chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Gastrointestinal disorder, Hypoaesthesia, Inflammation, Nerve injury
Clinical narrative: Severely arthritic in my knees (both); Constant pain; Don't feel like walking.; Impacting my daily activity level to the point; Arm pain; Swelling arm; Rash on arm; Fever; GI issues; Flu-like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of knee arthritis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had bad case in 2022).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced knee arthritis (Verbatim: Severely arthritic in my knees (both)), pain (Verbatim: Constant pain), walking difficulty (Verbatim: Don't feel like walking.), activities of daily living impaired (Verbatim: Impacting my daily activity level to the point), pain in arm (Verbatim: Arm pain), swelling arm (Verbatim: Swelling arm), rash (Verbatim: Rash on arm), fever (Verbatim: Fever), gastrointestinal disorder (Verbatim: GI issues) and influenza-like symptoms (Verbatim: Flu-like symptoms). The outcome of the knee arthritis was not resolved and the outcome of the pain, walking difficulty and activities of daily living impaired were resolved and the outcome of the pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms were not reported.   It was unknown if the reporter considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023, 16-OCT-2023 and 17-OCT-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine at the recommendation of her physician and since then experienced severely arthritic in her both knees. The patient experienced constant pain all day long.  The patient was an active person so she was very concerned and it was impacting her daily activity level to the point where she do not felt like walking. The patient was reached out to her physician for follow up.  The patient stated that all other issues had resolved except for the arthritis.  She was afraid. The patient experienced arm pain, swelling arm, rash on arm, fever, GI issues and flu-like symptoms. The patient stated that she will not be getting her second dose of Shingrix because of this reaction.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Severely arthritic in my knees (both); Constant pain; Don't feel like walking.; Impacting my daily activity level to the point; Arm pain; Swelling arm; Rash on arm; Fever; GI issues; Flu-like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of knee arthritis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had bad case in 2022).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced knee arthritis (Verbatim: Severely arthritic in my knees (both)), pain (Verbatim: Constant pain), walking difficulty (Verbatim: Don't feel like walking.), activities of daily living impaired (Verbatim: Impacting my daily activity level to the point), pain in arm (Verbatim: Arm pain), swelling arm (Verbatim: Swelling arm), rash (Verbatim: Rash on arm), fever (Verbatim: Fever), gastrointestinal disorder (Verbatim: GI issues) and influenza-like symptoms (Verbatim: Flu-like symptoms). The outcome of the knee arthritis was not resolved and the outcome of the pain, walking difficulty and activities of daily living impaired were resolved and the outcome of the pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms were not reported.   It was unknown if the reporter considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023, 16-OCT-2023 and 17-OCT-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine at the recommendation of her physician and since then experienced severely arthritic in her both knees. The patient experienced constant pain all day long.  The patient was an active person so she was very concerned and it was impacting her daily activity level to the point where she do not felt like walking. The patient was reached out to her physician for follow up.  The patient stated that all other issues had resolved except for the arthritis.  She was afraid. The patient experienced arm pain, swelling arm, rash on arm, fever, GI issues and flu-like symptoms. The patient stated that she will not be getting her second dose of Shingrix because of this reaction.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Gait disturbance, Gastrointestinal disorder, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Severely arthritic in my knees (both); Constant pain; Don't feel like walking.; Impacting my daily activity level to the point; Arm pain; Swelling arm; Rash on arm; Fever; GI issues; Flu-like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of knee arthritis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had bad case in 2022).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced knee arthritis (Verbatim: Severely arthritic in my knees (both)), pain (Verbatim: Constant pain), walking difficulty (Verbatim: Don't feel like walking.), activities of daily living impaired (Verbatim: Impacting my daily activity level to the point), pain in arm (Verbatim: Arm pain), swelling arm (Verbatim: Swelling arm), rash (Verbatim: Rash on arm), fever (Verbatim: Fever), gastrointestinal disorder (Verbatim: GI issues) and influenza-like symptoms (Verbatim: Flu-like symptoms). The outcome of the knee arthritis was not resolved and the outcome of the pain, walking difficulty and activities of daily living impaired were resolved and the outcome of the pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms were not reported.   