chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-DEC-2023, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue). The outcome of the fatigue was resolved.   The reporter considered the fatigue to be related to Arexvy.     The company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-Dec-2023 The reporter reported that the patient received Arexvy vaccine and experienced fatigue. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Alpha 1 foetoprotein normal, Aspartate aminotransferase increased, Blood bilirubin, Hepatic failure
Clinical narrative: 2 weeks after second dose of Spikevax (11/03/2023) failing liver symptoms started to appear and greatly worsened after 3rd dose on 12/01/2023  (following CDC guidelines for the unvaccinated and immunosuppressed). Now on tapering doses of prednisone with significant improvement.
Age: 23.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pregnancy GA 36 weeks
Age: 64.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received the Covid 19 vaccine 5 days after the refrigeration expiration date
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Fatigue, Heart rate increased
Clinical narrative: At first I had regular expected symptoms such as soreness at the injection site, Covid like symptoms like fatigue, nausea, body aches, headaches but then I started getting an itchy rash all over my body including my face and it just kept getting worse. I am dealing with high heart rate and high blood pressure since. Now I feel tingling in my feet and hands when I try to lay down as well.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site pain, Magnetic resonance imaging, Nausea, Paraesthesia
Clinical narrative: At first I had regular expected symptoms such as soreness at the injection site, Covid like symptoms like fatigue, nausea, body aches, headaches but then I started getting an itchy rash all over my body including my face and it just kept getting worse. I am dealing with high heart rate and high blood pressure since. Now I feel tingling in my feet and hands when I try to lay down as well.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: At first I had regular expected symptoms such as soreness at the injection site, Covid like symptoms like fatigue, nausea, body aches, headaches but then I started getting an itchy rash all over my body including my face and it just kept getting worse. I am dealing with high heart rate and high blood pressure since. Now I feel tingling in my feet and hands when I try to lay down as well.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dizziness, Headache, Mobility decreased, Nasal congestion
Clinical narrative: Exactly 24 hrs after vaccine - very dizzy,  onset of intense clear nasal secretions dripping out of nose,  sneezing 3 times in a row repeatedly, achey all over, headache from sinus congestion. Exactly 36 hrs post vaccine nose secretions stop, then able to sleep. Now 48 hrs after vaccine still achey all over no temp but head feels warmer than typical.  Still weak, all I can do is lie on couch but I can read. Sinus stuffy, used afrin with some relief.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Rhinorrhoea, Sinus congestion, Skin warm, Sneezing
Clinical narrative: Exactly 24 hrs after vaccine - very dizzy,  onset of intense clear nasal secretions dripping out of nose,  sneezing 3 times in a row repeatedly, achey all over, headache from sinus congestion. Exactly 36 hrs post vaccine nose secretions stop, then able to sleep. Now 48 hrs after vaccine still achey all over no temp but head feels warmer than typical.  Still weak, all I can do is lie on couch but I can read. Sinus stuffy, used afrin with some relief.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Pt experienced a raised red rash (back, arm, stomach, sole of right foot), states the rash does not hurt, but does itch at times.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product expiration date issue
Clinical narrative: VACCINE EXPIRED 12/25, NOT MARKED IN SYSTEM AS HAVING CORRECT EXPIRATION DATE, SYSTEM STATES EX DATE IS 12/31/2024, VACCINE GIVEN.  NO ADVERSE REACTION FROM PATIENT OCCURED
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inflammation, Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: I got two vaccines yesterday: the Moderna Covid Vaccine and a flu shot. Instead of pain and swelling at the injection site, though, I?ve got swelling and pain on the inside of my left arm below my elbow.  I also have some inflammation at the site of an old injury: my lumbar back and my left hip.  These are far from serious side effects, but I wanted to report them nonetheless.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Arrhythmia, Arthralgia, Chest discomfort, Chest pain, Condition aggravated
