chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 antibody test negative, Tongue discomfort
Clinical narrative: It feels like "long COVID"- still having side effects for weeks to months; difficulty concentrating/issues focusing; dizziness; memory issues/wooziness; balancing issues; Numbness in face; burning sensation in the tongue; difficulty articulating; fogginess; fatigue; have not got the 2nd shot; the whole left side was numb/got some numbness on the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness) and BALANCE DISORDER (balancing issues) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm). On an unknown date, the patient experienced MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess), FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot). At the time of the report, MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess) and FATIGUE (fatigue) had not resolved, HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm) was resolving and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) The MRI is normal. On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) has no antibodies, has not contracted COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter was reported that he was experienced side effects are all intermittent and been suffering for about 2 months Reporter reported as  side effects at variant degrees of severity Concomitant medications includes Vitamins and Minerals.  On 09-Aug-2021, the whole left side was numb.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little bit of arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of arm ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer stage IV (terminal cancer patient).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of arm ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little bit of arm ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was on several medications but did not mention them.   The patient received vaccine in unknown arm.   This case was linked to MOD-2021-326213 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Migraine, Myalgia, Pain of skin
Clinical narrative: Raised dry lumps on scalp after second shot; Itchy scalp constantly after second shot; Pain in scalp constantly after second shot; Rash spots on the scalp spread more after second shot; Fever >101.2F after second shot; Chills after second shot; Aches entire body after second shot; Very ill after second shot; Migraine headache after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill after second shot), MIGRAINE (Migraine headache after second shot), SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot) and PAIN OF SKIN (Pain in scalp constantly after second shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Very ill after second shot), MIGRAINE (Migraine headache after second shot), PYREXIA (Fever >101.2F after second shot) and CHILLS (Chills after second shot). 07-Sep-2021, the patient experienced MYALGIA (Aches entire body after second shot). On 08-Sep-2021, the patient experienced SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot), PAIN OF SKIN (Pain in scalp constantly after second shot) and RASH (Rash spots on the scalp spread more after second shot). On 09-Sep-2021, ILLNESS (Very ill after second shot), PYREXIA (Fever >101.2F after second shot), CHILLS (Chills after second shot) and MYALGIA (Aches entire body after second shot) had resolved. On 14-Sep-2021, MIGRAINE (Migraine headache after second shot) had resolved. At the time of the report, SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot) and RASH (Rash spots on the scalp spread more after second shot) outcome was unknown and PAIN OF SKIN (Pain in scalp constantly after second shot) had resolved.             No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-326169 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin irritation
Clinical narrative: Raised dry lumps on scalp after second shot; Itchy scalp constantly after second shot; Pain in scalp constantly after second shot; Rash spots on the scalp spread more after second shot; Fever >101.2F after second shot; Chills after second shot; Aches entire body after second shot; Very ill after second shot; Migraine headache after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill after second shot), MIGRAINE (Migraine headache after second shot), SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot) and PAIN OF SKIN (Pain in scalp constantly after second shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Very ill after second shot), MIGRAINE (Migraine headache after second shot), PYREXIA (Fever >101.2F after second shot) and CHILLS (Chills after second shot). 07-Sep-2021, the patient experienced MYALGIA (Aches entire body after second shot). On 08-Sep-2021, the patient experienced SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot), PAIN OF SKIN (Pain in scalp constantly after second shot) and RASH (Rash spots on the scalp spread more after second shot). On 09-Sep-2021, ILLNESS (Very ill after second shot), PYREXIA (Fever >101.2F after second shot), CHILLS (Chills after second shot) and MYALGIA (Aches entire body after second shot) had resolved. On 14-Sep-2021, MIGRAINE (Migraine headache after second shot) had resolved. At the time of the report, SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot) and RASH (Rash spots on the scalp spread more after second shot) outcome was unknown and PAIN OF SKIN (Pain in scalp constantly after second shot) had resolved.             No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-326169 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.   No concomitant medication was reported.  No treatment medication use was reported.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Aching; Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (Aching) and INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 (Aching) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PAIN (Aching) and INFLUENZA LIKE ILLNESS (Flu like symptoms) 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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: It makes most people sick; I know people that has gotten worse than me, the side effects of this drug are terrible.; 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 ILLNESS (It makes most people sick) and VACCINATION COMPLICATION (I know people that has gotten worse than me, the side effects of this drug are terrible.) 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 ILLNESS (It makes most people sick) and VACCINATION COMPLICATION (I know people that has gotten worse than me, the side effects of this drug are terrible.). At the time of the report, ILLNESS (It makes most people sick) and VACCINATION COMPLICATION (I know people that has gotten worse than me, the side effects of this drug are terrible.) 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 provided.  No treatment medication was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Felt like I was going to catch the flu; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I was going to catch the flu) and PAIN (Body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I was going to catch the flu) and PAIN (Body aches). On 05-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like I was going to catch the flu) and PAIN (Body aches) had resolved.            No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Additional information received and patient demographics were updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nodule, Vaccination site mass
