chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Electrocardiogram normal, Eyelid ptosis, Fatigue, Headache
Clinical narrative: Patient reported feeling intense fatigue 2 days post vaccination. On days 3-4 post vaccine, she reports increased fatigue with pain throughout her body including sharp joint pain as well as "skin, scalp, and nerve endings throughout body extremely enervated and painful." She reports a "dull but intense headache on left side above left eye" that persisted despite taking aspirin and ibuprofen. She developed an unproductive dry cough with "severe coughing fits" and "right ribcage pain" when taking deep breaths. By day 4 post vaccine, Patient reports the overall pain had subsided 70% but continued to have persistent ribcage pain when coughing or deep breathing as well as persistent left frontal and parietal headache and scalp pain. On day 7 post vaccine Patient noted left sided eye droop. Days 8-14 post vaccine the patient reported a slow decrease in symptoms with persistent left eye droop and persistent left frontal and parietal headache. Patient presented to our office on 12/20/2023 for the first time since receiving the vaccine on 12/06/2023. Her physical examination at that time revealed LEFT eye ptosis NOT affecting eyebrow or forehead, pupils responsive to light but unequal (L>R), convergence insufficiency, paresthesia with sensitivity to touch in a distribution affecting the CNV1 opthalmic CNV2 maxillary branches of the trigeminal nerve (CNV3 mandibular branch unaffected), 1+ bilateral achilles, patellar, radial, and brachial reflexes (patient reports constitutional diminished reflexes), 2+ bilateral muscle strength. The patient was then seen in the emergency department to which an MRI and CT scan were done. CT of the head showed multifocal small vessel disease without acute cortical infarct. MRI  of the brain with and without contrast ultimately showed no acute features as well. Labs were reassuring without leukocytosis. Labs also showed slightly elevated platelets at 612. INR unremarkable. Chemistry was normal. Troponin negative. No ischemic changes or other concerns on EKG. Ultimately, trigeminal neuralgia is suspected with symptoms. One month post Shingrix vaccine, Patient repots pain at 1.5-2/10 with 10 being the worst that it was. At that time she reported ongoing mild LEFT eye ptosis and LEFT tongue elevation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyporeflexia, International normalised ratio normal, Laboratory test normal, Magnetic resonance imaging head normal, Musculoskeletal chest pain
Clinical narrative: Patient reported feeling intense fatigue 2 days post vaccination. On days 3-4 post vaccine, she reports increased fatigue with pain throughout her body including sharp joint pain as well as "skin, scalp, and nerve endings throughout body extremely enervated and painful." She reports a "dull but intense headache on left side above left eye" that persisted despite taking aspirin and ibuprofen. She developed an unproductive dry cough with "severe coughing fits" and "right ribcage pain" when taking deep breaths. By day 4 post vaccine, Patient reports the overall pain had subsided 70% but continued to have persistent ribcage pain when coughing or deep breathing as well as persistent left frontal and parietal headache and scalp pain. On day 7 post vaccine Patient noted left sided eye droop. Days 8-14 post vaccine the patient reported a slow decrease in symptoms with persistent left eye droop and persistent left frontal and parietal headache. Patient presented to our office on 12/20/2023 for the first time since receiving the vaccine on 12/06/2023. Her physical examination at that time revealed LEFT eye ptosis NOT affecting eyebrow or forehead, pupils responsive to light but unequal (L>R), convergence insufficiency, paresthesia with sensitivity to touch in a distribution affecting the CNV1 opthalmic CNV2 maxillary branches of the trigeminal nerve (CNV3 mandibular branch unaffected), 1+ bilateral achilles, patellar, radial, and brachial reflexes (patient reports constitutional diminished reflexes), 2+ bilateral muscle strength. The patient was then seen in the emergency department to which an MRI and CT scan were done. CT of the head showed multifocal small vessel disease without acute cortical infarct. MRI  of the brain with and without contrast ultimately showed no acute features as well. Labs were reassuring without leukocytosis. Labs also showed slightly elevated platelets at 612. INR unremarkable. Chemistry was normal. Troponin negative. No ischemic changes or other concerns on EKG. Ultimately, trigeminal neuralgia is suspected with symptoms. One month post Shingrix vaccine, Patient repots pain at 1.5-2/10 with 10 being the worst that it was. At that time she reported ongoing mild LEFT eye ptosis and LEFT tongue elevation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain of skin, Painful respiration, Paraesthesia
