chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Psoriatic arthropathy
Clinical narrative: Psoriasis symptoms within a month of second vaccine dose. Developed into sever outbreak of psoriasis resulting in psoriatic arthritis of the right wrist. No history of psoriasis prior to vaccine event. No abnormal life events during the same period.
Age: 17.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination error
Clinical narrative: Given in error
Age: 31.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Client received extraneous and unnecessary dose of Varicella on 09/06/23 at 1546 by vaccinator.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Heart rate increased
Clinical narrative: Elevated temperature and increased heart rate.  Heart rate has been over 110 for more than 2 days.  It is starting to go back down.  Today it is 85-95.  Normal RHR is 68-70.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient became dizzy immediately following vaccine administration.  Dizziness lasted several days.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Off label use
Clinical narrative: box labeled with lot P5572, recall per GSK documentation. GSK was called, pharmaceutical company employee indicates it is not a question of quality. but off abel lettering.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Brain fog, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Headaches15 days, dizziness 17 days( on going) "brain fog", 15 days, on going, just better, fatigue 10 days, getting better, poor focus and memory 17 days, better but on going, poor balance 18 days, on going and getting better
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Memory impairment, SARS-CoV-2 test negative
Clinical narrative: Headaches15 days, dizziness 17 days( on going) "brain fog", 15 days, on going, just better, fatigue 10 days, getting better, poor focus and memory 17 days, better but on going, poor balance 18 days, on going and getting better
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Off label use
Clinical narrative: Not an issue with box labeled, recall per GSK documentation. GSK was called, pharmaceutical company employee indicates it is not a question of quality. but off abel.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: 10 minutes after receiving a vaccine patient notified pharmacist of possible reaction. Patient stated that she has had tingling in the lips and a little bit of throat swelling, but denied any difficulty breathing. Patient was given 1 dose of benadryl (25mg) and water. Patient remained in the pharmacy for 45 minutes for observation. Symptoms subsided after benadryl.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast cancer female, Breast mass
Clinical narrative: Pt felt a lump in breast; diagnosed with right breast cancer
Age: 61.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Vaccination error
Clinical narrative: Client received extraneous and unnecessary dose of hepatitis B vaccine by RN on 09/07/23 at 1702.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Mother called clinic ~22 hours after vaccine was administered and reports softball size redness and warmth on patients arm around vaccination site and reports child denies any pain or other symptoms at this time.  ~48 hours after vaccine was administered spoke with mother again; softball size redness and warmth continues, child now complains of pain and itching at site. Mother gave child OTC ibuprofen and Benadryl, plans to alternate cold and warm compress
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy lung, Breath sounds abnormal, Computerised tomogram, Lung disorder, Pulmonary function test
Clinical narrative: lung issues
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Depressed mood, Gait disturbance, Gait inability, Injection site pain, Injection site swelling
Clinical narrative: no symptoms / signs immediately after 4p vaccination. Then the following morning upon wake up pt was very sad, and inconsolable. Stating he didn't feel good and his leg hurt. When you would pick him up he would yell in pain if you touched his left leg (injection site). He was feverish and sitting / unable to walk. Then the next morning 9/3/23 He woke up feeling better still slightly feverish but no longer inconsolable and able to play but his leg was swollen and stiff unable to bend his knee he walked with a lim all day.  This continued until the following day when some mobility returned but he was still noticeably limping.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Joint stiffness, Malaise, Pain in extremity, Pyrexia
Clinical narrative: no symptoms / signs immediately after 4p vaccination. Then the following morning upon wake up pt was very sad, and inconsolable. Stating he didn't feel good and his leg hurt. When you would pick him up he would yell in pain if you touched his left leg (injection site). He was feverish and sitting / unable to walk. Then the next morning 9/3/23 He woke up feeling better still slightly feverish but no longer inconsolable and able to play but his leg was swollen and stiff unable to bend his knee he walked with a lim all day.  This continued until the following day when some mobility returned but he was still noticeably limping.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Heart rate increased, Pain in extremity
Clinical narrative: Just a sore arm after day one.....then on day 3 noted significant increase in heart rate with any activity.  Just a relaxing walk - heart rate would jump to 130s.  The last time I had this- was when I had my pericardial effusion in the spring of 2022.   On day 9, developed slightly elevated temperature from baseline - with intermittent significant fatigue.   Working closely with cardiology to monitor - and see if it will pass on its own - or if medical intervention is needed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Vaccination error
Clinical narrative: Patient was given a pentacel vaccine that was adminsitered after 30 mins of being drawn up.  Patient has no adverse symptoms.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Arrhythmia, Pleural effusion
