chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and no treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: non significant follow up appended
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose from expired vial administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from expired vial administered to patient) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose from expired vial administered to patient). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose from expired vial administered to patient) had 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.   A nurse reported that one of her facilities gave 10 doses between 8 am to 12 pm on 01-Sep-2021 from a vial that expired on 31-Aug-2021, lot 037A21B. It was a new vial that had never been opened. It had been moved into the refrigerator on 25-Aug-2021 (8 days prior). Upon follow up it was reported that the vaccine given at 9 am  on 01-Sep-2021. No adverse reaction noted.  It was reported that the patient had no known allergies (NKA) and not diagnosed or tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before vaccination. It was unknown if prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken by the patient at the time of vaccination.  No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated reporter information. Added ethnicity of patient, vaccination time, route of administration and location of vaccination. Added facility information.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1st dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated patient ethnicity, route of administration and anatomical location.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1st dose administered to patient from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, a nurse had given 10 doses between 8AM - 12 PM on 01/Sep/2021 from a Moderna vial that expired she stated that it was a new vial that had never been opened. It had been moved into the refrigerator on 25/Aug/2021 (8 days prior).    Concomitant product use was not provided.  Treatment product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The significant followup was received on 7-SEP-2021 and contains Patient details, Vaccine facility information and Vaccine information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1st dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. Patient dose not have any adverse reaction   This case was linked to MOD-2021-305415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up document received and updated route of administration and anatomical location On 07-Sep-2021: Follow-up received and contains no significant information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Expired product administered, Muscle swelling, Peripheral swelling
Clinical narrative: Patient got a first dose from a vial 3 days after it's expiry date.; Swelling to left arm and leg; Swelling of buttock; Swelling to breast; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Swelling to left arm and leg), MUSCLE SWELLING (Swelling of buttock), BREAST SWELLING (Swelling to breast) and EXPIRED PRODUCT ADMINISTERED (Patient got a first dose from a vial 3 days after it's expiry date.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2011, Hyperlipidaemia since 2017, Hypothyroidism since 2011, Hormone level abnormal (Abnormal hormone), Drug allergy (Acetaminophen), Drug allergy (Ibuprofen), Drug allergy (Oxycodone) and Allergy (Glycol). Concomitant products included BROMOCRIPTINE MESILATE (PARLODEL) from 2011 to an unknown date for Hormone level abnormal, ATORVASTATIN from 2018 to an unknown date for Hyperlipidaemia, NIFEDIPINE and HYDROCHLOROTHIAZIDE (HYDROCHLORTHIAZID) from 2011 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) from 2011 to an unknown date for Thyroid disorder.    On 31-Aug-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a first dose from a vial 3 days after it's expiry date.). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling to left arm and leg), MUSCLE SWELLING (Swelling of buttock) and BREAST SWELLING (Swelling to breast). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient got a first dose from a vial 3 days after it's expiry date.) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling to left arm and leg), MUSCLE SWELLING (Swelling of buttock) and BREAST SWELLING (Swelling to breast) 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.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Reporter details updated, patient demographic details, allergic information, medical history updated, suspect drug route and site of administration updated, concomitant medication information updated, new concomitant medication hydrochlorothiazide, parlodel added, new event peripheral swelling, breast swelling and muscle swelling added.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Simply tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Simply tired) 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 FATIGUE (Simply tired). At the time of the report, FATIGUE (Simply tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 7:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Patient did not report any adverse event   This case was linked to MOD-2021-305415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Added relevant history, patient demographics and vaccine information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: she's feeling very sick; Chilling/ Shivering; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she's feeling very sick) and CHILLS (Chilling/ Shivering) 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 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced MALAISE (she's feeling very sick) and CHILLS (Chilling/ Shivering). At the time of the report, MALAISE (she's feeling very sick) and CHILLS (Chilling/ Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment medications provided.  Patient stated that she needs urgent care.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Were given doses of the Moderna COVID-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Were given doses of the Moderna COVID-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Were given doses of the Moderna Covid-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Were given doses of the Moderna COVID-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided by the reporter. Treatment medication was  not reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received includes no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Headache, Illness, Influenza like illness
