chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, White blood cell count
Clinical narrative: Knee swelling/My knees swelled significantly; Patient had such extreme symptions and pain.; My hands were swollen to the point that I was unable to dress; Diminished my mobility; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling/My knees swelled significantly), PAIN IN EXTREMITY (Patient had such extreme symptions and pain.), PERIPHERAL SWELLING (My hands were swollen to the point that I was unable to dress) and MOBILITY DECREASED (Diminished my mobility) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Still's disease adult onset (Significant swelling, pain that patient never experienced prior to Moderna) since August 2000.    On 19-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced JOINT SWELLING (Knee swelling/My knees swelled significantly), PAIN IN EXTREMITY (Patient had such extreme symptions and pain.), PERIPHERAL SWELLING (My hands were swollen to the point that I was unable to dress) and MOBILITY DECREASED (Diminished my mobility). The patient was treated with PREDNISONE ongoing from June 2021 for Swelling and Pain, at a dose of 60-mg-5mg. At the time of the report, JOINT SWELLING (Knee swelling/My knees swelled significantly), PAIN IN EXTREMITY (Patient had such extreme symptions and pain.), PERIPHERAL SWELLING (My hands were swollen to the point that I was unable to dress) and MOBILITY DECREASED (Diminished my mobility) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 189 C-Reactive Protein- 189. On an unknown date, Red blood cell sedimentation rate: 80 SED rate was 80. On an unknown date, White blood cell count: 17.2 WBC -17.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was unable to make a twisting movement such as to remove a water bottle lid and patient had to hold their coffee cup with 2 hands. Patient started Prednisone after receiving Moderna. The patient had never experienced such intense pain, swelling. No concomitant medications was provided by the reporter.   This case was linked to MOD-2022-510038, MOD-2022-452278 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Stem cell transplant
Clinical narrative: Patient receieved stem cell transplant after receiving vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In November 2021, the patient experienced STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine). At the time of the report, STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine) to be not related.    Concomitant medication list was not provided. The reporter, a pharmacy intern, confirmed that the stem cell transplant was not related to the patient getting the primary doses. Treatment information was not provided.   This case was linked to MOD-2022-510119 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received booster dose instead of full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant in November 2021.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Pharmacy Intern stated that a patient who had a stem cell transplant in Nov 2021 completed her primary doses in Aug 2021. The doctor recommended that the patient should get revaccinated but instead, the patient received the booster dose 0.25 mL on11FEB2022. She confirmed that the stem cell transplant was not related to the patient getting the primary doses. No treatment medications were provided.   This case was linked to MOD-2022-510100 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: felt sore for two days or three but not bad; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt sore for two days or three but not bad) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (felt sore for two days or three but not bad). At the time of the report, MYALGIA (felt sore for two days or three but not bad) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included cholesterol medicine. No treatment was reported by the reporter.   This case was linked to MOD-2022-510205, MOD-2022-510207 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 5 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen vaccine (First dose) on 24-Jun-2021. Past adverse reactions to the above products included No adverse event with Janssen vaccine.    On 02-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Report was received on 10-MARCH-2022 under QE-016008. No Treatment information was reported. The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow-up received added Quality complaint number. On 11-Mar-2022: Follow-up received added additional reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient received second and Booster in right arm shoulder deltoid muscle. It was reported that patient did not experience any adverse reactions with all doses of moderna. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up received contains Product Quality complaint number updated. On 11-Mar-2022: Follow up received contains Additional reporter was updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Rash pruritic
Clinical narrative: Rash also itches; Muscle pain; Rash on her left hand, left foot, right arm elbow and below stomach after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her left hand, left foot, right arm elbow and below stomach after 1st dose), RASH PRURITIC (Rash also itches) and MYALGIA (Muscle pain) in a 44-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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced RASH (Rash on her left hand, left foot, right arm elbow and below stomach after 1st dose). On an unknown date, the patient experienced RASH PRURITIC (Rash also itches) and MYALGIA (Muscle pain). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on her left hand, left foot, right arm elbow and below stomach after 1st dose), RASH PRURITIC (Rash also itches) and MYALGIA (Muscle pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. It was reported that the symptoms flared up if she stopped usage of the cream. Treatments also included Other skin creams.   This case was linked to MOD-2022-510173 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2022: Follow-up received updated No New information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 5 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The vial did not undergo any temperature excursions. The patient experienced no adverse events after all three doses. The patient received her booster dose on right arm shoulder deltoid muscle.   No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up received included product quality compliant number, added in reference section. On 11-Mar-2022: Follow up received contains additional Reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to a patient.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Moderna website the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Significant live follow up (Quality complaint number updated) On 11-Mar-2022: Follow up document includes reporter information was added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Rash pruritic, Scar
