chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Neuropathy peripheral, Pain
Clinical narrative: The patient has chronic neuropathy and reported worsening about 2 hours after receiving the vaccine and the extreme pain lasted about 24 hours.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Chills, Chromaturia, Dehydration, Diarrhoea
Clinical narrative: Wed Jan 10, 2024 11:30 am Covid shot at pharmacy (Moderna) ? It?s my 4th Covid shot. 5:00 pm hot bath 6:40 pm arm hurts 6:40 pm dinner ? chicken soup/crackers, ice cream 7:35 pm chills *8:15 ? 8:30 pm ? slept on couch 15 min *9:15 pm ? chills, body aches, shivering *9:40 pm ? Tylenol x1 *10 pm go to bed, skin feels hot *10:05 pm restless *10:37 pm dry heaves *11:33 pm congestion *11:20 pm Advil x 2 Thursday Jan 11, 2024 *1:09 am Nyquil 3o ml *1:49 am complete sinus block & sinus pain *3:46 am dry heaves *4:30 dry heaves, diarrhea *5:05 am dry heaves, diarrhea *5:05 am Advil x 2, squirt nasal spray x 2 each nostril *8am cold washcloth to face *8:40 am sore throat *11:45 am sinus pain continues so bad teeth throb *4:30 pm Sudafed x 1 *9:47 pm Nyquil Friday Jan 12, 2024 *7:30 am HA, Advil x 2 *8:41 am HA 50% gone  *ongoing extreme fatigue, urine orange when dehydrated, foggy mentation
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Wed Jan 10, 2024 11:30 am Covid shot at pharmacy (Moderna) ? It?s my 4th Covid shot. 5:00 pm hot bath 6:40 pm arm hurts 6:40 pm dinner ? chicken soup/crackers, ice cream 7:35 pm chills *8:15 ? 8:30 pm ? slept on couch 15 min *9:15 pm ? chills, body aches, shivering *9:40 pm ? Tylenol x1 *10 pm go to bed, skin feels hot *10:05 pm restless *10:37 pm dry heaves *11:33 pm congestion *11:20 pm Advil x 2 Thursday Jan 11, 2024 *1:09 am Nyquil 3o ml *1:49 am complete sinus block & sinus pain *3:46 am dry heaves *4:30 dry heaves, diarrhea *5:05 am dry heaves, diarrhea *5:05 am Advil x 2, squirt nasal spray x 2 each nostril *8am cold washcloth to face *8:40 am sore throat *11:45 am sinus pain continues so bad teeth throb *4:30 pm Sudafed x 1 *9:47 pm Nyquil Friday Jan 12, 2024 *7:30 am HA, Advil x 2 *8:41 am HA 50% gone  *ongoing extreme fatigue, urine orange when dehydrated, foggy mentation
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Restlessness, Retching, Sinus congestion, Sinus pain
Clinical narrative: Wed Jan 10, 2024 11:30 am Covid shot at pharmacy (Moderna) ? It?s my 4th Covid shot. 5:00 pm hot bath 6:40 pm arm hurts 6:40 pm dinner ? chicken soup/crackers, ice cream 7:35 pm chills *8:15 ? 8:30 pm ? slept on couch 15 min *9:15 pm ? chills, body aches, shivering *9:40 pm ? Tylenol x1 *10 pm go to bed, skin feels hot *10:05 pm restless *10:37 pm dry heaves *11:33 pm congestion *11:20 pm Advil x 2 Thursday Jan 11, 2024 *1:09 am Nyquil 3o ml *1:49 am complete sinus block & sinus pain *3:46 am dry heaves *4:30 dry heaves, diarrhea *5:05 am dry heaves, diarrhea *5:05 am Advil x 2, squirt nasal spray x 2 each nostril *8am cold washcloth to face *8:40 am sore throat *11:45 am sinus pain continues so bad teeth throb *4:30 pm Sudafed x 1 *9:47 pm Nyquil Friday Jan 12, 2024 *7:30 am HA, Advil x 2 *8:41 am HA 50% gone  *ongoing extreme fatigue, urine orange when dehydrated, foggy mentation
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin warm, Toothache
Clinical narrative: Wed Jan 10, 2024 11:30 am Covid shot at pharmacy (Moderna) ? It?s my 4th Covid shot. 5:00 pm hot bath 6:40 pm arm hurts 6:40 pm dinner ? chicken soup/crackers, ice cream 7:35 pm chills *8:15 ? 8:30 pm ? slept on couch 15 min *9:15 pm ? chills, body aches, shivering *9:40 pm ? Tylenol x1 *10 pm go to bed, skin feels hot *10:05 pm restless *10:37 pm dry heaves *11:33 pm congestion *11:20 pm Advil x 2 Thursday Jan 11, 2024 *1:09 am Nyquil 3o ml *1:49 am complete sinus block & sinus pain *3:46 am dry heaves *4:30 dry heaves, diarrhea *5:05 am dry heaves, diarrhea *5:05 am Advil x 2, squirt nasal spray x 2 each nostril *8am cold washcloth to face *8:40 am sore throat *11:45 am sinus pain continues so bad teeth throb *4:30 pm Sudafed x 1 *9:47 pm Nyquil Friday Jan 12, 2024 *7:30 am HA, Advil x 2 *8:41 am HA 50% gone  *ongoing extreme fatigue, urine orange when dehydrated, foggy mentation
