chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: FluLaval given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 7-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 5M2H2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2023, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th February 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comment: The reporter reported a similar situation that involved Engerix B, but they realized that Flulaval QIV was also involved.  The reporter was consented to follow up. Additional supportive information: The patient received FluLaval Quadrivalent vaccine after a below temperature excursion, which led to incorrect storage of drug. This case is linked with case US2023025426 and US2023024476 reported by same reporter for other patients.; Sender's Comments:  US-GSK-US2023025426:Same reporter - other male patient US-GSK-US2023024476:Same reporter - Engerix B case
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 12/27/2022, 2nd on 1/16/2023; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number PC53Y, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe (batch number unknown, expiry date 30th June 2023) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 16th January 2023, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 16th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's comment: The Nurse reported that an infant received the first dose of Flulaval on 27 February 2022 and 2nd dose on 16 January 2023.  The reporter consented to follow up via postal. The Vaccine Administration Facility is the same as Primary Reporter. Additional supportive information: The patient received the 2nd dose, two weeks after the 1st dose Flulaval leading to shortening of vaccination schedule.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: 2 patients received their dose of SHINGRIX from the same reconstituted vial Unsure if patients received partial doses; Wrong technique in drug usage process; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 5yr3p, expiry date 17th June 2024) for prophylaxis.   On 13th February 2023, the patient received the 1st dose of Shingrix. On 13th February 2023, unknown after receiving Shingrix, the patient experienced underdose and wrong technique in drug usage process. On an unknown date, the outcome of the underdose and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter who stated that patient received their dose of Shingrix from the same reconstituted vial.  She stated that she was unsure if one patient got a full dose and the other received no dose or if both patient received partial doses. The reporter reported about a patient who potentially received Shingrix underdose. The reporter consented to follow up. Additional Supportive Information: The reporter reported about a patient who potentially received Shingrix underdose, which led to underdose and wrong technique in drug usage process. This was 2 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026659:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Unsure if patients received partial doses; wrong technique in drug  usage process; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 5yr3p, expiry date 17th June 2024) for prophylaxis.   On 13th February 2023, the patient received the 1st dose of Shingrix. On 13th February 2023, unknown after receiving Shingrix, the patient experienced underdose and wrong technique in drug usage process. On an unknown date, the outcome of the underdose and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter who stated that patient received their dose of Shingrix from the same reconstituted vial.  She stated that she was unsure if one patient got a full dose and the other received no dose or if both patient received partial doses. The reporter reported about a patient who potentially received Shingrix underdose. The reporter consented to follow up. Additional Supportive Information:The reporter reported about a patient who potentially received Shingrix underdose, which led to underdose and wrong technique in drug usage process. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026657:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received back in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The report called to inquire about Shingrix information for a person who received the first dose back in 2019.  The reporter wanted to know when should they get the second dose. The reporter stated that pharmacy told her to call us and during gathering additional AE details about the person before transfer to agency. The caller stated that let me get back with you and then caller hung up. The reporter did not provide vaccine or patient details. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dosegiven to an adult; Pediatric dosegiven to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   On 16th February 2023, the patient received the 2nd dose of Engerix B pediatric. On 16th February 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comments: The medical assistant reported that the adult patient received pediatric second dose of Engerix B. The reporter consented to follow up by email.  Additional Supportive Information: The adult patient received pediatric second dose of Engerix B, which led to underdose and adult use of a child product.