chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Tremor
Clinical narrative: As soon as the nurse was finished giving the shot to my daughter, she fell forward and passed out. I just happened to be standing in front of her so i laid her on her back. I thought it was just anxiety and she freaked herself out. But then her body locked up and it looked like she had a seizure-like event. she started shaking and her body was jerking. Her lips were pale but then she got color back. A few minutes later her body locked up again and she had another seizure-like event. Once again her lips were pale and after a few minutes color started coming back to her face. She was sitting up and talking to me and the nurse even gave her a drink and a snack. After a few minutes she told me she was going to pass out and, once again, her body locked and she had her 3rd seizure-like event. The nurses elevated her legs and she laid there for 10-15 minutes until the nurses and doctor allowed her to stand up and leave.
Age: 61.0
Sex: F
Vaccine: FLUC4, RSV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever; swelling and redness in left arm the size of a baseball; pain
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: sensitive pain in and around the right ear
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Pyrexia, Rash, Skin discolouration, Swelling
Clinical narrative: Rash, swelling,  discoloration of the feet, fever, diarrhea,
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Dysstasia, Fatigue, Gait inability, Myalgia
Clinical narrative: Tiredness, fever 101.2, muscle aches, crippling pain left leg like a pinched nerve. Could not stand or walk on it was so bad. Pain in lower spine. Lower spine felt like it was burning or on fire.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: Tiredness, fever 101.2, muscle aches, crippling pain left leg like a pinched nerve. Could not stand or walk on it was so bad. Pain in lower spine. Lower spine felt like it was burning or on fire.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Thrombosis
Clinical narrative: blood clot in neck on right side
Age: 83.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Administration site pain, Haematoma, Pruritus
Clinical narrative: hematoma, dolor en area de administracion, hinchazon
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Significant increase in weakness in legs.  Increasingly getting worse over time.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Chest pain, Fatigue, Labile blood pressure, Malaise
Clinical narrative: I had my usual post covid vaccine myalgias , fatigue and low grade fever the day after. On day 5 I felt unwell and had a nurse practitioner at  my workplace take my blood pressure and it was 188/100. I do not have hypertension and frequently take my pressues and they never exceed 130/70 with average of less than 120/80. The nurse practitioner prescribed amlodipine 5 mg and HCTZ 25 mg. By the afternoon it had gone down to 150/90. The pressures continued to be labile and on day 9 I developed chest pain and went to the ED. I had a negative workup for an MI but had a nuclear stress test several days later and it showed a small infarct in the area of the LAD artery.  I still did not feel well until  today which is day 12. As background I am usually fit and exercise on a Stairmaster on level 10 -6 days per week for 45 minutes. And in fact I did so 2 days after the vaccine -3 days in a row without any symptoms. Another interesting symptom was the night before my blood pressure was elevated I did not get up to urinate at night which i do every night.   Today my pressure was 188/70 on 10mg lisinopril.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Myocardial infarction, Pyrexia, Scan myocardial perfusion abnormal
Clinical narrative: I had my usual post covid vaccine myalgias , fatigue and low grade fever the day after. On day 5 I felt unwell and had a nurse practitioner at  my workplace take my blood pressure and it was 188/100. I do not have hypertension and frequently take my pressues and they never exceed 130/70 with average of less than 120/80. The nurse practitioner prescribed amlodipine 5 mg and HCTZ 25 mg. By the afternoon it had gone down to 150/90. The pressures continued to be labile and on day 9 I developed chest pain and went to the ED. I had a negative workup for an MI but had a nuclear stress test several days later and it showed a small infarct in the area of the LAD artery.  I still did not feel well until  today which is day 12. As background I am usually fit and exercise on a Stairmaster on level 10 -6 days per week for 45 minutes. And in fact I did so 2 days after the vaccine -3 days in a row without any symptoms. Another interesting symptom was the night before my blood pressure was elevated I did not get up to urinate at night which i do every night.   Today my pressure was 188/70 on 10mg lisinopril.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED ON 12/22/23.  IT WAS DISCOVERED ON 12/24/23, TO HAVE A  BEYOND USE DATE OF 12/18/23 .
