chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expired vaccine was stored in refrigerator on 30Mar2023; no adverse event; PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023) and NO ADVERSE EVENT (no adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023).    No concomitant medications were reported.  It was reported that 4 expired doses of vaccines were administered on 31-Mar-2023. Patient received Monovalent 6 months to 5 years vaccine, there was individual vial of size 2.5 ml. The vial was initially stored in the refrigerator on 30-Mar-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case was reported for Patient 1 of 4 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718108, US-MODERNATX, INC.-MOD-2023-718179, US-MODERNATX, INC.-MOD-2023-718157 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718108:same reporter, patient 4 US-MODERNATX, INC.-MOD-2023-718179:same reporter, patient 2 US-MODERNATX, INC.-MOD-2023-718157:same reporter, patient 3
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nodule, Prostatic specific antigen
Clinical narrative: Nodule at the bottom of his bladder; This spontaneous case was reported by a patient and describes the occurrence of NODULE (Nodule at the bottom of his bladder) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included Prostate cancer (5 years ago).    On 12-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced NODULE (Nodule at the bottom of his bladder). At the time of the report, NODULE (Nodule at the bottom of his bladder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: PSA was creeping up and it finally went up to 0.5..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  Patient found a nodule at the bottom of his bladder and he is going to undergo radiation treatment in 2 weeks time. Patient stated that 5 years ago he had a prostate cancer that was removed.  Patient received Moderna COVID-19 vaccine first dose on 18Feb2021, lot number  031M20A, second dose was on 18Mar2021, lot number - 001B21A, third dose was on 28Oct2021, lot number - 058F21A, 4th dose was on 30Mar2022, lot number - 048L21A.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered dose of expired vial to patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, 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 31-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) 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 dose of expired vial to patient).    The concomitant medication was not reported by reporter. It was reported that the 2 vials were transferred to another site this morning and vaccines were showing expired. Vaccines expired on 11-Feb-2023. Site administered 3 doses from these expired vials to patients this morning. It was unknown if they experienced symptoms. The treatment medication was not reported by reporter. This case contains information for the 1st of 3 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718085, US-MODERNATX, INC.-MOD-2023-718084 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718085:Patient 3 out of 3 patients
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Site administered 3 doses from these expired vials to patients this morning.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Site administered 3 doses from these expired vials to patients this morning.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, 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 31-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Site administered 3 doses from these expired vials to patients this morning.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Site administered 3 doses from these expired vials to patients this morning.) 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 (Site administered 3 doses from these expired vials to patients this morning.).    Concomitant medication details not reported by the reporter. It was unknown if patients experienced any symptoms. Treatment details was not reported by the reporter. This case contains information about patient 3rd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718084, US-MODERNATX, INC.-MOD-2023-718082 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718084:Patient 2 out of 3 patients US-MODERNATX, INC.-MOD-2023-718082:Patient 1 out of 3 patients
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Influenza, Myalgia, Product administration interrupted
Clinical narrative: simply wanted to receive his second dose of the Moderna Covid-19 primary series; Body aches; fever; chills; all (flu-ish); got really sick; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (all (flu-ish)), ILLNESS (got really sick), PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series), MYALGIA (Body aches) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In March 2023, the patient experienced INFLUENZA (all (flu-ish)), ILLNESS (got really sick), MYALGIA (Body aches), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series). In March 2023, INFLUENZA (all (flu-ish)), ILLNESS (got really sick), MYALGIA (Body aches), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  It was reported that not able to find a second dose and says that patient just gonna get a Pfizer. patient did not want to speak with anyone about it, didn't even want to give more information.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2023: Follow-up  Live Significant  information accepted, Myalgia, Fever, Chills, Flu, Sickness Event added.