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 16Feb2023, 1st a month ago/ 1 month after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number FG7RF, expiry date 21st April 2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16th February 2023, the patient received the 2nd dose of Shingrix. On 16th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 16-Feb-2023. Reporter's Comment: The pharmacist reported that the 2nd dose of Shingrix was given only 1 month after the 1st dose to a patient. The reporter consent to follow-up. Additional Supportive Information: Patient received 2nd dose early than the recommended schedule, which led to shortening of vaccination schedule.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AB377, expiry date 29th September 2023) for prophylaxis.   On 16th February 2023, the patient received the 1st dose of Shingrix. On 16th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that on 16th February 2023 the patient received only the AS01B adjuvant portion of the Shingrix vaccine. The reporter did consent to follow up. Additional supportive information: Only adjuvant of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Bilater swollen knees; pain, could be related to Osteoarthritis; This case was reported by a physician via call center representative and described the occurrence of swelling of knees in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis.   In November 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling of knees and pain. On an unknown date, the outcome of the swelling of knees was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the swelling of knees and pain to be related to Shingrix.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment:  The reporter reported that a friend received Shingrix on November 2022 (not exact date provided) and developed bilateral swollen knees after it. Symptoms abated 1-2 weeks after the episode. The patient remained with pain but could be related to Osteoarthritis (patient had Osteoarthritis before receiving Shingrix but was not under treatment)  The facility of administration unknown. The reporter did not consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Jun2022, did not complete the series; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (on 22nd June 2022 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter reported that the patient did not return for the rest of the series of the Twinrix. The reporter consented to follow up by postal. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. This case was linked with US2023026720 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023026720:Same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 2018, 2nd on 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   Previously administered products included Shingrix (On 13th June 2018, received 1st dose ).   On 15th September 2022, the patient received the 2nd dose of Shingrix. On 15th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 17-Feb-2023. Reporters Comment: Reporter enquired about the third dose. Confirmed no third dose administered. The reporter did not consent to follow-up. Additional Supportive Information: Patient received 2nd dose of Shingrix late than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: The reporter called to report an expired dose of Havrix was administered to a patient. The lot number for the vaccine was asked but declined. The reporter consented to follow up via email. Additional Supportive Information: The reporter called to report an expired dose of Havrix was administered to a patient, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Echocardiogram
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 50 year old female . The patient's weight was 120 pounds, and height was 63 inches. The patient's concurrent conditions included: atrial fibrillation (first episode in MAY-2019). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 into left arm for covid-19 prophylaxis. Age at time of vaccination 50 years old. No concomitant medications were reported.  On unspecified date in APR-2021, few days later after the vaccination patient had second episode of atrial fibrillation. Patient had more episodes like heart palpitation, shortness of breath, weakness and all symptoms of atrial fibrillation. The patient had an ER (emergency room) visit on April 2021. The patient stated that she had episodes of atrial fibrillation every two weeks, which was more frequently. On an unspecified date in AUG-2022, patient had visit to cardiologist. On an unspecified date in AUG-2022, patient had an echo ultrasound on the heart and which result that the heart structure was good "heart looked normal". The physician was unable to tell what the cause was. On an unspecified date in DEC-2022, patient had visit to Electrophysiologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230252476-Atrial fibrillation . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: MENSTRUAL CYCLE DYSREGULATED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual cycle dysregulated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual cycle dysregulated was not reported. This report was non-serious. This case, from the same reporter is linked to 20230247687.
