chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram abnormal, Electrocardiogram ambulatory, Fine motor skill dysfunction, Heart rate decreased
Clinical narrative: Sinus tachycardia ( diagnosed svt), therapist accelerating and deceleration if heart rate, shortness of breath, Dizziness, fainting, left side of body, legs and face numbness, vision changes, severe chest pain, palputations, complete color in skin loss, motorskills and coordination loss, memory issues.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Laboratory test, Memory impairment, Pallor
Clinical narrative: Sinus tachycardia ( diagnosed svt), therapist accelerating and deceleration if heart rate, shortness of breath, Dizziness, fainting, left side of body, legs and face numbness, vision changes, severe chest pain, palputations, complete color in skin loss, motorskills and coordination loss, memory issues.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Sinus tachycardia, Supraventricular tachycardia, Syncope, Visual impairment
Clinical narrative: Sinus tachycardia ( diagnosed svt), therapist accelerating and deceleration if heart rate, shortness of breath, Dizziness, fainting, left side of body, legs and face numbness, vision changes, severe chest pain, palputations, complete color in skin loss, motorskills and coordination loss, memory issues.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC20
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Large amount of swelling & redness to the left thigh on 2/23/25. Parent took pt to ER and was prescribed steroid cream. Patient seen 2/25/25 by PCP who noted a tennis ball size area of redness w/ small ecchymosis, minimal edema.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported, office practice manager requested report be made
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, X-ray
Clinical narrative: On 10/3/24 I started having some lower back pain. On 11/12/24 I went to my doctor because the pain worsened. On 11/15/24 the pain was very bad so my doctor suggested ER They prescribed & xrayed sent to orthopedic surgeon I went to ortho, they referred me to P.T. I went to therapy the pain got better. I now have pain again & will return to PT. Possibly now sciata
Vaccine: COVID19, COVID19, FLUX
Symptoms: Abdominal distension, Abdominal pain, Blindness, Chills, Fatigue
Clinical narrative: Fever; Body aches; Loss of vision; Nausea; Abdominal cramping; Bloating; Vomiting; Vomitting; Fainting; Chills; Extreme fatigue; This serious initial Spontaneous safety report was received by Novavax on 18-Feb-2025 from a consumer or other non-health professional via agency (Web Portal) (ref. no. US-1000000481-NVAX).  A 28 Year(s) old individual of an unspecified gender was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 15-Feb-2025.  The following secondary suspect medications were reported: INFLUENZA VACCINE (influenza vaccine).  The following medical history was reported: NICKEL ALLERGY.   No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced Loss of vision (Blindness)(Serious: Other Medically Important Condition), Fever (Pyrexia), Body aches (Pain), Nausea (Nausea), and Abdominal cramping (Abdominal pain). On 15-Feb-2025, the same day after vaccination the patient experienced Fainting (Syncope)(Serious: Other Medically Important Condition), Chills (Chills), Extreme fatigue (Fatigue), Vomiting (Vomiting) and Bloating (Abdominal distension).  Relevant lab tests included: RAPID POC TEST (Result: Positive, Test Date: 01-Dec-2020) and RAPID POC TEST (Result: Positive, Test Date: 01-Sep-2023).  At the time of reporting, the event outcome of Blindness, Pyrexia, Pain, Nausea, Abdominal pain, and Syncope was Recovering/Resolving. The event outcome of Chills, Fatigue, Vomiting was Recovered/Resolved on 17-Feb-2025 and Abdominal distension was Recovered/Resolved on 18-Feb-2025.  A discrepancy was identified in the source document where the outcome for the events of Chills, Fatigue, Vomiting, and Abdominal distension was captured as Recovered/Resolved as cessation dates were provided. The events of Blindness and Syncope were considered as serious as these are listed on the IME list.; Sender's Comments: This 28-year-old of an unspecified sex experienced Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Syncope and Blindness were assessed as serious.  The events Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension were reported as non-serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension is considered Possible.