Clinical narrative: Patient wife states that patient was hospitalized with arrhythmia and fluid on the lungs.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 33.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client received Extraneous and unnecessary dose of Hepatitis B vaccine by RN on 09/07/2023 at 1659.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Palpitations, Pyrexia, Vomiting
Clinical narrative: Low-grade fever (99.5) with muscle aches started at around 4pm, Aleve was taken at 4:30.  Fever spiked to 100 at 6:00p.  600mg of Ibuprofen was taken, fever spiked to 101 at 10p with muscle aches worsening.  800 mg of Ibuprofen was taken at 10p, fever spiked to 102.5 at midnight.  Nausea began and had to vomit.  Low-grade fever in 99-100 range remained until 36 hours post-vaccination.  Experienced sporadic, but mild palpitations in the chest area throughout the symptomatic period
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: none
Age: 32.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Ataxia, Disorientation, Hyperventilation, Hyporeflexia, Postictal state
Clinical narrative: Patient with history of seizure activity presented with seizure-like activity approximately 5 hours after vaccination. Patient appeared disoriented and postictal following the episode. Episode lasted approximately 2 minutes. Patient was hyperventilating, and alert but not oriented during the postictal phase. Patient bit his tongue during the episode, but did not have significant bleeding. Patient was evaluated by EMS, and refused transport against medical advise. Neuro-exam by on-site medical provider revealed sluggish reflexes, and minor dystaxia. Patient was picked up from work by his wife, with instructions to follow up with previously established Neurology provider.
Age: 32.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Seizure like phenomena, Tongue biting
Clinical narrative: Patient with history of seizure activity presented with seizure-like activity approximately 5 hours after vaccination. Patient appeared disoriented and postictal following the episode. Episode lasted approximately 2 minutes. Patient was hyperventilating, and alert but not oriented during the postictal phase. Patient bit his tongue during the episode, but did not have significant bleeding. Patient was evaluated by EMS, and refused transport against medical advise. Neuro-exam by on-site medical provider revealed sluggish reflexes, and minor dystaxia. Patient was picked up from work by his wife, with instructions to follow up with previously established Neurology provider.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral disorder, Rash erythematous, Skin discolouration, Skin disorder, Skin reaction
Clinical narrative: Patient received her 1st Shingrix vaccine on 10/07/2023. She began to experience spots on/in her mouth and chin the morning of 10/10/2023. The bumps are red with white in the middle. The patient was concerned of the appearance of these spots. She was not sure if it was the vaccine causing her to experience this reaction or not. The patient was advised to seek additional medical attention to determine the cause of her skin reaction.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Hyperhidrosis, Injection site pain
Clinical narrative: He got his vaccine, for one day he had a little bit of soreness at the point of injection, which he had gotten with all the others, which did not feel it was much of a reaction.  On 10/5/23 he had stomach pain, then he started throwing up, chills, and sweating.  He called the doctor and he may have taken some Tylenol and let it run it's course.  He was informed by his doctor that he did not know what it was, the gentleman felt it was something he ate, but is convinced that it was the shot as his son had the shot the day before and he had the same reaction.  He had loss of appetite with this as well.  His symptoms lasted for a couple of days.  He is back to feeling better now.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: He got his vaccine, for one day he had a little bit of soreness at the point of injection, which he had gotten with all the others, which did not feel it was much of a reaction.  On 10/5/23 he had stomach pain, then he started throwing up, chills, and sweating.  He called the doctor and he may have taken some Tylenol and let it run it's course.  He was informed by his doctor that he did not know what it was, the gentleman felt it was something he ate, but is convinced that it was the shot as his son had the shot the day before and he had the same reaction.  He had loss of appetite with this as well.  His symptoms lasted for a couple of days.  He is back to feeling better now.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: fine rash itchy turned to hives day after through 3 days
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: pt reports that her arm was a little more painful than she expected immediately after the vaccination. She had pain but normal ROM for the first 4-5 days, but then has been getting progressively more painful, and abduction of the left shoulder is now intensely painful 13 days after the vaccination. No other injury. She has tried ice, topicals. I gave her oral steriods. She pointed to the site of the injection and it was a little closer to the acromion process than ideal, less than 2 fingers away.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Injection site bruising, Injection site haematoma, Injection site pain
Clinical narrative: There was an apparent burning sensation when the needle was injected. The next days, I developed a hematoma on the site of the injection and a  large dark red/purple bruise followed.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Incorrect vaccine was given for childs age group. Pfizer vaccine for ages 12years and older was given to this 8 year old. This submission is to report the vaccine error, no adverse reaction noted at this time.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Erythema, Herpes zoster, Oropharyngeal pain
