chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Polymenorrhoea
Clinical narrative: ongoing variability in menstrual cycle; started period again today after 2 weeks; bled all of January; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (ongoing variability in menstrual cycle), POLYMENORRHOEA (started period again today after 2 weeks) and HEAVY MENSTRUAL BLEEDING (bled all of January) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced HEAVY MENSTRUAL BLEEDING (bled all of January). On 15-Feb-2022, the patient experienced POLYMENORRHOEA (started period again today after 2 weeks). On an unknown date, the patient experienced MENSTRUAL DISORDER (ongoing variability in menstrual cycle). At the time of the report, MENSTRUAL DISORDER (ongoing variability in menstrual cycle), POLYMENORRHOEA (started period again today after 2 weeks) and HEAVY MENSTRUAL BLEEDING (bled all of January) had not resolved.            No concomitant medication was reported. The patient experiencing ongoing variability in menstrual cycle to the point where it was unacceptable. Had followed up with OBGYN to do ultrasounds looking for cause. No attributable cause. She reported to V-safe. It had been stated that wanted to report to AE hotline feels "it needs to be taken more seriously by Moderna" States she was frustrated because she bled all of January said just started period again today after only 2 weeks.  No treatment medication was reported.   This case was linked to MOD-2022-483629 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the 2nd dose 7 months after receiving the 1st dose.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose 7 months after receiving the 1st dose.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose 7 months after receiving the 1st dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose 7 months after receiving the 1st dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-484276 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Urticaria chronic
Clinical narrative: Chronic Urticaria; he cannot sleep because it itched too much/Difficulty sleeping; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (Chronic Urticaria) and INSOMNIA (he cannot sleep because it itched too much/Difficulty sleeping) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 032B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-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 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 20-Dec-2021, the patient experienced URTICARIA CHRONIC (Chronic Urticaria) and INSOMNIA (he cannot sleep because it itched too much/Difficulty sleeping). The patient was treated with CETIRIZINE at a dose of 1 dosage form once a day. At the time of the report, URTICARIA CHRONIC (Chronic Urticaria) had not resolved and INSOMNIA (he cannot sleep because it itched too much/Difficulty sleeping) outcome was unknown.            Patient had rashes all over his body and had itched too much. Patient then consulted an allergologist who advised the patient had chronic urticaria. Treatment medications included antihistamines to be taken for months.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster) 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 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 14-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster). At the time of the report, ACCIDENTAL OVERDOSE (thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 11-May-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved.            Concomitant medication and treatment information was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: Patient had a lot of side effects after the 2nd Moderna vaccination; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient had a lot of side effects after the 2nd Moderna vaccination) and ILLNESS (Very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had a lot of side effects after the 2nd Moderna vaccination) and ILLNESS (Very sick). At the time of the report, VACCINATION COMPLICATION (Patient had a lot of side effects after the 2nd Moderna vaccination) and ILLNESS (Very sick) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received 2 full does and a booster (improper series); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 2 full does and a booster (improper series)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant since an unknown date. Concurrent medical conditions included Immunocompromised.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 2 full does and a booster (improper series)). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 2 full does and a booster (improper series)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No Treatment medications were reported
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Give two booster doses accidently from vials that were expired past their beyond use date; Date the vial was initially stored in the refrigerator-13JAN2022 and date of  administration of vaccine-15FEB2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Give two booster doses accidently from vials that were expired past their beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator-13JAN2022 and date of  administration of vaccine-15FEB2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Give two booster doses accidently from vials that were expired past their beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator-13JAN2022 and date of  administration of vaccine-15FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Give two booster doses accidently from vials that were expired past their beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator-13JAN2022 and date of  administration of vaccine-15FEB2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported Date the vial was initially stored in the refrigerator-13JAN2022 6:00AM   This case was linked to MOD-2022-483945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Non Significant Follow Up appended
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 10 patients after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 10 patients after more than 30days of storagein the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to 10 patients after more than 30days of storagein the fridge; Dose administered to patient after more than 30 days of storage in the fridge prior to first use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days of storage in the fridge prior to first use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to patient after more than 30 days of storage in the fridge prior to first use; Dose administered to patient after more than 30 days of storage in the fridge prior to first use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days of storage in the fridge prior to first use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days of storage in the fridge prior to first use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The 4 vials were stored in the fridge since 22-Dec-2021 and did not undergo temperature excursions.  The patient received the booster dose of the vaccine.  