chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Abdominal pain, Barium double contrast, Constipation, Diarrhoea, Influenza
Clinical narrative: Ileocolic intussusception of the intestine, initial symptoms on 2/4/2024 of diarrhea, 2/5/2024 had vomiting and more sleepy and listless with congestion and abdominal pain, negative swab for flu A and B, RSV and COVID-19.  Presented to ED a second time with worsening vomiting symptoms with no stool x 3 days  and swabbed positive for influenza A at that time.  Abdominal ultrasound showed ileocolic intussusception.  Air enema unsuccessful at reducing, so patient taken to OR for ex-lap and small bowel resection completed.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Influenza A virus test positive, Influenza B virus test, Influenza virus test negative, Intussusception, Laparotomy
Clinical narrative: Ileocolic intussusception of the intestine, initial symptoms on 2/4/2024 of diarrhea, 2/5/2024 had vomiting and more sleepy and listless with congestion and abdominal pain, negative swab for flu A and B, RSV and COVID-19.  Presented to ED a second time with worsening vomiting symptoms with no stool x 3 days  and swabbed positive for influenza A at that time.  Abdominal ultrasound showed ileocolic intussusception.  Air enema unsuccessful at reducing, so patient taken to OR for ex-lap and small bowel resection completed.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Listless, Procedural failure, Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Ileocolic intussusception of the intestine, initial symptoms on 2/4/2024 of diarrhea, 2/5/2024 had vomiting and more sleepy and listless with congestion and abdominal pain, negative swab for flu A and B, RSV and COVID-19.  Presented to ED a second time with worsening vomiting symptoms with no stool x 3 days  and swabbed positive for influenza A at that time.  Abdominal ultrasound showed ileocolic intussusception.  Air enema unsuccessful at reducing, so patient taken to OR for ex-lap and small bowel resection completed.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Small intestinal resection, Somnolence, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Ileocolic intussusception of the intestine, initial symptoms on 2/4/2024 of diarrhea, 2/5/2024 had vomiting and more sleepy and listless with congestion and abdominal pain, negative swab for flu A and B, RSV and COVID-19.  Presented to ED a second time with worsening vomiting symptoms with no stool x 3 days  and swabbed positive for influenza A at that time.  Abdominal ultrasound showed ileocolic intussusception.  Air enema unsuccessful at reducing, so patient taken to OR for ex-lap and small bowel resection completed.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fear, Hypoaesthesia, Laboratory test
Clinical narrative: A week after second Moderna shot I started going numb randomly (fingers/arms/side/face). This was very scary and went on for a year until I had a stroke.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Bacterial test, Borrelia test negative, C-reactive protein normal, CSF cell count normal, CSF oligoclonal band absent
Clinical narrative: Development of acute weakness of left tricep muscle, numbness in left ulnar distribution, hyperaesthesia in right S1 dermatome 6 days after vaccination of COVID 19 and flu.  Subsequently diagnosed with segmental myelitis of C5-6 on MRI with negative workup for other neurologic or infectious disease.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: CSF protein normal, Demyelination, Full blood count normal, Hyperaesthesia, Hypoaesthesia
Clinical narrative: Development of acute weakness of left tricep muscle, numbness in left ulnar distribution, hyperaesthesia in right S1 dermatome 6 days after vaccination of COVID 19 and flu.  Subsequently diagnosed with segmental myelitis of C5-6 on MRI with negative workup for other neurologic or infectious disease.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Myelitis, Red blood cell sedimentation rate normal
Clinical narrative: Development of acute weakness of left tricep muscle, numbness in left ulnar distribution, hyperaesthesia in right S1 dermatome 6 days after vaccination of COVID 19 and flu.  Subsequently diagnosed with segmental myelitis of C5-6 on MRI with negative workup for other neurologic or infectious disease.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Viral test
Clinical narrative: Development of acute weakness of left tricep muscle, numbness in left ulnar distribution, hyperaesthesia in right S1 dermatome 6 days after vaccination of COVID 19 and flu.  Subsequently diagnosed with segmental myelitis of C5-6 on MRI with negative workup for other neurologic or infectious disease.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Polymyalgia rheumatica
Clinical narrative: Severe Polymyalgia Rheumatica (PMR) after 2nd booster of Modera Vaccine
