chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Hypoaesthesia, Malaise, Mobility decreased
Clinical narrative: Patient stated that she started to not feel well Friday evening and her husband said she was not talking like herself, she was in bed all day Saturday, couldn't move her left leg and her arm was numb, she states that she had diarrhea for the next 2 days. Nurse asked if she had gotten checked since she has a history of CVA and patient stated she thought about it but her sister had the same reaction to her COVID vaccine.  States she finally felt good enough to get out of bed 10/31/24. Stated that her other COVID vaccines were Pfizer so she thinks it was because it was Moderna
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Gait disturbance, Guillain-Barre syndrome, Loss of personal independence in daily activities, Malaise
Clinical narrative: Patient received vaccine on 9/10/2024, she sent a message on 9/26/2024 stating she has not been feeling well since receiving the vaccine. Nurse contacted member and she described symptoms generalized leg & hand weakness, muscles cramps, facial edema, currently has difficulty walking, leg pain, needs assistance to maneuver stairs, open lids/ doors.  Increased muscle cramps & pain. Member advised to go to the Emergency room. One 9/27/2024 nurse followed up with member who said symptoms seemed to improve, patient advised to return to ER if they worsen. On 10/17/2024 provider received information that patient did not go to Neuro appointment, reached out to patient who stated she returned to the ER on 10/1/2024  and was scheduled an appointment with Neurology, patient was advised to return to ER if symptoms worsen. On 11/1 followed up with patient who stated she was admitted to the hospital on 10/26 and diagnosed with Guillan Barre.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Patient received vaccine on 9/10/2024, she sent a message on 9/26/2024 stating she has not been feeling well since receiving the vaccine. Nurse contacted member and she described symptoms generalized leg & hand weakness, muscles cramps, facial edema, currently has difficulty walking, leg pain, needs assistance to maneuver stairs, open lids/ doors.  Increased muscle cramps & pain. Member advised to go to the Emergency room. One 9/27/2024 nurse followed up with member who said symptoms seemed to improve, patient advised to return to ER if they worsen. On 10/17/2024 provider received information that patient did not go to Neuro appointment, reached out to patient who stated she returned to the ER on 10/1/2024  and was scheduled an appointment with Neurology, patient was advised to return to ER if symptoms worsen. On 11/1 followed up with patient who stated she was admitted to the hospital on 10/26 and diagnosed with Guillan Barre.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Heart rate increased, Insomnia
Clinical narrative: rapid heart rate, insomnia and headache.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Decreased appetite, Hypersomnia
Clinical narrative: Stomach pain, stomach swelling, Jaundice, temperature dysregulation, slept all the time no appetite. Weakness, feeling fluish and achy all as of 11/06
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Jaundice, Pain, Temperature regulation disorder
Clinical narrative: Stomach pain, stomach swelling, Jaundice, temperature dysregulation, slept all the time no appetite. Weakness, feeling fluish and achy all as of 11/06
Age: 63.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Diarrhoea, Fatigue, Headache, Sinus congestion
Clinical narrative: Fatigue, Headache, Sinus congestion lasted 5 days starting 1 day after receiving vaccine.      Diarrhea started 6 days after receiving vaccine, lasting for 3 days
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This patient is 2 yrs old 11 months and was given the moderna 12 years and up covid vaccine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Impaired work ability, Pyrexia
Clinical narrative: Flu vaccine given in left arm and COVID in right.  In addition to developing a fever of 101 degrees  should pain and discomfort was so significant that shoulder movement was limited for 3 days.  Work day was lost in full time job and productivity was limited for part time job.    Policy was at my workplace which completed vaccination that any side effects from vaccination are still paid time.  Without an announcement I was denied.  I asked if a VAERS report was completed and told no this case doesn't rise to reporting.  I was never asked what my symptoms were.  When I reported sick to work I stated I have "a fever among other issues".
