chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.   A female patient received BNT162b2, on 08Oct2021 as dose 1, single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Grand-Mal Seizures/Clonic tonic seizures"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic to it"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "not conscious for much of it". The patient underwent the following laboratory tests and procedures: Body temperature: (2021) pyrexia high. Clinical details: The patient was trying to find out the full name of the Pfizer Covid 19 vaccine she got based on the lot number. She didn't know which was the one she got. She got two of them, one on 08Oct2021 and 21Oct2021. The two lots numbers were FF8841 and FF2593. Lot: FF8841, with this one she had Grand-Mal Seizures, but later clarified as Clonic Tonic Seizures. After getting it, she had grand mal seizures and a high fever. She was not conscious for much of it but said she had to get the second one. She's allergic to it.    No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500027976 same patient, different doses/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.   A female patient received BNT162b2, on 08Oct2021 as dose 1, single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Grand-Mal Seizures/Clonic tonic seizures"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic to it"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "not conscious for much of it". The patient underwent the following laboratory tests and procedures: Body temperature: (2021) pyrexia high. Clinical details: The patient was trying to find out the full name of the Pfizer Covid 19 vaccine she got based on the lot number. She didn't know which was the one she got. She got two of them, one on 08Oct2021 and 21Oct2021. The two lots numbers were FF8841 and FF2593. Lot: FF8841, with this one she had Grand-Mal Seizures, but later clarified as Clonic Tonic Seizures. After getting it, she had grand mal seizures and a high fever. She was not conscious for much of it but said she had to get the second one. She's allergic to it.    No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500027976 same patient, different doses/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Loss of consciousness, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot number: FF8841)), administration date: 08Oct2021, for COVID-19 immunisation, reaction(s): "Grand-Mal Seizures/Clonic tonic seizures", "not conscious for much of it", "high fever", "allergic to it". The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Grand-Mal Seizures/Clonic tonic seizures"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic to it"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "not conscious for much of it"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: Body temperature: high. Clinical course: The patient was trying to find out the full name of the Pfizer COVID-19 vaccine, she got based on the lot number. She did not know which is the one she got. She got two of them, one on 08Oct2021 and 21Oct2021. The two lots numbers were FF8841and FF2593. After getting them, she had grand mal seizures and had body jerking for 14 hours and a high fever. She was not conscious for much of it but said she had to get the second one. She needs to know specifically the name of the COVID-19 Vaccine, which one she is allergic to and which one to select to show she is allergic to it. She provided there were only 2 lot numbers involved. Lot: FF8841 with this one she had Grand-Mal Seizures, but later clarified the actual name is Clonic-Tonic Seizures. The other Lot: FF2593. She had a seizure. She also had body jerking for 12-14 hours.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500026937 same patient, different doses/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Body temperature, Generalised tonic-clonic seizure, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: Inappropriate schedule of vaccine administered; Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot number: FF8841)), administration date: 08Oct2021, for COVID-19 immunisation, reaction(s): "Grand-Mal Seizures/Clonic tonic seizures", "not conscious for much of it", "high fever", "allergic to it". The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Grand-Mal Seizures/Clonic tonic seizures"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic to it"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "not conscious for much of it"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: Body temperature: high. Clinical course: The patient was trying to find out the full name of the Pfizer COVID-19 vaccine, she got based on the lot number. She did not know which is the one she got. She got two of them, one on 08Oct2021 and 21Oct2021. The two lots numbers were FF8841and FF2593. After getting them, she had grand mal seizures and had body jerking for 14 hours and a high fever. She was not conscious for much of it but said she had to get the second one. She needs to know specifically the name of the COVID-19 Vaccine, which one she is allergic to and which one to select to show she is allergic to it. She provided there were only 2 lot numbers involved. Lot: FF8841 with this one she had Grand-Mal Seizures, but later clarified the actual name is Clonic-Tonic Seizures. The other Lot: FF2593. She had a seizure. She also had body jerking for 12-14 hours.