chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003959 is a spontaneous case report initially received on 05-Oct-2022 from nurse via agency (reference number: USBAV22-1628) and concerns a patient of unknown demographics (fifth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via agency (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003960 is a spontaneous case report initially received on 05-Oct-2022 from nurse via agency (reference number: USBAV22-1628) and concerns a patient of unknown demographics (fourth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 03-Oct-2022 and 04-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via agency (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003956, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003961 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (sixth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number BN-2022-003962 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: BAV22-1628) and concerns a patient of unknown demographics (seventh out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: BAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003963 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (eighth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003964 is a spontaneous case report initially received on 05-Oct-2022 from nurse via agency (reference number: USBAV22-1628) and concerns a patient of unknown demographics (ninth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via agency (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003965 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (tenth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Med Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963 and US-BN-2022-003964, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have 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 patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue
Clinical narrative: after all of my covid vaccines I felt tired for a few days after starting day after but this has persisted to today, I am tired all the time, poor attention/concentration. this is similar to my episodic energy loss i have had since as well as i can remember since 10yo-no episode has ever lasted this long
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Conversion disorder
Clinical narrative: Developed Functional Neurological Disorder after taking the Moderna Vaccine.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Blood urine present, Dysstasia, Speech disorder
Clinical narrative: I could get up to stand My Body Slammed me back down  I couldn't Talk, no one could understand me I had a Toilet full of Blood Not sure if any of this has to do with my Kidneys or the Booster
Sex: U
Vaccine: SMALLMNK
Symptoms: HIV test negative, Monkeypox, Orthopoxvirus test positive, Polymerase chain reaction positive, Product dose omission issue
Clinical narrative: PCR confirmed Monkeypox; One Jynneos dose administered two months prior to monkeypox diagnosis; Case reference number US-BN-2022-004666, is a spontaneous case report initially received from a healthcare professional via (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history was not provided.  The patient's concomitant medication was not provided.  On an unspecified date, the patient was negative to human immunodeficiency virus (HIV).  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.   On unspecified date, reported as two months after the Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox. As reported, one Jynneos dose was administered two months prior to monkeypox diagnosis (explicitly coded as 'missed dose').  At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004667, US-BN-2022-004668 and US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) two months after the first dose of Jynneos vaccine was administered, which is also considered as missed dose. Monkeypox is unlisted. Missed dose is listed per convention. The patient's medical history and concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Missed dose is not related to Jynneos, but to a human factor.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) two months after the first dose of Jynneos vaccine was administered, which is also considered as missed dose. Monkeypox is unlisted. Missed dose is listed per convention. The patient's medical history and concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Missed dose is not related to Jynneos, but to a human factor.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: 1st dose approx. 30 days prior; fainted, was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th November 2019, the patient received Shingrix. On 9th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In November 2019, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR171834   Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patient also stated that she received 1st dose approximately 30 days prior did not lead any adverse reaction The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agree to follow up from GlaxoSmithKline. Additional supportive information: The patient received the 2nd dose approximately 30 days prior to 1st dose of Shingrix, which led to shortening of vaccinations schedule. This case had been linked with US2022AMR171834 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171834:same reporter ,different patient US-GSK-US2022AMR171947:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Nausea, Pyrexia, Syncope, Unresponsive to stimuli
Clinical narrative: 1st dose approx. 30 days prior; fainted, was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th November 2019, the patient received Shingrix. On 9th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In November 2019, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR171834   Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patient also stated that she received 1st dose approximately 30 days prior did not lead any adverse reaction The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agree to follow up from GlaxoSmithKline. Additional supportive information: The patient received the 2nd dose approximately 30 days prior to 1st dose of Shingrix, which led to shortening of vaccinations schedule. This case had been linked with US2022AMR171834 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171834:same reporter ,different patient US-GSK-US2022AMR171947:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: 1st dose approx. 30 days prior; fainted, was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th November 2019, the patient received Shingrix. On 9th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In November 2019, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR171834   Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patient also stated that she received 1st dose approximately 30 days prior did not lead any adverse reaction The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agree to follow up from GlaxoSmithKline. Additional supportive information: The patient received the 2nd dose approximately 30 days prior to 1st dose of Shingrix, which led to shortening of vaccinations schedule. This case had been linked with US2022AMR171834 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171834:same reporter ,different patient US-GSK-US2022AMR171947:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: fainted / was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, 12 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agrees to follow up from GlaxoSmithKline. Less than a day, the patient experienced fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. Additional supportive information: This case had been linked with US2022AMR171802 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171802:same reporter, different patient