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Noticed hives 30 mins- 1 hour after vaccine admin. No SOB, N/V, lightheaded. Resolved on own. Evaluated the following day.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: RED AND SWOLLEN ARM. WARM TO THE TOUCH. PAINFUL. SWOLLEN FOR 4  DAYS. RESOLVED ON ITS OWN.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Both vaccines were given in the same arm. The Flu shot was in the upper left arm while the Covid vaccine was lower in the arm, in the middle.  After 24 hours what appeared to be a rash started to develop at the Covid injection site. Approximately 40 hours after receiving the shot, the redness had spread and the arm was swollen, tender to touch, and very warm. I went to my doctor's office and was diagnosed with cellulitis. I was given Keflex 500mg 3x/day for 7 days. It continued to spread and after 48 hours I returned to my doctor and was switched to Bactrim 800-160mg 2x/day for 7 days.  The area started clearing about 12 hours after taking the first dose of Bactrim.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth
Clinical narrative: Both vaccines were given in the same arm. The Flu shot was in the upper left arm while the Covid vaccine was lower in the arm, in the middle.  After 24 hours what appeared to be a rash started to develop at the Covid injection site. Approximately 40 hours after receiving the shot, the redness had spread and the arm was swollen, tender to touch, and very warm. I went to my doctor's office and was diagnosed with cellulitis. I was given Keflex 500mg 3x/day for 7 days. It continued to spread and after 48 hours I returned to my doctor and was switched to Bactrim 800-160mg 2x/day for 7 days.  The area started clearing about 12 hours after taking the first dose of Bactrim.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt given an extra dose; no adverse event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Neck pain, Peripheral swelling, Ultrasound Doppler
Clinical narrative: Swollen hands and arms with pain in neck
Age: 26.0
Sex: F
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Hives started on arms, then legs and abdomen; patient ingested one benadryl and reported relief of symptoms.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient wanted a meningitis B vaccine and he was given a hepatitis B vaccine
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient had requested a pfizer covid vaccination and was given a Fluad in error
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hepatitis A was administered to the patient before age 1
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received 2 flu shots this season, one in July and one on 11/4/24. The patient requested a flu shot on 11/4/24 and the person typing it in did not see that it had already been received in July. The patient INTENTIONALLY got another flu shot because she said her school required proof of flu vaccine after August 2024.  She did NOT have an adverse reaction.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Angioedema
Clinical narrative: angioedema upper lip only. No other symptoms. (Pharmacy did not provide me lot number. Provided at store and he came to my office 3 hours later with the angioedema.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Skin warm
Clinical narrative: Patient presented to the pharmacy reporting that her arm became red and warm 2 days after receiving  Prevnar 20.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Cough, slight fever, congestion
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle contractions involuntary
Clinical narrative: 3 days after administration, patient described developing fasiculations in her left thumb (received injection in the left arm) and decreased sensation from thumb to elbow on radial aspect of left forearm.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Vaccination site mass
Clinical narrative: "lump" at vaccination site for 4 days, no pain. Rash on day 2 that was from elbow to mid bicep and resolved within an hour of applying hydrocortisone OTC cream. Day 3 rash returned to same area, but less severe and once again completely resolved within an hour of applying hydrocortisone OTC cream.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Back pain, Blood test normal, Contusion, Cyanosis, Dizziness
Clinical narrative: She felt fine for a few days, then she developed fatigue and became dizzy. Her face started to swell and her lips turned blue. Her neck felt like it was closing in and she couldn't breath. She went to Hospital. They did an EKG that was negative. Blood work was normal. She was given Tylenol and sent home. She was still feeling very ill. On Nov 2nd, she had a virtual video appt with UC. She was prescribed medrol dose pack. She has an appt to follow up with her PCP tomorrow. Today she feels much better but still has swelling in face and neck. She noticed bruising underneath her right breast and she now has pain in her right arm and her back. She feels congested but does not have fever.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: She felt fine for a few days, then she developed fatigue and became dizzy. Her face started to swell and her lips turned blue. Her neck felt like it was closing in and she couldn't breath. She went to Hospital. They did an EKG that was negative. Blood work was normal. She was given Tylenol and sent home. She was still feeling very ill. On Nov 2nd, she had a virtual video appt with UC. She was prescribed medrol dose pack. She has an appt to follow up with her PCP tomorrow. Today she feels much better but still has swelling in face and neck. She noticed bruising underneath her right breast and she now has pain in her right arm and her back. She feels congested but does not have fever.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Respiratory tract congestion, Swelling, Swelling face, Throat tightness