Clinical narrative: Patient reported feeling intense fatigue 2 days post vaccination. On days 3-4 post vaccine, she reports increased fatigue with pain throughout her body including sharp joint pain as well as "skin, scalp, and nerve endings throughout body extremely enervated and painful." She reports a "dull but intense headache on left side above left eye" that persisted despite taking aspirin and ibuprofen. She developed an unproductive dry cough with "severe coughing fits" and "right ribcage pain" when taking deep breaths. By day 4 post vaccine, Patient reports the overall pain had subsided 70% but continued to have persistent ribcage pain when coughing or deep breathing as well as persistent left frontal and parietal headache and scalp pain. On day 7 post vaccine Patient noted left sided eye droop. Days 8-14 post vaccine the patient reported a slow decrease in symptoms with persistent left eye droop and persistent left frontal and parietal headache. Patient presented to our office on 12/20/2023 for the first time since receiving the vaccine on 12/06/2023. Her physical examination at that time revealed LEFT eye ptosis NOT affecting eyebrow or forehead, pupils responsive to light but unequal (L>R), convergence insufficiency, paresthesia with sensitivity to touch in a distribution affecting the CNV1 opthalmic CNV2 maxillary branches of the trigeminal nerve (CNV3 mandibular branch unaffected), 1+ bilateral achilles, patellar, radial, and brachial reflexes (patient reports constitutional diminished reflexes), 2+ bilateral muscle strength. The patient was then seen in the emergency department to which an MRI and CT scan were done. CT of the head showed multifocal small vessel disease without acute cortical infarct. MRI  of the brain with and without contrast ultimately showed no acute features as well. Labs were reassuring without leukocytosis. Labs also showed slightly elevated platelets at 612. INR unremarkable. Chemistry was normal. Troponin negative. No ischemic changes or other concerns on EKG. Ultimately, trigeminal neuralgia is suspected with symptoms. One month post Shingrix vaccine, Patient repots pain at 1.5-2/10 with 10 being the worst that it was. At that time she reported ongoing mild LEFT eye ptosis and LEFT tongue elevation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count increased, Scan with contrast normal, Trigeminal neuralgia, Troponin normal, White blood cell count normal
Clinical narrative: Patient reported feeling intense fatigue 2 days post vaccination. On days 3-4 post vaccine, she reports increased fatigue with pain throughout her body including sharp joint pain as well as "skin, scalp, and nerve endings throughout body extremely enervated and painful." She reports a "dull but intense headache on left side above left eye" that persisted despite taking aspirin and ibuprofen. She developed an unproductive dry cough with "severe coughing fits" and "right ribcage pain" when taking deep breaths. By day 4 post vaccine, Patient reports the overall pain had subsided 70% but continued to have persistent ribcage pain when coughing or deep breathing as well as persistent left frontal and parietal headache and scalp pain. On day 7 post vaccine Patient noted left sided eye droop. Days 8-14 post vaccine the patient reported a slow decrease in symptoms with persistent left eye droop and persistent left frontal and parietal headache. Patient presented to our office on 12/20/2023 for the first time since receiving the vaccine on 12/06/2023. Her physical examination at that time revealed LEFT eye ptosis NOT affecting eyebrow or forehead, pupils responsive to light but unequal (L>R), convergence insufficiency, paresthesia with sensitivity to touch in a distribution affecting the CNV1 opthalmic CNV2 maxillary branches of the trigeminal nerve (CNV3 mandibular branch unaffected), 1+ bilateral achilles, patellar, radial, and brachial reflexes (patient reports constitutional diminished reflexes), 2+ bilateral muscle strength. The patient was then seen in the emergency department to which an MRI and CT scan were done. CT of the head showed multifocal small vessel disease without acute cortical infarct. MRI  of the brain with and without contrast ultimately showed no acute features as well. Labs were reassuring without leukocytosis. Labs also showed slightly elevated platelets at 612. INR unremarkable. Chemistry was normal. Troponin negative. No ischemic changes or other concerns on EKG. Ultimately, trigeminal neuralgia is suspected with symptoms. One month post Shingrix vaccine, Patient repots pain at 1.5-2/10 with 10 being the worst that it was. At that time she reported ongoing mild LEFT eye ptosis and LEFT tongue elevation.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient developed full-body hives approximately 1h after administration of Menquadfi (U7853BA) and Bexsero (95NJ4). Seen at clinic 4/3/24 with hives without evidence of anaphylaxis. Unclear if reaction secondary to vaccine. Recommended anti-histamines and allergy referral (per family preference).
