chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: By error the nurse administered Jynneos vaccine beyond use date to 6 patients; Case reference number US-BN-2022-004310 is a spontaneous case report initially received on 24-Oct-22 from health care professional via Communications (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with a dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004308, US-BN-2022-004309 and US-BN-2022-004311 (same reporter).  Additional information received from on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: By error the nurse administered Jynneos vaccine beyond use date; Case reference number US-BN-2022-004311 is a spontaneous case report initially received on 24-Oct-22 from health care professional via Communications (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with an unknown dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, the patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004308, US-BN-2022-004309 and US-BN-2022-004310 (same reporter).  Additional information received from on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intradermally; Case reference number US-BN-2022-004329 is a spontaneous case received from a consumer on 21-Oct-2022 via Agency (reference number: USBAV22-1756) and concerns a 39-year-old male patient.  The patient's medical history was not provided. The patient's concomitant medications included fluvic acid and COVID-19 vaccine.  On an unspecified date in Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at unknown dose, administered subcutaneously, for monkeypox prophylaxis.  On 20-Oct-2022, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at unknown dose, administered intradermally (explicitly coded as 'Intradermal injection'), for monkeypox prophylaxis.  At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination.   Additional information received on 21-Oct-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A 39-year-old male patient was vaccinated with the second dose of Jynneos vaccine, at unknown dose, administered intradermally, which is considered as intradermal injection, for monkeypox prophylaxis. At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination. Intradermal injection is considered as listed per company convention. The patient's medical history was not provided, and concomitant medications included fluvic acid and COVID-19 vaccine. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 39-year-old male patient was vaccinated with the second dose of Jynneos vaccine, at unknown dose, administered intradermally, which is considered as intradermal injection, for monkeypox prophylaxis. At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination. Intradermal injection is considered as listed per company convention. The patient's medical history was not provided, and concomitant medications included fluvic acid and COVID-19 vaccine. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Accidental exposure to product, Exposure via eye contact, Needle issue
Clinical narrative: I was giving the monkeypox vaccination and it sprayed in my eye; I was giving the monkeypox vaccination and it sprayed in my eye; The vaccine always sprays when removing the dose, while pulling the needle; Case reference number US-BN-2022-004489 is a spontaneous case report initially received on 02-Nov-2022 from a nurse via Communications (reference number: USBAV22-1838) concerning a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at an unknown dose, via an unspecified route of administration, at an unspecified site, for an unknown indication.  During the vaccination, the monkeypox vaccine sprayed in nurses' eye (explicitly coded as 'Accidental occupational exposure to product' and 'Exposure via eye contact'). As reported by nurse, the vaccine always sprays when removing the dose and when pulling the needle (explicitly coded as 'Needle issue').  At the time of this report, the event outcome was unknown.   The reporter assessed the event as non-serious and possibly related to Jynneos vaccine.  Additional information received from on 02-Nov-2022 included the local case ID.; Reporter's Comments: A female nurse had an accidental occupational exposure to Jynneos via eye contact, while attempting to vaccinate a patient. Reportedly, the vaccine sprayed into the nurse's eye while pulling the needle (which is considered needle issue). Accidental exposure to product, exposure via eye contact and needle issue are considered listed per company convention. Medical history and concomitant medications information was not available. The events are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A female nurse had an accidental occupational exposure to Jynneos via eye contact, while attempting to vaccinate a patient. Reportedly, the vaccine sprayed into the nurse's eye while pulling the needle (which is considered needle issue). Accidental exposure to product, exposure via eye contact and needle issue are considered listed per company convention. Medical history and concomitant medications information was not available. The events are considered not related to Jynneos, but to human error. The case is non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0.1 mL of Jynneos administered intradermally; 17 year old patient received Jynneos vaccine; Case reference number US-BN-2022-004544 is a spontaneous case report initially received on 04-Nov-2022 from other health professional via Communication (reference number: USBAV22-1862) and concerns a 17-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 24-Sep-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00003), at dose reported as 0,1 mL administered intradermally at an unknown site, for monkeypox prophylaxis. As reported, the patient was vaccinated with an adult dosage but since the patient was a minor, the smaller dose of vaccine 0,1 mL instead of 0,5 mL was administered intradermally (explicitly coded as 'intradermal injection' and 'inappropriate age at vaccine administration').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  This case is linked with case US-BN-2022-004542 (same reporter).  Non-significant case correction received on 11-Nov-2022 from included local case ID.; Reporter's Comments: A 17-year-old female patient was vaccinated with the first dose of Jynneos, at dose reported as 0,1 mL administered intradermally at an unknown site, for monkeypox prophylaxis. Reportedly, the patient was vaccinated with an adult dosage but since the patient was a minor, the smaller dose of vaccine 0,1 mL instead of 0,5 mL was administered intradermally (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 17-year-old female patient was vaccinated with the first dose of Jynneos, at dose reported as 0,1 mL administered intradermally at an unknown site, for monkeypox prophylaxis. Reportedly, the patient was vaccinated with an adult dosage but since the patient was a minor, the smaller dose of vaccine 0,1 mL instead of 0,5 mL was administered intradermally (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: The patient received the expired vaccine; Jynneos was administered intradermal; Case reference number US-BN-2022-004593 is a spontaneous case report initially received on 07-Nov-2022 from a pharmacist via agency (reference number: USBAV22-1883) and concerns a male patient.  