Clinical narrative: She felt fine for a few days, then she developed fatigue and became dizzy. Her face started to swell and her lips turned blue. Her neck felt like it was closing in and she couldn't breath. She went to Hospital. They did an EKG that was negative. Blood work was normal. She was given Tylenol and sent home. She was still feeling very ill. On Nov 2nd, she had a virtual video appt with UC. She was prescribed medrol dose pack. She has an appt to follow up with her PCP tomorrow. Today she feels much better but still has swelling in face and neck. She noticed bruising underneath her right breast and she now has pain in her right arm and her back. She feels congested but does not have fever.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Dysphagia, Dyspnoea, Lymphadenopathy, Throat tightness
Clinical narrative: She felt fine for a few days, then she developed fatigue and became dizzy. Her face started to swell and her lips turned blue. Her neck felt like it was closing in and she couldn't breath. She went to Hospital. They did an EKG that was negative. Blood work was normal. She was given Tylenol and sent home. She was still feeling very ill. On Nov 2nd, she had a virtual video appt with UC. She was prescribed medrol dose pack. She has an appt to follow up with her PCP tomorrow. Today she feels much better but still has swelling in face and neck. She noticed bruising underneath her right breast and she now has pain in her right arm and her back. She feels congested but does not have fever.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Alanine aminotransferase increased, Analgesic drug level therapeutic, Aspartate aminotransferase increased, Biopsy liver abnormal, Blood alkaline phosphatase increased
Clinical narrative: Patient began feeling malaise about 24 hours after her immunizations. On 10/25, she contacted clinic after noting that she looked yellow. She was found to have AST/ALT in the 2,000s. Imaging showed no gallstones or signs of cholangitis. She was admitted to the hospital and had work up to rule out infectious and autoimmune causes of acute hepatitis. Tylenol levels were negative. She drinks rarely.  Iron levels and ceruloplasmin were normal. She also had a liver biopsy and this showed acute hepatitis but no autoimmune causes. She does not take medications or supplements and is otherwise healthy. No cause was found other then potentially the vaccines given 10 days prior.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood bilirubin increased, Blood iron normal, Ceruloplasmin normal, Hepatitis acute, Imaging procedure
Clinical narrative: Patient began feeling malaise about 24 hours after her immunizations. On 10/25, she contacted clinic after noting that she looked yellow. She was found to have AST/ALT in the 2,000s. Imaging showed no gallstones or signs of cholangitis. She was admitted to the hospital and had work up to rule out infectious and autoimmune causes of acute hepatitis. Tylenol levels were negative. She drinks rarely.  Iron levels and ceruloplasmin were normal. She also had a liver biopsy and this showed acute hepatitis but no autoimmune causes. She does not take medications or supplements and is otherwise healthy. No cause was found other then potentially the vaccines given 10 days prior.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Malaise, Metabolic function test, Yellow skin
Clinical narrative: Patient began feeling malaise about 24 hours after her immunizations. On 10/25, she contacted clinic after noting that she looked yellow. She was found to have AST/ALT in the 2,000s. Imaging showed no gallstones or signs of cholangitis. She was admitted to the hospital and had work up to rule out infectious and autoimmune causes of acute hepatitis. Tylenol levels were negative. She drinks rarely.  Iron levels and ceruloplasmin were normal. She also had a liver biopsy and this showed acute hepatitis but no autoimmune causes. She does not take medications or supplements and is otherwise healthy. No cause was found other then potentially the vaccines given 10 days prior.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Cough, Injection site erythema, Injection site oedema, Oedema peripheral, Oropharyngeal pain
Clinical narrative: Patient reported "Shortley after getting an RSV injection yesterday developed a cough congestion fever, and sore throat" Skin is warm and dry there is some mild erythema and edema at the injection site in the left deltoid region.  CTA bilaterally, no wheezed, rales or rhonchi
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Patient reported "Shortley after getting an RSV injection yesterday developed a cough congestion fever, and sore throat" Skin is warm and dry there is some mild erythema and edema at the injection site in the left deltoid region.  CTA bilaterally, no wheezed, rales or rhonchi
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: left deltoid local site reaction after receiving the COVID vaccine on 11/01/2024 , overall she is doing better today. - She is concerned because the area is painful to touch, itchy, warm to the touch, and swollen. She has tried icing the area, which made it hurt more. She states the day of the injection she had severe myalgias, however, they resolved today.                                                                     Start allergy medication (Claritin, Zyrtec), once daily. Start warm compresses to the area 4-5 times per day. Monitor for any signs of worsening; She will take Doxycycline 100 mg BID x 10 days with food if symptoms worsen through the week. Rx sent to Pharmacy.  administered Kenalog 40 mg, IM for itching
