chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme, Hypersensitivity, Rash
Clinical narrative: The rash looks like erthema multiforme, with no oral lesions, or skin peeling; Patient developed a delayed rash from her neck down throughout her body; Allergic reaction; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA MULTIFORME (The rash looks like erthema multiforme, with no oral lesions, or skin peeling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced ERYTHEMA MULTIFORME (The rash looks like erthema multiforme, with no oral lesions, or skin peeling) (seriousness criterion medically significant), RASH (Patient developed a delayed rash from her neck down throughout her body) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, ERYTHEMA MULTIFORME (The rash looks like erthema multiforme, with no oral lesions, or skin peeling), RASH (Patient developed a delayed rash from her neck down throughout her body) and HYPERSENSITIVITY (Allergic reaction) outcome 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.  Company Comment: This case concerns a 76-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of erythema multiforme and other associated expected, non-serious events. The events occurred 4 days after administration of the booster dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up document contains new serious event, dose details, reporter details and patient details were updated.; Sender's Comments: This case concerns a 76-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of erythema multiforme and other associated expected, non-serious events. The events occurred 4 days after administration of the booster dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Potential preparation error of doses administered to patients; 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Potential preparation error of doses administered to patients) 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 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Potential preparation error of doses administered to patients). On 29-Oct-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Potential preparation error of doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  Pharmacist left the needle in the vial and and drew up 4 doses from that one needle by attaching the syringes to the one needle to draw up the dose and then re-attaching another needle to administer the dose to 4 patients.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Additional information received and reporter information updated On 09-Nov-2021: Non-Significant Follow up contains no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Feeling abnormal, Mobility decreased, Myalgia
Clinical narrative: on bed all day; could not move; it was so painful; his body was just like "owww",felt like a caterpillar machine ran over him; left hand felt like it was going to fall out from the pain; Joints in pain; Whole body was aching; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him) and PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 031M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him), PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain), ARTHRALGIA (Joints in pain) and MYALGIA (Whole body was aching). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him), PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain), ARTHRALGIA (Joints in pain) and MYALGIA (Whole body was aching) had resolved.            No Concomitant medication were reported.   This case was linked to MOD-2021-377214, MOD-2021-377282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Events (Bedridden, Mobility decreased, Pain in extremity, Arthralgia) added. On 10-Nov-2021: Events (Feeling abnormal) (Pain) added. Events outcome were updated. On 10-Nov-2021: Follow-up contains No New Information
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: on bed all day; could not move; it was so painful; his body was just like "owww",felt like a caterpillar machine ran over him; left hand felt like it was going to fall out from the pain; Joints in pain; Whole body was aching; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him) and PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 031M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him), PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain), ARTHRALGIA (Joints in pain) and MYALGIA (Whole body was aching). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him), PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain), ARTHRALGIA (Joints in pain) and MYALGIA (Whole body was aching) had resolved.            No Concomitant medication were reported.   This case was linked to MOD-2021-377214, MOD-2021-377282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Events (Bedridden, Mobility decreased, Pain in extremity, Arthralgia) added. On 10-Nov-2021: Events (Feeling abnormal) (Pain) added. Events outcome were updated. On 10-Nov-2021: Follow-up contains No New Information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient received a dose after the vial was punctured more than 20 times.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (Patient received a dose after the vial was punctured more than 20 times.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 026A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT PREPARATION ERROR (Patient received a dose after the vial was punctured more than 20 times.). On 08-Nov-2021, PRODUCT PREPARATION ERROR (Patient received a dose after the vial was punctured more than 20 times.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non-Significant follow up, contact information updated.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the expired vaccine was administered to 36 patients and wanted to know if the dose administered was good or if they would need to re vaccinate. On 08-Nov-2021, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  No concomitant drugs were reported. No treatment drugs were reported.   This case was linked to MODERNATX, INC.-MOD-2021-383189 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up includes patient and dose information. On 12-Nov-2021: Follow up received contains NNI.; Sender's Comments: MODERNATX, INC.-MOD-2021-383189:master case
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased
Clinical narrative: physical exam on 01Oct2021 that showed an elevated platelet count; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (physical exam on 01Oct2021 that showed an elevated platelet count) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced PLATELET COUNT INCREASED (physical exam on 01Oct2021 that showed an elevated platelet count). At the time of the report, PLATELET COUNT INCREASED (physical exam on 01Oct2021 that showed an elevated platelet count) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Platelet count: elevated platelet count (High) elevated platelet count.         No concomitant medications were reported. No treatment information was provided. Patient and parent are worried this may be contraindicated for the booster dose and their HCP instructed them to look at the CDC website patient is having difficulties to find the information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of 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 (Administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No adverse events experienced by the patient On 14-Oct-2021 the vial was initially stored in the refrigerator   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Additional information received and has no events reported for experienced vaccine On 12-Nov-2021: Follow up received and contains no new information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia
