chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Ophthalmic herpes zoster, Pain of skin, Rash
Clinical narrative: small patch in eye,diagnosed with Shingles; rash in forehead, scalp and back of the head; pain in scalp; pain in back of head, left forehead; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-MAR-2023, 3 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: small patch in eye,diagnosed with Shingles) (serious criteria GSK medically significant), rash (Verbatim: rash in forehead, scalp and back of the head), scalp pain (Verbatim: pain in scalp) and headache (Verbatim: pain in back of head, left forehead).  The outcome of the ophthalmic herpes zoster, rash, scalp pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash, scalp pain and headache to be related to Shingrix.     It was unknown if the company considered the ophthalmic herpes zoster, rash, scalp pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2023 The case was self reported by the patient. The patient received first dose of Shingrix vaccine then on Monday she started with pain and rash in left side of forehead, scalp and back of the head. The patient reported that she was having a small patch in her left eye too and was diagnosed with shingles.  The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 64 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, and keflex allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received first booster of non-company suspect vaccine included: Pfizer (tozinameran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer (tozinameran) (Dose number in series 2). The patient received second booster of non-company suspect vaccine included: Pfizer (tozinameran) (Dose number in series 3) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included fluoxetine hydrochloride (Prozac) for drug used for unknown indication.  On 20-FEB-2023, the patient experienced sore throat, sneezing, stuffy nose (suspected covid-19 infection) (Dose number in series 3). The patient was treated with drug Paxlovid (nirmatrelvir/ritonavir) from 02-MAR-2023 to 07-MAR-2023 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and tozinameran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Electrocardiogram
Clinical narrative: COVID-19 Symptoms returned No better; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 Symptoms returned No better) 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. unknown) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Comirnaty. Past adverse reactions to the above products included Tachycardia with Comirnaty.    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 COVID-19 (COVID-19 Symptoms returned No better). At the time of the report, COVID-19 (COVID-19 Symptoms returned No better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: tachycardia.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   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.   Concomitant medications were not reported. Treatment medications were not reported.  On an unknown date, the patient, with no cardiac history, developed tachycardia several weeks after Pfizer COVID-19 vaccine. The patient seemed better until then and after having Moderna booster, the COVID-19 symptoms returned and was not better.   On an unknown date, the patient saw a cardiologist and the tachycardia was documented on electrocardiogram (EKG) and halter monitors.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given to patient after expiry; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) 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 (Vaccine was given to patient after expiry).    Concomitant drugs were not reported.  It was reported that the 6 doses monovalent vial of 5. size was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial was not exposed to temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806, US-MODERNATX, INC.-MOD-2023-715780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715785:same reporter US-MODERNATX, INC.-MOD-2023-715792:same reporter US-MODERNATX, INC.-MOD-2023-715804:same reporter US-MODERNATX, INC.-MOD-2023-715806:same reporter US-MODERNATX, INC.-MOD-2023-715780:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given to patient after expiry; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry).    Concomitant drugs were not reported.  It was reported that the 6 doses monovalent vial of 5. size was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial was not exposed to temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715806 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730:same reporter US-MODERNATX, INC.-MOD-2023-715780:same reporter US-MODERNATX, INC.-MOD-2023-715785:same reporter US-MODERNATX, INC.-MOD-2023-715792:same reporter US-MODERNATX, INC.-MOD-2023-715806:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cousin died from cancer today. Diagnosed with cancer. 6th person I know who has died from cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cousin died from cancer today. Diagnosed with cancer. 6th person I know who has died from cancer) in an adult 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. ASKU) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cousin died from cancer today. Diagnosed with cancer. 6th person I know who has died from cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The treatment medication was not reported.  Company Comment  This fatal spontaneous case concerns an adult patient with no medical history  reported who experienced the unexpected seriousness criteria death and medically significant event of neoplasm malignant unknown days after a dose of mRNA-1273 bivalent vaccine. Concomitant medication nor treatment medication were reported Death occurred on unknown day. The cause of death was not reported.  It is unknown if an autopsy was performed  The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-715634 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715634:Other Patient Case; Reported Cause(s) of Death: Cancer