It was unknown if the reporter considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023, 16-OCT-2023 and 17-OCT-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine at the recommendation of her physician and since then experienced severely arthritic in her both knees. The patient experienced constant pain all day long.  The patient was an active person so she was very concerned and it was impacting her daily activity level to the point where she do not felt like walking. The patient was reached out to her physician for follow up.  The patient stated that all other issues had resolved except for the arthritis.  She was afraid. The patient experienced arm pain, swelling arm, rash on arm, fever, GI issues and flu-like symptoms. The patient stated that she will not be getting her second dose of Shingrix because of this reaction.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Severely arthritic in my knees (both); Constant pain; Don't feel like walking.; Impacting my daily activity level to the point; Arm pain; Swelling arm; Rash on arm; Fever; GI issues; Flu-like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of knee arthritis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had bad case in 2022).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced knee arthritis (Verbatim: Severely arthritic in my knees (both)), pain (Verbatim: Constant pain), walking difficulty (Verbatim: Don't feel like walking.), activities of daily living impaired (Verbatim: Impacting my daily activity level to the point), pain in arm (Verbatim: Arm pain), swelling arm (Verbatim: Swelling arm), rash (Verbatim: Rash on arm), fever (Verbatim: Fever), gastrointestinal disorder (Verbatim: GI issues) and influenza-like symptoms (Verbatim: Flu-like symptoms). The outcome of the knee arthritis was not resolved and the outcome of the pain, walking difficulty and activities of daily living impaired were resolved and the outcome of the pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms were not reported.   It was unknown if the reporter considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023, 16-OCT-2023 and 17-OCT-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine at the recommendation of her physician and since then experienced severely arthritic in her both knees. The patient experienced constant pain all day long.  The patient was an active person so she was very concerned and it was impacting her daily activity level to the point where she do not felt like walking. The patient was reached out to her physician for follow up.  The patient stated that all other issues had resolved except for the arthritis.  She was afraid. The patient experienced arm pain, swelling arm, rash on arm, fever, GI issues and flu-like symptoms. The patient stated that she will not be getting her second dose of Shingrix because of this reaction.
Age: 38.0
Sex: F
Vaccine: FLU4, FLUA4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash, Hives  and Itching
Sex: U
Vaccine: PPV
Symptoms: Chronic kidney disease
Clinical narrative: Retired physician calling to request information on dosing schedule of pneumococcal vaccines. He reports a patient who has chronic kidney disease. Filing as I cannot rule out weather this occured before or after administration of PNEUMOVAX 23. AEFU l; This spontaneous report was received from a retired physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, route of administration, anatomical location not provided) as prophylaxis.         On an unknown date, the patient experienced chronic kidney. The physician requested information about dosing schedule of pneumococcal vaccine. At the reporting time, the outcome of chronic kidney disease was unknown.        Causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is a non-valid case due to lack of patient's identifiers.  Follow up information has been received from the physician on 16-OCT-2023.   The physician reported that the patient had previously received pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient was over 65 years when he/she received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient had questionable chronic kidney disease.  This is now a valid report since patient's age group was provided.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE. The only product that was administered during the excursion was ROTATEQ. TE case number 02493530. No additional AE/PQC.    ?   ROTATEQ LOT:1965644 EXP: 10/02/2024 ?    15.9c for 4 hours 0 minutes 0 seconds  ? no previou; This spontaneous report was received from a nurse and refers to a 3-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-OCT-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1965644 and expiration date 02-OCT-2024, 2 milliliters for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event). The temperature excursion lasted for 4 hours in 15.9 Celsius degrees.