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient came in pharmacy to get a covid vaccine. her insurance had an alert stating she was due for rsv. pharmacist offered to give her abrysvo.  patient agreed to the vaccine.  after giving the vaccine on 2/17/24, it was discovered that pt had another rsv vaccine, arexvy on 8/28/2023.     Pt reported no concerns of this duplicate vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Came down with fever, headache, chills, muscle aches, joint pain, nausea at around 2am, 7/16/2024. Lasted for roughly 24 hrs. Afterward I have no sense of taste.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pyrexia
Clinical narrative: Came down with fever, headache, chills, muscle aches, joint pain, nausea at around 2am, 7/16/2024. Lasted for roughly 24 hrs. Afterward I have no sense of taste.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever, and soreness in the arm
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis. Pt self-treated with diphenhydramine and epinephrine auto injector on way to emergency room
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Auscultation, Cough, Dry mouth, Dysphagia
Clinical narrative: Anaphylaxis. Pt self-treated with diphenhydramine and epinephrine auto injector on way to emergency room
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Hypersensitivity, Nausea, Odynophagia, Oropharyngeal pain
Clinical narrative: Anaphylaxis. Pt self-treated with diphenhydramine and epinephrine auto injector on way to emergency room
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Throat irritation, Wheezing
Clinical narrative: Anaphylaxis. Pt self-treated with diphenhydramine and epinephrine auto injector on way to emergency room
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: During administration a small amount of the medication leaked down patients arm. Patient was not harmed. No injury occurred.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen left arm, swollen armpit lymph node, swollen neck lymph nodes and clavicle lymph nodes
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Gait inability, Irritability, Lethargy, Pain in extremity
Clinical narrative: High fever for 24 hours after vaccination, severe pain in thigh and swelling. Most of his thigh swelled up turned red and was hot and painful to the touch. Did not want to walk due to leg pain and didn?t want leg looked at or touched, was lethargic and whiny, pale looking skin. He also had tiny red dots under his eyes. Still has leg pain on 2/17/2024
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: High fever for 24 hours after vaccination, severe pain in thigh and swelling. Most of his thigh swelled up turned red and was hot and painful to the touch. Did not want to walk due to leg pain and didn?t want leg looked at or touched, was lethargic and whiny, pale looking skin. He also had tiny red dots under his eyes. Still has leg pain on 2/17/2024
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram head, Eye pain, Eye swelling, Magnetic resonance imaging head, Scan with contrast
Clinical narrative: Swelling in left eye with severe pain behind eye, symptoms very similar to ocular  neuritis
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: generalized hives noted the next morning
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Acute short term memory loss that is worsens overtime as of today.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Exposure during pregnancy, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Swelling red at injection site right in the next day of injection. Fatique, extreme nausea, stomachace happens three days later when the swelling partially reduced. 28 week pregnant, est deliver May 8 2024
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea
Clinical narrative: Swelling red at injection site right in the next day of injection. Fatique, extreme nausea, stomachace happens three days later when the swelling partially reduced. 28 week pregnant, est deliver May 8 2024
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: Tinnitus
Clinical narrative: Tinitus, never previously suffered and told it would likely stop within weeks or months but now has been present for 2 years and is constant
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Palpitations
Clinical narrative: fatigue, chest pain, palpitations, tiredness
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Exactly three months of vaccine received got COVID 19. Just wanted CDC to know the length of coverage was short.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error, Pyrexia
Clinical narrative: Patient came in for booster of Pfizer vaccine 6months to 4 years. Medical assistant did not dilute vial and administered full vial to patient instead of 0.3ml. Followed up with mother the next day and mother stated the patient is doing well, just has a fever. Followed up again 2 days later and mother stated that the patient is doing well, has no more fevers, and no vaccine site reaction.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diabetes mellitus