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disorientation, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: fever (4 days, from 99.4 to 102.2), nausea (14 hours first day early), dizziness (12-14 hours first day early), fatigue (4 days), disorientation (first 36 hours), arm pain (4.5 days), blurred vision (sporadic), headache (first 2 days)
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: fever (4 days, from 99.4 to 102.2), nausea (14 hours first day early), dizziness (12-14 hours first day early), fatigue (4 days), disorientation (first 36 hours), arm pain (4.5 days), blurred vision (sporadic), headache (first 2 days)
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: was mixed with sterile diluent instead of DTAP/IPV component of pentacel
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event, besides receiving 2 flu shots in same season (fall 2023)
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Swollen tongue
Clinical narrative: Patient claims pain at injection site at time of administration.  Pt reports being unable to move her arm.  Reports allergic reaction - tongue swelling.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Balance disorder, Blood test, Body temperature increased, Cognitive disorder, Computerised tomogram head normal
Clinical narrative: Within a few hours of the shot, patient had flu like symptoms (lethargy, body aches, elevated temperature, headache) which did not go away in a few days.  Urgent care doctor didn't have xray avaiible, but thought she heard blockage in lower left lobe of lung. A few days later, PCP doctor didn't do a chest xray, but thought it might be sinusitis.  Four days after that, after being on antibiotics, patient became delirious, cognitively impared, unsteady on his feet, and slid in the backyard. Went to ER and was admitted (Head CT scans & MRI did not show any brain events from the fall.) However, delirium and hallucinations continued for nearly a month.  Cognitive function is still decreased and may not return to normal.    the immunization was listed as Comirnaty (Covid-19 Vaccine, mRNA, 2023-2024 formula), which the footnote said is made the same way as Pfizer-BioNTech Covid-19 Vaccine (original monovalent) and Pfizer-BioNTech Covid-19 vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron varient lineage XBB.1.5 (Omicron XBB.!.5)  I couldn't find what kind of flu vaccine was given on 10-2-23, I assumed it was the fluad for persons over 65..
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Delirium, Fall, Hallucination, Headache, Influenza like illness
Clinical narrative: Within a few hours of the shot, patient had flu like symptoms (lethargy, body aches, elevated temperature, headache) which did not go away in a few days.  Urgent care doctor didn't have xray avaiible, but thought she heard blockage in lower left lobe of lung. A few days later, PCP doctor didn't do a chest xray, but thought it might be sinusitis.  Four days after that, after being on antibiotics, patient became delirious, cognitively impared, unsteady on his feet, and slid in the backyard. Went to ER and was admitted (Head CT scans & MRI did not show any brain events from the fall.) However, delirium and hallucinations continued for nearly a month.  Cognitive function is still decreased and may not return to normal.    the immunization was listed as Comirnaty (Covid-19 Vaccine, mRNA, 2023-2024 formula), which the footnote said is made the same way as Pfizer-BioNTech Covid-19 Vaccine (original monovalent) and Pfizer-BioNTech Covid-19 vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron varient lineage XBB.1.5 (Omicron XBB.!.5)  I couldn't find what kind of flu vaccine was given on 10-2-23, I assumed it was the fluad for persons over 65..