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A Merck employee called to report an AE that was reported to her by a HCP. The HCP said her friend called her, who's daughter sees another pediatrician, and told the HCP that her daughter inadvertently received a dose of GARDASIL 9 at her four month; her daughter inadvertently received a dose of GARDASIL 9 at her four month well check up, rather than receiving her scheduled PREVNAR 20; No additional AE reported; This spontaneous report was received from a physician and refers to a 4-month-old female patient. No information on patient's medical history, current conditions and concomitant medication was provided.  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) instead of scheduled pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (product administered to patient of inappropriate age, no adverse event and wrong product administered).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist called to report AE for PNEUMOVAX23. Caller stated she received "third hand" information that a 75-year-old female was administered a dose of PNEUMOVAX23 after it's expiration date at a Health Care Provider's office. Caller stated date o; This spontaneous report was received from a pharmacist refers to a 75-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-OCT-2023, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   The caller stated she received ''third hand'' information that a 75-year-old female was administered a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) after its expiration date at a Health Care Provider's office (expired product administered). The patient was asymptomatic. No additional adverse event reported (no adverse event).
Sex: M
Vaccine: RSV
Symptoms: Blood sodium decreased, Blood test normal, Coma, Confusional state, Depressed level of consciousness
Clinical narrative: hospital for Coma; confusion; shortness of breath; thrombocytopenia; This serious case was reported by a other health professional and described the occurrence of coma in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included intubation.   On 08-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 1 days after receiving Arexvy, the patient experienced coma (Verbatim: hospital for Coma) (serious criteria hospitalization and GSK medically significant). In OCT-2023, the patient experienced confusion (Verbatim: confusion) (serious criteria hospitalization), shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization) and thrombocytopenia (Verbatim: thrombocytopenia ) (serious criteria hospitalization and GSK medically significant). On 17-OCT-2023, the outcome of the coma was not resolved. The outcome of the confusion, shortness of breath and thrombocytopenia were not reported.   It was unknown if the reporter considered the coma, confusion, shortness of breath and thrombocytopenia to be related to Arexvy.     It was unknown if the company considered the coma, confusion, shortness of breath and thrombocytopenia to be related to Arexvy.   Additional Information: GSK receipt date: 17-Oct-2023 The patient was in his usual state of health up to the day he received the vaccine.  24 hours later he came to the office for his routine visit and had blood work performed that was unremarkable.  In October 2023, he was admitted to the hospital with confusion and shortness of breath in the next 72 hours.  His labs demonstrated a low sodium, he had thrombocytopenia with platelets of 25,000 and became obtunded.  The reporter consented to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Platelet count decreased, Thrombocytopenia
Clinical narrative: hospital for Coma; confusion; shortness of breath; thrombocytopenia; This serious case was reported by a other health professional and described the occurrence of coma in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included intubation.   On 08-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 1 days after receiving Arexvy, the patient experienced coma (Verbatim: hospital for Coma) (serious criteria hospitalization and GSK medically significant). In OCT-2023, the patient experienced confusion (Verbatim: confusion) (serious criteria hospitalization), shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization) and thrombocytopenia (Verbatim: thrombocytopenia ) (serious criteria hospitalization and GSK medically significant). On 17-OCT-2023, the outcome of the coma was not resolved. The outcome of the confusion, shortness of breath and thrombocytopenia were not reported.   It was unknown if the reporter considered the coma, confusion, shortness of breath and thrombocytopenia to be related to Arexvy.     It was unknown if the company considered the coma, confusion, shortness of breath and thrombocytopenia to be related to Arexvy.   Additional Information: GSK receipt date: 17-Oct-2023 The patient was in his usual state of health up to the day he received the vaccine.  24 hours later he came to the office for his routine visit and had blood work performed that was unremarkable.  In October 2023, he was admitted to the hospital with confusion and shortness of breath in the next 72 hours.  His labs demonstrated a low sodium, he had thrombocytopenia with platelets of 25,000 and became obtunded.  The reporter consented to follow-up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Influenza, Influenza A virus test positive, Pneumonia