Clinical narrative: (1) Low fever 100.2, slight sore throat, lasted 1  & 1/2 days, then returned to normal. (2) Slight flare-up of old shingles disease, small patch 1.5 inch by 3/4 inch, slightly irritated, pink spots, no blisters, at same site on clavicle where  a  worse shingles flare-up occurred a year or so ago after a previous series of covid shots.  The original serious shingles infection occurred 25 or so years ago, and in 2021 I had the Shingrix series vaccinations.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Right arm was sore for a couple of days and warm. now has redness, warm to touch, and swelling at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Product administration error
Clinical narrative: ADDITIONAL DOSE OF VARICELLA GIVEN IN ERROR
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt did not received the correct dosage, given 0.5mL instead of 1mL
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bone pain, Injected limb mobility decreased, Muscle swelling, Underdose
Clinical narrative: When giving customer shot, RN noticed "bumpy" areas on shoulder muscle. She believes she gave shot at appropriate landmarks but became difficult to push last small amount of vaccine in so she stopped and removed needle. Customer started having anterior shoulder pain and clavicle pain following administration of vaccine. Customer felt shot "given too high" (unseen by staff). Customer seen in ER with x-rays performed and given meds to help with pain. Seen by company Occupational Health following ER visit. Customer still unable to move arm higher than waist level and will be seen again by OCC Health first part of next week for further follow up.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: When giving customer shot, RN noticed "bumpy" areas on shoulder muscle. She believes she gave shot at appropriate landmarks but became difficult to push last small amount of vaccine in so she stopped and removed needle. Customer started having anterior shoulder pain and clavicle pain following administration of vaccine. Customer felt shot "given too high" (unseen by staff). Customer seen in ER with x-rays performed and given meds to help with pain. Seen by company Occupational Health following ER visit. Customer still unable to move arm higher than waist level and will be seen again by OCC Health first part of next week for further follow up.
Age: 63.0
Sex: F
Vaccine: HEP, RSV
Symptoms: Full blood count, Hypersensitivity, Metabolic function test, Pruritus, Rash
Clinical narrative: I do not know which vaccine brand she received - only  that it was RSV and Hep B vaccine given by her primary doctor.   She has a diffuse itchy painful rash consistent with allergic reaction, not resolved after 5 days while being on Prednisone.   rash started a couple of hours after receiving the vaccinations.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong patient
Clinical narrative: During system balance patients name appeared twice on the borrowed log one on 9/12/23 and once on 10/6/23. Pt. 1/12/11 received Tdap, Men A and HPV on 9/12/23 during office visit with Dr. Mom instructed to schedule a nurse visit for influenza vaccine since we had just ran out of the vaccine in office to give to our patients. Mom scheduled nurse visit on 10/6/23 for immunizations. Vaccines (Tdap, Men A, HPV) for this day were documented on the wrong patient on 9/12/23 by accident.  During the nurse visit on 10/6/23 the systems didn't reflect previous immunizations given on 9/12/23. Patient was given Tdap, Men A, HPV and Influenza vaccine during nurse visit  consent and Screening questions answered. Mom filled out the screening checklist for contraindications to vaccines for children and teens marking no to all questions even the question asking has the child received vaccinations in the past 4 weeks. Staff administered all vaccines that were due at this point using EMR information.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: PATIENT COMPLAINED OF MODERATE LEVEL OF ITCHINESS LOCALIZED AT SITE OF INJECT.  ALSO HAD SOME SLIGHT RASH AND FORMATION OF PAPULE.  EVENT OCCURED ON 10/09 FOLLOWING INJECTION ON 10/07. SEEMS TO HAVE IMPROVED TODAY. DID NOT EXPERIENCE SAME REACTION TO RSV VACCINE PT RECEIVED IN LEFT ARM.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Peripheral swelling, Pyrexia, Vaccination site haemorrhage
Clinical narrative: Patient became nauseated, febrile, left arm extremely swollen, bleeding from site.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Reddish patch approximately 2 inches in diameter, mid-bicep, outside of arm, approximately 2-3 inches BELOW injection site. Patch was well defined, moderately painful to the touch and warm to the touch. Patch was not raised or itchy.  First noticed approximately 84 hours post vaccination and has faded over the last 24 hours but is still present.  No other significant reactions (cardiac, respiratory or severe pain) at this time. Taking NSAID and monitoring. No clinical visits scheduled at this time but, may be if situation worsens or does not resolve.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Client received High Dose FluZone vaccine and should have received regular dose. At time of report, client unavailable to discuss if adverse reaction or treatment was received.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain
Clinical narrative: Sharp pain on sides above hip.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Donor received Tetanus Vaccine.  He c/o fatigue, muscle aches and joint pain for 2 days starting on 10/06/2023
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV, PNC15
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: STARTED WITH FEVER ON SATURDAY 10/7/2023 RASH STARTED MONDAY 10/9/2023 RASH IS WIDESPREAD-FLAT, RED, SMALL TO B LEGS, B ARMS, TRUNK, BACK, AND FACE
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injury associated with device
Clinical narrative: when administering the vaccination, pt was held by father who at first had a firm grip on him. When the vaccine entered pt's leg he jumped and the needle came out and scraped his leg forming a small gash on the lower left thigh. sight was cleansed and bandages applied. Pt was examined by Dr. and she gave them some antibiotic cream to put on the site.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: Patient states rash and swelling at injecion site and rash on abdoment
Age: 4.0
Sex: F
