chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Product leakage
Clinical narrative: nurse was attempting to withdraw Shingrix adjuvant from the vial and the adjuvant shot out; leaked onto the nurse's skin; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix (cutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced accidental occupational exposure to product (Verbatim: nurse was attempting to withdraw Shingrix adjuvant from the vial and the adjuvant shot out), exposure via skin contact (Verbatim: leaked onto the nurse's skin) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental occupational exposure to product, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date:15-NOV-2023 The reporter was the healthcare professional (practice manager). An experienced nurse was attempting to withdraw Shingrix adjuvant from the vial and the adjuvant shot out and leaked onto the nurse's skin. The product was not administered to a patient. It was confirmed that all operations were performed appropriately before defect was discovered. The vial held upside-down when the vaccine was being withdrawn. The nurse tried to inject 0.5 ml into the adjuvant vial prior to withdrawing, but air would not go into vial. Vial felt too pressurized to accept the air. The leak occurred when trying to withdraw the adjuvant. The leak was from needle puncture in the stopper. The vial rubber stopper/metallic skirt did not detach or become loose. The plastic flip-off or also the metallic skirt/ring of the vial before handling. There was no evidence of leakage in package or carton. The suspect (adjuvant) vial was discarded in sharps container and was not available for return to GSK. The reporter consented to follow up.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: a pediatric dose of Engerix-B was administered to an adult patient; a pediatric dose of Engerix-B was administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 32-year-old male patient who received HBV (Engerix B pediatric) (batch number 97KT7) for prophylaxis.   On 15-NOV-2023, the patient received Engerix B pediatric. On 15-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: a pediatric dose of Engerix-B was administered to an adult patient) and underdose (Verbatim: a pediatric dose of Engerix-B was administered to an adult patient). The outcome of the adult use of a child product and underdose 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: 15-NOV-2023 The nurse called to inform that earlier that day, a pediatric dose of Engerix-B was administered to an adult patient which led to Adult use of a child product and underdose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Nov-2023 At the time of reporting, a second dose has not been administered.  Pharmacist did not had the lot number/expiration date information of the first dose. Reporter gave permission for follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose of Shingrix in March 2020 and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the 1st dose of Shingrix in March 2020 and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2023 The pharmacist reported that the patient was late for the 2nd dose. The healthcare professional did not know the exact date of 1st dose given. The reporter had consented to follow up via email. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo was reconstituted with sterile water instead of the supplied adjuvant; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA761A, expiry date 30-NOV-2023) for prophylaxis.   On 09-NOV-2023, the patient received Menveo. On 09-NOV-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile water instead of the supplied adjuvant) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2023 The vaccine administration facility was the same as primary reporter The health care professional (HCP) stated that Menveo was reconstituted with sterile water instead of the supplied adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via postal.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: inadvertently administered two Engerix pediatric doses to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 29-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 05-APR-2024) for prophylaxis.   On 15-NOV-2023, the patient received the 1st dose of Engerix B pediatric 10 ug and the 2nd dose of Engerix B pediatric 10 ug. On 15-NOV-2023, an unknown time after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: inadvertently administered two Engerix pediatric doses to an adult). The outcome of the adult use of a child product 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-NOV-2023 The medical assistant reported that they had inadvertently administered two Engerix pediatric doses to an adult patient (employee) on the date of reporting to complete an adult dose, which led to adult use of the child product. The reporter inquired was dose valid. The reporter did not consent to follow-up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a patient received an expired dose of Kinrix today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 15-NOV-2023, the patient received Kinrix. On 15-NOV-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: a patient received an expired dose of Kinrix today). 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: 15-NOV-2023 The LVN (licensed vocational nurse) reported that a patient received an expired dose of Kinrix today (on the day of reporting), which led to an expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, Incorrect route of product administration