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500026937 same patient, different doses/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Grand-Mal Seizures/Clonic tonic seizures; not conscious for much of it; high fever; allergic to it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot number: FF8841)), administration date: 08Oct2021, for COVID-19 immunisation, reaction(s): "Grand-Mal Seizures/Clonic tonic seizures", "not conscious for much of it", "high fever", "allergic to it". The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Grand-Mal Seizures/Clonic tonic seizures"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic to it"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "not conscious for much of it"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: Body temperature: high. Clinical course: The patient was trying to find out the full name of the Pfizer COVID-19 vaccine, she got based on the lot number. She did not know which is the one she got. She got two of them, one on 08Oct2021 and 21Oct2021. The two lots numbers were FF8841and FF2593. After getting them, she had grand mal seizures and had body jerking for 14 hours and a high fever. She was not conscious for much of it but said she had to get the second one. She needs to know specifically the name of the COVID-19 Vaccine, which one she is allergic to and which one to select to show she is allergic to it. She provided there were only 2 lot numbers involved. Lot: FF8841 with this one she had Grand-Mal Seizures, but later clarified the actual name is Clonic-Tonic Seizures. The other Lot: FF2593. She had a seizure. She also had body jerking for 12-14 hours.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500026937 same patient, different doses/events;
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: It cracked when drawing it from the vial, the diluent tip cracked; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "It cracked when drawing it from the vial, the diluent tip cracked".  Causality for "it cracked when drawing it from the vial, the diluent tip cracked" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: While drawing it up the tip cracked instantly. Normally this does not happen. It cracked when drawing it from the vial, the diluent tip cracked. NDC: 0069-0344-01. Abrysvo Vial Adapter: Lot number: J591, expiration date:  29Nov2028. Abrysvo Diluent Syringe: Lot number: HT4720, expiration date: Dec2026. NDC: 0069-0250-01. A sample of the product is available to be returned.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Sometimes I get to sleep, you know, two or three hours at a time; daily intense pruritus head to toe; Intense head to toe pruritus; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8732, Expiration Date: Jul2021) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Multivitamin, notes: only took a multivitamin. Vaccination history included: Flu shot (annual/every fall). The following information was reported: INSOMNIA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Sometimes I get to sleep, you know, two or three hours at a time"; PRURITUS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "daily intense pruritus head to toe; Intense head to toe pruritus". The event "daily intense pruritus head to toe; intense head to toe pruritus" required physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: The patient had multiple visits to the Physician's office in 2021 and early 2022. GP MDs and RNs prescribed various type of steroids, antihistamines and antibiotics but none resolved the AE. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient was not taking any other medication within 2 weeks prior to the event onset and did not receive any other vaccine within 4 weeks prior to first administration of the suspect product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381378 Pfizer Inc.;US-PFIZER INC-202200845402 same patient/drug, different dose;
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired 02/08/2025, administered on 02/10/2025
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Patient reports nerve pain/ tingle in left arm shortly after getting vaccine
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site rash
Clinical narrative: felt dizzy and had skin rash at the site of her vaccine.  Monitored in office, stable vitals signs, provided with Gatorade, rash resolved, no longer dizzy.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eye swelling
Clinical narrative: Eye swelling
Age: 82.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Chills, Feeling cold
Clinical narrative: Patient wants pharmacist to report she has a bad chill-cold with her teeth was shaking for 1 days.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a flu shot and it was missed they had already received a flu shot in August 2024.  No adverse events occurred with patient.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Feeling of body temperature change, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Chills, hot and cold at injection site, swelling & pain under left arm all  for 5 days
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: She felt dizzy and lightheaded after vaccines. She was watched and monitored for about 20 minutes after. We did give her some Gatorade and crackers while waiting and she eventually felt better.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: She requested to receive the RSV vaccine. After administration of this vaccine, we checked her vaccination history and realized she had gotten vaccinated in 2023 and had forgotten to state it prior to her request. Essentially, she received 2 doses in a period of approximately 2 years span.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient requested to get vaccinated but did not remember he had received this vaccine in 2023 along with his wife. He stated his Dr. recommends they get it. As a result, he received 2 total doses of the RSV vaccine in a span of 2 years.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema, Rash
