chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medications were provided. No adverse events were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662377, US-MODERNATX, INC.-MOD-2022-662382, US-MODERNATX, INC.-MOD-2022-662383, US-MODERNATX, INC.-MOD-2022-662384, US-MODERNATX, INC.-MOD-2022-662385, US-MODERNATX, INC.-MOD-2022-662387, US-MODERNATX, INC.-MOD-2022-662389, US-MODERNATX, INC.-MOD-2022-662390 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662377:same reporter US-MODERNATX, INC.-MOD-2022-662382:same reporter US-MODERNATX, INC.-MOD-2022-662383:same reporter US-MODERNATX, INC.-MOD-2022-662384:same reporter US-MODERNATX, INC.-MOD-2022-662385:same reporter US-MODERNATX, INC.-MOD-2022-662387:same reporter US-MODERNATX, INC.-MOD-2022-662389:same reporter US-MODERNATX, INC.-MOD-2022-662390:same reporter
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose) and NO ADVERSE EVENT (No Adverse Event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 041L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant information provided.  Patient has received Moderna covid-19 vaccines by injection to the left arm on 29JAN2021 (expiration date 31JUN2021).  Patient has not had any reactions with previous doses.  No treatment information provided   This case was linked to MOD-2022-662394 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered).    No concomitant medications were reported.  It was reported that 2.5 mL size vial of Moderna COVID-19 vaccine, Bivalent had passed beyond use date i.e. 13-Oct-2022. Only one patient was administered the vaccine. It was not reported when the vial was initially stored in the refrigerator It was unknown if vial had undergone any temperature excursions.  No treatment medications were reported.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; there might have been a wrong dose given to a customer; customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 19-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose).    No concomitant medication were reported.   Patient received 1st dose of the Moderna Covid-19 vaccine on 5-OCT-2021.  No treatment information was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: Felt a slight muscle spasm in the abdomen; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Felt a slight muscle spasm in the abdomen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 039A21A and 002A21A) for COVID-19 vaccination.     Patient had no allergies. No medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  The patient's past medical history included COVID-19 (Patient felt woozy, cough for 3 hours straight, went to a sleepy phase, phlegm in the throat. No Hospitalization due to COVID-19. Treated with Claritin and Tylenol.) on 09-Mar-2020 and COVID-19 (No Hospitalization due to COVID-19. No Treatment received.) on 20-Nov-2020.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced MUSCLE SPASMS (Felt a slight muscle spasm in the abdomen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Felt a slight muscle spasm in the abdomen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2020, SARS-CoV-2 test: (Positive) Positive. In November 2020, SARS-CoV-2 test: (Positive) Positive.         No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was not taking other medications. Patient had no side effect after the 1st and 2nd dose of the vaccine.   This case was linked to MOD-2022-662413 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a Moderna vaccine past the 12 hour shelf life post opening the vial; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial).    No concomitant drug information was provided.  Reporter stated that when they referred to the CDC's page for administration errors and deviations, the BN medical information line was listed.  No treatment drug information was provided.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza, Myalgia, Pyrexia
Clinical narrative: flu symptoms; fever; chills; body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 017B21A and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). In 2021, INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.            Patient never had COVID positive test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  After the primary series and first booster, the patient experienced flu symptoms like fever chills and body aches during 3 or 4 days.  The patient did not take any treatment.   This case was linked to MOD-2022-662419 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Flue like symptoms; Fever over 102 F°; Bodyache; Headche; Chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     Patient did not had any allergies.  Previously administered products included for Product used for unknown indication: pfizer vaccine (All previous doses). Past adverse reactions to the above products included No adverse event with pfizer vaccine.    On 15-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 100 mg every 8 hours and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, Body temperature: over 102 Fahrenheit degrees.         No concomitant medication information provided. Patient never had side effects from previous doses of Pfizer. Patient had the symptoms for 6 days now and was very worried because he had already had the symptoms 6 days and they don´t seem to go away. Patient was looking for solutions. Treatment drug included antacid.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Flue like symptoms; Fever over 102 F°; Bodyache; Headche; Chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     Patient did not had any allergies.  Previously administered products included for Product used for unknown indication: pfizer vaccine (All previous doses). Past adverse reactions to the above products included No adverse event with pfizer vaccine.    On 15-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 100 mg every 8 hours and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PYREXIA (Fever over 102 F°), MYALGIA (Bodyache), HEADACHE (Headche) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, Body temperature: over 102 Fahrenheit degrees.         No concomitant medication information provided. Patient never had side effects from previous doses of Pfizer. Patient had the symptoms for 6 days now and was very worried because he had already had the symptoms 6 days and they don´t seem to go away. Patient was looking for solutions. Treatment drug included antacid.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml; No adverse event; This spontaneous case was reported by a physician assistant and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Heart rate, Pyrexia