Clinical narrative: Community acquired pneumonia; Shortness of Breath; Influenza A; This serious case was reported by a physician via sales rep and described the occurrence of community acquired pneumonia in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-SEP-2023, the patient received the 1st dose of Arexvy. In SEP-2023, less than 2 weeks after receiving Arexvy, the patient experienced shortness of breath (Verbatim: Shortness of Breath) (serious criteria hospitalization) and influenza a virus infection (Verbatim: Influenza A) (serious criteria hospitalization). On 25-SEP-2023, the patient experienced community acquired pneumonia (Verbatim: Community acquired pneumonia) (serious criteria hospitalization and GSK medically significant). The outcome of the community acquired pneumonia, shortness of breath and influenza a virus infection were not reported.   The reporter considered the community acquired pneumonia to be related to Arexvy. It was unknown if the reporter considered the shortness of breath and influenza a virus infection to be related to Arexvy.     The company considered the community acquired pneumonia to be related to Arexvy. It was unknown if the company considered the shortness of breath and influenza a virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2023 Patient over 60 received a dose of RSV vaccine at the pharmacy. Patient presented at the (unspecified) on 25th September 2023 with primary complaint of shortness of breath. Patient was admitted to hospital within 1-2 days of immunization for RSV with primary diagnosis of community acquired pneumonia.  Patient was tested for influenza more than one time. The second test showed positive for influenza A. The patient was discharged on 27th September 2023. Advanced registered nurse practitioner that treated her was not certain if patient received AREXVY or ABRYSVO because they were vaccinated at the pharmacy. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Trismus
Clinical narrative: Jaw spasm; This non-serious case was reported by a consumer and described the occurrence of jaw spasm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-SEP-2023, the patient received Shingrix. On 07-OCT-2023, 24 days after receiving Shingrix, the patient experienced jaw spasm (Verbatim: Jaw spasm).  The outcome of the jaw spasm was not resolved.   It was unknown if the reporter considered the jaw spasm to be related to Shingrix.     It was unknown if the company considered the jaw spasm to be related to Shingrix.   Additional Information: GSK Receipt date: 13-OCT-2023 The concomitant was provided as multiple, but none were new. It was reported that just wanting to know if this has been reported before. Not looking for compensation of any kind, just looking to both report my experience and learn if this side effect has been reported before. The Jaw spasm were treated. The reporter consented to follow up. Note: Outcome captured as per code 3 however outcome date was same as Initial GRD date.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Drug Exposure During Pregnancy; patient received Arexvy by mistake yesterday; 32 years patient received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 32-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number mr5hx, expiry date 01-FEB-2025) for prophylaxis.   On 12-OCT-2023, the patient received Arexvy (intramuscular, right deltoid). On 12-OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: patient received Arexvy by mistake yesterday) and inappropriate age at vaccine administration (Verbatim: 32 years patient received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: 34.5 week pregnant   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter stated that a 34.5-week pregnant patient received Arexvy by mistake yesterday. She was supposed to receive Abrysvo, which led to wrong vaccine administered. The reporter did not have due date available to share. The reporter consented to follow up. The patient below recommended age received Arexvy, which led to inappropriate age at vaccine administration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Periorbital swelling, Pruritus, Swelling face
Clinical narrative: facial swelling; swelling around both of her eyes/ facial swelling around the eyes/ she could barely open her eyes; uncomfortable/ discomfort; her face felt itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2021 09:30, the patient received the 1st dose of Shingrix. On 28-AUG-2021, 1 days after receiving Shingrix, the patient experienced facial swelling (Verbatim: facial swelling), periorbital swelling (Verbatim: swelling around both of her eyes/ facial swelling around the eyes/ she could barely open her eyes), discomfort (Verbatim: uncomfortable/ discomfort) and pruritus facial (Verbatim: her face felt itchy). The outcome of the facial swelling, periorbital swelling and discomfort were resolved and the outcome of the pruritus facial was not reported.   It was unknown if the reporter considered the facial swelling, periorbital swelling, discomfort and pruritus facial to be related to Shingrix.     It was unknown if the company considered the facial swelling, periorbital swelling, discomfort and pruritus facial to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023 The patient self-reported this case. The consumer (patient) stated she experienced a reaction after Shingrix, adding it was the first reaction she has ever had to a vaccine, despite receiving all recommended vaccinations.  She further clarified the reaction as facial swelling around the eyes after receiving dose one of Shingrix at 9:30 in the morning at her doctor's office. She stated the swelling was initially noted the next morning.  The next morning, her face felt itchy, and when she looked into the mirror, she had swelling around both of her eyes, in which she could barely open her eyes. Since the patient experienced discomfort and swelling. She had placed a bag of peas on her face the whole day and kept the area cool for a day and a half. The patient iced the area with a bag of peas and the swelling resolved after about one and a half days in Aug 2021.  She reported it was uncomfortable, but never felt hot. The patient gave consent to follow up with HCP (health care professional).