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: left deltoid local site reaction after receiving the COVID vaccine on 11/01/2024 , overall she is doing better today. - She is concerned because the area is painful to touch, itchy, warm to the touch, and swollen. She has tried icing the area, which made it hurt more. She states the day of the injection she had severe myalgias, however, they resolved today.                                                                     Start allergy medication (Claritin, Zyrtec), once daily. Start warm compresses to the area 4-5 times per day. Monitor for any signs of worsening; She will take Doxycycline 100 mg BID x 10 days with food if symptoms worsen through the week. Rx sent to Pharmacy.  administered Kenalog 40 mg, IM for itching
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Extra dose administered
Clinical narrative: My daughter had received these vaccines on 4/19/2024 and they gave them to her a 2nd time on Oct. 24th due to negligence. While we are concerned of long term effects due to her blood transfusion at birth. Right now, she has been extremely angry. She went in for a sick visit, and they did a well child visit instead. Moving forward giving her a 2nd dose of the vaccines, and she has still not gotten over her illness and developed a cough.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture negative, C-reactive protein increased, Full blood count normal, Injection site cellulitis, Red blood cell sedimentation rate normal
Clinical narrative: Cellulitis of left thigh, Workup for cellulitis to rule out any developing abscess or bacteremia.  Blood Culture, CBC, Sed Rate CRP. Started patient on Clindamycin
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect dose administered.  Received Moderna 12+ SpikeVax and should have received Moderna 6 mo-11 yrs.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriosclerosis coronary artery, Computerised tomogram heart, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: PFIZER #1 4/6/2021 PFIZER #2 4/27/2021 PFIZER #3 4/18/2022 DEVELOPED CORONARY ATHEROSCLEROSIS BY IMAGING.  TREATED WITH OTC SUPPLEMENTS AND PROTOCOL BASE SPIKE DETOXIFICATION
Age: 0.33
Sex: F
Vaccine: HIBV, PNC20, RV5, UNK
Symptoms: Electroencephalogram, Seizure
Clinical narrative: Seizure, patient was brought to the ED and admitted overnight for observation.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The night after immunization, a slight itch developed then a redness and warmth developed at the site. This morning, it has grown to 2" x 1" in size and is sore.
Age: 2.67
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: .50 mL was administered instead of the recommended 0.25mL dose for the patients age.  Parent was contacted on 11/5/2024 as soon as the error was detected and was unable to be reached, and unable to leave a voicemail. Will call again 11/6/2024 AM. No adverse reports have been made to this clinic.
Age: 1.75
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 22  m/o pt was administered a Kinrix combo (Dtap/IPV) instead of only a Dtap.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient is given pfizer comirnaty 2024-2025 formula for 12 years of age and older. As of 11/05/2024 at 5pm, patient does not have any sign or symptoms of vaccine side effects other than sore arm. Patient will be monitored by the mother for any discomfort or side effects. Patient's doctor will be notified.
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received wrong  COVID vaccine for age. Patient is 9 years old and received vaccine FDA approved for 12+. I called family day after and they have not noticed any side effects or symptoms.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was given to low on the arm.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4yo child inadvertently given high dose flu vaccine.  Medical officers notified and directed the following guidance / instructions.  ? Instructed parent to monitor child for fever and arm soreness. ? Instructed parent to give child fever reducer and watch injection site for increased swelling/redness. ? Parent encouraged to notify child?s pediatrician of incident. Parent called at 2:45 pm, 11/04/2024, stated child doing fine, denied any fever, parent had contacted pediatrician who said to keep an eye on child, parent reports injection site sore but has not caused any restriction of movement. 11/15/2024 12:10 PM Spoke with parent via phone, parent stated child has not had a fever, went to school today, arm a little sore, and no restrictions with movement.  Parent to contact health department with any additional questions or concerns
Age: 53.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is a 53-year-old male who came in for second and final dose of Varicella and MMR and was administered Varicella and MMRV (ProQuad)  instead of Varicella and MMR.
Age: 28.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Shingrix (dose 1) today - patient received varivax (dose 2) 3 weeks ago. CDC recommendation of 8 weeks. no information found as to whether or not to revaccinate. varivax mnfr had no information other than concomitant is okay due to live and non-live nature. waiting to hear back from GSK (Shingrix)
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of product administration
Clinical narrative: Injection given subcutaneously. Indicated for Intramuscular administration only.