Clinical narrative: Flu vaccine was administered subcutaneously instead of intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2023-2024 season (subcutaneous) and Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season and Fluarix Quadrivalent 2023-2024 season, the patient experienced inappropriate route of vaccination (Verbatim: Flu vaccine was administered subcutaneously instead of intramuscularly). The outcome of the inappropriate route 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: 15-NOV-2023 A licensed practical nurse (LPN) called to inquire if the vaccine was considered valid and if not, how would one proceed, should the patient be revaccinated. The LPN stated a patient reported to the doctor that they received a Flu shot at another facility within the last couple of weeks but thought it was not administered correctly.  The patient thought the unknown Flu vaccine was administered subcutaneously instead of intramuscularly, and asked if that dose would still count. The LPN mentioned they did not know what Flu vaccine was administered to the patient that inquired about information because it was administered somewhere else.  The LPN stated they called GlaxoSmithKline for information because that's the Flu vaccines they used in their facility just for a general answer. The LPN confirmed they did not administer the patient's Flu vaccine and does not know what brand of Flu vaccine the patient received. The reporter did not consent to follow-up. The patient received the Flu vaccine subcutaneously, which led to inappropriate route of vaccination.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired Infanrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa (Infanrix) (batch number 5N259, expiry date 05-OCT-2023) for prophylaxis.   On 14-NOV-2023, the patient received Infanrix. On 14-NOV-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired Infanrix dose). 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: 15-Nov-2023 The reporter reported that the 2 month old patient received an expired dose of Infanrix vaccine, which led to which led to expired vaccine used. The reporter wanted to know if the dose was considered valid. The reporter did consent to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who got first dose of Twinrix a year ago and 2nd dose a month ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received a year ago on an unknown date).   In OCT-2023, the patient received the 2nd dose of Twinrix. In OCT-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient who got first dose of Twinrix a year ago and 2nd dose a month ago). The outcome of the drug dose administration interval too long 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-NOV-2023 The pharmacist had a patient who got first dose of Twinrix a year ago and 2nd dose a month ago (from the date of reporting).  The reporter wanted to know, patient need to restart series or get the next dose. The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccination schedule.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: came to receive a Shingrix 1st shot but instead he was given a Boostrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 32D42) for prophylaxis.   On 29-AUG-2023, the patient received Boostrix. On 29-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: came to receive a Shingrix 1st shot but instead he was given a Boostrix). The outcome of the wrong vaccine administered 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-NOV-2023 The reporter was the wife of the patient. The patient's wife indicated that her husband (patient) went to the pharmacy on 29-Aug-2023 to receive a Shingles (Shingrix) 1st shot but instead he was given a tetanus shot (Boostrix), which led to wrong vaccine administered. She said that the paperwork he received indicated that he had received a Shingles shot.  Th outbound call was made to pharmacy to clarify.  The pharmacy indicated that their system shows that a digital appointment was made requesting Boostrix and that Boostrix was administered on 29-Aug-2023. Pharmacist indicated that his system goes back two years, and he did not see any record of Shingrix being administered at that pharmacy. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itchiness all over his body from his knees to his head; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included RSV vaccine (Participant in RSV vaccine study for GSK).   In SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, 1 day after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: itchiness all over his body from his knees to his head). The outcome of the generalized pruritus was not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.     It was unknown if the company considered the generalized pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 16-NOV-2023 The reporter was a patient. The patient received the dose of Shingrix and since that following day, the patient had been experiencing itchiness all over his body from knee to his head. Reporter reported that itchiness comes and goes, but was experienced primarily at night. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Headache, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: Pain and soreness at the injection site; redness at the injection site; Nausea; Dry-heaving; Headache; Elevated pulse; High blood pressure; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-NOV-2023, the patient received Arexvy (right arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain and soreness at the injection site), injection site erythema (Verbatim: redness at the injection site), nausea (Verbatim: Nausea), dry heaves (Verbatim: Dry-heaving), headache (Verbatim: Headache), pulse increased (Verbatim: Elevated pulse) and blood pressure high (Verbatim: High blood pressure). The outcome of the injection site pain and injection site erythema were not resolved and the outcome of the nausea, dry heaves, headache, pulse increased and blood pressure high were resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, dry heaves, headache, pulse increased and blood pressure high to be related to Arexvy.  It was unknown if the company considered the injection site pain, injection site erythema, nausea, dry heaves, headache, pulse increased and blood pressure high to be related to Arexvy.   Additional Information: GSK receipt date: 16-NOV-2023 The reporter was the patient who stated that she received Arexvy vaccine and developed some side effects.  According to the patient that was the first time she had a reaction to a vaccine.  The first and the second day after vaccination the patient had nausea, dry-heaving, headache, elevated pulse and high blood pressure.  Reported was having pain, soreness and and redness at the injection site.  The treating physician was not aware of the events after the vaccination. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Retching