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He received the whole primary series and one boosters with Pfizer's COVID-19 Vaccine and one of the boosters was from Moderna. However, he tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He received the whole primary series and one boosters with Pfizer's COVID-19 Vaccine and one of the boosters was from Moderna. However, he tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (He received the whole primary series and one boosters with Pfizer's COVID-19 Vaccine and one of the boosters was from Moderna. However, he tested positive for COVID-19). At the time of the report, COVID-19 (He received the whole primary series and one boosters with Pfizer's COVID-19 Vaccine and one of the boosters was from Moderna. However, he tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2023, SARS-CoV-2 test: (Positive) Tested positive again. On an unknown date, SARS-CoV-2 test: Positive.         Concomitant product use was not provided by the reporter.    The patient was fully vaccinated, received the whole primary series and one boosters with Pfizer's COVID- 19 vaccine and one of the boosters was from Moderna. However, patient tested positive for COVID-19. At the time of the report, patient had to take Paxlovid whose last dose was the Sunday prior to the report and on the day of this report patient tested positive again for COVID-19.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 1805018) for COVID-19 prophylaxis.     It was unknown that patient had any acute illness or any chronic or long-standing health conditions.    On 20-Mar-2021 at 9:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Dec-2021 at 10:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Dec-2021 at 10:19 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-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 had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704639 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704639:Bivalent Dose
Sex: F
Vaccine: COVID19-2
Symptoms: Blister, Burning sensation, Chills, Erythema, Feeling hot
Clinical narrative: Burning sensation; Cannot sleep at night; Fever; Vomiting; Chills; Sickness; Cold; Feeling hot; Pain in arm; I cant hardly lift it, when i pick up something / i can't hardly raise that arm; Blister; Lip pain; Face so red; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-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 27-Oct-2022, the patient experienced ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm), MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm), BLISTER (Blister ), LIP PAIN (Lip pain), ERYTHEMA (Face so red) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation), INSOMNIA (Cannot sleep at night), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, ILLNESS (Sickness) had not resolved and NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm), MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm), BLISTER (Blister ), LIP PAIN (Lip pain), ERYTHEMA (Face so red), BURNING SENSATION (Burning sensation), INSOMNIA (Cannot sleep at night), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter.  Patient felt so bad, lips were hurting so bad like they have fluid in them. COVID-19 shot broke patient out all over the face, neck, back and legs. Running a fever. Patient could not keep water down or anything. It was reported that patient received Dose 1 on 01-Mar-2020 with lot 006M20A, Dose 2 on  29-Mar-2020 with lot 064A21A , Dose 3 on 06-Jan-2022 , Dose 4 on 29-Apr-2022 from moderna.  No treatment medication reported by reporter.   This case was linked to MOD-2023-712194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Significant live follow-up received. Events added. Patient details added.
Sex: F
Vaccine: COVID19-2
Symptoms: Illness, Insomnia, Lip pain, Mobility decreased, Nasopharyngitis
Clinical narrative: Burning sensation; Cannot sleep at night; Fever; Vomiting; Chills; Sickness; Cold; Feeling hot; Pain in arm; I cant hardly lift it, when i pick up something / i can't hardly raise that arm; Blister; Lip pain; Face so red; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-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 27-Oct-2022, the patient experienced ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm), MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm), BLISTER (Blister ), LIP PAIN (Lip pain), ERYTHEMA (Face so red) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation), INSOMNIA (Cannot sleep at night), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, ILLNESS (Sickness) had not resolved and NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm), MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm), BLISTER (Blister ), LIP PAIN (Lip pain), ERYTHEMA (Face so red), BURNING SENSATION (Burning sensation), INSOMNIA (Cannot sleep at night), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter.  Patient felt so bad, lips were hurting so bad like they have fluid in them. COVID-19 shot broke patient out all over the face, neck, back and legs. Running a fever. Patient could not keep water down or anything. It was reported that patient received Dose 1 on 01-Mar-2020 with lot 006M20A, Dose 2 on  29-Mar-2020 with lot 064A21A , Dose 3 on 06-Jan-2022 , Dose 4 on 29-Apr-2022 from moderna.  No treatment medication reported by reporter.   This case was linked to MOD-2023-712194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Significant live follow-up received. Events added. Patient details added.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Burning sensation; Cannot sleep at night; Fever; Vomiting; Chills; Sickness; Cold; Feeling hot; Pain in arm; I cant hardly lift it, when i pick up something / i can't hardly raise that arm; Blister; Lip pain; Face so red; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-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 27-Oct-2022, the patient experienced ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm), MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm), BLISTER (Blister ), LIP PAIN (Lip pain), ERYTHEMA (Face so red) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation), INSOMNIA (Cannot sleep at night), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, ILLNESS (Sickness) had not resolved and NASOPHARYNGITIS (Cold), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Pain in arm), MOBILITY DECREASED (I cant hardly lift it, when i pick up something / i can't hardly raise that arm), BLISTER (Blister ), LIP PAIN (Lip pain), ERYTHEMA (Face so red), BURNING SENSATION (Burning sensation), INSOMNIA (Cannot sleep at night), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter.  