chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Streptococcus test negative, White blood cell count normal
Clinical narrative: Patient received COVID booster on 12/26/23 along with flu vaccine at the same time. She developed mild flu-like symptoms for the next couple of days. Then around 1/3/24, noticed a low grade fever along with sore throat. She was seen by a provider in urgent care, strept swab was negative (no other swabs for flu/rsv/covid obtained). She was treated with azithromycin for presumed strept. She states "right after" this, she developed PMR symptoms. (Tried to clarify few times what "right after" meant but she did not give specific times/dates).  The following information was obtained from office visit on 3/2024 in which she was finally seen for these symptoms: Initially had muscle soreness after Pilates.  She stopped Pilates but the soreness persisted. Thought may be medication related.  Trial of stopping the anastrazole didn't change symptoms.  Then stopped the pravastatin about one week ago.  She hasn't noticed any improvement yet though.   Describes significant soreness in her shoulders, biceps, hips/back of thighs and calves. At times there is also stiffness mainly in the shoulders but maybe in the back and hips too.  She doesn't feel that her muscle are weak at all but describes difficulty getting up from a chair without using her hands.  Is also afraid to even walk around outside as she thinks she won't be able to make it back home.  Notes the soreness is most pronounced in the daytime or when at rest for a while, is able to get loosened up after more activity. Taking ibuprofen daily which is really effective. Going to chiropractor weekly now instead of every other week.  No fever, rashes, night sweats. No new headaches, no significant vision changes. No jaw or temple pain.  No significant weight changes (maybe up 5 lbs due to lack of exercise). No n/v, abdominal pain.  Has gotten much worse over time but not worse in the past month. No problems swallowing/speaking, no coughing, sob, chest pain.  Does have hx of adrenoleukodystrophy, mom developed symptoms later on in life and younger brother died from this.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Erythema, Immediate post-injection reaction, Skin irritation
Clinical narrative: Patient reports she experienced slight redness/irritation immediately following vaccination. The spot did not improve, and instead grew slightly in size. On 8/8/24 she reached out to the pharmacy to report the spot was biopsied and found to be Basal Cell Carcinoma.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia, Rash
Clinical narrative: Both thighs showed erythema, warmth to touch, worse on Right thigh.  Light rash on trunk.  Fever up to 101* by 8/8/24, then up to 99* on 8/9/24.  Itching on both thighs.  No shortness of breath, no difficulty swallowing, no tongue swelling per mother by phone. Office Manager and then RN talked to mother by phone for extended time.  Cautioned if any SOA, difficulty swallowing or tongue swelling to call EMS or proceed to ER.  Mother said child has had local reactions and spread of rash with every vaccine he has ever had, but reaction worse this time.  Has Eczema with frequent flareups and seasonal allergies.  Reaction reported to PCP Dr.  Since he is improving, no further treatment at this time.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Seven days after immunization (8/6/24) was administered, pt called and reported that in the area of his arm where he received the immunization, he was experiencing pain, swelling, redness, heat, and "welps" all around the area. I instructed him to see PCP urgently or proceed to urgent care center.  Pt saw the PA at his PCP's office.  She prescribed cephalexin.  The next day, 8/7/24, the pt reported that having had several doses of cephalexin, he had noticed a decrease in the pain, swelling, redness, and heat.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Seven days after immunization (8/6/24) was administered, pt called and reported that in the area of his arm where he received the immunization, he was experiencing pain, swelling, redness, heat, and "welps" all around the area. I instructed him to see PCP urgently or proceed to urgent care center.  Pt saw the PA at his PCP's office.  She prescribed cephalexin.  The next day, 8/7/24, the pt reported that having had several doses of cephalexin, he had noticed a decrease in the pain, swelling, redness, and heat.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness and pain around injection site started the evening of the vaccine. Ppt reported reaction while seen in clinic 8/9/2024. Left upper arm still red, but Ppt says it has improved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Cyanosis, Hyperhidrosis, Hypotension, Lethargy
Clinical narrative: Patient  had pre-syncope episode 15-20 mins after vaccine was given  and watching twin sibling  become upset and anxious and receive his 4 yr old vaccines ( proquad & kinrix).  Patient was pale, diaphoretic , weak and lethargic when walking out to waiting room with mom and sibling.  Lips were blue.   Staff were able to  carry patient back to an exam room qiuckly and placed flat and in supine position. Dr, and Dr.  attended at this time , Bp was taken - patient was mildly hypotensive. Food and juice were offered  patient took sips of water and recovered steadily in exam room over 30-40 min time frame . No further intervention necessary.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Presyncope
Clinical narrative: Patient  had pre-syncope episode 15-20 mins after vaccine was given  and watching twin sibling  become upset and anxious and receive his 4 yr old vaccines ( proquad & kinrix).  Patient was pale, diaphoretic , weak and lethargic when walking out to waiting room with mom and sibling.  Lips were blue.   Staff were able to  carry patient back to an exam room qiuckly and placed flat and in supine position. Dr, and Dr.  attended at this time , Bp was taken - patient was mildly hypotensive. Food and juice were offered  patient took sips of water and recovered steadily in exam room over 30-40 min time frame . No further intervention necessary.