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: simply wanted to receive his second dose of the Moderna Covid-19 primary series; Body aches; fever; chills; all (flu-ish); got really sick; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (all (flu-ish)), ILLNESS (got really sick), PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series), MYALGIA (Body aches) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In March 2023, the patient experienced INFLUENZA (all (flu-ish)), ILLNESS (got really sick), MYALGIA (Body aches), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series). In March 2023, INFLUENZA (all (flu-ish)), ILLNESS (got really sick), MYALGIA (Body aches), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  It was reported that not able to find a second dose and says that patient just gonna get a Pfizer. patient did not want to speak with anyone about it, didn't even want to give more information.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2023: Follow-up  Live Significant  information accepted, Myalgia, Fever, Chills, Flu, Sickness Event added.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Moderna booster as first dose But never received any Covid-19 vaccines before.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.   On 27-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before) 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 WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before.).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 30-Mar-2023; No adverse event; 30-day Use By Date or after manufacturer date of expiry (11-Feb-2023); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry (11-Feb-2023)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 31-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry (11-Feb-2023)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry (11-Feb-2023)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry (11-Feb-2023)) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023).    Concomitant medication was not provided.   It was reported that the vial was individual vial and size was 2.5 ml. The vial was initially stored in refrigerator on 30-Mar-2023. The vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-718108, MODERNATX, INC.-MOD-2023-718009 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-718108:same reporter MODERNATX, INC.-MOD-2023-718009:same reporter, patient 2
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023).    No concomitant information was reported. The 2.5 ml vial was initially stored in refrigerator on 30-Mar-2023 and did not underwent any temperature excursions. No treatment information was provided. This case is reported for patient 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-718009, US-MODERNATX, INC.-MOD-2023-718157, US-MODERNATX, INC.-MOD-2023-718179 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718009:same reporter, patient 1 US-MODERNATX, INC.-MOD-2023-718157:same reporter, patient 3 US-MODERNATX, INC.-MOD-2023-718179:same reporter, patient 2
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (pains on their left shoulders (injection site).) and ARTHRALGIA (having pain in other joints - right shoulder and the knees. For his wife - she complains about the pain too) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Pollen allergy.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pains on their left shoulders (injection site).) and ARTHRALGIA (having pain in other joints - right shoulder and the knees. For his wife - she complains about the pain too). At the time of the report, VACCINATION SITE PAIN (pains on their left shoulders (injection site).) and ARTHRALGIA (having pain in other joints - right shoulder and the knees. For his wife - she complains about the pain too) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient received 1st booster dose on 25-Oct-2021, lot number 014F21A. The patient and husband got the 2nd booster dose of the Moderna Covid- 19 vaccine, they have been experiencing pains on their left shoulders (injection site). Patient complains about the pain too. Patient husband stated that they never got sick before they got the shot. No treatment information was provided by the reporter.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 30-day Use By Date or after manufacturer date of expiry; No adverse event; 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial size was reported as 2.5 mL The vial was initially stored in the refrigerator on 30-Mar-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718108:same reporter US-MODERNATX, INC.-MOD-2023-718009:same reporter, patient 3
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP accidentally administered an expiry dose of Moderna Covid19; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19).    No concomitant medications was reported. No treatment medications was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees; have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees) and VACCINATION SITE PAIN (have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A and 014F21A) for COVID-19 prophylaxis.     Patient had no medical history or conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: J and J (1st dose). Past adverse reactions to the above products included No adverse event with J and J.   