chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) 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.  28 doses of vaccine were administered on 18OCT2021 after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) 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 PARAESTHESIA (Tingling sensation). At the time of the report, PARAESTHESIA (Tingling sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided   This case was linked to MOD-2021-357985 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (Feeling really crappy/feeling overwhelmed) and MALAISE (Feeling really sick) 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 FEELING ABNORMAL (Feeling really crappy/feeling overwhelmed) and MALAISE (Feeling really sick). At the time of the report, FEELING ABNORMAL (Feeling really crappy/feeling overwhelmed) and MALAISE (Feeling really sick) 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 provided. No treatment medications were provided.  Reporters husband said that his company reported multiple people feeling sick after taking the vaccine but not specified the company.   This case was linked to MOD-2021-357737 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin, Blood creatine, IgA nephropathy, Pericarditis, Protein urine
Clinical narrative: IgA nephropathy; Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy) in a 66-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 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 IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant). an unknown date, the patient experienced PERICARDITIS (Pericarditis). The patient was treated with PREDNISONE for Pericarditis, at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 4.1 g/dl serum albumin 4.1 g/dl. On an unknown date, Blood creatine: normal (normal) baseline SCr 1.1(mg/dl), 1.5 g/dl SCr 1.5(g/dl) and 1.4  g/dl SCr 1.4(g/dl). On an unknown date, Protein urine: 1.2 g/d 1.2 g/d and 0.3 g/d 0.3 g/d. On an unknown date, Red blood cells urine: 51-100 (/hpf) 51-100 (/HPF) and 3  10 (/hpf) 3  10 (/HPF).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) to be possibly related.    Patient responded to Prednisone treatment  Follow up time was reported as 5 months  Presenting symptom included Gross Hematuria  Concomitant product use was not provided by the reporter.    Company Comment: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine.  The rechallenge was not applicable since only information about the first dose was disclosed  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-357261, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety on 22-Oct-2021 included an Email with Agency received from team and does not contain any new information; Sender's Comments: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine.  The rechallenge was not applicable since only information about the first dose was disclosed  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cells urine
Clinical narrative: IgA nephropathy; Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy) in a 66-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 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 IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant). an unknown date, the patient experienced PERICARDITIS (Pericarditis). The patient was treated with PREDNISONE for Pericarditis, at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 4.1 g/dl serum albumin 4.1 g/dl. On an unknown date, Blood creatine: normal (normal) baseline SCr 1.1(mg/dl), 1.5 g/dl SCr 1.5(g/dl) and 1.4  g/dl SCr 1.4(g/dl). On an unknown date, Protein urine: 1.2 g/d 1.2 g/d and 0.3 g/d 0.3 g/d. On an unknown date, Red blood cells urine: 51-100 (/hpf) 51-100 (/HPF) and 3  10 (/hpf) 3  10 (/HPF).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) to be possibly related.    Patient responded to Prednisone treatment  Follow up time was reported as 5 months  Presenting symptom included Gross Hematuria  Concomitant product use was not provided by the reporter.    Company Comment: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine.  The rechallenge was not applicable since only information about the first dose was disclosed  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-357261, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety on 22-Oct-2021 included an Email with Agency received from team and does not contain any new information; Sender's Comments: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine.  The rechallenge was not applicable since only information about the first dose was disclosed  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment medications provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-357638, MOD21-144365 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-357638:mother case MOD21-144365:mother dose 1 case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The dose was administered to the patient after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants are provided No treatments are provided.  The caller had a vaccine documented as expiring in November but the system had the lot number incorrect by one letter. The actual expiry date was October 10th 2021. Lot: 006C21A
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; Post Vaccination caught Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Post Vaccination caught Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B01A and 012A21) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced COVID-19 (Post Vaccination caught Covid-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Post Vaccination caught Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive Positive.         No concomitant medication information was provided. No treatment product information was provided.   Patient tested positive for Covid-19 two weeks ago Monday.3OCT2021. Patient was not hospitalized.; Sender's Comments: This is a spontaneous case concerning a 68 -year-old  male patient with no relevant medical  history reported who experienced  The non serious and AESI event of COVID-19 approximately 6 month after the second dose of a proper vaccination schedule with spikevax. Additional event of drug ineffective was added. Rechallenge is not applicable for these events. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Paraesthesia, Vaccination site pain
Clinical narrative: tingling sensation on her left knee down and her left elbow down/tingling on her right side; a little bit of tiredness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side), VACCINATION SITE PAIN (sore arm) and FATIGUE (a little bit of tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Sep-2021, the patient experienced FATIGUE (a little bit of tiredness). On 06-Oct-2021, the patient experienced PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side). On 08-Oct-2021, PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (a little bit of tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) patient was told that she was perfect..     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 was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after use date/Expired vaccine given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given) 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.  It was reported that the HCP was trying to figure out whether the patient should be re-administered with another dose. The HCP did not know if the vial had undergone any temperature excursions and regarding date of vial initially stored in the refrigerator.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Brugada syndrome, Electrocardiogram, Loss of consciousness
Clinical narrative: Patient blacked out, twice, and had to go to the Emergency Room; Patient's EKG test results presented Brugada; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) (seriousness criterion medically significant) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, Electrocardiogram: abnormal (abnormal) results presented Brugada.     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 listed. No treatment information provided.  Company Comment : This case concerns a 56-year-old male patient with no reported medical history who experienced the unexpected event of loss of consciousness and Brugada syndrome. The event occurred 1day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The rechallenge was nunknoen as details pertaining to second dose was not disclosed. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The event was assessed as serious per regulatory authority reporting.  Both events are important medical events; Sender's Comments: This case concerns a 56-year-old male patient with no reported medical history who experienced the unexpected event of loss of consciousness and Brugada syndrome. The event occurred 1day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The rechallenge was nunknoen as details pertaining to second dose was not disclosed. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The event was assessed as serious per regulatory authority reporting.  Both events are important medical events
