chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Language disorder, Magnetic resonance imaging, Medical procedure, Scan abnormal
Clinical narrative: He got his vaccine, he did not have any immediate response to the vaccine.  Then 10 days later he was in the shower and he kind of felt that he was going to pass, and he went to the bed.  His wife asked if he was alright and he said yes, was asking weird and called some of her healthcare providers that she works with who told her to take him to the ER.  As soon as he went to the ER he was asked his name, which he did not resopnd to as he did not know it.  Then he was worked up for a stroke protocol with an MRI, CT scan, and had to stay in the hospital over night and was discharged the next day.  He was told what part of the brain that it impacted, and he was diagnosed with a TIA.  He also had a heart scan and it looked and determined that he had a PFO.  He has never been diagnosed with a PFO in his entire life.  Never had a problem with running, breathing and that's why he eluded to the fact that the COVID vaccine caused an inflammation of his heart and caused it.  He spoke with his cardiologist.  He read a report from Health Authority that there was a hypothesis in the artical - associated stroke and COVID 19 vaccination.  Afterwards as at the hospital he saw a Cardiology PA and told him that he did not have to close the PFO unless he has another incidence then they would probably close it up.  He was then stationed in Cardiology that he was told that it was supposed to be closed right away.  In June of 2021 he had a PFO closure in his heart.  Gore Cardioform Septal occluder on 6/22/22, and cardiothoracic surgeon was Dr.  Since then he has not had the closure compelted, and has had a bubble study that showed a small hole and still has a little bit coming through, significantly then without it.  When he had his stroke he had a problem with language problem, and had to relearn of language skills, synonyms, and things of that nature.  For some odd reason he does not like to write, and some of the other issues when he is writing he does not know if it's a question or not, he has to reread the question to see what it was to answer it and review it.   He had all kinds of tests to determine what had caused it but he feels it was related to the vaccine that he had 10 days prior to the stroke.   His wife had to buy flash cards to get him to recognize what things were.  He feels it has impacted his speech function and wanting to communicate with higher levels of the employer and is delayed and uses one of lesser meaning.  He has four degrees, 2 bachelors and 2 masters so this has affected his brain functions.   He just wants people to be aware if they have a PFO that they could have this reaction, and educate them on perhaps potential reactions.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Transient ischaemic attack, Unresponsive to stimuli
Clinical narrative: He got his vaccine, he did not have any immediate response to the vaccine.  Then 10 days later he was in the shower and he kind of felt that he was going to pass, and he went to the bed.  His wife asked if he was alright and he said yes, was asking weird and called some of her healthcare providers that she works with who told her to take him to the ER.  As soon as he went to the ER he was asked his name, which he did not resopnd to as he did not know it.  Then he was worked up for a stroke protocol with an MRI, CT scan, and had to stay in the hospital over night and was discharged the next day.  He was told what part of the brain that it impacted, and he was diagnosed with a TIA.  He also had a heart scan and it looked and determined that he had a PFO.  He has never been diagnosed with a PFO in his entire life.  Never had a problem with running, breathing and that's why he eluded to the fact that the COVID vaccine caused an inflammation of his heart and caused it.  He spoke with his cardiologist.  He read a report from Health Authority that there was a hypothesis in the artical - associated stroke and COVID 19 vaccination.  Afterwards as at the hospital he saw a Cardiology PA and told him that he did not have to close the PFO unless he has another incidence then they would probably close it up.  He was then stationed in Cardiology that he was told that it was supposed to be closed right away.  