chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Rash, Rhinorrhoea
Clinical narrative: ear pain, stomach pain, loose stool, fatigue, headache, rash on left arm, sore throat, runny nose, insomnia; applied heat and ice; took tylenol; all resolved as of now.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine administration error - it was given sooner than the recommended interval
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Advised mother of the immunization error, patient is okay and mother expressed no concerns.
Age: 6.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Chills, Fatigue, Feeling cold, Somnolence, Tremor
Clinical narrative: Denies:  current illness,allergies to immunization component,reaction to vaccine in the past    Student was sent to the nurse 2 hours after receiving vaccine of IPV and Hepatitis B vaccine because he was sleeping with his head down on his desk. When he arrived at the nurse's office he sat down and put his head down on the table . They tried to get him to wake but he was sleeping . I saw student and he was able to sit up but appeared tired, cold and shaking . His initial temp was 97.8 and repeat was 99.2 in 20 minutes. Notes: Pt presented with chills and fever a s temperature went to 99.8 and he responded to his name but could not focus onother questions. he had no breathing difficulties. EMS was called and reported as a possible reaction to receiving 2 vaccines today. Emergency medical care was dispatched and they arrived vitals were monitored and pulse went to120. Father was notified and arrived at the school. copies of his vaccine records were given to ambulence and the names and lot number of both the IPV vaccine and the Hepatitis B vaccine Student was transported to Hospital. Dad rode with student in the ambulence.   Fever, unspecified Notes: Student"s temperature was rising and he was transported by ambulence for further evaluation. I called Dad and student was discharged and no medication was given according to dad, He was observed at clinic and Dad told me that he was directed to observe student.  i called on march 29 and  was told by dad that in the evening of march 27 he was still tired and had a fever but mom did not have a thermometer to mesuare it.  The following days he had no symptoms, no fever and no fatigue.
Age: 25.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Bell's palsy, Laboratory test
Clinical narrative: Above 2 vaccines given 3/28/24 12:00pm noon.  On 3/29/24 at 6pm patient developed Left sided facial Bell's Palsy, and went to Hospital.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NON-ADVERSE REACTIONS NOTED
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine came from a box that had a Use Before Date of 4/1/24.  The vaccine was administered on 4/1/24, which would be one day after the refrigerator beyond use date.
Age: 17.0
Sex: F
Vaccine: COVID19, HEPA, TDAP
Symptoms: Feeling hot, Loss of consciousness, Syncope, Tinnitus
Clinical narrative: syncope - patient felt warm, ears ringing, passed out momentarily
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given NDC 58160-827-03. This is the liquid formulation intended for patients 10 years and older. We contacted CDC, they said this would not cause harm to patients less than 10 and would not require revaccination but that we should submit to VAERs.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN WRONG AGE COVID VACCINE NO SYMPTONS, NO SIGNS OF THE VACCINE PATIENT WAS GOOD.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Cardiac hypertrophy, Death, Myocarditis
Clinical narrative: Death. Cause of death: sudden cardiac arrest in the setting of cardiac hypertrophy; myocarditis
Age: 7.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given NDC 58160-827-03. This is the liquid formulation intended for patients 10 years and older. We contacted CDC, they said this would not cause harm to patients less than 10 and would not require revaccination but that we should submit to VAERs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Weight increased
Clinical narrative: My metabolism has stopped. Without any major changes to diet and exercise, I have gained weight and have become fatigued. I cannot seem to lose the weight I have gained no matter what I try. My sister, who is 9 years older than me started having the same symptoms at the same time. We cannot both be entering menopause as she already went through it. We are of very similar genetic make up being full blooded sister however. And we both got the vaccine at the same time.  I suspect this could be the cause.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Decreased appetite, Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Mom reported about 5 hours after administration of Vaxelis patient's left thigh swelled, became very hot to touch, and tender. She was fussy most of the evening and did not nurse.  Mom administered Tylenol and compresses, and she seemed to get some relief.  Mom reported the redness was gone the next morning (4/2/2024). Mom reported no fever noted but, that it still seemed very tender. Mom sent images of the patient's leg both from day after administration and the next morning for provider to view.  Provider instructed parent to continue to give either Tylenol or ibuprofen for the next 24 hours and compresses if it continues to be red or tender.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11yo pt was given Spikevax indicated in 12+ ; COVID Vaccine was pulled from stock but box was mislabeled and the Adult vaccine was pulled by the medical assistant. It was not caught during the provider check for verification and was administered to the pediatric patient.  Pt experienced no adverse reaction after adult vaccine was administered; parent was offered r/s for re-vaccinating but declined at time. The error in labeling was immediately fixed and information regarding the error was provided to the pt and parent with information on risk and resolution.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Oropharyngeal pain