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra dose of flu vaccine. She had one on 9/11/23. The 2nd one was not needed
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 03/31/2024 and was given to a patient on 04/02/2024.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: Client reported today (April 3, 2024) that a couple hours after the Twinrix vaccine that he developed a "deep pain" in his lower leg. He reports that he took Aleeve which completely resolved it. He did not seek medical attention. He said that this happened multiple more times over the following few weeks, mainly happening at night, and always in the same location on the same leg. He also noted that the vaccine site (Left Deltoid) never had any signs of adverse effects. He said that he never saw any swelling, discoloration, or anything out of the ordinary on the affected leg, he would just feel the pain. He was clear that this felt very different from a muscle ache or spasm, which he has felt before. Client denied all allergic reactions, and was urged to contact his doctor today. Client said his symptoms completely resolved 5 days ago.
Age: 1.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was suppose to received Tdap, MenQuafi, and HPV (Gardasil), instead the patient received MenQuafi, Bexero and HPV, the Bexero was given in error.
Age: 44.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: On April 3, 2024, at approximately 3:30 pm, patient received an adult dose of Hepatitis B. The patient had a reactive Hepatitis B surface antibody on February 14, 2024, therefore he was already immune.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hot flush, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Started shivering at 2030 night after the injection that day "uncontrollable shaking throughout my whole body" About 30 minutes after that he experienced hot flashes and "a really high fever", He was sweating profusely. This lasted 4 hours. He did not have a thermometer to check his temperature.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache, Mouth ulceration, Neck pain, Rash
Clinical narrative: Headache, neck pain, Full body rash (trunk, arms, legs, and one spot on left cheek).  Pain in bilateral shoulders, hips, knees.  Oral ulcer x 1
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Joint range of motion decreased, Magnetic resonance imaging abnormal, Rotator cuff syndrome, Tenodesis
Clinical narrative: Patient requested to report a reaction of Left Rotator cuff tear and bicep tenodesis surgery in January 2024 status post vaccination. Denies a fall, injury or issues of left arm prior to vaccination. Had decreased range of motion. Had MRI to confirm diagnosis that lead to surgery.
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given NDC 58160-827-03. This is the liquid formulation intended for patients 10 years and older. We contacted CDC, they said this would not cause harm to patients less than 10 and would not require revaccination but that we should submit to VAERs.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given vaccine too early in series.  Had dose #1 of Hep B series on 2/9/24.  Family had requested modified vaccine schedule.  Office accommodating, but they came later then agreed upon, which threw off the rest of the vaccine schedule and previously prescheduled appointments.  There was no adverse event other than a mistake was made in spacing.  Pt got what family thought was dose #3 on 4/1/24.  Advised parents that it would count as #2 and he would need an additional dose to be considered appropriately and fully immunized.
Age: 1.5
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dermatitis atopic, Product administered to patient of inappropriate age, Rash
Clinical narrative: Vaccine error occurred-patient was given incorrect vaccines for age. MD was notified, CDC reference-no immediate SE listed. Mom informed to monitor and seek care. Patient seen at UC on 04/01/2024 -was reported that patient has a rash which started two days after vaccination. Dx of UC was atopic dermatitis, unspecified.  Patient seen at UC.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Biliary dilatation, Brain fog, Burning sensation, Computerised tomogram
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram abdomen, Deafness unilateral, Dilatation intrahepatic duct acquired, Dry eye, Eye inflammation
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Eye pain, Eye pruritus, Gallbladder enlargement, Immediate post-injection reaction
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging, Oral pustule, Pain of skin, Pruritus, Rash pustular
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Renal cyst, Tinnitus, Ultrasound biliary tract, Ultrasound liver, Vertigo
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Brain fog, Disturbance in attention, Eye pain, Immediate post-injection reaction, Incomplete course of vaccination
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain, Pruritus, Vertigo, Vision blurred
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: Within seconds-minutes of getting Shingrix shot patient felt burning itching pain in and behind eyes, burning itching radiating throughout her body especially felt strongly in vagina.  Right away her vision went bad, had severe vertigo, brain fog, loud ringing in Left Ear, and loss of hearing in Left Ear.  She had to call for ride home, some day later called her Primary Care, Dr to describe symptoms and he disregarded her, so she changed to another Dr who still does not record symptoms in patient's records.  Symptoms continue months later to-date April 2024. Symptoms continue including intense itching skin, eye pain, vertigo and now pustular-like exudation insi pustular excudation on skin and inside mucosal cavities including eyes, mouth, vagina.