Clinical narrative: Became diabetic within days of the Pfizer vaccine. Blood sugar was always around 108 until the vaccine, jumped to 150.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: patient states his arm is very sore and has been since after his vaccine, patient also states he has limited mobility
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Visual field defect
Clinical narrative: Stroke that caused the loss of my right peripheral vision.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient came in today (4 days post vaccination) with a skin rash on the left upper and lower arm (opposite arm of vaccination). It appeared as tiny small red dots in a straight line (on the lower arm) and 3 short straight lines side by side on the upper arm. It almost looked as if it was a scratch but he had not done anything. Patient stated that he woke up this morning and it was there.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness, Eye irritation
Clinical narrative: EYE IRRITATION LEADING TO BLINDNESS
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Blood test, Magnetic resonance imaging, Optic ischaemic neuropathy, Optic neuritis
Clinical narrative: EYE IRRITATION LEADING TO BLINDNESS
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred
Clinical narrative: EYE IRRITATION LEADING TO BLINDNESS
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt states she had a headache the day after the Arexvy shot and then the read brusied looking area occured with the warm to touch in the area and itching.  Pt states she has not taken anything for the reaction.  Requested pt  take Benadyl for the itching and you cool compresses on the area.  Also told patient to seek medical attention if symptoms worsen or does not improve in the next couple of days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pt received the Spikevax vaccine on 2/16/2024. The vaccine was moved from the freezer to the fridge and was one day beyond the BUD of 30 days. BUD was 2/15/2024. Although the vaccine expiration date was still good it was just passed the BUD.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Pruritus, Rash, Urticaria
Clinical narrative: Patient woke up 2/16/2024 complaining of posterior head itching, rash on back of neck, trunk and legs noted in AM. Gave 2.5 ml benadryl and had clinic visit in early afternoon. Provider unsure if related to amoxicillin hypersensitivity but no Hx of previous reaction. Also told it could possibly be viral rash but also had 2nd Hep A vaccine a couple of days prior. Hives worse on 02/17/2024, and spreading into axilla, groin, buttocks, and flanks. Benadryl continue in 2 divided doses each day. 02/18/2024 some hives fading but still progressing to anterior neck, face, arms, hands, distal legs and feet. No airway issues.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccination administered to patient.  Administration date was 02/17/2024.    Expiration Date of Administered vaccine was 01/18/2024.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient called Sunday 2/18/24 to report she had redness and swelling at injection site that started shortly after the vaccine that had not completely resolved.  She was treating with warm compresses and Tylenol.  The swelling has come down, but not completely resolved.  Patient also stated having a fever(she did not confirm with thermometer) she felt very hot the day following the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Asthenia, Blood test normal, Bronchitis, Chest X-ray normal
Clinical narrative: Over the past time since receiving this booster, I have had no energy, being completely fatigued to the point in which I had to stop my daily walk and stationary bike.  I have had severe headaches for 6 weeks and now go to massage therapy weekly.  I because of this unknown as to why I?m no longer me has caused me severe anxiety.  I also have had bronchitis constantly.  I have never had anything like this happen to me.  When I saw my Drlast fall, he said it sounded like long haul Covid.  I self tested for Covid many time and all were negative.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exercise tolerance decreased, Fatigue, Headache, SARS-CoV-2 test negative
Clinical narrative: Over the past time since receiving this booster, I have had no energy, being completely fatigued to the point in which I had to stop my daily walk and stationary bike.  I have had severe headaches for 6 weeks and now go to massage therapy weekly.  I because of this unknown as to why I?m no longer me has caused me severe anxiety.  I also have had bronchitis constantly.  I have never had anything like this happen to me.  When I saw my Drlast fall, he said it sounded like long haul Covid.  I self tested for Covid many time and all were negative.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac monitoring, Cognitive disorder, Electroencephalogram, Magnetic resonance imaging
Clinical narrative: Suffered a mini stroke followed by heart problems, memory, cognitive and other neurological issues. Am currently still having ongoing testing with the hospital.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Neurological symptom, Neuropsychological test, Transient ischaemic attack