Clinical narrative: eczema and skin rashes on back and legs
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness, Osteoarthritis
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray abnormal
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Chondropathy, Condition aggravated
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Joint stiffness, Lip disorder, Lip pain, Magnetic resonance imaging
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Meniscus injury, Mobility decreased, Muscle tightness, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Osteoarthritis, X-ray, X-ray abnormal
Clinical narrative: Arthritis flare up all over body, especially in L knee and R shoulder.  Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaemia, Arthralgia, Back pain, Blood pressure decreased, Confusional state
Clinical narrative: terrible pain; sick; could not move; Threw up; Urinated on her self; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received dose in 2017), Shingrix with an associated reaction of pain in extremity (received 1st dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447) and RSV vaccine with an associated reaction of pain in extremity (received a dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447).   On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 25-JAN-2025 01:30, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: terrible pain), sickness (Verbatim: sick), mobility decreased (Verbatim: could not move), vomiting (Verbatim: Threw up), enuresis (Verbatim: Urinated on her self) and diarrhea (Verbatim: Diarrhea). The outcome of the pain, sickness, mobility decreased and enuresis were unknown and the outcome of the vomiting was resolved and the outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.     It was unknown if the company considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR010447   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient received the second dose on Friday. On Saturday 25 January 2025, at 1:30 am after the second dose of Shingrix, the patient woke up in terrible pain, she was sick and could not move. She threw up, urinated on herself and had diarrhea. The vomiting recovered in JAN-2025.; Sender's Comments:  US-GSK-US2025AMR010447:Dose 1/ Same patient
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Neck pain, Urinary incontinence, Vomiting
Clinical narrative: terrible pain; sick; could not move; Threw up; Urinated on her self; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received dose in 2017), Shingrix with an associated reaction of pain in extremity (received 1st dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447) and RSV vaccine with an associated reaction of pain in extremity (received a dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447).   On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 25-JAN-2025 01:30, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: terrible pain), sickness (Verbatim: sick), mobility decreased (Verbatim: could not move), vomiting (Verbatim: Threw up), enuresis (Verbatim: Urinated on her self) and diarrhea (Verbatim: Diarrhea). The outcome of the pain, sickness, mobility decreased and enuresis were unknown and the outcome of the vomiting was resolved and the outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.     It was unknown if the company considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR010447   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient received the second dose on Friday. On Saturday 25 January 2025, at 1:30 am after the second dose of Shingrix, the patient woke up in terrible pain, she was sick and could not move. She threw up, urinated on herself and had diarrhea. The vomiting recovered in JAN-2025.; Sender's Comments:  US-GSK-US2025AMR010447:Dose 1/ Same patient
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Illness, Movement disorder, Pain, Urinary incontinence
Clinical narrative: terrible pain; sick; could not move; Threw up; Urinated on her self; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received dose in 2017), Shingrix with an associated reaction of pain in extremity (received 1st dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447) and RSV vaccine with an associated reaction of pain in extremity (received a dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447).   On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 25-JAN-2025 01:30, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: terrible pain), sickness (Verbatim: sick), mobility decreased (Verbatim: could not move), vomiting (Verbatim: Threw up), enuresis (Verbatim: Urinated on her self) and diarrhea (Verbatim: Diarrhea). The outcome of the pain, sickness, mobility decreased and enuresis were unknown and the outcome of the vomiting was resolved and the outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.     It was unknown if the company considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR010447   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient received the second dose on Friday. On Saturday 25 January 2025, at 1:30 am after the second dose of Shingrix, the patient woke up in terrible pain, she was sick and could not move. She threw up, urinated on herself and had diarrhea. The vomiting recovered in JAN-2025.; Sender's Comments:  US-GSK-US2025AMR010447:Dose 1/ Same patient