Clinical narrative: Did not feel well; Lump on the arm where he got the shot; A little nodule (which maybe a lymph node) on his right temple in front of his ear; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (A little nodule (which maybe a lymph node) on his right temple in front of his ear), MALAISE (Did not feel well) and VACCINATION SITE MASS (Lump on the arm where he got the shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21, 013L20A and 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Did not feel well). In September 2021, the patient experienced NODULE (A little nodule (which maybe a lymph node) on his right temple in front of his ear) and VACCINATION SITE MASS (Lump on the arm where he got the shot). In September 2021, MALAISE (Did not feel well) had resolved. At the time of the report, NODULE (A little nodule (which maybe a lymph node) on his right temple in front of his ear) and VACCINATION SITE MASS (Lump on the arm where he got the shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Patient  did not feel well and this lasted for a day or so. 2-3 days after he noticed a lump on the arm where he got the shot and a little nodule (which maybe a lymph node) on his right temple in front of his ear.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered less than 25 days after the first one; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered less than 25 days after the first one) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered less than 25 days after the first one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered less than 25 days after the first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment Drug was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) 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 information was provided   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up information received on 23SEP 2021 contains Non- Significant  information.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was reported.  No treatment medication was reported.  The patient wants to know about the  booster shot of Moderna COVID-19 vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: Mini-flu; Headache; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Mini-flu), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Mini-flu), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, INFLUENZA (Mini-flu), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.      No concomitant medication were reported.  No treatment information was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine Facility type was health clinic.  No Concomitant medication was reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Updated patient initials. Added patient demographic include Updated Gender, Race information, Ethnic group. Updated Vaccine Facility Information.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain, Vision blurred
Clinical narrative: pain from head to the back; blurred vision; I'm in pain; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (pain from head to the back), VISION BLURRED (blurred vision) and PAIN (I'm in pain) 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 21-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain from head to the back), VISION BLURRED (blurred vision) and PAIN (I'm in pain). At the time of the report, BACK PAIN (pain from head to the back), VISION BLURRED (blurred vision) and PAIN (I'm in pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up for the past day; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up for the past day) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 049E21A) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced VOMITING (throwing up for the past day). At the time of the report, VOMITING (throwing up for the past day) outcome was unknown.            No concomitant medications reported.  No treatment medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Vaccine of Moderna COVID-19 Vaccine; 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 (Received Expired Vaccine of Moderna COVID-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine of Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose came from a vial that was more than 30 days on the fridge; Dose came from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose came from a vial that was more than 30 days on the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose came from a vial that was more than 30 days on the fridge) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021 at 1:18 PM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Dose came from a vial that was more than 30 days on the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose came from a vial that was more than 30 days on the fridge). On 21-Sep-2021, PRODUCT STORAGE ERROR (Dose came from a vial that was more than 30 days on the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose came from a vial that was more than 30 days on the fridge) 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 drug details were provided.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up received included :Patient demographics updated(Race & Ethnicity).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the expiration/beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-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 EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant  and treatment medications were not provided. The went straight from freezer to thawed on 21-Sep-2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot at the injection site; big rash at the injection site; deep red at the injection site; a bit swollen at the injection site; incorrect schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PAIN (big rash at the injection site), VACCINATION SITE ERYTHEMA (deep red at the injection site), VACCINATION SITE SWELLING (a bit swollen at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule of vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 011620A and 012M20A) 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 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule of vaccine). On 21-Sep-2021, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PAIN (big rash at the injection site) and VACCINATION SITE ERYTHEMA (deep red at the injection site). 21-Sep-2021, the patient experienced VACCINATION SITE SWELLING (a bit swollen at the injection site). At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PAIN (big rash at the injection site), VACCINATION SITE ERYTHEMA (deep red at the injection site) and VACCINATION SITE SWELLING (a bit swollen at the injection site) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule of vaccine) had resolved.            Patient got the flu shot the same day  as the 3rd dose but in her right arm and did not experience a reaction in that arm. No concomitant and treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Product dose omission issue, Vaccination complication
Clinical narrative: Side effects reactions; Allergic reaction; Missed Dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects reactions), HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed Dose) 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 reactions), HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed Dose). The patient was treated with EPINEPHRINE (EPIPEN) for Allergic reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Side effects reactions), HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. The patient experienced a severe allergic reaction after receiving the Moderna vaccine. After 18 min of vaccination the medical personnel of a health department had to apply an EpiPen to shut down the allergic reaction.The patient returned they recommended her not to take the second shoot and go for of of Johnson&Johnson.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Upon follow-up receipt: Event added.