Clinical narrative: she get very ill; Little achy; A little feverish; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she get very ill), PAIN (Little achy) and PYREXIA (A little feverish) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Bedridden (bed bound) and Housebound. Concurrent medical conditions included Myalgic encephalomyelitis, Connective tissue disorder, Immunodeficiency, IgM decreased (lack of IgM) and Neuropathy peripheral (hardly any peripheral nerve left, severe amount of auto neuropathy). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (she get very ill), PAIN (Little achy) and PYREXIA (A little feverish). At the time of the report, ILLNESS (she get very ill), PAIN (Little achy) and PYREXIA (A little feverish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-380774, MOD-2021-380841 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Wrong technique in product usage process
Clinical narrative: 1 vial was thawed out 9Oct2021 and then was punctured and put back in freezer; patient receiving expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; 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 (patient receiving expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial was thawed out 9Oct2021 and then was punctured and put back in freezer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient receiving expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial was thawed out 9Oct2021 and then was punctured and put back in freezer). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient receiving expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial was thawed out 9Oct2021 and then was punctured and put back in freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2 patients were administered a first dose on 9Oct2021. 1 patient given 2nd dose 4Nov2021. Concomitant medications was not reported. Treatment medications was not reported. This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: follow up 10-nov-21 contain no new information On 15-Nov-2021: Follow up received included,reporter information ,suspect drug and event  information was updated.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling cold, Headache
Clinical narrative: felt cold; feeling tired; Joint pain; Nauseated; Headache; fever at 101.2degF; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), FATIGUE (feeling tired), ARTHRALGIA (Joint pain), NAUSEA (Nauseated) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 010M20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021 at 1:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced FEELING COLD (felt cold), FATIGUE (feeling tired), ARTHRALGIA (Joint pain), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (fever at 101.2degF) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Joint pain, at an unspecified dose and frequency. At the time of the report, FEELING COLD (felt cold), FATIGUE (feeling tired), ARTHRALGIA (Joint pain), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (fever at 101.2degF) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: high (High) 101.2 degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient was under observation for too much protein in blood and that she was not on any medication.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: felt cold; feeling tired; Joint pain; Nauseated; Headache; fever at 101.2degF; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), FATIGUE (feeling tired), ARTHRALGIA (Joint pain), NAUSEA (Nauseated) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 010M20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021 at 1:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced FEELING COLD (felt cold), FATIGUE (feeling tired), ARTHRALGIA (Joint pain), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (fever at 101.2degF) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Joint pain, at an unspecified dose and frequency. At the time of the report, FEELING COLD (felt cold), FATIGUE (feeling tired), ARTHRALGIA (Joint pain), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (fever at 101.2degF) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: high (High) 101.2 degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient was under observation for too much protein in blood and that she was not on any medication.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 Doses administered beyond the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2000. Concomitant products included LOSARTAN from 2000 to an unknown date for an unknown indication.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.  Patient received the booster dose on 08-Nov-2021.  Patient stated from the three people she heard from there was no adverse event.   This case was linked to MOD-2021-381182, MOD-2021-381177 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up. Information captured in I narative On 12-Nov-2021: follow-up received on 12-Nov-2021 includes information concomitant drug.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Mild fever; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and PYREXIA (Mild fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (Heart condition), Thyroid disorder (Thyroid), Diabetes, Hives (Chronic hives), Immune disorder (NOS) (Immune condition), Kidney disorder (Kidney condition) and Blood pressure high (high blood pressure).    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced PYREXIA (Mild fever). In November 2021, VERTIGO (Vertigo) had resolved. At the time of the report, PYREXIA (Mild fever) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 3 patients were given full dose as a booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster). On 02-Nov-2021, ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported   This case was linked to MOD-2021-162950 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-370327 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for an unknown indication.    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 MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) 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.   Treatment medication were not reported.   This case was linked to MOD-2021-370259 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Numbness in her lower left calf (from her knee to her ankle).; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in her lower left calf (from her knee to her ankle).) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced HYPOAESTHESIA (Numbness in her lower left calf (from her knee to her ankle).) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness in her lower left calf (from her knee to her ankle).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) a cyst in her liver.  No concomitant medications were provided.  No treatment information was provided.  Patient started experiencing numbness in her lower left calf (from her kneel to her ankle). Patient saw a neurologist to look at her leg.  