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: terrible pain; sick; could not move; Threw up; Urinated on her self; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received dose in 2017), Shingrix with an associated reaction of pain in extremity (received 1st dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447) and RSV vaccine with an associated reaction of pain in extremity (received a dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447).   On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 25-JAN-2025 01:30, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: terrible pain), sickness (Verbatim: sick), mobility decreased (Verbatim: could not move), vomiting (Verbatim: Threw up), enuresis (Verbatim: Urinated on her self) and diarrhea (Verbatim: Diarrhea). The outcome of the pain, sickness, mobility decreased and enuresis were unknown and the outcome of the vomiting was resolved and the outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.     It was unknown if the company considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR010447   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient received the second dose on Friday. On Saturday 25 January 2025, at 1:30 am after the second dose of Shingrix, the patient woke up in terrible pain, she was sick and could not move. She threw up, urinated on herself and had diarrhea. The vomiting recovered in JAN-2025.; Sender's Comments:  US-GSK-US2025AMR010447:Dose 1/ Same patient
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: My husband got Gillian Barre syndrome from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: My husband got Gillian Barre syndrome from the vaccine) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient got Guillain Barre syndrome from the vaccine and he was paralyzed The reporter asked not to get the vaccine.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; have now had shingles twice in the past 3 months; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: have now had shingles twice in the past 3 months). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025 The patient got the 2 Shingrix shots in 2022 and now had shingles twice in the past 3 months.  The reporter asked if it was recommended that he/she got a booster of some sort and it would help or harm his/her. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: UNK
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Diagnosed with the flu A; This spontaneous case initially received on 30-Jan-2025, was reported by a non health professional and concerns a child female patient.  Medical history or concomitant medications were reported as unknown. No allergy information provided.  There was no product complaint associated with this case.  Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Flu immunization, Dose regimen: 0.5 ml, Route of administration: not reported, anatomical location: right deltoid Lot number: 946624.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 28-Jan-2025, the patient experienced Diagnosed with the flu A (Medically Significant, outcome: Unknown).  The reporter informed that her child was diagnosed with the flu during a trip to her pediatrician then. Vaccination was given at Health Services Clinic. Flu was verified by nasal swab. Flu virus was Flu A. Onset date was 28-Jan-2025 and Recovery date was 20-Jan-2025 (as reported). Source of infection was unknown (likely a peer at her school).  Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Unknown  Reporter assessment The reporter provide the seriousness of the event as unknown and did not provide a causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(relevant medical history, concomitant medications, diagnostic report)
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Gait inability, Gaze palsy
Clinical narrative: Extreme joint pain through body.  Unable to walk.  Headache.. chills..
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ascites, Balance disorder, Blood loss anaemia, Coma, Death
Clinical narrative: Liver damage, diagnosed after throwing up blood and having blood in stool. Esophageal varices bleeding, ended up in ICU in a coma for 4 days. 5 varices closed.  Still had problems with leaking blood, was anemic as a result. Had balance issues, lost 100 pound of weight between the time of the shot and his final hospitalization January 23rd 2025. Had a second banding done, another 5 clips. Anemia treatments (blood and plasma and IV iron), Removal of ascites started a month apart and by the end was having it every other week, then daily. Patient died in hospital January 30, 2025, 9: 30 pm.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis, Haematochezia, Intensive care, Liver injury, Oesophageal variceal ligation
Clinical narrative: Liver damage, diagnosed after throwing up blood and having blood in stool. Esophageal varices bleeding, ended up in ICU in a coma for 4 days. 5 varices closed.  Still had problems with leaking blood, was anemic as a result. Had balance issues, lost 100 pound of weight between the time of the shot and his final hospitalization January 23rd 2025. Had a second banding done, another 5 clips. Anemia treatments (blood and plasma and IV iron), Removal of ascites started a month apart and by the end was having it every other week, then daily. Patient died in hospital January 30, 2025, 9: 30 pm.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oesophageal varices haemorrhage, Paracentesis, Transfusion, Weight decreased