In June of 2021 he had a PFO closure in his heart.  Gore Cardioform Septal occluder on 6/22/22, and cardiothoracic surgeon was Dr.  Since then he has not had the closure compelted, and has had a bubble study that showed a small hole and still has a little bit coming through, significantly then without it.  When he had his stroke he had a problem with language problem, and had to relearn of language skills, synonyms, and things of that nature.  For some odd reason he does not like to write, and some of the other issues when he is writing he does not know if it's a question or not, he has to reread the question to see what it was to answer it and review it.   He had all kinds of tests to determine what had caused it but he feels it was related to the vaccine that he had 10 days prior to the stroke.   His wife had to buy flash cards to get him to recognize what things were.  He feels it has impacted his speech function and wanting to communicate with higher levels of the employer and is delayed and uses one of lesser meaning.  He has four degrees, 2 bachelors and 2 masters so this has affected his brain functions.   He just wants people to be aware if they have a PFO that they could have this reaction, and educate them on perhaps potential reactions.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was meant for IM injection but was administered subcutaneously
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone normal, Chest pain, Dysstasia, Full blood count normal, Headache
Clinical narrative: Shingrix here 8/8 reaction started that evening. Symptoms: headache on the top of the head, whole body pain especially back/hunching, could not stand straight, high fever, pain in the thoracic spine area with breathing "lung area", chest and torso pain, pelvic pain came back. Better after a week. Now: mild "lung area" thoracic back pain Occasional prickly pain on her legs and buttocks Occasional suprapubic ache, mostly when waking up (sleeps on her side).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Pain, Painful respiration, Pelvic pain, Pyrexia
Clinical narrative: Shingrix here 8/8 reaction started that evening. Symptoms: headache on the top of the head, whole body pain especially back/hunching, could not stand straight, high fever, pain in the thoracic spine area with breathing "lung area", chest and torso pain, pelvic pain came back. Better after a week. Now: mild "lung area" thoracic back pain Occasional prickly pain on her legs and buttocks Occasional suprapubic ache, mostly when waking up (sleeps on her side).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain, Suprapubic pain, Vitamin B12 normal
Clinical narrative: Shingrix here 8/8 reaction started that evening. Symptoms: headache on the top of the head, whole body pain especially back/hunching, could not stand straight, high fever, pain in the thoracic spine area with breathing "lung area", chest and torso pain, pelvic pain came back. Better after a week. Now: mild "lung area" thoracic back pain Occasional prickly pain on her legs and buttocks Occasional suprapubic ache, mostly when waking up (sleeps on her side).
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: large red spot, warm, knot, cold compress, ibuprofen
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC20, RV5
Symptoms: Extra dose administered
Clinical narrative: PATIENT WAS GIVEN 2 HIB VACCINES.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Eye irritation, Eye swelling
Clinical narrative: Swollen eye lids, burning eyes, hoarse throat.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: requested arexvy but received shingrix- no adverse events were reported from cutomer
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: patient fainted shortly after vaccine administration, a few minutes afterwards. Patient was attended to by her mother and a staff pharmacist. She fainted for less than a minute, she was given water, an ice pack and was observed in the pharmacy waiting area for 15 minutes after. After such a time she was released and her mother took her home.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Tdap vaccine was ordered in chart by NP and Dtap vaccine was erroneously pulled by machine and given instead. MA reported error to supervisor. Pt's mother notified. No side effects reported.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive arexvy and received Shingrix. No adverse event
