chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Lymphadenopathy, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Incident occurred 24 hours after vaccine, patient experienced redness, swollen, hot to touch, and pain around the injection area and 4 inches down the arm from the injection site. Additionally, patient experienced headaches and swollen lymph nodes as well. Patient has been icing the area and taking benadryl to help with the reaction at the recommendation of her PCP when she visited also for this reason., Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: ; LotNumber: LP8151; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 01/13/2025
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Incident occurred 24 hours after vaccine, patient experienced redness, swollen, hot to touch, and pain around the injection area and 4 inches down the arm from the injection site. Additionally, patient experienced headaches and swollen lymph nodes as well. Patient has been icing the area and taking benadryl to help with the reaction at the recommendation of her PCP when she visited also for this reason., Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: ; LotNumber: LP8151; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 01/13/2025
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient experiencing shoulder pain
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Malaise, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Covid symptoms-Severe, Systemic: Vomiting-Severe
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Covid symptoms-Severe, Systemic: Vomiting-Severe
Age: 13.0
Sex: M
Vaccine: MNQ, PNC20, TDAP
Symptoms: Wrong product administered
Clinical narrative: Administered PCV 20 instead of ordered vaccine HPV 9
Age: 80.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Mobility decreased, Pain
Clinical narrative: starting a week after administration, patient started experiencing occasional pain , sometimes having to take tylenol to relieve the pain.  During times of pain, patient stated she has trouble lifting her arm
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given a Prevnar 20 shot who already had it back in 2023. I remember checking registry myself and thought that his last dose was 2019. I have already reached out to the patient. He is currently fine and was not upset.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site discolouration, Injection site erythema, Injection site hypertrichosis, Injection site nodule, Injection site swelling
Clinical narrative: Right thigh swelling and redness  at injection site that began the same day vaccine was given. Progressed to a small nodule noted 3 days after and darkened overlying skin. Nodule has gradually decreased in size, mild hyperpigmentation continues along with localized hypertrichosis in area - about 8 mm.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PATIENT GIVEN MODERNA COVID-19 6MO-11YR DOSE INSTEAD OF SPIKEVAX 12+. REVACCINATED WITH SPIKEVAX 12+ ON 1/21/2025 TO ENSURE FULL COVERAGE
Age: 1.0
Sex: M
Vaccine: MMRV, PNC20
Symptoms: Wrong product administered
Clinical narrative: MMR ordered; MMRV given
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diarrhoea
Clinical narrative: Death
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pain
Clinical narrative: pt says she the next day after getting the 2nd shot she wasn't able to get out of bed because she had a bad headache and body aches. The following days  diarrehea, was light headed, and was nauseated. She developed heart palpatations on and off for the next few days. The once again she would get light headed and feel like she was going to pass out and would also experience heart palpatations on and off. She is feeling better today and will let her cardiologist know about these symptoms next month at her appt.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: pt says she the next day after getting the 2nd shot she wasn't able to get out of bed because she had a bad headache and body aches. The following days  diarrehea, was light headed, and was nauseated. She developed heart palpatations on and off for the next few days. The once again she would get light headed and feel like she was going to pass out and would also experience heart palpatations on and off. She is feeling better today and will let her cardiologist know about these symptoms next month at her appt.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient received a second dose of RSV (Arexy) because we didn't realize she had previously received a dose in August 2024. Patient has some soreness at the injection site but reports no other adverse effects.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: This child was seen on 01/15/2025 and received only the DTaP/IPV(liquid) portion of the Pentacel because it was not reconstituted with the HIB portion (lyophilized powder).