Clinical narrative: Got really sick after 2nd vaccine; Swollen feet and ankles after 2nd vaccine; Malaise for 4-5 days after 2nd vaccine; Upset Stomach for 4-5 days after 2nd vaccine; Flu Like Symptoms for 4-5 days after 2nd vaccine; Pain in the Lymph node for 2 days after 2nd vaccine; Pain on the Injection site for 2 days after 2nd vaccine; Headache for 4-5 days after 2nd vaccine; Fever 101 F for 2 days after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine) and INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine) in a 62-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.     Concurrent medical conditions included Cardiac disorder NOS and Osteoarthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Got really sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine), INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine), LYMPH NODE PAIN (Pain in the Lymph node for 2 days after 2nd vaccine), VACCINATION SITE PAIN (Pain on the Injection site for 2 days after 2nd vaccine), HEADACHE (Headache for 4-5 days after 2nd vaccine) and PYREXIA (Fever 101 F for 2 days after 2nd vaccine). In April 2021, PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine), INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine), LYMPH NODE PAIN (Pain in the Lymph node for 2 days after 2nd vaccine), VACCINATION SITE PAIN (Pain on the Injection site for 2 days after 2nd vaccine), HEADACHE (Headache for 4-5 days after 2nd vaccine) and PYREXIA (Fever 101 F for 2 days after 2nd vaccine) had resolved. At the time of the report, ILLNESS (Got really sick after 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101 F.   No treatment information was provided Concomitant medications included Heart medications and Arthritis medications
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Malaise, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Got really sick after 2nd vaccine; Swollen feet and ankles after 2nd vaccine; Malaise for 4-5 days after 2nd vaccine; Upset Stomach for 4-5 days after 2nd vaccine; Flu Like Symptoms for 4-5 days after 2nd vaccine; Pain in the Lymph node for 2 days after 2nd vaccine; Pain on the Injection site for 2 days after 2nd vaccine; Headache for 4-5 days after 2nd vaccine; Fever 101 F for 2 days after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine) and INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine) in a 62-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.     Concurrent medical conditions included Cardiac disorder NOS and Osteoarthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Got really sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine), INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine), LYMPH NODE PAIN (Pain in the Lymph node for 2 days after 2nd vaccine), VACCINATION SITE PAIN (Pain on the Injection site for 2 days after 2nd vaccine), HEADACHE (Headache for 4-5 days after 2nd vaccine) and PYREXIA (Fever 101 F for 2 days after 2nd vaccine). In April 2021, PERIPHERAL SWELLING (Swollen feet and ankles after 2nd vaccine), MALAISE (Malaise for 4-5 days after 2nd vaccine), ABDOMINAL DISCOMFORT (Upset Stomach for 4-5 days after 2nd vaccine), INFLUENZA LIKE ILLNESS (Flu Like Symptoms for 4-5 days after 2nd vaccine), LYMPH NODE PAIN (Pain in the Lymph node for 2 days after 2nd vaccine), VACCINATION SITE PAIN (Pain on the Injection site for 2 days after 2nd vaccine), HEADACHE (Headache for 4-5 days after 2nd vaccine) and PYREXIA (Fever 101 F for 2 days after 2nd vaccine) had resolved. At the time of the report, ILLNESS (Got really sick after 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101 F.   No treatment information was provided Concomitant medications included Heart medications and Arthritis medications
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Scar, Vaccination site erythema
Clinical narrative: Arm red  raised; Arm  itchy raised; Faint outline; Injection site red, like a bullseye, Red mark; It itches a lot/itchy,raised/itched for two days; Raised mark/faint outline; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red, like a bullseye, Red mark), PRURITUS (It itches a lot/itchy,raised/itched for two days), SCAR (Raised mark/faint outline), ERYTHEMA (Arm red  raised) and PRURITUS (Arm  itchy raised) in a 63-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.     Concurrent medical conditions included Asthma since 01-Mar-1970, Epilepsy since 25-Jun-1968, Cholesterol and Blood pressure high. Concomitant products included ATENOLOL from 16-May-2000 to an unknown date for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR OD) from 18-Apr-2001 to an unknown date for Cholesterol, PHENOBARBITAL SODIUM (PHENOBARBITAL [PHENOBARBITAL SODIUM]) from 15-Sep-1999 to an unknown date and TOPIRAMATE (TOPAMAX) from 12-Feb-2001 to an unknown date for Epilepsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red, like a bullseye, Red mark), PRURITUS (It itches a lot/itchy,raised/itched for two days) and SCAR (Raised mark/faint outline). On 02-Sep-2021, the patient experienced ERYTHEMA (Arm red  raised), PRURITUS (Arm  itchy raised) and SCAR (Faint outline). On 28-Aug-2021, VACCINATION SITE ERYTHEMA (Injection site red, like a bullseye, Red mark) and PRURITUS (It itches a lot/itchy,raised/itched for two days) had resolved with sequelae. On 03-Sep-2021, ERYTHEMA (Arm red  raised) and PRURITUS (Arm  itchy raised) had resolved with sequelae, SCAR (Faint outline) had resolved. At the time of the report, SCAR (Raised mark/faint outline) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The consumer stated that one week after getting the shot, she woke up with the injection site red, like a bullseye. It itched for two days and cleared except there was a faint outline.   The consumer stated that one week later it happened again, but only lasted for a day and the faint outline for a day.   The consumer stated that her events resolved with Residual effects- Circle visible.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow up document was added and had significant information. Added events- Vaccination site erythema, Erythema, Pruritus, scar, concomitant medications. Updated Vaccine facility information, Events outcome, events start date and stop date, relevant history,Patient's demographic. On 07-Sep-2021: The follow up document was received and had no new information