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Autoimmune disorder, Balance disorder, Blood test normal, COVID-19
Clinical narrative: Within roughly 1-2 months, developed autoimmune symptoms, doctor ignored. Few months later, got Covid, and weeks after that, developed tingling in hands, then feet, then progressed up legs and arms and then to face. Developed tinnitus, imbalance and loss of direction in dark, loss of grip in fingers (dry, cold).  Deep muscle pain. Mental fatigue. Had couple months of irregular heartbeat. Condition slowly intensified. Legs began feeling weak. Went to ER. Full spine MRI there. Normal. Many blood tests there and elsewhere, all normal except positive ANA. EMG tests, normal. Diagnosed as peripheral neuropathy. Also eventually seen at Neurological. Prescribed 900mg/day gabapentin, there. Have since also been prescribed 100mg/day amitrtriptyline.  Condition is slowly intensifying. [note: I had also received 2 shingles shots and the first two Covid shots and possibly an annual flu shot in the calendar year 2021]  I believe the neuropathy is related to the Covid shots because: 1) autoimmune symptoms were noticed shortly after 3d (booster) shot 2) neuropathy started shortly after my having Covid (likely due to the known effect of antibody-dependent enhancement) 3) known neurologic problems due to vaccines  4) known large increase in neurological problems in population since rollout of Covid shots.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram normal, Heart rate irregular, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Magnetic resonance imaging normal
Clinical narrative: Within roughly 1-2 months, developed autoimmune symptoms, doctor ignored. Few months later, got Covid, and weeks after that, developed tingling in hands, then feet, then progressed up legs and arms and then to face. Developed tinnitus, imbalance and loss of direction in dark, loss of grip in fingers (dry, cold).  Deep muscle pain. Mental fatigue. Had couple months of irregular heartbeat. Condition slowly intensified. Legs began feeling weak. Went to ER. Full spine MRI there. Normal. Many blood tests there and elsewhere, all normal except positive ANA. EMG tests, normal. Diagnosed as peripheral neuropathy. Also eventually seen at Neurological. Prescribed 900mg/day gabapentin, there. Have since also been prescribed 100mg/day amitrtriptyline.  Condition is slowly intensifying. [note: I had also received 2 shingles shots and the first two Covid shots and possibly an annual flu shot in the calendar year 2021]  I believe the neuropathy is related to the Covid shots because: 1) autoimmune symptoms were noticed shortly after 3d (booster) shot 2) neuropathy started shortly after my having Covid (likely due to the known effect of antibody-dependent enhancement) 3) known neurologic problems due to vaccines  4) known large increase in neurological problems in population since rollout of Covid shots.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal normal, Mental fatigue, Muscular weakness, Myalgia, Nervous system disorder
Clinical narrative: Within roughly 1-2 months, developed autoimmune symptoms, doctor ignored. Few months later, got Covid, and weeks after that, developed tingling in hands, then feet, then progressed up legs and arms and then to face. Developed tinnitus, imbalance and loss of direction in dark, loss of grip in fingers (dry, cold).  Deep muscle pain. Mental fatigue. Had couple months of irregular heartbeat. Condition slowly intensified. Legs began feeling weak. Went to ER. Full spine MRI there. Normal. Many blood tests there and elsewhere, all normal except positive ANA. EMG tests, normal. Diagnosed as peripheral neuropathy. Also eventually seen at Neurological. Prescribed 900mg/day gabapentin, there. Have since also been prescribed 100mg/day amitrtriptyline.  Condition is slowly intensifying. [note: I had also received 2 shingles shots and the first two Covid shots and possibly an annual flu shot in the calendar year 2021]  I believe the neuropathy is related to the Covid shots because: 1) autoimmune symptoms were noticed shortly after 3d (booster) shot 2) neuropathy started shortly after my having Covid (likely due to the known effect of antibody-dependent enhancement) 3) known neurologic problems due to vaccines  4) known large increase in neurological problems in population since rollout of Covid shots.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Night blindness, Paraesthesia, Tinnitus