No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2022-482129 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine  stored on the fridge for more than 30 days prior to first use.; Dose administered to 10 patients after more than 30days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storage in the fridge) and PRODUCT STORAGE ERROR (Vaccine  stored on the fridge for more than 30 days prior to first use.) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storage in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine  stored on the fridge for more than 30 days prior to first use.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storage in the fridge) and PRODUCT STORAGE ERROR (Vaccine  stored on the fridge for more than 30 days prior to first use.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  HCP stated there were 4 vials from Moderna COVID-19 Vaccine that were stored on the fridge for more than 30 days prior to first use. Vials were stored in the fridge since 22-Dec-2021.  No treatment information was reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A., 010A21A. and 039KZCA) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 24-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster.). At the time of the report, ACCIDENTAL OVERDOSE (Dose on 24Aug2021 was 1ml and she was informed it was 0.25ml./immunocompromised and received two-dose as primary series and booster.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient has  reported not had COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.   It was reported that the vials were stored in the fridge since 22-Dec-2021.   No treatment information was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after more than 30 days of storage in the fridge; Dose administered after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) and PRODUCT STORAGE ERROR (Dose administered after more than 30 days of storage in the fridge) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) and PRODUCT STORAGE ERROR (Dose administered after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that they found out there are 4 vials form Moderna COVID-19 vaccine that were stored in the fridge for more than 30 days prior to first use. Vials were stored in the fridge since 22-Dec-2021. Patient received booster dose of Moderna COVID-19 vaccine.  No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 10 patients after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter who was an HCP stated that they found there were 4 vials form Moderna COVID-19 vaccine that were stored on the fridge for more than 30 days prior to first use. Vials were stored in the fridge since 22-Dec-2021. It was reported that the HCP didn't know if any of the patient experienced any symptoms.  It was also reported that the reporter did not know if the patient was under any concomitant or regular medication and had no information about the clinical history of the patient.  The expiration date of vaccine reported was 25-Mar-2022.  No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM; Left at room temperature for more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM) and PRODUCT STORAGE ERROR (Left at room temperature for more than 24 hours) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022 at 10:21 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2022 at 8:12 AM, the patient experienced PRODUCT STORAGE ERROR (Left at room temperature for more than 24 hours). On 15-Feb-2022 at 10:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was removed from the refrigerator at 8:12 AM yesterday and was administered at 10:21 AM) and PRODUCT STORAGE ERROR (Left at room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the patient received Moderna booster dose which was left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12 AM on 14-Feb-2022 and was administered at 10:21 AM.  No treatment information was provided. No symptoms were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to 10 patients after more than 30days of storagein the fridge; Dose administered to 10 patients after more than 30days of storagein the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30days of storagein the fridge) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30days of storagein the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30days of storagein the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Vials were stored in fridge since 22-Dec-2021
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses). At the time of the report, ACCIDENTAL UNDERDOSE (Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 15-Feb-2022, case MOD-2022-484085   became invalid as they were no patient identifier reported . Therefore , this case will be logically deleted from the safety database.  No concomitant medications details were reported. No treatment information details were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Memory impairment, Pain
Clinical narrative: She was amazingly thirsty; Ache; Generally weak; Her memory dull; Sick; Feeling fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull) and ILLNESS (Sick) in a 54-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 Allergy to nuts.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull), ILLNESS (Sick) and FATIGUE (Feeling fatigued). At the time of the report, THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull), ILLNESS (Sick) and FATIGUE (Feeling fatigued) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication were provided.  Patient stated that flu shot had never bothered her.   This case was linked to MOD-2022-484102 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: She was amazingly thirsty; Ache; Generally weak; Her memory dull; Sick; Feeling fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull) and ILLNESS (Sick) in a 54-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 Allergy to nuts.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull), ILLNESS (Sick) and FATIGUE (Feeling fatigued). At the time of the report, THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull), ILLNESS (Sick) and FATIGUE (Feeling fatigued) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication were provided.  Patient stated that flu shot had never bothered her.   This case was linked to MOD-2022-484102 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Fatigue, Illness
Clinical narrative: Unusually thirsty; Trouble clrearing throat; Became hoarse; Extremely achy; Many Symptoms of a very bad cold; Cough lingered for 2 weeks; Inflammatory reaction to Vaccine; Missed three days of work; Never tested for COVID, but was sick with similar symptoms for five days; Fatigued; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy) and NASOPHARYNGITIS (Many Symptoms of a very bad cold) in a 54-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.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot has never bothered her). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to nuts.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), IMPAIRED WORK ABILITY (Missed three days of work), ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days), FATIGUE (Fatigued) and CHILLS (Bad chills). At the time of the report, THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), FATIGUE (Fatigued) and CHILLS (Bad chills) outcome was unknown and IMPAIRED WORK ABILITY (Missed three days of work) and ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days) had resolved.            No concomitant medications were provided.  It was reported that within a few hours of having shot, patient was unusually thirsty and had trouble clearing her throat and became hoarse. Within 12 hours of the booster, patient had bad chills, was extremely achy, fatigued and had many symptoms of a very bad cold. Patient had contacted her doctor and he told her she had an inflammatory reaction to a vaccine.  No treatment medications were provided.   This case was linked to MOD-2022-484093 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Inflammation, Nasopharyngitis, Oropharyngeal discomfort, Pain
