnia, Pyrexia
Clinical narrative: spine so hurt and hurting on the left side; hurt in my left kidney in the back; short breathe; afraid to sleep; temperature go 104, 102; back pain/back so hurt/feel pain in my left back; feels so bad, unbelievable; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), SPINAL PAIN (spine so hurt and hurting on the left side), RENAL PAIN (hurt in my left kidney in the back) and DYSPNOEA (short breathe) in a 50-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.     The patient's past medical history included COVID-19 in January 2021 and Stroke.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), DYSPNOEA (short breathe), INSOMNIA (afraid to sleep) and PYREXIA (temperature go 104, 102). On 08-Oct-2021, the patient experienced SPINAL PAIN (spine so hurt and hurting on the left side) and RENAL PAIN (hurt in my left kidney in the back). At the time of the report, BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), SPINAL PAIN (spine so hurt and hurting on the left side), RENAL PAIN (hurt in my left kidney in the back), DYSPNOEA (short breathe), INSOMNIA (afraid to sleep) and PYREXIA (temperature go 104, 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Body temperature: 104-102 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she had an appointment on Monday 11Oct2021 with her doctor. had hurt in her left kidney in the back She states that this is the same as when she had COVID previously  No concomitant medication were reported  No treatment information was provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Spinal pain, Vaccination complication
Clinical narrative: spine so hurt and hurting on the left side; hurt in my left kidney in the back; short breathe; afraid to sleep; temperature go 104, 102; back pain/back so hurt/feel pain in my left back; feels so bad, unbelievable; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), SPINAL PAIN (spine so hurt and hurting on the left side), RENAL PAIN (hurt in my left kidney in the back) and DYSPNOEA (short breathe) in a 50-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.     The patient's past medical history included COVID-19 in January 2021 and Stroke.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), DYSPNOEA (short breathe), INSOMNIA (afraid to sleep) and PYREXIA (temperature go 104, 102). On 08-Oct-2021, the patient experienced SPINAL PAIN (spine so hurt and hurting on the left side) and RENAL PAIN (hurt in my left kidney in the back). At the time of the report, BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), SPINAL PAIN (spine so hurt and hurting on the left side), RENAL PAIN (hurt in my left kidney in the back), DYSPNOEA (short breathe), INSOMNIA (afraid to sleep) and PYREXIA (temperature go 104, 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Body temperature: 104-102 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she had an appointment on Monday 11Oct2021 with her doctor. had hurt in her left kidney in the back She states that this is the same as when she had COVID previously  No concomitant medication were reported  No treatment information was provided
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received first dose administered through deltoid muscle. No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Pyrexia
Clinical narrative: Not feeling good; Patient's body felt hot; Running a fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good), FEELING HOT (Patient's body felt hot) and PYREXIA (Running a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (Not feeling good), FEELING HOT (Patient's body felt hot) and PYREXIA (Running a fever). At the time of the report, FEELING ABNORMAL (Not feeling good), FEELING HOT (Patient's body felt hot) and PYREXIA (Running a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Myalgia, Rash
Clinical narrative: they have trouble breathing  but was not that bad; having muscle weakness; when they close their eyes they feel very dizzie; experiencing  a rush all over their body that is not that bad, but small, that started in their face and that it is bumpy; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (they have trouble breathing  but was not that bad), MUSCULAR WEAKNESS (having muscle weakness,), DIZZINESS (when they close their eyes they feel very dizzie), RASH (experiencing  a rush all over their body that is not that bad, but small, that started in their face and that it is bumpy) and MYALGIA (body aches) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced DYSPNOEA (they have trouble breathing  but was not that bad), MUSCULAR WEAKNESS (having muscle weakness,), DIZZINESS (when they close their eyes they feel very dizzie), RASH (experiencing  a rush all over their body that is not that bad, but small, that started in their face and that it is bumpy) and MYALGIA (body aches). At the time of the report, DYSPNOEA (they have trouble breathing  but was not that bad), MUSCULAR WEAKNESS (having muscle weakness,), DIZZINESS (when they close their eyes they feel very dizzie), RASH (experiencing  a rush all over their body that is not that bad, but small, that started in their face and that it is bumpy) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st dose in her left arm and the pain at that injection site has never gone away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (1st dose in her left arm and the pain at that injection site has never gone away) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (1st dose in her left arm and the pain at that injection site has never gone away). At the time of the report, VACCINATION SITE PAIN (1st dose in her left arm and the pain at that injection site has never gone away) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information provided was Compresses.   This case was linked to MOD-2021-346463 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhage, Pathology test
Clinical narrative: Hemorrhaging again after 2nd shot; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Oct-2021 and was forwarded to Moderna on 08-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Hemorrhaging again after 2nd shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibroids, Hemorrhage, DIC and Hysterectomy on 11-Mar-2021.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HAEMORRHAGE (Hemorrhaging again after 2nd shot) (seriousness criteria hospitalization and medically significant) and FATIGUE (fatigue). The patient was treated with PROGESTERONE for Adverse event, at an unspecified dose and frequency and Surgery for Haemorrhage. On 11-Mar-2021, HAEMORRHAGE (Hemorrhaging again after 2nd shot) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pathology test: pathology results were okay (normal) Pathology results were okay.         Concomitant therapy not reported.  The patient started hemorrhaging again, and had  Progesterone therapy.  On 11 Mar 2021, after receiving second shot, the patient had Hysterectomy.   