Age: 68.0
Sex: M
Vaccine: HEPAB, PNC20, RSV, VARZOS
Symptoms: Impaired work ability, Mobility decreased, Muscular weakness, Pyrexia
Clinical narrative: Patient stated he had a fever and difficulty moving his arms, legs, and neck.  As of 4/3/24, patient's fever was reducing and he was unable to make it to work due to weakness in extremities.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous, Rash papular
Clinical narrative: pt started to get raised and red rash on larger that encircled! ot took 3-5 weeks to get
Age: 2.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered by wrong person, Product preparation error
Clinical narrative: no adverse event; Nurse stated that a colleague accidently reconstituted a patient's dose of PROQUAD with 5 mL of 0.9% normal saline and administered it on 19FEB2024; Nurse stated that a colleague accidently reconstituted a patient's dose of PROQUAD with 5 mL of 0.9% normal saline and administered it on 19FEB2024; patient 2 years, received second dose of PROQUAD; the operator was not trained; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, concomitant therapies, and drug reactions/allergies were not reported.  On 19-FEB-2024, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, lot #, expiry date, and route of administration were not provided) as prophylaxis, which was accidently reconstituted with 5 mL of 0.9% normal saline (product preparation error, product administered error). It was confirmed that the patient had not reported any additional adverse events (AEs) (no adverse event).  This is a non-valid case due to no patient identifier.  Upon receipt of follow-up information, it was determined that this case is now valid because patient's identifier was received.  Follow-up information has been received from the nurse on 28-MAR-2024 referring to a 2-year-old female patient.  The patient had 3 siblings. There were no known allergies, no preexisting medical conditions, nor illness at time of vaccination.  On 19-FEB-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection (1 dose, lot #X009883, expiration date: 06-SEP-2024) administered subcutaneously in left arm for prophylaxis, which was accidently reconstituted with 5 mL of 0.9% normal saline by the operator who wasn't trained (product preparation error, product administered error, product administered by wrong person and product administered to patient of inappropriate age).  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) would be resumed in 2 months.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient who was administered improperly stored PNEUMOVAX23; This spontaneous report was received from a nurse and refers to a patient with unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The vaccine storage temperature was set as 2.7 C for 23 min, 1.5C for 23 min, 1.5C for 22 min, 1.5C for 22 min, 1.5C for 21 min, 1.7C for 15 min, 1.7C for 16 min, 1.6C for 22 min, 1.6C for 22 min, 1.6C for 21 min, 1.7C for 19 min, 1.7C for 18 min, 1.7C for 17 min, 1.7C for 16 min, 1.7C for 16 min, 1.7C for 16 min, -0.8C for 14 hours (1 cycle), which was improperly stored. On 12-MAR-2024, the patient vaccinated the improperly stored pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, lot #X022827 has been verified to be a valid lot number, expiration date established as 14-AUG-2025, administered as prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event was reported. On 15-MAR-2024, current excursion was occurred.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: when the first half of the dose was administered, the patient vomited up the product, then , when the second half was administered the patient vomited again; patient vomited up the product; This spontaneous report was received from a nurse and refers to a 2-month-old female patient.  The patients' medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 21-MAR-2024, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, (lot #1979980, expiration date: 29-NOV-2024, valid per internal review), administered orally for rotavirus immunisation (strength was not provided) and when the first half of the dose was administered, the patient vomited up the product, then , when the second half was administered the patient vomited again (vomiting, accidental underdose). On 21-MAR-2024, the patient recovered from the event of vomiting.    The causal relationship between vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no patient symptoms have been reported/ No additional AE; a dose of PROQUAD was administered to a patient after the expiration date; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 18-MAR-2024, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 1 dose, lot # reported and confirmed as: W029543, expiration date reported and confirmed as: 14-MAR-2024, administered for prophylaxis (site and route of administration were not provided). The vaccine was not involved in any temperature excursions. No symptoms or additional adverse event reported.