Sex: F
Vaccine: COVID19
Symptoms: Discharge, Feeling hot, Infection, Muscle spasms, Pruritus
Clinical narrative: cramps; possible bacterial or yeast infection; discharge; arm itching; arm feeling like fire; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching), FEELING HOT (arm feeling like fire), MUSCLE SPASMS (cramps), INFECTION (possible bacterial or yeast infection) and DISCHARGE (discharge) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (arm itching) and FEELING HOT (arm feeling like fire). In May 2021, the patient experienced MUSCLE SPASMS (cramps), INFECTION (possible bacterial or yeast infection) and DISCHARGE (discharge). At the time of the report, PRURITUS (arm itching), FEELING HOT (arm feeling like fire), MUSCLE SPASMS (cramps), INFECTION (possible bacterial or yeast infection) and DISCHARGE (discharge) outcome was unknown.            Concomitant medications were not provided. Treatment medication includes Vaginal gel as treatment.  After the second dose, the patient reported her arm itching and feeling like fire. Patient reports in May experiencing cramps, discharge and possible bacterial or yeast infection still waiting for results from her doctor.No concomitant medication were given by reporter.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage patient received the first Moderna dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received the first Moderna dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received the first Moderna dose). On 23-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received the first Moderna dose) 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.   Concomitant medication use was unknown Treatment information was unknown
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (his arms "go numb") and decreased libido ("his sex drive has depleted") in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (his arms "go numb") and decreased libido ("his sex drive has depleted"). At the time of the report, hypoesthesia (his arms "go numb") and decreased libido ("his sex drive has depleted") outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hypoaesthesia, Increased appetite, Libido decreased, Ovulation disorder
Clinical narrative: Not ovulating; Sex drive has depleted; Gained 20 pounds; Feet started to feel numb; Had more appetite; "not normal period"/not as heavy as usual/not having period for 3 months/period is gone; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone), OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds) and HYPOAESTHESIA (Feet started to feel numb) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for Headache.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone). On an unknown date, the patient experienced OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds), HYPOAESTHESIA (Feet started to feel numb) and INCREASED APPETITE (Had more appetite). At the time of the report, AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone), OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds), HYPOAESTHESIA (Feet started to feel numb) and INCREASED APPETITE (Had more appetite) outcome was unknown.            No treatment medications were reported.  The patient stated that before vaccination as the patient "was on a weight lost thing" and also stated she was very concerned and upset.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Not ovulating; Sex drive has depleted; Gained 20 pounds; Feet started to feel numb; Had more appetite; "not normal period"/not as heavy as usual/not having period for 3 months/period is gone; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone), OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds) and HYPOAESTHESIA (Feet started to feel numb) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for Headache.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone). On an unknown date, the patient experienced OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds), HYPOAESTHESIA (Feet started to feel numb) and INCREASED APPETITE (Had more appetite). At the time of the report, AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone), OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds), HYPOAESTHESIA (Feet started to feel numb) and INCREASED APPETITE (Had more appetite) outcome was unknown.            No treatment medications were reported.  The patient stated that before vaccination as the patient "was on a weight lost thing" and also stated she was very concerned and upset.