chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Hypoxia, Insurance issue, Oxygen saturation decreased
Clinical narrative: BRIEF OVERVIEW: Discharge Provider: MD  Primary Care Physician at Discharge: MD   Admission Date: 8/10/2024  Discharge Date: 8/12/2024 DETAILS OF HOSPITAL STAY: Tracheostomy status  [Z93.0] Hypoxia [R09.02] Increased oxygen demand [R68.89]   HOSPITAL COURSE: Patient is a 4-year-old M with complex PMHx including premature birth at 22 weeks, trach and GJ-tube dependent, cerebral ventriculomegaly s/p VP shunt, pulmonary hypertension, and global developmental delay who is admitted for increased oxygen demand at home in the setting of COVID-19 infection.    ED Course: Grandmother reported needing up to 1.5L at home, increased from b/l at 0.2-0.3L. Recent admission from 8/4 - 8/7 due to increased oxygen demand, treated with 3x steroids and 2x doses of remdesivir due to exposure to COVID from multiple family members. In the ED, patient was afebrile and nontoxic appearing. Productive cough and crackles in biltaeral bases appreciated. Initially placed on 1L then weaned to 0.5L, however patient desatted to 87% and was increased back to 1L. Patient tested positive for COVID. Pulmonology was consulted and recommended admission for observation of oxygen requirements.    Floor Course:  On the floor, patient was started on yellow zone medication Albuterol Q4. Consulted ID for restarting the remdesivir given re-admission. Given 2x during this admission. Patient was also started on steroids due to patient being unable to complete the steroid course from the first admission outpatient due to insurance difficulties. Patient was monitored and slowly weaned back to his baseline oxygen at 0.3L. Pulmonology consulted for home-going recommendations. Recommended completing 5 day steroid course outpatient with plans to call grandmother within a few days from discharge to work on a follow up appointment.    On day of discharge, patient had stable vital signs and was clinically improved on exam. Grandmother was notified that Peds Pulmonology will call her to schedule outpatient follow-up after discharge. Patient was discharged home in stable condition.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Productive cough, Rales, SARS-CoV-2 test positive
Clinical narrative: BRIEF OVERVIEW: Discharge Provider: MD  Primary Care Physician at Discharge: MD   Admission Date: 8/10/2024  Discharge Date: 8/12/2024 DETAILS OF HOSPITAL STAY: Tracheostomy status  [Z93.0] Hypoxia [R09.02] Increased oxygen demand [R68.89]   HOSPITAL COURSE: Patient is a 4-year-old M with complex PMHx including premature birth at 22 weeks, trach and GJ-tube dependent, cerebral ventriculomegaly s/p VP shunt, pulmonary hypertension, and global developmental delay who is admitted for increased oxygen demand at home in the setting of COVID-19 infection.    ED Course: Grandmother reported needing up to 1.5L at home, increased from b/l at 0.2-0.3L. Recent admission from 8/4 - 8/7 due to increased oxygen demand, treated with 3x steroids and 2x doses of remdesivir due to exposure to COVID from multiple family members. In the ED, patient was afebrile and nontoxic appearing. Productive cough and crackles in biltaeral bases appreciated. Initially placed on 1L then weaned to 0.5L, however patient desatted to 87% and was increased back to 1L. Patient tested positive for COVID. Pulmonology was consulted and recommended admission for observation of oxygen requirements.    Floor Course:  On the floor, patient was started on yellow zone medication Albuterol Q4. Consulted ID for restarting the remdesivir given re-admission. Given 2x during this admission. Patient was also started on steroids due to patient being unable to complete the steroid course from the first admission outpatient due to insurance difficulties. Patient was monitored and slowly weaned back to his baseline oxygen at 0.3L. Pulmonology consulted for home-going recommendations. Recommended completing 5 day steroid course outpatient with plans to call grandmother within a few days from discharge to work on a follow up appointment.    On day of discharge, patient had stable vital signs and was clinically improved on exam. Grandmother was notified that Peds Pulmonology will call her to schedule outpatient follow-up after discharge. Patient was discharged home in stable condition.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: Possible sinus infection, body aches, tired, difficulty breathing
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered too early. Patient received varicella vaccine on 7/30/2024. Should have been 28 days between varicella and MMR. Parents notified that child will need to be revaccinated on or after 9/10/2024
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out in parking lot after shots
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Arm pain
Age: 37.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Patient came to primary care clinic requesting an RSV vaccine. The administered vaccine was Arexvy which is for patients 60 years old and over. Patient should have received Pfizer RSV vaccine which is approved during pregnancy. At time of vaccination patient was GA 35 weeks 5 days. This has been reported to GSK and patient's OB. There have been no reported adverse events following vaccination.