Clinical narrative: Within roughly 1-2 months, developed autoimmune symptoms, doctor ignored. Few months later, got Covid, and weeks after that, developed tingling in hands, then feet, then progressed up legs and arms and then to face. Developed tinnitus, imbalance and loss of direction in dark, loss of grip in fingers (dry, cold).  Deep muscle pain. Mental fatigue. Had couple months of irregular heartbeat. Condition slowly intensified. Legs began feeling weak. Went to ER. Full spine MRI there. Normal. Many blood tests there and elsewhere, all normal except positive ANA. EMG tests, normal. Diagnosed as peripheral neuropathy. Also eventually seen at Neurological. Prescribed 900mg/day gabapentin, there. Have since also been prescribed 100mg/day amitrtriptyline.  Condition is slowly intensifying. [note: I had also received 2 shingles shots and the first two Covid shots and possibly an annual flu shot in the calendar year 2021]  I believe the neuropathy is related to the Covid shots because: 1) autoimmune symptoms were noticed shortly after 3d (booster) shot 2) neuropathy started shortly after my having Covid (likely due to the known effect of antibody-dependent enhancement) 3) known neurologic problems due to vaccines  4) known large increase in neurological problems in population since rollout of Covid shots.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Ecchymosis, Erythema, Pain, Pruritus, Tenderness
Clinical narrative: 6cm diameter red circle that was painful, tender and then became itchy 6 days later. Then it turned eccymotic and is still very itchy and eccymotic 20 days later.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: PT REPORTED A V ERY SORE AR,M WITH LIMITED RANGE OF MOTION WHICH SHE HAS NEVER EXPERIENCED WITH A VACCINE PREVIOUSLY.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fall, Fatigue, General physical condition abnormal, Loss of consciousness, Pallor
Clinical narrative: 7-year-old patient received 2 vaccinations (fluzone and Moderna 6-11 covid vaccine) on 12/24/23. After receiving the vaccines, he was fine walking around waiting for his sister's vaccination turn. About 5 minutes later he came back to the clinic booth, sat on the chair with mom, started to fall (on Mom's hand patted against the table), losing consciousness for about 15 seconds, then got back up slowly. Code White was called. His pulse was at normal range. We gave him some orange juice and he got better. He got better for about 5 minutes and then started to look pale and droopy again. We tried to talk to him to keep him awake, and the patient said he was very tired and sleepy. Ambulance was called. When the ambulance arrived, the patient got better and became active again.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Somnolence
Clinical narrative: 7-year-old patient received 2 vaccinations (fluzone and Moderna 6-11 covid vaccine) on 12/24/23. After receiving the vaccines, he was fine walking around waiting for his sister's vaccination turn. About 5 minutes later he came back to the clinic booth, sat on the chair with mom, started to fall (on Mom's hand patted against the table), losing consciousness for about 15 seconds, then got back up slowly. Code White was called. His pulse was at normal range. We gave him some orange juice and he got better. He got better for about 5 minutes and then started to look pale and droopy again. We tried to talk to him to keep him awake, and the patient said he was very tired and sleepy. Ambulance was called. When the ambulance arrived, the patient got better and became active again.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Pain and swelling at site of injection. Patient can not lift arm.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: High-pitched crying, Tinnitus
Clinical narrative: Severe tinnitus developed; high pitched screeching in my ears that won't stop
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation reaction, Skin discolouration
Clinical narrative: diarrhea 6-hrs after.   Covid finger right index finger dark discoloration of joint above knuckle (no bumps or pain) - onset 12/24/23
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram normal, Full blood count, Metabolic function test, Palpitations
Clinical narrative: About 4-5 hours after vaccination, had high fever (103 at highest), vomiting, chest tightness, heart palpitations, and heart racing/ tachycardia. Went to ER about an hour after heart symptoms began and was released after fluids, fever reduction, and acceptable ekg. Since then have had intermittent heart palpitations, but seem to have mostly recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Urine analysis, Vomiting
Clinical narrative: About 4-5 hours after vaccination, had high fever (103 at highest), vomiting, chest tightness, heart palpitations, and heart racing/ tachycardia. Went to ER about an hour after heart symptoms began and was released after fluids, fever reduction, and acceptable ekg. Since then have had intermittent heart palpitations, but seem to have mostly recovered.