Clinical narrative: Seen for well check 2/26, got 4 yr imms MMRV, DTaP-IPV and flu Flu RA, MMRV and DTaP-IPV L arm Developed bump initially. "hard mosquito bite". Seen in office on 3/25/24 left arm itchy and  red, no fever or uri but did have fever x 48 hrs uri and sore throat 1 wk ago, resolved. No body aches. No numbness or tingling or weakness. No injury or scratch to arm. No history of prior vaccine reaction or concerns. Concerns for cellulitis and given cephALEXin 250 mg/5 mL Suspension twice daily for 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Seen for well check 2/26, got 4 yr imms MMRV, DTaP-IPV and flu Flu RA, MMRV and DTaP-IPV L arm Developed bump initially. "hard mosquito bite". Seen in office on 3/25/24 left arm itchy and  red, no fever or uri but did have fever x 48 hrs uri and sore throat 1 wk ago, resolved. No body aches. No numbness or tingling or weakness. No injury or scratch to arm. No history of prior vaccine reaction or concerns. Concerns for cellulitis and given cephALEXin 250 mg/5 mL Suspension twice daily for 10 days.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia
Clinical narrative: Left shoulder pain  (sharp) that started the same day that she received the vaccine, no visible injury (no redness/swelling per Mom). She had no other injury that could be attributed to the pain.  Mom started to be concerned when she continued to complain of pain, and made an appt with our office 11 days after her vaccine to evaluate her.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Intussusception, Large intestinal obstruction reduction
Clinical narrative: pt was taken into the ED at hospital and life flighted to another hospital for a procedure called Intussusception that was done to correct the bowel. Dr. here at Pediatrics saw this patient for a follow up, pt. doing well, Dr. wanted this reported as it can be a side effect to the Rotavirrus vaccine
Age: 15.0
Sex: M
Vaccine: FLUC4, HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Appears patient received Moderna Covid-19 Spikevax, meant for ages 12+ instead of formulation for his age range.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: unknown, given in date vaccine after beyond use date
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was given Comirnaty, Pfizer Covid-19 vaccination, when she actually wanted to receive a Shingrix vaccination
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: UNKOWN, VACCINE GIVEN THAT EXPIRES 4/30/24 BUT BEYOND USE DATE 3/2/24
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received Arexvy on 3/1/24, and we gave administered Arexvy again on 4/1/24.  Patient is not experiencing any adverse effects upon speaking with her today (4/2/24).
Age: 0.5
Sex: F
Vaccine: HEP, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated with vaccine that was three days after expiration date. The vaccine was Engerix and no adverse reactions occured.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP called to report ROTATEQ was given after possibly experiencing a temperature excursion. HBP did not provide details of the excursion at the time of the call.; This spontaneous report was received from a health business profession (HBP), referring to a 6-month-old patient with unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 11-JAN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally as prophylaxis (formulation, dose, frequency, lot # and expiry date were not provided).  Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was given on 11-JAN-2024 after possibly experiencing a temperature excursion (Improper storage of product in use). Details of the excursion at the time of the call were not provided. Adverse event (AE) being filed as precaution. No additional information/clarification provided. No additional AE/no product quality concern (PQC). Lot number is being requested and will be provided if available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (x024543   10/10/2025) Temperature: (-0.3; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 26-MAR-2024 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X024543 and expiration date 10-OCT-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The length of temperature excursion was 4 hours 26 minutes in temperature of -0.3 Celsius degrees (C) (product storage error and no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (x024543   10/10/2025) Temperature: (-0.3; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions. concomitant therapies, drug reactions and allergies were not reported.  On 26-MAR-2024, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X024543, expiration date: 10-OCT-2025, (strength, exact dose, dose#,  route of administration, and anatomical site of vaccination were not provided) for prophylaxis. The suspect vaccine underwent a temperature excursion of - 0.3 Celsius (C) degrees for 4 hours and 26 minutes. There was not previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; The medical assistant is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions. concomitant therapies, drug reactions and allergies were not reported.  On 26-MAR-2024, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X024543, expiration date: 10-OCT-2025, (strength, exact dose, dose#,  route of administration, and anatomical site of vaccination were not provided) for prophylaxis. The suspect vaccine underwent a temperature excursion of - 0.3 Celsius (C) degrees for 4 hours and 26 minutes. There was not previous temperature excursion. No additional adverse event was reported (no adverse event).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Coordination abnormal, Fall, Head injury
