chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site; General Arm pain; they are barely able to use the arm, due to the pain; HCP hit the bone while injecting  dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2023, the patient received the 2nd dose of Shingrix. On 10th January 2023, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On 13th January 2023, the patient experienced injection site pain, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, pain in arm and injected limb mobility decreased were not recovered/not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Shingrix.     Additional Information: GSK receipt date: 13 JAN 2023 Reporters comment:  The reporter reported that the patient received the 2nd dose of Shingrix on Tuesday 10th January 2023. The reporter stated that the patient experienced pain at the injection site, general arm pain and was barely able to use the arm on Friday 13th January 2023. The patient administered the dose advised they had hit the bone while injecting the dose. Additional  supportive information: As patient had hit the bone while injecting the dose which led to wrong technique in drug usage process. The reporter did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20th May 2024) for prophylaxis.   On 13th January 2023, the patient received Shingrix. On 13th January 2023, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The physician called to report that Shingrix suffer temperature excursion and was administered to a patient. The vaccine was exposed to minus 10 degree Fahrenheit. The reporter consent to follow up via email. Additional supportive information: The vaccine was exposed to -10 degree Fahrenheit, which led to incorrect storage of drug.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 1st January 2023) 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.   In January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In January 2023, unknown after receiving Twinrix and Twinrix 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: 13-JAN-2023 Reporter's comments: A pharmacist had called up to ask for information regarding the expiration date of Twinrix. The reporter had asked if there was information about extended stability after the expiration date of Twinrix. The reporter had mentioned that her vaccine got expired on 1st January 2023. The reporter had confirmed that the expired dose was administered to a patient. However, she declined to share information about the patient and the vaccine lot number. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Shingrix, which had led to expired vaccine used.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Incorrect dose administered, Needle issue
Clinical narrative: Received part of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number B97G2, expiry date 26th January 2024) for prophylaxis.   On 13th January 2023, the patient received the 1st dose of Shingrix. On 13th January 2023, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's comments: Pharmacist had stated during administration of a Shingrix dose to a 50 year old patient,  the needle had dislodged and part of the product had leaked out.  The patient only had received a part of the vaccine, and the amount actually received was unknown.  This was the patient's first dose in the series. The reporter consented to follow-up. Additional supportive information: At the time of reporting, the needle had dislodged and part of the product had leaked out, which had led to Incomplete dose administered.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Injection site erythema, Pain in extremity
Clinical narrative: Arm pain/ rotator cuff contributes to arm pain; 1st dose in 2020, 2nd dose on 2023; Redness at injection site; Chills/ shivering; Fatigue; Heart palpitations; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2020).   On 12th January 2023, the patient received the 2nd dose of Shingrix. On 12th January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th January 2023, the patient experienced pain in arm, injection site erythema, chills, fatigue and palpitation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site erythema, chills, fatigue and palpitation were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, injection site erythema, chills, fatigue and palpitation to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received first dose of Shingrix vaccine on November 2020 and the second dose was received on 12th January 2023. The patient reported that there was no adverse reaction after the first dose. The patient stated than on 13th January 2023, 1 day after received Shingrix vaccine she experienced arm pain, redness at injection site, chills, shivering, fatigue, and heart palpitations. The patient reported that the redness, chills, shivering, fatigue and heart palpitation are resolved after 2 days. The patient stated that the arm pain was ongoing.  The patient believed that she had a rotator cuff in need of replacement was a contributing to the arm pain, but also noted that they did not experience this type of pain when receiving other vaccinations in the same arm, nor did the pain with other vaccinations last for as many days. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Arm pain/ rotator cuff contributes to arm pain; 1st dose in 2020, 2nd dose on 2023; Redness at injection site; Chills/ shivering; Fatigue; Heart palpitations; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2020).   On 12th January 2023, the patient received the 2nd dose of Shingrix. On 12th January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th January 2023, the patient experienced pain in arm, injection site erythema, chills, fatigue and palpitation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site erythema, chills, fatigue and palpitation were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, injection site erythema, chills, fatigue and palpitation to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received first dose of Shingrix vaccine on November 2020 and the second dose was received on 12th January 2023. The patient reported that there was no adverse reaction after the first dose. The patient stated than on 13th January 2023, 1 day after received Shingrix vaccine she experienced arm pain, redness at injection site, chills, shivering, fatigue, and heart palpitations. The patient reported that the redness, chills, shivering, fatigue and heart palpitation are resolved after 2 days. The patient stated that the arm pain was ongoing.  The patient believed that she had a rotator cuff in need of replacement was a contributing to the arm pain, but also noted that they did not experience this type of pain when receiving other vaccinations in the same arm, nor did the pain with other vaccinations last for as many days. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received HAB (Twinrix adult) (batch number unknown, expiry date 1st January 2023) 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.   Concurrent medical conditions included hypertension and renal disease.   On 17th January 2023, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 17th January 2023, unknown after receiving Twinrix adult and Twinrix 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: 17-JAN-2023 Reporter comment: The patient received a dose of Twinrix that expired on 1st January 2023. Nothing else was reported. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix vaccine which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 66-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   On 17th January 2023, the patient received the 1st dose of Engerix B pediatric. On 17th January 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: 18-JAN-2023 Reporter's Comment: The reporter reported that the adult patient received a pediatric dose of Engerix B instead of the adult dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The adult patient was administered a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Administration 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 an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patients received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patients 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: 19-Jan-2023 Reporter's comment: A medical assistant reported that Bexsero vaccines were exposed, in October 2022, to a temperature of 8.7 degree Celsius for 120 hours (temperature excursion determined that vaccines were no longer viable).  