Clinical narrative: Feeling terrible; Had a little temperature, basically 100.6; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling terrible) and PYREXIA (Had a little temperature, basically 100.6) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced FEELING ABNORMAL (Feeling terrible) and PYREXIA (Had a little temperature, basically 100.6). At the time of the report, FEELING ABNORMAL (Feeling terrible) outcome was unknown and PYREXIA (Had a little temperature, basically 100.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6. On an unknown date, Heart rate: 100.  No concomitant medications were provided. Patient took the bivalent vaccine on Thursday. Patient had a little temperature, basically 100.6 for the past four days and think that Patient was heading down to the E. R, hopefully they'll be able to give some information there. No treatment medication was provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Varicose vein
Clinical narrative: develop a bulge in the vein that is starting to get bigger every day.; painful; This spontaneous case was reported by a patient and describes the occurrence of VARICOSE VEIN (develop a bulge in the vein that is starting to get bigger every day.) and PAIN (painful) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 072E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In October 2022, the patient experienced VARICOSE VEIN (develop a bulge in the vein that is starting to get bigger every day.) and PAIN (painful). At the time of the report, VARICOSE VEIN (develop a bulge in the vein that is starting to get bigger every day.) and PAIN (painful) outcome was unknown.            No concomitant medications was reported.  Reported that patient received a dose of the bivalent vaccine and experienced side effects.   Patient received 4 doses of the Moderna COVID-19 vaccines by intramuscular injection on 05-APR-2021 (lot number 032B21A, expiration date unknown), 08-MAY-2021 (lot number 033C21A, expiration date unknown), 23-NOV-2021 (lot number 939909, expiration date unknown), and 15-OCT-2022 (bivalent, lot number 072E22A, expiration date unknown).  Patient had not taken any medications or treatments. Patient had an appointment to speak to his HCP next week.   This case was linked to MOD-2022-662427 (Patient Link).
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Patient had no allergies . Patient had no medical history relating to adverse events and both Acute and Chronic illnesses at the time of vaccination.  On 17-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine). Concomitant medications details were not reported by the reporter. Patient ever had COVID positive test or diagnosis was reported as unknown. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; given bivalent booster from a vial punctured >12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours).    No concomitant medications were reported.  Nurse reported that they inadvertently administered the bivalent vaccine from a vial punctured for more than 12 hours. The vial was a 2.5mL vial. It was initially stored in the refrigerator on19-Oct-2022. The vial was first punctured on  20-Oct-2022 between 9-12 noon. The vial was stored in fridge post puncture and it did not undergo any temperature excursions.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; only received the first dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (only received the first dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (only received the first dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (only received the first dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported. It was reported that patient lost the vaccination records as patient was in prison. Treatment medications were not provided.   Reporter did not allow further contact
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore left arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (slight sore left arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (The patient received the Pfizer covid-19 vaccine for her Primary Series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine. Concurrent medical conditions included Myelodysplastic syndrome, Myasthenia gravis and Macular degeneration. Concomitant products included PYRIDOSTIGMINE and LOSARTAN for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slight sore left arm). At the time of the report, PAIN IN EXTREMITY (slight sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2022-662522 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Oct-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine).    No concomitant medication was reported.    The Pharmacist did not have any information on the patient's primary series or their first Moderna booster dose.    No treatment information was reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, No adverse event
Clinical narrative: No adverse event; During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out; During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out), ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Oct-2022, the patient experienced DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out), ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out).    No concomitant medications was reported.  There were no reported symptoms.  No additional doses, medications, or treatments had been administered to the patient up to that point.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID - symptoms; tested positive Oct 13, 17 and 19; This serious initial spontaneous safety report was received by Novavax on 19-OCT-2022 from a patient/consumer via contact center.  A male of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 02-AUG-2022, intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 2 on 23-AUG-2022.  No medical history was reported.  No concomitant medications were reported.  On 10-OCT-2022, after receiving both the doses of vaccine, the individual experienced COVID symptoms and tested positive for COVID-19 on 13-OCT-2022, 17-OCT-2022 and 19-OCT-2022 (PT: Vaccination failure) (Serious: Medically Significant). At the time of reporting, the individual stated that he was currently recovering from COVID-19, and that his symptoms were in remission since 13-OCT-2022.   Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 13-OCT-2022), SARS-CoV-2 test (Result: Positive; 17-OCT-2022) and SARS-CoV-2 test (Result: Positive; 19-OCT-2022).  At the time of reporting, the event outcome of Vaccination failure was recovered/resolved on 02-AUG-2022.  Lot number for dose 1 and dose 2 was not provided in the report.  This report is associated with product compliant (Private).  No additional information was provided.; Sender's Comments: This male of an unspecified age experienced: Vaccination failure after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL.  The event Vaccination failure was reported as serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Echocardiogram
