chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only liquid given; Menveo only liquid given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30-SEP-2023) for prophylaxis.   On 22-AUG-2023, the patient received Menveo. On 22-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid given) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid given).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt Date: 23-AUG-2023 The reporter called to report that only the liquid portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Less Than Approved Age/ a female patient aged 49 years received one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   On 15-MAR-2023, the patient received the 1st dose of Shingrix. On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Less Than Approved Age/ a female patient aged 49 years received one dose of Shingrix).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: Receipt Date: 23-AUG-2023 The reporter reported that the patient of 49 years old received first dose of Shingrix vaccine. The reporter did not believed that the patient had any sort of immunodeficiency or immunosuppression. The reporter stated that at the time of reporting the second dose had not been administered. The vaccine administration facility was the same as primary reporter. The patient received Shingrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received his first Shingrix vaccine on 20Nov2020 and did not receive the second dose until 09Sep2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th November 2020).   On 09-SEP-2022, the patient received the 2nd dose of Shingrix. On 09-SEP-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received his first Shingrix vaccine on 20Nov2020 and did not receive the second dose until 09Sep2022).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter was a medical office manager. The reporter did not had the vaccine lot numbers and expiration dates. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo was administered using sterile diluent instead of the supplied diluent; Menveo was administered using sterile diluent instead of the supplied diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA928A, expiry date 31-MAY-2024) for prophylaxis.   On 22-AUG-2023, the patient received Menveo. On 22-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was administered using sterile diluent instead of the supplied diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo was administered using sterile diluent instead of the supplied diluent).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 16 year old patient received 1st dose of Menveo on 05sep12019 (12yrs & 3 months) and a 2nd dose on 12May2023 (15yrs & 11 months). Got it 4 months early.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose of Menveo on 05sep12019 (12yrs & 3 months)).   On 12-MAY-2023, the patient received Menveo. On 12-MAY-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too short (Verbatim: 16 year old patient received 1st dose of Menveo on 05sep12019 (12yrs & 3 months) and a 2nd dose on 12May2023 (15yrs & 11 months). Got it 4 months early.).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 24-Aug-2023 Health care professional (HCP) did not have the lot and expiry. The medical assistant reported that a patient received 1st dose of Menveo and a 2nd dose of Menveo 4 months early, which led to shortening of vaccine schedule. The reporter consented to follow up via postal mail
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix 4 years ago hadn't received the 2nd one yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix 4 years ago hadn't received the 2nd one yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-AUG-2023 The pharmacist called to inform that a patient that received the 1st dose of Shingrix 4 years ago had not received the 2nd dose yet, which led to incomplete course of vaccination. The reporter consented to follow up
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 0051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2023, SARS-CoV-2 test: (Positive) Home test. On an unknown date, SARS-CoV-2 test: (Positive) Home test.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient tested positive for Covid, but he did not have a whole lot of symptoms. Reporter does not know when the patient got COVID, but he had minimal symptoms on 09-Aug-2023, when they both tested positive.  The patient had 2 positive home tests.  Doctor prescribed Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2023-738502 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2023: Live follow-up information received included Reference numbers added from PQC Document.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738502:Case for Wife
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She did a home COVID-19 test twice on 09AUG2023, and both times it came back positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She did a home COVID-19 test twice on 09AUG2023, and both times it came back positive) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     The patient's past medical history included Surgery. Concurrent medical conditions included Mite allergy and Immune system disorder.    On 17-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. On 09-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (She did a home COVID-19 test twice on 09AUG2023, and both times it came back positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (She did a home COVID-19 test twice on 09AUG2023, and both times it came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2023, SARS-CoV-2 test: Positive and Positive.     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 medication was not reported. Patient received first primary monovalent dose on 29-Jun-2021 (Lot number: 0051C21A & Exp. Date: unknown) and 2nd primary monovalent dose on 28-Jul-2021 (Lot number: 040C21A & Exp. Date: unknown) of Moderna.  Patient had symptoms of muscle aches and pain, arms were hurting, then got extremely sick on 09-Aug-2023. Patient did home Covid-19 test twice and was positive. Patient was treated with Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2023-738502 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738502:Wife case (Monovalent product)
