chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, Off label use
Clinical narrative: interchange of vaccine; Moderna first dose and Pfizer second dose; Second dose given on day 23; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine), OFF LABEL USE (Moderna first dose and Pfizer second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and OFF LABEL USE (Moderna first dose and Pfizer second dose). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and OFF LABEL USE (Moderna first dose and Pfizer second dose) 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.   A patient had received the first COVID-19 vaccination from Moderna on 09Aug2021 on  unknown deltoid muscle  Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        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 product was not provided by the reporter  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered past the 30 day refrigeration time; storage medication error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin discolouration, Vaccination complication, Vaccination site rash
Clinical narrative: Purple band around my arm; Covid hands; Skin began to peel/down to the 3rd or 4th layer of skin; Weird bumps on my hands; low grade fever; really bad reaction on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (really bad reaction on my arm), SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema. Concomitant products included CORTISONE for Rash.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever). On 12-Sep-2021, the patient experienced RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands). On an unknown date, the patient experienced SKIN DISCOLOURATION (Purple band around my arm) and VACCINATION COMPLICATION (Covid hands). At the time of the report, VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever) outcome was unknown and SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided by reporter. She has tried multiple different lotions and creams for her hands including cortisone, eczema medication and psoriasis medication. She has an appointment to see a dermatologist on Thursday.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant followup appended-Start date, medical history, new events added.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Purple band around my arm; Covid hands; Skin began to peel/down to the 3rd or 4th layer of skin; Weird bumps on my hands; low grade fever; really bad reaction on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (really bad reaction on my arm), SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema. Concomitant products included CORTISONE for Rash.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever). On 12-Sep-2021, the patient experienced RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands). On an unknown date, the patient experienced SKIN DISCOLOURATION (Purple band around my arm) and VACCINATION COMPLICATION (Covid hands). At the time of the report, VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever) outcome was unknown and SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided by reporter. She has tried multiple different lotions and creams for her hands including cortisone, eczema medication and psoriasis medication. She has an appointment to see a dermatologist on Thursday.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant followup appended-Start date, medical history, new events added.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ALPRAZOLAM from 01-Jan-2015 to an unknown date for Anxiety, AMLODIPINE from 01-Jan-2020 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Jan-2017 to an unknown date and LOSARTAN POTASSIUM from 01-Jan-2015 to an unknown date for Blood pressure, ROSUVASTATIN from 01-Jan-2013 to an unknown date for Cholesterol, LEVOTHYROXINE from 01-Jan-2013 to an unknown date for an unknown indication.   On 02-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021 at 5:00 PM, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). On 12-Mar-2021, VACCINATION SITE PAIN (sore left injection site arm) had resolved.            Patient treatment include Ice packs on shoulder.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up information on 22-SEP-2021 included reporter mail id, vaccine facility information, patient demographics and concomitant medications were added. Event stop date and outcome updated.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Anxiety. Concomitant products included TRAZODONE, PAROXETINE and BUSPIRONE for an unknown indication.   On 27-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 16-Sep-2021 at 3:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose). On 16-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up was received on 20-SEP-2021 and Patient's demographics added, race and ethnicity added, medical history added, concomitant medication dosage details and frequency added
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Discomfort, Gait disturbance, Testicular pain, Testicular swelling
Clinical narrative: swollen testicles for a few days (blueballs); could not walk right for a few days; second vaccination gave me only slight feeling of body imbalance; 10 or so hours after receiving it my testcles ached; Just an ache, making me uncomfortable; This case was received via Regulatory Authority(Reference number: US-irms-MOD21-145833) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (swollen testicles for a few days (blueballs)), GAIT DISTURBANCE (could not walk right for a few days), BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Testicular swelling (40 years ago), Blood pressure high since 2008 and Non-consummation. Concomitant products included METOPROLOL from 2008 to an unknown date and AMLODIPINE from 2008 to an unknown date for Blood pressure.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TESTICULAR SWELLING (swollen testicles for a few days (blueballs)), GAIT DISTURBANCE (could not walk right for a few days), BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable). In 2021, TESTICULAR SWELLING (swollen testicles for a few days (blueballs)) and GAIT DISTURBANCE (could not walk right for a few days) had resolved. At the time of the report, BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable) outcome was unknown.            