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered 1 ml of the Moderna COVID-19 vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 EXTRA DOSE ADMINISTERED (Administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Administered 1 ml of the Moderna COVID-19 vaccine) had 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 reported.  No treatment information was reported by reporter.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Weak/ feeling weak; Bones are hurting all over the body; Hot to touch injection site (left arm); Swelling at injection site (left arm); Tender injection site (left arm); Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/ feeling weak), BONE PAIN (Bones are hurting all over the body), VACCINATION SITE WARMTH (Hot to touch injection site (left arm)), VACCINATION SITE SWELLING (Swelling at injection site (left arm)) and VACCINATION SITE PAIN (Tender injection site (left arm)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced ASTHENIA (Weak/ feeling weak), BONE PAIN (Bones are hurting all over the body), VACCINATION SITE WARMTH (Hot to touch injection site (left arm)), VACCINATION SITE SWELLING (Swelling at injection site (left arm)), VACCINATION SITE PAIN (Tender injection site (left arm)) and FATIGUE (Very tired). At the time of the report, ASTHENIA (Weak/ feeling weak), BONE PAIN (Bones are hurting all over the body), VACCINATION SITE WARMTH (Hot to touch injection site (left arm)), VACCINATION SITE SWELLING (Swelling at injection site (left arm)), VACCINATION SITE PAIN (Tender injection site (left arm)) and FATIGUE (Very tired) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Weak/ feeling weak; Bones are hurting all over the body; Hot to touch injection site (left arm); Swelling at injection site (left arm); Tender injection site (left arm); Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/ feeling weak), BONE PAIN (Bones are hurting all over the body), VACCINATION SITE WARMTH (Hot to touch injection site (left arm)), VACCINATION SITE SWELLING (Swelling at injection site (left arm)) and VACCINATION SITE PAIN (Tender injection site (left arm)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced ASTHENIA (Weak/ feeling weak), BONE PAIN (Bones are hurting all over the body), VACCINATION SITE WARMTH (Hot to touch injection site (left arm)), VACCINATION SITE SWELLING (Swelling at injection site (left arm)), VACCINATION SITE PAIN (Tender injection site (left arm)) and FATIGUE (Very tired). At the time of the report, ASTHENIA (Weak/ feeling weak), BONE PAIN (Bones are hurting all over the body), VACCINATION SITE WARMTH (Hot to touch injection site (left arm)), VACCINATION SITE SWELLING (Swelling at injection site (left arm)), VACCINATION SITE PAIN (Tender injection site (left arm)) and FATIGUE (Very tired) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a 28-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported Treatment medication were not reported    This case was linked to MOD-2021-306220 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Ear pain, Glossitis, Swollen tongue
Clinical narrative: Irritation with my tongue; My both inner ear are aching, happens when I swallow; Dry mouth; Swelling with my tongue on right side; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSITIS (Irritation with my tongue), EAR PAIN (My both inner ear are aching, happens when I swallow), DRY MOUTH (Dry mouth), SWOLLEN TONGUE (Swelling with my tongue on right side) and DYSPNOEA (Shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 043L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), ROSUVASTATIN CALCIUM (CRESTOR), FUROSEMIDE, FLUOCINONIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), DABIGATRAN ETEXILATE MESILATE (PRADAXA), LISINOPRIL, PROMETHAZINE, EZETIMIBE and GABAPENTIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced GLOSSITIS (Irritation with my tongue), EAR PAIN (My both inner ear are aching, happens when I swallow), DRY MOUTH (Dry mouth), SWOLLEN TONGUE (Swelling with my tongue on right side) and DYSPNOEA (Shortness of breath). At the time of the report, GLOSSITIS (Irritation with my tongue), EAR PAIN (My both inner ear are aching, happens when I swallow), DRY MOUTH (Dry mouth), SWOLLEN TONGUE (Swelling with my tongue on right side) and DYSPNOEA (Shortness of breath) had not resolved.            It was reported that patient discontinued medication lisinopril, promethazine, ezetimibe and gabapentin on advise by PCP which did not help much. Patient took allergy test on an unknown date which came back positive for many environmental allergies.  Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: arm was red; right fingers was swollen; fingers still/stiff back/left fingers were stiff; arm was red and sore/arm was a little sore; nauseas; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005621A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired). On 23-Aug-2021, the patient experienced ERYTHEMA (arm was red) and PERIPHERAL SWELLING (right fingers was swollen). At the time of the report, ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm was red; right fingers was swollen; fingers still/stiff back/left fingers were stiff; arm was red and sore/arm was a little sore; nauseas; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005621A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired). On 23-Aug-2021, the patient experienced ERYTHEMA (arm was red) and PERIPHERAL SWELLING (right fingers was swollen). At the time of the report, ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick for 3 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for 3 days after first dose) in a 72-year-old male 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 (Got sick for 3 days after first dose). At the time of the report, ILLNESS (Got sick for 3 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  The patient received first dose of vaccine 3 weeks ago from tomorrow and was scheduled for his second dose after 1 week from tomorrow.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Peripheral arterial occlusive disease