Clinical narrative: head injury; possible loss of conciousness; extreme uncoordination; weakness/too weak to get up; fall; This serious case was reported by a consumer and described the occurrence of loss of consciousness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna Covid vaccine with an associated reaction of loss of consciousness (experienced Incoordination, Weakness, Fall, Head injury with Moderna Covid vaccine).   On 25-JUN-2020, the patient received Shingrix (intramuscular) 50 ug. On 25-JUN-2020, 24 hrs after receiving Shingrix, the patient experienced loss of consciousness (Verbatim: possible loss of conciousness) (serious criteria GSK medically significant), incoordination (Verbatim: extreme uncoordination), weakness (Verbatim: weakness/too weak to get up) and fall (Verbatim: fall). On an unknown date, the patient experienced head injury (Verbatim: head injury). On 29-JUN-2020, the outcome of the loss of consciousness, weakness and fall were resolved with sequelae (duration 4 days) and the outcome of the incoordination was resolved with sequelae. The outcome of the head injury was not reported.   It was unknown if the reporter considered the loss of consciousness, incoordination, weakness, fall and head injury to be related to Shingrix.     It was unknown if the company considered the loss of consciousness, incoordination, weakness, fall and head injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2024 The patient self-reported this case. The patient received the Shingrix vaccine and 24 hours after vaccination she first time experienced dramatic symptoms like extreme uncoordination, weakness, fall, possible loss of consciousness and she felt too weak to get up at first. The patient also felt the same reaction with the Moderna Covid vaccine except that fall resulted in a head injury and ongoing symptoms. The patient's symptoms were not treated.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAR-2024 This case was reported by a patient's wife via interactive digital media. The reporter stated the patient got shingles from the vaccine.  The reporter did not want it and would not get the vaccine.  The reporter stated that he need to tell the truth. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Immunisation reaction
Clinical narrative: Hospitalization; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization 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 hospitalization (Verbatim: Hospitalization) (serious criteria hospitalization). The outcome of the hospitalization was not reported.   It was unknown if the reporter considered the hospitalization to be related to Arexvy.     It was unknown if the company considered the hospitalization to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was received from patient via interactive digital media. The patient had adverse reaction to this Vaccine and 21 days hospitalization.
Sex: U
Vaccine: RSV
Symptoms: Insomnia
Clinical narrative: countless night whith long hours without sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness 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 sleeplessness (Verbatim: countless night whith long hours without sleep). The outcome of the sleeplessness was not reported.   It was unknown if the reporter considered the sleeplessness to be related to Arexvy.     It was unknown if the company considered the sleeplessness to be related to Arexvy.   Additional Information: GSK receipt date: 21-MAR-2024 This case was reported by a patient via interactive digital media. The patient had countless night with long hours without sleep after receiving Arexvy. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that she had side effects for about 36 hours. Injection site pain was continuing at 48 hours. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat; Cough; Feel exhausted; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sore throat 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 sore throat (Verbatim: Sore throat), cough (Verbatim: Cough) and exhaustion (Verbatim: Feel exhausted). The outcome of the sore throat, cough and exhaustion were not reported.   It was unknown if the reporter considered the sore throat, cough and exhaustion to be related to Arexvy.     It was unknown if the company considered the sore throat, cough and exhaustion to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-Mar-2024 The patient received Arexvy vaccine and experienced sore throat, cough and felt exhausted. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Headache). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Arexvy.     It was unknown if the company considered the headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-Mar-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she received Arexvy vaccine and experienced headache. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pain in injection area; Joints pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain in injection area) and joint pain (Verbatim: Joints pain). The outcome of the injection site pain and joint pain were not reported.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site pain and joint pain to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAR-2024 This case was reported the patient via interactive digital media. The patient had pain in injection are and joints