The vaccines were administered to an unknown quantity of patients.  The reporter mentioned that once she got the information she would call and provide information about patients who received the vaccine. Additional supportive information: The patients received Bexsero vaccine after temperature excursion, which led to incorrect storage of drug.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero 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 male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Bexsero and Bexsero 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: 19-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expire dose of Bexsero, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to an adult; Pediatric dose administered to an adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number yy203, expiry date 4th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2023, the patient received Engerix B pediatric 10 µg and Engerix B Pre-Filled Syringe Device. On 17th January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, 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.     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: 19-Jan-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: An adult patient was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: 1st dose 10jan2023, 2nd 17Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 17th January 2023, the patient received the 2nd dose of Boostrix. On 17th January 2023, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The health center manager called to inquired how to proceed or what to look for  or any harm to the patient. The reporter mentioned the first dose of Boostrix was administered in the facility but in a different department and the second dose was administered in the facility but in their department. Did not consent to follow-up. Additional supportive information: The patient received the second dose of Boostrix, which led to extra dose administered.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix administered subcutaneously; This case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Shingrix (subcutaneous). On 19th January 2023, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The patient's daughter called on behalf of the patient. The  dose of Shingrix was administered subcutaneously, in the back of the patient's left arm. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Diluent not mixed with  powder; Only diluent was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number B2C9F, expiry date 11th February 2024) for prophylaxis.   On 19th January 2023, the patient received Shingrix. On 19th January 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: 19-Jan-2023 Reporter's comment: The licensed practical nurse called to inquired that any guidance. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered the Shingrix diluent (AS01b) component only without the lyophilized powder component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Reynaud's (some circulatory issues), penicillin allergy, alcohol user (couple of times a week, moderate), and cigarette smoker (10 cigarettes a day, half a pack), and other pre-existing medical conditions included: The patient had no history of any drug abuse or illicit drug usage. Patient had been in good health at the time of vaccination. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total administered on 03-APR-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following first dose of vaccination (Dose number in series 1). The patient also received dose 2 (first booster) with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose was not reported, 1 total administered on 12-NOV-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first booster (Dose number in series 2). The patient received additional dose 3 (second booster) with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 total administered on 08-APR-2022 to left arm for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (Dose number in series 3). Age at time of vaccination 64 years old. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Myelopathy, Swelling face
Clinical narrative: I was diagnosed with 'cervical myelopathy'.; I had swelling of right side of my face, near nose & eye area; severe pain in the back of my head; This spontaneous case was reported by a patient and describes the occurrence of MYELOPATHY (I was diagnosed with 'cervical myelopathy'.) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:I already have migraines & allergy stuff.  Concurrent medical conditions included Migraine and Allergy NOS.    On 14-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELOPATHY (I was diagnosed with 'cervical myelopathy'.) (seriousness criterion medically significant), SWELLING FACE (I had swelling of right side of my face, near nose & eye area) and HEADACHE (severe pain in the back of my head). The patient was treated with HYDROCODONE at an unspecified dose and frequency; CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 milligram. At the time of the report, MYELOPATHY (I was diagnosed with 'cervical myelopathy'.) and SWELLING FACE (I had swelling of right side of my face, near nose & eye area) had not resolved and HEADACHE (severe pain in the back of my head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: After 2 MRIs, I was diagnosed with 'cervical myelopathy'.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had had swelling of right side of face, near nose & eye area before the head pain. Patient had severe pain in the back of head that began a few weeks after getting the 1st dose. Patient going to see a surgical spine surgeon soon, because they said they saw something else on the 2nd MRI.  Company comment: This spontaneous case concerns a 61-year-old patient of unknown gender with no relevant medical history, who experienced the unexpected serious (medically significant) event of Myelopathy (cervical myelopathy) which occurred unknown days after administration of first dose of mRNA-1273 vaccine. Patient had severe pain in the back of head that began a few weeks after getting the vaccine. MRI was performed and patient was diagnosed with cervical myelopathy. The patient was treated with hydrocodone, cefixime, and ibuprofen. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case belongs to adult patient 6 of the 17 adult patients reported.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received and contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.            Concomitant product information was not provided by the reporter.   It was reported that patient had a stroke following the second moderna shot.  Treatment information was not provided.  Company comment: This is a spontaneous case regarding a male patient of an unknown age, with no reported medical history, who experienced unexpected and medically significant event of cerebrovascular accident (AESI) after receiving mRNA-1273 vaccine, reported as the second dose of the COVID-19 vaccination schedule. Vaccination date and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-698692.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698692:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 25th of 40 adult patients.  Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 28th of 40 adult patients. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 34th of 40 adult patients.  Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650: case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case