On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees) and VACCINATION SITE PAIN (have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered). At the time of the report, ARTHRALGIA (it is also affecting the shoulder joint, is now having pain in other joints - right shoulder and the knees) and VACCINATION SITE PAIN (have been experiencing pains on their left shoulders (injection site), kinda hurts where it was administered) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient stated that since the 2nd booster dose patient have been experiencing pains on their left shoulders (injection site). Patient stated that they never got sick before they got the shot. The pain started shortly after they got the shot. For the patient, initially the pain was coming and going, but now it been there all the time. It was kind of hurting where it was administered but it was also affecting the shoulder joint. No treatment information was provided by the reporter.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2023, 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 29-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM) 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 (Date(s) and time(S) vial was first punctured: 28MAR2023 at 4:00 PM Date(s) and time(s) of administration of vaccine: 29MAR2023 at 1:30 PM).    No concomitant medication details was reported. It was reported that the patient had not reported any adverse reactions to this dose. Vial size was 0.4ml. The vial was initially stored in the refrigerator on 10-MAR-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023) and NO ADVERSE EVENT (No adverse event) in a 72-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 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Sinus congestion, Blood pressure high and Temperature intolerance (heat and cold temperature).   On 12-Sep-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 03-Apr-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023) 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 EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023).    No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site pain
Clinical narrative: Fatigue; arm pain at site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 23Mar2023 at 01:30 as dose 3, single (Batch/Lot number: unknown) at the age of 25 years, in arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 23Mar2023 at 16:45, outcome "recovered" (25Mar2023); INJECTION SITE PAIN (non-serious) with onset 23Mar2023 at 16:45, outcome "recovered" (25Mar2023), described as "arm pain at site of injection". Therapeutic measures were not taken as a result of fatigue, injection site pain.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, SARS-CoV-2 test
Clinical narrative: Really tired; really sick; 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 female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Really tired"; ILLNESS (non-serious), outcome "unknown", described as "really sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter and her husband were coming off a trip. They both were really sick coming home and really tired. They tested in blue box, orange box and white box after returning home. Her husband took test and had COVID. Reporter tested in orange and white box and saw C. She thought she was positive for COVID and needed Paxlovid and her doctor prescribed Paxlovid. The patient was not positive as she read the test completely wrong. She asked if Paxlovid do any damage if someone took it with COVID negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300059314 same reporter, different patient, same drug, different event;US-PFIZER INC-202300137868 same reporter, same patient, different product, different event;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Tachycardia, Tremor, Ventricular tachycardia
Clinical narrative: Ventricular Tachycardia; Dysautonomia; Tremors: The day after my 2nd, it started with a mild tremor in my hands; Attacks of tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0150) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity with no other pre-existing conditions" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6208, Location of injection: Arm Right), administration date: 17Mar2021, when the patient was 38-year-old, for COVID-19 immunization. The following information was reported: TACHYCARDIA (hospitalization, disability) with onset 08Apr2021, outcome "recovering", described as "Attacks of tachycardia"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (hospitalization, disability) with onset 08Apr2021, outcome "recovering", described as "Dysautonomia"; TREMOR (hospitalization, disability) with onset 08Apr2021, outcome "recovering", described as "Tremors: The day after my 2nd, it started with a mild tremor in my hands"; VENTRICULAR TACHYCARDIA (hospitalization, disability, medically significant) with onset 08Apr2021, outcome "recovering". The patient was hospitalized for ventricular tachycardia, autonomic nervous system imbalance, tremor, tachycardia (hospitalization duration: 1 day(s)). The events "ventricular tachycardia", "dysautonomia", "tremors: the day after my 2nd, it started with a mild tremor in my hands" and "attacks of tachycardia" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of ventricular tachycardia, autonomic nervous system imbalance, tremor, tachycardia.  Clinical Course:  It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any medication within 2 weeks of vaccination. The patient reported that after the second vaccination she had mild tremor in hands and over time symptoms progressed to attacks of tachycardia, NSVT, and tremors. Patient was broadly diagnosed with Dysautonomia. At first, she didn't suspect vaccine and thought it was safe and effective.