Clinical narrative: scar left from the rash; Itchy rash reoccurred; experienced muscle pain as well/Muscle pain reoccurred; Shortly after 2nd dose, rash on her left hand, left foot, right arm elbow and below stomach flared up; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scar left from the rash), RASH (Shortly after 2nd dose, rash on her left hand, left foot, right arm elbow and below stomach flared up), RASH PRURITIC (Itchy rash reoccurred) and MYALGIA (experienced muscle pain as well/Muscle pain reoccurred) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The doctors thought that the patient had COVID in Mar 2020. It was never formally diagnosed due to lack of staff that time.) in March 2020.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced RASH (Shortly after 2nd dose, rash on her left hand, left foot, right arm elbow and below stomach flared up). On an unknown date, the patient experienced SCAR (scar left from the rash), RASH PRURITIC (Itchy rash reoccurred) and MYALGIA (experienced muscle pain as well/Muscle pain reoccurred). The patient was treated with CORTISONE at an unspecified dose and frequency and VITAMIN E [VITAMIN E NOS] at an unspecified dose and frequency. At the time of the report, SCAR (scar left from the rash), RASH (Shortly after 2nd dose, rash on her left hand, left foot, right arm elbow and below stomach flared up), RASH PRURITIC (Itchy rash reoccurred) and MYALGIA (experienced muscle pain as well/Muscle pain reoccurred) had not resolved.            No concomitant medications were reported.  Patient had no allergic conditions. Patient had no history related to mentioned adverse event, acute and chronic illnesses at the time of vaccination. It was reported that the adverse events were worsening. No information provided on other vaccines given 1 month prior to Moderna COVID-19 vaccine. It was reported that one doctor thought that the events were eczema and another doctor thought that the patient had scabies. Patient stated that the rash not gone away and it was flaring up.  Patient also stated that other skin creams were also used as treatment.   This case was linked to MOD-2022-510160 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2022: Follow-up received contains no new information.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was not known on which arm the patient received her first and second dose and the patient reported no adverse reactions after the first or second doses.   The facility received the vaccine in October 2021. The reporter reported that when the lot number of Moderna COVID-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on website the expiration date was found as August 14, 2021. The reporter also reported that she had a screenshot of the lot number 010A21A, entered into the lot number expiration date check program that showed the expiration date as October 14, 2022.  Date the vial was initially stored in the refrigerator was not provided and the vial did not undergo any temperature excursions.  The patient received the booster dose in her left arm shoulder deltoid muscle. Also, after the booster dose, no other adverse reactions were reported by the patient.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Product Quality Complaint number was added. On 11-Mar-2022: Additional reporter was added.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: After first and second dose, they felt sore for two days or three but not bad; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (After first and second dose, they felt sore for two days or three but not bad) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020b21a and 022m20a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 MYALGIA (After first and second dose, they felt sore for two days or three but not bad). At the time of the report, MYALGIA (After first and second dose, they felt sore for two days or three but not bad) had resolved.            Concomitant products include cholesterol medicine. No treatment information was provided.   This case was linked to MOD-2022-510135, MOD-2022-510207 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: swelling in their arm/ sometime swells up; wants to know what's its making arm felling wrong. tiered of hurting/ arm hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in their arm/ sometime swells up), LIMB DISCOMFORT (wants to know what's its making arm felling wrong.) and PAIN IN EXTREMITY (tiered of hurting/ arm hurts so bad) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PERIPHERAL SWELLING (swelling in their arm/ sometime swells up), LIMB DISCOMFORT (wants to know what's its making arm felling wrong.) and PAIN IN EXTREMITY (tiered of hurting/ arm hurts so bad). At the time of the report, PERIPHERAL SWELLING (swelling in their arm/ sometime swells up), LIMB DISCOMFORT (wants to know what's its making arm felling wrong.) and PAIN IN EXTREMITY (tiered of hurting/ arm hurts so bad) had not resolved.            Concomitant drugs included cholesterol medicine.  It was reported that patient was planning to take X-rays for the arm and visited orthopedic doctor. It was reported that the events worsened.  Treatment medications were not provided.   This case was linked to MOD-2022-510135, MOD-2022-510205, MOD-2022-510214 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received half dose for third dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the moderately immunocompromised patient received primary series with Moderna in May 2021 (two 0.5ml, 4 weeks apart) and then received booster dose (0.25 ml) in November 2021.  No concomitant medications were reported. No treatment  medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling 3 weeks after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling 3 weeks after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling 3 weeks after the shot). At the time of the report, VACCINATION SITE SWELLING (swelling 3 weeks after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Patient became pregnant after 1st dose of moderna vaccine/ 6 weeks pregnant/ found out she was pregnant when she missed her period/ Patient is pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient became pregnant after 1st dose of moderna vaccine/ 6 weeks pregnant/ found out she was pregnant when she missed her period/ Patient is pregnant) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 037F21A and 045L21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 14-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 14-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-Nov-2022. On 14-Feb-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient became pregnant after 1st dose of moderna vaccine/ 6 weeks pregnant/ found out she was pregnant when she missed her period/ Patient is pregnant). On 14-Feb-2022, MATERNAL EXPOSURE DURING PREGNANCY (Patient became pregnant after 1st dose of moderna vaccine/ 6 weeks pregnant/ found out she was pregnant when she missed her period/ Patient is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2022, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had no past medical history and no allergies. No treatment medications was reported. Patient's last menstrual cycle was on 26-FEB-2022.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines) 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 MIGRAINE (Migraines). At the time of the report, MIGRAINE (Migraines) had not resolved.            No concomitant medication was provided by the reporter  No treatment medication was provided by the reporter.  Patient has migraines everyday since receiving the booster