Clinical narrative: He got his vaccine, had the normal arm soreness that started the following day.  Then the 2nd day it was more sore and then the 2nd or 3rd day had shoulder pain and elbow pain, arm soreness which he still has.  Then had tightness in his left chest where his heart is and chest pains that were sharp in his chest as well, palpitations very 1-2 minutes every day since.  You can see the pounding of his heart with the palpitations coming through the T-shirt.  If he is sitting in a chair his feet will jump off the ground with the strength of them.   He did have an EKG and the arrhythmias were off the charts.  He is waiting on the results of the Holter monitor results but thinks his PVC's are 6000-7000 and was told at Hospital that it's myocarditis.  He is taking more of his anti-arrhythmia medicines to see if that takes care of it, but his arm, shoulder and left elbow are still sore and inflamed, having a strong reaction to the vaccine.  He was told that they were not surprised by the reaction and they told him that they have been seeing a lot of it.   He had his other COVID vaccines with no problems at all.   He had a 48 hour Holter Monitor that he has not had the results from.  It was ventricular reactions, which is his heart condition as well, but were completely stable and under control.  His condition has PVC's, but the amount were 5-6 times of what they are usually, and all of a sudden that correlates with the vaccine.  He has never had palpitations like this before.  He is having hundreds all day, every day, at all times of the day and night and very strong like he has never had before.    He had the ICD already and was not overly concerned about sudden death, and they got him by his doctor due to the readings that they would see him first thing in the morning by his cardiologist.  His cardiologist is Dr at Hospital.  He got his flu shot at the same time in his right arm and then had a sore arm, but that went away after a day or so, and the left arm pain has continued.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory, Injection site inflammation, Myocarditis, Pain in extremity
Clinical narrative: He got his vaccine, had the normal arm soreness that started the following day.  Then the 2nd day it was more sore and then the 2nd or 3rd day had shoulder pain and elbow pain, arm soreness which he still has.  Then had tightness in his left chest where his heart is and chest pains that were sharp in his chest as well, palpitations very 1-2 minutes every day since.  You can see the pounding of his heart with the palpitations coming through the T-shirt.  If he is sitting in a chair his feet will jump off the ground with the strength of them.   He did have an EKG and the arrhythmias were off the charts.  He is waiting on the results of the Holter monitor results but thinks his PVC's are 6000-7000 and was told at Hospital that it's myocarditis.  He is taking more of his anti-arrhythmia medicines to see if that takes care of it, but his arm, shoulder and left elbow are still sore and inflamed, having a strong reaction to the vaccine.  He was told that they were not surprised by the reaction and they told him that they have been seeing a lot of it.   He had his other COVID vaccines with no problems at all.   He had a 48 hour Holter Monitor that he has not had the results from.  It was ventricular reactions, which is his heart condition as well, but were completely stable and under control.  His condition has PVC's, but the amount were 5-6 times of what they are usually, and all of a sudden that correlates with the vaccine.  He has never had palpitations like this before.  He is having hundreds all day, every day, at all times of the day and night and very strong like he has never had before.    He had the ICD already and was not overly concerned about sudden death, and they got him by his doctor due to the readings that they would see him first thing in the morning by his cardiologist.  His cardiologist is Dr at Hospital.  He got his flu shot at the same time in his right arm and then had a sore arm, but that went away after a day or so, and the left arm pain has continued.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: He got his vaccine, had the normal arm soreness that started the following day.  Then the 2nd day it was more sore and then the 2nd or 3rd day had shoulder pain and elbow pain, arm soreness which he still has.  Then had tightness in his left chest where his heart is and chest pains that were sharp in his chest as well, palpitations very 1-2 minutes every day since.  You can see the pounding of his heart with the palpitations coming through the T-shirt.  If he is sitting in a chair his feet will jump off the ground with the strength of them.   He did have an EKG and the arrhythmias were off the charts.  He is waiting on the results of the Holter monitor results but thinks his PVC's are 6000-7000 and was told at Hospital that it's myocarditis.  He is taking more of his anti-arrhythmia medicines to see if that takes care of it, but his arm, shoulder and left elbow are still sore and inflamed, having a strong reaction to the vaccine.  