chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Laboratory test, Metabolic function test, Petechiae, Rash maculo-papular
Clinical narrative: Henoch Schonlein Purpura - Maculopapular rash over both of her legs. Started as petechiae. No abdominal pain, hematochezia. No fevers, chills, nausea, vomiting or other symptoms.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fall, Pulmonary embolism
Clinical narrative: Vaccine on 11/25.  On 11/26 resident had increased weakness and increased confusion.  Fall on 11/26.  Cont confusion.  11/29 Resident fell again.  Sent to ER  11/30  Admitted to MC with findings of multiple sub segmental pulmonary emboli.  RTF 12/3/24
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache, Oropharyngeal pain, Pain, Tinnitus
Clinical narrative: I had pain al over but ears, head & throat were the worse, now I have a persistent ringing in my ear everyday since it's started.  I went to Urgent Care and received a steroid to stop the ear pain and ringing nut it's still with me as I write this.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Unevaluable event
Clinical narrative: Flu and Covid vaccine on 10/30/2024, and pneumonia and 1st shingles vaccine on 11/20/2024.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given High Dose Flu vaccine at age 61.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Chest pain, Fall, Gait inability, Hypoaesthesia
Clinical narrative: Two weeks prior to presentation in ER developed thoracic back pain, one week prior to presentation to ER patient had progressive numbness in hands and feet, immediately prior to presentation patient with sudden loss of gait and falling.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Blood pressure systolic decreased, Heart rate decreased, Hyperhidrosis, Pallor
Clinical narrative: Patient was given two vaccines then stayed in clinic for little time.  Initial vitals before vaccine (BP 120/62 & HR 96).  After vaccine patient became very very pale, sweating,  HR lowered to 40s and Blood pressure decreased to systolics 50s.  Was talking and responsive EMS activated; while waiting  vitals did improve (BP 76/42 & HR 66); and then last set before taken by EMS (BP 114/60 & HR75) which was about 30 minutes after. Was talking and responsive.  Oxygen saturations were 98-99% whole time before and after vaccines.  Taken by EMS to hospital for eval and monitoring
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Mom called on 12/4/24 & subsequently given an appointment in office; she described reaction on left arm as red, swollen & very hard, she states the area is about 3 in x 3 in. When examined in the office area measured 5 in x 4 in circular erythematous macule, warm to touch, hard, no discharge, no bleeding, nonfluctuant.  Patient started on Clindamycin HCI capsule 150 mg PO every 8 hrs x 7 days.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest X-ray, Chest pain, Computerised tomogram heart, Dyspnoea
Clinical narrative: Palpitations, precordial catch and shortness of breath
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Full blood count, Metabolic function test
Clinical narrative: Palpitations, precordial catch and shortness of breath
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations, precordial catch and shortness of breath
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hemiparesis
Clinical narrative: Right sided weakness and falling
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC20, RV5
Symptoms: Crying, Extra dose administered, Infant irritability
Clinical narrative: Beyfortus also given that day although not a vaccine.   Concerns are that two doses of IPV were given, Hepatitis B vaccination given that parents had previously declined.  Symptoms include excessive crying and fussiness. Much less the following day.  Acetaminophen administered by parents.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC20, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Beyfortus also given that day although not a vaccine. Concerns are that two doses of IPV were given., Hepatitis B vaccination given that parents had previously declined.  No unexpected symptoms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in upper left arm with large area of redness, hot to touch, very painful, small raised area under skin. Continued to get worse even after ice applied every day for 5 days so far.  Symptoms localized to injection site. Have never had reaction to any shot before this.