Age: 29.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site swelling
Clinical narrative: ONGOING INJECTION SITE SWELLING (13 DAYS)
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: One week later still has soreness, redness and warm to touch on injection site/arm.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pt given havrix 720 should have received havrix 1440, dosing error no adverse effect
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pt given havrix 720, should have gotten havrix 1440  dosing error no adverse effects
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Decreased appetite, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fever, decreased appetite, severe left arm swelling, redness, warmth, pain. Actually injection site was intact, adverse reaction was below to elbow of left arm.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: fever, decreased appetite, severe left arm swelling, redness, warmth, pain. Actually injection site was intact, adverse reaction was below to elbow of left arm.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood glucose normal, Blood test normal, Dizziness, Dyspnoea
Clinical narrative: Within seconds of injection, sudden and severe onset. Throat closed up, difficulty breathing, nausea, dizziness, and total body skin flushing (red/purple). Presumed anaphylaxis. Epi-pen was given and symptoms improved rapidly. Given benadryl in ambulance/hospital. Monitored for several hours before discharge,  prescribed two Epi-pens and instructed to follow-up with PCP and allergist, potentially cardiologist.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram QT prolonged, Electrocardiogram abnormal, Flushing, Nausea, Throat tightness
Clinical narrative: Within seconds of injection, sudden and severe onset. Throat closed up, difficulty breathing, nausea, dizziness, and total body skin flushing (red/purple). Presumed anaphylaxis. Epi-pen was given and symptoms improved rapidly. Given benadryl in ambulance/hospital. Monitored for several hours before discharge,  prescribed two Epi-pens and instructed to follow-up with PCP and allergist, potentially cardiologist.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Within seconds of injection, sudden and severe onset. Throat closed up, difficulty breathing, nausea, dizziness, and total body skin flushing (red/purple). Presumed anaphylaxis. Epi-pen was given and symptoms improved rapidly. Given benadryl in ambulance/hospital. Monitored for several hours before discharge,  prescribed two Epi-pens and instructed to follow-up with PCP and allergist, potentially cardiologist.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Erythema, Immunoglobulin therapy, Oral mucosal blistering, Platelet count decreased
Clinical narrative: 1 WEEK AFTER THE VACCINE, PATIENT NOTICED BRUISES ALL OVER HER BODY AND BLISTERS  IN HER MOUTH AND RED SPOTS ON HER LEGS. SHE WENT TO HER PRIMARY WHO TOOK HER BLOOD WORK AND HER PLATELETS WERE 4000. SHE WAS ADVISED TO GO TO THE EMERGENCY ROOM. THEY GAVE HER A TRANSFUSION HER PLATELETS WERE AT 3000. THEY GAVE HER DEXAMETHASONE SHOTS AND IMMUNE GLOBULIN INJECTIONS. THEN THE PLATELETS WENT UP AND IN THE MORNING THEY WERE BACK UP TO 35,000. SHE RECEIVED THE SAME TREATMENT DAY 2 AND LET HER GO HOME. THEN SHE PICKED UP 2 MORE DAYS WORTH OF DEXAMETHASONE FROM THE PHARMACY AT 40MG A DAY DOSING. NOW ALL THE LAB WORK IS NORMAL. THEY ARE CALLING THIS DRUG INDUCED THROMBOCYTOPENIA .
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Platelet transfusion, Thrombocytopenia
Clinical narrative: 1 WEEK AFTER THE VACCINE, PATIENT NOTICED BRUISES ALL OVER HER BODY AND BLISTERS  IN HER MOUTH AND RED SPOTS ON HER LEGS. SHE WENT TO HER PRIMARY WHO TOOK HER BLOOD WORK AND HER PLATELETS WERE 4000. SHE WAS ADVISED TO GO TO THE EMERGENCY ROOM. THEY GAVE HER A TRANSFUSION HER PLATELETS WERE AT 3000. THEY GAVE HER DEXAMETHASONE SHOTS AND IMMUNE GLOBULIN INJECTIONS. THEN THE PLATELETS WENT UP AND IN THE MORNING THEY WERE BACK UP TO 35,000. SHE RECEIVED THE SAME TREATMENT DAY 2 AND LET HER GO HOME. THEN SHE PICKED UP 2 MORE DAYS WORTH OF DEXAMETHASONE FROM THE PHARMACY AT 40MG A DAY DOSING. NOW ALL THE LAB WORK IS NORMAL. THEY ARE CALLING THIS DRUG INDUCED THROMBOCYTOPENIA .