Age: 18.0
Sex: U
Vaccine: UNK
Symptoms: Eye movement disorder, Head injury, Loss of consciousness, Seizure like phenomena, Tremor
Clinical narrative: flu and Gardasil was given to the patient about 8-9 minutes after the vaccines were administered in her left arm, she had seizure like activity; eye rolled back, shaking and unconscious  after 30 seconds patient woke up while MA was holding in the chair so she would not fall out. patient woke up and hit her head on the wall behind her. Dr. came in and assessed her and states she passed out and had a reaction to the Gardasil. patient laid for about 15 minutes. VSS, mom in the room, patient back to A/O. EMS also was called and stated for her to call 911 if she stayers having symptoms again.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report a TE. HCP also called yesterday for a TE and was mistakenly given supported outcomes for MMR II and VARIVAX. (Case 02685548). Due to this, MMR II and VARIVAX were administered to patients. No additional AE/No PQC.; This spontaneous report was received from an Other Health Care Professional (HCP) and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  It was reported that the HCP was calling to report temperature excursion (TE) and that they were mistakenly given supported outcomes for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX). On 08-OCT-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #X018902, which was confirmed to be a valid lot#, expiration date: 12-JUL-2025, administered for prophylaxis (strength, dose, and route of administration were not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot# X018902, which was considered to be not valid, expiration date: 12-JUL-2025, administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error). No additional adverse event (AE) was reported.
Sex: M
Vaccine: MMR, MMRV
Symptoms: Brain injury, Febrile convulsion
Clinical narrative: brain damage; febrile seizure; This spontaneous report as received from the patient's father via a company representative refers to a male patient of unknown age.  Concurrent conditions, medical history and concomitant therapies were not reported.   On unknown dates, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot #, expiration date, dose and route of administration not provided) or measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot #, expiration date, dose and route of administration not provided).  7-10 days after vaccination, the patient had febrile seizure (febrile convulsion) and lived with brain damage (brain injury) at the reporting time.  The outcome of brain injury and febrile convulsion was unknown.  The causal relationship between the vaccines and the events of brain injury and febrile convulsion was not reported.  Upon internal review, the event of brain injury was determined to be medically significant.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report T/E for VAXNEUVANCE (PFS) HCP stated it was administered to 7 patient.; This spontaneous report was received from a certified medical assistant (C.M.A.) regarding a patient of unspecified age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.    On 06-SEP-2024, an unspecified number of doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, underwent a temperature excursion (T/E) at a temperature of 13.0 C during 6 hours and on 22-OCT-2024, the patient was vaccinated with one of these doses,  lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided) (Improper storage of product in use).The reporter stated that the T/E had not occurred as a result of a data logger and that there had not been previous T/E's. There were no additional adverse events (AE) or product quality complaints (PQC). No other information was known or provided.  This is one of 7 reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA012969: US-009507513-2410USA013279: US-009507513-2410USA013346: US-009507513-2410USA013358: US-009507513-2410USA013374: US-009507513-2410USA013415: US-009507513-2410USA013467:
Age: 61.0
Sex: M
Vaccine: PNC21
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: I feel like I have been run over by a bus; I have fever; chills; injection site pain; This spontaneous report was received from a 61-year-old male patient reporting on himself via company representative. His concomitant medications included GLP1 (not further specified) and insulin. His concurrent conditions included type 2 diabetes. There was no information about the patient's medical history provided.  On an unknown date in October 2024 (stated as 27 hours before the time of reporting), the patient was vaccinated with pneumococcal 21v conj vaccine (CRM197) (CAPVAXIVE) 168 mcg/mL, administered intramuscularly (dose, anatomical location, lot# and expiration date were not reported) for prophylaxis.  On 28-OCT-2024, the patient felt like he has been run over by a bus, experienced fever, chills and injection site pain. Outcome of the events was unknown.  Causality assessment was not provided.  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The caller said they have a 26 year old patient who received 1 dose of GARDASIL 9 at the age of 16 years. The caller said the patient never received a second or third dose.; No other AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown gender who was 26-year-old at the time of reporting. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (when the patient was 16-year-old), the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dose (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient never received a second or third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; patient received improperly stored GARDASIL 9; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 28-OCT-2024, the patient received an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot: Y007197, expiration date: 18-AUG-2026 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis during a non-supported temperature excursion (product storage error). The aforementioned vaccine experienced a temperature excursion of -13.2 degrees Celsius (C) for 16 hours. It was unknown if a digital data logger was involved. There were no reported previous temperature excursions. No adverse effects were noted and there was no additional adverse event reported (no adverse event).