Age: 12.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received MMR vaccine and Tdap vaccine and was not due for those two vaccines.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Recipient received the high dose flu vaccine and was not 65yo, so was not eligible to receive the high dose.  This error was discovered upon receiving the denied claim after billing - 12/4/2024.  Recipient has not reported adverse reactions to the high dose flu vaccine to the Health Department.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Impaired work ability, Pain, Peripheral swelling, Pyrexia
Clinical narrative: EMPLOYEE STATED THAT  SHE DEVELOPED A RASH, AND ARM WAS SWOLLEN ON SAT.  SUNDAY AND MONDAY SHE DEVELOPED FEVER, BODY ACHES. CHILLS, AND VOMITING.  SHE STATED THAT SHE HAD TO TAKE MONDAY 12/2 AND TUESDAY 12/3 OFF
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vomiting
Clinical narrative: EMPLOYEE STATED THAT  SHE DEVELOPED A RASH, AND ARM WAS SWOLLEN ON SAT.  SUNDAY AND MONDAY SHE DEVELOPED FEVER, BODY ACHES. CHILLS, AND VOMITING.  SHE STATED THAT SHE HAD TO TAKE MONDAY 12/2 AND TUESDAY 12/3 OFF
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hepatic failure, Hepatic vascular thrombosis, Laboratory test, Malaise
Clinical narrative: My father received the first of 2 Moderna Covid 19 injections on Jan 5, 2021. On January 20, 2021 he became emergently ill. His condition was of unknown origin with symptoms leading to possible CHF diagnosis but was found to be blockages due to blood clots that settled in his liver. He died February 3, 2021 of liver failure.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large (4-5 inch) round area of erythema and induration around injection site.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A previously described error that PHN filed incident report due to using Hepatitis A vaccine rather than VFC. The product is licensed for 19 yrs and older and client is only 18.5 yrs old. Because of this error department had to purchase privately pediatric vaccine to "repay" the VFC program. The vaccine was ordered but there are conflicting labelling--dose was repaid (a VFC inventory item was created) but the note in immunization history labelled it as to program.   Due to user error and then mis-labelling, additional administration errors occurred.  Late December 2023-Jan 2024, the department became aware of a family exposure to active Hepatitis disease. Per protocol and State Dept. of Health request, nurses went to the address and administered prophylaxis to those exposed. This entails one dose of the appropriate Hepatitis A vaccine. In error, nurse used one of the privately purchased pediatric doses on one of the adults.  An inventory check for the clinic 11/27/24, reporting staff noticed the errors. Stock was immediately pulled to the correct age stock area. Supervisor was notified of finding.  It was agreed the report would need to wait until return from upcoming holiday break. The client involved are: redacted 7/XX/19XX, 36 year old at time of vaccination, Client number:  on 1/5/2024;  Patient has moved out of state and could not be notified.   There is no ill effects anticipated. Doses may have offered some protection but most likely not as effective as an adult vaccine.  Vaccine stock involved: Hepatitis A Vaqta Pediatric/Adolescent formulation Lot # X021007 Expiration 12/26/2024 NDC0006409502  Typical vaccine schedule 2 dose series of 0.5 mL intermuscular injections at a 6 months interval. Note: the packaging is very similar with adult having an orange band on the package and pediatric adolescent having a purple band. It is this band that the reporter noticed 11/27/24 that triggered findings and report.  Respectfully submitted. RN PHN
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test, Loss of consciousness, Syncope
Clinical narrative: Had a vasovagal syncope  episode in the middle of the night.  Passed out, hit the wall, was out for about five seconds as per husband
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a dose of Flu vaccine in 9/13/2024 and then received additional dose of Flu vaccine in 12/3/2024. Called and confirmed with patient, and patient has no issue after received additional dose of Flu vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Fall, Mental status changes, SARS-CoV-2 test
Clinical narrative: Weakness, frequent falls, altered mental status
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A previously described error that PHN filed incident report due to using program Hepatitis A vaccine rather than VFC. The program product is licensed for 19 yrs and older and client is only 18.5 yrs old. Because of this error department had to purchase privately pediatric vaccine to "repay" the VFC program. The vaccine was ordered but there are conflicting labelling--dose was repaid (a VFC inventory item was created) but the note in immunization history labelled it as to program.   Due to user error and then mislabelling, additional administration errors occurred.  Mid-August, as a regular function of vaccine inventory, it was noted that the remaining doses of the privately purchased Hepatitis A vaccine would expire in December. Doses were moved to try to use before expiration. I think because the agency has faced constrained budget for adult vaccine via the program, the reporting nurse did not think and placed these doses in the adult inventory with a post-it instructing other staff to use for program. The box is clearly a pediatric/adolescent manufacturer labelled box.  Due to this, staff administered a dose in October in what she thought per the nurse label was ok to use for an adult.  