chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RVX
Symptoms: Oropharyngeal pain, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected Vaccination failure/ I have RSV now; I have RSV now; have been so sick for days.; can't sleep; elevated temperature; my throat is so sore; coughing; so tired; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure/ I have RSV now) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I have RSV now), sickness (Verbatim: have been so sick for days.), sleeplessness (Verbatim: can't sleep), body temperature increased (Verbatim: elevated temperature), sore throat (Verbatim: my throat is so sore), cough (Verbatim: coughing) and tiredness (Verbatim: so tired). The outcome of the vaccination failure, sleeplessness, body temperature increased, sore throat, cough and tiredness were not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the sickness was resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness, sleeplessness, body temperature increased, sore throat, cough and tiredness to be related to RSV vaccine.   The company considered the vaccination failure to be related to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, sickness, sleeplessness, body temperature increased, sore throat, cough and tiredness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-AUG-2024 This case was reported by a patient via interactive digital media. The patient was pretty sure that he/she had RSV at the time of reporting. The patient was so sick for days. The patient could not sleep and his/her throat was so sore from all of the coughing and had an elevated temperature The patient was so tired after receiving the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding RSV were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK RSV vaccine.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Intervertebral disc protrusion
Clinical narrative: herniated a disk in my back; This non-serious case was reported by a consumer via call center representative and described the occurrence of intervertebral disc protrusion in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at the 34 years of age). Concurrent medical conditions included psoriasis (has for over 10 years). Concomitant products included Ustekinumab (Stelara).   On 02-JUL-2024, the patient received Shingrix (left arm). On 04-JUL-2024, 2 days after receiving Shingrix, the patient experienced intervertebral disc protrusion (Verbatim: herniated a disk in my back). The patient was treated with prednisone acetate (Prednisone). The outcome of the intervertebral disc protrusion was not reported.   It was unknown if the reporter considered the intervertebral disc protrusion to be related to Shingrix.     It was unknown if the company considered the intervertebral disc protrusion to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-AUG-2024 The patient self-reported this case. The patient received his first dose of Shingrix injection and 2 days later he had herniated a disk in his back and was put on prednisone for two weeks starting with a daily 50 mg dose and finishing with 10 to 14 days later.  The patient also received Stelara 45 gm injections every 84 days for psoriasis, and had for over 10 years (pre existing receiving Shingrix).  The patient also reported that he did had shingles when he was 34 years of age (pre existing Shingrix). The patient asked what did that do to the effectiveness of the vaccine and how should he proceed with the second shot.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: head that once and it was painful for about a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Additional patient notes included Ethnicity.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: head that once and it was painful for about a week). The outcome of the headache was resolved (duration 1 week).   It was unknown if the reporter considered the headache to be related to Shingrix.     It was unknown if the company considered the headache to be related to Shingrix.   Additional Information: GSK receipt date: 20-JUL-2024 This case was reported by a patient via interactive digital media. The last time the patient was in the country he received a second injection. In the head that once and it was painful for about a week.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Cough
Clinical narrative: coughed; 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 (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: coughed). The outcome of the cough was resolved (duration 3 months).   It was unknown if the reporter considered the cough to be related to RSV vaccine.     It was unknown if the company considered the cough to be related to RSV vaccine.   Additional Information: GSK receipt date: 23-AUG-2024 This case was reported the patient via interactive digital media. The patient got the shot and had coughed for 3 months.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash
Clinical narrative: rash and brusise on arm large circular area- below the deltoid area
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills, muscle aches, extreme fatigue
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gait disturbance, Vertigo
Clinical narrative: Vértigo? - Can't walk a straight line without holding on to something. Feel like I'm being pulled to the right whenever I move suddenly.  I feel alright when sitting or laying down.  My partner, who had the vaccine the same day, also has the problem but she is pulled to the left side, which is the side she had the vaccine.
Age: 67.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Botulinum toxin injection, Laboratory test abnormal, Muscle spasms, Sensory disturbance, Spasmodic dysphonia
Clinical narrative: Approximately 2 weeks after injections, I was experiencing tightening sensations in my arms in legs, randomly throughout the day and in bed if I just moved slightly.  Approximately 2 months after injections I was diagnosed with Spasmodic Dysphonia.  I feel all muscle spasms related to having both vaccines at the same time.