Vaccine: COVID19, COVID19, FLUX
Symptoms: Nausea, Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: Fever; Body aches; Loss of vision; Nausea; Abdominal cramping; Bloating; Vomiting; Vomitting; Fainting; Chills; Extreme fatigue; This serious initial Spontaneous safety report was received by Novavax on 18-Feb-2025 from a consumer or other non-health professional via agency (Web Portal) (ref. no. US-1000000481-NVAX).  A 28 Year(s) old individual of an unspecified gender was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 15-Feb-2025.  The following secondary suspect medications were reported: INFLUENZA VACCINE (influenza vaccine).  The following medical history was reported: NICKEL ALLERGY.   No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced Loss of vision (Blindness)(Serious: Other Medically Important Condition), Fever (Pyrexia), Body aches (Pain), Nausea (Nausea), and Abdominal cramping (Abdominal pain). On 15-Feb-2025, the same day after vaccination the patient experienced Fainting (Syncope)(Serious: Other Medically Important Condition), Chills (Chills), Extreme fatigue (Fatigue), Vomiting (Vomiting) and Bloating (Abdominal distension).  Relevant lab tests included: RAPID POC TEST (Result: Positive, Test Date: 01-Dec-2020) and RAPID POC TEST (Result: Positive, Test Date: 01-Sep-2023).  At the time of reporting, the event outcome of Blindness, Pyrexia, Pain, Nausea, Abdominal pain, and Syncope was Recovering/Resolving. The event outcome of Chills, Fatigue, Vomiting was Recovered/Resolved on 17-Feb-2025 and Abdominal distension was Recovered/Resolved on 18-Feb-2025.  A discrepancy was identified in the source document where the outcome for the events of Chills, Fatigue, Vomiting, and Abdominal distension was captured as Recovered/Resolved as cessation dates were provided. The events of Blindness and Syncope were considered as serious as these are listed on the IME list.; Sender's Comments: This 28-year-old of an unspecified sex experienced Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Syncope and Blindness were assessed as serious.  The events Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension were reported as non-serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension is considered Possible.
Vaccine: COVID19, COVID19, FLUX
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test, Syncope
Clinical narrative: Fever; Body aches; Loss of vision; Nausea; Abdominal cramping; Bloating; Vomiting; Vomitting; Fainting; Chills; Extreme fatigue; This serious initial Spontaneous safety report was received by Novavax on 18-Feb-2025 from a consumer or other non-health professional via agency (Web Portal) (ref. no. US-1000000481-NVAX).  A 28 Year(s) old individual of an unspecified gender was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 15-Feb-2025.  The following secondary suspect medications were reported: INFLUENZA VACCINE (influenza vaccine).  The following medical history was reported: NICKEL ALLERGY.   No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced Loss of vision (Blindness)(Serious: Other Medically Important Condition), Fever (Pyrexia), Body aches (Pain), Nausea (Nausea), and Abdominal cramping (Abdominal pain). On 15-Feb-2025, the same day after vaccination the patient experienced Fainting (Syncope)(Serious: Other Medically Important Condition), Chills (Chills), Extreme fatigue (Fatigue), Vomiting (Vomiting) and Bloating (Abdominal distension).  Relevant lab tests included: RAPID POC TEST (Result: Positive, Test Date: 01-Dec-2020) and RAPID POC TEST (Result: Positive, Test Date: 01-Sep-2023).  At the time of reporting, the event outcome of Blindness, Pyrexia, Pain, Nausea, Abdominal pain, and Syncope was Recovering/Resolving. The event outcome of Chills, Fatigue, Vomiting was Recovered/Resolved on 17-Feb-2025 and Abdominal distension was Recovered/Resolved on 18-Feb-2025.  A discrepancy was identified in the source document where the outcome for the events of Chills, Fatigue, Vomiting, and Abdominal distension was captured as Recovered/Resolved as cessation dates were provided. The events of Blindness and Syncope were considered as serious as these are listed on the IME list.; Sender's Comments: This 28-year-old of an unspecified sex experienced Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Syncope and Blindness were assessed as serious.  The events Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension were reported as non-serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension is considered Possible.