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diplegia, Gait inability, Guillain-Barre syndrome, Vascular graft
Clinical narrative: As patient's daughter reported, her Dad (Patient) had a triple bypass surgery, and 2 days later he developed Guillain-Barre syndrome which was thought to be linked with his COVID vaccination. She said that her dad is not able to walk since February 2024 as he got paralyzed from waist down.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: patient states she had a fever in the evening around bedtime and she took tylenol to help treat. In the morning her temp was 98.2F. Patient states her arm was sore and she felt tired. Per consult with patient, states no difficulty breathing, no swelling/inflammation, no dizziness, no paleness, no headache. The next morning she felt better but was still a bit tired for a total of about 32 hours post vaccine administration.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient was at the state fair and fainted at approximately 1630. Per father of patient, EMT evaluated her and her vital signs were stable. She felt no symptoms afterwards.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No side effects; a patient potentially received GARDASIL 9 instead of PREVNAR 20; This spontaneous report was received from a health care professional and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 06-AUG-2024, the patient potentially received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1965045 has been verified to be a valid lot number, expiration date reported and also upon internal validation established as 19-JAN-2026) for prophylaxis (dose, strength, and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (wrong product administered). No side effects were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Skin mass, Vaccination failure
Clinical narrative: Suspected vaccination failure/ I had the vaccine and still got them; I had the vaccine and still got them; And I itch really bad; still have the lumps and bumps under the skin on my arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: Suspected vaccination failure/ I had the vaccine and still got them) (serious criteria GSK medically significant), shingles (Verbatim: I had the vaccine and still got them), pruritus (Verbatim: And I itch really bad) and local swelling (Verbatim: still have the lumps and bumps under the skin on my arm). The outcome of the vaccination failure, shingles and pruritus were not reported and the outcome of the local swelling was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and local swelling to be related to Shingles vaccine.   The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, pruritus and local swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-AUG-2024 The case was received from the patient via (social media) interactive digital media. The patient had the vaccine and still got them. The patient reported that yes he/she did, 5 months for him/her. The patient had itch really bad. The patient still had the lumps and bumps under the skin on his/her arm. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset ) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Rash
Clinical narrative: chills; fever; small rash; the site of the shot started burning and hurting a lot; This non-serious case was reported by a consumer and described the occurrence of injection site burning in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, 9 hrs after receiving Shingrix, the patient experienced injection site burning (Verbatim: the site of the shot started burning and hurting a lot). On an unknown date, the patient experienced chills (Verbatim: chills), fever (Verbatim: fever) and rash (Verbatim: small rash). The outcome of the injection site burning, chills, fever and rash were not reported.   It was unknown if the reporter considered the injection site burning, chills, fever and rash to be related to Shingrix.     It was unknown if the company considered the injection site burning, chills, fever and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-AUG-2024 The patient received 2nd dose of Shingrix and at first it was fine, but after approximately 9 hours, the site of the shot started burning and hurting a lot. Then started getting chills, a 102-degree fever and a small rash.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: I got the shingles right after I got the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got the shingles right after I got the vaccine). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-AUG-2024 This case was reported by the patient via interactive digital media. The patient got the shingles right after he/she got the shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Feeling hot, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: arm was swollen; arm painful; arm was hot; muscle aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of peripheral swelling (On an unknown date, the patient received 1st dose, for the tolerance of previous dose refer case - US2024AMR105646).   On 21-AUG-2024, the patient received the 2nd dose of Shingles vaccine. On 22-AUG-2024, 1 days after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: arm was swollen), pain in arm (Verbatim: arm painful), extremities hot feeling of (Verbatim: arm was hot) and muscle pain (Verbatim: muscle aches). The patient was treated with paracetamol (Tylenol). Rechallenge with Shingles vaccine was positive. The outcome of the swelling arm, pain in arm, extremities hot feeling of and muscle pain were not resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, extremities hot feeling of and muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm, pain in arm, extremities hot feeling of and muscle pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR105646   Additional Information: GSK Receipt Date: 22-AUG-2024 This case was reported by the patient via interactive digital media. The patient received a 2nd dose of the Shingles vaccine and got up this morning with swollen arm, hot and painful. The patient had muscle aches from back to the top of legs. The patient took Tylenol 3 times on the day of reporting but it didn't help until the second dose. The reporter further stated that he/she was thankful to have gotten this vaccine. The stories he/she has heard were horrible.; Sender's Comments:  US-GSK-US2024AMR105646:SECOND DOSE
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red Rings; itched all over her body; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of red rash in a elderly female patient who received Herpes zoster (Shingrix) (batch number 559T9, expiry date 09-JUN-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced red rash (Verbatim: Red Rings) and generalized pruritus (Verbatim: itched all over her body). The outcome of the red rash and generalized pruritus were resolved.   It was unknown if the reporter considered the red rash and generalized pruritus to be related to Shingrix.     It was unknown if the company considered the red rash and generalized pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 19-AUG-2024  An HCP reported that a patient was in the pharmacy for her second dose of vaccine. States that patient reports 2 days after receiving first dose of suspect vaccine she had two inch red rings that itched all over her body.  Red rings and itch resolved in approximately a week and a half.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; muscle aches; joint pain; headache; back hurt; that even her fingers and back hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-AUG-2024, the patient received Arexvy (right arm). In AUG-2024, an unknown time after receiving Arexvy, the patient experienced back pain (Verbatim: back hurt) and pain in fingers (Verbatim: that even her fingers and back hurt). On 17-AUG-2024, the patient experienced fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle aches), joint pain (Verbatim: joint pain) and headache (Verbatim: headache). The outcome of the fatigue, muscle pain, joint pain, headache, back pain and pain in fingers were resolved.   It was unknown if the reporter considered the fatigue, muscle pain, joint pain, headache, back pain and pain in fingers to be related to Arexvy.     It was unknown if the company considered the fatigue, muscle pain, joint pain, headache, back pain and pain in fingers to be related to Arexvy.   Additional Information: GSK Receipt date: 20-AUG-2024  The patient self-reported. She was vaccinated with the RSV vaccine (unsure which manufacturer) on 12-AUG-2024 and she stated that on 17-AUG-2024 she began to experience a headache, joint pain, muscle aches and fatigue. She stated that even her fingers and back hurt, these adverse events lasted for approximately 3 days before she started to feel better.