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023; No adverse event; patient received expired monovalent first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023).    No concomitant medications were reported. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered a 2nd dose of the Vaccine on 14MAR2023 but they realized the vaccine was expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a 2nd dose of the Vaccine on 14MAR2023 but they realized the vaccine was expired) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine.    On 14-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a 2nd dose of the Vaccine on 14MAR2023 but they realized the vaccine was expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a 2nd dose of the Vaccine on 14MAR2023 but they realized the vaccine was expired) 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 (administered a 2nd dose of the Vaccine on 14MAR2023 but they realized the vaccine was expired).    No concomitant medication were reported. It was stated that no AEs were reported. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster) 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 PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine they received was expired but it was given to 6 patients.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.) 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 (Vaccine they received was expired but it was given to 6 patients.).    No concomitant medications were reported.  The vaccine they received was expired, but it was given to six patients. The caller wanted to call and reference what to do. Patient received monovalent. Six doses were administered. Vial size was not reported. On 16Feb2023, the vial was initially stored in the refrigerator. Vaccine administration dates of 24Feb2023, 28Feb2023, 01Mar2023, and 06Mar2023. The vial did not undergo any temperature excursions. No women were pregnant or post-partum at the time of administration.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806, US-MODERNATX, INC.-MOD-2023-715730 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715785: US-MODERNATX, INC.-MOD-2023-715792: US-MODERNATX, INC.-MOD-2023-715804: US-MODERNATX, INC.-MOD-2023-715806: US-MODERNATX, INC.-MOD-2023-715730:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023).    No concomitant medications were reported.     No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023) 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 (The online tool showed the expiration date to be 3/12/2023 Vaccine administration on 15-MAR-2023).    No concomitant medication were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2023: Live non significant follow up received
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.) 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 stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated no Adverse' s event were reported No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was given to the patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) 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 (Expired vaccine was given to the patient).    No concomitant medications was reported.  It was reported that the 6 doses monovalent vaccines vial size of 5 ml was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial did not undergone any temperature excursions.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730: US-MODERNATX, INC.-MOD-2023-715785: US-MODERNATX, INC.-MOD-2023-715780: US-MODERNATX, INC.-MOD-2023-715804: US-MODERNATX, INC.-MOD-2023-715806:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 2nd patient out of 2 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715783 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715783:Child case (1st patient)
Age: 61.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; We gave 1 dose of Moderna bivalent to a customer BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 1 dose of Moderna bivalent to a customer BUD) and NO ADVERSE EVENT (no adverse event) in a 61-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)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Feb-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 21-Feb-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 (We gave 1 dose of Moderna bivalent to a customer BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 1 dose of Moderna bivalent to a customer BUD) 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 (We gave 1 dose of Moderna bivalent to a customer BUD).    No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was given to the patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), 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 was given to the patient).    No concomitant medications was reported.  It was reported that the 6 doses monovalent vaccines vial size of 5ml was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial did not undergone any temperature excursions.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730: US-MODERNATX, INC.-MOD-2023-715780: US-MODERNATX, INC.-MOD-2023-715792: US-MODERNATX, INC.-MOD-2023-715804: US-MODERNATX, INC.-MOD-2023-715806:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023; The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023), EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 15-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023), EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.) 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 assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose on 28Sep2022,Date(s) of administration of 2nd vaccine:15-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12-Mar-2023, but they gave it today 15-Mar-2023.).    It was unknown did patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 10-Mar-2023. The vial did not undergo any temperature excursions. Nurse has reported that only one expired dose was given. No treatment information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: mild case of COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild case of COVID) in an elderly 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.    In September 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 24-Dec-2022, the patient experienced COVID-19 (mild case of COVID). At the time of the report, COVID-19 (mild case of COVID) outcome was unknown.        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.   The patient had mild case of COVID-19 back the day before holiday last year. The patient had mild because of booster.  The concomitant medication was not reported.  The treatment medication was not reported.   Reporter did not allow further contact