Treatment medications was not reported. The patient received the first dose of Moderna COVID-19 vaccine 2-3 months ago. He also received the second shot of Moderna COVID-19 vaccine about 2 months ago. The patient was not sexually active now. The patient did not have any history of prostate problems.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up contains significant information of patient history, concomitants, new events and patient demographics.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of kidney, except pelvis (Malignant neoplasm of left kidney). Concomitant products included LENVATINIB MESILATE (LENVIMA) for Malignant neoplasm of kidney, except pelvis.    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 PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-331510 (Patient Link).   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: headache; Chills; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Headache with Flu shot.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting). On 01-Mar-2021, HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) had resolved.            Concomitant medication was not reported. Treatment information was not reported.  Reporter stated that headache and vomiting are the same symptoms patient experienced when they get a flu shot.   This case was linked to MOD-2021-333400 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Historical vaccine and events associated with it were updated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Moderna COVID-19 vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On 01-Sep-2021, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that the vaccine was administered intramuscularly in the upper deltoid and the patients did not experience any adverse reactions following administration. The reporter stated that the vial was moved from freezer to fridge on 31Aug2021, and was only in fridge for a day prior to administration.  No concomitant medication details were provided. No treatment medication details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-SEP-2021 contains non significant information. On 01-Oct-2021: Additional information received on 04-OCT-2021: Vaccination anatomical site  added and Patient demographics added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose administered from a carton of vials some of which did not thaw as expected; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a carton of vials some of which did not thaw as expected) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD since 14-Feb-2014, Chronic pain since 11-Oct-2019, Anxiety on 09-Dec-2013, Hypertension, Allergy (Bee) and Pollen allergy. Concomitant products included FERROUS GLUCONATE (FERGON) from 11-Mar-2016 to an unknown date for Anemia, ALPRAZOLAM (XANAX) from 09-Dec-2013 to an unknown date for Anxiety, OXYCODONE from 28-Nov-2010 to an unknown date for Chronic pain, METOPROLOL from 18-Jul-2014 to an unknown date for Hypertension, ERGOCALCIFEROL (DRISDOL) from 11-Mar-2016 to an unknown date for Vitamin D deficiency.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a carton of vials some of which did not thaw as expected). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a carton of vials some of which did not thaw as expected) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-Sep-2021. Patient's information (age, race, demographics), medical history and concomitant medications were updated. New reporter added.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered covid vaccine outside 12-hour range of puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (patient is immunocompromised so got the 3rd dose).   On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  Initially, vial was stored in the refrigerator, on 21Sept2021 and was  first punctured: on 28Sept2021 @ 4PM and  vial stored post puncture in room temperature (RT), not  undergone any temperature excursions. and totally vial exposed to 21 hours of room temperature.  Patient has reported that he has no allergies to any medications, food, and other products.  Also reported that he has never been diagnosed with COVID-19, positive.  In addition, said that he didn't report any adverse effects and  as per manufacture, he took third dose on opposite arm (i.e., right arm).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 04-Oct-2021 and included reporter's contact information (Address). On 06-Oct-2021: Follow up received on 06-OCT-2021 and included race and ethnicity.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Pain
Clinical narrative: Felt like he had a mild case of the flu; Felt achy and gross; Didn't feel good; Felt like he had a bad case of the flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy and gross), FEELING ABNORMAL (Didn't feel good), INFLUENZA (Felt like he had a bad case of the flu) and INFLUENZA (Felt like he had a mild case of the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-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 20-Apr-2021, the patient experienced PAIN (Felt achy and gross), FEELING ABNORMAL (Didn't feel good) and INFLUENZA (Felt like he had a bad case of the flu). On 21-Apr-2021, the patient experienced INFLUENZA (Felt like he had a mild case of the flu). At the time of the report, PAIN (Felt achy and gross), FEELING ABNORMAL (Didn't feel good), INFLUENZA (Felt like he had a bad case of the flu) and INFLUENZA (Felt like he had a mild case of the flu) had resolved.            No concomitant medication were provided. No treatment information were provided.   This case was linked to MOD-2021-336800 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Maternal exposure during pregnancy