Clinical narrative: Suffered a mini stroke followed by heart problems, memory, cognitive and other neurological issues. Am currently still having ongoing testing with the hospital.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: numbness in left arm, shooting pain in arm, headache, feet started to ache
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Periorbital swelling, Skin discolouration
Clinical narrative: soreness at injection site; purplish brown spot under left eye, it appears as if someone punched him in the eye; The spot is raised and puffy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LL942, expiry date 31-MAR-2025) for prophylaxis.   On 06-NOV-2023, the patient received Arexvy (intramuscular, left arm) .5 ml. On 06-NOV-2023, 1 hr after receiving Arexvy, the patient experienced injection site pain (Verbatim: soreness at injection site) and skin discoloration (Verbatim: purplish brown spot under left eye, it appears as if someone punched him in the eye). In NOV-2023, the patient experienced periorbital swelling (Verbatim: The spot is raised and puffy). The outcome of the injection site pain was resolved and the outcome of the skin discoloration and periorbital swelling were not resolved.   It was unknown if the reporter considered the injection site pain, skin discoloration and periorbital swelling to be related to Arexvy.     It was unknown if the company considered the injection site pain, skin discoloration and periorbital swelling to be related to Arexvy.   Additional Information: GSK receipt date: 10-NOV-2023 The reporter reported that, the patient received Arexvy vaccine on his left arm. The reporter reported a purplish brown spot under the left eye of the patient. The reporter stated that it appears as if someone had punched him in the eye, the spot was raised and puffy. The reporter had notified all three of his healthcare professionals (HCP's) about the adverse reaction. The reporter consented to follow up and gives permission to contact all three HCP's.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Foreign travel, Life support, Malaise
Clinical narrative: cardiac arrest, ecmo, remdesivir treatment death after 20 days
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: cardiac arrest, ecmo, remdesivir treatment death after 20 days
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Lung assist device therapy
Clinical narrative: cardiac arrest, ecmo, remdesivir treatment death after 20 days
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Dizziness, Lung assist device therapy, Malaise
Clinical narrative: cardiac arrest, ecmo, remdesivir treatment death after 20 days
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, SARS-CoV-2 test positive, Skin discolouration, Syncope
Clinical narrative: cardiac arrest, ecmo, remdesivir treatment death after 20 days
Age: 66.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Anxiety, Balance disorder, Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in right arm,tingling sensation, burning, numbness in feet
Age: 66.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Burning sensation, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: numbness in right arm,tingling sensation, burning, numbness in feet
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE. No PQC.; Nurse Practitioner called to report a dose of expired ROTATEQ was administered to a patient. Date of administration 01/10/2024. Expiration date of the product was 12/10/2023. Caller confirmed there has never been a temperature excursion with the prod; This spontaneous report was received from nurse practitioner and refers to a 6-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Patient was under concomitant therapies.  On 10-JAN-2024, the patient was vaccinated with the 2nd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1890316, expiration date: 10-DEC-2023 (expired product administered), administered orally for prophylaxis (strength was not provided).  No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; A HCP called to report a TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 01/10/2024.; This spontaneous report has been received from a medical assistant and refers to an 8-week-old patient of unknown gender.  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 02-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) suffered a temperature excursion within a timeframe of 9 hours and 32 minutes at a 54.3 Fahrenheit (F) temperature. On 05-DEC-2023, excursion happened in a 15 hours and 30 minutes timeframe at a 57.7 F temperature, on 06-DEC-2023, timeframe of 5 hours and 43 minutes at 50.2 F; on 07-DEC-2023, in a 1-hour, 55-minute timeframe and for 11 hours and 3 minutes at a 52.7 F. The last one took place on 11-DEC-2023 in 1 hour, 47 minutes at 48.4 F. On 10-JAN-2024, the patient was vaccinated with both, hamophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at a dose of 0.5 milliliter (mL) (lot number X003664 has been determined to be valid for b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and validated as 10-NOV-2025); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose (lot number 1965644 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and validated as 02-OCT-2024). Both vaccines were administered for prophylaxis after they had suffered a temperature excursion (product storage error) (for both vaccines, strength, vaccination scheme, anatomical site of administration and route of administration were not provided). The patient did not report any adverse issues or side effects.; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015432: US-009507513-2401USA015463:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Serology negative