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: fainted / was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, 12 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agrees to follow up from GlaxoSmithKline. Less than a day, the patient experienced fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. Additional supportive information: This case had been linked with US2022AMR171802 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171802:same reporter, different patient
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got second dose 20 days early; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On 14th November 2022, the patient received the 2nd dose of Shingles vaccine. On 14th November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The nurse reported that the patient received the second dose 20 days earlier. Additional Supportive Information: The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: No 2nd dose due to COVID pandemics, 1st dose 2020; This case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received first dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: A health care professional had reported that several patients did not receive the second dose at the time of reporting, due to the COVID pandemics. The reporter did not consent to follow up. The case was linked with case US2022168178, reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2022168178:Same reporter. 2019 case.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe ongoing arm pain; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 4CN59, expiry date unknown) for prophylaxis.   On 5th July 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. The patient was treated with non-drug therapy (Physiotherapy). On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comment: The reporter reported that the patient experienced severe ongoing left arm pain after her 2nd Shingrix vaccination.  The patient was referred to physical therapy to regain normal use of her arm. The reporter was consented to follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arthralgia, Chills, Culture, Headache, Illness
Clinical narrative: chills; low grade fever; nausea; extreme joint pain; muscle pain,; extreme headache; Had to leave work, used a sick day; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 333TE, expiry date unknown) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included allergy (Unknown Allergy).   On 10th November 2022, the patient received Shingrix and COVID-19 VACCINE. On 11th November 2022 08:00, 1 days after receiving Shingrix, the patient experienced chills, fever, nausea, joint pain, muscle pain, headache and sickness. On an unknown date, the outcome of the chills, fever, nausea, joint pain, muscle pain, headache and sickness were recovering/resolving.   It was unknown if the reporter considered the chills, fever, nausea, joint pain, muscle pain, headache and sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: The reporter had reported that after taking the Shingrix and COVID-19 vaccine, the patient had experienced chills, low-grade fever, nausea, extreme joint pain and muscle pain, extreme headache.  She had to leave work and she have not used a sick day in over 2 years. The patient was tested positive for COVID-19 before and after the Shingrix vaccination. The reporter had consented to follow-up. Additional supportive information: It was unknown if the reporter considered the chills, fever, nausea, joint pain, muscle pain, headache and sickness to be related to COVID-19 vaccine and  days after receiving COVID-19 vaccine the patient experienced chills, fever, nausea, joint pain, muscle pain, headache and sickness.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: chills; low grade fever; nausea; extreme joint pain; muscle pain,; extreme headache; Had to leave work, used a sick day; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 333TE, expiry date unknown) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included allergy (Unknown Allergy).   On 10th November 2022, the patient received Shingrix and COVID-19 VACCINE. On 11th November 2022 08:00, 1 days after receiving Shingrix, the patient experienced chills, fever, nausea, joint pain, muscle pain, headache and sickness. On an unknown date, the outcome of the chills, fever, nausea, joint pain, muscle pain, headache and sickness were recovering/resolving.   It was unknown if the reporter considered the chills, fever, nausea, joint pain, muscle pain, headache and sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: The reporter had reported that after taking the Shingrix and COVID-19 vaccine, the patient had experienced chills, low-grade fever, nausea, extreme joint pain and muscle pain, extreme headache.  She had to leave work and she have not used a sick day in over 2 years. The patient was tested positive for COVID-19 before and after the Shingrix vaccination. The reporter had consented to follow-up. Additional supportive information: It was unknown if the reporter considered the chills, fever, nausea, joint pain, muscle pain, headache and sickness to be related to COVID-19 vaccine and  days after receiving COVID-19 vaccine the patient experienced chills, fever, nausea, joint pain, muscle pain, headache and sickness.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Shingrix. On 14th 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: 14-Nov-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter. Additional Supportive Information: The patients received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022AMR169910:same reporter US-GSK-US2022AMR169909:same reporter US-GSK-US2022168220:same reporter
Sex: U
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: Bexsero was subQ instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     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-2022 Reporter's Comment: Bexsero was given subcutaneous instead of intramuscular. The reporter asked what possible side effects were. Additional Supportive Information: the patient received Bexsero was given subcutaneous instead of intramuscular, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: Seizure; This case was reported by a other health professional via sales rep and described the occurrence of seizure in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 14-Nov-2022. Reporter's Comment:  The reporter think Seizure not related to product. The reporter agrees to follow up from GlaxoSmithKline
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: lower back hurt; Feeling flu-like symptoms; felt icky; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th November 2022, several hours after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On 13th November 2022, the patient experienced low back pain. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and low back pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and low back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comment: The case was self reported by the patient. The patient received dose of Shingrix into right arm and few hours later, the patient began feeling flu like symptoms and just felt icky. The patient reported that she was feeling much better today but still not completely resolved. The patient also reported that 5 days after vaccination her lower back hurt starting Sunday. The patient reported that she did not know if it was related to the Shingrix vaccine, but it was better today but not resolved. The reporter did not consent to follow up. The reporter does not give permission to contact HCP.