chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Biliary dilatation, Brain fog, Burning sensation, Computerised tomogram
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram abdomen, Deafness unilateral, Dilatation intrahepatic duct acquired, Dry eye, Eye inflammation
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Eye pain, Eye pruritus, Gallbladder enlargement, Immediate post-injection reaction
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging, Oral pustule, Pain of skin, Pruritus, Rash pustular
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Renal cyst, Tinnitus, Ultrasound biliary tract, Ultrasound liver, Vertigo
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Brain fog, Disturbance in attention, Eye pain, Immediate post-injection reaction, Incomplete course of vaccination
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain, Pruritus, Vertigo, Vision blurred
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: itching all over her body; body pain; looked like shingles nerve pain; pain in the back of the eye; vertigo; difficulty seeing; blurry vision; brain fog; difficulty concentrating; This non-serious case was reported by a other health professional via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2023, the patient received the 1st dose of Shingrix. On 24-JUL-2023, immediately after receiving Shingrix, the patient experienced eye pain (Verbatim: pain in the back of the eye), vertigo (Verbatim: vertigo), visual impairment (Verbatim: difficulty seeing), blurred vision (Verbatim: blurry vision), brain fog (Verbatim: brain fog) and mental concentration difficult (Verbatim: difficulty concentrating). On an unknown date, the patient experienced generalized pruritus (Verbatim: itching all over her body), general body pain (Verbatim: body pain) and neuralgia (Verbatim: looked like shingles nerve pain). The outcome of the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia were unknown.   The reporter considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.     The company considered the eye pain, vertigo, visual impairment, blurred vision, brain fog, mental concentration difficult, generalized pruritus, general body pain and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 and 26-MAR-2024 The reporter was a friend of the patient.  The reporter reported that a 72-year-old female patient had the 1st dose of Shingrix vaccine at her physicians office.  The reporter stated that the patient had not received the 2nd dose of Shingrix due to the side effects experienced with the 1st dose. The reporter reported that, the patient immediately after receiving the vaccine had pain in the back of the eye, vertigo, blurry vision, difficulty seeing, brain fog, difficulty concentrating.  The patient had itching all over her body, and body pain. The patient's body pain was like shingles nerve pain.  The reporter believe that he/she had good communication with the service to talk to regarding this severs adverse reaction due to the Shingrix vaccine the patient received in and the reporter was a health advocate of the patient that's was going to help her at the time of reporting (right now), so he/she just reported this severe adverse reaction that was described to the reporter by the patient that she was experiencing and the reporter gonna go there to be with her to help her alright. The reporter consented to follow up.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No ae; some products experienced multiple TEs; This spontaneous report has been received from a nurse practitioner and refers to a 14-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 27-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (valid lot number: 1957405 [expiration date 11-NOV-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion.  No additional adverse event.  This is one of several reports from the same reporter.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Administered after Temperature Excursion; This spontaneous report has been received from a nurse practitioner and refers to a 11-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (valid lot number 1957405 [expiration date 11-NOV-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion.  No additional adverse event.  This is one of several reports from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "panic disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, MANUFACTURE: UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, MANUFACTURE: UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, MANUFACTURE: UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, MANUFACTURE: UNKNOWN), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a consumer.  