Age: 67.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Tremor
Clinical narrative: Approximately 2 weeks after injections, I was experiencing tightening sensations in my arms in legs, randomly throughout the day and in bed if I just moved slightly.  Approximately 2 months after injections I was diagnosed with Spasmodic Dysphonia.  I feel all muscle spasms related to having both vaccines at the same time.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Herpes zoster, Influenza like illness
Clinical narrative: Day of vaccination, extreme pain in left shoulder and down left arm and flu like symptoms continued for 3 days.  One week later developed shingles like pain on left abdomen and around entire torso.  Extreme sensitivity to the touch and nerve type pain all over the body.  This lasted for two weeks before it began to ease.  Took 7 weeks to subside.  Also approximately 4 weeks after vaccination developed chronic fatigue and weakness along with severe muscle pain and stiffness throughout both upper arms through shoulder and into neck and upper back and jaw area.  Muscle pain and stiffness continues to this day.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Neuralgia, Pain in extremity, Sensitive skin
Clinical narrative: Day of vaccination, extreme pain in left shoulder and down left arm and flu like symptoms continued for 3 days.  One week later developed shingles like pain on left abdomen and around entire torso.  Extreme sensitivity to the touch and nerve type pain all over the body.  This lasted for two weeks before it began to ease.  Took 7 weeks to subside.  Also approximately 4 weeks after vaccination developed chronic fatigue and weakness along with severe muscle pain and stiffness throughout both upper arms through shoulder and into neck and upper back and jaw area.  Muscle pain and stiffness continues to this day.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Dyspnoea, Fatigue, Vision blurred
Clinical narrative: 9/1/24: Fluad administeredd at 4:40pm; had patient sit down for observation 15 minutes. Patient complained of difficulty breathing, dizziness, and blurry vision within 2 to 5 minutes of administration. Called EMS; Patient's son, came and he said  she is allergic to shellfish. He decided to administer a dose of epipen to right thigh while Rph on the phone with EMS agent. Her blood pressure checked was 171/110.  EMS arrived then brought her to ER. Dr sent four medications: prednison 20mg, famotidine 20 mg, benadryl 25 mg, and epipen 0.3 mg. 9/2/24 - able to speak to son - he said his mother is still tired. He will picked up the medication at another pharmacy closed to his home on Tuesday 9/3/24. His mother does have epipen and benadryl at home. Advise to pick up medication today but got refused.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: 101.6 F fever, muscle aches moving all over body, especially legs.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal X-ray, Chest X-ray, Eye swelling, Full blood count, Laboratory test
Clinical narrative: Nausea, Vomiting and respiratory Failure, eyes swelling and rash on her back
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Rash, Respiratory failure, Respiratory pathogen panel, Vomiting
Clinical narrative: Nausea, Vomiting and respiratory Failure, eyes swelling and rash on her back
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: Vertigo, feel like I?m going to fall to the right. Has happened 3 times, once while standing, sitting, and lying down.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Dermatitis contact, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: At approximately 10pm, pt woke up itchy severe. Rash presented in the am of 8/29.  Rash on left arm grew up to 5 inches in diameter, red and swollen. Pt also presents with smaller rashes on back of the arm and also on left inner arm.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Anti-GAD antibody positive, Diabetic complication, Extra dose administered, Gastrointestinal disorder, Ill-defined disorder
Clinical narrative: Symptoms of type 1 diabetes (LADA) starting immediately following 4th dose, following 5th dose I got extremely sick with upper res illnesses, had a seizure according to mom, and slowly developed T1D in addition to some unknown secondary conditions excluding the hashimotos
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Latent autoimmune diabetes in adults, Malaise, Neurological symptom, Respiratory disorder, Seizure
Clinical narrative: Symptoms of type 1 diabetes (LADA) starting immediately following 4th dose, following 5th dose I got extremely sick with upper res illnesses, had a seizure according to mom, and slowly developed T1D in addition to some unknown secondary conditions excluding the hashimotos
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Systemic lupus erythematosus, Type 1 diabetes mellitus
Clinical narrative: Symptoms of type 1 diabetes (LADA) starting immediately following 4th dose, following 5th dose I got extremely sick with upper res illnesses, had a seizure according to mom, and slowly developed T1D in addition to some unknown secondary conditions excluding the hashimotos
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: pain at shot site, fever, feeling tired, headache
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The state vaccine database did not show patient had already received two doses of Shingrix in 2020, only one shot was showing. Patient did not know that they had received the second shot, so they were given an additional one to complete the series; the dose given would technically be 3rd dose on 8/29/24. No adverse events have been reported by patient.