Clinical narrative: Liver damage, diagnosed after throwing up blood and having blood in stool. Esophageal varices bleeding, ended up in ICU in a coma for 4 days. 5 varices closed.  Still had problems with leaking blood, was anemic as a result. Had balance issues, lost 100 pound of weight between the time of the shot and his final hospitalization January 23rd 2025. Had a second banding done, another 5 clips. Anemia treatments (blood and plasma and IV iron), Removal of ascites started a month apart and by the end was having it every other week, then daily. Patient died in hospital January 30, 2025, 9: 30 pm.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; my wife had the double shot so she wouldn't and still got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: my wife had the double shot so she wouldn't and still got Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 05-FEB-2025 This case was reported by a patient's husband via interactive digital media. The patient had the double shot so she would not and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose until January 15th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 12-JUL-2024 with batch number 797F9 and lot expiry 30-DEC-2025).   On 15-JAN-2025, the patient received the 2nd dose of Twinrix. On 15-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose until January 15th 2025). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: The pharmacist reported that a patient got their first dose of Twinrix and late second dose  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Dyskinesia, Influenza virus test negative, Laboratory test normal, Metabolic function test normal, Respiratory syncytial virus test negative
Clinical narrative: Father reports grandmother got patient up from nap and while changing diaper patient stretched out limbs with shaking/rhythmic jerking of limbs. Had 2-3 episodes back to back lasting only 5-30 seconds. ER evaluation 2-7-25 where COVID 19, flu, RSV testing negative and CBL and CMP labs normal. Reports no more seizure like activity since first occurance.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: SARS-CoV-2 test negative, Seizure like phenomena, Tremor
Clinical narrative: Father reports grandmother got patient up from nap and while changing diaper patient stretched out limbs with shaking/rhythmic jerking of limbs. Had 2-3 episodes back to back lasting only 5-30 seconds. ER evaluation 2-7-25 where COVID 19, flu, RSV testing negative and CBL and CMP labs normal. Reports no more seizure like activity since first occurance.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Patient had hives and face streaking after shots. Patient was monitor for one hour post injection with no complications no meds were given
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Computerised tomogram head normal, Computerised tomogram spine abnormal, Disorientation, Dysstasia
Clinical narrative: Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Per provider note: 94 year old male with PMHx of HFrEF (<20%), HTN, SSS s/p PPM, PMR, BPH, Osteoarthritis and Osteoporosis who present for weakness. Patient first presented to ED on 12/6/24 after experiencing a ground level fall. While in the ED he received a dose of the TDAP (Boostrix) vaccine. He tripped on a step and fell hitting the left side of his head on the wall. Patient's only complaint was mild headache. He was at his baseline state of health before and after the fall. CT head was negative. CT C spine revealed age indeterminate C4 fracture. No tenderness over cervical spine. Neurosurgery weighed in on imaging finding and determined no intervention since most likely present before fall. Patient was discharged from the ED with strict return precautions. Of note, he received TDAP vaccine prior to discharge. Patient went home and later developed weakness. He states around 11pm he woke up, got disoriented and couldnt find walker. He laid on the ground and crawed around home until 6pm the next day. Couldnt stand or walk. He denies falling, hitting his head or LOC. Only complaint is generalized weakness. Neurologist was consulted who stated this weakness isnt consistent with spinal cord injury or Guillain-Barre. Neurologist was concerned that the vaccine could have flared up PMR. Other Relevant HX: Other: weakness
Sex: M
Vaccine: TDAP
Symptoms: Gait inability
Clinical narrative: Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Per provider note: 94 year old male with PMHx of HFrEF (<20%), HTN, SSS s/p PPM, PMR, BPH, Osteoarthritis and Osteoporosis who present for weakness. Patient first presented to ED on 12/6/24 after experiencing a ground level fall. While in the ED he received a dose of the TDAP (Boostrix) vaccine. He tripped on a step and fell hitting the left side of his head on the wall. Patient's only complaint was mild headache. He was at his baseline state of health before and after the fall. CT head was negative. CT C spine revealed age indeterminate C4 fracture. No tenderness over cervical spine. Neurosurgery weighed in on imaging finding and determined no intervention since most likely present before fall. Patient was discharged from the ED with strict return precautions. Of note, he received TDAP vaccine prior to discharge. Patient went home and later developed weakness. He states around 11pm he woke up, got disoriented and couldnt find walker. He laid on the ground and crawed around home until 6pm the next day. Couldnt stand or walk. He denies falling, hitting his head or LOC. Only complaint is generalized weakness. Neurologist was consulted who stated this weakness isnt consistent with spinal cord injury or Guillain-Barre. Neurologist was concerned that the vaccine could have flared up PMR. Other Relevant HX: Other: weakness