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site pain, Musculoskeletal disorder, Pain
Clinical narrative: left arm black and blue at injection site with blood trail down arm.  loss full use of hand and fingers on left hand. went to clinic for evaluation and referred to physical therapy. exercises that required lifting arm increased pain.  after almost 5 months still have pain at injection site.  pain worse at night when arm is at rest.  full use of left hand and fingers has returned.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of the COVID vaccine
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Pulmonary embolism, Urine analysis, X-ray
Clinical narrative: Pulmonary Embolism on Dec 4 2024
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Injected limb mobility decreased, Musculoskeletal stiffness, Pain, Peripheral swelling
Clinical narrative: Our pharmacy received an email on 01/21/2025 from our clinical team stating the patient received the RSV vaccine on 10/17/2023 and on 01/20/2025. Our system did not flag that she had previously had this vaccine. The patient did not know she received the vaccine before and came in to receive it on 01/20/25 since her MD recommended it. According the VAERS reporting procedures we must report since this was a "vaccine administration error." When I talked to the patient at 3:30pm on 01/21/2025 she said she early this morning her body felt stiff and sore, her left arm was swollen/stiff/could barely move it. At the current time when I talked to her, she said she is feeling much better and the stiffness and movement is a lot better.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia
Clinical narrative: Patient reports having shoulder pain after getting both vaccinations. Patient will be seen by PCP on 2/11/2025 to check if the pain is due to vaccinations.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: none
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt may have accidentally been given a flu vaccine instead of a COVID vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site erythema, Ocular hyperaemia
Clinical narrative: LEFT ARM WAS RED (ELBOW TO INJECTION SITE). LOOKED LIKE A RASH. FLU LIKE SYMPTOMS. RED EYES
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Disturbance in attention, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Around 10-12 days following the vaccination I began experiencing lightheartedness & dizziness. Mild difficulty concentrating, particularly late morning. The symptoms typically improved some by late afternoon or early evening. As time progressed, the symptoms lessened but are still present as of this writing.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Laboratory test
Clinical narrative: Around 10-12 days following the vaccination I began experiencing lightheartedness & dizziness. Mild difficulty concentrating, particularly late morning. The symptoms typically improved some by late afternoon or early evening. As time progressed, the symptoms lessened but are still present as of this writing.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Patient called 1/21/25 stating she has had shoulder pain for months post vaccination, saw doctor and was told to report adverse event to pharmacy
Age: 1.25
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine was given erroneously by nursing staff. Provider and parent aware. Provider does not expect any significant adverse reactions based on the CDC review. Nursing staff repeated 12 month vaccines Patient was here for 15 month well child. Patient received 1st MMR, Havrix, Hiberix on 10/16/2024. Provider plans to give varivax, Infanrix, Prevnar at 18 month visit.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Urticaria
Clinical narrative: HIVES AND RASH OVER CHEST STARTED 1 WEEK AFTER VACCINE
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Computerised tomogram head, Dysarthria, Gait disturbance, Hemiparesis, Ischaemic stroke
Clinical narrative: Ischemic stroke resulting in slurred speech, left sided weakness, unsteady gait
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Magnetic resonance imaging head
Clinical narrative: Ischemic stroke resulting in slurred speech, left sided weakness, unsteady gait
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event
Clinical narrative: Patient did not have any adverse reactions.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is not in the recommended age group for the MMRV vaccine. Mother reported day after vaccine given that Patient is over the recommended age group to receive this vaccine and is inquiring about adverse effects and how to move forward with vaccine series.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Autoimmune thyroiditis, Brain fog, Thyroid function test abnormal
Clinical narrative: A week after the shot I noticed my ears were constantly ringing and I began having extreme low energy and anxiety.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A week after the shot I noticed my ears were constantly ringing and I began having extreme low energy and anxiety.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Peripheral swelling