Clinical narrative: Sore left injection site arm; Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left injection site arm) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). On an unknown date, the patient experienced INJECTION SITE PAIN (Sore left injection site arm). On 01-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (Sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  The patient reported a sore left injection site arm. The due date was reported as Nov-2021.  This case concerns a 32-year-old pregnant female patient with no reported medical history, who experienced the non-serious  unexpected events Injection site pain and maternal exposure during pregnancy.  The events occurred  after the first dose  of mRNA-1273 Moderna vaccine. Last menstrual period and estimated date of delivery were not provided.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-336953 (Patient Link).; Sender's Comments: This case concerns a 32-year-old pregnant female patient with no reported medical history, who experienced the non-serious  unexpected events Injection site pain and maternal exposure during pregnancy.  The events occurred  after the first dose  of mRNA-1273 Moderna vaccine. Last menstrual period and estimated date of delivery were not provided.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: sore left arm; Patient received expired vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was pregnant and pregnancy due date was Nov 2021. No concomitant medication information were provided. No treatment medication information was given.  This case involves a 32-year-old female subject with n information on medical history who experienced the unlisted non-serious adverse event of expired product administered and the listed adverse event of vaccination site pain at her second vaccination. The patient was pregnant at the time of both vaccinations. The due date of the pregnancy has been reported for November 2021. The pregnancy has not been impacted by the vaccinations The re-challenge is positive for vaccination site pain.   The benefit-risk relationship of mRNA-1273 is no affected by this report.   This case was linked to MOD-2021-336915 (Patient Link).; Sender's Comments: This case involves a 32-year-old female subject with n information on medical history who experienced the unlisted non-serious adverse event of expired product administered and the listed adverse event of vaccination site pain at her second vaccination. The patient was pregnant at the time of both vaccinations. The due date of the pregnancy has been reported for November 2021. The pregnancy has not been impacted by the vaccinations The re-challenge is positive for vaccination site pain.   The benefit-risk relationship of mRNA-1273 is no affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Pruritus
Clinical narrative: \itching in different body parts\head itched; Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (\itching in different body parts\head itched) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's syndrome (Causes dry mouth and dry eyes suffering for more than 20 years), Fibromyalgia (for more than 20 years along with Sjogren Syndrome), Diabetes, Thyroid disorder and Asthma.    On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021). On 21-Sep-2021, the patient experienced PRURITUS (\itching in different body parts\head itched). On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021) had resolved. At the time of the report, PRURITUS (\itching in different body parts\head itched) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypersensitivity: negativen (Negative) negative.         Concomitant medications include medicines for thyroid, diabetes, asthma and head. Treatment information includes intake of steroids for hives.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune inner ear disease, Deafness, Dizziness
Clinical narrative: autoimmune inner ear disease; hearing loss; dizziness; This literature-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease) and DEAFNESS (hearing loss) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune inner ear disease (5 plus years of duration).    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 AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease) (seriousness criterion medically significant), DEAFNESS (hearing loss) (seriousness criterion medically significant) and DIZZINESS (dizziness). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease), DEAFNESS (hearing loss) and DIZZINESS (dizziness) 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 considered AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease), DEAFNESS (hearing loss) and DIZZINESS (dizziness) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient had Hearing loss and Dizziness as symptoms.  Company Comment: A 74-year-old female, with concurrent autoimmune inner ear disease, presented with serious unexpected events of autoimmune inner ear disease with hearing loss and dizziness. Event latency 7 days after first dose. Event outcome not reported. Rechallenge unknown. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with known immunomodulation effect of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010.; Sender's Comments: A 74-year-old female, with concurrent autoimmune inner ear disease, presented with serious unexpected events of autoimmune inner ear disease with hearing loss and dizziness. Event latency 7 days after first dose. Event outcome not reported. Rechallenge unknown. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with known immunomodulation effect of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine that had experienced a temperature excursion was given as 1st dose; vaccine that had experienced a temperature excursion was given as 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 1st dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 1st dose). At the time of the report, PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: vaccine that had experienced a temperature excursion was given as 1st dose; poor quality product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered). At the time of the report, PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The refrigerator was cooled a little bit more than normal. Six vials stored in the refrigerator were exposed to temperatures below 36°F. Minimum temperature was 34.7°F. There were 145 incidents in total and each one lasted less than 15 minutes: 142 times fridge temperatures were between 35°F and 36°F; while three times temperatures were under 35°F, reaching 34.7°F (minimum).  Five patients received doses from  four of the 6 vials.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Influenza, Myalgia, Pain