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter didn't knew the patients height, allergies, if patient had ever tested positive for Covid-19, if the patient had any acute or chronic illness and if the patient received any other vaccine within 1 month prior to Moderna. The patient was taking concomitant medication but HCP didn't had permission to provide this information. The reporter confirmed that the patient received the Booster dose in his deltoid muscle but no information on administration route was provided for primary series.  No concomitant medications were reported. No treatment details were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Received this poison and had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Received this poison and had side effects) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Received this poison and had side effects). At the time of the report, VACCINATION COMPLICATION (Received this poison and had side effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose 2 weeks after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose 2 weeks after the 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose 2 weeks after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose 2 weeks after the 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took unknown drug for blood pressure as concomitant.  Patient had schedule procedure of colonoscopy for constipation. The constipation that patient had been experiencing since before patient received her doses of the Moderna COVID-19 vaccine.  No treatment medication was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Got the Covid arm but can't remember which dose it was something going on covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got the Covid arm but can't remember which dose it was something going on covid arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic pain and Sleep disorder. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Chronic pain, TIZANIDINE for Muscle relaxant, HYDROXYZINE for Sleep disorder, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], SEROTONIN, DOCUSATE SODIUM (STOOL SOFTENER), ASPIRIN [ACETYLSALICYLIC ACID] and SENNOSIDE A+B (SENNA [SENNOSIDE A+B]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got the Covid arm but can't remember which dose it was something going on covid arm). At the time of the report, VACCINATION COMPLICATION (Got the Covid arm but can't remember which dose it was something going on covid arm) outcome was unknown.            The patient broke ankle 2 weeks ago, had a surgery and was put on aspirin. The patient had COVID over Christmas break 2021.  Treatment medications were not reported.   This case was linked to MOD-2022-510774 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave one booster dose from an expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave one booster dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave one booster dose from an expired vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The health department brought vaccines and when they went on the website too look up the expiration date they did not realize when they wrote it down it was already expired. No concomitant medication was reported. No treatment information was reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours; dose given greater than 12 hour post-puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given greater than 12 hour post-puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) 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 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given greater than 12 hour post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given greater than 12 hour post-puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date the vial was initially stored in the refrigerator was unknown. The vial was first punctured on 12-Mar-2022 at 10:18 AM. The vaccine was administered around 11:30 AM on 13-Mar-2022. It was reported that the vial was stored at room temperature post puncture. The vial had not went under temperature excursion.  No treatment medications were reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got a booster (0.25 ml) 5 months after a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a booster (0.25 ml) 5 months after a second dose) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Immunocompromised.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a booster (0.25 ml) 5 months after a second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a booster (0.25 ml) 5 months after a second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.  The pharmacist wanted to know if the patient should be getting a fourth dose with the 0.5 ml. If so, when should the patient get that dose?
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given >12 hour post-puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date and time vial was first punctured: 12Mar2022 at 10:18 AM The vial was stored post puncture at room temperature. No concomitant and treatment medication were reported. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 24 hours.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the date and time vial was first punctured was on 12 Mar 2022 at 10:18 AM. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius = 46 to 77 degree Fahrenheit ) was 24 hours. No concomitant medications information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Two weeks after this injection develop severe joint pain in my shoulder, hips and knees; Symptoms of aching in my body; Fever; Chills; Severe swelling at the injection site for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Symptoms of aching in my body), PYREXIA (Fever), CHILLS (Chills), INJECTION SITE SWELLING (Severe swelling at the injection site for 2 weeks) and ARTHRALGIA (Two weeks after this injection develop severe joint pain in my shoulder, hips and knees) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (Two weeks after this injection develop severe joint pain in my shoulder, hips and knees). On an unknown date, the patient experienced MYALGIA (Symptoms of aching in my body), PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE SWELLING (Severe swelling at the injection site for 2 weeks). At the time of the report, MYALGIA (Symptoms of aching in my body), PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE SWELLING (Severe swelling at the injection site for 2 weeks) had resolved and ARTHRALGIA (Two weeks after this injection develop severe joint pain in my shoulder, hips and knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Exactly two weeks after receiving the injection,patient developed severe joint pain in shoulder, hips and knees. No treatment medication information provided.   This case was linked to MOD-2022-511125 (Patient Link).
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm after first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after first dose of Moderna Covid-19 vaccine) in a 101-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm after first dose of Moderna Covid-19 vaccine). At the time of the report, PAIN IN EXTREMITY (sore left arm after first dose of Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  The patient received the vaccine in her left arm shoulder deltoid muscle.  No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Follow-up received with no newinformation
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue; Fever; Chills; Nausea; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 33-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 FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) 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 product use was reported.  The reporter had a patient who after the after the first Moderna Covid-19 vaccine experienced fatigue, fever, chills, and nausea. It was not known which arm the patient received their first Moderna Covid-19 vaccines in.  No treatment information was provided.   This case was linked to MOD-2022-511201, MOD-2022-511202 (Patient Link).