Sex: M
Vaccine: HPV4
Symptoms: Electrocauterisation, Skin papilloma
Clinical narrative: The patient had surgery in 2017 and two bars were placed in his breastbone to fix a congenital anomaly.The patient was hospitalized after this surgery for a unknown period of time; The HCP states that her nephew has been experiencing warts on his fingers for over a year now; This spontaneous report was received from a nurse regarding her nephew, a male patient of currently 30-year-old.  The patient's medical history included thoracic operation, and non-genital warts. The patient's concurrent conditions included cholesterol high. Concomitant therapy was reported as statin (unspecified).  On an unknown date, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5 milliliters/series, administered for prophylaxis (strength, lot #, expiration date, anatomical location and route of administration were not provided).  The patient had surgery in 2017 and two bars were placed in his breastbone to fix a congenital anomaly (Thoracic operation). The patient was hospitalized after this surgery for an unknown period of time. Additionally, since an unspecified day in March 2023 (reported as for over a year now), the patient had been experiencing warts on his fingers (skin papilloma). He underwent three treatments where the dermatologist had burned off the warts only for them to kept returning. At the time of reporting, the patient had not recovered from skin papilloma and the outcome of thoracic operation was unknown.  The causal relationship between the events of thoracic operation and skin papilloma, and vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects reported; HCP reporting that Adult patient received pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a pharmacist concerning an adult patient of unknown gender. Patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided.  On 25-MAR-2024, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis, lot number W038864 with expiration date reported as 16-JUL-2025 (strength, and route of administration were not provided) (incorrect dose administered).  The healthcare professional was notified by the patient's physician after reviewing paperwork from vaccination and it was unknown how or why the error was made.  No adverse effects reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles pain; Patient had Shingles after receiving 2 doses of Shingrix/ Suspected vaccination of failure; Patient had Shingles after receiving 2 doses of Shingrix: (From: 13 Feb 2024 To: Ongoing); This serious case was reported by a pharmacist and described the occurrence of vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28-JUN-2021, the patient received the 2nd dose of Shingrix (unknown deltoid). On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid). On 13-FEB-2024, 960 days after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Patient had Shingles after receiving 2 doses of Shingrix/ Suspected vaccination of failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient had Shingles after receiving 2 doses of Shingrix: (From: 13 Feb 2024 To: Ongoing)). On an unknown date, the patient experienced pain (Verbatim: Shingles pain). The patient was treated with valaciclovir (Valacyclovir) and lidocaine. The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   The reporter considered the vaccination failure, shingles and pain to be related to Shingrix. The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure, shingles and pain to be related to Shingrix. The company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2024 The reporter reported that after receiving both doses of Shingrix vaccine patient had shingles. Patient was diagnosed with shingles and prescribed valacyclovir for 10 days and lidocaine ointment. On 14th March 2024 patient was saw in office for another issue but still had shingles pain. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccine 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine and still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAR-2024 This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles; patient stated it did not prevent them. This case was considered as suspected vaccination failure since the details regarding completion of primary schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Cough, Feeling abnormal, Headache, Injection site pain
Clinical narrative: injection site pain; joint in my body aches; headache; coughing; Feel terrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain (Verbatim: injection site pain), generalized joint pain (Verbatim: joint in my body aches), headache (Verbatim: headache), cough (Verbatim: coughing) and feeling bad (Verbatim: Feel terrible). The outcome of the injection site pain, generalized joint pain, headache, cough and feeling bad were not reported.   It was unknown if the reporter considered the injection site pain, generalized joint pain, headache, cough and feeling bad to be related to Arexvy.     It was unknown if the company considered the injection site pain, generalized joint pain, headache, cough and feeling bad to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The patient experienced body ache in joint, headache, injection site pain was an understatement and also had some coughing. The patient felt terrible.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue
Clinical narrative: joint pain; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain 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 joint pain (Verbatim: joint pain) and tiredness (Verbatim: tiredness). The outcome of the joint pain and tiredness were not reported.   It was unknown if the reporter considered the joint pain and tiredness to be related to Arexvy.     It was unknown if the company considered the joint pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The patient experienced joint pain and tiredness worst side effect.