Vaccine: FLUA4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: High Dose given to pediatric patient. Patient has not had any adverse reaction at this time.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 26.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: On 10/07/2023 around 11PM, I noticed swelling and warmth near the injection site. I figured it was a normal reaction but still marked the area. I checked an hour later as my arm was very sore and it had spread./ By that point, I was feeling the effects of the vaccine- chills, fatigue and body aches so I went to bed. I checked again when I woke up on 10/08/2023. It had spread further. I put ice on it, and monitored throughout the day. It continued to hurt. I monitored the following day on 10/09/2023. On 10/10/2023 I decided to go into urgent care, who prescribed antibiotics for cellulitis. The injection site is swollen, red and warm to the touch, about 3 inches in diameter. My entire arm hurts and it itches as the skin is stretched. The itching didn't begin until 10/09/2023.
Age: 26.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Injection site warmth, Pain, Pain in extremity, Pruritus
Clinical narrative: On 10/07/2023 around 11PM, I noticed swelling and warmth near the injection site. I figured it was a normal reaction but still marked the area. I checked an hour later as my arm was very sore and it had spread./ By that point, I was feeling the effects of the vaccine- chills, fatigue and body aches so I went to bed. I checked again when I woke up on 10/08/2023. It had spread further. I put ice on it, and monitored throughout the day. It continued to hurt. I monitored the following day on 10/09/2023. On 10/10/2023 I decided to go into urgent care, who prescribed antibiotics for cellulitis. The injection site is swollen, red and warm to the touch, about 3 inches in diameter. My entire arm hurts and it itches as the skin is stretched. The itching didn't begin until 10/09/2023.
Sex: M
Vaccine: PNC15
Symptoms: Blood test, Gait inability, X-ray
Clinical narrative: HCP stating patient inability to walk after receiving VAXNEUVANCE administration. Caller stated patient then had blood work and x-rays performed. Caller confirmed adverse event did not relate to PQC case. Additional AE case 02472371 and PQC case 0247; This spontaneous report was received from a Consumer and refers to a 5-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X005583, expiration date: 10-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 28-AUG-2023, the patient experienced inability to walk after receiving pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) administration. Caller stated patient then had blood work and x-rays performed (results not provided). On an unknown date in 2023, the patient recovered from inability to walk.   The causal relationship inability to walk after and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: bubbling of the supraclavicular lymph node in the same arm following a GARDASIL 9 administration; This spontaneous report was received from a physician referring to a male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant medication were unknown.  On an unknown date, the patient started HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, anatomical location, route of administration, exact indication, lot #, expiry date were not reported) as prophylaxis.   On an unknown date, the patient experienced bubbling of the supraclavicular lymph node in the same arm (Lymphadenopathy) following a HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration. On an unknown date, the patient recovered from the event (reported as the condition resolved on it's own and has not come back). The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causal relationship between the event and the suspect therapy was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; RN calls to report MMR II Lot#u013035 exp 4/23/2023 administered to a patient. No further AE.  No PQC; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-AUG-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, lot #u013035, expiration date: 23-APR-2023, administered as prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: no additional AE; Caller reports patient was administered VARIVAX and PROQUAD at same office visit.  No other information provided.  No additional AEs or PQC reported.; interchange of vaccine products; Information has been received from a pharmacist, referring to 4 years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter,  lot #W035466, expiration date: 06-MAY-2024, administered subcutaneously in the Right thigh for prophylaxis (strength was not provided); additional, the patient also received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W025277, expiration date: 10-AUG-2024, administered in Left thigh for prophylaxis (strength, and route of administration were not provided).  The reporter said that the nurse made the mistake as she thought that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was the same as Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-AUG-2023 and 28-AUG-2023, temperature excursions were reported at 8.9C for 12 hours and 20 minutes and 9.4C for 8 hours and 20 minutes, respectively. No previous temperature excursions were reported. On 25-SEP-2023, the patient was vaccinated with an improperly storage (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, valid lot #1968393, expiration date: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, Incorrect dose administered, Wrong product administered