Age: 37.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Patient came to primary care clinic requesting an RSV vaccine. The administered vaccine was Arexvy which is for patients 60 years old and over. Patient should have received Pfizer RSV vaccine which is approved during pregnancy. At time of vaccination patient was GA 35 weeks 5 days. This has been reported to GSK and patient's OB. There have been no reported adverse events following vaccination.
Age: 0.08
Sex: M
Vaccine: HIBV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme increased, Pyrexia
Clinical narrative: Patient had fever and elevated liver enzymes after receiving vaccine. needed to be hospitalized for 5 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Immediate post-injection reaction, Loss of personal independence in daily activities
Clinical narrative: The arm ache was pretty immediate and expected, the low grade chills/fever and feeling sick to my stomach about 12 hours later was not. Definitely a hard headache with this one.  I have been unable to work today because I feel so poorly (and I work from home).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: The arm ache was pretty immediate and expected, the low grade chills/fever and feeling sick to my stomach about 12 hours later was not. Definitely a hard headache with this one.  I have been unable to work today because I feel so poorly (and I work from home).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: Almost exactly 1 hour after I received the initial vaccine my thigh muscles on both legs suddenly became so rigid I could barely stand up. They stayed rigid continuously for 3 days then relaxed back to normal.   On Apr. 6, 2021 I had a COVID booster through Health Dept. (Moderna Lot 025B21A) - same method and injection site. When the nurse was prepping my arm for the booster I mentioned the reaction I'd had to the first shot and she responded by telling me she sure wouldn't be getting a booster after that, but never mentioned anything about reporting the reaction. About an hour after the booster my thigh muscles on both legs again went rigid and stayed that way for about 24 hours. Continue....... On Nov. 30, 2021 I had the 2nd COVID booster from pharmacy (Moderna Lot 012H21B) - same method and injection site. About an hour after the 2nd booster, my thigh muscles on both legs went rigid again and stayed that way for 2 - 3 hours then relaxed.   At this point, August 13, 2024, I continue to have problems with my thigh muscles suddenly getting rigid to the point where I fall down if I'm squatting or I have to sit down if I'm standing or walking. The muscles then stay hard and sore for several hours and sometimes for a couple of days, regardless of how much I massage them or stretch them. This happens when I'm doing what for me had always been normal activities that, until the first Covid vaccine, I was able to do for several hours continuously. Now my duration for squatting while moving (gardening activities) is about 1/2 hour, for standing without moving it's about 15 minutes, and for walking continuously it's about 45 minutes.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness postural, Fall, Loss of consciousness
Clinical narrative: Patient was dizzy when standing for a brief period after vaccines, fell, and loss consciousness briefly.  Patient laid on floor in a safe area.  Had patient stay on back and elevated patient feet on a stool.  Provided ice packs and assessed for wounds.  Patient remained on the floor with feet elevated for 10 minutes then she was slowly sat up.  Patient talking and doing well.  Patient drank a poweraid and had a popsicle while sitting.  Patient was able to stand after sitting for 10 minutes.  Patient was then escorted to personal vehicle and taken home by parent.  Telephone follow up and at 7:00pm and patient was doing well and recovering at home.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Cardiac ablation
Clinical narrative: A Flutter. Resulted in hospital stay and ablation.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Patient stated that she has been breaking out in a rash every since she received the vaccine. She has tried OTC benadryl and Hydrocortisone and no relief.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, UNK
Symptoms: Hypotonia, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Child sat on fathers lap and vaccine was administered. Child was unusually calm and quiet. Approximately 1-2 minutes after completion, she first went limp, then rigid. Was rigid approximately 1 min. Child laid on table, VS HR 62, BP 82/48, SpO2 98%. Child became responsive, was assessed by EMS in the clinic. VS improved for EMS and child returned to usual state. Father reports that his brother has fainted after injections also. Parents took the child home under direct supervision.