Vaccine: COVID19, COVID19, FLUX
Symptoms: Vomiting
Clinical narrative: Fever; Body aches; Loss of vision; Nausea; Abdominal cramping; Bloating; Vomiting; Vomitting; Fainting; Chills; Extreme fatigue; This serious initial Spontaneous safety report was received by Novavax on 18-Feb-2025 from a consumer or other non-health professional via agency (Web Portal) (ref. no. US-1000000481-NVAX).  A 28 Year(s) old individual of an unspecified gender was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 15-Feb-2025.  The following secondary suspect medications were reported: INFLUENZA VACCINE (influenza vaccine).  The following medical history was reported: NICKEL ALLERGY.   No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced Loss of vision (Blindness)(Serious: Other Medically Important Condition), Fever (Pyrexia), Body aches (Pain), Nausea (Nausea), and Abdominal cramping (Abdominal pain). On 15-Feb-2025, the same day after vaccination the patient experienced Fainting (Syncope)(Serious: Other Medically Important Condition), Chills (Chills), Extreme fatigue (Fatigue), Vomiting (Vomiting) and Bloating (Abdominal distension).  Relevant lab tests included: RAPID POC TEST (Result: Positive, Test Date: 01-Dec-2020) and RAPID POC TEST (Result: Positive, Test Date: 01-Sep-2023).  At the time of reporting, the event outcome of Blindness, Pyrexia, Pain, Nausea, Abdominal pain, and Syncope was Recovering/Resolving. The event outcome of Chills, Fatigue, Vomiting was Recovered/Resolved on 17-Feb-2025 and Abdominal distension was Recovered/Resolved on 18-Feb-2025.  A discrepancy was identified in the source document where the outcome for the events of Chills, Fatigue, Vomiting, and Abdominal distension was captured as Recovered/Resolved as cessation dates were provided. The events of Blindness and Syncope were considered as serious as these are listed on the IME list.; Sender's Comments: This 28-year-old of an unspecified sex experienced Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Syncope and Blindness were assessed as serious.  The events Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension were reported as non-serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension is considered Possible.
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No symptoms reported; Pharmacist calling to report the inadvertent administration of an expired dose of a VAQTA to a patient on 02/18/2025.  No symptoms reported and no additional details provided; This spontaneous report has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 18-FEB-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), administered as prophylaxis (lot number reported as W038118, which has been verified as valid, expiration date reported and validated as 06-APR-2024) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported) (Expired product administered).  No symptoms reported and no additional details provided.
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient involved has not reported any medical concerns or symptoms after the administration.; an improperly stored and administered dose of ROTATEQ.  Medical Assistant stated that the dose of ROTATEQ has been exposed to multiple temperature excursions dating back to Decembe; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 22-FEB-2025, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (2 mL / three dose series, lot#: 2051974, expiration date: 16-NOV-2025; strength was not provided) for prophylaxis by a health care professional. The administered rotavirus vaccine live, pentavalent (ROTATEQ) was improperly stored and was exposed to multiple temperature excursions dating back to December 2024 (product storage error). The patient did not report any medical concerns or symptoms after the vaccination (no adverse event).
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; the inadvertent administration of an expired dose of PROQUAD to a 12 month old patient. Expired on 1/5/2025, administered on 2/24/2025.; This spontaneous report was received from a healthcare professional referring to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 24-FEB2-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (0.5 ml, lot#: X018574, expiration date: 05-JAN-2025; strength was not provided) by a healthcare professional for prophylaxis inadvertently (expired product administered). No adverse effects were reported.