Clinical narrative: No additional AE/PQC.; inadvertent administration of MMR-II and PROQUAD to a patient.; Patient was scheduled to receive their second dose of MMR-II and VARIVAX on 10/05/2023 but instead inadvertently received MMR-II and PROQUAD.; This spontaneous report was received from  a medical assistant and refers to a 5-year-old patient. The patient's medical history, concurrent conditions and concomitant  therapies were not reported.  On 05-OCT-2023, the patient was inadvertent vaccinated  with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, both  administered for prophylaxis (strengths, doses description, lot #s, expiry dates, anatomical locations, and routes of administration were not provided) (accidental overdose). It was stated that the patient was schedule to received  varicella virus vaccine live (oka/merck) (VARIVAX) injection, for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (Wrong vaccine administered). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: A HCP called with a question about VARIVAX and reported an AE. The HCP reported that patient came into the pharmacy yesterday and stated they had one dose of VARIVAX as a one year old. The patient is currently 26 years old and has not received a seco; No additional adverse event reported; This spontaneous report has been received from a pharmacist regarding a 26-years-old of unknown gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unknown date in 1998 (also reported as when the patient was 1-year-old), the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency, lot # and expiration date were not reported) as prophylaxis.   On 05-OCT-2023 (also reported as yesterday), the patient went to the pharmacy and reported that she/he had not received a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient requested was requesting a second dose. No additional adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Staff calling on behalf of HCP to report adverse event. Caller stated HCP reported a student received 2 doses of MMRII outside of schedule some time in the end of August. Caller stated patient is an early 20s males, date of administ; No AE event; Staff calling on behalf of HCP to report adverse event. Caller stated HCP reported a student received 2 doses of MMRII outside of schedule some time in the end of August. Caller stated patient is an early 20s males, date of administ; This spontaneous report was received from a nurse via company representative, concerning a male patient in his earlys 20s.  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with 2 doses of mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided), outside of product information (PI) schedule sometime in the end of August 2023 (Inappropriate age at vaccine administration  and Inappropriate schedule of vaccine administered). No Adverse event reported.
Age: 40.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE Event; HCP called to ask about next steps regarding inadvertent administration of an expired dose of PNEUMOVAX 23.  Expired 8/29/2023 and was administered 10/6/2023. Referenced post expiry memo. Request case reference 02486527. Consent to contact is yes. No; This spontaneous report was received from a nurse, concerning a 40-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 06-OCT-2023, the patient was vaccinated with an expired dose of  with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #u032086, has been verified to be valid expiration date: 29-AUG-2023)  administered for prophylaxis (strength, and route of administration were not provided). No adverse events reported.
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Patient developed shingles; patient experienced nerve pain in her breast; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (The patient was a breast cancer survivor).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Patient developed shingles) and post herpetic neuralgia (Verbatim: patient experienced nerve pain in her breast).  The outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-OCT-2023 The doctor reported a previously vaccinated 78 year old female patient experienced nerve pain in her breast. The patient developed shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, the patient received INFLUENZA VACCINE. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was not reported.   The reporter considered the pain in arm to be related to Arexvy.     The company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt date: 27-SEP-2023 The patient stated that Flu vaccine was administered at the same visit and her arm hurts otherwise no other side effects. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.    The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Throat tightness
Clinical narrative: Body aches; throat closing up; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Body aches) and throat constriction (Verbatim: throat closing up). The outcome of the general body pain and throat constriction were resolved.   It was unknown if the reporter considered the general body pain and throat constriction to be related to Shingrix.     It was unknown if the company considered the general body pain and throat constriction to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient reported after administration of first dose she had bad reaction of throat closing up. The reaction has been worst. In addition, she also had body aches which was no surprise. The symptoms were not treated. She wanted to get information on efficacy after just having the first dose of Shingrix. The pharmacist thought she had heard 65 percent efficacy and her MD refused to provide more information or advice. The reporter gave permission to contact on her mail address.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site injury, Injection site scab, Wound
Clinical narrative: Injection site scab; wound at injection site; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site scab in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-AUG-2023, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site scab (Verbatim: Injection site scab) and injection site injury (Verbatim: wound at injection site).  The outcome of the injection site scab was not resolved and the outcome of the injection site injury was not reported.   The reporter considered the injection site scab to be related to Arexvy. It was unknown if the reporter considered the injection site injury to be related to Arexvy.     The company considered the injection site scab to be related to Arexvy. It was unknown if the company considered the injection site injury to be related to Arexvy.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist gave vaccination and the patient developed a wound at injection site. Referring health care professional phone number. The reporter consented to follow-up.