He was told that they were not surprised by the reaction and they told him that they have been seeing a lot of it.   He had his other COVID vaccines with no problems at all.   He had a 48 hour Holter Monitor that he has not had the results from.  It was ventricular reactions, which is his heart condition as well, but were completely stable and under control.  His condition has PVC's, but the amount were 5-6 times of what they are usually, and all of a sudden that correlates with the vaccine.  He has never had palpitations like this before.  He is having hundreds all day, every day, at all times of the day and night and very strong like he has never had before.    He had the ICD already and was not overly concerned about sudden death, and they got him by his doctor due to the readings that they would see him first thing in the morning by his cardiologist.  His cardiologist is Dr at Hospital.  He got his flu shot at the same time in his right arm and then had a sore arm, but that went away after a day or so, and the left arm pain has continued.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alanine aminotransferase increased, Alpha 1 foetoprotein normal, Aspartate aminotransferase increased, Blood bilirubin, Hepatic failure
Clinical narrative: 2 weeks after second dose of Spikevax, (11/03/2023) failing liver symptoms started to appear and greatly worsened after this 3rd dose on 12/01/2023 (following  CDC guidelines for unvaccinated and immunosuppressed). Now on tapering doses of prednisone with significant improvement.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave patient vaccine that had expired on 12/8/2023. No adverse reactions.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Tremor
Clinical narrative: Patient claims they were dizzy and shaking 6 days after getting the vaccine.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired COVID vaccine administered. Date on the box of medication marked
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given at an offsite clinic. Due to patient being allergic to eggs, Flublok was given by the floater pharmacist in charge of the clinic that day. However, the pharmacist did not realize patient was under 17 years old (Flublok is allowed for 18 years and older). Patient was not notified at the time of injection. Mistake was not found until today as the pharmacy was trying to process information for the patient so could receive her records. Called patient's father to explain the situation. Patient did not have any known ADE.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain of skin
Clinical narrative: Sensations of heat, stinging throughout the skin.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Continuous sharp pain in or underneath deltoid of left shoulder for two days, then sharp lesser pain in same location for 4 weeks when using that muscle or when resting on left side.  Discouraging use of that shoulder.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4, PNC20, RSV
Symptoms: Neck pain, Pain, Pain in extremity, X-ray normal
Clinical narrative: received 4 vaccines on 9/27/23, consistent arm pain since then, and now has travelled to her neck.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Adult formulation given to 18 year old instead of adolescent formulation
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization due to COVID
Age: 67.0
Sex: M
Vaccine: FLUA4, PNC20, RSV
Symptoms: Arthralgia, Laboratory test, Mobility decreased, Pain, Polymyalgia rheumatica
Clinical narrative: A few hours after receiving immunizations at Pharmacy, patient had swelling in his tongue-was instructed by pharmacist to take Benadryl-which cleared the issue. Next day had all over body aches and joint pain-could barely get out of bed. Seen in PCP office on 11/28 for body aches. Admitted to hospital 11/29-11/30, diagnosed with polymyalgia rheumatica and prescribed prednisone
Age: 67.0
Sex: M
Vaccine: FLUA4, PNC20, RSV
Symptoms: Swollen tongue
Clinical narrative: A few hours after receiving immunizations at Pharmacy, patient had swelling in his tongue-was instructed by pharmacist to take Benadryl-which cleared the issue. Next day had all over body aches and joint pain-could barely get out of bed. Seen in PCP office on 11/28 for body aches. Admitted to hospital 11/29-11/30, diagnosed with polymyalgia rheumatica and prescribed prednisone
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Unevaluable event
Clinical narrative: Unknown
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, COVID-19, Differential white blood cell count, Full blood count, Pain