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: fatigue; muscle aches; joint pain; headache; back hurt; that even her fingers and back hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-AUG-2024, the patient received Arexvy (right arm). In AUG-2024, an unknown time after receiving Arexvy, the patient experienced back pain (Verbatim: back hurt) and pain in fingers (Verbatim: that even her fingers and back hurt). On 17-AUG-2024, the patient experienced fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle aches), joint pain (Verbatim: joint pain) and headache (Verbatim: headache). The outcome of the fatigue, muscle pain, joint pain, headache, back pain and pain in fingers were resolved.   It was unknown if the reporter considered the fatigue, muscle pain, joint pain, headache, back pain and pain in fingers to be related to Arexvy.     It was unknown if the company considered the fatigue, muscle pain, joint pain, headache, back pain and pain in fingers to be related to Arexvy.   Additional Information: GSK Receipt date: 20-AUG-2024  The patient self-reported. She was vaccinated with the RSV vaccine (unsure which manufacturer) on 12-AUG-2024 and she stated that on 17-AUG-2024 she began to experience a headache, joint pain, muscle aches and fatigue. She stated that even her fingers and back hurt, these adverse events lasted for approximately 3 days before she started to feel better.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: A 48 years old male patient received a pediatric dose of Engerix-B.; A 48 years old male patient received a pediatric dose of Engerix-B.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 48-year-old male patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of 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: A 48 years old male patient received a pediatric dose of Engerix-B.) and underdose (Verbatim: A 48 years old male patient received a pediatric dose of Engerix-B.). 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-AUG-2024 The pharmacist called and reported that they administered a pediatric dose of Engerix-B to the patient of an inappropriate age, which led to adult use of a child product and underdose. This was the first dose of the patient.  The pharmacist asked what to do next.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chapped lips, Headache, Injection site pain
Clinical narrative: general aches and pains; slight fever; headache; pain at the injection site; feel weak; felt like COVID symptoms; stomach hurting and nausea; lips chapped; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-AUG-2024, the patient received the 2nd dose of Shingrix (left arm). In AUG-2024, an unknown time after receiving Shingrix, the patient experienced feelings of weakness (Verbatim: feel weak), suspected covid-19 (Verbatim: felt like COVID symptoms), stomach pain (Verbatim: stomach hurting and nausea), chapped lips (Verbatim: lips chapped) and nausea (Verbatim: nausea). On 17-AUG-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), general body pain (Verbatim: general aches and pains), fever (Verbatim: slight fever) and headache (Verbatim: headache). The patient was treated with mefenamic acid (Advil). The outcome of the injection site pain was resolved and the outcome of the feelings of weakness was not resolved and the outcome of the suspected covid-19, general body pain, fever, headache, stomach pain, chapped lips and nausea were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, feelings of weakness, suspected covid-19, general body pain, fever, headache, stomach pain, chapped lips and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, feelings of weakness, suspected covid-19, general body pain, fever, headache, stomach pain, chapped lips and nausea to be related to Shingrix.   Additional Information: GSK Receipt date: 20-AUG-2024  The patient self-reported. She received Shingrix dose 2 on Saturday 17 August 2024 in left arm and she stated Saturday evening she experienced pain at injection site, aches and pains, headache and a slight fever. She took Advil Saturday night and Sunday and stated she felt weak and her lips chapped and stomach hurting with nausea.  She stated she was feeling better except that she was still feeling weak.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: general aches and pains; slight fever; headache; pain at the injection site; feel weak; felt like COVID symptoms; stomach hurting and nausea; lips chapped; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-AUG-2024, the patient received the 2nd dose of Shingrix (left arm). In AUG-2024, an unknown time after receiving Shingrix, the patient experienced feelings of weakness (Verbatim: feel weak), suspected covid-19 (Verbatim: felt like COVID symptoms), stomach pain (Verbatim: stomach hurting and nausea), chapped lips (Verbatim: lips chapped) and nausea (Verbatim: nausea). On 17-AUG-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), general body pain (Verbatim: general aches and pains), fever (Verbatim: slight fever) and headache (Verbatim: headache). The patient was treated with mefenamic acid (Advil). The outcome of the injection site pain was resolved and the outcome of the feelings of weakness was not resolved and the outcome of the suspected covid-19, general body pain, fever, headache, stomach pain, chapped lips and nausea were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, feelings of weakness, suspected covid-19, general body pain, fever, headache, stomach pain, chapped lips and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, feelings of weakness, suspected covid-19, general body pain, fever, headache, stomach pain, chapped lips and nausea to be related to Shingrix.   