Age: 1.58
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Injection site oedema
Clinical narrative: light edema at site of injection but no associated erythema and no signs of infection
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyspnoea, Fall, Head injury, Loss of consciousness, Mouth injury
Clinical narrative: Pt received three vaccines. As pt was leaving facility with parent, pt fell to ground unconscious. Pt hit head on ground when fell and had at least one cut in mouth. Pt was tense while unconscious and appeared to have difficulty breathing due/to lack of chest movement and presence of wheezing. 911 was called and an EpiPen 0.3 mg  was administered in pt's right thigh. Pt came to after administration of EpiPen and was alert and oriented. Ice pack was given. EMS arrived and took pt to emergency room to be evaluation
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tension, Wheezing
Clinical narrative: Pt received three vaccines. As pt was leaving facility with parent, pt fell to ground unconscious. Pt hit head on ground when fell and had at least one cut in mouth. Pt was tense while unconscious and appeared to have difficulty breathing due/to lack of chest movement and presence of wheezing. 911 was called and an EpiPen 0.3 mg  was administered in pt's right thigh. Pt came to after administration of EpiPen and was alert and oriented. Ice pack was given. EMS arrived and took pt to emergency room to be evaluation
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Patient's father called today because 3-4 hours after receiving her PPSV23 vaccine in clinic today, she developed an erythematous, pruritic rash across her body. Some aspects are raised. She is otherwise acting like herself and denies vomiting, abdominal pain, swelling, difficulty breathing, or dizziness.   These symptoms and the timing are concerning for an allergic reaction to the vaccine. Since her only symptom is urticaria, I recommended Benadryl and close monitoring.  Note from Dr. 7/17/24
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given unprescribed vaccine
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The protocol changed to 18 and over, from 7 and older-and RPh was not aware of the change. Patient had no adverse effects from the shot.
Age: 65.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient came in and requested his second shot of Shingrix, but we did not realize his first dose was administered only 3 weeks earlier. Patient received 2 doses of Shingrix 3 weeks apart. First dose was administered on 6/18/24 and the second dose was administered on 7/9/24. Patient misunderstood and thought we told him to come back in 2 weeks instead of in 2 months. Patient said he has felt fine and was not upset. He asked us to please remind him to come in for the next dose when appropriate.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Headache, Nausea, Neck pain, Rash
Clinical narrative: Started feeling bad on 8/7/2024. Stopped taking Bactrim at this time. Developed a rash on elbows and knees on 8/8/2024 which was red and raised. Also developed headache, nausea, and neck pain. Rash progressed to full body 2-3mm maculopapular erythematous rash including palms but not soles on 8/9/2024 at which point she presented to my office.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Rash maculo-papular, Rash papular
Clinical narrative: Started feeling bad on 8/7/2024. Stopped taking Bactrim at this time. Developed a rash on elbows and knees on 8/8/2024 which was red and raised. Also developed headache, nausea, and neck pain. Rash progressed to full body 2-3mm maculopapular erythematous rash including palms but not soles on 8/9/2024 at which point she presented to my office.