Clinical narrative: Pain and soreness at the injection site; redness at the injection site; Nausea; Dry-heaving; Headache; Elevated pulse; High blood pressure; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-NOV-2023, the patient received Arexvy (right arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain and soreness at the injection site), injection site erythema (Verbatim: redness at the injection site), nausea (Verbatim: Nausea), dry heaves (Verbatim: Dry-heaving), headache (Verbatim: Headache), pulse increased (Verbatim: Elevated pulse) and blood pressure high (Verbatim: High blood pressure). The outcome of the injection site pain and injection site erythema were not resolved and the outcome of the nausea, dry heaves, headache, pulse increased and blood pressure high were resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, dry heaves, headache, pulse increased and blood pressure high to be related to Arexvy.  It was unknown if the company considered the injection site pain, injection site erythema, nausea, dry heaves, headache, pulse increased and blood pressure high to be related to Arexvy.   Additional Information: GSK receipt date: 16-NOV-2023 The reporter was the patient who stated that she received Arexvy vaccine and developed some side effects.  According to the patient that was the first time she had a reaction to a vaccine.  The first and the second day after vaccination the patient had nausea, dry-heaving, headache, elevated pulse and high blood pressure.  Reported was having pain, soreness and and redness at the injection site.  The treating physician was not aware of the events after the vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: On 17/Oct/2023, the patient received another dose of; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: On 17/Oct/2023, the patient received another dose of). The outcome of the overdose was unknown.   Additional Information: GSK Receipt date: 16-NOV-2023 Reporter called to informed that a patient that received the 2 doses of Shingrix on same day, which led to overdose. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: only received the diluent; one of the two received the full vaccination and the other only received the diluent; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only received the diluent.) and inappropriate dose of vaccine administered (Verbatim: one of the two received the full vaccination and the other only received the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-NOV-2023 The field representative reported that a husband and wife received the Arexvy vaccine. It was later discovered that one of the two received the full vaccination and the other only received the diluent. The reporter stated that he was informed of that error on morning of reporting day. The event occurred sometime last week from the day of reporting. The reporter had put the healthcare professional (HCP) in touch which the Medical Science Team and he expects they would be following up.  The reporter consented to follow up. The patient received only diluent part of Arexvy vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient received by mistake 2doses of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 324B2, expiry date 30-JAN-2026) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX).   On 15-NOV-2023, the patient received the 2nd dose of Boostrix. On 15-NOV-2023, an unknown time after receiving Boostrix, the patient experienced accidental overdose (Verbatim: patient received by mistake 2doses of Boostrix). The outcome of the accidental overdose was unknown.   Additional Information: GSK receipt date: 16-NOV-2023 HCP mentioned that there were not any previous Tdap vaccine record on patient' s history. The health care professional (HCP) reported that a patient received by mistake 2doses of Boostrix, which led to accidental overdose.  The reporter consented to follow up via email
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pharmacy technician stated that a patient inadvertently received a third dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number GY7P7, expiry date 22-NOV-2025) for prophylaxis.   On 14-NOV-2023, the patient received the 3rd dose of Shingrix. On 14-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Pharmacy technician stated that a patient inadvertently received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 16-NOV-2023 The pharmacy technician stated that a patient inadvertently received a third dose of Shingrix, which led extra dose administered. The reporter consented to follow up via email okay.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered to the reported patients under recommended age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis.   On 10-NOV-2023, the patient received Menveo. On 10-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered to the reported patients under recommended age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 16-Nov-2023 The medical physician called to inquired that how to proceed. The reporter reported the inadvertently administered two patients under the age of 10 the Menveo 1 vial presentation. The reporter mentioned that they carried the Menveo 2 vial presentation before and now had the 1 vial, which they inadvertently administered to the reported patients under recommended age, which led to inappropriate age at vaccine administration. The reporter declined to follow-up from safety. The case was linked with case US2023159125, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023159125:Same Reporter , same Product .