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). In October 2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  The vaccine was administered to an unknown number of patients over the weekend (16-Oct-2021 to 17-Oct-2021).  The vaccine was only moved from  the freezer to the refrigerator 2 weeks ago
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients; 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 EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients). In October 2021, EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The dates of administration of vaccine are 15-Oct-2021 to 8 or 9 patient and 18-Oct-2021 to 8 or 9 patient.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (she was diagnosed with lymphoma in perhaps in February2021/March 2021.) since 2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) outcome was unknown.            Concomitant medications not reported by the reporter.   This case was linked to MOD-2021-357742 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Bone pain, Chills, Fear of death, Head discomfort
Clinical narrative: every bone in my body was hurting/my face bones hurt; my skull hurt; I thought I was going to die; I hurt so much I couldn't talk; violent chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk) and CHILLS (violent chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-357771 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: every bone in my body was hurting/my face bones hurt; my skull hurt; I thought I was going to die; I hurt so much I couldn't talk; violent chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk) and CHILLS (violent chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-357771 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product dose omission issue
Clinical narrative: may have only received one COVID-19 dose; caller thinks 1st dose Moderna, 2nd dose Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer) 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 PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer) had resolved.            Patient thinks she received Moderna for the first dose and Pfizer for the second dose but is unsure. Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Restless legs syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Leg cramps) 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 RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Leg cramps). At the time of the report, RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 032L20A.) for COVID-19 vaccination.     The patient's past medical history included Surgery (Abdominal surgery) on 19-Aug-2021. Previously administered products included for Influenza immunisation: flu shot (Patient was reported to take the flu shot after the abdominal surgery).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 26-Feb-2021, PYREXIA (Fever) had resolved.            No concomitant medications were reported.  No treatment information was reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot on head and eyebrows) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced RASH MACULAR (Red spot on head and eyebrows). At the time of the report, RASH MACULAR (Red spot on head and eyebrows) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient confirmed it was not itching or burning and it was just there. There were no pre-existing condition and no allergic to many medications or food.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient did not report any symptoms or received any known treatments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had a sore right arm after each dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a sore right arm after each dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer. Concomitant products included PALBOCICLIB (IBRANCE) and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He had a sore right arm after each dose). At the time of the report, PAIN IN EXTREMITY (He had a sore right arm after each dose) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-358000 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: She never had a heart problem before and after the vaccine she started having them.; shortness of breath; fast heartbeat; getting dizzy in the mornings when she was getting up; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (She never had a heart problem before and after the vaccine she started having them.), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat) and DIZZINESS (getting dizzy in the mornings when she was getting up) in a 69-year-old female patient 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 CARDIAC DISORDER (She never had a heart problem before and after the vaccine she started having them.), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat) and DIZZINESS (getting dizzy in the mornings when she was getting up). At the time of the report, CARDIAC DISORDER (She never had a heart problem before and after the vaccine she started having them.), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat) and DIZZINESS (getting dizzy in the mornings when she was getting up) had resolved.            Concomitant medication use was unknown. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Therapeutic response unexpected
Clinical narrative: No longer has recurring pain in the shoulder/90% reduction in pain; Fever for 24 hours after vaccination; Chills for 24 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (No longer has recurring pain in the shoulder/90% reduction in pain), PYREXIA (Fever for 24 hours after vaccination) and CHILLS (Chills for 24 hours after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shoulder pain (recurring pain in the shoulder).   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 THERAPEUTIC RESPONSE UNEXPECTED (No longer has recurring pain in the shoulder/90% reduction in pain). On an unknown date, the patient experienced PYREXIA (Fever for 24 hours after vaccination) and CHILLS (Chills for 24 hours after vaccination). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (No longer has recurring pain in the shoulder/90% reduction in pain) outcome was unknown and PYREXIA (Fever for 24 hours after vaccination) and CHILLS (Chills for 24 hours after vaccination) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had a sore right arm after each dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a sore right arm after each dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient is a cancer survivor). Concurrent medical conditions included Immunocompromised. Concomitant products included PALBOCICLIB (IBRANCE) and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He had a sore right arm after each dose). At the time of the report, PAIN IN EXTREMITY (He had a sore right arm after each dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-357979, MOD-2021-358010 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: He had a sore right arm after each dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a sore right arm after each dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (he is a cancer survivor). Concurrent medical conditions included Immunocompromised. Concomitant products included PALBOCICLIB (IBRANCE) and ANASTROZOLE (Anastrazole) for Cancer.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (He had a sore right arm after each dose). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (He had a sore right arm after each dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-358000, MOD-2021-357979 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EXPIRED PRODUCT ADMINISTERED (Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours) 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 medication was mentioned. No treatment medication was mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-358137 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: felt crappy; had cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt crappy) and NASOPHARYNGITIS (had cold symptoms) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt crappy) and NASOPHARYNGITIS (had cold symptoms). At the time of the report, MALAISE (felt crappy) and NASOPHARYNGITIS (had cold symptoms) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-358069 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-358220 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Felt crappy; had cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt crappy) and NASOPHARYNGITIS (had cold symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt crappy) and NASOPHARYNGITIS (had cold symptoms). At the time of the report, MALAISE (Felt crappy) and NASOPHARYNGITIS (had cold symptoms) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-358185 (Patient Link).