Age: 38.0
Sex: M
Vaccine: FLUC4, FLUC3
Symptoms: Muscle spasms, Musculoskeletal stiffness, Syncope
Clinical narrative: Turned neck to side like a spasm; Locked up legs; This spontaneous case was retrieved on 07-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2712771-1), reported by other healthcare professional and concerned a 38-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included unspecified flu vaccines, on unspecified dates, for flu vaccination after which the patient experienced vagal syncope, and unspecified adverse event.  As reported, the patient warned pharmacist before hand that he usually had vagal syncope when getting vaccinations. The patient had no known allergies.  On 10-Nov-20223, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported). The batch number reported was 944464.   On the same date, after receiving Flucelvax Quadrivalent vaccine, the patient had a vagal syncope and sat on the floor for about five minutes, then got up and sat in the chair. About seven to ten minutes later, the patient sat on the floor and laid back flat. Within a few seconds, the patient turned his neck to side like a spasm and locked up his legs. The reporter raised his legs up in the chair and called his name twice and patient responded. The patient then laid on floor for about 20 minutes or so and was provided a bottle of water when he asked. The pharmacist recorded liability form was recorded and patient walked out the door. No lab data was reported.  On the same date, the patient had recovered from  events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 38-year-old patient experienced muscle spasms and musculoskeletal stiffness within approximately seven to ten minutes after receiving the suspect product Flucelvax Quadrivalent vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 38-year-old patient experienced muscle spasms and musculoskeletal stiffness within approximately seven to ten minutes after receiving the suspect product Flucelvax Quadrivalent vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUC3
Symptoms: Chest pain, Erythema, Heart rate increased, Hyperhidrosis, Migraine
Clinical narrative: Migraine; Chest pain; Increased heart rate; Pale; Diaphoretic; Pain in left arm; Pain in left arm with erythema; Pain in left arm with edema; This spontaneous case was retrieved on 08-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2714093-1), reported by other healthcare professional and concerned a 34-year-old, female patient.   The patient's concurrent conditions included allergy to eggs and Saxenda (liraglutide). The patient's concomitant medications included Benadryl (diphenhydramine hydrochloride) and ibuprofen, both used for unreported indications.   It was reported that on 30-Oct-2023, the patient was vaccinated with influenza vaccine (brand not specified (reported as egg free); dose reported as 'dose 1', route of administration: intramuscular, and anatomical location: left arm) as influenza vaccination. The batch number reported was 374529 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product influenza vaccine). Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced migraine, chest pain, increased heart rate, pain in left arm with erythema and oedema, and was pale and diaphoretic.  On an unspecified date in 2023, the patient recovered from all events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 34-year-old patient experienced migraine, chest pain, increased heart rate, pallor, and diaphoresis, as well as pain, erythema, and oedema in left arm on the same date, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 34-year-old patient experienced migraine, chest pain, increased heart rate, pallor, and diaphoresis, as well as pain, erythema, and oedema in left arm on the same date, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUC3
Symptoms: Oedema peripheral, Pain in extremity, Pallor
Clinical narrative: Migraine; Chest pain; Increased heart rate; Pale; Diaphoretic; Pain in left arm; Pain in left arm with erythema; Pain in left arm with edema; This spontaneous case was retrieved on 08-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2714093-1), reported by other healthcare professional and concerned a 34-year-old, female patient.   The patient's concurrent conditions included allergy to eggs and Saxenda (liraglutide). The patient's concomitant medications included Benadryl (diphenhydramine hydrochloride) and ibuprofen, both used for unreported indications.   It was reported that on 30-Oct-2023, the patient was vaccinated with influenza vaccine (brand not specified (reported as egg free); dose reported as 'dose 1', route of administration: intramuscular, and anatomical location: left arm) as influenza vaccination. The batch number reported was 374529 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product influenza vaccine). Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced migraine, chest pain, increased heart rate, pain in left arm with erythema and oedema, and was pale and diaphoretic.  On an unspecified date in 2023, the patient recovered from all events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 34-year-old patient experienced migraine, chest pain, increased heart rate, pallor, and diaphoresis, as well as pain, erythema, and oedema in left arm on the same date, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 34-year-old patient experienced migraine, chest pain, increased heart rate, pallor, and diaphoresis, as well as pain, erythema, and oedema in left arm on the same date, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired vaccine was given to a patient; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired vaccine was given to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2023 This report was submitted via the program.  The reporter was office staff. The expired Menveo vaccine was given to a patient, which led to expired vaccine used. No other details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-DEC-2023. The patient received Shingrix and had injection site pain rest information was unknown. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: RSV
Symptoms: Cough, Nasopharyngitis
Clinical narrative: cough; cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced cough (Verbatim: cough) and cold (Verbatim: cold). The outcome of the cough and cold were not reported.   It was unknown if the reporter considered the cough and cold to be related to Arexvy.     It was unknown if the company considered the cough and cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-DEC-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she came down with a cough and cold symptoms after the injection the next day. The follow-up could not be possible as no contact details were available.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered an adult Havrix(1mL) dose to a pediatric patient; inadvertently administered an adult Havrix(1mL) dose to a pediatric patient; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 1-year-old male patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 01-DEC-2023, the patient received the 1st dose of Havrix adult 1 ml. On 01-DEC-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: Administered an adult Havrix(1mL) dose to a pediatric patient) and adult product administered to child (Verbatim: inadvertently administered an adult Havrix(1mL) dose to a pediatric patient). The outcome of the accidental overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the accidental overdose to be related to Havrix adult and Havrix Pre-Filled Syringe Device.     It was unknown if the company considered the accidental overdose to be related to Havrix adult and Havrix 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: 13-DEC-2023 Doctor called to inquire how to proceed.  The physician reported that inadvertently administered an adult Havrix (1mL) dose to a pediatric patient which led to accidental overdose and adult product administered to child. Consent to follow up.