Age: 80.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Blister, Pain, Pruritus, Rash
Clinical narrative: Patient has symptoms of full body rash that is not causing pain or pruritus. Patient also had blisters form on the midline of his back that are mildly painful/ itchy. No alternative cause was identified.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Epistaxis, Gingival pain, Glossodynia, Haemorrhage
Clinical narrative: Patient experienced bleeding, painful gums, a sore throat,  a bloody nose and fever of 101 two days after the vaccine. 3 days after her fever spiked to 103.1 and she started to get mouth sores on her lips, tongue, and gums.  Her fever lasted four days and her mouth sores got worse. She had appetite loss and was lethargic for four days and lost 3lbs.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes virus infection, Lethargy, Noninfective gingivitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient experienced bleeding, painful gums, a sore throat,  a bloody nose and fever of 101 two days after the vaccine. 3 days after her fever spiked to 103.1 and she started to get mouth sores on her lips, tongue, and gums.  Her fever lasted four days and her mouth sores got worse. She had appetite loss and was lethargic for four days and lost 3lbs.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Stomatitis, Weight decreased
Clinical narrative: Patient experienced bleeding, painful gums, a sore throat,  a bloody nose and fever of 101 two days after the vaccine. 3 days after her fever spiked to 103.1 and she started to get mouth sores on her lips, tongue, and gums.  Her fever lasted four days and her mouth sores got worse. She had appetite loss and was lethargic for four days and lost 3lbs.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fine motor skill dysfunction, Hypoaesthesia, Injection site swelling, Muscular weakness, Near death experience
Clinical narrative: Extreme swelling for 7 days on arm at injection site, Followed by intense nerve pain and swelling in right shoulder, down arm and into fingers lasting 3 weeks at this time. Numbness and tingling. Back is visibly swollen on right side near shoulder blade. Arm weakness and loss of fine motor control in hands on right side.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Paraesthesia, Peripheral swelling
Clinical narrative: Extreme swelling for 7 days on arm at injection site, Followed by intense nerve pain and swelling in right shoulder, down arm and into fingers lasting 3 weeks at this time. Numbness and tingling. Back is visibly swollen on right side near shoulder blade. Arm weakness and loss of fine motor control in hands on right side.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest discomfort, Dizziness, Feeling hot, Immediate post-injection reaction, Skin warm
Clinical narrative: Immediately following administration of both vaccines, the patient reported feeling very hot and warm to the touch.  She also reported that she felt like she was going to faint and that she had some feeling in her chest but denied any difficulty breathing.  She was asked if she checked her blood sugar this morning or recently and she stated that she forgot to check today.  She was given some water and 4 glucose tablets over a period of about ten minutes and she slowly stated that she felt better and was no longer warm.  The paramedics were called and resumed patient care upon arrival.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: ordered the wrong Meningococcal. They ordered Bexsero and non Menactra, or the Menquad B. So, he got the Bexsero and when he come back and get the correct meningococcal which is the Menquad B"; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male 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: ordered the wrong Meningococcal. They ordered Bexsero and non Menactra, or the Menquad B. So, he got the Bexsero and when he come back and get the correct meningococcal which is the Menquad B"). 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 The nurse called and reported that they had a patient in there clinic yesterday and the provider ordered the wrong Meningococcal as they ordered Bexsero and non Menactra or the Menquad B and the patient got the Bexsero but he was not due to get that he was not 16 to get that, which led to wrong vaccine administered. So they were trying to figure out what were the guidelines for getting Bexsero too early and when he will came back and get the correct meningococcal which was the Menquad B The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: Patient reported lump in arm at injection site. still there on 9/2/2024 when she reported it to me. She stated it does not hurt.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, red circle appeared at injection site - circle about 4 inches wide - pt also described as hot and itchy - is currently resolving on its own
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At the injection site: redness, warm to touch, raised (warm/red) circle going on day 3. Patient is pregnant.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Urinary retention
Clinical narrative: Severe Chills, feeling like I have to urinate, but unable to urinate.  I had prostatitis many years ago, seemed to be in remission. Whatever infection that may still exist in my prostate, the vaccine seems to have woken it up. After 12 hours of sleep it has gone away.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axonal and demyelinating polyneuropathy, Blood test, Electromyogram, Gait disturbance, Hypotonia
Clinical narrative: Within 5/6 months of vaccine I started waddling Dr thought I had a stroke sent me for an MRI no stroke that led me to a neurologist and many many different test and doctors , now I have to walk with a walker. I cannot walk without one. I'm losing my muscle tone. I have a  been diagnosed with severe sensory and motor length dependent axonal demyelinating neuropathy.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Walking aid user
Clinical narrative: Within 5/6 months of vaccine I started waddling Dr thought I had a stroke sent me for an MRI no stroke that led me to a neurologist and many many different test and doctors , now I have to walk with a walker. I cannot walk without one. I'm losing my muscle tone. I have a  been diagnosed with severe sensory and motor length dependent axonal demyelinating neuropathy.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The arm where the vaccine was given is red for over a week now and it still hurts.