This case was linked to MOD-2021-346344 (Patient Link).; Sender's Comments: This case concerns a  47 year old female patient with medical history of fibroids and hemorrhaging from fibroids and disseminated intravascular coagulation who experienced the unexpected event of hemorrhage. The event occurred approximately 13 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. Patient's history of fibroids, hemorrhage and DIC is a confounder. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm was hurting; A little fever; Nausea for at least 1 week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), PYREXIA (A little fever) and NAUSEA (Nausea for at least 1 week) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting), PYREXIA (A little fever) and NAUSEA (Nausea for at least 1 week). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), PYREXIA (A little fever) and NAUSEA (Nausea for at least 1 week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported. No treatment information was provided.  The reporter was calling on behalf of their daughter who received both the doses of the Moderna COVID-19 vaccine in April. The patient immediately after receiving the first dose of the vaccine stated that their arm was hurting, had a little fever, and nausea for at least 1 week. The reporter was not sure if the patient took any treatments during this time.   This case was linked to MOD-2021-346454 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; 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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) 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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The reporter stated that many people experienced fatigue and a sore arm after receiving Moderna's COVID-19 vaccination. No additional details were provided.   This case was linked to MOD-2021-347496 (Patient Link).   Reporter did not allow further contact
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Yawning
Clinical narrative: She yawned about 6 times and she doesn't usually yawn; She further stated that she was not hungry and did not want to eat anything; She also felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (She yawned about 6 times and she doesn't usually yawn), DECREASED APPETITE (She further stated that she was not hungry and did not want to eat anything) and FATIGUE (She also felt very tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced YAWNING (She yawned about 6 times and she doesn't usually yawn), DECREASED APPETITE (She further stated that she was not hungry and did not want to eat anything) and FATIGUE (She also felt very tired). On 08-Oct-2021, YAWNING (She yawned about 6 times and she doesn't usually yawn), DECREASED APPETITE (She further stated that she was not hungry and did not want to eat anything) and FATIGUE (She also felt very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment medications were not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Otorrhoea
Clinical narrative: Cyst in their right ear; Liquid pulsed from it in their ear; This spontaneous case was reported by a consumer and describes the occurrence of CYST (Cyst in their right ear) and OTORRHOEA (Liquid pulsed from it in their ear) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-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 CYST (Cyst in their right ear) and OTORRHOEA (Liquid pulsed from it in their ear). At the time of the report, CYST (Cyst in their right ear) and OTORRHOEA (Liquid pulsed from it in their ear) had not resolved.            The patient stated that a couple of days after the second dose patient noticed a cyst in their right ear, and had liquid pulsed from it in their ear. And consulted with an HCP who prescribed ear drops.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nasal congestion, Vaccination site pain
Clinical narrative: nasal congestion; a heavy head; About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), HEAD DISCOMFORT (a heavy head) and VACCINATION SITE PAIN (About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion), HEAD DISCOMFORT (a heavy head) and VACCINATION SITE PAIN (About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm). At the time of the report, NASAL CONGESTION (nasal congestion), HEAD DISCOMFORT (a heavy head) and VACCINATION SITE PAIN (About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-346418 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: feeling dizzie/ light head / every time they move their head they feel dizzie; weakness all over; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzie/ light head / every time they move their head they feel dizzie) and ASTHENIA (weakness all over) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MINOCYCLINE, OMEPRAZOLE, MAGNESIUM OXIDE, DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]), CALCIUM, ATORVASTATIN, MONTELUKAST SODIUM (SINGULAIR), PREGABALIN (LYRICA), ESCITALOPRAM OXALATE (LEXAPRO), ASPIRIN [ACETYLSALICYLIC ACID], POTASSIUM, ERGOCALCIFEROL (VITAMIN D2), NADOLOL, TERBUTALINE and HYDROMORPHONE for an unknown indication.   On 07-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 08-Oct-2021, the patient experienced DIZZINESS (feeling dizzie/ light head / every time they move their head they feel dizzie) and ASTHENIA (weakness all over). At the time of the report, DIZZINESS (feeling dizzie/ light head / every time they move their head they feel dizzie) and ASTHENIA (weakness all over) outcome was unknown.            Tourmaline 300 mg twice a day and proguard, Sulphate, Bath lysine  and Tomalin were concomitant drugs used and no treatment drugs were provided.  Every time the patient sound more sleepy and less and less coherent.   This case was linked to MOD-2021-079363 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration; 4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration) and PRODUCT STORAGE ERROR (4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration) and PRODUCT STORAGE ERROR (4 patients received their 3rd doses of the Moderna Covid-19 Vaccine 33 days after the vial was moved to refrigeration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today; Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to 2 patients today) 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
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.No treatment medications were reported.   This case was linked to MOD-2021-346572 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain that is in my injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain that is in my injection site 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 07-Oct-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 VACCINATION SITE PAIN (Pain that is in my injection site arm). At the time of the report, VACCINATION SITE PAIN (Pain that is in my injection site arm) outcome was unknown.            Concomitant drugs were not reported.  Patient received the booster dose.  Treatment medications were not provided.