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received Twinrix in May 2023 and is just coming back for his second dose today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix vaccine (1st dose received on May 2023 from lot number 2pg39 and expiry date 19th September 2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received Twinrix in May 2023 and is just coming back for his second dose today).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter reported that the patient came back for second dose today. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Prothrombin time abnormal
Clinical narrative: Arexvy - Change in PT/INR; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of prothrombin time abnormal in a 86-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7SY2S, expiry date 19-OCT-2024) for prophylaxis.   Concomitant products included warfarin.   On 27-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced prothrombin time abnormal (Verbatim: Arexvy - Change in PT/INR).The outcome of the prothrombin time abnormal was unknown.   It was unknown if the reporter considered the prothrombin time abnormal to be related to Arexvy.   It was unknown if the company considered the prothrombin time abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-OCT-2023 A reporter called to report that patient was vaccinated with Arexvy.  The patient had been under Warfarin treatment at the same dose for a very long time.  After the vaccination with Arexvy, the patient tested for PT/INR and since this changed he had to double the Warfarin dose. The healthcare professional mentioned that the patient had not changed his diet or other medications and now the patient was testing the PT/INR weekly. The healthcare professional asked for any information regarding Arexvy in patients under Warfarin treatment. The healthcare professional mentioned that next week after seeing the PT/INR results she would ask the patient if he would allow us to follow up.  The case number was shared and the healthcare professional would inform if the PT/INR was back to the value before vaccination.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: was administered a Hepatitis B vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 63-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 13-JUL-2023, the patient received Hepatitis B vaccine. On 13-JUL-2023, an unknown time after receiving Hepatitis B vaccine and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered (Verbatim: was administered a Hepatitis B vaccine).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 13-OCT-2023 The patient self-reported this case. The patient returned on 13th July 2023 and was administered a Hepatitis B vaccine (manufacturer not specified) instead of TWINRIX, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Device leakage, Occupational exposure to product, Syringe issue
Clinical narrative: Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand; syringe or the vial leaked; Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand; Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number BX7YF) for prophylaxis. This case was associated with a product complaint.   On 12-OCT-2023, the patient did not receive Shingrix. On 12-OCT-2023, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand) and exposure via skin contact (Verbatim: Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand). On an unknown date, the patient experienced product leakage (Verbatim: Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand) and pharmaceutical product complaint (Verbatim: syringe or the vial leaked). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, product leakage and pharmaceutical product complaint were unknown.  Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter was the technician at the healthcare professional (HCP) office. Upon drawing up Shingrix to administer to a patient the syringe or the vial leaked out all over the reporters hand, which led to occupational exposure while preparing product for administration and exposure via skin contact.  No further description was made. There was no administration of the medication. The reporter consented to follow up.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: MA reports administration of Boostrix stored at 31.7F x 14 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: MA reports administration of Boostrix stored at 31.7F x 14 hours.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-OCT-2023 Medical Assistant (MA) reported administration of Boostrix stored at 31.7 Fahrenheit for 14 hours, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received 2 doses of Fluarix 1 week apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUARIX).   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced drug dose administration interval too short (Verbatim: patient received 2 doses of Fluarix 1 week apart).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Oct-2023 The health care professional reported no reactions. The reporter declined to follow-up. The patient received 2 doses of Fluarix 1 week apart, which led to shortening of vaccine schedule.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: patient was accidentally given just the adjuvant for AREXVY; patient was accidentally given just the adjuvant for AREXVY; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G2MG3, expiry date 24-FEB-2025) for prophylaxis.   On 13-OCT-2023, the patient received Arexvy. On 13-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was accidentally given just the adjuvant for AREXVY) and inappropriate dose of vaccine administered (Verbatim: patient was accidentally given just the adjuvant for AREXVY).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 13-OCT-2023, 16-OCT-2023 Reporter is the HPC (pharmacist). He states that a patient was accidentally given just the adjuvant for AREXVY. The patient was then administered a full dose of AREXVY which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. Arexvy administered on 13th October 2023 (full dose and adjuvant only administered on 13th October 2023) Permission granted for Safety Team follow-up with Healthcare Professional.