Age: 64.0
Sex: F
Vaccine: FLUR4, TDAP
Symptoms: Feeling abnormal, Headache, Neck pain, Pain in jaw
Clinical narrative: UPPER JAW PAIN, FEELING LIKE SHE HAD MUMPS, SEVERE NECK PAIN, SEVERE HEADACHE STARTING 30 MINUTES AFTER RECIEVING IMMUNIZATIONS AND STILL OCCURING 6 DAYS LATER
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: NAUSEA/VOMITING, SWEATING
Age: 55.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: Low fever, headache, Arm pain and swelling, with swelling spreading to hands and face over course of 3 days.
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Cardiac arrest, Intensive care, Lung assist device therapy, Multiple organ dysfunction syndrome, Pulseless electrical activity
Clinical narrative: covid - comirnaty 2024-2025 (12Y up) . 13 yo patient developed symptoms of dyspnea with exertion on 8/28 (2 days before the vaccines) however on 9/1 had syncopal episodes at home x2 with subsequent witnessed cardiac arrest (initially PEA) with ROSC by EMS. Another cardiac arrest at Hospital with eCPR onto VVA ECMO (rhythm torsades in ED at hospital). Now in PICU in multi-organ failure.
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Resuscitation, Syncope, Torsade de pointes
Clinical narrative: covid - comirnaty 2024-2025 (12Y up) . 13 yo patient developed symptoms of dyspnea with exertion on 8/28 (2 days before the vaccines) however on 9/1 had syncopal episodes at home x2 with subsequent witnessed cardiac arrest (initially PEA) with ROSC by EMS. Another cardiac arrest at Hospital with eCPR onto VVA ECMO (rhythm torsades in ED at hospital). Now in PICU in multi-organ failure.
Age: 70.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Headache (including for several hours before reported onset of other symptoms around 9 P.M. on 8-31-24).  Elevated temperature up to 100.6.  Extreme chills, teeth chattering, body aches, extreme weakness, especially in arms, extreme fatigue, no appetite, slight cough occasionally, very red, raised large areas on both arms at injection site.  Still present 56 hours after injection.  Injection sites are still quite sore to slightest touch.  Ibuprofen used to mitigate fever and aches.  Marginally effective.  In bed for almost 24 hours, gradually improving at 56 hours after (no fever or headache), but fatigue, soreness and some aches remain while continuing ibuprofen.
Age: 70.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Headache (including for several hours before reported onset of other symptoms around 9 P.M. on 8-31-24).  Elevated temperature up to 100.6.  Extreme chills, teeth chattering, body aches, extreme weakness, especially in arms, extreme fatigue, no appetite, slight cough occasionally, very red, raised large areas on both arms at injection site.  Still present 56 hours after injection.  Injection sites are still quite sore to slightest touch.  Ibuprofen used to mitigate fever and aches.  Marginally effective.  In bed for almost 24 hours, gradually improving at 56 hours after (no fever or headache), but fatigue, soreness and some aches remain while continuing ibuprofen.