Age: 93.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out the following day after administration, Pt couldn't raise arms to catch fall, Pt couldn't reach phone. Pt has been hospitalized ever since.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Computerised tomogram head, Dyspnoea
Clinical narrative: Over time, I began to notice increased blood pressure and my resting heart rate was always over 100. Walking at an average pace would raise my heart rate to 150. I started getting tired very easily, losing my breath just from things like walking room to room or changing my clothes. On August 19, 2024, I was having a normal day and was sitting when I began to feel weak. Moments later, I could not move at all. My whole body felt paralyzed. I was able to get out the words "911" and "stroke" to my daughter. Long story short, I the ambulance took me to the ER where they couldn't figure it out. I was offered Ativan for an anxiety attack which it was not and I refused. After several hours, I was finally able to move about normally. I had 4 more if these attacks over the next 4 weeks. Since then, my fatigue had reached an all time extreme. I have had multiple issues where I felt like my chest would explode out of my chest because it was breathing so hard. Not from running a marathon, from carrying in groceries. I have had many times where I've become very nauseated such as standing in a long line waiting to vote. I have had times where I did vomit, repeatedly. From just taking a shower without sit breaks. I can no longer cook a quick meal because I become so fatigued from standing longer than a few minutes. My whole life is upside down. My doctor says I have RA, but I have no pain or swelling that I can see anywhere. My inflammation markers and RF factor it through the roof. I'm not able to see a rheumatologist until October 2025.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Heart rate increased, Hepatitis viral test, Inflammatory marker increased
Clinical narrative: Over time, I began to notice increased blood pressure and my resting heart rate was always over 100. Walking at an average pace would raise my heart rate to 150. I started getting tired very easily, losing my breath just from things like walking room to room or changing my clothes. On August 19, 2024, I was having a normal day and was sitting when I began to feel weak. Moments later, I could not move at all. My whole body felt paralyzed. I was able to get out the words "911" and "stroke" to my daughter. Long story short, I the ambulance took me to the ER where they couldn't figure it out. I was offered Ativan for an anxiety attack which it was not and I refused. After several hours, I was finally able to move about normally. I had 4 more if these attacks over the next 4 weeks. Since then, my fatigue had reached an all time extreme. I have had multiple issues where I felt like my chest would explode out of my chest because it was breathing so hard. Not from running a marathon, from carrying in groceries. I have had many times where I've become very nauseated such as standing in a long line waiting to vote. I have had times where I did vomit, repeatedly. From just taking a shower without sit breaks. I can no longer cook a quick meal because I become so fatigued from standing longer than a few minutes. My whole life is upside down. My doctor says I have RA, but I have no pain or swelling that I can see anywhere. My inflammation markers and RF factor it through the roof. I'm not able to see a rheumatologist until October 2025.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging head, Mobility decreased, Nausea
Clinical narrative: Over time, I began to notice increased blood pressure and my resting heart rate was always over 100. Walking at an average pace would raise my heart rate to 150. I started getting tired very easily, losing my breath just from things like walking room to room or changing my clothes. On August 19, 2024, I was having a normal day and was sitting when I began to feel weak. Moments later, I could not move at all. My whole body felt paralyzed. I was able to get out the words "911" and "stroke" to my daughter. Long story short, I the ambulance took me to the ER where they couldn't figure it out. I was offered Ativan for an anxiety attack which it was not and I refused. After several hours, I was finally able to move about normally. I had 4 more if these attacks over the next 4 weeks. Since then, my fatigue had reached an all time extreme. I have had multiple issues where I felt like my chest would explode out of my chest because it was breathing so hard. Not from running a marathon, from carrying in groceries. I have had many times where I've become very nauseated such as standing in a long line waiting to vote. I have had times where I did vomit, repeatedly. From just taking a shower without sit breaks. I can no longer cook a quick meal because I become so fatigued from standing longer than a few minutes. My whole life is upside down. My doctor says I have RA, but I have no pain or swelling that I can see anywhere. My inflammation markers and RF factor it through the roof. I'm not able to see a rheumatologist until October 2025.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor increased, Vomiting
Clinical narrative: Over time, I began to notice increased blood pressure and my resting heart rate was always over 100. Walking at an average pace would raise my heart rate to 150. I started getting tired very easily, losing my breath just from things like walking room to room or changing my clothes. On August 19, 2024, I was having a normal day and was sitting when I began to feel weak. Moments later, I could not move at all. My whole body felt paralyzed. I was able to get out the words "911" and "stroke" to my daughter. Long story short, I the ambulance took me to the ER where they couldn't figure it out. I was offered Ativan for an anxiety attack which it was not and I refused. After several hours, I was finally able to move about normally. I had 4 more if these attacks over the next 4 weeks. Since then, my fatigue had reached an all time extreme. I have had multiple issues where I felt like my chest would explode out of my chest because it was breathing so hard. Not from running a marathon, from carrying in groceries. I have had many times where I've become very nauseated such as standing in a long line waiting to vote. I have had times where I did vomit, repeatedly. From just taking a shower without sit breaks. I can no longer cook a quick meal because I become so fatigued from standing longer than a few minutes. My whole life is upside down. My doctor says I have RA, but I have no pain or swelling that I can see anywhere. My inflammation markers and RF factor it through the roof. I'm not able to see a rheumatologist until October 2025.