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: having a sore arm; administered both the Moderna bivalent and HPV vaccine and then she realized that she already received her booster at pharmacy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (having a sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered both the Moderna bivalent and HPV vaccine and then she realized that she already received her booster at pharmacy) in a 12-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Type 1 Diabetes, a few food allergies.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 09-Dec-2022. Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Type 1 diabetes mellitus and Food allergy. Concomitant products included HPV VACCINE for an unknown indication.    On 15-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (having a sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered both the Moderna bivalent and HPV vaccine and then she realized that she already received her booster at pharmacy). At the time of the report, PAIN IN EXTREMITY (having a sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered both the Moderna bivalent and HPV vaccine and then she realized that she already received her booster at pharmacy) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient received Vaccine in the 4 weeks prior to COVID-19 vaccine. Patient received Pfizer bivalent booster on 9Dec2022. The reporter stated her daughter had her annual well visit and she was told she is due for the COVID booster. They administered both the Moderna bivalent and HPV vaccine and then she realized that she already received her booster at pharmacy but Dr didn't knew it. She Asked Doctor if there was problem but she didn't hear back from Doctor. Reporter daughter reported to had sore arm No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine they received was expired but it was given to 6 patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients).    No concomitant medication details was reported. Vaccine was administered on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial was initially stored in the refrigerator on 16-Feb-2023.  The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730: US-MODERNATX, INC.-MOD-2023-715780: US-MODERNATX, INC.-MOD-2023-715792: US-MODERNATX, INC.-MOD-2023-715804:same reporter US-MODERNATX, INC.-MOD-2023-715785:
Age: 0.17
Sex: U
Vaccine: PNC13
Symptoms: Device leakage, Incorrect dose administered by device, Vaccination site discharge, Vaccination site haemorrhage
Clinical narrative: What came out was just blood; Some of the vaccine had leaked out from the injection site; Patient received Prevnar 13, however, some of it leaked out; Patient received Prevnar 13, however, some of it leaked out; This is a spontaneous report received from a contactable nurse from medical information team.  A 2-month-old patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) at the age of 2 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "What came out was just blood"; VACCINATION SITE DISCHARGE (non-serious), outcome "unknown", described as "Some of the vaccine had leaked out from the injection site"; INCORRECT DOSE ADMINISTERED BY DEVICE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Patient received Prevnar 13, however, some of it leaked out".  Additional Information: The nurse asked if they need to revaccinate the patient who received Prevnar 13, however, some of it leaked out. The events were considered non-serious. As of 10Mar2023, according to the nurse, that (some of it leaked out) is what the parents are saying happened. The clinic employee is saying that none of it leaked out. What came out was just blood. The nurse was calling because she was wanting to get some product information for what to do if some of the vaccine had leaked out from the injection site. The nurse doesn't know if it was an actual adverse event. Person who administered the vaccine said the vaccine did not leak out. The nurse doesn't think that it's really an issue. She just she wanted to make sure she had as much information as possible before she spoke with the parents.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) has been requested and will be submitted if and when received.  Follow-up (10Mar2023): This is a spontaneous follow-up report received from the same contactable nurse,. Updated Information: new events (added "What came out was just blood" and "Some of the vaccine had leaked out from the injection site"), reporter information, and course of events.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, C-reactive protein, HIV test, Hepatitis B virus test
Clinical narrative: Rheumatoid arthritis; This is a literature report for the following literature source(s): Private. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antinuclear antibody: negative; C-reactive protein: 3.7 mg/dl; Hepatitis B virus test: negative; Hepatitis C virus test: negative; HIV test: negative; classsification criteria for rheumatoid arthritis.: met the 2010 ACR, notes: classification; remarkable for synovitis, notes: at the bilateral wrists and second to fourth MCP joints; Red blood cell sedimentation rate: 41, notes: Unit:mm/h; Rheumatoid factor (0-13.9): 16 IU/ml; SARS-CoV-2 test: negative; X-ray limb: negative, notes: for erosive changes; negative, notes: for erosive changes. Therapeutic measures were taken as a result of rheumatoid arthritis.  Clinical course: The patient was presented to rheumatology with 4 months of symmetric polyarthritis involving the wrists and MCP joints in the setting of prolonged morning stiffness. Symptom onset occurred 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a history of Hashimoto thyroiditis, no history COVID infection, and no family history of autoimmune disease. The patient never received immunosuppression in the past, and no medication changes were made at the time of vaccination. Examination was remarkable for synovitis at the bilateral wrists and second to fourth MCP joints. The patient met the 2010 ACR classification criteria for rheumatoid arthritis. She was treated initially with a prednisone taper and achieved clinical remission on oral methotrexate.; Sender's Comments: Based on the temporal relation, the association between the event of rheumatoid arthritis and the suspect product cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.