Age: 46.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash, non-painful, non-itchy/not bother some - face, torso, extremities
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness at vaccine site.  Improving without intervention.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Back pain, Fatigue, Muscular weakness, Nausea
Clinical narrative: Per patient's  mother: "He got tired,sleepy, then nauseous, then his muscles started trembling, back pain, stomach pain, breathing started going out, threw up 4 times, gave him his rescue inhaler 4 times, fever climbing...at one point 103.6 and then his muscles started shutting down.  At one point he couldn't open his hand or move his legs.  We called the after hours line when the uncontrollable shaking began.  And as I was talking to them he got worse and worse."
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Respiration abnormal, Somnolence, Tremor, Vomiting
Clinical narrative: Per patient's  mother: "He got tired,sleepy, then nauseous, then his muscles started trembling, back pain, stomach pain, breathing started going out, threw up 4 times, gave him his rescue inhaler 4 times, fever climbing...at one point 103.6 and then his muscles started shutting down.  At one point he couldn't open his hand or move his legs.  We called the after hours line when the uncontrollable shaking began.  And as I was talking to them he got worse and worse."
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: after injection pt described arm feeling sore; by the evening hours the injection site had a raised welted area of golf ball size; MOC applied Vick's Vapor Rub and gave pt oral Ibuprofen. The area was red and swollen and hot to touch like a boil as described by MOC. Pt describes level of pain as 7 out of 10 on pain scale and states site is very tender and still very sore. Today patient has a baseball sized raised bump on upper right arm to the right deltoid, there is no obvious sign of redness/discoloration. Doctor advised oral OTC Cetirizine and Ibuprofen for resolution of symptoms. Patient and MOC given instructions on monitoring and discussed when to further follow up should symptoms worsen/persist. Patient and MOC verbalized understanding.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Urticaria
Clinical narrative: after injection pt described arm feeling sore; by the evening hours the injection site had a raised welted area of golf ball size; MOC applied Vick's Vapor Rub and gave pt oral Ibuprofen. The area was red and swollen and hot to touch like a boil as described by MOC. Pt describes level of pain as 7 out of 10 on pain scale and states site is very tender and still very sore. Today patient has a baseball sized raised bump on upper right arm to the right deltoid, there is no obvious sign of redness/discoloration. Doctor advised oral OTC Cetirizine and Ibuprofen for resolution of symptoms. Patient and MOC given instructions on monitoring and discussed when to further follow up should symptoms worsen/persist. Patient and MOC verbalized understanding.
Age: 49.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC15
Symptoms: No adverse event, Product preparation issue
Clinical narrative: During administration of Pentacel, only the DTAP-IPV component was administered. No adverse reactions were noted. Client returned to receive HIB.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Fatigue, Mobility decreased
Clinical narrative: Fever, diarrhea, tiredness, difficulty moving, fatigue, dehydration, soreness, abdominal pain, dehydration
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, diarrhea, tiredness, difficulty moving, fatigue, dehydration, soreness, abdominal pain, dehydration
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: RIGHT DELTOID SWELLING /HOT
Age: 67.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Prevnar 20 (May 18, 2024) 13 days after receiving Pneumovax 23 (May 5, 2024)
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Eye movement disorder, Posture abnormal, Seizure
Clinical narrative: pt was given vaccines today in office MenQuadfi, HPV and Trumenba while sitting and resting afterwards I was speaking to the patient when his eyes started to roll and he slowly started to slump to the right. He began having a seizure that lasted about 5-7 seconds
Age: 43.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Experienced tightness in center of chest about 30 min after the vaccine. Client described soreness as "feels like I was lifting heavy weights" but in the center of my chest. Did not feel short of breath. Checked blood pressure and heart rate and both were normal. Had been feeling "under the weather" in weeks prior. Took aleve and symptoms seemed to subside. 2 days later the same symptoms returned with tightness and sore in chest but no elevated blood pressure or heart rate. Client was advised to call doctor regarding symptoms.
Age: 56.0
Sex: M
Vaccine: PNC20
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: Patient with nonproductive cough, fever, and body aches for 2 days after receiving Prevnar 20. The cough has persisted, with today being the 10th day of symptoms. No fever/body aches after the first two days.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Pt was given an extra dose of Hep A vaccine
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received a second Prevnar 20 vaccine, despite not needing it.  Patient had no issues from the vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Varicella zoster virus infection
Clinical narrative: Started having a sudden rash on hand. Went to urgent care and diagnosed with zoster. Given an antiviral
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Pt was given a Pentacel. Mom only wanted to give HIB.