Age: 61.0
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix second dose on Sep 5th 2024 and received Engerix-B on Nov 5th 2024; Twinrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 15-SEP-2022).   On 05-SEP-2024, the patient received the 2nd dose of Twinrix. On 05-NOV-2024, the patient received Engerix B. On 05-SEP-2024, an unknown time after receiving Twinrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Twinrix - Late second dose). On 05-NOV-2024, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Twinrix second dose on Sep 5th 2024 and received Engerix-B on Nov 5th 2024). The outcome of the drug dose administration interval too long and inappropriate schedule of vaccine administered 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: 03-FEB-2025 The pharmacist reported that a patient received the first dose and second dose on 5th September 2024 of Twinrix series and that patient received a monovalent Hepatitis B vaccine (Engerix-B vaccine) on 5th November 2024, which led to inappropriate schedule of vaccine administered The reporter asked if they could complete the hepatitis A and B series with a Twinrix dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lung disorder
Clinical narrative: he had a bad reaction and got sick; lung problems; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (he had a bad reaction and got sick) and LUNG DISORDER (lung problems) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In December 2024, the patient experienced ILLNESS (he had a bad reaction and got sick) and LUNG DISORDER (lung problems). At the time of the report, ILLNESS (he had a bad reaction and got sick) and LUNG DISORDER (lung problems) had not resolved.            No concomitant medication was reported. He received vaccine on 5-Dec-2024, right after he had a bad reaction and got sick. As of 22-Feb-2025, he continued to suffer from lung issues. It was unknown if the patient had any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vertigo
Clinical narrative: Extreme vertigo for 3 months after the vaccine and then on and off until present day
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Fall
Clinical narrative: Patient received shot, was being counceled on returned for 2nd shot. Upon leaving she fell back and stopped full fall with arm. She lay still then sat up then left after waiting to feel better. She was called after 30 minutes at home, she felt better.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site cellulitis, Vaccination site joint erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt developed increased swelling extending distally from vaccine sitefor approxmiately 6 inches with pain and redness, which has been diagnosed as resolving cellulitis. This swelling continued for approxmately 5 to 6 days and has resovled.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus, Rash, Skin warm
Clinical narrative: itching, warm, red, swollen, painful, rash
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: itching, warm, red, swollen, painful, rash
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Pt. came to office stating he thinks he is experiencing a S/E from the covid vaccine he received last month; he has no sense of smell. Pt states it started slow after vaccine to now when he has lost the sense of smell entirely. He only first reported this S/E today.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: 2nd dose of GARDASIL 9 was inadvertently administered to a pregnant woman on 02/10/2025. No reported signs or symptoms of adverse effects. Permission to contact the HCP was given. No additional AE/n; no adverse event; This spontaneous Prospective pregnancy report was received from a physician and refers to a currently 15-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date the patient became pregnant (last menstrual period date and due date were not provided).   On 10-FEB-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9)(lot #Y007197 was confirmed to be valid, expiration date: 18-AUG-2026) , the dose of was inadvertently administered to a pregnant woman. No reported signs or symptoms of adverse effects (vaccine exposure during pregnancy, no adverse event). The fetal outcome and pregnancy outcome were Unknown.  Follow up information has been received from a physician on 25-FEB-2025 via telephone call. The reporter confirmed that she had a patient that was exposed to Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) during pregnancy. No further information provided.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: 2nd dose of GARDASIL 9 was inadvertently administered to a pregnant woman on 02/10/2025. No reported signs or symptoms of adverse effects. Permission to contact the HCP was given. No additional AE/n; no adverse event; This spontaneous Prospective pregnancy report was received from a physician and refers to a currently 15-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date the patient became pregnant (last menstrual period date and due date were not provided).   On 10-FEB-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9)(lot #Y007197 was confirmed to be valid, expiration date: 18-AUG-2026) , the dose of was inadvertently administered to a pregnant woman. No reported signs or symptoms of adverse effects (vaccine exposure during pregnancy, no adverse event). The fetal outcome and pregnancy outcome were Unknown.  Follow up information has been received from a physician on 25-FEB-2025 via telephone call. The reporter confirmed that she had a patient that was exposed to Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) during pregnancy. No further information provided.