Clinical narrative: Received A Hepatitis B Series And Show No Antibodies; Initial report received on 01-Dec-2023  A patient in the reported that she, a female (age, race, and ethnicity not provided), received a hepatitis B vaccine series (not sure which one) for hepatitis B immunization and showed no antibodies when tested.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On unknown dates in 2020, the patient received a hepatitis B vaccine series (name and details not provided).   On an unknown date, after having been vaccinated with the hepatitis B series, the patient was tested and had no antibodies.  The patient refused to provide any other information.   Company Comment: The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure since the vaccine dosing schedule and the time to serological marker testing were not specified.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure since the vaccine dosing schedule and the time to serological marker testing were not specified.
Age: 64.0
Sex: M
Vaccine: RVX
Symptoms: Fatigue, Pain, Somnolence
Clinical narrative: tired and achy; Achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 06-FEB-2024 22:00, the patient received RSV vaccine. In FEB-2024, an unknown time after receiving RSV vaccine, the patient experienced tiredness (Verbatim: tired and achy) and pain (Verbatim: Achy). The outcome of the tiredness and pain were not resolved.   It was unknown if the reporter considered the tiredness and pain to be related to RSV vaccine.     It was unknown if the company considered the tiredness and pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-FEB-2024 The reporter was the wife of the patient. The reporter said that her husband (patient) had received same shot of RSV vaccine at the same time at 10 PM on Tuesday (from the date of reporting) and he was tired and achy still (till the time of reporting). He took skipped dinner to last night (day before reporting) to sleep. The reporter wanted to know was this a reaction to the shot or should she report it. The patient was skipped dinner to last night to sleep. The reporter wanted to know for how long tiredness would be last. This case was linked with US2024AMR018464, reported by same reporter for herself. The consent to follow up requested.; Sender's Comments:  US-GSK-US2024AMR018464:Same reporter, different patient
Sex: F
Vaccine: FLUX, RSV
Symptoms: Fatigue, Limb discomfort, Malaise, Pain in extremity
Clinical narrative: not feel well at all; had increased fatigue; significant injected arm pain; She felt like her arm was going to fall off; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm) and Influenza vaccine (unknown arm). On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving Influenza vaccine, the patient experienced feeling unwell (Verbatim: not feel well at all), fatigue (Verbatim: had increased fatigue), pain in arm (Verbatim: significant injected arm pain) and arm discomfort (Verbatim: She felt like her arm was going to fall off). The outcome of the feeling unwell, fatigue, pain in arm and arm discomfort were resolved.   It was unknown if the reporter considered the feeling unwell, fatigue, pain in arm and arm discomfort to be related to Arexvy.     It was unknown if the company considered the feeling unwell, fatigue, pain in arm and arm discomfort to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-FEB-2024 The nurse reported that the patient had received Arexvy vaccine and an Influenza vaccine in the same arm. The patient did not feel well at all, and she had increased fatigue, significant injected arm pain. The patient felt like her arm was going to fall off. The reporter reported that symptoms resolved, and no treatment was needed. It was unknown if the reporter considered the feeling unwell, fatigue, pain in arm and arm discomfort to be related to Influenza vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Exposure via skin contact, Incorrect dose administered, Underdose