A 56-year-old female patient (not pregnant) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy". Vaccination history included: Pfizer BioNTech (DOSE 1; Lot Number: EP6955; left arm), administration date: 19Mar2021, when the patient was 53-year-old, for COVID-19 immunization; Pfizer BioNTech (DOSE 2; Lot Number: FR8737; left arm), administration date: 09Apr2021, when the patient was 53-year-old, for COVID-19 immunization; Pfizer BioNTech (DOSE 3 (BOOSTER); Lot Number: FC3180; left arm), administration date: 03Sep2021, when the patient was 53-year-old, for COVID-19 immunization; Pfizer BioNTech (DOSE 4 (BOOSTER); Lot Number: FJ9943; left arm), administration date: 15Apr2022, when the patient was 54-year-old, for COVID-19 immunization; Pfizer BioNTech (DOSE 5 (BOOSTER); Lot Number: GJ2524; left arm), administration date: 15Oct2023, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Oct2023, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered with sequelae" (30Mar2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Mar2024) Negative. Therapeutic measures were taken as a result of Drug ineffective and COVID-19 which included nirmatrelvir/ritonavir (PAXLOVID) from 23Mar2024 to 28Mar2024 as antiviral treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: unspecified pneumococcal vaccine administered on 01-OCT-2003 (pt was 1 year 2 months old); This spontaneous report has been received from an other health care professional via a medical records (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (MARRS # 2402USA008515), concerning male 1-year-old patient. Concomitant therapies included Haemophilus influenzae type B vaccine. His historical vaccines included diphteria (+) tetanus (+) pertussis vaccine, Haemophilus influenzae type B vaccine, hepatitis B vaccine, measles (+) mumps (+) rubella vaccine, pneumococcal conjugate PCV 7 vaccine, polio vaccine and varicella vaccine. His concurrent conditions and medical history were not provided.   On 01-OCT-2003, at the age of 1 year and 2 months, the patient was vaccinated with unspecified pneumococcal vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration).  This is one of 4 reports created for the same patient.; Sender's Comments:  US-009507513-2402USA008515: US-009507513-2402USA008405: US-009507513-2404USA001265: US-009507513-2404USA001266: US-009507513-2402USA008515:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he and his wife both received the first SHINGRIX dose 08/03/2023 and have not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 08-MAR-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he and his wife both received the first SHINGRIX dose 08/03/2023 and have not yet had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter stated that his wife received the 1st dose of Shingrix vaccine on 08th March 2023 and have not yet had the 2nd dose. Till time of reporting patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter did not consent to follow up. This case had been linked with US2024042649, reported by same reporter.; Sender's Comments:  US-GSK-US2024042649:HUSBAND CASE
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: reporter did not think he/she gave half or a big more than half of the 2nd dose/ underdose/ syringe used to without it from the vial it was defected; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number YN592, expiry date 10-FEB-2026) for prophylaxis.   On 25-MAR-2024, the patient received the 2nd dose of Shingrix. On 25-MAR-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: reporter did not think he/she gave half or a big more than half of the 2nd dose/ underdose/ syringe used to without it from the vial it was defected). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 25-MAR-2024 The pharmacist reported that, he/she administered the second Shingles (Shingrix) vaccine today (on the day of reporting) but the vaccine was defective, so the reporter did not think he/she gave half or a big more than half of the second dose, which led to an accidental underdose. The pharmacist was not sure if he/she should administer a new vaccine or what should happen. Further reporter stated that, not the actual vaccine but the syringe he/she used to without it from the vial it was defected. Shingrix did not come with syringes or needles. The vaccine administration facility was the same as primary reporter
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I'm sick in bed and don't want to get up to look Location of injection: Arm Left; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I'm sick in bed and don't want to get up to look Location of injection: Arm Left) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (amoxicillin), Vegetable allergy (mushrooms), Allergy to legumes (lentils), Allergy to seeds (quinoa), Vegetable allergy (beans), Gastritis and Asthma. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) for Birth control, DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 01-Jan-2023, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2023, the patient experienced ILLNESS (I'm sick in bed and don't want to get up to look Location of injection: Arm Left). At the time of the report, ILLNESS (I'm sick in bed and don't want to get up to look Location of injection: Arm Left) outcome was unknown.            On 26-Mar-2024, the patient took Paxlovid for COVID 19 Treatment and end treatment on 31-Mar-2024. The patient took the full round of Paxlovid and felt better at the 5-day mark and had 2 days of feeling like getting back to normal when patients symptoms came back. All the symptoms. The patient took another test, and it was positive for covid. And felt like total crap.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Leukemia.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The reporter mentioned that many of his friends had taken the Moderna Vaccine. He highlighted one of them who is 64 years old and has Leukemia. The friend had multiple surgeries and been hospitalized for unknown reasons. He had COVID 4 to 5 times and has received an unknown number of shots of the Moderna vaccine.  The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong patient received product, Wrong product administered