Age: 62.0
Sex: M
Vaccine: HEPAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Elevated labs ALT; elevated AST; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of alanine aminotransferase increased in a 62-year-old male patient who received HAB (Twinrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Twinrix. In OCT-2023, 1 week after receiving Twinrix, the patient experienced alanine aminotransferase increased (Verbatim: Elevated labs ALT) and aspartate aminotransferase increased (Verbatim: elevated AST). The outcome of the alanine aminotransferase increased and aspartate aminotransferase increased were not resolved.   It was unknown if the reporter considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 13-DEC-2023 The wife of the patient was reporting that her husband received his first Twinrix dose on October 7 or 8, 2023.  One week later he was having routine labs done and noted elevated Alanine aminotransferase and Aspartate aminotransferase with the Alanine aminotransferase reading of 175.  Repeated blood work had been done (date unknown) and it was slowing coming down. The patient had not received his 2nd dose of Twinrix and was waiting on more information on the event.  The patient's wife reported that she requested that the pharmacy where the vaccination was received report the Adverse event to VAERS unknown whether it was reported or not. Husband was not in attendance, therefore not able to obtain consent to contact Healthcare professional. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient took the first vaccine for Shingrix but did not take the 2nd vaccine and it's 1-year plus later; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient took the first vaccine for Shingrix but did not take the 2nd vaccine and it's 1-year plus later). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-DEC-2023 The Physician wanted to knew if a patient took the first vaccine for Shingrix but did not take the 2nd vaccine and it was 1-year plus later, if they start over with the vaccine series or can they still got the 2nd vaccine only. Till the time to reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Discomfort, Fatigue, Muscular weakness
Clinical narrative: feeling tired; general feeling of discomfort; weakness on the legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-DEC-2023, the patient received Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: feeling tired), general discomfort (Verbatim: general feeling of discomfort) and lower extremities weakness of (Verbatim: weakness on the legs). The outcome of the tiredness, general discomfort and lower extremities weakness of were unknown.   It was unknown if the reporter considered the tiredness, general discomfort and lower extremities weakness of to be related to Arexvy.     It was unknown if the company considered the tiredness, general discomfort and lower extremities weakness of to be related to Arexvy.   Additional Information: GSK receipt date: 14-DEC-2023 The reporter was the patient. The reporter reported that he had received the Arexvy vaccine. The reporter stated that after receiving the vaccine he had experienced feeling tired, and had weakness on the legs, and had a general feeling of discomfort. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Potential 3rd dose/some days earlier a dose of Shingrix had been administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2023) and Shingrix (2nd dose received in November 2023).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Potential 3rd dose/some days earlier a dose of Shingrix had been administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 14-DEC-2023 A reporter reported that some days earlier a dose of Shingrix had been administered to such patient.  The reporter also mentioned that the whole series of Shingrix had already been finished because a dose was received in October, and the 2nd one in November.  The patient received 3rd dose of Shingrix which led to extra dose administered. Follow up was not possible, as no contact details were available.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: male patient received 1 dose of AREXVY in October and another dose of AREXVY about a week ago; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   In DEC-2023, the patient received the 2nd dose of Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: male patient received 1 dose of AREXVY in October and another dose of AREXVY about a week ago). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-DEC-2023 The reporter was other health professional (hcp). The hcp reported that a male patient received 1st dose of Arexvy in October and another dose of Arexvy about a week ago which led extra dose administered. No other information provided. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Cough, Fatigue