Clinical narrative: Havrix dose the patient move causing about half the dose to spill down; half the dose to spill down the patient's leg; half the dose to spill down the patient's leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a 19-month-old male patient who received HAV (Havrix) (batch number G79C4, expiry date 20-SEP-2025) for prophylaxis.   On 08-FEB-2024, the patient received the 2nd dose of Havrix. On 08-FEB-2024, an unknown time after receiving Havrix, the patient experienced incomplete dose administered (Verbatim: Havrix dose the patient move causing about half the dose to spill down), inadvertent exposure to vaccine (Verbatim: half the dose to spill down the patient's leg) and exposure via skin contact (Verbatim: half the dose to spill down the patient's leg). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 09-FEB-2024 Immunization clinic coordinator called to report that while administrating a Havrix dose the patient move causing about half the dose to spill down the patient's leg, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female 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 pain in arm (Verbatim: Arm soreness). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-FEB-2024 The case was reported by patient itself. The patient developed soreness on her arm after receiving the Arexvy vaccine.  The patient reports soreness has persisted for 5 months.  Soreness changes depending on the position of the arm and movements of the arm.  The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: inadvertently reconstituted Arexvy antigen with Shingrix diluent and administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-FEB-2024, the patient received Arexvy. On 09-FEB-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: inadvertently reconstituted Arexvy antigen with Shingrix diluent and administered). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 12-FEB-2024 The pharmacist reported that, she inadvertently reconstituted Arexvy antigen with Shingrix diluent and administered to a patient, which led to wrong solution used in drug reconstitution. At the time of reporting lot, expiration date of vaccine and patient's date of birth not available. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 6-month-old patient had received a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 09-FEB-2024, the patient received Kinrix. On 09-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 6-month-old patient had received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration 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: 12-FEB-2024 The primary care supervisor called to inform that a 6 months old patient had received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: MMR
Symptoms: Intercepted product preparation error
Clinical narrative: Intercepted Med Error (Priorix reconstituted with diluent not supplied with vaccine); This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product preparation error in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced intercepted product preparation error (Verbatim: Intercepted Med Error (Priorix reconstituted with diluent not supplied with vaccine)). The outcome of the intercepted product preparation error 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: 12-FEB-2024 The vaccine with a diluent or sterile water that was not accompanied with the vaccine and the vaccine was prepared but was not administered to a patient, which led to intercepted product preparation error. The vaccine coordinator asks if they were to mix Priorix with sterile water that did not come with the vaccine, was that okay?  The vaccine administration Facility was the same as Primary Reporter. No additional information available as the decision was made to file the adverse event was made after the call was disconnected.  Unknown if follow up was permissible.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: She does not know the temps they were exposed to but states that they were below the recommended temperature.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: She does not know the temps they were exposed to but states that they were below the recommended temperature.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2024 The reporter stated that they received a Boostrix recall letter from their wholesaler, stating that there was a below temperature excursion before the vaccines arrived to the facility.  She was asking for below stability data as she believed that some patients received the recalled Boostrix and she did not know the temperature they were exposed to but stated that they were below the recommended temperature, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No patient demographics (exact number of patient was unknown at this time) or other information available at this time.  The reporter forgot to ask the formulation so prefilled syringe was chosen and asked to follow up via postal.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: gave a patient the hib portion of pentacel separate from the dtap polio portion with no reported adverse event; Initial information was received on 08-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who received the hib portion of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] separate from the dtap polio portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine) for Immunisation.  On 06-Feb-2024, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine  (Suspension for injection) (lot UJ985AA,Expiry date: 14-Feb-2025, strength was unknown) via unknown route in the left thigh for Prophylactic vaccination (Immunization) and gave a patient the hib portion of pentacel separate from the dtap polio portion with no reported adverse event (product preparation error) (latency : same day).  Reportedly "Treatment One 06Feb2024, a patient received the HIB portion of Pentacel in the left thigh. The HIB portion received was reconstituted with sterile water instead of the DTaP-IPV diluent provided in the Pentacel kit. The patient did not receive the DTaP-IPV portion"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Cough, Pyrexia, Vaccination site pain