Age: 68.0
Sex: M
Vaccine: CHIK, YF
Symptoms: Arthralgia, Decreased appetite, Dizziness, Dysacusis, Fatigue
Clinical narrative: Reports that on 08/05/2024, he experienced joint pain when he got up from his chair and felt dizzy. Had a headache and poor appetite and severe fatigue. Also, " buzzing in left ear and pain in left side of head". Took Tylenol, spoke to his PCP and went to the ER where the lab report stated " everything was fine", but was referred to a neurologist for trigeminal neuralgia. Was given "Lobaradol" for joint pain and fever, and Carbamazepine for neuralgia. "Since then, pain on the left has stopped, but has increased on the right, with some new swelling in the ankle to 1/2 above the knee". Also reports things sound echo-y. Also reports "sun burn type pain on bilateral calves." Fever lasted 1 week, and was as high as 103 or so. Had to take tylenol/ibuprofen around the clock.
Age: 68.0
Sex: M
Vaccine: CHIK, YF
Symptoms: Headache, Joint swelling, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Reports that on 08/05/2024, he experienced joint pain when he got up from his chair and felt dizzy. Had a headache and poor appetite and severe fatigue. Also, " buzzing in left ear and pain in left side of head". Took Tylenol, spoke to his PCP and went to the ER where the lab report stated " everything was fine", but was referred to a neurologist for trigeminal neuralgia. Was given "Lobaradol" for joint pain and fever, and Carbamazepine for neuralgia. "Since then, pain on the left has stopped, but has increased on the right, with some new swelling in the ankle to 1/2 above the knee". Also reports things sound echo-y. Also reports "sun burn type pain on bilateral calves." Fever lasted 1 week, and was as high as 103 or so. Had to take tylenol/ibuprofen around the clock.
Age: 68.0
Sex: M
Vaccine: CHIK, YF
Symptoms: Tinnitus, Trigeminal neuralgia
Clinical narrative: Reports that on 08/05/2024, he experienced joint pain when he got up from his chair and felt dizzy. Had a headache and poor appetite and severe fatigue. Also, " buzzing in left ear and pain in left side of head". Took Tylenol, spoke to his PCP and went to the ER where the lab report stated " everything was fine", but was referred to a neurologist for trigeminal neuralgia. Was given "Lobaradol" for joint pain and fever, and Carbamazepine for neuralgia. "Since then, pain on the left has stopped, but has increased on the right, with some new swelling in the ankle to 1/2 above the knee". Also reports things sound echo-y. Also reports "sun burn type pain on bilateral calves." Fever lasted 1 week, and was as high as 103 or so. Had to take tylenol/ibuprofen around the clock.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received incorrect vaccine dose. She received the pediatric dose of 5 mcg. She did not experience any symptoms
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Brain fog, Chills, Dyskinesia
Clinical narrative: BACK/SHOULDER PAIN, MUSCLE ACHES, CHILLS STARTED 8/8/24. SLIGHT HEADACHE. BRAIN FOG WEDNESDAY-SUNDAY. THE LEFT ARM SHE RECEIVED THE SHOT IN SHE SAID BECAME WEAK, COULD NOT HOLD THINGS, WOULD DROP ITEMS BECAUSE OF WEAKNESS AND FINGERS WOULD MOVE INVOLUNTARILY. 8/13 /24 SHE CALLED US TO REPORT ADVERSE EVENT AND SHE SAID THE ADVERSE EFFECTS WERE 80% RESOLVED, SHE NEVER CALLED OR SAW HER PHYSICIAN TO BE CHECKED OUT AND I URGED HER TO FOLLOW UP WITH THEM TO MAKE SURE NOTHING ELSE WAS GOING ON.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Myalgia
Clinical narrative: BACK/SHOULDER PAIN, MUSCLE ACHES, CHILLS STARTED 8/8/24. SLIGHT HEADACHE. BRAIN FOG WEDNESDAY-SUNDAY. THE LEFT ARM SHE RECEIVED THE SHOT IN SHE SAID BECAME WEAK, COULD NOT HOLD THINGS, WOULD DROP ITEMS BECAUSE OF WEAKNESS AND FINGERS WOULD MOVE INVOLUNTARILY. 8/13 /24 SHE CALLED US TO REPORT ADVERSE EVENT AND SHE SAID THE ADVERSE EFFECTS WERE 80% RESOLVED, SHE NEVER CALLED OR SAW HER PHYSICIAN TO BE CHECKED OUT AND I URGED HER TO FOLLOW UP WITH THEM TO MAKE SURE NOTHING ELSE WAS GOING ON.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Body temperature increased, Chills, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: Friday late night patient started having chills, shivering and temperature ( patient never checked temperature). Took Tylenol OTC for Friday, Saturday and Sunday.  Went to work on Monday and on Tuesday, at work patient started feeling pain and hot on left arm ( around vaccination site). Saw primary care doctor on Tuesday afternoon. Vaccination site was red .