Clinical narrative: Resident received the 2023-2024 Spikevax Moderna COVID vaccine on 11/17/23, he started experiencing a rash after administration. Initial assessment was possible Shingles, treated with Valtrex  500mg BID x 8 days total (11/17-11/25/23). No improvement noted with Valtrex. Topical creams applied for c/o itching (Hydrocortisone) and oral Benadryl given. Rash progressed over the past 6 weeks and is now blisters. Appears to be Bullous Pemphigoid an autoimmune response to the COVID vaccine and the spike protein in his system. The blisters affect all extremities and are painful and itch at times. Resident tested positive for COVID on 12/5/23 also.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pemphigoid antibody panel, Pruritus, Rash, SARS-CoV-2 test positive, Vitamin D
Clinical narrative: Resident received the 2023-2024 Spikevax Moderna COVID vaccine on 11/17/23, he started experiencing a rash after administration. Initial assessment was possible Shingles, treated with Valtrex  500mg BID x 8 days total (11/17-11/25/23). No improvement noted with Valtrex. Topical creams applied for c/o itching (Hydrocortisone) and oral Benadryl given. Rash progressed over the past 6 weeks and is now blisters. Appears to be Bullous Pemphigoid an autoimmune response to the COVID vaccine and the spike protein in his system. The blisters affect all extremities and are painful and itch at times. Resident tested positive for COVID on 12/5/23 also.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Sex: F
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: Itching all over; This non-serious case was reported by a consumer and described the occurrence of generalized pruritus in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease, depression and smoking cessation therapy. Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta), citalopram hydrobromide (Celexa) and bupropion hcl.   On 14-DEC-2023, the patient received Arexvy. On 15-DEC-2023, 1 days after receiving Arexvy, the patient experienced generalized pruritus (Verbatim: Itching all over). The outcome of the generalized pruritus was not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Arexvy.     It was unknown if the company considered the generalized pruritus to be related to Arexvy.   Additional Information: GSK receipt date: 18-DEC-2023 This report was submitted via the online direct entry reporting system. The reporter was the patient. The reporter wondered how long this symptom will last and how common it was (Itching all over)? The reporter wanted to know if anyone else had experienced the same symptoms. The reporter stated that the symptoms were treated. The reporter did not consent to follow up.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: No symptoms. Wife recently recovered from COVID, patient went to ER for other c/o's.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash that was generalized, itchy, and red. Last for months. now have the rash localized to feet bilaterally but improving.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Incorrect dose, this was from the pediatric stock
Age: 14.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urticaria
Clinical narrative: Hives to bilateral joints to arms and knees.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: no adverse reactions occurred
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse event. No treatment needed. Vaccine was given out of age range.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Flu zone High dose instead of regular dose. No outcome.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: PT DEVELOPED SOB AND ANAPHYLACTIC REACTION. NO HIVES OR ORAL SWELLING ADMINISTERED EPI PEN AND O2
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse event. NO treatment needed. Vaccine given out of age range.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt only reported having arm soreness at the injection site.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule
Clinical narrative: Nodule at injection site. Stated day after vaccination and has not improved after 3 weeks.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Wheezing
Clinical narrative: Employee received first dose of hepatitis vaccine although employee stated she had received previous dose in high school and did not experience reaction. Received dose at 1105 and felt fine at 1120 however over next 15 minutes felt very hot, lightheaded and states she was wheezing. No wheezing noted upon auscultation. vitals 126/66 pulse 72 rr 22
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy was given to client today per her request. Consent signed and vaccination given. Nurse looked client up to get her Medical Record for documentation and noticed that client had came in earlier that month for a COVID and RSV vaccination. Pt. was called and told she received another RSV today. Her first RSV vaccine was on 12/19/23. Pt. was told to call back or talk to her primary doctor if she is feeling any adverse reactions to vaccine.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Covid vaccine box had 2 expiration dates , and wrong date used.