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: 36 week pregnant woman were to mistakenly be vaccinated with Arexvy; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 week pregnant woman were to mistakenly be vaccinated with Arexvy).  The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 14-OCT-2023 The reporter had a question regarding the new RSV vaccine Arexvy that were there studies conducted on pregnant women. If a 36 week pregnant woman were to mistakenly be vaccinated with Arexvy what would be things to be worried about and should she be vaccinated with the correct RSV vaccine. The reporter consented to follow up. No additional details available due to web form submission. The patient who was pregnant received Arexvy vaccine, which led to vaccine exposure during pregnancy.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 13 Oct 2023 The Pharmacist stated that Arexvy diluent only given to patient. The patient returned to receive a complete dose of Arexvy and was administered a complete dose.  The reporter wanted to know what to the patient should expect after receiving 2 diluents. HCP didn't give permission for Safety follow-up and didn't provide additional details of when Arexvy diluent was administered or the complete dose of Arexvy vaccine was administered to the patient. The patient received Arexvy diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Stem cell transplant
Clinical narrative: The patient had a stem cell transplant in 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced stem cell transplant (Verbatim: The patient had a stem cell transplant in 2023). The outcome of the stem cell transplant was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix and Shingrix.     It was unknown if the company considered the stem cell transplant to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023 and 16-Oct-2023 The reporter reported that patient received Zostavax in 2020 and both doses of Shingrix vaccine in 2022. The patient had a stem cell transplant in 2023 the reason was unknown for stem cell transplant. No patient demographics known except the patient gender. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Thrombosis
Clinical narrative: experienced blood clots; This serious case was reported by a physician via sales rep and described the occurrence of clot blood in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced clot blood (Verbatim: experienced blood clots) (serious criteria GSK medically significant). The outcome of the clot blood was unknown.   It was unknown if the reporter considered the clot blood to be related to Arexvy.     It was unknown if the company considered the clot blood to be related to Arexvy.   Additional Information: GSK receipt date: 17-Oct-2023 The physician reported that his patient got Arexvy (RSV vaccine) and then experienced blood clots. The reporter described blood clots as in the patients legs.  Uncertain if the vaccine was GlaxoSmithKline or Pfizer. The reporter consented to follow-up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: seizures after receiving a dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-OCT-2023, the patient received Shingrix. On 06-OCT-2023, less than a day after receiving Shingrix, the patient experienced seizure (Verbatim: seizures after receiving a dose of Shingrix) (serious criteria GSK medically significant).  The outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Shingrix.     It was unknown if the company considered the seizure to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 A member of the public called in to request information about the incidence of seizures after receiving a dose of Shingrix. The reporter accepted to receive follow up and were transferred to the agency. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Decreased appetite, Mobility decreased, Myalgia
Clinical narrative: After his most recent dose, he felt sluggish the next day.; The next morning (Sunday) he had no energy and couldn't get out of bed all day.; He has had no appetite and only ate a slice of toast yesterday; He was achy in his lower back, muscles, and kidneys; He had extreme nausea and vomited 5 times Saturday night; He had extreme nausea and vomited 5 times Saturday night; He was achy in his lower back, muscles, and kidneys; He was achy in his lower back, muscles, and kidneys; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.), BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.) and DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2023 at 6:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), MYALGIA (He was achy in his lower back, muscles, and kidneys), NAUSEA (He had extreme nausea and vomited 5 times Saturday night) and VOMITING (He had extreme nausea and vomited 5 times Saturday night). On 15-Oct-2023, the patient experienced ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.) and DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday). On an unknown date, the patient experienced SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.). At the time of the report, SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.), BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.), DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday), MYALGIA (He was achy in his lower back, muscles, and kidneys), NAUSEA (He had extreme nausea and vomited 5 times Saturday night) and VOMITING (He had extreme nausea and vomited 5 times Saturday night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2023, SARS-CoV-2 test: Negative.         Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745822 (E2B Linked Report). This case was linked to MOD-2023-745830 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745822:Wife Case