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site warmth
Clinical narrative: Friday late night patient started having chills, shivering and temperature ( patient never checked temperature). Took Tylenol OTC for Friday, Saturday and Sunday.  Went to work on Monday and on Tuesday, at work patient started feeling pain and hot on left arm ( around vaccination site). Saw primary care doctor on Tuesday afternoon. Vaccination site was red .
Age: 70.0
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: 23.0
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.
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Staff accidently gave infant Acthib instead of ordered Hepatitis B.   Mother advised to monitor for fever over the weekend and call after hours triage if any concerns
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/; a patient received a fourth dose of GARDASIL 9 on 6/19/2024 after already previously completing a 3 dose series; This spontaneous report was received from a nurse and refers to a 25-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 unknown dates, the patient was vaccinated with 3 dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 3 dose series, administered for prophylaxis (strength, doses, lots #, expiry dates, and route of administration were not provided).  On 19-JUN-2024, the patient received a 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, lot #, expiry date, and route of administration were not provided) after already previously completing a 3 dose series (conflict information, also reported as it was restarted because the previous set was not completed per the product information (PI)) (Extra dose administered). No side effects reported. No additional adverse event (AE). (No adverse event).
Age: 1.0
Sex: M
Vaccine: MMR, PNC20, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; multiple temperature excursions; This spontaneous report has been received from a medical assistant, referring to a 12-month-old male patient. His medical history included vaccination with 2 doses of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) and 1 dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). The information regarding the patient's concurrent conditions, historical conditions or concomitant therapies was not provided.  Since 22-APR-2024 through approximately 14-JUN-2024, the following vaccines underwent multiple temperature excursions: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot# W028734, expiry date 08-SEP-2024; varicella virus vaccine live (oka/merck) (VARIVAX) lot# X018954, expiry date 13-JUL-2025; and pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) lot# HL3889 expiry date 31-MAY-2025.  On 14-JUN-2024, the patient was vaccinated with 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered in right thigh, lot# W028734, expiry date 08-SEP-2024 (dose and route of administration were not reported), with 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered in right thigh, lot# X018954, expiry date 13-JUL-2025 (dose and route of administration were not reported), and with 3rd dose of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), administered in left thigh, lot# HL3889 expiry date 31-MAY-2025 (dose and route of administration were not reported); all the suspect vaccines were administered for prophylaxis. The administered vaccines underwent temperature excursion prior to administration (Product storage error); the excursion occurred as a result of a reading from a Digital Data Logger. The vaccines were purchased with public funds and administered by the trained healthcare professional according to the instruction leaflet at a private doctor's office/hospital. No additional adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2406USA005882: US-009507513-2407USA010406: US-009507513-2407USA011187: US-009507513-2407USA011821: US-009507513-2407USA011791: US-009507513-2407USA010830: US-009507513-2407USA011459: US-009507513-2407USA011471: US-009507513-2407USA010559: US-009507513-2407USA012349:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes simplex test negative, Pharyngeal lesion, Pyrexia, Rash, Varicella virus test
Clinical narrative: rash on right thigh; patient presented with a fever; pharyngeal lesion; This spontaneous report has been received from a physician, referring to a 13-month-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 30-APR-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection at a dose of 0.5 mL, administered subcutaneously on anterior left thigh, lot# X025845, expiry date 31-OCT-2024, for prophylaxis (reported as "against varicella virus").  On 16-JUL-2024, the patient experienced a rash on right thigh and pharyngeal lesion and presented with a fever. Pharyngeal lesion swab was negative for herpes simplex virus (HSV). The results of swab for varicella and zoster had not come in yet. On 17-JUL-2024, the patient started treatment with acyclovir. On 18-JUL-2024, the patient's fever abated (conflicting information, the outcome reported as not recovered). The patient was coming in for follow-up treatment/testing on 19-JUL-2024.  At the time of reporting, the patient was being treated with acyclovir and had not recovered from the events.  Causality assessment was not provided.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral test