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 010M20A and 030H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .25 milliliter. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine dose on 05-Jan-2021 and second Moderna vaccine dose on 03-Mar-2021).    No concomitant medications were reported.  On 23-Aug-2023, the patient received Pfizer bivalent Covid-19 vaccine (that was intended for use in patients having ages 12 and above of dose 0.3 ml given via intramuscular route in her left arm in the afternoon) that was 2 days past 10-week allowance in the refrigerator. It was given at 72 days and not at 70 days that was allowed, having it's in refrigerator beyond use date as 21-Aug-2023. Currently, patient had no issues. The patient did not receive the Moderna bivalent dose and was due for a bivalent dose.  No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: My right arm developed a large hive, very hot, and red below the injection site; same location was painful to the touch and ached; My right arm developed a large hive, very hot, and red below the injection site; My right arm developed a large hive, very hot, and red below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (My right arm developed a large hive, very hot, and red below the injection site), INJECTION SITE ERYTHEMA (My right arm developed a large hive, very hot, and red below the injection site), INJECTION SITE URTICARIA (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE PAIN (same location was painful to the touch and ached) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On 16-Aug-2023, the patient experienced INJECTION SITE ERYTHEMA (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE URTICARIA (My right arm developed a large hive, very hot, and red below the injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE PAIN (same location was painful to the touch and ached). On 22-Aug-2023, INJECTION SITE WARMTH (My right arm developed a large hive, very hot, and red below the injection site), INJECTION SITE ERYTHEMA (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE URTICARIA (My right arm developed a large hive, very hot, and red below the injection site) had resolved. At the time of the report, INJECTION SITE PAIN (same location was painful to the touch and ached) outcome was unknown.            No concomitant or treatment medications were provided. It was reported that the reactions with previous Moderna Covid injections were similar in reaction but not as severe as this time. Reactions were lasted through 18-Aug-2023 and started to reduce slowly through 21-Aug-2023. On 22-Aug-2023 the hive was gone, skin temperature normal, no pain or achiness, and only a pink color instead of red.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 048B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient experienced symptoms of itchiness, rash, and felt annoyed and sleeplessness.  Diagnosis of eczema was received on May-2022. Patient treatment medication included  cream, oral steroids, topical steroids. Patient also read on internet that Moderna vaccination was associated with delayed skin conditions.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2023: Live follow up has been appended.
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient who received a dose was administered 0.2 mL from the dark pink cap vial; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female 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.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial).    It was unknown if the patient was vaccinated with any other vaccinations 4 weeks prior to the COVID-19 vaccine.  Concomitant medication not reported.   Two patients were involved. The facility ordered Bivalent Moderna COVID-19 Vaccines, but they only got the dark pink cap vials. They had two patients, one that was 8 months and 7 days who had not received the dose and one that was 6 months and 2 days who had received a dose. The patient who received a dose was administered 0.2 mL from the dark pink cap vial (lot number 216K22A). Both patients were previously unvaccinated.  Treatment medication not reported.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 21-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent) 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 INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent).    No concomitant medication was reported. Patient was not previously vaccinated.  No treatment medication was reported.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023; No adverse event; 42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7661B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Aug-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 27-Aug-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 (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023).    No concomitant medication was reported.  Vial size was reported as 2.5 ml. Vial did not undergo temperature excursion. It was reported that MFG lot number expiration date was extended to OCT2023. No treatment medication was reported
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023; No adverse event; Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Aug-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 28-Aug-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 (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. The 2.5 ml vial didn't undergo any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-738725 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738725:same reporter ( Patient 2)
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 0554A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 08-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (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 expired vaccine).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial did not undergo any temperature excursions.  Vial size given as 10 dose vial.  Vial was initially stored in the refrigerator on 07 Apr 2023 and Date of administration of vaccine on 08 Apr 2023.  Treatment medication not reported.  This case was for patient 1 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-738752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738752:Patient 2
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0554A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Apr-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 expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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 expired vaccine).    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Vial size was initially stored in refrigerator 07-APR-2023. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738751 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738751:Patient 1