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Lethargy, Magnetic resonance imaging head normal, Pain
Clinical narrative: Within a few hours of the shot, patient had flu like symptoms (lethargy, body aches, elevated temperature, headache) which did not go away in a few days.  Urgent care doctor didn't have xray avaiible, but thought she heard blockage in lower left lobe of lung. A few days later, PCP doctor didn't do a chest xray, but thought it might be sinusitis.  Four days after that, after being on antibiotics, patient became delirious, cognitively impared, unsteady on his feet, and slid in the backyard. Went to ER and was admitted (Head CT scans & MRI did not show any brain events from the fall.) However, delirium and hallucinations continued for nearly a month.  Cognitive function is still decreased and may not return to normal.    the immunization was listed as Comirnaty (Covid-19 Vaccine, mRNA, 2023-2024 formula), which the footnote said is made the same way as Pfizer-BioNTech Covid-19 Vaccine (original monovalent) and Pfizer-BioNTech Covid-19 vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron varient lineage XBB.1.5 (Omicron XBB.!.5)  I couldn't find what kind of flu vaccine was given on 10-2-23, I assumed it was the fluad for persons over 65..
Age: 58.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Contusion, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: IMMEDIATELY AFTER RECEVING THE COMIRNATY 23-24 VACCINE ON THE LEFT ARM, IT SWELLED UP MORE THAN USUAL. PATIENT WAS FEELING FINE. PATIENT WAS TO PUT UNDER OBSERVATION FOR 15 MINS AND RELEASED. THE SWELLING WENT DOWN LITTLE BIT WHEN PATIENT WAS RELEASED. PATIENT WAS CONTACTED ON 1/16/2024. PATIENT SAID THE SWELLING IS COMPLETELY GONE, BUT THERE IS A BRUISE. PATIENT
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 60.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Acne
Clinical narrative: seven pimples appeared at various spots on my left arm
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Severely painful, red, hot inflammation at site of injection, on the left deltoid, the size of a human hand.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Generalized itching that began about a week after injection.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 10 days beyond use date on product.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Urticaria
Clinical narrative: Patient states ended up developing hives 2 days after vaccine administration. Patient also experienced fatigue the day after administration.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 10 days beyond use date on product.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 10 days beyond use date on product.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 10 days beyond use date on product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, Neuropsychological test
Clinical narrative: Within 12 hours of receiving vaccine, patient went from normal state of health to encephalopathic.; This spontaneous case was reported by a physician and describes the occurrence of ENCEPHALOPATHY (Within 12 hours of receiving vaccine, patient went from normal state of health to encephalopathic.) in a 69-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 12-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ENCEPHALOPATHY (Within 12 hours of receiving vaccine, patient went from normal state of health to encephalopathic.) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in December 2023 due to ENCEPHALOPATHY. In December 2023, ENCEPHALOPATHY (Within 12 hours of receiving vaccine, patient went from normal state of health to encephalopathic.) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neuropsychological test: He has had neuropsychiatric testing and is completely normal again.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient had severe confusion which ultimately led to a hospitalization. He had a normal workup in the hospital and not had a stroke. His symptoms resolved after 48 hours. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.  Company Comment This is an spontaneous case concerning a 69-years-old female patient with no medical history reported who experienced the seriousness criteria medically significant and hospitalization unexpected event of encephalopathy the same day after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. At the time of the report, the event had resolved with sequelae. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; expired dose of GARDASIL 9 was inadvertently administered to a patient; This spontaneous report was received from an other health care professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 20-DEC-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: U019412, expiration date: 30-OCT-2023; strength, dose, and route of administration were not reported) for prophylaxis (expired product administered). It was reported that did not undergo any temperature excursions. No additional adverse events (AE) were reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients who received the vaccines reported any adverse issues or side effects.; A HCP called to report a TE for PROQUAD and VARIVAX occurring between 01/05/2024 through 01/07/2024.  The caller stated that the cord from the data logger became dislodged and stopped tracking data during the time frame reported.  The caller was unaw; This spontaneous report was received from a medical assistant refers to a 12-month-old patient of unknown gender.  The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included sterile diluent (STERILE DILUENT).  On 05-JAN-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), formulation: injection, lot # X006982, expiration date: 07-MAR-2025, 0.5 milliliter once (route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of -2.0 degrees Fahrenheit for 72 hours (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/PQC reported; HBP calling to report adverse event regarding VARIVAX and PROQUAD.  HBP reporting that the vaccines were given to the same 12 month old patient during a routine wellness and vaccination appointment.  HBP stated that the vaccines were given due to an; This spontaneous report was received from an office manager and refers to a 12-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 09-JAN-2024 the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # W034209 and expiration date 24-APR-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # W039688 and expiration date 13-DEC-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). Reported stated that the vaccines were given due to an error in the health care professional's process in preparing for administration for the patient (accidental overdose and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product availability issue
Clinical narrative: due to having no vaccine in stock; No additional AE; patient who missed their dose of PROQUAD; This spontaneous report was received from a nurse, referring to a patient of unknown gender and age.  The patient's pertinent previous drug reactions, allergies, medical history, concurrent conditions and concomitant therapies were not reported.  On 11-JAN-2024, the patient missed their second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product dose omission issue) injection, at a dose of 0.5 milliliter, administered for prophylaxis (vaccination scheme, strength, lot #, expiry date, and route of administration were not provided), and she would receive their dose until 12-JAN-2023, due to having no vaccine in stock (Product availability issue). No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient has no symptoms or side effects; HBP called to report that a dose of MMR II vaccine was administered to a patient today 1/11/2024 and expired on 1/7/2024. HBP reports that the lot number is W019425. HBP gives permission to contact. HBP reports that the patient has no symptoms or sid; This spontaneous report was received from a office manager (other) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 11-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # W019425, expiration date: 07-JAN-2024, 0.5 milliliter once (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The patient has no symptoms or side effects (no adverse event).   Lot number W019425 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with albumin status rHa.