Age: 15.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, Product label confusion
Clinical narrative: Covid vaccine box had 2 expiration dates, and the wrong date used.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Product expiration date issue
Clinical narrative: Covid vaccine box had 2 expiration dates and wrong date used.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: muscle aches/ Muscle pain is mostly in lower back; thigh muscle pain; Joints aches/pain is significant enough to make some ADL's a challenge; the pain is significant enough to make ADl challenge; This non-serious case was reported by a consumer and described the occurrence of muscular back pain in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 58160-848-11, expiry date DEC-2023) for prophylaxis.   Concomitant products included Multi Vitamins & Minerals and denosumab (Prolia).   On 27-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscular back pain (Verbatim: muscle aches/ Muscle pain is mostly in lower back), myalgia of lower extremities (Verbatim: thigh muscle pain), joint pain (Verbatim: Joints aches/pain is significant enough to make some ADL's a challenge) and activities of daily living impaired (Verbatim: the pain is significant enough to make ADl challenge). The outcome of the muscular back pain, myalgia of lower extremities and joint pain were not resolved and the outcome of the activities of daily living impaired was not reported.   It was unknown if the reporter considered the muscular back pain, myalgia of lower extremities, joint pain and activities of daily living impaired to be related to Arexvy.     It was unknown if the company considered the muscular back pain, myalgia of lower extremities, joint pain and activities of daily living impaired to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-DEC-2023 The reporter was a patient. The reporter reported that the joint aches move around with multiple sights hurting at the same time. Muscle pain is mostly in lower back and thighs.  The pain is significant enough to make some Activity of Daily Living a Challenge. Multiple joint and muscle aches. The reporter also reported that for osteoporosis the medicinal product taken are multi vitamins, calcium supplements and prolia. The reporter requested to consent the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: Skin pain abdomen lower back; This non-serious case was reported by a consumer and described the occurrence of skin pain in a 64-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included esomeprazole magnesium (Nexium).   On 12-NOV-2023, the patient received Shingles vaccine. On 12-DEC-2023, 30 days after receiving Shingles vaccine, the patient experienced skin pain (Verbatim: Skin pain abdomen lower back). The outcome of the skin pain was not resolved.   The reporter considered the skin pain to be possibly related to Shingles vaccine.     The company considered the skin pain to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-DEC-2023 The reporter was a patient. The reporter went to his physician his quess was skin pain no blistering was the result of the vaccine the patient received 6 weeks ago. He lived in pain for 4 weeks to see if it goes away. This was terrible skin pain abdomen lower back. The reporter requested to consent the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis of arm; This non-serious case was reported by a consumer and described the occurrence of cellulitis of arm in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-DEC-2023, the patient received Shingrix. On 21-DEC-2023, 2 days after receiving Shingrix, the patient experienced cellulitis of arm (Verbatim: Cellulitis of arm). The patient was treated with antibiotics. On 22-DEC-2023, the outcome of the cellulitis of arm was resolved.   It was unknown if the reporter considered the cellulitis of arm to be related to Shingrix.     It was unknown if the company considered the cellulitis of arm to be related to Shingrix.   Additional Information: GSK receipt date: 23-DEC-2023 The patient self-reported this case. The reporter stated that she did not had to visit the ER (emergency room) or the hospital, she stated she go to the urgent care and had just started a course of antibiotics and the symptoms were treated. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Headache it is for me; 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 it is for me). 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: 21-DEC-2023 This non-serious case was reported by a consumer via (Open field AE monitoring)interactive digital media. The patient was received the Arexvy  vaccine and experienced headache.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeding disorder, Malaise, Mobility decreased
Clinical narrative: has not been able to move for the past few days; she is not feeling good; Mucus; Weakness; Chills; Unable to eat; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (1st dose received on September 2023).   In DEC-2023, the patient received the 2nd dose of Shingles vaccine. In DEC-2023, less than a week after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: has not been able to move for the past few days), feeling unwell (Verbatim: she is not feeling good), mucus discharge (Verbatim: Mucus), weakness (Verbatim: Weakness), chills (Verbatim: Chills) and unable to eat (Verbatim: Unable to eat). The outcome of the mobility decreased, feeling unwell and unable to eat were resolving and the outcome of the mucus discharge, weakness and chills were not resolved.   It was unknown if the reporter considered the mobility decreased, feeling unwell, mucus discharge, weakness, chills and unable to eat to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased, feeling unwell, mucus discharge, weakness, chills and unable to eat to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-Dec-2023 The patient was self-reported this case. The patient reported that she received her Shingles and Pneumonia vaccine about 4 days ago. The reporter stated that she was not feeling good at all and had not been able to move for the past few days.  