Clinical narrative: Patient received Hep B vaccine on 01/20/2025 and reported that he started getting swelling  on the left feet 2-3 hours after receiving vaccination. Patient called today i.e., 01/21/2025 to get advise and I advised him to seek urgent care. He checked in with hospital.  In a follow up call today, patient reported swelling on the right leg and feet too.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Exercise tolerance decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient's right shoulder was sore at the injection site; after a couple of days, the pain increased and patient struggled to work out. He noticed his range of motion and strength have been affected. He is a baseball pitcher and is struggling throwing, it is painful. The injection site is also still very painful to the touch at 8 days post-injection. He has done warm compress, ice, Aleve, stretching. He went to his pediatrician today who confirmed symptoms are not normal and likely from the MenB shot. Dr recommended a visit to orthopedist and physical therapy. Patient will also visit our chiropractor for laser to help with any possible inflammation and pain.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Patient's right shoulder was sore at the injection site; after a couple of days, the pain increased and patient struggled to work out. He noticed his range of motion and strength have been affected. He is a baseball pitcher and is struggling throwing, it is painful. The injection site is also still very painful to the touch at 8 days post-injection. He has done warm compress, ice, Aleve, stretching. He went to his pediatrician today who confirmed symptoms are not normal and likely from the MenB shot. Dr recommended a visit to orthopedist and physical therapy. Patient will also visit our chiropractor for laser to help with any possible inflammation and pain.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: 1/16/25 3:16  Under observation,  Pt c/o tingling sensation in throat, tongue and face.  Vitals taken and pt assessed.  All vitals, lung and heart sounds within normal range.  No swelling present in face, tongue or throat, no signs of distress noted.  Patient given Diphenhydramine 2 tables 25 mg each with water.  Continually assessed pt until discharge.  Monitored for 30 mins longer.  Pt reported 0 tingling or any other symptoms.  Pt " stated I feel normal".   3:50 Pt up walking around and then left.   Called pt next morning, reported no more signs for symptoms of adverse reaction. RN
Age: 8.0
Sex: M
Vaccine: DTIPV, MMR
Symptoms: Chills, Fatigue, Febrile convulsion, Malaise, Pyrexia
Clinical narrative: febrile seizures; fatigue; drowsiness; chill; feeling unwell; fever; This spontaneous report was received from consumer and referred to an 8-year-old male patient.  The patient's medical history was not reported. The patient's concurrent condition was not reported. Concomitant therapies were not reported.  On 09-JUL-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) subcutaneous injection, 0.5 milliliter, lot #X007521, expiration date: 28-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided); and  diphtheria vaccine toxoid, polio vaccine inact 3v (vero), tetanus vaccine toxoid (REVAXIS) suspension for injection, 0.5 milliliter, lot # W3H052V, administered for prophylaxis (strength, expiry date, and route of administration were not provided).   On the same day, the patient experienced febrile seizures, fatigue, drowsiness, chill, feeling unwell and fever with body temperature 38 to 40.5 degrees Celsius. At the time of reporting, the patient was recovering from the events of febrile seizures, chill and feeling unwell.  At the time of reporting, the patient had not recovered from the events of fatigue, drowsiness or fever.     The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) was unknown.
Age: 8.0
Sex: M
Vaccine: DTIPV, MMR
Symptoms: Somnolence
Clinical narrative: febrile seizures; fatigue; drowsiness; chill; feeling unwell; fever; This spontaneous report was received from consumer and referred to an 8-year-old male patient.  The patient's medical history was not reported. The patient's concurrent condition was not reported. Concomitant therapies were not reported.  On 09-JUL-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) subcutaneous injection, 0.5 milliliter, lot #X007521, expiration date: 28-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided); and  diphtheria vaccine toxoid, polio vaccine inact 3v (vero), tetanus vaccine toxoid (REVAXIS) suspension for injection, 0.5 milliliter, lot # W3H052V, administered for prophylaxis (strength, expiry date, and route of administration were not provided).   On the same day, the patient experienced febrile seizures, fatigue, drowsiness, chill, feeling unwell and fever with body temperature 38 to 40.5 degrees Celsius. At the time of reporting, the patient was recovering from the events of febrile seizures, chill and feeling unwell.  At the time of reporting, the patient had not recovered from the events of fatigue, drowsiness or fever.     The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) was unknown.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included giant cell arteritis (other), shingles and ear carcinoma (cancer left ear). Concomitant products included Influenza vaccine (Fluzone), prednisone and hydrocodone.   On 12-OCT-2020, the patient received Shingrix. On 15-OCT-2020, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-DEC-2024 The patient started therapy with Shingrix and experienced shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with 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 the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Broke out with shingles). The outcome of the shingles was not reported.   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: 04-JAN-2025 This case was reported by a patient via interactive digital media. Patient had the shingles shots and two days later after the patient broke out with shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had the two shots 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the two shots and still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JAN-2025 This case was reported by a patient via interactive digital media. The patient stated that they had the two shots and still got shingles and also stated that doctor said it did not work. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles  (1st dose)and Shingles (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and shingles again/ suspected vaccination failure; Got the vaccine and shingles again; 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.   