Sex: F
Vaccine: RSV
Symptoms: Neurological symptom
Clinical narrative: neurological event; This serious case was reported by a physician via sales rep and described the occurrence of neurological symptom in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced neurological symptom (Verbatim: neurological event) (serious criteria hospitalization). The outcome of the neurological symptom was resolved.   It was unknown if the reporter considered the neurological symptom to be related to Arexvy.     It was unknown if the company considered the neurological symptom to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-JAN-2024 The patient experienced neurological event and for that patient was hospitalized. The reporter denied consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JAN-2024 The case was received from the patient via interactive digital media.  The patient took the shingles vaccine and he/she still got shingles, but it lasts for a shorter time. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Shingles/suspcted vaccination failure; Shingles; Itching; Poison ivy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles/suspcted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pruritus (Verbatim: Itching) and poison ivy rash (Verbatim: Poison ivy). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and poison ivy rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and poison ivy rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and poison ivy rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JAN-2024 The case was received from the patient via interactive digital media. The patient got shingles this summer but because of the vaccine the patient and his/her doctor were not sure if it was not just poison ivy but just had some itching. The patient could not recommend the vaccine enough. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Cutaneous vasculitis
Clinical narrative: Leukacytoclastic vasculitis; This serious case was reported by a physician via sales rep and described the occurrence of leukocytoclastic vasculitis in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7p299) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced leukocytoclastic vasculitis (Verbatim: Leukacytoclastic vasculitis) (serious criteria GSK medically significant). The outcome of the leukocytoclastic vasculitis was not reported.   It was unknown if the reporter considered the leukocytoclastic vasculitis to be related to Arexvy.     It was unknown if the company considered the leukocytoclastic vasculitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-Jan-2024 The reporter reported that the patient received Arexvy vaccine and experienced leukacytoclastic vasculitis. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Neuralgia, Pain, Pyrexia
Clinical narrative: Covid; Fever; Pain associated with having shingles/horrible pain; Pain associated with having shingles; nerve related pain; Whole torso, front and back, along with my arms, have the burning/Sun burnt feeling over multiple parts of body; This non-serious case was reported by a consumer and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 2 times in 2023).   On 10-NOV-2023, the patient received Shingrix. On 11-NOV-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: Pain associated with having shingles), post herpetic neuralgia (Verbatim: nerve related pain) and burning sensation (Verbatim: Whole torso, front and back, along with my arms, have the burning/Sun burnt feeling over multiple parts of body). On an unknown date, the patient experienced covid-19 (Verbatim: Covid), fever (Verbatim: Fever) and pain (Verbatim: Pain associated with having shingles/horrible pain). The patient was treated with pregabalin (Lyrica). The outcome of the shingles, post herpetic neuralgia, covid-19, fever and pain were not reported and the outcome of the burning sensation was not resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, burning sensation, covid-19, fever and pain to be related to Shingrix.     It was unknown if the company considered the shingles, post herpetic neuralgia, burning sensation, covid-19, fever and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2024 The patient was reporter. The patient received Shingrix vaccine and felt sun burnt over multiple parts of her body. The patient was recently diagnosed with covid. The patient had a fever and her whole torso, front, back, arm had the burning. The pain was associated with shingles. The patient had shingles 2 times in 2023 and she knows what shingles felt like when shingles had a breakout. Her doctor gave her prescription of Lyrica to help with the burning and pain. The patient had passed her isolation period for covid.  The patient stated since the Lyrica was nerve related it had not alleviated any of the pain and burning. The patient want to know if there was any recommendations and how to help me with this. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test positive, Skin burning sensation