Age: 70.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headache (including for several hours before reported onset of other symptoms around 9 P.M. on 8-31-24).  Elevated temperature up to 100.6.  Extreme chills, teeth chattering, body aches, extreme weakness, especially in arms, extreme fatigue, no appetite, slight cough occasionally, very red, raised large areas on both arms at injection site.  Still present 56 hours after injection.  Injection sites are still quite sore to slightest touch.  Ibuprofen used to mitigate fever and aches.  Marginally effective.  In bed for almost 24 hours, gradually improving at 56 hours after (no fever or headache), but fatigue, soreness and some aches remain while continuing ibuprofen.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patietn recieved second shignrix vaccine on 8/30/24. patient presented to the pharmacy on 9/2/24 with injection arm slighlty swollen and red. counseld patient on necessary steps, instructed to contact health care provider along with reporting the adverseevent to VAERs
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Pruritus
Clinical narrative: Patient reported allergic reaction to the flu shot, claimed that her arm is red and itching.  She will come in for us to take a look and we will go from there.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Gout, Malaise
Clinical narrative: Gout flare up with joint pain in new area (left hip, left knee).  9/1/24 night time with night sweats. Malaysia and extremely tired.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Gout flare up with joint pain in new area (left hip, left knee).  9/1/24 night time with night sweats. Malaysia and extremely tired.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Hypoaesthesia, Influenza like illness, Lethargy, Nausea
Clinical narrative: NUMB LEGS, SHIVERS, FLU LIKE SYMPTOMS, NAUSEA, LETHARGIC.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red around injection site, a bit hot to the touch
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Crying, Discomfort, Extra dose administered, Gastrostomy
Clinical narrative: My daughter was "inadvertently" double dosed with the flu vaccine in 2020. The first was 2/7/202; lot # 9579P; IM; to LVL site; ;Manufacturer Biomedical. Per facility staff, it was "time" for another flu shot, although I was told when asked about the timing that she was dosed in February of the same year and was assured there would be no issue. The evening following vaccination, pt. presented with fever >100 for weeks to a month; consistent coughing; excessive crying; emergency room visits 2-3 times within the month following vaccination; low SpO2 between 92-94 for the full month; spitting up mucus regularly, greater than usual amounts/frequencies; throwing up; could not tolerate G-tube feeds; and inability to sleep due to discomfort.  I made at least 5-8 overnight all call outreaches to doctors seeking protocols for how to handle her care and at least 1-2 doctors visits in addition to the 2-3 ER visits previously mentioned. First vaccine (2/7/202) was Fluzone/Flulaval; 2nd vaccine (11/4/2020) was Flulaval/Fluarix/Fluzone.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Oxygen saturation decreased, Pyrexia, Secretion discharge, Vomiting
Clinical narrative: My daughter was "inadvertently" double dosed with the flu vaccine in 2020. The first was 2/7/202; lot # 9579P; IM; to LVL site; ;Manufacturer Biomedical. Per facility staff, it was "time" for another flu shot, although I was told when asked about the timing that she was dosed in February of the same year and was assured there would be no issue. The evening following vaccination, pt. presented with fever >100 for weeks to a month; consistent coughing; excessive crying; emergency room visits 2-3 times within the month following vaccination; low SpO2 between 92-94 for the full month; spitting up mucus regularly, greater than usual amounts/frequencies; throwing up; could not tolerate G-tube feeds; and inability to sleep due to discomfort.  I made at least 5-8 overnight all call outreaches to doctors seeking protocols for how to handle her care and at least 1-2 doctors visits in addition to the 2-3 ER visits previously mentioned. First vaccine (2/7/202) was Fluzone/Flulaval; 2nd vaccine (11/4/2020) was Flulaval/Fluarix/Fluzone.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: male patient (6 months old) was given KINRIX instead of INFANRIX in the third dose of the DTAP series for this specific patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 20-AUG-2024, the patient received Kinrix. On 20-AUG-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: male patient (6 months old) was given KINRIX instead of INFANRIX in the third dose of the DTAP series for this specific patient). 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  The patient was given Kinrix instead of Infanrix in the third dose of the DTAP series for this specific patient, which led wrong vaccine administered. Clinical pharmacist wants to know which recommendations could be issued in this situation. The case was linked to case US2023105255 for same reporter.; Sender's Comments:  US-GSK-US2023105255:Same reporter
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 year old recieved Kinrix; catching up with DTAP and IPV for her age but instead they gave kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 23-JUL-2024, the patient received the 1st dose of Kinrix. On 23-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 year old recieved Kinrix) and wrong vaccine administered (Verbatim: catching up with DTAP and IPV for her age but instead they gave kinrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 23-AUG-2024 Nurse called to report that a 2 year old child for some vaccines and accidentally gave her the Kinrix vaccine. Patient was catching up with DTAP and IPV for her age but instead they gave kinrix (which is for patients aged between 4 and 6 years old) which led to which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: most patients don't return for second dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: most patients don't return for second dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2024 The physician reported that he would like more information since most patients didn't return for the second dose.  