The patient's past medical history included shingles.   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: Got the vaccine and shingles again/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the vaccine and shingles again). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and the shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: kicked my butt HARD; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of buttock pain 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 buttock pain (Verbatim: kicked my butt HARD). The outcome of the buttock pain was not reported.   It was unknown if the reporter considered the buttock pain to be related to Shingles vaccine.     It was unknown if the company considered the buttock pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JAN-2024 The patient reported that he/she did not if it was the shingles vaccine, or the one for pneumonia (got them simultaneously) but one of them kicked on buttock hard.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received only the adjuvant of Shingrix without reconstituting the vaccine; received only the adjuvant of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a specified number of patients 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 inappropriate preparation of medication (Verbatim: received only the adjuvant of Shingrix without reconstituting the vaccine) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:17-DEC-2024 Pharmacist called to inform that two patients (gender unknown) received only the adjuvant of Shingrix (without reconstituting the vaccine),which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Also mentioned that a few days later when they realized the error, the patient was called back and was given the vaccine, the adjuvant with the actual vaccine product.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Underage administration of a vaccine dose.; administer Gardasil for HPV but Shingrix was administered in error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 4878Y, expiry date 13-NOV-2026) for prophylaxis.   Co-suspect products included HPV vaccine VLP rL1 4v (yeast) (Gardasil) for prophylaxis.   On 08-JAN-2025, the patient received Shingrix. On an unknown date, the patient received Gardasil. On 08-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration of a vaccine dose.) and wrong vaccine administered (Verbatim: administer Gardasil for HPV but Shingrix was administered in error). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 The vaccine coordinator or medical assistant called to reporting the underage administration or maladministration of a Shingrix dose to a female patient. The vaccine coordinator or medical assistant asked about any safety concerns or any information they had to be aware. No further information was obtained during this call. The vaccine administration facility was the same as primary reporter. The reporter mentioned that the intention was to administer Gardasil for HPV but Shingrix was administered in error which led to wrong vaccine administered.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.; 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number BL3ES, expiry date 31-DEC-2024) for prophylaxis.   On 07-JAN-2025, the patient received Menveo. On 07-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 A medical assistant called to inform that they administered an expired dose Menveo (1 vial) to a 11 years old male patient. The vaccine expired on 31st December 2024. It was administered on 07th January 2025 which led to expired vaccine used. The reporter asked was there any safety information regarding this.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix in 2018. He did not know that he needed a second dose at the time; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2018. He did not know that he needed a second dose at the time). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter was the patient who received his first dose of Shingrix in 2018. The patient did not know that he needed a second dose at the time. The patient received his second dose on the day of reporting which led to lengthening of vaccination schedule.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I accidentally gave her Kinrix; a 15 month old baby coming for her shot today; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 15-JAN-2025, the patient received Kinrix. On an unknown date, the patient received Infanrix. On 15-JAN-2025, immediately after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: I accidentally gave her Kinrix) and inappropriate age at vaccine administration (Verbatim: a 15 month old baby coming for her shot today). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JAN-2025 The nurse called and reported that she had a 15 month old baby coming for her shot on the day of reporting and supposed to did Dtap (Infanrix), and the nurse accidentally gave the patient Kinrix which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. During the call, the healthcare professional mentioned that the intended vaccine was Infanrix, instead of Kinrix.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Post-acute COVID-19 syndrome