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects reported.; HBP reports 18 year old female received dose of PROQUAD instead of MMR II and VARIVAX.; This spontaneous report was received from other and refers to an 18-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-AUG-2024, the patient was vaccinated with with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, as a single dose, lot #Y008785, which have been verified to be valid, expiration date: 30-OCT-2025, administered for prophylaxis (dose, strength, route and anatomical site of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (oka/merck) (VARIVAX) injection (for both lot # and expiry date were not provided) (Wrong product administered). No adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional adverse event reported; NSS transferred HCP who reported 17 year old patient was administered PROQUAD.  Patient has not received any previous doses of MMRII or VARIVAX.   No symptoms reported.  Consent to correspond was granted.  See related request case 02699616.  No addit; This spontaneous report was received from medical assistant and refers to a 17-year-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y009589, expiration date: 17-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 79.0
Sex: F
Vaccine: FLU3, RSV, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: Acute CVA stroke within 24 hours after receiving Arexvy; This serious case was reported by a other health professional via sales rep and described the occurrence of cerebrovascular accident in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   Co-suspect products included Influenza vaccine rHA 3v (baculovirus) (Flublok) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Arexvy (right arm) and Flublok (left arm). On 22-OCT-2024, 24 hrs after receiving Arexvy, the patient experienced cerebrovascular accident (Verbatim: Acute CVA stroke within 24 hours after receiving Arexvy) (serious criteria GSK medically significant). The outcome of the cerebrovascular accident was not resolved.   It was unknown if the reporter considered the cerebrovascular accident to be related to Arexvy.     The company considered the cerebrovascular accident to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter reported that the patient received the Arexvy vaccine and FluBlok vaccine and had acute cerebrovascular accident stroke within 24 hours. The event was reported as worsened. It was unknown if the reporter considered the cerebrovascular accident to be related to Flublok.; Sender's Comments: Cerebrovascular accident is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 79.0
Sex: F
Vaccine: FLU3, RSV, UNK
Symptoms: Arteriogram carotid, Cerebrovascular accident, Echocardiogram normal, Hemiparesis, Magnetic resonance imaging head abnormal
Clinical narrative: Acute CVA stroke within 24 hours after receiving Arexvy; This serious case was reported by a other health professional via sales rep and described the occurrence of cerebrovascular accident in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   Co-suspect products included Influenza vaccine rHA 3v (baculovirus) (Flublok) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Arexvy (right arm) and Flublok (left arm). On 22-OCT-2024, 24 hrs after receiving Arexvy, the patient experienced cerebrovascular accident (Verbatim: Acute CVA stroke within 24 hours after receiving Arexvy) (serious criteria GSK medically significant). The outcome of the cerebrovascular accident was not resolved.   It was unknown if the reporter considered the cerebrovascular accident to be related to Arexvy.     The company considered the cerebrovascular accident to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter reported that the patient received the Arexvy vaccine and FluBlok vaccine and had acute cerebrovascular accident stroke within 24 hours. The event was reported as worsened. It was unknown if the reporter considered the cerebrovascular accident to be related to Flublok.; Sender's Comments: Cerebrovascular accident is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 79.0
Sex: F
Vaccine: FLU3, RSV, UNK
Symptoms: Scan with contrast abnormal
Clinical narrative: Acute CVA stroke within 24 hours after receiving Arexvy; This serious case was reported by a other health professional via sales rep and described the occurrence of cerebrovascular accident in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   Co-suspect products included Influenza vaccine rHA 3v (baculovirus) (Flublok) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Arexvy (right arm) and Flublok (left arm). On 22-OCT-2024, 24 hrs after receiving Arexvy, the patient experienced cerebrovascular accident (Verbatim: Acute CVA stroke within 24 hours after receiving Arexvy) (serious criteria GSK medically significant). The outcome of the cerebrovascular accident was not resolved.   It was unknown if the reporter considered the cerebrovascular accident to be related to Arexvy.     The company considered the cerebrovascular accident to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter reported that the patient received the Arexvy vaccine and FluBlok vaccine and had acute cerebrovascular accident stroke within 24 hours. The event was reported as worsened. It was unknown if the reporter considered the cerebrovascular accident to be related to Flublok.; Sender's Comments: Cerebrovascular accident is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle atrophy
Clinical narrative: severe should droop/Atrophy of muscle in injected arm; This non-serious case was reported by a consumer and described the occurrence of muscle atrophy in a 71-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included osteoarthritis. Concomitant products included naproxen.   On 01-NOV-2023, the patient received the 1st dose of Shingles vaccine. On 09-DEC-2023, 38 days after receiving Shingles vaccine, the patient experienced muscle atrophy (Verbatim: severe should droop/Atrophy of muscle in injected arm). The outcome of the muscle atrophy was resolving.   It was unknown if the reporter considered the muscle atrophy to be related to Shingles vaccine.     It was unknown if the company considered the muscle atrophy to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 06-OCT-2024 The patient saw muscle atrophy now in warnings.  The reporter asked if you were aware of any successful treatments or exercises patients had used. The patient did not go for a second shot after noting the effect.  Noticed as severe shoulder droop from his tailor fitting a sports coat. The patient was otherwise a healthy, walking 18 holes of golf every day with no comorbidities.