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy liver, Computerised tomogram, Decreased appetite, Epstein-Barr virus infection reactivation
Clinical narrative: On or around August 30, 2021 I started feeling weak, low energy, my legs started to hurt, no appetite, extremely fatigued.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hepatic failure, Laboratory test, Liver function test increased, Pain in extremity
Clinical narrative: On or around August 30, 2021 I started feeling weak, low energy, my legs started to hurt, no appetite, extremely fatigued.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Bronchitis, Chills, Cough, Pain, Pyrexia
Clinical narrative: Bronchitis type cough, fever 100. degrees. chills, aches
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received two doses of Prevnar 20 with no reported side effects.  Original dose was given 10/21/2023 along with Fluzone HD.  A 2nd dose was given 3/8/2023.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: The patient stated she experienced numbing in her arm after the vaccine
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Neck pain, Pain
Clinical narrative: PAIN BEGAN DURING INJECTION THEN RADIATED UP TO SHOULDER AND NECK-SUBSIDED A LITTLE AFTER- THEN 2 HOURS LATER PAIN WAS ENOUGH TO PASS OUT- USESD ICE PACK , TYLENOL- INTENSE PAIN LASTED 24 HOURS, FOLLOWING DAY PAIN MANAGEBALE TO DO DAILY ACTIVITY-STILL SORENESS CANT SLEEP ON THAT ARM
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: PAIN BEGAN DURING INJECTION THEN RADIATED UP TO SHOULDER AND NECK-SUBSIDED A LITTLE AFTER- THEN 2 HOURS LATER PAIN WAS ENOUGH TO PASS OUT- USESD ICE PACK , TYLENOL- INTENSE PAIN LASTED 24 HOURS, FOLLOWING DAY PAIN MANAGEBALE TO DO DAILY ACTIVITY-STILL SORENESS CANT SLEEP ON THAT ARM
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Nodule, Tenderness
Clinical narrative: Nodule developed the day of injection and has not gone away in 2 weeks. I followed up with my doctor, who advised me that no treatment is needed unless I have concerns due to pain, swelling, or warmth. I haven't - it's been a benign lump that mildly hurts (no worse than a bruise) if I press on it. Googling it, I found that this is a rare adverse reaction and decided to report it.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Malaise, Pain, Pain in extremity
Clinical narrative: Redness at the puncture site. Fever, malaise, pain, swelling, and extreme pain in the ankle and heel of the left foot
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Redness at the puncture site. Fever, malaise, pain, swelling, and extreme pain in the ankle and heel of the left foot
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling to left arm by day 3
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Heart rate increased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Headache; Neck stiffness; Muscle pain; Elevated heartrate of 100-120 bpm while laying down; This non-serious case was reported by a other health professional via call center representative and described the occurrence of headache in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number Y9344, expiry date 31-JAN-2026) for prophylaxis.   Concurrent medical conditions included yeast infection and lactose intolerance.   On 06-MAR-2024, the patient received the 1st dose of Bexsero. On 06-MAR-2024, less than a day after receiving Bexsero, the patient experienced headache (Verbatim: Headache), stiff neck (Verbatim: Neck stiffness), muscle pain (Verbatim: Muscle pain) and heart rate increased (Verbatim: Elevated heartrate of 100-120 bpm while laying down). The outcome of the headache, stiff neck, muscle pain and heart rate increased were resolved.   It was unknown if the reporter considered the headache, stiff neck, muscle pain and heart rate increased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the headache, stiff neck, muscle pain and heart rate increased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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:19-MAR-2024 The reporter reported that a patient received Bexsero vaccine and where they could saw the ingredients to the vaccine, she had some allergies and reporter wants to confirm it was not through the vaccine administered. If the allergies to the vaccine then patient talk with the physician for the second dose. The patient states that there was a severe headache, neck stiffness, muscle pain in the area, but she had an elevated heartrate while laying down, she had allergies to celiac, yeast, and lactose. When asked when the symptoms started, the vaccine was recorded at 9:02am and the patient was picked up from the school at around 12pm. When asked how long they lasted, Wednesday, Thursday, Friday,each day with improvement, but they was making sure that the vaccine was not made with something had allergies to. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cyanosis, Diarrhoea, Gastrointestinal disorder, Headache