In review of approaching expiration dates and an inventory check for the clinic 11/27/24, reporting staff noticed the errors. Stock was immediately pulled to the correct age stock area. Supervisor was notified of finding.  It was agreed the report would need to wait until return from upcoming holiday break. The client involved patient 11/x/19xx, 39 year old on 8/28/2024  Patient's notification is in progress. A dose of adult vaccine will be offered.   There is no ill effects anticipated. Doses may have offered some protection but most likely not as effective as an adult vaccine.  Vaccine stock involved: Hepatitis A Vaqta Pediatric/Adolescent formulation Lot # X021007 Expiration 12/26/2024 NDC0006409502  Typical vaccine schedule 2 dose series of 0.5 mL intermuscular injections at a 6 months interval. Note: the packaging is very similar with adult having an orange band on the package and pediatric adolescent having a purple band. It is this band that the reporter noticed 11/27/24 that triggered findings and report.  Respectfully submitted. RN PHN
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Death
Clinical narrative: patient expired on 12/4/2024
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: The patient was given the adjuvant suspension only, the vaccine was not mixed
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, Nasal congestion, Pain, SARS-CoV-2 test
Clinical narrative: Headache, body aches, nasal congestion, mild cough
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient was given the adjuvant suspension only, vaccine not mixed
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Paraesthesia oral
Clinical narrative: At 0850 the Nursing Supervisor and Medical Director of the clinic were called into station 3, the immunization station, due to PT having a possible allergic reaction to vaccines administered. PT was sitting up in a phlebotomy chair and was speaking clearly, did not appear in distress. PT report "about 5 minutes after receiving my Anthrax and Typhoid vaccines, the right rear of tongue and upper pallet on the right side started having minor tingling sensations". PT received Anthrax at 0834 in the right deltoid and Typhoid at 0834 in the left deltoid. PT reported that he has had the Typhoid vaccine before and did not have any type of reaction. At 0853, the Medical Center Allergist was contacted and advised that the PT stay within the clinic for monitoring until the symptoms subside. Also recommended that the second dose of Anthrax be scheduled as a referral in clinic, PT verbalizes understanding.  0903, PT reporting the symptoms have dissipated and he would like to continue with travel processing.  PT educated that if the symptoms happen again to contact his clinic and, in the event, they are worse, to seek emergency care. PT verbalized understanding with repeat back. PCM to be notified by the Nursing Supervisor. PT received influenza vaccine at Pharmacy on 19 October 2024, no other information for the influenza vaccine available. No other vaccines within the previous month.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site bruising, Injection site nodule, Injection site swelling
Clinical narrative: Large nodule with bruising and swelling to right thigh. Max swelling approx 11cm. 12/04 measured in office and site is 8cm in diameter.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Dizziness
Clinical narrative: Dizziness, Lightheadedness at 12:30 PM to Current time (2:36 PM)
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt notified the clinic she had and itchy rash on 12/2/24 and appointment was made for 12/3/24. Patient has red lacy rash to entire torso, worst on lower abdomen, bilateral arms and legs, and neck. pt reports rash is very itchy. Was seen by provider on 12/3/24 and instructed to self quarantine by provider.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling and redness measuring  2x2 inch  in R thigh where vaccine given.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Eyelid margin crusting, Ocular hyperaemia
Clinical narrative: BURNING, RED ICTCHY EYES, SWEOLLEN EYES, BLURY VISON,CRUSTY EYES.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: BURNING, RED ICTCHY EYES, SWEOLLEN EYES, BLURY VISON,CRUSTY EYES.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: EXPIRED PENTACEL GIVEN TO PT ON 12/02/2024 STATE DATABASE NOTIFIED
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Nasopharyngitis
Clinical narrative: Developed a bad cold 11/25/2024. Developed severe chest pains on left side 9am 11/27/2024.  Called 911.  Pains stopped while they were here.  They found nothing wrong, but insisted I go to the ER, which I did, but they could find nothing wrong either.  Very small incidence of chest pains while in ER. None since.  Cold is still hanging on, but  is much better.  ER visit was at hospital.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety disorder, Hysterectomy, Vaginal haemorrhage
Clinical narrative: Day after 2nd Covid shot (19 March 2021) began to experience significant vaginal bleeding which remained until a full hysterectomy in Feb 2022.   Vaccine induced anxiety disorder.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Got this vaccine series twice within 2 yrs
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Received the flu shot at a workplace flu clinic.  Nurse put shot very high on my right arm, closer to the joint and and it was abnormally painful.  The pain became quite intense as the day went on. Needing about 600 mg of ibuprofen to sleep that night (11/1/24).  Limited range of motion in my right has persisted since that vaccine.  I cannot lift my arm straight out and up.  It's still incredibly painful.