Sex: U
Vaccine: VARZOS
Symptoms: Oral pruritus, Swollen tongue
Clinical narrative: My tongue got a little swollen; mouth was itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swollen tongue (Verbatim: My tongue got a little swollen) and oral pruritus (Verbatim: mouth was itchy). The outcome of the swollen tongue and oral pruritus were not reported.   It was unknown if the reporter considered the swollen tongue and oral pruritus to be related to Shingrix.     It was unknown if the company considered the swollen tongue and oral pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2024 The patient self-reported this case. The patient wanted to know, was there a health care facility that administers the Shinto's vaccine near him/her and requested for medical advice or recommendation. The GlaxoSmithKline chatbot reverted to the patient that, GSK made medicines and vaccines that need a prescription. They could not give medical advice. It was important to talk with physician or other healthcare provider for guidance based on patient's medical history. Further reporter said that he/she had a strange reaction to Shingrix vaccine, and his/her physician recommended getting vaccine in hospital setting. Where could he/she does that. The patient stated that it was not so severe but enough that she (physician) said that.  The patient's tongue got a little swollen and mouth was itchy along with usual side effects. The patient would have to get both shots since it was 4 years ago when it happened. And then Covid happened so he/she did not pursue it till now (till the time of reporting). The patient did report it before. He/she just wanted to know information that he/she could get vaccine in a health care facility nearby in case he/she needs an epi pen. The patient did not provide any information, he/she just wanted information on availability of getting vaccine in health care setting since only pharmacies were listed.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise
Clinical narrative: second vaccine got me very sick; second vaccine got me very sick to where I couldn't go to work; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of illness (received 1st dose of Shingles vaccine on an unknown date, refer linked case US2024AMR125729).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: second vaccine got me very sick) and inability to work (Verbatim: second vaccine got me very sick to where I couldn't go to work). Rechallenge with Shingles vaccine was positive. The outcome of the sickness and inability to work were not reported.   It was unknown if the reporter considered the sickness and inability to work to be related to Shingles vaccine.     It was unknown if the company considered the sickness and inability to work to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR125729   Additional Information: GSK Receipt Date: 10-OCT-2024 This case was reported by a patient via interactive digital media. The second dose of Shingle vaccine got him/her very sick to where he/she could not go to work, but to him/her it was well worth it. This case had been linked with US2024AMR125729, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR125729:Same patient/first dose
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles from the Vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles from the Vaccine). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-OCT-2024 This case was reported by a Consumer via interactive digital media. The reporter reported that his/her dad (patient) got shingles from the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: she jumped when needle pocked her arm and she did not get the full injection since the fluid spread across the room; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 99C3K, expiry date 31-JAN-2023) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past, 10 years ago, prior to Shingrix vaccination). Previously administered products included Shingrix (received first dose on 08-JUN-2021).   On 28-OCT-2021, the patient received the 2nd dose of Shingrix (unknown arm). On 28-OCT-2021, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: she jumped when needle pocked her arm and she did not get the full injection since the fluid spread across the room). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The nurse practitioner reported that the patient received 2 doses of Shingrix vaccine in 2021 and patient claimed that at the time of receiving the 2nd dose, she jumped when needle pocked her arm and she did not get the full injection since the fluid spread across the room, which led to an accidental underdose. The reporter wanted to know should be patient revaccinated. They were not sure if the full dose, part of it or none was administered to the patient. The patient was worried about the immunogenicity.  The vaccine administration facility was the same as primary reporter.