Sex: M
Vaccine: RSV
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: pain and nodule at injection site; pain and nodule at injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain and nodule at injection site) and injection site nodule (Verbatim: pain and nodule at injection site). The outcome of the injection site pain and injection site nodule were unknown.   It was unknown if the reporter considered the injection site pain and injection site nodule to be related to Arexvy.     It was unknown if the company considered the injection site pain and injection site nodule to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-NOV-2023 The caller was a GlaxoSmithKline representative reporting an adverse event for her HCP (health care professional) that she was made aware.  Caller reported it was the HCP himself that experienced the adverse event.  Caller reported 12 days ago (from the date of reporting) the HCP received the Arexvy vaccine and he experienced pain and a nodule at the injection site.  No other information was known. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM POSSIBLY FELT A LITTLE SORE AFTER VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: tartrazine allergy. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm possibly felt a little sore after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm possibly felt a little sore after vaccination was not reported. This report was non-serious.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Pharmacist calling to report a dose of expired PNEUMOVQAX 23 was inadvertently administered to a patient and requesting potency data. The vaccine had never undergone temperature excursion. Date of administration: 11/11/2023, date of expiration: 10/30; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-NOV-2023, the patient was inadvertently vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml, administered for Prophylaxis, lot#: W007035, expiry date was 20-OCT-2023 (also reported as 30-OCT-2023, conflicting information) (anatomical location and route of administration were not provided) (Expired product administered). This vaccine had never undergone temperature excursion.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Infusion site warmth, Injection site erythema, Injection site warmth, Overdose
Clinical narrative: Redness at the injection site; swelling; She reports that 2 pediatric patients (11-year-old and 8-Year-old) received 0.5 ml Spikevax Moderna COVID-19 vaccine 12+ (Lot# 3031283 & Exp. Date: 24APR2024) on 17OCT2023.; Warmth; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE WARMTH (swelling), INFUSION SITE WARMTH (Warmth) and OVERDOSE (She reports that 2 pediatric patients (11-year-old and 8-Year-old) received 0.5 ml Spikevax Moderna COVID-19 vaccine 12+ (Lot# 3031283 & Exp. Date: 24APR2024) on 17OCT2023.) in an 8-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 17-Oct-2023, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE WARMTH (swelling) and OVERDOSE (She reports that 2 pediatric patients (11-year-old and 8-Year-old) received 0.5 ml Spikevax Moderna COVID-19 vaccine 12+ (Lot# 3031283 & Exp. Date: 24APR2024) on 17OCT2023.). On an unknown date, the patient experienced INFUSION SITE WARMTH (Warmth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Oct-2023, INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE WARMTH (swelling) had resolved. At the time of the report, INFUSION SITE WARMTH (Warmth) had resolved and OVERDOSE (She reports that 2 pediatric patients (11-year-old and 8-Year-old) received 0.5 ml Spikevax Moderna COVID-19 vaccine 12+ (Lot# 3031283 & Exp. Date: 24APR2024) on 17OCT2023.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2023: Significant information received. Suspect details, treatment medications, new events and reference number added.
Sex: U
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (breast cancer) had not resolved. Not Provided      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient states she has two friends with breast cancer after shots 5 and 6. No treatment medication reported.  This case was for the second of two patients reported. Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of breast cancer, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. No details of previous doses were provided. No treatment information was reported. No further clinical information was available for medical review. The event was considered unrelated to the vaccine due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750549 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2023: Live follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750549:Different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The patient was vaccinated with COVID and got it twice mildly; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (The patient was vaccinated with COVID and got it twice mildly) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (The patient was vaccinated with COVID and got it twice mildly). At the time of the report, COVID-19 (The patient was vaccinated with COVID and got it twice mildly) outcome was unknown.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   No concomitant and treatment information was provided.  It was reported that the reporter was sharing a house with a friend who was vaccinated with covid and got it twice mildly. Patient was not hospitalized. They lived in same house and reporter had 2 vaccines of Pfizer and did not catch covid from her.  It was mentioned that patient had moderna covid vaccine if recalls. The fact event got it mild was good.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: After the 5th dose his IBS was aggravated for about two weeks; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (After the 5th dose his IBS was aggravated for about two weeks) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 049022A) for COVID-19 prophylaxis.     Patient never tested positive for COVID-19.  Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (first dose, lot number is 041L20A) on 10-Feb-2021, Moderna Covid-19 vaccine (third dose) on 23-Nov-2021, Moderna Covid-19 vaccine (fourth dose and lot number 058A22.2A) on 10-Jun-2022; for Product used for unknown indication: Moderna Covid-19 vaccine (second dose and lot number is 001A21A) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. Concurrent medical conditions included Irritable bowel syndrome (had IBS his entire life).    On 05-Nov-2022, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (After the 5th dose his IBS was aggravated for about two weeks). At the time of the report, IRRITABLE BOWEL SYNDROME (After the 5th dose his IBS was aggravated for about two weeks) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received the latest Moderna vaccine on 18-Oct-2023. It was the sixth Moderna dose he received.  No treatment information was provided by the reporter.   This case was linked to MOD-2023-750735 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Nov-2023, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with AZITHROMYCIN (AZO) in November 2023 at an unspecified dose and frequency and NITROFURANTOIN (NITROFURANTOIN MONO/MACRO) in November 2023 at a dose of 100 milligram twice a day. At the time of the report, URINARY TRACT INFECTION (UTI) was resolving.            Concomitant product use was not provided by the reporter.  Patient had been receiving the Moderna shots since 2021. Most recent Spikevax vaccine was booster.  It was reported that 10 days after the shot she had a Urinary tract infection (UTI) with a sensation that she always had to go to the bathroom and stinging with urination. She attempted to treat this with AZO initially, but then went to a doctor a week later who gave a prescription for nitrofurantoin-n mono mcr, 100mg. Taken twice daily for 10 days.