Age: 9.0
Sex: F
Vaccine: PNC20
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: I did not double check the vaccine name  on the vaccine injection.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Swollen tongue
Clinical narrative: Rash on legs and arms within 30 minutes to an hour. Tongue swelling after 2 hours. Had to go to ER, and is now doing better 4 hours after initial symptoms.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: The patient developed body aches and fatigue the evening of 12/02/2024 which progressed to nausea and multiple episodes of diarrhea accompanied by abdominal cramps. He presented back to the public health office the following morning at 9:30 AM on 12/03/2024. He was given #1 sublingual 4mg dose of Zofran. B/P was 118/80, pulse 76, and temperature 97.8 orally. He was attempting to keep oral fluids down but had not retained anything in 12 hours. A 20G IV catheter was placed in his right dorsal hand and 500ml of NS was administered.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Computerised tomogram head normal, Dysarthria, Echocardiogram normal
Clinical narrative: Pt presented to the ER with TIA-LIKE symptoms, unilateral arm weakness and slurred speech.  All imaging was normal, echo with EF 60%.  Pt loaded with Aspirin and Plavix and discharged from the ER with close follow-up.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Magnetic resonance imaging head normal, Muscular weakness, Neurological symptom
Clinical narrative: Pt presented to the ER with TIA-LIKE symptoms, unilateral arm weakness and slurred speech.  All imaging was normal, echo with EF 60%.  Pt loaded with Aspirin and Plavix and discharged from the ER with close follow-up.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Angiogram cerebral normal, Arteriogram carotid, Computerised tomogram head normal, Echocardiogram normal, Magnetic resonance imaging head normal
Clinical narrative: TIA-LIKE symptoms, arm weakness and speech difficulties.  Pt worked up for stroke with negative imaging.  Symptoms resolved in 2-3 hours, pt discharged home from the ER with aspirin and plavix.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Muscular weakness, Neurological symptom, Speech disorder
Clinical narrative: TIA-LIKE symptoms, arm weakness and speech difficulties.  Pt worked up for stroke with negative imaging.  Symptoms resolved in 2-3 hours, pt discharged home from the ER with aspirin and plavix.
Age: 1.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, HIBV, MMRV
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Patient started with a rash on 11/29 and a fever on 11/30.  Rash started on the chin, spread to full face, then down torso/back and legs.  Rash is itchy.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Influenza like illness, Myalgia
Clinical narrative: Left Pharmacy and felt ?flu like? symptoms for 3 days, as did my husband. He was without symptoms in 3 days. I continued with multiple areas of muscle pain that has only continued through to today. Very painful.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Haemoglobin normal, Loss of consciousness, Malaise, Pallor
Clinical narrative: Patient reported to provider that she was not feeling well after provider entered the room shortly after receiving one vaccine. Patient then became very pale, held her head down and began to snore while provider stood in front of patient with emesis bag and called MA team for assistance. Provider moved patient's head back, spoke to patient several times to attempt to arouse patient. Patient regained consciousness in about 15 seconds and proceeded to vomit large volume into emesis bag. There was no witnessed jerky or involuntary movements during this episode. Patient did not fall and remained in exam room chair.  Blood pressure after regaining consciousness was 101/67, HR 97, pulse ox 96%. Ordered in house Hemoglobin- 13.9 and glucose- 81. Patient recalls vasovagal syncopal  episode after last Depo Provera dose in May 2023. Patient reports she has a fear of needles. No injury, did not fall. Patient stable and able to tolerate oral fluids after episode.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Snoring, Vomiting
Clinical narrative: Patient reported to provider that she was not feeling well after provider entered the room shortly after receiving one vaccine. Patient then became very pale, held her head down and began to snore while provider stood in front of patient with emesis bag and called MA team for assistance. Provider moved patient's head back, spoke to patient several times to attempt to arouse patient. Patient regained consciousness in about 15 seconds and proceeded to vomit large volume into emesis bag. There was no witnessed jerky or involuntary movements during this episode. Patient did not fall and remained in exam room chair.  Blood pressure after regaining consciousness was 101/67, HR 97, pulse ox 96%. Ordered in house Hemoglobin- 13.9 and glucose- 81. Patient recalls vasovagal syncopal  episode after last Depo Provera dose in May 2023. Patient reports she has a fear of needles. No injury, did not fall. Patient stable and able to tolerate oral fluids after episode.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Tongue discomfort
Clinical narrative: Patient was seen today in clinic and stated that she received the covid vaccine from her pharmacy, she then proceeded to say that within 24 hours of her taking the vaccine she experienced a metallic taste in her mouth, then loss of taste and a burning sensation of her tongue.