The patient stated that today was the first day that she felt a little better and was able to move around and eat breakfast. The patient had been experiencing mucus, weakness, chills and she was unable to eat.  The patient stated that she knows from these vaccines that flu like symptoms may be experienced but what she was experienced was worse than that. The patient was supposed to start her first dose of Cosentyx 300mg/mL today on 8th December 2023. She was going to be taking the medication weekly.  The patient stated that she knows there are some side effects taking Cosentyx while having received live vaccines and feeling sick and therefore wanted further information as to if there was a specific time frame that with her healthcare professional regarding a specific timeframe needed between Cosentyx and the Shingles and Pneumonia vaccine. It was unknown if the reporter considered the feeling unwell, immobile, mucus discharge, weakness, chills and unable to eat to be related to Pneumonia vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Secretion discharge
Clinical narrative: has not been able to move for the past few days; she is not feeling good; Mucus; Weakness; Chills; Unable to eat; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (1st dose received on September 2023).   In DEC-2023, the patient received the 2nd dose of Shingles vaccine. In DEC-2023, less than a week after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: has not been able to move for the past few days), feeling unwell (Verbatim: she is not feeling good), mucus discharge (Verbatim: Mucus), weakness (Verbatim: Weakness), chills (Verbatim: Chills) and unable to eat (Verbatim: Unable to eat). The outcome of the mobility decreased, feeling unwell and unable to eat were resolving and the outcome of the mucus discharge, weakness and chills were not resolved.   It was unknown if the reporter considered the mobility decreased, feeling unwell, mucus discharge, weakness, chills and unable to eat to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased, feeling unwell, mucus discharge, weakness, chills and unable to eat to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-Dec-2023 The patient was self-reported this case. The patient reported that she received her Shingles and Pneumonia vaccine about 4 days ago. The reporter stated that she was not feeling good at all and had not been able to move for the past few days.  The patient stated that today was the first day that she felt a little better and was able to move around and eat breakfast. The patient had been experiencing mucus, weakness, chills and she was unable to eat.  The patient stated that she knows from these vaccines that flu like symptoms may be experienced but what she was experienced was worse than that. The patient was supposed to start her first dose of Cosentyx 300mg/mL today on 8th December 2023. She was going to be taking the medication weekly.  The patient stated that she knows there are some side effects taking Cosentyx while having received live vaccines and feeling sick and therefore wanted further information as to if there was a specific time frame that with her healthcare professional regarding a specific timeframe needed between Cosentyx and the Shingles and Pneumonia vaccine. It was unknown if the reporter considered the feeling unwell, immobile, mucus discharge, weakness, chills and unable to eat to be related to Pneumonia vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: reports redness at the injection site that extended from his deltoid to his elbow; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: reports redness at the injection site that extended from his deltoid to his elbow). The outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK receipt date 8th Dec 2023: The reporter was the patient.  The patient reported that getting the first SHINGRIX vaccine at the end of August 2023, the patient had redness at the injection site that extended from his deltoid to his elbow. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: the administration of two doses of Arexvy given a month apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number RX74B, expiry date 22-FEB-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 11-DEC-2023, the patient received the 2nd dose of Arexvy. On 11-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: the administration of two doses of Arexvy given a month apart). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2023 The reporter called to ask for information regarding the administration of two doses of Arexvy given a month apart, which led to extra dose administered. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received at age 1 year 4 month and 3rd at 1 year 7 month; 1st dose received at age 8 months and 2nd dose at age 1 year 4 month; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (1st dose received at the age of 8 months).   On an unknown date, the patient received the 3rd dose of Pediarix and the 2nd dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix and not applicable after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received at age 1 year 4 month and 3rd at 1 year 7 month) and drug dose administration interval too long (Verbatim: 1st dose received at age 8 months and 2nd dose at age 1 year 4 month). The outcome of the drug dose administration interval too long and drug dose administration interval too long 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: 18-Dec-2023 The reporter reported that the patient received 3 doses of Pediarix at 8 months, 1 year and 4 months and 1 year and 7 months.  The reporter stated that then the patient received a Dtap vaccine alone from other manufacture. The reporter was trying to figure out which TDap vaccine can be administer to an 8 year old male patient. The patient received 2nd dose and 3rd dose of Pediarix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: the administration of a second dose during the same influenza season; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 30-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number DC49G, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Flulaval quadrivalent).   