Clinical narrative: It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches; got me in tears; extreme arm pain in the left arm - "got me in tears; arm is sore now; fever/cannot keep the fever down and has reached 103.9°F; feel really sick; full blown flu; severe arm pain, non stop for hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), ILLNESS (feel really sick), INFLUENZA (full blown flu), PAIN IN EXTREMITY (severe arm pain, non stop for hours) and TEARFULNESS (got me in tears) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no  medical history was reported.     On 29-Sep-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced ILLNESS (feel really sick) and INFLUENZA (full blown flu). 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain, non stop for hours) and PYREXIA (fever/cannot keep the fever down and has reached 103.9°F). On 01-Oct-2021, the patient experienced MYALGIA (arm is sore now). On an unknown date, the patient experienced PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), TEARFULNESS (got me in tears) and VACCINATION SITE PAIN (extreme arm pain in the left arm - "got me in tears). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of 600 mg and PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), INFLUENZA (full blown flu), TEARFULNESS (got me in tears), VACCINATION SITE PAIN (extreme arm pain in the left arm - "got me in tears) and MYALGIA (arm is sore now) outcome was unknown and ILLNESS (feel really sick), PAIN IN EXTREMITY (severe arm pain, non stop for hours) and PYREXIA (fever/cannot keep the fever down and has reached 103.9°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 103.9 (High) fever reached 103.9°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication was provided   This case was linked to MOD-2021-338403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: follow-Up received contains patient's city updated , new events added , new treatment medication added
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tearfulness, Vaccination site pain
Clinical narrative: It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches; got me in tears; extreme arm pain in the left arm - "got me in tears; arm is sore now; fever/cannot keep the fever down and has reached 103.9°F; feel really sick; full blown flu; severe arm pain, non stop for hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), ILLNESS (feel really sick), INFLUENZA (full blown flu), PAIN IN EXTREMITY (severe arm pain, non stop for hours) and TEARFULNESS (got me in tears) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no  medical history was reported.     On 29-Sep-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced ILLNESS (feel really sick) and INFLUENZA (full blown flu). 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain, non stop for hours) and PYREXIA (fever/cannot keep the fever down and has reached 103.9°F). On 01-Oct-2021, the patient experienced MYALGIA (arm is sore now). On an unknown date, the patient experienced PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), TEARFULNESS (got me in tears) and VACCINATION SITE PAIN (extreme arm pain in the left arm - "got me in tears). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of 600 mg and PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), INFLUENZA (full blown flu), TEARFULNESS (got me in tears), VACCINATION SITE PAIN (extreme arm pain in the left arm - "got me in tears) and MYALGIA (arm is sore now) outcome was unknown and ILLNESS (feel really sick), PAIN IN EXTREMITY (severe arm pain, non stop for hours) and PYREXIA (fever/cannot keep the fever down and has reached 103.9°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 103.9 (High) fever reached 103.9°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication was provided   This case was linked to MOD-2021-338403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: follow-Up received contains patient's city updated , new events added , new treatment medication added
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Memory impairment, SARS-CoV-2 test
Clinical narrative: does not remember a thing; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (does not remember a thing) and COVID-19 (tested positive for COVID-19) 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 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (does not remember a thing) (seriousness criterion hospitalization) and COVID-19 (tested positive for COVID-19) (seriousness criterion hospitalization). At the time of the report, MEMORY IMPAIRMENT (does not remember a thing) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO Concomitant medication was reported NO treatment Drug was reported  On 27Aug2021 the patient was in hospital until recently (about a month ) and tested positive for COVID-19   company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of COVID-19 and Memory impairment. The events occurred after the first dose of Moderna Covid-19 vaccine. Hospitalization was on 27-AUG-2021 for a month and the patient tested positive for Covid-19. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since the events occurred only after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of COVID-19 and Memory impairment. The events occurred after the first dose of Moderna Covid-19 vaccine. Hospitalization was on 27-AUG-2021 for a month and the patient tested positive for Covid-19. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since the events occurred only after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 31 Patients were administered a dose after the 30 day beyond use date.; 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 (31 Patients were administered a dose after the 30 day beyond use date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.). In July 2021, EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications were reported.  Dose Count is 31 Refrigeration Date is 5/21/2021 Vaccination Dates 2021 , 01-July and 02-july. Refrigerated Storage Temperature  35°F to 38°F, It was reported that Moderna cannot guarantee patients received full protection against the COVID-19 Virus.      This case was linked to MOD-2021-323906 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Dose details were captured On 06-Oct-2021: Follow-up received on 06-OCT-2021 contains no newsignificant information found.