The physician asked if there was clinical trial data available after just one dose of Bexsero.  Till the time of reporting, the patients did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: rse used the wrong solution (sterile saline) to reconstitute the Shingrix vaccine; nurse used the wrong solution (sterile saline) to reconstitute the Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 45N4Z, expiry date 19-JUN-2026) for prophylaxis.   On 22-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular). On 22-AUG-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: rse used the wrong solution (sterile saline) to reconstitute the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: nurse used the wrong solution (sterile saline) to reconstitute the Shingrix vaccine). The outcome of the wrong solution used in drug reconstitution was resolved and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK Receipt Date: 23-AUG-2024 The reporter was the Medical Assistant at the Healthcare professional office. Reporter stated the nurse used the wrong solution (sterile saline) to reconstitute the Shingrix vaccine which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Reporter stated that the nurse did not use the adjuvant that came in the box with the Shingrix vaccine. Medication was administered by an experienced provider.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Fatigue, Influenza, Pain
Clinical narrative: body aches; chills; high fever; arm pain; exhausted; flu symptoms; bedridden; This non-serious case was reported by a consumer via call center representative and described the occurrence of bedridden in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAR-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bedridden (Verbatim: bedridden), general body pain (Verbatim: body aches), chills (Verbatim: chills), fever (Verbatim: high fever), pain in arm (Verbatim: arm pain), exhaustion (Verbatim: exhausted) and flu symptoms (Verbatim: flu symptoms). (Dechallenge was negative). The outcome of the bedridden was resolved (duration 8 days) and the outcome of the general body pain, chills, fever and pain in arm were unknown and the outcome of the exhaustion was unknown (duration 8 days) and the outcome of the flu symptoms was resolved (duration 10 days).   It was unknown if the reporter considered the bedridden, general body pain, chills, fever, pain in arm, exhaustion and flu symptoms to be related to Shingrix.     It was unknown if the company considered the bedridden, general body pain, chills, fever, pain in arm, exhaustion and flu symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-AUG-2024 Patient reported that she received the 1st dose of Shingrix on March 20th 2024 in the left arm at her physician's office and had severe flu symptoms over 10 days. Patient reported being exhausted, arm pain, high fever, chills, body aches. Patient reported she was bedridden for at least 8 days. The patient wanted specific information for patients who had an adverse grade three reaction to dose one of Shingrix that lasted over ten days and felt was given general information. The patient just felt that she was given the standard answer that was not really specific to her case. Lot and expiration were not available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: body aches; chills; high fever; arm pain; exhausted; flu symptoms; bedridden; This non-serious case was reported by a consumer via call center representative and described the occurrence of bedridden in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAR-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bedridden (Verbatim: bedridden), general body pain (Verbatim: body aches), chills (Verbatim: chills), fever (Verbatim: high fever), pain in arm (Verbatim: arm pain), exhaustion (Verbatim: exhausted) and flu symptoms (Verbatim: flu symptoms). (Dechallenge was negative). The outcome of the bedridden was resolved (duration 8 days) and the outcome of the general body pain, chills, fever and pain in arm were unknown and the outcome of the exhaustion was unknown (duration 8 days) and the outcome of the flu symptoms was resolved (duration 10 days).   It was unknown if the reporter considered the bedridden, general body pain, chills, fever, pain in arm, exhaustion and flu symptoms to be related to Shingrix.     It was unknown if the company considered the bedridden, general body pain, chills, fever, pain in arm, exhaustion and flu symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-AUG-2024 Patient reported that she received the 1st dose of Shingrix on March 20th 2024 in the left arm at her physician's office and had severe flu symptoms over 10 days. Patient reported being exhausted, arm pain, high fever, chills, body aches. Patient reported she was bedridden for at least 8 days. The patient wanted specific information for patients who had an adverse grade three reaction to dose one of Shingrix that lasted over ten days and felt was given general information. The patient just felt that she was given the standard answer that was not really specific to her case. Lot and expiration were not available.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Reports that a pediatric dose of suspect vaccine was given by mistake to an adult.; Reports that a pediatric dose of suspect vaccine was given by mistake to an adult.; 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 20-year-old male patient who received HAV (Havrix pediatric) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   On 20-AUG-2024, the patient received Havrix pediatric (injection, left deltoid). On 20-AUG-2024, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Reports that a pediatric dose of suspect vaccine was given by mistake to an adult.) and underdose (Verbatim: Reports that a pediatric dose of suspect vaccine was given by mistake to an adult.). 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: 23-AUG-2024  An HCP reported that a pediatric dose of suspect vaccine was given by mistake to an adult which led to Adult use of a child product and underdose.