Company Comment - This is a spontaneous case concerning a 43 years old, female patient with no clinical history who experienced the unexpected event of HYPOAESTHESIA The event occurred unknown days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 43 years old, female patient with no clinical history who experienced the unexpected event of HYPOAESTHESIA The event occurred unknown days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Little headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache) and MYALGIA (Body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Had heart attack a year ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, ATORVASTATIN and OLMESARTAN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEADACHE (Little headache) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Little headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-382241, MOD-2021-382303 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: But this time, it is more severe; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (But this time, it is more severe), HEADACHE (Headache) and MYALGIA (Body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (a year ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, ATORVASTATIN and OLMESARTAN for Heart attack.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HEADACHE (But this time, it is more severe), HEADACHE (Headache) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (But this time, it is more severe), HEADACHE (Headache) and MYALGIA (Body ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-382241 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Eustachian tube dysfunction, Vaccination site pain
Clinical narrative: lost hearing in one of my ears; he had pain after his injections; This spontaneous case was reported by a consumer and describes the occurrence of EUSTACHIAN TUBE DYSFUNCTION (lost hearing in one of my ears) and VACCINATION SITE PAIN (he had pain after his injections) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 020B21A and 032F21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (myocardial infarction two years ago) in 2019.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced EUSTACHIAN TUBE DYSFUNCTION (lost hearing in one of my ears) and VACCINATION SITE PAIN (he had pain after his injections). At the time of the report, EUSTACHIAN TUBE DYSFUNCTION (lost hearing in one of my ears) and VACCINATION SITE PAIN (he had pain after his injections) outcome was unknown.            Concomitant product was not provided. Treatment medication was not reported. Patient taking a string of medications following a heart attack two years ago was reported.   This case was linked to MOD-2021-382420, MOD-2021-382441 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Sore arm; Inappropriate schedule of vaccine administered; feeling extremely cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling extremely cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 an unknown date, the patient received third 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), FEELING COLD (feeling extremely cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and FEELING COLD (feeling extremely cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided          No concomitant medication information provided by the reporter.  No treatment information  was provided.  Patient had received first two doses of Pfizer vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered a Moderna COVID-19 first dose to a 16 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a Moderna COVID-19 first dose to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a Moderna COVID-19 first dose to a 16 year old). On 08-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a Moderna COVID-19 first dose to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: Patient's arm was very sore; Patient felt that the vaccine was incorrectly administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient's arm was very sore) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient felt that the vaccine was incorrectly administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN IN EXTREMITY (Patient's arm was very sore) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient felt that the vaccine was incorrectly administered). On 10-Nov-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient felt that the vaccine was incorrectly administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Patient's arm was very sore) outcome was unknown.        Patient's mother reported that patient received her booster on 10-Nov-2021. She also stated that the patient received booster shot above where vaccination provider sanitized her left arm.  She was concerned about getting an infection and went to Urgent care.   No concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  On 01-Nov-2021, the vial or Moderna COVID-19 vaccine was opened at around 11a.  The vaccine administrator did not check time and date on vial, before administering a dose to the patient on 02-Nov-2021 at around 9a.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pruritus
Clinical narrative: Itching; soreness; headache; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itching), MYALGIA (soreness) and HEADACHE (headache) 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 10-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PRURITUS (Itching), MYALGIA (soreness) and HEADACHE (headache). At the time of the report, PRURITUS (Itching), MYALGIA (soreness) and HEADACHE (headache) 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 medications were reported. No treatment information was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient/expiration date was on 07Nov2021/Expired vaccine dose administered to patient as their booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/expiration date was on 07Nov2021/Expired vaccine dose administered to patient as their booster dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 024m20A and 04220A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/expiration date was on 07Nov2021/Expired vaccine dose administered to patient as their booster dose). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/expiration date was on 07Nov2021/Expired vaccine dose administered to patient as their booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported.  the booster dose was administered after 30-day Use By Date or after manufacturer date of expiry. patient had reported that according to what she had written down, the expiration date was 17Nov2021 but when she scanned it, it said the expiration date was on 07Nov2021.   This case was linked to MOD21-163166 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety.    On 10-Nov-2021 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021)). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Expiration date was showing 11/10/21 in Osiis & ECW so nurse administered vaccine.  Patient did not expierence any side effects, was monitored for 15 minute without signs of reaction noted.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Patient demographics, Medical history,Vaccine dose route of administration, Anatomical location, Concomitant medication added.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: site of injection swelled up a little, it is not painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (site of injection swelled up a little, it is not painful) 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 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (site of injection swelled up a little, it is not painful). At the time of the report, VACCINATION SITE SWELLING (site of injection swelled up a little, it is not painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient wanted to know if he can apply alcohol on his arm after receiving the Moderna COVID 19 vaccine.  Concomitant medications were not reported. Treatment information was not reported.