Clinical narrative: rash on right thigh; patient presented with a fever; pharyngeal lesion; This spontaneous report has been received from a physician, referring to a 13-month-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 30-APR-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection at a dose of 0.5 mL, administered subcutaneously on anterior left thigh, lot# X025845, expiry date 31-OCT-2024, for prophylaxis (reported as "against varicella virus").  On 16-JUL-2024, the patient experienced a rash on right thigh and pharyngeal lesion and presented with a fever. Pharyngeal lesion swab was negative for herpes simplex virus (HSV). The results of swab for varicella and zoster had not come in yet. On 17-JUL-2024, the patient started treatment with acyclovir. On 18-JUL-2024, the patient's fever abated (conflicting information, the outcome reported as not recovered). The patient was coming in for follow-up treatment/testing on 19-JUL-2024.  At the time of reporting, the patient was being treated with acyclovir and had not recovered from the events.  Causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; improper storage of product in use; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 30-APR-2024, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion which lasted for 3 days and 23 hours with maximum temperature 74.84 Fahrenheit degrees and minimal temperature of 39.02 Fahrenheit degrees. On 06-JUN-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # X015245 and expiration date 22-NOV-2024 for prophylaxis (exact dose, dose number and route of administration were not provided) (product storage error). Confirmed no symptomatic adverse events (no adverse event).; Sender's Comments:  US-009507513-2407USA013069:
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant and refers to a 7-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 30-APR-2024, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion which lasted for 3 days and 23 hours with maximum temperature 74.84 Fahrenheit degrees and minimal temperature of 39.02 Fahrenheit degrees. On 05-JUL-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # X015245 and expiration date 22-NOV-2024 for prophylaxis (exact dose, dose number and route of administration were not provided) (product storage error). Confirmed no symptomatic adverse events (no adverse event).; Sender's Comments:  US-009507513-2407USA013069:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient might have only received 1 dose of GARDASIL9 on an unspecified date in 2019.; No additional AE; This spontaneous report was received from Pharmacist and refers to a 17-year-old male patient.  The patient's medical history, concurrent conditions, previous drug reaction or allergies and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection,  administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), now the Pharmacist called to get information on revaccination of the patient (Inappropriate schedule of vaccine administered). No additional adverse event was provided.  Lot# will be provided upon request.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report was received from a nurse via company representative and refers to a 16-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 first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown date, the patient fainted after receiving his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination (Syncope). It was unknown whether the patient received treatment.  At the time of reporting, the outcome of the event syncope was unknown. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was as not applicable.    The causal relationship between the event syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event syncope was determined to be medically significant.  Lot is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Still hurts; Itches; Suspected vaccination failure; got shingles 2 months ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2024, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 2 months ago). On an unknown date, the patient experienced pain (Verbatim: Still hurts) and pruritus (Verbatim: Itches). The outcome of the vaccination failure and shingles were not reported and the outcome of the pain and pruritus were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, pain and pruritus to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 06-AUG-2024 The case was received from the patient via interactive digital media. The patient had both shots 3 years ago and got shingles 2 months ago. The patient had bad case, still hurts and itches. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine Dose 1 and Shingles vaccine Dose 2.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired product administered; This non-serious case was reported by a nurse via patient support programs and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   On 05-AUG-2024, the patient received Bexsero .5 ml. On 05-AUG-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired product administered). 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: 05-AUG-2024 The nurse reported that, the patient  was administered an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymph node pain, Pain in extremity, Syringe issue, Tenderness
Clinical narrative: unsure how many volume leaked but stated was less than 0.45ml and maybe only very little was administered to the patient; a little swelling around the site; arm was sore/tenderness under the arm; the lymph node was a little sore with tenderness under the arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 745JK, expiry date 19-JUN-2026) for prophylaxis.   On 25-JUL-2024, the patient received the 1st dose of Shingrix. In JUL-2024, several days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: a little swelling around the site), pain in arm (Verbatim: arm was sore/tenderness under the arm) and lymph node pain (Verbatim: the lymph node was a little sore with tenderness under the arm). On 25-JUL-2024, the patient experienced underdose (Verbatim: unsure how many volume leaked but stated was less than 0.45ml and maybe only very little was administered to the patient). The outcome of the injection site swelling, lymph node pain and underdose were not reported and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site swelling, pain in arm and lymph node pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, pain in arm and lymph node pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUL-2024 The pharmacist called and reported a dose of Shingrix with less volume than recommended was administered to a patient and a few days later arm was sore, a little swelling around the site and the lymph node was a little sore with tenderness under the arm. It was stated that while administering the Shingrix the needle leaked and only administered very little volume of the dose to the patient. The reporter was unsure how many volume leaked but stated was less than 0.45 ml and maybe only very little was administered to the patient, which led to underdose. The reporter mentioned a bunch (of the vaccine) didn't went in and didn't felt resistance in the plunger and needle leaked (syringes and needle not provided by GSK as per prescribing information of Shingrix). The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: unsure how many volume leaked but stated was less than 0.45ml and maybe only very little was administered to the patient; a little swelling around the site; arm was sore/tenderness under the arm; the lymph node was a little sore with tenderness under the arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 745JK, expiry date 19-JUN-2026) for prophylaxis.   On 25-JUL-2024, the patient received the 1st dose of Shingrix. In JUL-2024, several days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: a little swelling around the site), pain in arm (Verbatim: arm was sore/tenderness under the arm) and lymph node pain (Verbatim: the lymph node was a little sore with tenderness under the arm). On 25-JUL-2024, the patient experienced underdose (Verbatim: unsure how many volume leaked but stated was less than 0.45ml and maybe only very little was administered to the patient). The outcome of the injection site swelling, lymph node pain and underdose were not reported and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site swelling, pain in arm and lymph node pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, pain in arm and lymph node pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUL-2024 The pharmacist called and reported a dose of Shingrix with less volume than recommended was administered to a patient and a few days later arm was sore, a little swelling around the site and the lymph node was a little sore with tenderness under the arm. It was stated that while administering the Shingrix the needle leaked and only administered very little volume of the dose to the patient. The reporter was unsure how many volume leaked but stated was less than 0.45 ml and maybe only very little was administered to the patient, which led to underdose. The reporter mentioned a bunch (of the vaccine) didn't went in and didn't felt resistance in the plunger and needle leaked (syringes and needle not provided by GSK as per prescribing information of Shingrix). The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up via email.