Clinical narrative: Developed a rash in both legs; rash presents with redness and white around it; bluishness in her thighs; started this morning with diarrhea and some bowel problems; body aches; headaches; chills; started this morning with diarrhea and some bowel problems; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAR-2024, the patient received the 1st dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Developed a rash in both legs), red rash (Verbatim: rash presents with redness and white around it), blue skin (Verbatim: bluishness in her thighs), diarrhea (Verbatim: started this morning with diarrhea and some bowel problems), general body pain (Verbatim: body aches), headache (Verbatim: headaches), chills (Verbatim: chills) and gastrointestinal disorder (Verbatim: started this morning with diarrhea and some bowel problems). The outcome of the rash and red rash were resolving and the outcome of the blue skin, diarrhea and gastrointestinal disorder were unknown and the outcome of the general body pain, headache and chills were not resolved.   It was unknown if the reporter considered the rash, red rash, blue skin, diarrhea, general body pain, headache, chills and gastrointestinal disorder to be related to Shingrix.   It was unknown if the company considered the rash, red rash, blue skin, diarrhea, general body pain, headache, chills and gastrointestinal disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2024 The reporter was a female patient who received first dose of Shingrix last Sunday i.e on 17th March 2024 and developed a rash in both legs, rash presents with redness and white around it, also bluishness in her thighs. The reporter reported that at the time of reporting the rash was faded away on that day and started in the morning with diarrhea and some bowel problems, the patient was also had headaches, chills, and body aches. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Developed a rash in both legs; rash presents with redness and white around it; bluishness in her thighs; started this morning with diarrhea and some bowel problems; body aches; headaches; chills; started this morning with diarrhea and some bowel problems; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAR-2024, the patient received the 1st dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Developed a rash in both legs), red rash (Verbatim: rash presents with redness and white around it), blue skin (Verbatim: bluishness in her thighs), diarrhea (Verbatim: started this morning with diarrhea and some bowel problems), general body pain (Verbatim: body aches), headache (Verbatim: headaches), chills (Verbatim: chills) and gastrointestinal disorder (Verbatim: started this morning with diarrhea and some bowel problems). The outcome of the rash and red rash were resolving and the outcome of the blue skin, diarrhea and gastrointestinal disorder were unknown and the outcome of the general body pain, headache and chills were not resolved.   It was unknown if the reporter considered the rash, red rash, blue skin, diarrhea, general body pain, headache, chills and gastrointestinal disorder to be related to Shingrix.   It was unknown if the company considered the rash, red rash, blue skin, diarrhea, general body pain, headache, chills and gastrointestinal disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2024 The reporter was a female patient who received first dose of Shingrix last Sunday i.e on 17th March 2024 and developed a rash in both legs, rash presents with redness and white around it, also bluishness in her thighs. The reporter reported that at the time of reporting the rash was faded away on that day and started in the morning with diarrhea and some bowel problems, the patient was also had headaches, chills, and body aches. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her first dose on August and the second dose on March.; 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 71-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on AUG-2023).   In MAR-2024, the patient received Twinrix. In MAR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: her first dose on August and the second dose on March.). The outcome of the drug dose administration interval too long 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: 20-MAR-2024 The pharmacists called wanting to know if there was information on having to restart the series of Twinrix or just getting the last dose of Twinrix on a patient who got her first dose in August and the second dose in March, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient was inadvertently administered a pediatric dose of Engerix instead of the adult dose; adult patient was inadvertently administered a pediatric dose of Engerix instead of the adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient was inadvertently administered a pediatric dose of Engerix instead of the adult dose) and underdose (Verbatim: adult patient was inadvertently administered a pediatric dose of Engerix instead of the adult dose). The outcome of the adult use of a child product and underdose 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: 20-MAR-2024 A nurse reported that an adult patient was inadvertently administered a pediatric dose of Engerix instead of the adult dose which led to Underdose and Adult use of a child product. The reporter wanted to know how to proceed.