Clinical narrative: Some cough; Fever; Achy shot site; This spontaneous case from the (Privacy) was received on 06-Feb-2024 from an other healthcare professional via Med Communications (reference number SEQW24-00530) and concerned a 7-month-old, male patient.   The patient's concurrent condition included exposure to COVID-19, as it was reported that mom/dad had COVID. The patient had no known allergies. The patient's concomitant medications were not reported.    On 26-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: not reported, route of administration: intramuscular and anatomical location: left thigh) as active immunization against influenza disease. The batch number reported was 373546.  On the same date, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5 ml (instead of recommended 0.25ml), route of administration: intramuscular, anatomical location: right thigh and indication: not reported). The batch number reported was AU5558B.  On an unspecified date in 2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, the patient experienced achy shot site. The patient also experienced some cough and fever, as reported and so had to receive the protocol for cold/flu/COVID.  On an unspecified date in 2023, the patient recovered from all events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 7-month-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, on the same date. On unspecified date in 2023, an unknown amount of time after the vaccination, the patient experienced vaccination site pain, cough and pyrexia. The patient's concurrent condition included exposure to COVID-19, as it was reported that mom/dad had COVID. Based on anatomical plausibility, causality for vaccination site pain is assessed as possibly related. Causality for cough and pyrexia are unassessable due to unclear temporal relationship and reported exposure to COVID-19 infection.; Sender's Comments: A 7-month-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, on the same date. On unspecified date in 2023, an unknown amount of time after the vaccination, the patient experienced vaccination site pain, cough and pyrexia. The patient's concurrent condition included exposure to COVID-19, as it was reported that mom/dad had COVID. Based on anatomical plausibility, causality for vaccination site pain is assessed as possibly related. Causality for cough and pyrexia are unassessable due to unclear temporal relationship and reported exposure to COVID-19 infection.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Influenza
Clinical narrative: Influenza infection/ Flu virus A; This spontaneous case was received on 07-Feb-2024 from other non-healthcare professional (consumer) via Med Communications (reference number: SEQW24-00564) and concerned a 39-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. As reported, the patient had no underlying medical conditions.  On 24-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for active immunization against influenza disease. The batch number reported was 944444 and expiry date was 22-May-2024.  On 31-Jan-2024, three months and seven days after receiving Flucelvax Quadrivalent, the patient was diagnosed with influenza, type of flu virus A. As reported, the flu was not verified by nasal swab.  On an unspecified date in 2024, the patient was treated with Tamiflu (oseltamivir phosphate), at unknown dose and frequency and rest.  At the time of the initial reporting, the patient had not recovered from the event of an 'influenza A virus infection'. As reported, the patient still had symptoms that day.  The reporter did not provide a causality assessment.  The event of 'influenza A virus infection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  This case is linked to the case 202401052 (The same reporter).  Company comment: The patient was diagnosed with influenza three months and seven days after receiving the suspect product Flucelvax Quadrivalent. Reportedly, it was not verified by nasal swab. Based on the available information, causality is assessed as possibly related due to plausible chronology.; Sender's Comments: The patient was diagnosed with influenza three months and seven days after receiving the suspect product Flucelvax Quadrivalent. Reportedly, it was not verified by nasal swab. Based on the available information, causality is assessed as possibly related due to plausible chronology.