Clinical narrative: she knew someone that worked at her place of employment that developed GBS after the COVID shot; Patient also was reported to have Long Covid; This is a spontaneous report received from a Pharmacist from a sales representative.  A patient (age and gender not provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2024, outcome "unknown", described as "Patient also was reported to have Long Covid"; GUILLAIN-BARRE SYNDROME (medically significant) with onset 2024, outcome "unknown", described as "she knew someone that worked at her place of employment that developed GBS after the COVID shot". It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome, post-acute covid-19 syndrome.  Clinical course: It was reported that event happened approximately one year ago. She was unsure which COVID vaccine it was and unsure of the manufacturer (not known if Pfizer vaccine). Patient also was reported to have Long Covid. No other details provided. It was unknown if any treatment was received. It was unknown if patient received any other vaccines on the same date as the vaccine and unknown if the patient receive any other vaccines within 4 weeks PRIOR to the vaccine. It was unknown if the patient  was taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Guillain-Barre syndrome, and post-acute COVID-19 syndrome; and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Paralysis, Thrombosis
Clinical narrative: he is now paralyzed; Had a stroke due to blood clot; stroke; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "Had a stroke due to blood clot"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "stroke"; PARALYSIS (medically significant), outcome "unknown", described as "he is now paralyzed".  Clinical course: It was reported that patient had a stroke due to blood clot. Reporter was calling because her husband got the COVID vaccine, three and half years ago. She said she did not know the name of it, but she is just said it was the COVID Vaccine through Pfizer.When probed to clarify the vaccine name as COVID-19 Vaccine, transferring agent stated, "Yes, she said I guess that might just be the name of it, COVID-19 vaccine and I was sure she was not sure for the actual name too. So, she said it was the Pfizer COVID vaccine that her husband received three and a half years ago." The caller stated that her husband received the vaccine three and a half years ago and three months after receiving it, he had a stroke due to blood clot and he is now paralyzed." she was calling to see if they could receive help for physical therapy because insurance is not helping much. I am not sure if there is anything like that because she did state that. She is looking for a help  getting her husband physical therapy so, he could maybe walk again.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Tremor
Clinical narrative: flu; flu vaccination causing uncontrollable shaking; Initial information received on 13-Jan-2025 regarding an unsolicited valid serious case received from a Patient.  This case is linked to case 2024SA216487 (Same Patient).  This case involves elderly female patient (weight-76.36 kg) who had flu and flu vaccination causing uncontrollable shaking after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COQ10, Omeprazole-Sodium Bicarbonate, Singulair 10 Mg Tablet, Memantine HCL 10 Mg Tablet, Levothyroxine Sodium 75 Mcg Tablet, Potassium Chloride 20 Meq Tablet Er, Lasix 40 Mg Tablet, Breo Ellipta 100-25 mcg Blst W/Dev, Lipitor 20 Mg Tablet, Atenolol 25 Mg Tablet, Albuterol Sulfate Hfa, Pradaxa 150 Mg Capsule for Product used for unknown indication.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination.  On an unknown date the patient developed flu (influenza) and  flu vaccination causing uncontrollable shaking (tremor) (unknown latency) following the administration of Influenza Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Patient Wanted To Inquire About Taking Dupixent Dose Following Hospitalization For Flu And Flu Vaccination Causing Uncontrollable Shaking. Patient Was In The Hospital With Flu, Dose Was Missed 10-Jan-2025, Needs To Know When Ok To Take Next Dose. Reports Missing A Dose Of Her Medication Dupixent, Mentioned Being In The Hospital And Having The Flu. Patient To Hold Off On Dose Of Dupixent If Comfortable In Tolerating A Prurigo Nodularis Flare Up Until Patient Stabilizes By Advising Patient To Take Next Dose On 24-Jan-2025 (Original Due 10-Jan-2025That Was Missed). Patient Advised That She Was Recently In The Hospital That Caused Her To Miss A Dose On 10-Jan-2025.  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was unknown for both the events.  Seriousness criteria: The patient was hospitalized for the event (influenza).; Sender's Comments: Sanofi company comment dated 20-Jan-2025: This case involves elderly female patient (weight-76.36 kg) who had flu and flu vaccination causing uncontrollable shaking after receiving Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: UNK
Symptoms: Drug ineffective, Influenza, Influenza A virus test positive
Clinical narrative: Tested positive for Flu type A; Lack of efficacy; Started having symptoms which have progressed to moderate and occasionally severe; This spontaneous case  initially received on 13-Jan-2025, was reported by a non health professional and concerns an adult female patient.  No medical history was reported Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 28-Dec-2024, the patient received Flucelvax (TIV) for an unknown indication, dose regimen: not reported,  route of administration and anatomical location: not reported, Lot number: No batch number available, and wont be requested due to no follow-up consent.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 12-Jan-2025, 15 days after vaccination, the patient experienced Lack of efficacy (Medically Significant, outcome: Not Reported). On 12-Jan-2025, 15 days after vaccination, the patient experienced Tested positive for Flu type A (Medically Significant, outcome: Unknown). Associated symptoms included: Started having symptoms which have progressed to moderate and occasionally severe.  Patient received the Flucelvax vaccine on 28-Dec-2024 at a pharmacy. On 12-Jan-2025, she tested positive for Flu type A, started having symptoms on 10-Jan-2025 which had progressed to moderate and occasionally severe.   Quality assurance informed that this is not a PTC just an adverse event.  