Clinical narrative: Covid; Fever; Pain associated with having shingles/horrible pain; Pain associated with having shingles; nerve related pain; Whole torso, front and back, along with my arms, have the burning/Sun burnt feeling over multiple parts of body; This non-serious case was reported by a consumer and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 2 times in 2023).   On 10-NOV-2023, the patient received Shingrix. On 11-NOV-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: Pain associated with having shingles), post herpetic neuralgia (Verbatim: nerve related pain) and burning sensation (Verbatim: Whole torso, front and back, along with my arms, have the burning/Sun burnt feeling over multiple parts of body). On an unknown date, the patient experienced covid-19 (Verbatim: Covid), fever (Verbatim: Fever) and pain (Verbatim: Pain associated with having shingles/horrible pain). The patient was treated with pregabalin (Lyrica). The outcome of the shingles, post herpetic neuralgia, covid-19, fever and pain were not reported and the outcome of the burning sensation was not resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, burning sensation, covid-19, fever and pain to be related to Shingrix.     It was unknown if the company considered the shingles, post herpetic neuralgia, burning sensation, covid-19, fever and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2024 The patient was reporter. The patient received Shingrix vaccine and felt sun burnt over multiple parts of her body. The patient was recently diagnosed with covid. The patient had a fever and her whole torso, front, back, arm had the burning. The pain was associated with shingles. The patient had shingles 2 times in 2023 and she knows what shingles felt like when shingles had a breakout. Her doctor gave her prescription of Lyrica to help with the burning and pain. The patient had passed her isolation period for covid.  The patient stated since the Lyrica was nerve related it had not alleviated any of the pain and burning. The patient want to know if there was any recommendations and how to help me with this. The reporter consented to follow up via email.
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: dry cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dry cough in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced dry cough (Verbatim: dry cough). The outcome of the dry cough was not resolved.   The reporter considered the dry cough to be possibly related to Arexvy.     The company considered the dry cough to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 10-JAN-2024 The case was received from the patient via interactive digital media. The patient got her RSV vaccine (Arexvy) and had a dry cough since the day after getting the vaccine. The patient stated that just a cough.
Age: 0.75
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered a single vial presentation of Menveo on accident; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 9-month-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   The patient's past medical history included sickle cell disorders.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a single vial presentation of Menveo on accident). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2024 The 9 month old patient was administered a single vial presentation of Menveo on accident which was approved for 10 years old and up, which led to inappropriate age at vaccine administration. No adverse events associated with administration reported. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was resolved (duration 1 month).   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 10-JAN-2024 This case was reported by patient via interactive digital media. The patient reported that he/she got the shot and broke out with shingles 10 days later and took a prescription from doctor to keep them from spreading but it took a month to completely clear up. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: Splitting headache; hurt all over; Tired; Cannot function; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Splitting headache), general body pain (Verbatim: hurt all over), tiredness (Verbatim: Tired) and activities of daily living impaired (Verbatim: Cannot function). The outcome of the headache, general body pain, tiredness and activities of daily living impaired were not reported.   It was unknown if the reporter considered the headache, general body pain, tiredness and activities of daily living impaired to be related to Arexvy.     It was unknown if the company considered the headache, general body pain, tiredness and activities of daily living impaired to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-Jan-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she received Arexvy vaccine and experienced splitting headache. The patient hurt all over and he or she was so tired so he or she cannot function. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: small pink spot showed on the left side of his body/ pink rash looked like poison ivy; Itchy rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced red rash (Verbatim: small pink spot showed on the left side of his body/ pink rash looked like poison ivy) and itchy rash (Verbatim: Itchy rash). The patient was treated with calamine. The outcome of the red rash and itchy rash were resolved.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the red rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2024 The patient got the 1st dose of the vaccine at a local pharmacy. The date of the vaccination was unknown.  The patient reported stated that it has not been 6 months yet since the patient got the 1st dose vaccine.  The lot and expiry date were unknown. The patient had a small pink spot showed on the left side of his body about a week after vaccine was administered. The patient reported then it formed a 4-inch rash on the left side that continued spreading.  The pink rash looked like poison ivy.  The patient reported that the rash was itching . The patient reported he had applied calamine, and the itch went away.  The patient reported that the rash spread down to the hip area and under the arm.  No additional information was provided. The reporter did not consent to follow-up.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: pregnant patient was administered Arexvy; 36 year old patient received Arexvy; 36 year old patient received Arexvy; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number C9GB5, expiry date 30-MAR-2025) for prophylaxis.   