Age: 0.67
Sex: M
Vaccine: UNK
Symptoms: Lethargy, Pyrexia, Somnolence, Vomiting
Clinical narrative: LETHARGY; Pirexia; SOMNOLENCE; Vomiting; This spontaneous report was received from the Health Authority and refers to a(n) 8-month-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions included dairy sensitivity. Concomitant therapies were not reported.   On 30-Dec-2024, the patient started therapy with Pneumococcal 15-valent Conjugate Vaccine administered by Intramuscular route (indication, expiration date, and lot # were not reported).  On 30-Dec-2024, the patient experienced lethargy, pyrexia, somnolence, and vomiting.   At the reporting time, the outcome of lethargy, pyrexia, somnolence and vomiting was unknown.   The action taken with Pneumococcal 15-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between the events and Pneumococcal 15-valent Conjugate Vaccine not provided.
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Development of RSV; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Development of RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-FEB-2025  The nurse practitioner did not know which dose of the vaccine this was. The infectious diseases nurse practitioner mentioned that they were surprised that the patients in her skilled nursing facilities (SNF) had developed respiratory Syncytial Virus this season despite vaccination. She did not say whether they had received GSK or Pfizer product, but she did say that she had reviewed these patients with their research MD and may look at them more closely because they were surprised to see several cases. It was unexpected to them, so it might have been more than mild illness. there were multiple patients. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 Arexvy.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: residual pain in both biceps occurs with movement; residual pain in both Shoulder; General body pain/pain from the neck to both ankles; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number A2F3R, expiry date 26-OCT-2026) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On 07-OCT-2024, the patient received the 2nd dose of Shingrix (left deltoid). On 07-DEC-2024, 61 days after receiving Shingrix, the patient experienced general body pain (Verbatim: General body pain/pain from the neck to both ankles). On an unknown date, the patient experienced muscle pain (Verbatim: residual pain in both biceps occurs with movement) and shoulder pain (Verbatim: residual pain in both Shoulder). The patient was treated with prednisone. The outcome of the general body pain was resolved and the outcome of the muscle pain and shoulder pain were not resolved.   It was unknown if the reporter considered the general body pain, muscle pain and shoulder pain to be related to Shingrix.     It was unknown if the company considered the general body pain, muscle pain and shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2025 The patient self-reported this case. The reporter stated that two months after suspect vaccine administration reporter experienced pain from the neck to both ankles. Reporter went to his physician and was prescribed prednisone for the pain. Pain resolved in 2 days after taking Prednisone. Reporter stated that he had residual pain in both shoulders and both biceps that occurs with movement.
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness; tingling radiating from their shoulder to their fingers; This non-serious case was reported by a other health professional and described the occurrence of numbness of upper extremities in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number x449y, expiry date 20-OCT-2026) for prophylaxis.   On 26-SEP-2024, the patient received Boostrix (intramuscular) .5 ml. On 26-SEP-2024, less than a day after receiving Boostrix, the patient experienced numbness of upper extremities (Verbatim: numbness) and tingling of extremity (Verbatim: tingling radiating from their shoulder to their fingers). The outcome of the numbness of upper extremities and tingling of extremity were not resolved.   It was unknown if the reporter considered the numbness of upper extremities and tingling of extremity to be related to Boostrix.     It was unknown if the company considered the numbness of upper extremities and tingling of extremity to be related to Boostrix.   Additional Information: GSK Receipt Date : 21-FEB-2025 Patient received boostrix vaccine, complained of numbness and tingling radiating from their shoulder to their fingers on the arm the vaccine was administered on.  Still felt it months after receiving the vaccine.  Started day after they received the vaccine (Numbness). Symptoms were not treated.