The patient's medical history included lung transplant (the patient was immunocompromised).  The patient's concomitant medication details were not provided.  On 07-Nov-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00016; expiration date: 24-Oct-2022) at a dose of 0.1 ml, administered intradermal at an unknown site of administration for monkeypox prophylaxis (explicitly coded as 'intradermal injection' and 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 07-Nov-2022 from agency included expiration date of Jynneos.  Additional information received on 08-Nov-2022 from Bavarian Nordic included local BN case ID.  This case is linked with US-BN-2022-004589 due to the same reporter.; Reporter's Comments: A male patient was vaccinated on 07-Nov-2022 with the first dose of Jynneos vaccine (expiration date of vaccine was 24-Oct-2022) administered intradermally at a dose of 0,1 mL, for monkeypox prophylaxis, which is considered as expiration product administered. No associated adverse events were reported. Intradermal injection and inappropriate schedule of vaccine administered are listed per company convention. The patient's medical history included lung transplant (the patient was immunocompromised). The patient's concomitant medication details were not provided. Intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A male patient was vaccinated on 07-Nov-2022 with the first dose of Jynneos vaccine (expiration date of vaccine was 24-Oct-2022) administered intradermally at a dose of 0,1 mL, for monkeypox prophylaxis, which is considered as expiration product administered. No associated adverse events were reported. Intradermal injection and inappropriate schedule of vaccine administered are listed per company convention. The patient's medical history included lung transplant (the patient was immunocompromised). The patient's concomitant medication details were not provided. Intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Underdose
Clinical narrative: Received half a dose of Jynneos due to arm movement; Jynneos was administered intradermally; First Jynneos dose was on 01-Sep-2022, second dose on 24-Oct-2022; Case reference number US-BN-2022-004657 is spontaneous case report initially received on 24-Oct-2022 from a nurse and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 01-Sep-2022, the patient was vaccinated with first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating); batch number: unknown), at 0.1 mL, administered intradermally at an unknown anatomical location (explicitly coded as 'intradermal injection') for an unknown indication.   On 24-Oct-2022, 53 days after first dose, the patient was vaccinated with the second dose of Jynneos, (batch number: unknown), and only received about a half dose, intradermally due to arm movement (explicitly coded as underdose' and inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 11-Nov-2022 included confirmation of country of occurrence.; Reporter's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos vaccine intradermally and 53 days after first dose, was vaccinated with the second dose of Jynneos intradermally, and only received about a half dose due to arm movement, which is considered underdose and inappropriate schedule of vaccine administered. Intradermal injection, underdose and inappropriate schedule of vaccine administered are listed by convention. No associated adverse events have been reported. Intradermal injection, underdose and inappropriate schedule of vaccine administered have been considered not related to the suspect product. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos vaccine intradermally and 53 days after first dose, was vaccinated with the second dose of Jynneos intradermally, and only received about a half dose due to arm movement, which is considered underdose and inappropriate schedule of vaccine administered. Intradermal injection, underdose and inappropriate schedule of vaccine administered are listed by convention. No associated adverse events have been reported. Intradermal injection, underdose and inappropriate schedule of vaccine administered have been considered not related to the suspect product. The case is non-serious.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose given
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: hives
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Swelling
Clinical narrative: Shortness of breath and swelling of armpit and clavicle (right)
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I go shingles from the shot/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles from the shot. The reporter denied for follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shots and I still. Have them/Suspected vaccination failure; Still have them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots and still had them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got bothshots.This is 3rd break out/Suspected vaccination failure; Shingles/ 3rd time since the vaccines i have broke out. First 2; this time they hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter' s comment: The case was received from the patient via interactive digital media. The patient had got both the vaccines this year and this was the 3rd time since the vaccines, he/she broke out. The first 2 times were not bad but this time they hurt. The patient stated that so much for the vaccines for him/her. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot and got shingles now/suspected vaccination failure; Have shingles now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient had the shot and had shingles now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Herpes zoster, Insomnia, Pain