Sex: U
Vaccine: FLUX, RSV
Symptoms: Chills
Clinical narrative: chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced chills (Verbatim: chills). The outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Arexvy.     It was unknown if the company considered the chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient had chills after receiving Arexvy vaccine and also had flu vaccine at same time. It was unknown if the reporter considered the chills to be related to Influenza vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough 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 cough (Verbatim: cough). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-MAR-2024 This case was reported by consumer via (Open field AE monitoring) interactive digital media. The reporter reported that the patient had cough after receiving the Arexvy vaccine.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain; muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain 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 joint pain (Verbatim: Joint pain) and muscle pain (Verbatim: muscle pain). The outcome of the joint pain and muscle pain were not resolved.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Arexvy.     It was unknown if the company considered the joint pain and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient mentioned that, after 10 days he/she still had terrible joint and muscle pain.
Sex: U
Vaccine: RSV
Symptoms: Appetite disorder, Swollen tongue
Clinical narrative: tongue swollen; affecting one's appetite; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swollen tongue 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 swollen tongue (Verbatim: tongue swollen) and appetite disorder (Verbatim: affecting one's appetite). The outcome of the swollen tongue and appetite disorder were not reported.   It was unknown if the reporter considered the swollen tongue and appetite disorder to be related to Arexvy.     It was unknown if the company considered the swollen tongue and appetite disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported via (Open field AE monitoring) interactive digital media. The reporter stated, horrible and none ever mentioned as one of the symptoms was tongue swollen and affecting one's appetite.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue 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 fatigue (Verbatim: fatigue). The outcome of the fatigue was not reported.   The reporter considered the fatigue to be related to Arexvy.     The company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The vaccine has caused fatigue.
Sex: U
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site pain, Pruritus
Clinical narrative: sight is still back and blue; arm itch so bad; very little pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin discoloration 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 skin discoloration (Verbatim: sight is still back and blue), itchy upper limbs (Verbatim: arm itch so bad) and pain (Verbatim: very little pain). The outcome of the skin discoloration and pain were not resolved and the outcome of the itchy upper limbs was not reported.   It was unknown if the reporter considered the skin discoloration, itchy upper limbs and pain to be related to Arexvy.     It was unknown if the company considered the skin discoloration, itchy upper limbs and pain to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that itchy arm so bad, the sight was still back and blue and had very little pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Terrible joint; aches throughout body; Slightly fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain 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 joint pain (Verbatim: Terrible joint), general body pain (Verbatim: aches throughout body) and fever (Verbatim: Slightly fever). The outcome of the joint pain, general body pain and fever were not reported.   It was unknown if the reporter considered the joint pain, general body pain and fever to be related to Arexvy.     It was unknown if the company considered the joint pain, general body pain and fever to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The reporter reported that a patient received Arexvy vaccine and experienced terrible joint, aches throughout body and slight fever. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: very tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, several hours after receiving Arexvy, the patient experienced tiredness (Verbatim: very tired). The outcome of the tiredness was not reported.   The reporter considered the tiredness to be probably related to Arexvy.     The company considered the tiredness to be probably related to Arexvy.   Additional Information: GSK receipt date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient got inoculation earlier and after several hours feel very tired.  The reporter thought it was probably from the vaccine and this confirmed that probability. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fear, Gait inability
Clinical narrative: extreme joint pain; Scared; unable to walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain 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 joint pain (Verbatim: extreme joint pain), fear (Verbatim: Scared) and unable to walk (Verbatim: unable to walk). The outcome of the joint pain, fear and unable to walk were not reported.   It was unknown if the reporter considered the joint pain, fear and unable to walk to be related to Arexvy.     It was unknown if the company considered the joint pain, fear and unable to walk to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient got extreme joint pain to the point of almost unable to walk. The patient had all symptoms except injection site pain. The patient stated that he/she would get another shot of this sort, for sure. The patient was scared badly. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: sick from shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: sick from shot). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Arexvy.     The company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by consumer via interactive digital media. The reporter was a patient. The patient reported that he or she was sick from the shot.
Sex: U
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: 100 degree fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced fever (Verbatim: 100 degree fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient had 100 degree fever the day after vaccination. The follow-up could not be possible as no contact details were available.