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: the other was only injected with the diluent.; the other was only injected with the diluent.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: the other was only injected with the diluent.) and inappropriate dose of vaccine administered (Verbatim: the other was only injected with the diluent.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date 20-FEB-2025 Other Healthcare Professionals reported that two customers came in to get vaccinated for RSV.  Once customer received the properly mixed vaccine, the other was only injected with the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he never received it.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he never received it.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter was the patient that states he received Shingrix dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he never received it. The reporter asked if he has to restart series. Information provided per content. The patient stated that he would get dose 2 soon. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Age: 76.0
Sex: F
Vaccine: RVX, VARZOS
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: Hives; arm was sore; breaking out under my cheek bone and right arm; it itches like crazy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 09-JAN-2025, the patient received the 1st dose of Shingles vaccine (intramuscular, left arm) .5 ml and RSV vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced pruritus (Verbatim: it itches like crazy). On an unknown date, the patient experienced hives (Verbatim: Hives), pain in arm (Verbatim: arm was sore) and skin breakout (Verbatim: breaking out under my cheek bone and right arm). The outcome of the hives, pruritus and skin breakout were not resolved and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the hives, pruritus, pain in arm and skin breakout to be related to Shingles vaccine and RSV vaccine.     It was unknown if the company considered the hives, pruritus, pain in arm and skin breakout to be related to Shingles vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter reported that a patient received Shingles and RSV vaccine and experienced hives, sore arm and itching. She received many years ago a shingles vaccine (Zostavax).  The reporter states that her health care professional recommended Shingrix and she received her 1st dose on January 9th, 2025, at her health care professional office.  The patient reports she received the vaccine in her left arm.  The lot number and expiry date was unknown.  The patient reports that she received an RSV vaccine on the same date.  The reporter did not know the brand name of the RSV formulation.  The patient reports her arm was sore at the beginning but has resolved.  The patient reports 2 weeks ago had a breaking of a strange hive on one hand and right wrist and it itches like crazy.  The reporter states she was given a steroid shot (unknown name).   Now breaking out under cheek bone and right arm and it itches like fire.  The patient reports it was not resolved.  When asked about sharing other medical history or medications she states not at this time.  No additional event was reported.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; got it a year after the Shingrex shots/ It was the worst outbreak ever; Post herpetic neurologic pain; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (He/ she got in his/her early 20's, twice in his/her 50's).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got it a year after the Shingrex shots/ It was the worst outbreak ever) and post herpetic neuralgia (Verbatim: Post herpetic neurologic pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was resolved (duration 3 months).   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-FEB-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via (Facebook) interactive digital media. Patient had gotten it in his/her early 20s, twice in my 50s, and finally received the 2-shot Shingrix in his/her 60s.  Then he/she got it a year after the Shingrix shots.  It was the worst outbreak ever.  The post-herpetic neurologic pain had been unbearable for 3 months.  He/she had been told the vaccine was not 100 percent.  This case was considered as suspected vaccination failure as details regarding 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 about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; developed shingles after taking Shingrix; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 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: developed shingles after taking Shingrix). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2025 The patient developed shingles after taking Shingrix. This case was considered as suspected vaccination failure as details regarding completion of primary 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 vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Pain; swelling; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mucinous carcinoma.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Pain) and swelling (Verbatim: swelling). The outcome of the pain and swelling were not reported.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.     It was unknown if the company considered the pain and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-FEB-2025 Patient asked if they can take Shingrix while being treated for mucinous carcinoma. Patient had the first shot the day before diagnosis and had pain, swelling , etc