Age: 49.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Pyrexia, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Quickly onset high fever, vomiting, chills, seizure. Fever and vomiting happened very quickly, followed by seizure and no verbal responsiveness for several minutes. Total event, including post-seizure shaking was around 20-30 minutes.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Quickly onset high fever, vomiting, chills, seizure. Fever and vomiting happened very quickly, followed by seizure and no verbal responsiveness for several minutes. Total event, including post-seizure shaking was around 20-30 minutes.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Fatigue, Nodule, Pain in extremity, Pyrexia
Clinical narrative: Patient described IMZ reaction as very sore arm with a large red spot with a knot, fatigue and fever.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 40.0
Sex: F
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 48.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine  on Friday August 2nd, and started to notice that there was more swelling  in the area of injection site. The patient had some pain in the area too.  Patient had a moderate to severe injection site reaction to the Prevnar 20. Red area is about the size of a baseball and is a little warm to touch.  On 8/7 since patient did not see an improvement, the patient started taking OTC Benadryl. Patient called into the clinic to report his symptoms on 8/8. Provider instructed to enter VAERS report. 8/9 nurses called to gather additional detail for report and patient reported the same syptoms.
Age: 18.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No further information provided. No additional AE reported. No PQC reported.; Nurse explained patient received the first dose of VAQTA 0.5mL on Aug 10, 2023 at 18 year old. On Jun 25, 2024, patient returned for her second dose of VAQTA at 19 years old and patient was administered VAQTA 0.5mL; This spontaneous report was received from a licensed practical nurse referring to a 19-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-AUG-2023, at 18-year-old, the patient received the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #1971532, expiration date: 13-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided). Operator of device was health professional.  On 25-JUN-2024, at 19 years old, the patient returned for her second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X025484, expiration date: 13-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided) (Underdose). No further information provided. No additional adverse event (AE) reported (No adverse event).
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; product storage error; This spontaneous report was received from physician and refers to a 12-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). Historical vaccines included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).   On 22-MAY-2024, the patient started therapy with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (first dose, lot #W035041 was valid, expiration date: 24-MAY-2024, in right thigh) administered and  varicella virus vaccine live (oka/merck) (VARIVAX) injection (first dose, lot #X018954 was valid, expiration date: 13-JUL-2025, in right thigh) for prophylaxis (Product storage error). No adverse event (No adverse event). No product quality complaint (PQC). Multiple temperature excursions (TE) reported from 22-APR-2024 through approximately 14-JUN-2024. TE occurred as a result of a reading from a Digital Data Logger.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a T/E where RECOMBIVAX HB was potentially administered to a patient. HCP stated that fridge may have been open which had caused part of temperature excursion. Permission to contact HCP as correspondence. See T/E case #02641118. H; HCP called to report a T/E where RECOMBIVAX HB was potentially administered to a patient. HCP stated that fridge may have been open which had caused part of temperature excursion. Permission to contact HCP as correspondence. See T/E case #02641118. H; This spontaneous report was received from a registered nurse regarding a patient of unspecified age and gender. Their pertinent medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 18-JUL-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) formulation vial, 0.5 milliliter, lot #Y003688 that upon review it was confirmed to be a valid lot number for this suspect vaccine, expiration date: 23-NOV-2026, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) by an health care professional, who stated that the  fridge  in which the vaccine was stored, may have been open which had caused part of temperature excursion with a maximum (max) temperature of 48.2 degree Fahrenheit (F) for a time frame of 17 hours  and 14 minutes (Improper storage of product in use), but confirmed no symptomatic events.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects reported; HCP calling to report AE for patient who received a fourth dose of GARDASIL 9 on 15MAY2024. No side effects reported. Patient is male and 18 years old.; This spontaneous report was received from Other Health Professional and refers to an 18-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2024, the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). No side effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: HCP reported that the "patient received the VARIVAX vaccine on Monday and everything was fine". HCP reported that the patient had swelling and redness the next day; HCP reported that the "patient received the VARIVAX vaccine on Monday and everything was fine". HCP reported that the patient had swelling and redness the next day; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUL-2024 (reported as on Monday), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, dose and route of administration were not provided). After vaccination everything was fine.  On 30-JUL-2024 (reported as: next day), the patient experienced swelling and redness, it was two inches in size. On 31-JUL-2024 (reported as now, after the third day of administration), the swelling and redness was three inches in size. The reaction was not rash or lesion.   At the time of reporting, the patient had not recovered from the events. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) was not applicable.    The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.   Lot # is being requested and will be submitted if received.