Clinical narrative: Unusually thirsty; Trouble clrearing throat; Became hoarse; Extremely achy; Many Symptoms of a very bad cold; Cough lingered for 2 weeks; Inflammatory reaction to Vaccine; Missed three days of work; Never tested for COVID, but was sick with similar symptoms for five days; Fatigued; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy) and NASOPHARYNGITIS (Many Symptoms of a very bad cold) in a 54-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.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot has never bothered her). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to nuts.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), IMPAIRED WORK ABILITY (Missed three days of work), ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days), FATIGUE (Fatigued) and CHILLS (Bad chills). At the time of the report, THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), FATIGUE (Fatigued) and CHILLS (Bad chills) outcome was unknown and IMPAIRED WORK ABILITY (Missed three days of work) and ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days) had resolved.            No concomitant medications were provided.  It was reported that within a few hours of having shot, patient was unusually thirsty and had trouble clearing her throat and became hoarse. Within 12 hours of the booster, patient had bad chills, was extremely achy, fatigued and had many symptoms of a very bad cold. Patient had contacted her doctor and he told her she had an inflammatory reaction to a vaccine.  No treatment medications were provided.   This case was linked to MOD-2022-484093 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Unusually thirsty; Trouble clrearing throat; Became hoarse; Extremely achy; Many Symptoms of a very bad cold; Cough lingered for 2 weeks; Inflammatory reaction to Vaccine; Missed three days of work; Never tested for COVID, but was sick with similar symptoms for five days; Fatigued; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy) and NASOPHARYNGITIS (Many Symptoms of a very bad cold) in a 54-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.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot has never bothered her). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to nuts.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), IMPAIRED WORK ABILITY (Missed three days of work), ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days), FATIGUE (Fatigued) and CHILLS (Bad chills). At the time of the report, THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), FATIGUE (Fatigued) and CHILLS (Bad chills) outcome was unknown and IMPAIRED WORK ABILITY (Missed three days of work) and ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days) had resolved.            No concomitant medications were provided.  It was reported that within a few hours of having shot, patient was unusually thirsty and had trouble clearing her throat and became hoarse. Within 12 hours of the booster, patient had bad chills, was extremely achy, fatigued and had many symptoms of a very bad cold. Patient had contacted her doctor and he told her she had an inflammatory reaction to a vaccine.  No treatment medications were provided.   This case was linked to MOD-2022-484093 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore left arm only for a few hours; she felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm only for a few hours) and FATIGUE (she felt tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus (No Recent changes in status such as improvement or worsening) in 2016. Concurrent medical conditions included Lactose intolerant, Caffeine allergy, Food allergy (pork products and fatty products), Allergy to antibiotic, Drug allergy (antidepressant drugs (not all of them) and depression medications, Allergy to Novocaine.), Anxiety, Blood pressure high (No Recent changes in status such as improvement or worsening) since 2019 and Arthritis. Concomitant products included CORTISONE for Arthritis, AMLODIPINE BESYLATE for Hypertension, CLONAZEPAM, LOSARTAN, PARACETAMOL (TYLENOL [PARACETAMOL]), CALCIUM, NICOTINAMIDE (VITAMIN B3), MULTIVITAMINS [VITAMINS NOS] and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm only for a few hours) and FATIGUE (she felt tired). On 04-Feb-2021, PAIN IN EXTREMITY (sore left arm only for a few hours) and FATIGUE (she felt tired) had resolved.        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.   Patient's height reported as 5'3.  Reportedly, patient was not an immunocompromised person. Expiration date was reported as Unknown as per report. Patient had not received other vaccines within one month prior to Moderna COVID-19 vaccine, did not seek any medical care for any adverse event and also did not experienced a similar event in the past. Patient never tested positive to COVID-19 test or diagnosis.   No treatment was given for any of her symptoms after vaccination.   This case was linked to MOD-2022-484143, MOD-2022-484156 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore left arm; Patient felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Patient felt tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lactose intolerant, Caffeine allergy, Food allergy (Allergic to fatty products), Meat allergy (Allergic to pork products), Allergy to antibiotic, Drug allergy (Allergic to Novacaine), Drug allergy (antidepressant drugs (not all of them), depression medications), Anxiety, Type 2 diabetes mellitus (Recent change in status such as improvement or worsening: no) since 2016 and Blood pressure high (Recent change in status such as improvement or worsening: no) since 2019. Concomitant products included CORTISONE for Arthritis, AMLODIPINE BESYLATE for Blood pressure high, CLONAZEPAM, LOSARTAN, PARACETAMOL (TYLENOL [PARACETAMOL]), CALCIUM, NICOTINAMIDE (VITAMIN B3), MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Patient felt tired). On 04-Mar-2021, PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Patient felt tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication details was provided Cortisone shots on her knees for arthritis every 3 months Patient was reported that the patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The Adverse events did not cause patient to seek medical care and the patient had not experienced a similar event in the past. The adverse event outcome was reported as recovered and the symptoms had recovered. The patient's height reported as 5 feet 3 inch.   This case was linked to MOD-2022-484121, MOD-2022-484156 (Patient Link).