Clinical narrative: I failed to correctly identify the patient and she received vaccines that she did not need. She only needed the Havrix vaccine. The patient did not suffer any injury.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel was expired at the time of administration. Patient did not have any side effects or symptoms.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Following Administration of two vaccines. Pt reported having right shoulder/Arm Pain. Patient states unable to Lift Right arm due to severe pain and will follow-up with primary care physician.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine administration; This spontaneous report has been received from an other health care professional from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2401USA014913), concerning an 18-month-old male patient.  The patient's medical history, concomitant medications, and concurrent conditions were not provided.  On 29-MAR-2004, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis. On 28-JUL-2005, the patient was vaccinated with another dose of second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2401USA014913:Original case 2401USA014913
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 1608USA000622), concerning a 10-weeks-old female patient.  The patient's medical history, concomitant medications, and concurrent conditions were not provided.  On 15-NOV-1994, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis. On 24-JAN-1995, the patient was vaccinated with the second dose of second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). On 21-NOV-1995, she was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis.; Sender's Comments:  US-009507513-1608USA000622:Original case 1608USA000622
Age: 1.5
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; Caller states an 18 Month old Patient was inadvertently administered a PROQUAD Vaccine instead of their first dose of MMR II.; This spontaneous report was received from a registered nurse, referring to an 18-month-old patient of unknown gender.  The patient's concurrent conditions, medical history, concomitant therapies, and drug reactions/allergies were not reported.  On 25-MAR-2024, the patient was inadvertently vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X007087, expiration date: 04-SEP-2024, administered by health professional for prophylaxis (strength, dose, and route of administration were not provided), instead of the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). It was reported that this patient received the first varicella virus vaccine live (Oka/Merck) (VARIVAX) dose 4 months earlier. No symptoms were reported. No other adverse event (AE) was reported (no adverse event).
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 3rd dose of hepatitis B vaccine given on 14-APR-2003; 2nd dose of hepatitis B vaccine given on 05-SEP-2002; This spontaneous report has been received from an other health care proffesional via a MR from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (MARRS # 2402USA008515), concerning male 2-month-old patient. His concurrent conditions, medical history and concomitant therapies were not provided.   On 26-JUL-2002, the patient received the first dose of hepatitis B vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 05-SEP-2002, he was administered the second dose of hepatitis B vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). On 14-APR-2003, the patient was vaccinated with the third dose of hepatitis B vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered).   This is one of 4 reports created for the same patient (linked MARRS # 2404USA001265, 2404USA001267 and 2402USA008515).; Sender's Comments:  US-009507513-2402USA008405: US-009507513-2402USA008515: US-009507513-2404USA001267: US-009507513-2404USA001265:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional adverse event reported; received a first dose of GARDASIL 9 at age 11. The patient is now 16 and is in the clinic for a second dose; This spontaneous report was received from a licensed practical nurse and refers to a 16 years old patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, when the patient was 11 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 05-APR-2024, when 16 years old, the patient came back to a clinic for a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No ae; some products experienced multiple TEs; This spontaneous report has been received from a nurse practitioner and refers to a 15-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 30-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (valid lot number: 1957405 [expiration date 11-NOV-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion.  No additional adverse event.  This is one of several reports from the same reporter.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No ae; some products experienced multiple TEs; This spontaneous report has been received from a nurse practitioner and refers to a 11-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 27-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (valid lot number: 1957405 [expiration date 11-NOV-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion.  No additional adverse event.  This is one of several reports from the same reporter.