Age: 71.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo  over recommended age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 71-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 23-JUL-2024, the patient received the 1st dose of Menveo. On 23-JUL-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo  over recommended age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2024 Pharmacist called to report Menveo was administered to a 71 year old patient that was going to have a splenectomy which led to inappropriate age at vaccine administration. Doctor indicated a second dose of Menveo that has not been administered yet. Pharmacist is calling for information in order to make clinical decision. The case was linked to US2024105569, same reporter.; Sender's Comments:  US-GSK-US2024105569:Duplicate case
Sex: U
Vaccine: HEPAB
Symptoms: Product preparation issue
Clinical narrative: inappropriate reconstitution technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced inappropriate reconstitution technique (Verbatim: inappropriate reconstitution technique). The outcome of the inappropriate reconstitution technique 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: 23-AUG-2024 The health care professional (HCP) stated she did not followed steps to ensure she was shaking the syringe by tipping it upside down and back upright again (inappropriate reconstitution technique.)    Once the HCP followed PI instructions she was able to properly reconstitute Twinrix. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Today his arm is painful at the injection site, and painful with movement.; Arm pain with movement; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-AUG-2024, the patient received the 1st dose of Shingrix. On 23-AUG-2024, 2 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Today his arm is painful at the injection site, and painful with movement.) and pain in arm (Verbatim: Arm pain with movement). The outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-AUG-2024 The reporter reported that the patient received his first dose of Shingrix vaccine two days prior to the reporting day and today (on the reporting day) his arm was painful at the injection site and painful with movement.
Age: 75.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 3rd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 13 December 2020) and Engerix B (2nd dose received on  20 January 2021, lot number 5YY7T, expiration date 05 March 2021).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: 3rd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2024 Pharmacist reported that a 75 year old female patient received first dose of Engerix-B series on 13 December 2020, second dose on 20 January 2021, and then there was no record of the third dose ever being administered. The first two doses were administered from lot number 5YY7T (expiration date 05 March 2021). Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination.
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine administered; This non-serious case was reported by a physician via sales rep 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: Incorrect vaccine administered). 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: 23-AUG-2024 The reporter reported, the patient who had erroneously received a dose of Bexsero instead of Boostrix, which led wrong vaccine administered.  The reporter asked, when this patient comes of age for MenB vaccination, should the schedule be restarted or would the patient just need one more dose of Bexsero to be considered complete.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Incorrect dose administered
Clinical narrative: unfortunately he received 2 polio vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   Co-suspect products included Polio vaccine inact 3v (Vero) (Ipol) for prophylaxis.   On 23-AUG-2024, the patient received the 2nd dose of Kinrix and Ipol. On 23-AUG-2024, an unknown time after receiving Kinrix, the patient experienced accidental overdose (Verbatim: unfortunately he received 2 polio vaccines). The outcome of the accidental overdose 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: 23-AUG-2024 A patient that afternoon and unfortunately he received 2 polio vaccines, they received the Ipol and they received the Kinrix, which led to overdose of polio part of the vaccine.  The reporter did already spoke with Sanofi about the ipol but also wanted to spoke regarding the Kinrix and wanted if had any data regarding an Adverse Event if the child received the kinrix, about 2 doses of polio. Consented to follow up.