Age: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Influenza infection / Flu virus A; Influenza infection / Flu virus A /LoE; This spontaneous case was received on 07-Feb-2024 from other non-health professional (consumer) via Med Communications (reference number SEQW24-00564) and concerned a 7-year-old, male patient.   The patient had no relevant medical history and was not taking any concomitant medications. As reported, the patient had no underlying medical conditions.  On 24-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 mL, anatomical location: right deltoid, and route of administration: not reported) for active immunization against influenza disease. The batch number reported was 944444 and the expiry date was 22-May-2024.  On 05-Feb-2024, three months and 12 days after receiving Flucelvax Quadrivalent, the patient experienced influenza infection. No treatment was administered.  On an unspecified date in Feb-2024, flu virus type A was verified by nasal swab (explicitly coded as 'Vaccination failure').  On an unspecified date in Feb-2024, the patient recovered from the event of 'influenza A infection'. As reported, influenza infection lasted from three to seven days.  The reporter did not provide a causality assessment.  The event of 'influenza A virus infection' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  This case is linked with the case 202401051 (the same reporter).  Company comment: The patient was diagnosed with influenza three months and 12 days after receiving the suspect product Flucelvax Quadrivalent. Reportedly, flu virus type A was verified by nasal swab (explicitly coded as 'Vaccination failure'). Based on the available information, causality for influenza and vaccination failure is assessed as possibly related due to plausible chronology.; Sender's Comments: The patient was diagnosed with influenza three months and 12 days after receiving the suspect product Flucelvax Quadrivalent. Reportedly, flu virus type A was verified by nasal swab (explicitly coded as 'Vaccination failure'). Based on the available information, causality for influenza and vaccination failure is assessed as possibly related due to plausible chronology.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm rupture, Autopsy, Death, Heart rate increased
Clinical narrative: 11/10-11/25 Patient made statements about a Rapid Heart Rate, that he was monitoring with his apple watch. 11/28/23 presumed date of death based on last contact made with patient and clothing he was found in.  12/1/23 found in his home, documented dead. We were told it was likely a "medical event", which seemed unlikely as he was very athletic and healthy. He participated in marathons and exercised frequently. Autopsy later revealed a ruptured aortic aneurysm . The coroner never asked about vaccination status. We are surprised that out top rate CDC, the best in the world, does not have a protocol for investigating sudden and unexpected death in healthy young individuals as it relates to vaccination, particularly for such a novel vaccine. Patient had 5 covid vaccines over the course of 2 years. There is no family history of aneurysm. We have not been informed of any underlying genetic conditions that would have caused his aneurysm at such a young age. We hope that scientific attention is given to this particular long term and cumulative side effect of vaccination so that other young and healthy lives are saved.  Here are his other covid doses listed on his card: 1. 3/20/21 Pfizer (EP7534)   2. 4/10/21 Pfizer (EW0153)    3.  12/13/21  Moderna  (030H21B)  4.  9/25/22  Pfizer (GH9693).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Pruritus, Urticaria
Clinical narrative: Hives: sudden appearance of dramatic red patches in the morning three days after 2nd vaccine  2 Benadryl taken evening after appearance after confirmation of urticaria. Itchiness the following morning 1 Benadryl taken to try and relieve itch; This report made partially to distract from itch
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Death, Myocarditis
Clinical narrative: Expired of myocarditis
Age: 48.0
Sex: M
Vaccine: FLUC4, HEP, MMR, TDAP
Symptoms: Axillary pain, Back pain, Chest pain, Lymphadenopathy, Myalgia
Clinical narrative: Received flu, Hep B, MMR (R) Arm on 1/5/24 - On the evening of 1/5/24 he felt burning pain (R) armpit -> radiating to (R) chest /upper back Re-evaluation with HD on 1/8/24 when above reported - no redness, warmth, streaking, induration, discoloration at site: no adenopathy; 2 (2 mm) papulo lesions (R) inferior scapula 1/16/24 - Follow up - (+) adenopathy; multiple scabbed papular de roofed lesions (R) shoulder girdle (R) axilla  1/16/24 - Follow up -  (+) for myalgia; (-) for neck stiffness; (-) chills, fatigue, fever Follow up 1/22/24 - As above; no raw lesions abscessed - has been using topical steroid cream Follow up 1/31/24 - Lesions are 100% resolved; No cervical or axillary adenopathy - Discharged Am Care