Clinical narrative: Muscle pain; Peripheral artery disease; Could not put my foot down because it felt as if I were stepping on broken glass; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Peripheral artery disease), LIMB DISCOMFORT (Could not put my foot down because it felt as if I were stepping on broken glass) and MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Peripheral artery disease) and LIMB DISCOMFORT (Could not put my foot down because it felt as if I were stepping on broken glass). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Peripheral artery disease) and MYALGIA (Muscle pain) outcome was unknown and LIMB DISCOMFORT (Could not put my foot down because it felt as if I were stepping on broken glass) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  At the time of hospital visit her left leg had no pulse at one point.  Patient had multiple tests including CT Scan and doppler of the right and left leg but the results were unspecified.   Patient refused to take the medications and does not took any medication drug or alcohol.  Patient did exercises and her foot has improved.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Administered 1 ml of the Moderna COVID-19 vaccine) in a 26-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced OVERDOSE (Administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, OVERDOSE (Administered 1 ml of the Moderna COVID-19 vaccine) had 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.   Pharmacist didn't mentioned any side effect.  No concomitant product information was provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills; Minor body aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of CHILLS (Chills), MYALGIA (Minor body aches), HEADACHE (Headache) and the first episode of CHILLS (Chills) 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 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced HEADACHE (Headache) and the first episode of CHILLS (Chills). On 02-Sep-2021, the patient experienced the second episode of CHILLS (Chills) and MYALGIA (Minor body aches). On 01-Sep-2021, HEADACHE (Headache) had resolved. At the time of the report, last episode of CHILLS (Chills) and MYALGIA (Minor body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: eyelid twitching; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eyelid twitching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 BLEPHAROSPASM (eyelid twitching). At the time of the report, BLEPHAROSPASM (eyelid twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and  treatment medication was reported by patient.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore left injection site arm.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o23M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore left injection site arm.). At the time of the report, PAIN IN EXTREMITY (A sore left injection site arm.) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. No concomitant and treatment medications were given. No patient past history were provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Folow up received on 03-SEP-2021 lab data has been updated.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered more than 12 hours after initial puncture; Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours after initial puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021 at 2:58 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 11:05 AM, the patient experienced PRODUCT STORAGE ERROR (Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM). On 02-Sep-2021 at 2:58 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours after initial puncture). On 02-Sep-2021 at 2:58 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours after initial puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 01-Sep-2021 at 11:05 AM/dose was administered on 02-Sep-2021 at 2:58 PM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The reporter stated that a pharmacy intern had administered an expired dose to the patient. The vial was initially stored in the fridge on 30-Aug-2021. It did not undergo any previous temperature excursion. The total amount of time spent at room temperature was 20 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated correspondence contact box, patient initials and gender. On 07-Sep-2021: Follow up contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Full blood count, Full blood count abnormal, Polycythaemia, Red blood cell count
Clinical narrative: is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells; I am  having issues with my blood counts since the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of POLYCYTHAEMIA (is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells) and BLOOD COUNT ABNORMAL (I am  having issues with my blood counts since the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYCYTHAEMIA (is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells) and BLOOD COUNT ABNORMAL (I am  having issues with my blood counts since the vaccine). At the time of the report, POLYCYTHAEMIA (is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells) and BLOOD COUNT ABNORMAL (I am  having issues with my blood counts since the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: abnormal (abnormal) issues with blood counts. On an unknown date, Red blood cell count: increased (High) many red blood cells.     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 medication was reported.