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: the reporter did not provide a seriousness and causality assessment for the events.; Reporter's Comments: Causality: Related for influenza and drug ineffective. Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the onset of protective effects of vaccination is usually 21 days post vaccination.  This case is not considered an unusual failure of efficacy.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Registry immunization was down, Pt signed up to receive RSV vaccine on 1-18-25. Thoroughly went over the updated CDC guidelines and she was concerned with protection from RSV because she leaving to another country for 3 weeks and she has HX of asthma. Also, a friend of hers got RSV and was impacted and she did not want it. I was l led by her  to believe she hasn't received any prior doses. Later that day, I reverified the database to discover she had already received a dose on 11-22-23 RSv Arexvy. Spoke with Pt day after 1-19-25 to inform her of the second dose above CDC guidelines and she said she was fine, felt normal with just a sore arm as she has had in the past with other vaccines.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient is  a 20 month old who received adult dose of covid vaccine instead of infant dosing on december 4, 2024. Patient had no adverse reaction and was well at appearing with no issues at most recent visit.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Differential white blood cell count, Full blood count, Laboratory test, Rash
Clinical narrative: non blanching rash, lower limbs.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Migraine with aura, Photopsia, Vision blurred
Clinical narrative: 3 days after the injection, I starting have signs of migraine with aura.  I've never had this before.  The first episode was on day 3 after the shot, 2nd episode was on Jan. 5th, 3rd episode on Jan 18th, and again today (4th episode) on Jan 21st.  Episode of flashing lights and blurred vision in both eyes that last for 20 min.   Some are accompanied by headaches.  NEVER had this before in my life.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Priapism, Urine abnormality
Clinical narrative: Shot given gluteal. Patient experienced cloudy urine, numbness in leg, pain in buttox and back of leg, and temporary priapism
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Daily heart palpitations multiple times a day since flu shot was given.
Age: 34.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Patient got Prevnar 20, and her shoulder turned redness at injection site. She said she took Nyquil. The redness went away after 4 days.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Balance disorder, Dysphagia, Dyspnoea, Eye pain
Clinical narrative: Paresthesia head to toe, weakness head to toe, dysphagia, pain, malaise, mild sob, difficulty with balance, fatigue, muscle fasiculation, eye pain
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Malaise, Muscle contractions involuntary, Pain, Paraesthesia
Clinical narrative: Paresthesia head to toe, weakness head to toe, dysphagia, pain, malaise, mild sob, difficulty with balance, fatigue, muscle fasiculation, eye pain
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient showed photos  and stated she experienced swelling, redness, pain, and warm to the tough skin around the injection site that was 6 inches wide roughly. She stated it took about two weeks for the swelling to completely go away.
Age: 75.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Rash
Clinical narrative: Patient received 2 doses of Arexvy a little over one year apart.  Patient did report he had a chest rash after the second dose.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received 2024-2025 updated for covid (comirnity) as well as flu (fluzone).  Patient was accidentally administered HD flu, even though pt is only 40yo.  It was grabbed from the fridge by mistake, thinking that it was the regular Fluzone product, and not the HD.  Patient was contacted about the administration error and no adverse events have been self reported by patient.
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Patient is a 32yo otherwise healthy lady who is at 33w gestation who presented with epistaxis and gross hematuria, found to have a platelet count of 0 (baseline normal). We are concerned that this is vaccine-induced ITP (has been reported in post-COVID vaccine cases before but not with RSV)
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient is a 32yo otherwise healthy lady who is at 33w gestation who presented with epistaxis and gross hematuria, found to have a platelet count of 0 (baseline normal). We are concerned that this is vaccine-induced ITP (has been reported in post-COVID vaccine cases before but not with RSV)
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain, redness, swelling
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Brain natriuretic peptide increased, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Patient received the 2nd dose of his HPV vaccine on Tuesday 1/14/2025 morning (he received his 1st dose without issues). He woke up at 6-7 PM with chills, shivering, and temp 100.2F so mom gave him ibuprofen with relief. On Wednesday 1/15/2025, he began to complain about his chest "feeling weird" at 6-7PM, after which mom gave him his newly prescribed albuterol inhaler with relief. On Thursday 1/16/2025, he called mom from school at 11AM to ask if she can bring his inhaler because now he was having sternal chest pain (no radiation). He was fine until 9PM that evening when his sternal chest pain returned with associated shortness of breath, grunting, and "not feeling good", thus prompting presentation to Hospital. Found to have and treated for myopericarditis. Will follow up outpatient with Cardiology.