Clinical narrative: cough; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of cough in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 11-DEC-2023, the patient received Arexvy. On 12-DEC-2023, 1 days after receiving Arexvy, the patient experienced fatigue (Verbatim: fatigue). On 13-DEC-2023, the patient experienced cough (Verbatim: cough). On 13-DEC-2023, the outcome of the fatigue was resolved. The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough and fatigue to be related to Arexvy.     It was unknown if the company considered the cough and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-DEC-2023 The patient reported the following day of vaccination she experienced fatigue. The patient was still coughing. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash pruritic
Clinical narrative: developed an itchy skin rash that was treated in 2 different occasions with steroids and the rash went away; bumps like bug bites in legs, arms; bumps like bug bites in knees; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced itchy rash (Verbatim: developed an itchy skin rash that was treated in 2 different occasions with steroids and the rash went away), swelling of legs (Verbatim: bumps like bug bites in legs, arms) and swelling of knees (Verbatim: bumps like bug bites in knees). The outcome of the itchy rash, swelling of legs and swelling of knees were not resolved.   It was unknown if the reporter considered the itchy rash, swelling of legs and swelling of knees to be related to Arexvy.     It was unknown if the company considered the itchy rash, swelling of legs and swelling of knees to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-DEC-2023 The patient self-reported this case. The patient developed an itchy skin rash that was treated in 2 different occasions with steroids and the rash went away, then came back within a week, this time bumps like bug bites in legs, arms, knees, and it's really itchy. The reporter consented to follow up.
Sex: M
Vaccine: FLUC3
Symptoms: Cough, Fatigue, Nasal discomfort, Oropharyngeal pain, Sneezing
Clinical narrative: Sinus issues; Burning sensation in his sinuse/nasal pasages; Sore throat; Mild cough; Sneezing a lot; Fatigued; This spontaneous case was received on 12-Dec-2023 from other healthcare professional (nurse) (reference number: SEQW23-04811) and concerned a 64-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 06-Dec-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v) (anatomical location: left deltoid, dose, route of administration, and indication: not reported). The batch number was reported as 944444 (reported batch number was identified by Seqirus to be correct batch number) with an expiry date 22-May-2024.  On the same date, on the same evening as reported, after receiving the Flucelvax Quadrivalent the patient began having sinus issues, which he described as a burning sensation in his sinuses/nasal passages. The patient also developed a mild sore throat at that time as well as a mild cough. The patient experienced sneezing a lot and felt slightly fatigued. The patient denied having a fever, any respiratory issues, or any other symptoms. The patient had not been tested for the flu, the plan was to go to urgent care to did so, if symptoms would not improve.  At the time of initial reporting on 12-Dec-2023, the patient was recovering from all events. As reported, the patient woke up feeling much better today with near complete resolution of symptoms.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: On the same date, after receiving the Flucelvax Quadrivalent the patient began having sinus issues, which he described as a burning sensation in his sinuses/nasal passages. The patient also developed a sore throat, cough, sneezing and fatigued. The patient's medical history and concomitant medications were not reported. Causal role of the Flucelvax Quadrivalent is assessed as possibly related for reported events, based on chronological plausibility.; Sender's Comments: On the same date, after receiving the Flucelvax Quadrivalent the patient began having sinus issues, which he described as a burning sensation in his sinuses/nasal passages. The patient also developed a sore throat, cough, sneezing and fatigued. The patient's medical history and concomitant medications were not reported. Causal role of the Flucelvax Quadrivalent is assessed as possibly related for reported events, based on chronological plausibility.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Pyrexia
Clinical narrative: Low fever tired achy mild chest tightness. I never had side effects like this before
Sex: U
Vaccine: RSV
Symptoms: Immunisation reaction
Clinical narrative: Hospitalized; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hospitalization (Verbatim: Hospitalized) (serious criteria hospitalization). The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Arexvy.   It was unknown if the company considered the hospitalization to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-DEC-2023 This case was reported by a patient via interactive digital media. The patient had adverse reaction to Arexvy vaccine, 21 days hospitalization. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: golf sized lump at injection site; Fever/temp 100.5/felt hot; chills; itching at injection site; redness at injection site and spreading- encompassing all upper arm; pain at 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 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy (right arm) and Prevnar 20 (right arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced fever (Verbatim: Fever/temp 100.5/felt hot) and chills (Verbatim: chills). In DEC-2023, the patient experienced injection site pain (Verbatim: pain at injection site), injection site lump (Verbatim: golf sized lump at injection site), injection site itching (Verbatim: itching at injection site) and injection site erythema (Verbatim: redness at injection site and spreading- encompassing all upper arm). The patient was treated with diphenhydramine hydrochloride (Benadryl). In DEC-2023, the outcome of the injection site lump was resolved. The outcome of the injection site pain, injection site itching and injection site erythema were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.   Additional Information: GSK receipt date: 15-DEC-2023 The reporter reported that patient received Arexvy and Prevnar 20 vaccines in right arm.  The patient was experienced felt hot and chills.  The patient took her temperature, and it was 100.5.  The patient also experienced redness, pain and itching at injection sites. The redness spread to encompass all upper arm area. And golf size lump at injection sites.  The patient was called health care professional  who recommended Benadryl.  The patient still had redness, pain and itchiness at injection site.  It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Prevenar 20. The reporter did not consent to follow-up.
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Injection site pruritus, Pyrexia
Clinical narrative: golf sized lump at injection site; Fever/temp 100.5/felt hot; chills; itching at injection site; redness at injection site and spreading- encompassing all upper arm; pain at 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 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy (right arm) and Prevnar 20 (right arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced fever (Verbatim: Fever/temp 100.5/felt hot) and chills (Verbatim: chills). In DEC-2023, the patient experienced injection site pain (Verbatim: pain at injection site), injection site lump (Verbatim: golf sized lump at injection site), injection site itching (Verbatim: itching at injection site) and injection site erythema (Verbatim: redness at injection site and spreading- encompassing all upper arm). The patient was treated with diphenhydramine hydrochloride (Benadryl). In DEC-2023, the outcome of the injection site lump was resolved. The outcome of the injection site pain, injection site itching and injection site erythema were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.   Additional Information: GSK receipt date: 15-DEC-2023 The reporter reported that patient received Arexvy and Prevnar 20 vaccines in right arm.  The patient was experienced felt hot and chills.  The patient took her temperature, and it was 100.5.  The patient also experienced redness, pain and itching at injection sites. The redness spread to encompass all upper arm area. And golf size lump at injection sites.  The patient was called health care professional  who recommended Benadryl.  The patient still had redness, pain and itchiness at injection site.  It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Prevenar 20. The reporter did not consent to follow-up.
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Body temperature increased, Chills, Feeling of body temperature change, Hypersensitivity, Injection site erythema
Clinical narrative: golf sized lump at injection site; Fever/temp 100.5/felt hot; chills; itching at injection site; redness at injection site and spreading- encompassing all upper arm; pain at 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 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy (right arm) and Prevnar 20 (right arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced fever (Verbatim: Fever/temp 100.5/felt hot) and chills (Verbatim: chills). In DEC-2023, the patient experienced injection site pain (Verbatim: pain at injection site), injection site lump (Verbatim: golf sized lump at injection site), injection site itching (Verbatim: itching at injection site) and injection site erythema (Verbatim: redness at injection site and spreading- encompassing all upper arm). The patient was treated with diphenhydramine hydrochloride (Benadryl). In DEC-2023, the outcome of the injection site lump was resolved. The outcome of the injection site pain, injection site itching and injection site erythema were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.   Additional Information: GSK receipt date: 15-DEC-2023 The reporter reported that patient received Arexvy and Prevnar 20 vaccines in right arm.  The patient was experienced felt hot and chills.  The patient took her temperature, and it was 100.5.  The patient also experienced redness, pain and itching at injection sites. The redness spread to encompass all upper arm area. And golf size lump at injection sites.  The patient was called health care professional  who recommended Benadryl.  The patient still had redness, pain and itchiness at injection site.  It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Prevenar 20. The reporter did not consent to follow-up.