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: His son lost his vision after the second vaccination but it came back; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLINDNESS TRANSIENT (His son lost his vision after the second vaccination but it came back) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (His son lost his vision after the second vaccination but it came back) (seriousness criterion medically significant). At the time of the report, BLINDNESS TRANSIENT (His son lost his vision after the second vaccination but it came back) was resolving.            Concomitant product use was not provided by the reporter.  Suspect vaccine batch number and expiry date was not reported.  Treatment information was not provided.  Company Comment: This is a Spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the serious (per medically significant) unexpected events of Blindness transient which occurred on an unknown onset date and latency with a dose of mRNA-1273.815 received as the second dose for COVID-19 Vaccination. It was reported that he lost his vision after the second vaccination, but it came back. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain
Clinical narrative: Now when I receive any excessive pain, I have to fight unconsciousness.; I know this is a result of the vaccine because I know for a fact I used to have a significant pain tolerance.; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Now when I receive any excessive pain, I have to fight unconsciousness.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 028D21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 10 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Now when I receive any excessive pain, I have to fight unconsciousness.) (seriousness criterion medically significant) and PAIN (I know this is a result of the vaccine because I know for a fact I used to have a significant pain tolerance.). At the time of the report, LOSS OF CONSCIOUSNESS (Now when I receive any excessive pain, I have to fight unconsciousness.) and PAIN (I know this is a result of the vaccine because I know for a fact I used to have a significant pain tolerance.) had not resolved.            Concomitant medication not provided.  Patient went into shock anytime he feels excessive pain. He knows this was a result of the vaccine because he know for a fact he used to have a significant pain tolerance. Now when he receives any excessive pain, he had to fight unconsciousness. It was unknown if the patient experienced any additional symptoms/events.   tratment information was not provided.  COMPANY COMMENT:  This is a regulatory case concerns a 20-year-old male patient with no medical history reported who experienced the unexpected seriousness criteria medically significant event of loss of consciousness and the unexpected event of pain unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. Patient went into shock anytime he feels excessive pain The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.  Event´s seriousness assessed as reporting.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash, Urticaria
Clinical narrative: now my face is flush(red); Rash; hives; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (now my face is flush(red)), RASH (Rash) and URTICARIA (hives) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 19-Nov-2023, the patient experienced FLUSHING (now my face is flush(red)), RASH (Rash) and URTICARIA (hives). The patient was treated with METHYLPREDNISOLONE in November 2023 at a dose of 4 milligram and TRIAMCINOLONE ACETONIDE in November 2023 at a dose of 0.1. At the time of the report, FLUSHING (now my face is flush(red)), RASH (Rash) and URTICARIA (hives) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. She went to a dermatologist because of the rash.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity
Clinical narrative: lethargy for 3 days after receiving a Moderna Covid-19 vaccine; She also had a sore arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy for 3 days after receiving a Moderna Covid-19 vaccine) and PAIN IN EXTREMITY (She also had a sore arm for 3 days) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2023, the patient experienced LETHARGY (lethargy for 3 days after receiving a Moderna Covid-19 vaccine) and PAIN IN EXTREMITY (She also had a sore arm for 3 days). On 22-Nov-2023, LETHARGY (lethargy for 3 days after receiving a Moderna Covid-19 vaccine) and PAIN IN EXTREMITY (She also had a sore arm for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.