Age: 0.33
Sex: F
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Poor quality device used, Syringe issue, Underdose
Clinical narrative: No additional AE; Upon administration to patient, VAXNEUVANCE leaked and squirted out between syringe hub and Luer lock.; Upon administration to patient, VAXNEUVANCE leaked and squirted out between syringe hub and Luer lock./Was the product administered or exposed to patient's bodily fluids(i.e. biohazardous)? YES; Upon administration to patient, VAXNEUVANCE leaked and squirted out between syringe hub and Luer lock.; This spontaneous report was received from a nurse and refers to a 4-month-old female patient. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 06-AUG-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe, lot # reported and confirmed as: X019438, expiration date reported and confirmed as: 07-NOV-2025, administered intramuscularly (exact dose, site of administration and strength were not provided) for prophylaxis by a health professional. Upon administration to patient, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) leaked and squirted out between syringe hub and luer lock (syringe issue; poor quality device used; underdose). The vaccine was not available for retrieval, as it was discarded. The patient had no symptoms or side effects reported and there was no additional adverse event reported (no adverse event).
Age: 0.33
Sex: F
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; Upon administration to patient, VAXNEUVANCE leaked and squirted out between syringe hub and Luer lock.; Upon administration to patient, VAXNEUVANCE leaked and squirted out between syringe hub and Luer lock./Was the product administered or exposed to patient's bodily fluids(i.e. biohazardous)? YES; Upon administration to patient, VAXNEUVANCE leaked and squirted out between syringe hub and Luer lock.; This spontaneous report was received from a nurse and refers to a 4-month-old female patient. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 06-AUG-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe, lot # reported and confirmed as: X019438, expiration date reported and confirmed as: 07-NOV-2025, administered intramuscularly (exact dose, site of administration and strength were not provided) for prophylaxis by a health professional. Upon administration to patient, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) leaked and squirted out between syringe hub and luer lock (syringe issue; poor quality device used; underdose). The vaccine was not available for retrieval, as it was discarded. The patient had no symptoms or side effects reported and there was no additional adverse event reported (no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Product Lot number issue; no adverse event occured with administration of vaccination; Vaccine administered during temp excursion; This spontaneous report was received from a nurse refering to a 12-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies was not reported.   On 11-JUL-2024, the patient was vaccinated with an improperly stored dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered intramuscularly in the right arm for prophylaxis (exact dose and strength were not reported) (Product storage error). Reporter reported quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with lot # X024650, expiration date: 31-MAY-2026, which was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). However, lot # X024650 is valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Product lot number issue).  In addition, the reporter stated that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) were exposed to a temperature excursion and administered to multiple patients (captured in case # 2407USA009193).  The reporter stated that the Company was notified and the vaccine was deemed safe to use after it was administered.  No adverse event occurred with the administration of the vaccine (No adverse event). ; Sender's Comments:  US-009507513-2407USA009193:Same reporter link
Age: 0.17
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report Temperatur Excursion where products were administered to a patient; This spontaneous report was received from other health professional regarding a 10-weeks-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions or allergies were not reported.  On 18-JUL-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter administered orally as prophylaxis (lot number 2003139 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent [ROTATEQ], expiration date reported and validated as 30-APR-2025). On that same date, the patient was also vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) 0.5 milliliter injection, 0.5 milliliter administered as prophylaxis (lot number u7801aa has been verified to be a valid lot number for diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid [VAXELIS], expiration date reported as 30-JUN-2025, but upon internal validation stablished as 30-JUN-2026) (route of administration and anatomical location were not provided). Mentioned vaccines were administered to the patient after a temperature excursion (product storage error) at 62.4 degree Fahrenheit (F) for 10 hours, 45 minutes, and after a previous temperature excursion at 47.6 degree F for 0 hours, 15 minutes, 0 seconds. No symptoms nor additional adverse events were reported for the patient.