On 18-DEC-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 18-DEC-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: the administration of a second dose during the same influenza season). The outcome of the extra dose administered 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: 18-DEC-2023 The reporter inquired about Flulaval and what information was available about the administration of a second dose during the same influenza season, which led to extra dose administered. The partial information about event, vaccine and patients was provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: The child experience swelling around the right arm injection site; The child experienced redness around the right arm injection site; Right Arm Soreness; 4 year old patient received Meningococcal B vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 4-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 14-DEC-2023, the patient received Meningococcal B vaccine (right arm). On 14-DEC-2023, an unknown time after receiving Meningococcal B vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 year old patient received Meningococcal B vaccine). On 15-DEC-2023, the patient experienced injection site swelling (Verbatim: The child experience swelling around the right arm injection site), injection site erythema (Verbatim: The child experienced redness around the right arm injection site) and pain in arm (Verbatim: Right Arm Soreness). On 18-DEC-2023, the outcome of the injection site swelling, injection site erythema and pain in arm were resolved (duration 3 days). The outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and pain in arm to be related to Meningococcal B vaccine.     It was unknown if the company considered the injection site swelling, injection site erythema and pain in arm to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt Date: 18-DEC-2023 The MoP reported that her 4 year old daughter was administered a dose of meningicoccal B vaccine on 14-Dec-2023 in her right arm., which led to inappropriate age at vaccine administration. The patient experienced soreness and redness and swelling around the right arm injection site beginning 15-Dec-2023, which resolved 18-Dec-2023.  The reporter did not had product lot number information. She was not sure of the brand name of the vaccine, but her provider's office gave her GSK phone number she believes it was GSK product (Bexsero). The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the 2nd dose of the series yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on november 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received the 2nd dose of the series yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The pharmacist reported that a patient had not received the 2nd dose of the series yet. Age was not specified for the patient, when asked, reporter said that the patient was over 60 years old. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Soreness at injection site; pinkish rash at the injection site; pinkish rash at the injection site; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In DEC-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site), injection site rash (Verbatim: pinkish rash at the injection site) and injection site erythema (Verbatim: pinkish rash at the injection site). The outcome of the injection site pain, injection site rash and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site rash and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site rash and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-DEC-2023 The patient self reported this case. The patient received Shingrix vaccine at a local pharmacy. The patient reported soreness at the injection site, a pinkish rash at the injection site and rash was 7 inches long and 3 to 4 inches wide. The patient reported that neither events had resolved. Not all information was available. Patient disconnected abruptly without providing full demographics and email address. Patient was called back but was not available. Left voice mail to contact GSK at their earliest convenience. Patient had given consent to follow up with healthcare professional (HCP) but information was not provided before call disconnected. The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 36 yr old patient received a pediatric dose of Havrix; 36 yr old patient received a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 36-year-old male patient who received HAV (Havrix 720) (batch number BR2GD, expiry date 16-MAY-2025) for prophylaxis.   On 21-DEC-2023, the patient received the 1st dose of Havrix 720. On 21-DEC-2023, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: 36 yr old patient received a pediatric dose of Havrix) and adult use of a child product (Verbatim: 36 yr old patient received a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product 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: 21-DEC-2023 The other health professional reported that the adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up via postal.
Sex: U
Vaccine: FLU3
Symptoms: Sinusitis
Clinical narrative: Sinusitis; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of sinusitis in a patient who received Flu Seasonal TIV Dresden (Fluarix 2014-2015 season) for prophylaxis.   On an unknown date, the patient received Fluarix 2014-2015 season. On an unknown date, an unknown time after receiving Fluarix 2014-2015 season, the patient experienced sinusitis (Verbatim: Sinusitis). The outcome of the sinusitis was unknown.   It was unknown if the reporter considered the sinusitis to be related to Fluarix 2014-2015 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the sinusitis to be related to Fluarix 2014-2015 season and Fluarix Tetra 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: 22-DEC-2023 The patient developed an reaction to a 2014 Fluarix. The pharmacist called to inquire about the information in comparison of components in Fluarix and Arexvy. The reporter also wants to know if any components changed from the Fluarix current 2023 vaccine vs the Fluarix 2014 vaccine. The reporter was unable to provide any vaccine or patient details for adverse event. The reporter did not consent to follow-up.