Additional Information: GSK Receipt date: 20-AUG-2024  The patient self-reported. She received Shingrix dose 2 on Saturday 17 August 2024 in left arm and she stated Saturday evening she experienced pain at injection site, aches and pains, headache and a slight fever. She took Advil Saturday night and Sunday and stated she felt weak and her lips chapped and stomach hurting with nausea.  She stated she was feeling better except that she was still feeling weak.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early Third Dose; Late Second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose of Bexsero on 20th August 2022).   On 19-AUG-2024, the patient received the 3rd dose of Bexsero. On 15-JUL-2024, the patient received the 2nd dose of Bexsero. On 15-JUL-2024, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: Late Second dose). On 19-AUG-2024, the patient experienced drug dose administration interval too short (Verbatim: Early Third Dose). The outcome of the drug dose administration interval too short 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: 20-AUG-2024 The other health professional (medical Assistant) reported that they did speak with the patient, the patient was aware that a third dose was given by mistake that she was not need it. The patient was concerned about anything that they should keep an eye out for. The patient received second dose of Bexsero longer than the recommended interval which led to lengthening of the vaccination schedule. The patient received third dose of Bexsero shorter than the recommended interval which led to shortening of the vaccination schedule.
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: MenB instead of MCV4; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: MenB instead of MCV4). The outcome of the wrong vaccine 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: 21-AUG-2024  An HCP reported to ask about an administered dose of Bexsero in an eleven year old patient, which recommendations will be addressed for vaccination with another MenACWY vaccine. The HCP asked if the MenB vaccine counts as a MCV4 dose, during the call the HCP mentioned that MCV4 vaccine was indicated for this patient but the patient received MenB instead which led to Wrong vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Maladministration of Early 3rd dose/3rd dose was administered by mistake 1 week after the 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b) and Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Maladministration of Early 3rd dose/3rd dose was administered by mistake 1 week after the 2nd dose). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 21-AUG-2024  Licensed Practical Nurse Clinical Practice Manager asks about a dose of an early third dose maladministered to a patient (1 and 2 dose were administered with a 1 month interval and the 3rd dose was administered by mistake 1 week after the 2nd dose).  Licensed Practical Nurse Clinical Practice Manager wants to know about information/recommendations about this situation.  The patient received 2nd dose of Hepatitis B shorter than the recommended interval, which led to shortening of the vaccine schedule
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: After administration on today (22AUG2024), it was determined within the pharmacy database that the patients received Arexvy in January 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L5C22, expiry date 18-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in January 2024).   On 22-AUG-2024, the patient received the 2nd dose of Arexvy. On 22-AUG-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: After administration on today (22AUG2024), it was determined within the pharmacy database that the patients received Arexvy in January 2024.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 The pharmacist reported that the patient came into to receive the Arexvy vaccine and received it on today (on the reporting day) and it was determined within the pharmacy database that the patient received Arexvy in January 2024, which led to extra dose administered. This case is linked with US2024105099, reporter by same reporter for different patient.; Sender's Comments:  US-GSK-US2024105099:SAME REPORTER/ DIFFERENT PATIENT