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP called to report TE where products were administered to a patient . No symptoms reported. No Additional Information provided. No Additional AE/ No PQC.  ROTATEQ: 2003139 EXP: 04/30/2025 VAXELIS: u7801aa EXP: 06/30/2026   62.4f for 10 hours 45 min; This spontaneous report was received from certified medical assistant and refers to a 6-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUL-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2003139, expiration date: 30-APR-2025, administered orally for prophylaxis (strength was not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, unk, lot #u7801aa, expiration date: 30-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided). Those vaccine underwent temperature excursion in 62.4 Farenheit for 10 hours and 45 minutes (Product storage error) and previous excursion in 47.6 Farenheit for 15 minutes. No additional advers event was reported.
Sex: F
Vaccine: RSV, RSV
Symptoms: Pharyngeal swelling
Clinical narrative: Throat swelling; This non-serious case was reported by a consumer and described the occurrence of throat swelling in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma, hashimoto's disease and blood pressure high. Concomitant products included loratadine (Claritin), salmeterol xinafoate (Serevent), zafirlukast (Accolate), levothyroxine sodium (Synthroid) and spironolactone.   On an unknown date, the patient received Arexvy. On 17-APR-2024, an unknown time after receiving Arexvy, the patient experienced throat swelling (Verbatim: Throat swelling). The outcome of the throat swelling was resolved.   It was unknown if the reporter considered the throat swelling to be related to Arexvy.     It was unknown if the company considered the throat swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-JUL-2024 This case was self-reported by patient. The patient received the Arexvy vaccine and experienced the throat swelling. The symptoms were not treated. The patient stated that the pharmacist did not want to give the Shingrix vaccine because it uses the same adjuvant. The patient wants to know if it was safe for her to begin the Shingrix vaccine series
Sex: F
Vaccine: RSV, RSV
Symptoms: Anaphylactic reaction, Circumoral swelling, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Throat swelling; This non-serious case was reported by a consumer and described the occurrence of throat swelling in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma, hashimoto's disease and blood pressure high. Concomitant products included loratadine (Claritin), salmeterol xinafoate (Serevent), zafirlukast (Accolate), levothyroxine sodium (Synthroid) and spironolactone.   On an unknown date, the patient received Arexvy. On 17-APR-2024, an unknown time after receiving Arexvy, the patient experienced throat swelling (Verbatim: Throat swelling). The outcome of the throat swelling was resolved.   It was unknown if the reporter considered the throat swelling to be related to Arexvy.     It was unknown if the company considered the throat swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-JUL-2024 This case was self-reported by patient. The patient received the Arexvy vaccine and experienced the throat swelling. The symptoms were not treated. The patient stated that the pharmacist did not want to give the Shingrix vaccine because it uses the same adjuvant. The patient wants to know if it was safe for her to begin the Shingrix vaccine series
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pharyngeal swelling
Clinical narrative: suffered a mild anaphylaxis reaction/anaphalaxis; suffered throat swollen; suffered tingling; swelling and tingling around her mouth; swelling and tingling around her mouth; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A9KY9) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 times, once in her 40's and in the spring of 2024).   On 17-APR-2024, the patient received Arexvy (left arm). On 17-APR-2024, 15 min after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: suffered a mild anaphylaxis reaction/anaphalaxis) (serious criteria GSK medically significant), throat swelling (Verbatim: suffered throat swollen), tingling (Verbatim: suffered tingling), swollen mouth (Verbatim: swelling and tingling around her mouth) and tingling mouth (Verbatim: swelling and tingling around her mouth). The outcome of the anaphylaxis, throat swelling, tingling, swollen mouth and tingling mouth were resolved.   It was unknown if the reporter considered the anaphylaxis, throat swelling, tingling, swollen mouth and tingling mouth to be related to Arexvy.     The company considered the anaphylaxis to be related to Arexvy. It was unknown if the company considered the throat swelling, tingling, swollen mouth and tingling mouth to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-JUL-2024 The patient self-reported this case. The patient received Arexvy vaccine and 15 minutes later suffered a mild anaphylaxis reaction, throat swollen and tingling. The patient also experienced swelling and tingling around her mouth.  The patient didn't had to go to the hospital or anything. It was a mild reaction and it was not necessary to go to the hospital.  The patient stayed and her pharmacy for 30 minutes after having these adverse reactions to Arexvy and the concerns eventually went away. Yesterday (prior to reporting day) patient went to the pharmacy to get Shingrix first dose and pharmacist declined to administer the vaccine due that situation with Arexvy,  The reporter asked about it was safe to receive Shingrix. The patient had Shingles 3 times once in her 40's and one other time and in the spring of 2024 around the time of receiving Arexvy, but all prior to receiving the Arexvy vaccine (pre existing Arexvy).  The patient reports having received Boostrix in her left arm on 23th April 2024 with lot number 73J5L and expiry date 3rd May 2026, and the Pfizer Covid vaccine on 5th May 2024 (unknown product information).; Sender's Comments: Anaphylactic reaction is an unlisted event which, due to the following criteria (strong temporal association) is considered related to GSK vaccine Arexvy.