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: unapproved age /potential underage use; Circumstance or information capable of leading; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included respiratory syncytial virus infection. Concurrent medical conditions included respiratory syncytial virus infection and asthma.   On an unknown date, the patient did not receive the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: unapproved age /potential underage use) and circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading). The outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK Receipt Date: 21-MAR -2024 The reporter called to report that the reporter had a patient that was under the age of 60, who was wondering about potentially getting the vaccination which led to Inappropriate age at vaccine administration and Circumstance or information capable of leading to medication error. The patient recently had Respiratory Syncytial Virus, and starting to get better and has a history of asthma. Potential AE but no vaccine was administered until the end of the call. The health care professional informed that a patient 56 years of age with history of asthma and RSV The reporter denied permission for consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Twinrix on 4 NOV2013 and they missed the second dose 1 month later; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 4th November 2013).   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 the first dose of Twinrix on 4 NOV2013 and they missed the second dose 1 month later). 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: 22-MAR-2024 The reporter explained a patient received the first dose of Twinrix on 4th November 2013 and they missed the second dose 1 month later, currently they wanted to get a late second dose. The reporter consented to follow up. Lot number and expiration date of the first Twinrix dose were unknown by the reporter. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Injection site pain, Therapeutic response decreased
Clinical narrative: sore arm and injection site; Immunity is low; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included crohn's disease. Concomitant products included hydrocortisone (Humera).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced injection site pain (Verbatim: sore arm and injection site) and therapeutic response decreased (Verbatim: Immunity is low). The outcome of the injection site pain and therapeutic response decreased were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 The patient self reporter the case and stated that he received 2 doses of Shingrix about 3 years ago.  The patient took a titer test and stated his immunity was low despite the patient received Shingrix 2 doses. (the second given within correct time frame 2 to 6 months). The patient stated he has a history of Crohn's disease and takes an autoimmune medication. The patient's health care professional recommend he gets another Shingrix vaccine but the patient called to ask questions. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Device leakage, Exposure via skin contact, Occupational exposure to product
Clinical narrative: vial leaked onto her fingers during the removal of the adjuvant with the syringe; Occupational exposure while preparing product for administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a female patient who received Herpes zoster (Shingrix) (batch number 3ZT24) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: vial leaked onto her fingers during the removal of the adjuvant with the syringe) and occupational exposure while preparing product for administration (Verbatim: Occupational exposure while preparing product for administration). The outcome of the exposure via skin contact and occupational exposure while preparing product for administration were unknown.   Additional Information: GSK receipt date: 20-MAR-2024 The reporter was the pharmacist who stated a Shingrix vial leaked onto her fingers during the removal of the adjuvant with the syringe, which led to occupational exposure while preparing product for administration and exposure via skin contact. This was found upon a call review.  No further information was available. Did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Bradycardia, Feeling hot, Heart rate, Loss of consciousness, Oral surgery
Clinical narrative: BRADYCARDIA; PASSED OUT; ORAL SURGERY; BODY BECAME VERY HOT ALL OVER; This spontaneous report received from a patient via J&J managed social media site concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  Non-company suspect drugs included: azithromycin (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, Patient's heart was doing just fine before patient had to choose the product for Covid protection. Patient choose the product because it was one and done. Patient thought the product would cause the least damage. Patient was wrong. Our government forced us to receive untested products without the full testing. No tests were done for interaction with other drugs. Patient had oral surgery (dose series 1) and the dentist recommended Azithromycin. Patient took one pill and had an adverse reaction. This was months after patient had the Covid-19 vaccine. Patient's body became very hot all over (dose series 1) and passed out (dose series 1). Patient noticed that heart rate was very slow after regained consciousness. Patient's doctor told that patient was suffering from bradycardia (dose series 1). Patient had a dual pacemaker installed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with azithromycin was not reported for all the events. The outcome of the bradycardia, passed out, oral surgery and body became very hot all over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Bradycardia and Loss of consciousness; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: acrylic taste on her tongue; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (acrylic taste on her tongue) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE [DULOXETINE HYDROCHLORIDE]), AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, MONTELUKAST, CYCLOBENZAPRINE, PIOGLITAZONE HYDROCHLORIDE, GLYBURIDE, ATORVASTATIN, RISPERIDONE (RISPERDAL M), CLONIDINE HYDROCHLORIDE (CLONIDINE [CLONIDINE HYDROCHLORIDE]), INSULIN GLARGINE (BASAGLAR) and INSULIN LISPRO (LISPRO INSULIN) for an unknown indication.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (acrylic taste on her tongue). At the time of the report, TASTE DISORDER (acrylic taste on her tongue) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient reported that she is not having cartilage in knees and also had mental health issue. No treatment information was reported.   This case was linked to MOD-2024-764311 (Patient Link).