On 08-DEC-2023, the patient received Arexvy (intramuscular, left deltoid). On 08-DEC-2023, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was administered Arexvy), inappropriate age at vaccine administration (Verbatim: 36 year old patient received Arexvy) and wrong vaccine administered (Verbatim: 36 year old patient received Arexvy). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 26-JAN-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-JAN-2024 The nurse reported that a pregnant patient who was administered Arexvy. The reported they administered the Arexvy vaccine to a pregnant patient on 12 August 2023, which led to vaccine exposure during pregnancy.  The 36 year old pregnant patient received Arexvy vaccine, which led to inappropriate age at vaccine. The patient was administered in the Left Deltoid. The nurse unable to provide last menstrual period date.  The nurse had did not have contact information of the HCP who administered the vaccine but it was an medical assistant who administered it. The reported that any follow-up can funnel through her. After clarifying root cause, HCP stated, believed it was a misunderstanding and explained that it happened right around time when they initially stocked Arexvy and once Abrysvo was approved for pregnant patients they were going to switch over to Abrysvo but didn't yet have any in stock.  The nurse stated that She believes the provider didn't clear understanding. The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administration of expired dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 4-month-old patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: administration of expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2024 The field representative had a question about giving an expired Hiberix to a 4-month-old baby, which led to an expired vaccine used. The reporter wanted to know what the protocol was.  No other information provided. The vaccine administration facility was the same as primary reporter. The consent to follow up granted.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administration of Hiberix after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-month-old male patient who received Hib (Hiberix) (batch number 9939L, expiry date 16-DEC-2023) for prophylaxis.   On 09-JAN-2024, the patient received Hiberix. On 09-JAN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: administration of Hiberix after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2024 The Medical assistant contacted GlaxoSmithKline via phone to inquired about Hiberix and what information was available about the administration of Hiberix after the expiration date.  They gave partial information about vaccine, patient and event.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received an expired dose of Hiberix vaccine, which led to an expired vaccine used.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: patient noticed redness and mild itchiness near the injection site.; patient noticed redness and mild itchiness near the injection site.; patient noticed redness and mild itchiness near the injection site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 04-JAN-2024, the patient received Arexvy (left arm). On 09-JAN-2024, 5 days after receiving Arexvy, the patient experienced injection site itching (Verbatim: patient noticed redness and mild itchiness near the injection site.) and injection site erythema (Verbatim: patient noticed redness and mild itchiness near the injection site.). In JAN-2024, the patient experienced injection site pain (Verbatim: patient noticed redness and mild itchiness near the injection site.). The outcome of the injection site pain was unknown and the outcome of the injection site itching and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching and injection site erythema to be related to Arexvy.  It was unknown if the company considered the injection site pain, injection site itching and injection site erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-JAN-2024 The reporter was the patient. The patient received Arexvy and experienced pain at the injection site. A day before the day of reporting, the patient noticed redness and mild itchiness near the injection site. The reporter consented to follow-up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: patient had a fever of 101 degrees; vomiting; diarrhea; This non-serious case was reported by a dentist via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JAN-2024 10:00, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 10-JAN-2024 02:00, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: patient had a fever of 101 degrees), vomiting (Verbatim: vomiting) and diarrhea (Verbatim: diarrhea). The outcome of the fever, vomiting and diarrhea were not resolved.   It was unknown if the reporter considered the fever, vomiting and diarrhea to be related to Shingrix.     It was unknown if the company considered the fever, vomiting and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date:10-JAN-2024 The reporter was the spouse of a patient. The patient received Shingrix vaccine and it was administered at the physician's office.  The reporter did not know in which arm the vaccine was administered.  The reporter stated that at 2:00 am 10th January 2023, 16 hours after vaccination the patient had a fever of 101 degrees, vomiting and diarrhea. The patient reported to spouse that he had gone to the restroom 10 with diarrhea. The reporter stated that symptoms had not resolved. No additional information was provided. The reporter was a dentist and stated that she would provide patient with Tylenol and see if he could hold it in the stomach. The patient had not been given medication yet at the moment of the call. The reporter did not consent to follow-up.