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Anaphylactic reaction, Circumoral swelling, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: suffered a mild anaphylaxis reaction/anaphalaxis; suffered throat swollen; suffered tingling; swelling and tingling around her mouth; swelling and tingling around her mouth; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A9KY9) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 times, once in her 40's and in the spring of 2024).   On 17-APR-2024, the patient received Arexvy (left arm). On 17-APR-2024, 15 min after receiving Arexvy, the patient experienced anaphylaxis (Verbatim: suffered a mild anaphylaxis reaction/anaphalaxis) (serious criteria GSK medically significant), throat swelling (Verbatim: suffered throat swollen), tingling (Verbatim: suffered tingling), swollen mouth (Verbatim: swelling and tingling around her mouth) and tingling mouth (Verbatim: swelling and tingling around her mouth). The outcome of the anaphylaxis, throat swelling, tingling, swollen mouth and tingling mouth were resolved.   It was unknown if the reporter considered the anaphylaxis, throat swelling, tingling, swollen mouth and tingling mouth to be related to Arexvy.     The company considered the anaphylaxis to be related to Arexvy. It was unknown if the company considered the throat swelling, tingling, swollen mouth and tingling mouth to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-JUL-2024 The patient self-reported this case. The patient received Arexvy vaccine and 15 minutes later suffered a mild anaphylaxis reaction, throat swollen and tingling. The patient also experienced swelling and tingling around her mouth.  The patient didn't had to go to the hospital or anything. It was a mild reaction and it was not necessary to go to the hospital.  The patient stayed and her pharmacy for 30 minutes after having these adverse reactions to Arexvy and the concerns eventually went away. Yesterday (prior to reporting day) patient went to the pharmacy to get Shingrix first dose and pharmacist declined to administer the vaccine due that situation with Arexvy,  The reporter asked about it was safe to receive Shingrix. The patient had Shingles 3 times once in her 40's and one other time and in the spring of 2024 around the time of receiving Arexvy, but all prior to receiving the Arexvy vaccine (pre existing Arexvy).  The patient reports having received Boostrix in her left arm on 23th April 2024 with lot number 73J5L and expiry date 3rd May 2026, and the Pfizer Covid vaccine on 5th May 2024 (unknown product information).; Sender's Comments: Anaphylactic reaction is an unlisted event which, due to the following criteria (strong temporal association) is considered related to GSK vaccine Arexvy.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: administered Engerix after temperature excursion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of incorrect storage of drug in a male patient who received HBV (Engerix B) for prophylaxis.   On 11-JUL-2024, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: administered Engerix after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 30-JUL-2024 The reporter confirmed that Engerix was involved in the temperature excursion and the nurse gave caller the list of four patient's that were administered Engerix after temperature excursion which led to incorrect storage of drug. Caller was unknown if patients were administered or involved with Trumenba after the temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If it's been longer than one year since a patient received the first dose of shingrix; 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 1st dose of Shingrix on an unknown date).   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: If it's been longer than one year since a patient received the first dose of shingrix). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date: 30-JUL-2024 The reporter asked, if it's been longer than one year since a patient received the first dose of Shingrix, should they restart the series, or would they only need one more dose. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.