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she had Covid last Dec2022; she had Covid last Dec2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown (booster), single (Lot number: GJ3277) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FJ4991) and as dose number unknown (booster), single (Lot number: FF2590) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "she had Covid last Dec2022". Clinical course: The patient would be travelling to overseas in October and said that she got the original and the booster shot. She had 3 boosters with lot numbers GJ3277, FF2590, FJ4991 from her vaccination card. She added that she would like to get the newest booster but was not out yet. She wanted to know if she wanted to get the old one or should she wait.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lung Cancer" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 15Aug2023 to 20Aug2023. Clinical course: Patient also received concomitant medication in the time of administration of Paxlovid that are Sertraline, Bupropion SR on 31Jul2023 and Atorvastatin from 31Jul2023 to 15Aug2023.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna; vaccine dose number=4; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL9262), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Sep2022 as dose 4 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Vaccine brand other=Moderna; vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 16Aug2023 to 20Aug2023. Patient had no known allergies; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported events 'Drug Ineffective' and Covid-19. Interchange of vaccine products might have played a causal role in the reported events.,Linked Report(s) : US-PFIZER INC-202300285826 same patient, different drug/event;
Age: 66.0
Sex: F
Vaccine: 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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Hydroxychloroquine, reaction(s): "Known allergies: hydroxychloroquine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: When asked if this was a report about covid treatment, stated as Yes. The patient was not pregnant at the time of vaccination. Other medication in 2 weeks: Unknow. Anti-viral details included COVID-19 Treatment, Brand: Paxlovid, start date 05Aug2023 and stop date 08Aug2023. Developed rebound of Covid 4 days after finishing Paxlovid from 17Aug2023 09:00 PM, received no treatment and was recovering at the time of this report.  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, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Took 1st 3 vaccines from Pfizer, next 2 boosters Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-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) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Took 1st 3 vaccines from Pfizer, next 2 boosters Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 11Nov2014; NORTRIPTYLINE, start date: 01May2018. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on day #6; Faint positive, notes: Faint positive on those days; Florid positive, notes: Florid positive test on day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.; Sender's Comments: Based on the information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2, BNT162B2 OMI BA.4-5 administration.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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), on 05May2023 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: OMEPRAZOLE, start date: 05Sep2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment (brand: Pfizer) from 10Aug2023 to 15Aug2023.  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: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (13Aug2023) 80 over 50; SARS-CoV-2 test: (13Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: patient has had both Pfizer boosters. He contacted Covid on 11Aug. He was tested on the 13th and started Paxlovid on the 13th.  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.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Laboratory test, Mobility decreased, Monoplegia, Pain
Clinical narrative: I started getting paralysis in the arm; My arm got really sore; Pain is excruciating, on 1-10 its 9.5, its from the injection site up a little and all way down to my arm; Fever; cannot move it/ can barely move; I was moving it very slowly and its very painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient's relevant medical history included: "Pulmonary fibrosis" (unspecified if ongoing). Concomitant medication(s) included: OFEV taken for pulmonary fibrosis. The following information was reported: PYREXIA (non-serious) with onset 25Aug2023, outcome "unknown", described as "Fever"; MONOPLEGIA (medically significant) with onset 25Aug2023, outcome "unknown", described as "I started getting paralysis in the arm"; PAIN (non-serious) with onset 25Aug2023, outcome "unknown", described as "I was moving it very slowly and its very painful"; PAIN IN EXTREMITY (non-serious) with onset 25Aug2023, outcome "unknown", described as "My arm got really sore"; VACCINATION SITE PAIN (non-serious) with onset 25Aug2023, outcome "unknown", described as "Pain is excruciating, on 1-10 its 9.5, its from the injection site up a little and all way down to my arm"; MOBILITY DECREASED (non-serious) with onset 25Aug2023, outcome "unknown", described as "cannot move it/ can barely move". Therapeutic measures were taken as a result of monoplegia, pain in extremity, vaccination site pain, pyrexia, mobility decreased, pain. The patient got a shot of that Prevnar 20 the day before 26Aug2023 and it was in 3 hours his arm got really sore. He had excruciating pain up to like a number 10. He had this shot around 4 O'clock, 5 O'clock, pain started about 7 O'clock and then around 9 O'clock he started getting paralysis in the arm, he cannot move it and I was moving it very slowly and its very painful and he got a slight fever he thought from that. The pain was excruciating, on 1-10 its 9.5, it was from the injection site up a little and all way down to his arm and he can barely move. He had a lab test when prescribed the medication, it was physical. The treatment included Excedrin.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.