Clinical narrative: Suspected vaccination failure/I was told to get the vaccination for shingles, I did and got shingles; Got shingles on both sides of body, horrible; Pain; Constant itchiness, itch; Burned like you are on fire; Couldn't get comfortable enough to sleep at night; Couldn't get comfortable enough to sleep at night; Tingling; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus, burning sensation, discomfort, sleeplessness and tingling. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, discomfort and sleeplessness were unknown and the outcome of the pain, pruritus and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, burning sensation, discomfort, sleeplessness and tingling to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was told to get the vaccination for shingles, that did so he/she would never get shingles, well. The patient did and got shingles, horrible, the pain, constant itchiness and if you scratched, it burned like you were on fire. The patient got them on both sides of her body. The patient could not get comfortable enough to sleep night. The pain, tingling and itch came back, now and then. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure/I was told to get the vaccination for shingles, I did and got shingles; Got shingles on both sides of body, horrible; Pain; Constant itchiness, itch; Burned like you are on fire; Couldn't get comfortable enough to sleep at night; Couldn't get comfortable enough to sleep at night; Tingling; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus, burning sensation, discomfort, sleeplessness and tingling. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, discomfort and sleeplessness were unknown and the outcome of the pain, pruritus and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, burning sensation, discomfort, sleeplessness and tingling to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was told to get the vaccination for shingles, that did so he/she would never get shingles, well. The patient did and got shingles, horrible, the pain, constant itchiness and if you scratched, it burned like you were on fire. The patient got them on both sides of her body. The patient could not get comfortable enough to sleep night. The pain, tingling and itch came back, now and then. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Temp; Bad headache; My arm is sore; This case was reported by a consumer via interactive digital media and described the occurrence of pyrexia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingrix. On 11th November 2022, less than a day after receiving Shingrix, the patient experienced pyrexia, headache and pain in arm. On an unknown date, the outcome of the pyrexia, headache and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pyrexia, headache and pain in arm to be related to Shingrix.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the second dose of Shingrix on the day of reporting. The patient experienced temp, bad headache and arm sore. The patient was asking if we could take Motrin for any side effect. Note: Motrin was not coded as no confirmation if patient taken medication or not. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arms sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th November 2022, the patient received the 1st dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-NOV-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The patient had first shot on Monday.  His or her arms sore but know what family members went through with shingles.  Two shots required three months apart. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This 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 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31st August 2023) for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Menveo. On 8th November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment:  The reporter stated that Menveo reconstituted with sterile water. Additional supportive information: As Menveo was reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: adult patient received a Havrix expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 11th November 2022, the patient received Havrix. On 11th November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-NOV-2022 Reporters comment:  The patient received a Havrix expired vaccine.  The reporter consent to follow-up by email. Additional Supportive information: The patient received a Havrix expired vaccine which led to expired vaccine used.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered the adjuvant only; Administered the adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25th September 2023) for prophylaxis.   On 11th November 2022, the patient received Shingrix. On 11th November 2022, 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: 11-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was administered the Shingrix vaccine adjuvant without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Left sided lower back pain; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stroke.   On 5th November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2022, 1 days after receiving Shingrix, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was not recovered/not resolved.   It was unknown if the reporter considered the low back pain to be related to Shingrix.     Additional Information: GSK receipt date: 13-SEP-2022 Reporters comment: The reporter was the patient he received the first dose of shingrix and an about 24 hours after started with left sided lower back pain.  The back pain was still present. The reporter did not consent to follow-up. Note-As per narrative about 24 hours after his vaccine, he started with left sided lower back pain ,so the event started from after 24 hours the event onset date captured as 6-NOV-2022 so time to onset auto calculated as 1day that was 24 hours also.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Muscular weakness
Clinical narrative: She says that since 11/2/22, she has been experiencing a dizzy sensation when she gets up from her bed at night/She says the room is spinning/she is woozy; Tiredness; Muscle weakness; Headache; didn't feel good; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2022, the patient received the 1st dose of Shingrix. On 1st November 2022, 1 days after receiving Shingrix, the patient experienced tiredness, muscle weakness and headache. On 2nd November 2022, the patient experienced dizziness. In November 2022, the patient experienced feeling bad. On 2nd November 2022, the outcome of the tiredness and muscle weakness were recovered/resolved. On an unknown date, the outcome of the headache and dizziness were not recovered/not resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the tiredness, muscle weakness, headache, dizziness and feeling bad to be related to Shingrix.     Additional Information: GSK receipt date: 11-NOV-2022 Reporters comment:The reporter was the patient, she received the first dose of shingrix in left arm The patient said that the next day she had tiredness, muscle weakness and a headache. She reports that the tiredness and muscle weakness went away the following day after on 2nd November 2022. Since 2nd November 2022, 2 days after vaccination, she had been experiencing a dizzy sensation when she gets up from her bed at night. She says the room was spinning and she was woozy and didn't feel good.  The patient still had the mild headache. No further information was reported. The reporter did not consent to follow-up.  The patient was unable to provide lot number or expiration date for the shingrix dose she received