Age: 6.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, IPV, VARCEL
Symptoms: Abdominal pain upper, Dizziness, Fall, Head injury, Injection site pain
Clinical narrative: Patient received her vaccinations, Flu, Moderna, Hepatitis A, Polio, and Varicella at 12:38 while sitting in mom's lap. At 12:41, patient fell to the ground, out of mom's arms and hit her head on the cabinet. At 12:43, patient sat up with her blood pressure being 134/70 and pulse of 65. Patient stated she feels a little bit dizzy and her stomach hurts. She did share that her stomach "was hurting before." Patient stated she had eaten, having eggs and tortilla. At 12:44, while still sitting, her blood pressure was 122/76 and pulse 83. At that time, she drank an apple juice.  At 12:45, she stated that her head isn't hurting. At 12:47, no redness or bumps were noted to her head and she denied any pain upon touch. At 12:49, blood pressure was 126/61, and pulse 83. Patient stated no dizziness. She stated that her stomach hurts. Mom stated that she thinks this happened because she was given five vaccines. With previous vaccines, mom stated that she only had a fever. At 12:51, patient stated her arms hurt where she received the shots. She stated no dizziness and that her stomach is feeling a little bit better. At 12:53, patient stood up. She stated that she didn't have any dizziness, her stomach feels a little bit better and denies any pain to the head. Her blood pressure was 117/77 with a pulse of 82. She stated she has pain in her arms where she received the vaccines. Patient accepted a granola bar and drank water. At 12:55, patient stated she doesn't have any dizziness, no pain to the head, and a little pain in her stomach and arms. At 1300, she stated she doesn't have any dizziness and no pain to the head. At 1306, patient stated that she had no dizziness and a little pain in the stomach. While playing and laughing with dad, at 13:16, patient stated that she was "a little dizzy". Patient sat down again and at 1318, blood pressure was 107/64 and pulse 79. At 1321, she stated she felt a little dizzy. While sitting down, patient was playing and laughing with dad. At 13:27, she stated that she was feeling "better." She stated no dizziness, no stomach pain and a little pain in her arms. At 1337, while standing, her blood pressure was 105/68 and pulse 70. She stated she didn't have any dizziness and didn't have any pain to the head or stomach. She stated she had a little pain in her arms where she was vaccinated. She continued to laugh and play with dad. Parents stated that if after 10 more minutes she still felt better, they were okay to go home. At 1349, patient stated she didn't have any dizziness and denied any pain to her head and stomach. She stated the pain is getting better in her arms. At 1351, patient was discharged with parents, alert and oriented x3, ambulating with steady gait and no assistance. Post-vaccination administration education provided to parent/guardian. All questions and concerns addressed.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal disorder, X-ray limb
Clinical narrative: After flu shot, quick onset of right shoulder pain and limited function (no previous issues with pain or limited function in this shoulder)
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired PNEUMOVAX 23 was given to a patient on 11/8/2024.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies were not reported.  On 08-NOV-2024, the patient started therapy with expired pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #x018273, expiration date: 07-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional AEs were reported. No further information provided.