Age: 2.0
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old received the 1 vial formulation of Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 year old received the 1 vial formulation of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2024 The physician reported that the patient of an inappropriate age received the 1 vial formulation of Menveo (which is approved for ages 10 to 55) instead of the 2 vial formulation, which led to inappropriate age at vaccine administration.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Injection site discharge
Clinical narrative: vaccine ran down his arm; vaccine ran down his arm; Incomplete dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received one dose Zostavax in January 2015).   In AUG-2018, the patient received the 1st dose of Shingrix. In AUG-2018, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: vaccine ran down his arm), inadvertent exposure to vaccine (Verbatim: vaccine ran down his arm) and incomplete dose administered (Verbatim: Incomplete dose administered). The outcome of the exposure via skin contact and inadvertent exposure to vaccine were unknown and the outcome of the incomplete dose administered was not reported.   Additional Information: GSK Receipt Date: 05-AUG-2024 The patient self-reported this case for himself. The reporter stated that he received both doses of Shingrix and one dose of Zostavax when it was on the market.  The reporter reported that, when he had his first does of Shingrix administered in August 2018 he noticed that immediately after receiving his dose of Shingrix some of the vaccine ran down his arm to his wrist which led to exposure via skin contact and inadvertent exposure to vaccine and incomplete dose administered.  The patient received second dose in January 2019. Adverse event filed after call disconnected.  Minimal information obtained to file adverse event.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received a vaccine on 05-AUG-2024 that expired on 31-JUL-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   On 05-AUG-2024, the patient received the 1st dose of Bexsero. On 05-AUG-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: received a vaccine on 05-AUG-2024 that expired on 31-JUL-2024). 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: 05-AUG-2024 The pharmacist reported that the patient received an expired dose of Bexsero vaccine, which led to expired vaccine used. The reporter wanted to know how to procced. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Temperature went down to -2.9 °C, and then 8 hours later the vaccine was given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis.   On 05-AUG-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Temperature went down to -2.9 °C, and then 8 hours later the vaccine was given to a patient). The outcome of the incorrect storage of drug 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: 05-AUG-2024 The nurse called and reported a problem with the refrigerator that the temperature went down to minus 2.9 degree Celsius and then 8 hours later the Pediarix vaccine was given to a patient, which led to incorrect storage of drug. The reporter asked do they had to revaccinate the patient. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024097592:Same reporter/Different patient US-GSK-US2024097585:Same reporter/Different patient
Age: 6.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: a patient received a dose of Bexsero that had expired on 31/Jul/2024.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   On 05-AUG-2024, the patient received Bexsero. On 05-AUG-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: a patient received a dose of Bexsero that had expired on 31/Jul/2024.). 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: 05-AUG-2024 The nurse reported that earlier that day the patient received an expired dose of Bexsero vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidental dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B and an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: accidental dose of Engerix-B). The outcome of the wrong vaccine administered was not reported.   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: 06-AUG-2024 The pharmacist called in requesting data in case a patient received an accidental dose of Engerix-B when they were not supposed to which led to wrong vaccine administered. They provided data on the patient and event, but declined to receive follow-up. The vaccine administration facility was the same as primary reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: smooth generalized hives on her leg, stomach, abdomen and opposite arm; This non-serious case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 07-AUG-2024 14:30, the patient received the 1st dose of Bexsero. In AUG-2024, less than a week after receiving Bexsero, the patient experienced generalized urticaria (Verbatim: smooth generalized hives on her leg, stomach, abdomen and opposite arm). The outcome of the generalized urticaria was unknown.   It was unknown if the reporter considered the generalized urticaria to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the generalized urticaria to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2024 The nurse reported that, a patient received her first dose of Bexsero day before reporting in afternoon around 2:30ish. In the morning of day of reporting, the nurse reported that, the patient had really smooth generalized hives on her leg, stomach, abdomen and opposite arm. According to the nurse, the patient had no other symptoms.  The nurse also mentioned that they told patient to go to the emergency room if the symptoms worsened.  The Vaccine Administration Facility was the same as Primary Reporter
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) in a 30-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Aug-2024, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness at area of injection site along with itchiness, and small bumps appearing; Redness at area of injection site along with itchiness, and small bumps appearing; Redness at area of injection site along with itchiness, and small bumps appearing; This is a spontaneous report received from an Other HCP.  A 69-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29Jul2024 at 17:30 as dose 1, single (Lot number: HL3888) at the age of 69 years, in left arm for immunisation. The patient's relevant medical history included: "DM II" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 29Jul2024, outcome "unknown" and all described as "Redness at area of injection site along with itchiness, and small bumps appearing". Therapeutic measures were taken as a result of vaccination site mass, vaccination site pruritus, vaccination site erythema.  Additional information: The patient had no known drug allergy. Vaccine was administered in left upper arm. The patient did not receive any other vaccines on the same date as the vaccine PREVNAR 20 or within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Treatment included Triamcinolone acetonide cream, and Cetirizine.