Clinical narrative: she had an enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Basically the last Vaccine I have had before Jan2022 was Sep2021), administration date: Sep2021, for COVID-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 2022, outcome "unknown", described as "she had an enlarged heart". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter asked for information if one of the side effect of the Pfizer COVID Vaccine was enlarge heart. So, she asked if that was just for the younger ones or if that occurs in adult. It was reported that after she received the vaccine, In Jan2022 she had an enlarged heart and then she mentions that on Jul the same test was done but enlarged heart didn't show. Basically the last Vaccine I have had before Jan2022 was Sep2021 but in Jan the patient had an echo cardiogram, that's where they saw quite enlargement of left ventricle and in July when the patient went for another echo cardiogram they said well it doesn't matter, it's not there anymore.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: white substance that is floating inside that cannot be resuspended; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine  (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2602, Expiration Date: 30Jun2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "white substance that is floating inside that cannot be resuspended".  Additional information: Reporter received a box of PREVNAR 20 on the day of reporting. The product has a white substance that is floating inside that cannot be resuspended. Reporter asked for a replacement. She has prefilled syringes and she was about to use it for a patient and she got a blup of white stuff floating and she wanted to resuspend it. She did not shake it, she was twisting it back and forth for about 20 minutes and there were still floating substances in the syringe.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Myalgia
Clinical narrative: muscle pain so bad she was not able to walk properly or use her arms.; muscle pain so bad she was not able to walk properly or use her arms.; muscle pain so bad she was not able to walk properly or use her arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious), GAIT DISTURBANCE (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "muscle pain so bad she was not able to walk properly or use her arms.". Additional information: During the call she mentioned that after the third shot she had muscle pain so bad she was not able to walk properly or use her arms. She never had heart issues before, now if she made a deep breath, it was painful.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Overdose, Rash, Rash papular
Clinical narrative: Raised red bumps; Full body rash; DOSE 4 17Oct2022 and Dose 5 17Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 63 years, in left arm and on 17Oct2022 at 18:30 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Penicillin" (unspecified if ongoing), notes: Known allergies Penicillin. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 16Sep2022 as dose number unknown, single. Past drug history included: Amoxicillin, reaction(s): "Known allergies Amoxicillin", notes: Known allergies Amoxicillin. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 17Oct2022, outcome "unknown", described as "DOSE 4 17Oct2022 and Dose 5 17Oct2022"; RASH (non-serious) with onset 18Oct2022 at 14:00, outcome "not recovered", described as "Full body rash"; RASH PAPULAR (non-serious) with onset 18Oct2022 at 14:00, outcome "not recovered", described as "Raised red bumps". Therapeutic measures were not taken as a result of rash papular, rash.  Additional Information: The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Last time I got the shot I was sick for three months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to bovine protein" (unspecified if ongoing); "allergic to lactose" (unspecified if ongoing); "gluten intolerant" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing), notes: states he is gluten intolerant to the point it is almost Celiac Disease. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Last time I got the shot I was sick for three months".  Additional information: Caller asked if lactose, gluten and latex was a component of the Pfizer BioNTech Covid-19 Vaccine. Asked Caller why was it so important that people are immune compromised, he was told that immune compromised could be Celiac disease where your body starts attacking itself and killing the good tissue with the bad tissue. Caller asked if gluten was a component of the Pfizer BioNTech Covid-19 Vaccine. Caller stated he was gluten intolerant to the point it was almost Celiac Disease. Answer received as that Pfizer uses controlled manufacturing processes that meet quality standards of the pharmaceutical industry. However, Pfizer does not specifically manufacture or test Comirnaty; Pfizer-BioNTech COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine, Bivalent | COVID-19 Vaccine, mRNA [Monovalent and/or Bivalent] to be free of Gluten. Therefore, we cannot guarantee absence of trace amounts. Caller asked about the COVID-19 Vaccine booster. He was trying to get information from the Pharmacy. The pharmacy asked him if he was allergic to bovine protein. He looked up some information and says 20% bovine protein and lactose. He was highly allergic to lactose. The pharmacy can't tell him if there was lactose in the shot. The pharmacy doesn't ask him till he was in the store and with the shot in hand. He asked if lactose was in the shot and the pharmacy couldn't answer that question for him. He wanted to find out if there was lactose in the Pfizer shot and if not why ask the question.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever; The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine; The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 8-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GJ3275) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single), for COVID-19 immunization; Covid-19 vaccine (Dose 3, single), for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional Information: The reporter was under the impression her daughters, 9-year-old and 8-year-old daughters received covid 19 gray cap, monovalent instead of the omicron booster vaccine. She called the pharmacy, and the pharmacy was adamant that her daughters received the correct vaccine and asked what vaccine was this, based on Lot number recorded. Reporter stated that reporter's daughter received the monovalent Covid-19 vaccine as their booster dose. Patient was supposed to have been receiving the Bivalent booster dose (lot number: GJ3275). Reporter didn't think it was the new Omicron booster that her daughters received and didn't know if it was the pediatric dose or what. Her daughters were having side effects, but they had side effects with the other vaccines as well, so she's not really worried about that. But, when she found out they didn't get the right booster dose, it made her concerned. Pharmacy insisted that her daughters received the bivalent booster vaccine yesterday (18Oct2022). Reporter asked if someone can look up the lot number and tell her which vaccine that LOT was for. She trusted Pfizer over the pharmacy, so she wants to check the lot number first.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201243532 same reporter/ drug/ event for different patients;