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first Twinrix dose on 06-Jul-2024 and 2nd dose on 22-Aug-2024; 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 56-year-old male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 22-AUG-2024, the patient received the 2nd dose of Twinrix. On 22-AUG-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received first Twinrix dose on 06-Jul-2024 and 2nd dose on 22-Aug-2024). 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: 22-AUG-2024 The pharmacist reported that the patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.   At the time of reporting, the pharmacist did not had the product lot numbers or expiration dates. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: dose of Hep-B for birth-to-eighteen years given to patient, female, aged 32; dose of Hep-B for birth-to-eighteen years given to patient, female, aged 32; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 32-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On 22-AUG-2024, the patient received Engerix B pediatric. On 22-AUG-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: dose of Hep-B for birth-to-eighteen years given to patient, female, aged 32) and underdose (Verbatim: dose of Hep-B for birth-to-eighteen years given to patient, female, aged 32). 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: 22-AUG-2024 The reporter reported that the dose of Hepatitis B vaccine from birth to 18 years (Engerix B pediatric) was given to the adult patient, which led to adult use of a child product and underdose.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: Prevnar 20 prefilled syringe (PFS) breaking at the point where the needle attaches to the syringe; This is a spontaneous report received from a Nurse and a Consumer or other non HCP from medical information team and product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as no dose given (Lot number: HH9322, Expiration Date: 30Jun2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE CONNECTION ISSUE (non-serious), outcome "unknown", described as "Prevnar 20 prefilled syringe (PFS) breaking at the point where the needle attaches to the syringe".  The reporter considered "prevnar 20 prefilled syringe (pfs) breaking at the point where the needle attaches to the syringe" not related to pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).   Additional information: they had received some syringes of Prevnar from the vaccines program and there was like two syringes were the Luer lock tips had broken off. Packaging was sealed and intact. The reporter confirmed that there was no patient involvement. They were unable to administer those doses.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller is taking Paxlovid; Caller is taking Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller is taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller (patient) is taking Paxlovid. Caller mentioned that she had the Pfizer covid 19 vaccine shot way back 2021 and her second dose back month later and her 3rd dose was last June and haven't had any other shots of vaccination. Caller is wondering if what is the recommendation and how soon she should try to get another shot of Pfizer covid 19 vaccine or after taking the medication.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5, BNT162B2] will be requested and submitted if and when received.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Biopsy
Clinical narrative: Basal cell carcinoma at site of injection; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose 3 (booster), single (Lot number: FU6369) at the age of 43 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Basal cell carcinoma on face" (unspecified if ongoing); "precancerous lesion on cheek" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine on same date. No other vaccine in four weeks.  Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization.  The following information was reported: BASAL CELL CARCINOMA (medically significant, life threatening) with onset 02Feb2022, outcome "not recovered", described as "Basal cell carcinoma at site of injection". The patient underwent the following laboratory tests and procedures: Biopsy: (28Aug2024) Unknown Results. Therapeutic measures were not taken as a result of basal cell carcinoma. Clinical courses:Basal cell carcinoma at site of injection - Red mark appeared upon injection, got worse overtime, and never healed. Received results from biopsy today regarding the carcinoma. Waiting for appointment to have it removed.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain
Clinical narrative: can barely walk; pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 58-year-old male patient received BNT162b2 (COMIRNATY), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (medically significant), outcome "not recovered", described as "can barely walk"; PAIN (medically significant), outcome "not recovered". The events "can barely walk" and "pain" required physician office visit.  Clinical course: The patient needs to know if there is any treatment for long term Covid vaccine side effects. Patient went from a healthy 55-year-old to a man that can barely walk. The patient is in so much pain. All the doctors said there is something bad/wrong. Patient is now 58 and not getting any better.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.