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: a 12 month old baby received boostrix; a 12 month old baby received boostrix; a 12 month old baby received boostrix instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 12-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KP547, expiry date 29th November 2024) for prophylaxis.   On 28th September 2022, the patient received Boostrix. On 28th September 2022, unknown after receiving Boostrix, the patient experienced underdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the underdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-Nov-2022 Reporter's comment: The health-care professional reported the patient received boostrix instead of Infanrix. The consent to follow-up was granted. Additional supportive information: A 12-month old baby received boostrix instead of Infanrix, which led to underdose, inappropriate age at vaccine administration and wrong vaccine administered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 1st Apr2019, 2nd June 2019, 3rd 11Nov2022; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on April 2019) and Shingrix (2nd dose received on June 2019).   On 11th November 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 11th November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-NOV-2022 Reporter's comments: The reporter was the husband of the patient who had reported that his wife stated that her HCP had gave her a third Shingrix vaccine (extra dose) on the day of reporting, in the left arm. The reporter reported that his wife's physician did not had the second dose documented, so she had given her another Shingrix vaccine on the day of reporting. The reporter had consent to follow-up. Additional supportive information: At the time of reporting, the patient had received the 3rd dose of Shingrix vaccine, which had led to extra dose administered and wrong vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: He received Engerix-B today. The product expired 8-NOV-2022/Expired Drug Used; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HBV (Engerix B adult) (batch number unknown, expiry date 8th November 2022) for prophylaxis.   On 11th November 2022, the patient received Engerix B adult. On 11th November 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK receipt date: 11-NOV-2022 Reporter's comment: The reporter was the adult patient. He had received Engerix-B on the day of reporting.  The product was expired 8 November 2022. Nothing else was reported. The reporter wished to remain anonymous and had declined to provide demographics or lot number. The reporter had denied to provide further contact details. Additional supportive information: The patient had received an expired dose of Engerix-B, which had led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number AN599, expiry date 8th November 2022) for prophylaxis.   On 11th November 2022, the patient received Engerix B. On 11th November 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment:  A health care professional called to ask for information about the administration of an expired dose of Engerix-B to a patient. The reporter asked if the patient would be re vaccinated.  The reporter did not provide patient identifiers.  The reported did not consent to follow-up Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular
Clinical narrative: raised rash; This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was recovered/resolved.   It was unknown if the reporter considered the raised rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-NOV-2022 Reporter's Comment: The reporter reported that patient experienced a rash after dose one of Shingrix. Health care professional did not have time to complete safety report and did not provide patient demographics, lot number, or expiration date.  Health care professional described the rash as raised.  Health care professional noted the rash lasted for a couple of weeks, no exact dates provided, after dose one was received. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, Maternal exposure during pregnancy
Clinical narrative: Fluarix administered to pregnant patient  (Fluarix dose 6 weeks ago); Fluarix administered to pregnant patient (today); 1st dose 6weeks ago, 2nd 11nov2022; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of maternal exposure during pregnancy in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number 9PG4D, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Tetra 2022-2023 season at an unknown time during the pregnancy. On 11th November 2022, unknown after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device and not applicable after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the patient experienced maternal exposure during pregnancy and vaccine exposure during pregnancy. On an unknown date, the outcome of the maternal exposure during pregnancy, vaccine exposure during pregnancy and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   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: 11 NOV 2022 Reporter's comment: This case was reported by nurse. The nurse reported that the pregnant patient received the Fluarix quadrivalent first dose six weeks ago and today that is on 11th November 2022 the patient received the second extra dose. The reporter consented to follow up. Additional supportive information: As adult patient requires only one dose, however received the extra second dose which led to extra dose administered. Note: As per schedule only one dose is required for an adult patient, hence extra dose administered was captured.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Received Bexsero instead of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 22-year-old female patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31st March 2023) 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 21st October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 21st October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, 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: 11 NOV 2022 Reporter's comment:  The nurse reported that the patient was supposed to receive Menveo but administered dose of Bexsero vaccine on 21st October 2022. The reporter consented to follow up. Additional supportive information: As patient received Menveo instead of Bexsero which led to wrong vaccine administered.