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient had not developed any medical concerns or shown any symptom at this time; Medical Assistant calling with a report of an adverse event regarding a dose of VARIVAX that was administered inadvertently to a 6 month old.  Medical Assistant stated that a 6 month old patient was inadvertently administered their first dose of VARI; This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 25-NOV-2024, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # X023717, expiration date: 26-SEP-2025 (route of administration, anatomical location not provided) as prophylaxis, at the age of 6 months (product administered to patient of inappropriate age), due to an error in processing the patient during a routine visit. The patient had not developed any medical concern or any symptoms at this time.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse effects; patient received PEDAX HIB that had been reconstituted with 0.5 ml of STERILE DILUENT; human error; This spontaneous report as received from a registered nurse refers to a 4-month-old patient of unknown gender.  Concurrent conditions, medical history and concomitant medications were not reported.  On 22-NOV-2024, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot # X007544, expiration date: 20-NOV-2025; dose and route of administration not provided) reconstituted with 0.5 ml of sterile diluent solution for injection/infusion (lot #, expiration date, route of administration not provided) (product preparation error). No adverse effects (no adverse event) were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Pharmacist calling to report inadvertently administering an expired dose of PENUMOVAX 23. Caller stated vaccine expired on 11/22/2024 and was administered on 11/25/2024. Caller stated patient has not reported any symptoms. Product did not undergo any; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 25-NOV-2024, the patient was inadvertently vaccinated with an expired dose (expired product administered) of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) syringe injection, lot # X014729, expiration date: 22-NOV-2024 (route was not provided) for prophylaxis.    Caller stated patient had not reported any symptoms (no adverse event). Product did not undergo any temperature excursion and was supported Per Post-Expiry Memo.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; MD calling to report a TE (see TE case 02713450). VARIVAX was administered to one patient on 11/25/2024 following the excursion. The excursion was supported. No additional AE/No PQC.; This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.     On 25-NOV-2024, the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route were not reported) lot # Y007955, expiration date: 17-APR-2026 for prophylaxis.     The excursion was supported. No additional AE/No PQC (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: administered Shingrix and some liquid dripped off the needle after the vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose 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 accidental underdose (Verbatim: administered Shingrix and some liquid dripped off the needle after the vaccine was administered). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The healthcare professional reported that the nurse administered Shingrix and some liquid dripped off the needle after the vaccine was administered, which led to accidental underdose. The reporter asked should the vaccine dose be readministered. The reporter was concerned that this lot may be defective and the first dose the cap was stuck and there was no needle for administration.
Age: 78.0
Sex: U
Vaccine: RVX
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 78-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included RSV vaccine (1st dose received last year).   On 04-NOV-2024, the patient received the 2nd dose of RSV vaccine. On 04-NOV-2024, an unknown time after receiving RSV vaccine, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The patient stated that patient had the RSV Shot last year and just got another one on day of reporting. The patient had 2 RSV shot sin a year which led to extra dose administered. The patient enquired if he/she could had 2 RSV shots in a year or will this make him/her ill.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she got both doses of the Shingles shot and still contracted shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 Shingrix (1st dose)and Shingrix(2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of Shingrix that expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a elderly female patient who received Herpes zoster (Shingrix) (batch number ZS3D7, expiry date 08-OCT-2024) for prophylaxis.   On 01-NOV-2024, the patient received Shingrix. On 01-NOV-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Shingrix that expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024  The nurse reported that the patient was administered a dose of Shingrix that was expired, which led to an expired vaccine used. No PQC (product quality complaint) reported. The vaccine administration facility was the same as primary reporter.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 03-NOV-2024, the patient received the 2nd dose of Engerix B. On 03-NOV-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose). The outcome of the expired vaccine used 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: 04-NOV-2024 The pharmacist reported that a patient received Engerix B vaccine, the hep B vaccine on 03-NOV-2024, it was expired on 09-SEP-2024, which led to expired vaccine used. The administration facility was the same as primary reporter. The health care professional did not provide initials of patient first and last name, only age and gender.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: several patients asking if it has been several years since the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix several years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: several patients asking if it has been several years since the first dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The pharmacist reported that he/she had several patients asking if it had been several years since the first dose if they need to restart the series on just get the 2nd dose.  Till the time of reporting the patients did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a first shot three years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a first shot three years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 Pharmacy technician reported that they had another patient that received a first shot three years ago. No details regarding vaccine, patient demographics and specific vaccination date of this patient were provided. Consent for follow-up from safety department was not reactively confirmed from the Pharmacy Technician's end. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with case US2024136841, reported by same reporter.; Sender's Comments:  US-GSK-US2024136841:Same reporter, different patient