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Melanoma Insitu" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for antidepressant therapy, start date: 23Nov2022; NP THYROID; ALLERTEC [CETIRIZINE]; BIOTIN taken for supplementation therapy; CITRACAL MAXIMUM PLUS taken for supplementation therapy; TRIPLE ACTION taken for supplementation therapy; MULTIVITAMINS [VITAMINS NOS] taken for supplementation therapy; PROBIOTICS NOS taken for supplementation therapy; FISH OIL NATURE'S BOUNTY taken for supplementation therapy; MONTELUKAST taken for asthma. Past drug history included: Wellbutrin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (27Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that Paxlovid was taken as treatment for COVID-19 from 18Mar2023 to 23Mar2023 at day 1-6 of the event occurrence.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Post-acute COVID-19 syndrome
Clinical narrative: possibly has long COVID/symptoms keep mutating and has gotten a lot better and is still not 100%; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "possibly has long COVID/symptoms keep mutating and has gotten a lot better and is still not 100%". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was contemplating getting another Pfizer Booster and has had something for the past 5 months and she believed this is long COVID but no one can diagnose. Her symptoms keep mutating and has gotten a lot better and is still not 100% and she can't get any answers. The last time she got a COVID-19 Vaccine booster was 14Jul2022 and she doesn't know if long haulers get better or worse with a booster and looking for more information.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 48 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 03Apr2021 as dose 2, single (Lot number: ER8737), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing). Concomitant medication(s) included: NYSTATIN, start date: Oct2022; ASHWAGANDHA, start date: Oct2022; ALIVE! ONCE DAILY WOMEN'S ULTRA POTENCY, start date: Sep2022. Past drug history included: Beta blockers, reaction(s): "known allergies/Beta Blockers"; Nifedipine, start date: Sep2016; Asprin, start date: Jul2019; Xyzal, start date: May2020; Sumatriptan, start date: Jan2021; Flonaze, start date: Jan2013. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (Treatment start date: 23Mar2023, Treatment stop date: 27Mar2023).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: the injection site is swollen.; injection site has like a big red circle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2023, outcome "unknown", described as "injection site has like a big red circle"; VACCINATION SITE SWELLING (non-serious) with onset Mar2023, outcome "unknown", described as "the injection site is swollen.". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema.  Additional information: Patient got the bivalent booster on 30Mar2023 and she was fine but the injection site has like a big red circle and it's swollen, she was fine but it's just that her arm is swollen, wondering if she should put an ice pack or something or what she can do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Fibrin D dimer, Fibrin D dimer increased, Myalgia, Pain in extremity
Clinical narrative: small blood clots all over lungs; D-Dimmer elevated; Tenderness and pain in left calf muscle; pain in left calf muscle; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Back surgery" (unspecified if ongoing), notes: had last year and nothing showed up on lab work at that time regarding blood clots or any issues. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, (Confirmed just received two doses)), for COVID-19 Immunization. The patient stated he never had issue blood clots whatsoever. Then, on 24Mar2023, the patient stated he had symptoms that seemed to be related to a DVT. He went to urgent care and was referred to the Emergency Room. They did a lot of test. Thought was almost came done, but then blood work came back. The marker D-dimmer, showed indicative of blood clots. Due to this elevated marker in blood results and this was the only thing elevated also had CT Scan. The CT Scan was done which showed small blood all over lungs.  Also, had genetic testing to see if pre-disposed to blood clots and none came back positive. He does not have any genetic component to it.  The patient had to do follow-up with primary care for more blood work. This was when they did the genetic testing component to see if it was positive and it was not. The patient later clarified the DVT symptoms experienced to be tenderness and pain in left calf muscle which started on 19Mar2023.  This feeling then subsided, but then they reemerged and by 24Mar2023 thought needed to go to urgent care. This tenderness and pain has gone away. It went away 28Mar2023. The events AE required visit to: Urgent Care, then referred to Emergency Room; had to have follow-up at Physician Office. The outcome of the events Tenderness and pain in left calf muscle was recovered in 28Mar2023; the outcome of the other events was unknown. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (24Mar2023) Unknown results, notes: Result: small blood clots all over lungs;  Unit: Not Provided; Fibrin D dimer: (24Mar2023) Elevated, notes: Unit: Not Provided. Therapeutic measures were taken as a result of pulmonary thrombosis which includes blood thinner, Xarelto 15mg for the next 21 days twice daily then dosage is escalated to 20mg after that, then assuming this will be the dose on for the remainder of the 3-6 months course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.