Sex: U
Vaccine: RVX, UNK
Symptoms: Headache
Clinical narrative: Bad headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   On 29-SEP-2023, the patient received RSV vaccine and INFLUENZA SHOT. On 30-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced headache (Verbatim: Bad headache).The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to RSV vaccine.  It was unknown if the company considered the headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-SEP-2023 This case was reported by a patient via  interactive digital media. The patient got RSV and flu shot the day before reporting and bad headache at the time of reporting. It was unknown if the reporter considered the headache to be related to flu shot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose of Shingrix; This non-serious case was reported by a consumer and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included INFLUENZA VACCINE.   On 30-SEP-2023, the patient received the 3rd dose of Shingles vaccine. On 30-SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: received 3rd dose of Shingrix).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2023 It was reported by patient that on the day of reporting that he/she went for flu shot. The pharmacist suggested to patient that to also get the 2nd Shingles vaccine. When the patient got home, he/she was able to confirm that he/she already got the 2nd shingles vaccine which led to extra dose administered. The patient enquired were there any concerns about getting 3 doses of the shingles vaccine.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 36 weeks pregnant was given the AREXVY vaccination; given AREXVY vaccine instead of ABRYSVO vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2023, the patient received Arexvy. On 28-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: given AREXVY vaccine instead of ABRYSVO vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 weeks pregnant was given the AREXVY vaccination).  The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient states that she was 36 weeks pregnant and was given the Arexvy vaccine instead of Abrysvo vaccine which led to inappropriate age at vaccine administration. The patient who was pregnant received Arexvy vaccine, which led to vaccine exposure during pregnancy.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: was unaware that there was a 2nd dose; 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 (In 2021, received first dose).   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: was unaware that there was a 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2023 The reporter had a patient who received the first dose of the shingles vaccine back in 2021 and was unaware that there was a 2nd dose.  The reporter understood that they were supposed to administer the 2nd dose as soon as possible but, since it was over 2 years ago, she did not know if they needed to restart the series or not. No further details provided on web form. The reporter consented to follow up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: dose reconstituted with sterile water; dose reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number T5J32, expiry date 20-AUG-2024) for prophylaxis.   On 04-SEP-2023, the patient received the 1st dose of Shingrix. On 04-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: dose reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: dose reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 2 Oct 2023: The pharmacist reported that a nurse administered Shingrix first dose reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: have never received a 2nd dose; 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 (received a dose of Shingrix almost 5 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: have never received a 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose at 6 week interval instead of 2 month; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Patient received 2nd dose at 6 week interval instead of 2 month).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The reporter asked that what should office do or the patient need to be revaccinated. The patient received 2nd dose of Shingrix at 6 week interval instead of 2 month, which led to shortening of vaccine schedule. The case was linked with case US2023135132 and US2023133827 reported by the same reporter.; Sender's Comments:  US-GSK-US2023133827:Same reporter US-GSK-US2023135132:Same reporter
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: her son received his 1st dose of Bexsero on 9-MAR-2022, and the medication expired 31-JAN-2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31-JAN-2022) for prophylaxis.   On 09-MAR-2022, the patient received the 1st dose of Bexsero. On 09-MAR-2022, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: her son received his 1st dose of Bexsero on 9-MAR-2022, and the medication expired 31-JAN-2022).  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: 2-Oct-2023 The reporter was the patient's mother. The reporter did not have any other information beyond what had been reported about this vaccine administration. Consent to follow up with health care professional was obtained. The patient received an expired dose of Bexsero, which led to expired vaccine used.