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in MAY-2024 have not received another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received the first dose of Twinrix in May of 2024 ).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: first dose in MAY-2024 have not received another dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2024 Pharmacist reported that he had a patient had not received another dose yet. The reporter did not want to provide details about patient so he/she did not ask about follow up. Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Age: 77.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Decreased appetite, Dizziness, Hypotension, Injection site bruising
Clinical narrative: bruising at injection site; blood pressure was really low; can feel heart beating; weak; lethargic; sleeplessness; slight dizziness; muscle pain: whole body; loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 77-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix in September 2024). Concurrent medical conditions included type i diabetes mellitus.   On 25-OCT-2024, the patient received the 2nd dose of Twinrix (unknown arm) 1 ml. On 28-OCT-2024, 3 days after receiving Twinrix, the patient experienced injection site bruising (Verbatim: bruising at injection site), low blood pressure (Verbatim: blood pressure was really low), heart rate abnormal (Verbatim: can feel heart beating), weakness (Verbatim: weak), lethargy (Verbatim: lethargic), sleeplessness (Verbatim: sleeplessness), dizziness (Verbatim: slight dizziness), generalized muscle aches (Verbatim: muscle pain: whole body) and appetite lost (Verbatim: loss of appetite). The outcome of the injection site bruising, heart rate abnormal, weakness, lethargy, sleeplessness, dizziness, generalized muscle aches and appetite lost were resolving and the outcome of the low blood pressure was resolved.   The reporter considered the injection site bruising, heart rate abnormal, weakness, lethargy, sleeplessness, dizziness, generalized muscle aches and appetite lost to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the reporter considered the low blood pressure to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     The company considered the injection site bruising, heart rate abnormal, weakness, lethargy, sleeplessness, dizziness, generalized muscle aches and appetite lost to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the low blood pressure to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2024  The reporter self reported this case for herself.  The reporter received dose 2 of Twinrix on Friday.  The reporter reported that on Monday the side effects started, which were subsiding, but not completely resolved.  The reporter had bruising at injection site of the arm (though the injected arm itself does not hurt), some loss of appetite (though she can still eat), muscle pain in whole body, slight dizziness, sleeplessness, weak/lethargic. The reporter reported that she can feel her heart beating sometimes don't know if it was fast.  The reporter's blood pressure was really low the first day but she was fine at the time of reporting.
Age: 77.0
Sex: F
Vaccine: HEPAB
Symptoms: Insomnia, Lethargy, Myalgia, Palpitations
Clinical narrative: bruising at injection site; blood pressure was really low; can feel heart beating; weak; lethargic; sleeplessness; slight dizziness; muscle pain: whole body; loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 77-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix in September 2024). Concurrent medical conditions included type i diabetes mellitus.   On 25-OCT-2024, the patient received the 2nd dose of Twinrix (unknown arm) 1 ml. On 28-OCT-2024, 3 days after receiving Twinrix, the patient experienced injection site bruising (Verbatim: bruising at injection site), low blood pressure (Verbatim: blood pressure was really low), heart rate abnormal (Verbatim: can feel heart beating), weakness (Verbatim: weak), lethargy (Verbatim: lethargic), sleeplessness (Verbatim: sleeplessness), dizziness (Verbatim: slight dizziness), generalized muscle aches (Verbatim: muscle pain: whole body) and appetite lost (Verbatim: loss of appetite). The outcome of the injection site bruising, heart rate abnormal, weakness, lethargy, sleeplessness, dizziness, generalized muscle aches and appetite lost were resolving and the outcome of the low blood pressure was resolved.   The reporter considered the injection site bruising, heart rate abnormal, weakness, lethargy, sleeplessness, dizziness, generalized muscle aches and appetite lost to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the reporter considered the low blood pressure to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     The company considered the injection site bruising, heart rate abnormal, weakness, lethargy, sleeplessness, dizziness, generalized muscle aches and appetite lost to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the low blood pressure to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2024  The reporter self reported this case for herself.  The reporter received dose 2 of Twinrix on Friday.  The reporter reported that on Monday the side effects started, which were subsiding, but not completely resolved.  The reporter had bruising at injection site of the arm (though the injected arm itself does not hurt), some loss of appetite (though she can still eat), muscle pain in whole body, slight dizziness, sleeplessness, weak/lethargic. The reporter reported that she can feel her heart beating sometimes don't know if it was fast.  The reporter's blood pressure was really low the first day but she was fine at the time of reporting.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: some kind of rash; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a 81-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 24PL5, expiry date 09-JUN-2025) for prophylaxis.   Previously administered products included Fluaval QIV (patient did receive Flulaval QIV for last flu season).   On 18-OCT-2024, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced rash (Verbatim: some kind of rash). The outcome of the rash was unknown.   The reporter considered the rash to be possibly related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     The company considered the rash to be possibly related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2024 and 05-NOV-2024 The doctor reported that an adult patient received Flulaval Trivalent and had a possible reaction to the vaccine components. The nurse reported that the patient received the Flulaval Trivalent and was having a reaction which she clarified as some kind of rash. No further details were provided on the call by the nurse. The doctor reported that last year, patient received another influenza vaccine from other manufacture that contain Octylphenol ethoxylate (OPE), and had a more serious reaction. Doctor wanted to see the differences on the inactive ingredients between both vaccines. Flulaval Trivalent was not administered at doctor's office. The reporter did not consent to follow-up.