Patient felt so bad, lips were hurting so bad like they have fluid in them. COVID-19 shot broke patient out all over the face, neck, back and legs. Running a fever. Patient could not keep water down or anything. It was reported that patient received Dose 1 on 01-Mar-2020 with lot 006M20A, Dose 2 on  29-Mar-2020 with lot 064A21A , Dose 3 on 06-Jan-2022 , Dose 4 on 29-Apr-2022 from moderna.  No treatment medication reported by reporter.   This case was linked to MOD-2023-712194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Significant live follow-up received. Events added. Patient details added.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: My psoriasis inflamed; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (My psoriasis inflamed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis.    In August 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (My psoriasis inflamed). At the time of the report, PSORIASIS (My psoriasis inflamed) had not resolved.            Concomitant medications were not reported.  The patient received the booster and it was patient's 4th shot. Patient's psoriasis inflamed and won't go away. The patient received the shot back in August and the doctors and patient's dermatologist had been giving patient creams and pills to try to get the inflammation down. The patient wanted to know what patient can do to counter act it. It was itching and was driving patient crazy.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049G264, 066H264, 006M20A and 064A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022). 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 Dose 3  on 06-Jan-2022 and Dose 4 on 29-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2023-712185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Non-significant follow up received.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 doses of the vaccine were given today after they expired on 13FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) 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. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 (2 doses of the vaccine were given today after they expired on 13FEB2023).    No concomitant medications was reported.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had no reported symptoms.   No additional medications, doses, or treatments medications was reported.  This case contains information for the 2nd out of 2 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-711019 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711019:Master case - 1st child
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Patient only experienced headache and nausea during 24 hours after 2nd shot; Patient only experienced headache and nausea during 24 hours after 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Patient only experienced headache and nausea during 24 hours after 2nd shot) and NAUSEA (Patient only experienced headache and nausea during 24 hours after 2nd shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 001A21A, 012521D and 0B6L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Overweight. Concomitant products included LOSARTAN, CHARCOAL, ACTIVATED (CARBOTURAL), HYDROCHLOROTHIAZIDE, AMLODIPINE and POTASSIUM for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Patient only experienced headache and nausea during 24 hours after 2nd shot) and NAUSEA (Patient only experienced headache and nausea during 24 hours after 2nd shot). At the time of the report, HEADACHE (Patient only experienced headache and nausea during 24 hours after 2nd shot) and NAUSEA (Patient only experienced headache and nausea during 24 hours after 2nd shot) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient didn't received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710993 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710993:Bivalent case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; dose administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) 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. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-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 04-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (dose administered after the 30 day BUD).    Concomitant drugs were not reported.  Dosage text for suspect product was reported as unknown.  It was reported that 4 bivalent doses in total were administered to adult patients after the 30 day BUD. Two doses administered on 04-Feb-2023, one on  05-Feb-2023 and one dose on 16-Feb-2023. It was also reported that patient had no reported symptoms. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No additional doses, medications or treatments were administered in response.  This case was reported for adult patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-711667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711667:Master case - 1st adult
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 doses in total were administered after the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) 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. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD).    4 doses in total were administered after the 30 day BUD. 2 doses on 4FEB2023, 1 dose on 5FEB2023, and 1 dose on16FEB2023. No reported symptoms. No additional doses medications or treatments administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2023-711667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711667:Master case - 1st adult
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4 doses in total were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) 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. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-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 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (4 doses in total were administered after the 30 day BUD).    This case was reported for adult patient 4.  No concomitant medications were reported.  It was reported that 4 bivalent doses in total were administered to adult patients after the 30 day BUD. Two doses administered on 04-Feb-2023, one dose on 05-Feb-2023 and one dose on 16-Feb-2023. It was also reported that patient had no reported symptoms.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711667:Master case - 1st adult
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: low level fatigue for a day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (low level fatigue for a day) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-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 an unknown date, the patient experienced FATIGUE (low level fatigue for a day). At the time of the report, FATIGUE (low level fatigue for a day) had resolved.        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 product information was not provided by the reporter.   Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711664 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711664:Monovalent case