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema, Pyrexia
Clinical narrative: Reported Symptoms: 10014210:EDEMA; 10016558:FEVER; Narrative: Other Relevant HX: Other: skin edema
Age: 44.0
Sex: M
Vaccine: PNC10
Symptoms: Syringe issue
Clinical narrative: Reported Symptoms: 10069218:SYRINGE ISSUE; Narrative: Nurse administered needle and attempted to administer flu vaccine but was unable to due to syringe plunger being stuck during injection. Nurse pulled needle out of left deltoid and notified patient. Patient was offered to administer on right deltoid, but patient declined. Other Relevant HX: Other: syringe issue
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Headache, Hyperglycaemia
Clinical narrative: Reported Symptoms: 10019211:HEADACHE; 10020639:HYPERGLYCEMIA; Narrative: Patient received influenza vaccine on 9/26/24. Per clinical pharmacist on 10/7/24, patient reported having high blood glucose readings which would not come down since getting the flu vaccine and also had bad headaches. Other 10/18/2012, 04/30/2012, 11/05/2010, and 11/06/2009 Other: HEADACHE; HYPERGLYCEMIA
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Nausia, fever 101, headache, body, muscle and joint aches, dizzyness
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Nausia, fever 101, headache, body, muscle and joint aches, dizzyness
Age: 1.25
Sex: U
Vaccine: DTAP, HIBV, PNC20
Symptoms: Chills, Lethargy, Muscle twitching, Pyrexia
Clinical narrative: Within 12 hrs had fever, chills Temp 103 & twitching @ chin & eyes, no LOC. Fever went away 12-24hrs. Some lethargy. Has occasional twitching around eyes & on chin Sp in arm. When she wakes up, decreasing in intensity
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Hyperhidrosis, Malaise, Nervousness
Clinical narrative: Patient received her vaccination. After she was seated in the Observational area, the RN in OBS asked how the pt was feeling. Pt stated she felt clammy and sweaty. Pt stated she felt unwell and was nervous that she was having a stroke. RN obtained pt's Vitals. BP: 147/84, Pulse: 84; Pulse OX: 100%. Pt continue to state she was concerned, so RN called a Rapid Response. The ED team came and talked with the pt. After pt was reassessed by the Rapid Response Team,. After discussion, the pt decided to leave on her own with her
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received flu vaccine twice within 1 month two different facilities. No adverse reaction has been noted/documented Documenting per advice from vac coordinator helpline
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Intensive care, Pruritus, Throat clearing
Clinical narrative: Pt started experiencing severe itching 45-60 minutes after vaccine administered. Allergy extender evaluated pt and gave the verbal order for 50 mg Benadryl. Pt then started coughing and clearing throat. and itching became worse. Adult Epi was immediately administered and pt transported to ER for further treatment and was later admitted to the ICU.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever, red bumpy rash on abdomen, lethargic, decreased appetite. Symptoms started just over a week after vaccines.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient had swelling and a rash after receiving quadracel and fluarix intramuscular in right arm. The rash and swelling on right arm went from his should down to forearm.
Age: 4.0
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Anaphylactic reaction, Rash, Wheezing
Clinical narrative: Rash started directly after appointment, mom brought child back to the clinic, MD determined pt was wheezing and had rash now present all over body, epi pen given d/t anaphylaxis, ambulance called, pt transported to ED.
Age: 88.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED RSV VACCINE TWICE. FIRST VACCINE WAS GIVEN ON 12/21/23 THE BRAND WAS AREXVY. THIS VACCINE WAS NOT REPORTED TO GRITS SO PATIENT RECEIVED ANOTHER DOSE OF RSV VACCINE ON 2/8/25.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Several enlarged lymph nodes
Age: 6.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Syncope
Clinical narrative: Client fainted approximately 30 minutes after vaccination. Vitals checked. NP assessed. Client went home.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Skin exfoliation
Clinical narrative: Initially when the patient's caretaker called to report she stated there was redness and pain at the injection site.  She was told that could happen and was normal; but to notify us if the area got worse or looked different.  The patient's caretaker called today to state that the area was still in tact but looked hollowed out (like the tissue beneath the skin was gone) and that the area was still red and had started to peel.  The patient has a upcoming doctor visit and will have it looked at then.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Skin warm
Clinical narrative: redness about 4 inches in size, warm to the touch. adviced pt to draw a pen circumference around the redness and see if it continues to spread. keep an eye on fever. luckily no fever reported. pt went to urgent care and was given keflex for infection. we made joint decision to hold off on antibiotics unless color changes and fever appears