chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Muscle spasms, Nausea
Clinical narrative: Severe watery diarrhea, >20x day, stomach pain, cramping, headache, loss of appetite, nausea, leading to dehydration and weakness. Did not seek formal treatment because I couldn't get out of bed from 12/3-12/5. Slowly rehydrated with pedialyte and sports drinks. Did not eat from 12/2-12/6. Currently able to eat, however diarrhea-3-5x day, nausea and stomach cramping/pain continues. Ongoing brain fog. Continuing to focus on hydration and rest.
Age: 62.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Headache, Neck pain, Pain in extremity
Clinical narrative: I do not know the lot. My arm was sore aftr the vaccines but during the night it got worse and I had aches in my neck, head, and shoulders. The nest day my legs also were achy.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Muscle spasms
Clinical narrative: Felt like pressure and spasms in my chest.  It would come and go.  I tried taking OTC heartburn chewable meds.  No help.  I thought it might be esophageal spasms.  I took 1/2 of a muscle relaxant and that helped so I could sleep.  On the third day I went to the doc.  She put me on Omeprazole twice a day and it seems to be helping.  I've not had an episode since.
Age: 28.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood test, Magnetic resonance imaging, Metabolic dysfunction-associated liver disease, Pancreatitis acute
Clinical narrative: Acute pancreatitis onset about a month after the vaccine. This also presented with non-alcoholic fatty liver disease at the same time.  No history of pancreas or liver problems and minimal risk factors attributable to the diseases.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: no known adverse outcomes, other then needing to be revaccinated
Age: 11.0
Sex: M
Vaccine: COVID19, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Spikevax covid vaccine intended for patients 12 years old+, but pt is 11 years old. No adverse reaction
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain and limited range of motion.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Diarrhoea, Melaena, Tachycardia
Clinical narrative: Diarrhea, Melena, tachycardia
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: The patient is experiencing extended intense pain in arm after receiving the covid vaccine. She describes it as an intense, severe throbbing muscle pain. She said she has not noticed any redness or swelling at the injection site and it felt smooth after the vaccine (but still painful). It is severe enough to keep her up at night and inhibit her from being able to exercise or engage in various other activities of daily living.  She has not been seen by a doctor.
Age: 34.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, JEV1, TDAP, TYP
Symptoms: Disorientation, Dizziness
Clinical narrative: Pt called 12/10/2024 and spoke with RN stating he was feeling dizzy and disoriented (these symptoms are new from the other post vaccination symptoms he had experienced over the weekend). This nurse told Pt to have evaluation from PCP to determine if other illness was occurring or if there was correlation to vaccines.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, HPV9
Symptoms: Expired product administered, No adverse event, Underdose
Clinical narrative: Patient came in for hep a, b and hpv vaccine and patient received pediatric vaccine of hep a and hep b. Hep A was expired 10/14/24. Patient later returned on 10/24/24 to receive make up doses of the Hep A and Hep B vaccines. No reactions documented.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The patient inadvertently received 2 doses of the COVID vaccine 1 month apart.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Patient came in to catch up on vaccines after missing 6 month vaccinations. RN went over catch up vaccine schedule with supervisor and determined patient needed hib, polio and flu. RN pulled up vaccines and opened new polio for first time. RN was interrupted by secretary letting her know patients were waiting. RN told secretary the other nurse was busy in another department, so she asked her if she would see if anyone else was available to help. Went back to pulling vaccines and saw that hib was in its own vial, so mistakenly thought it needed to be diluted. Diluted hib with stock sterile water. Administered vaccines and then realized on the way back to the med room that hib does not need be diluted. Immediately told supervisor who called manufacturer and said that the dose was still valid and there should be no adverse affects. RN checked patient database and realized she should have also administered a Dtap. Let supervisor know this as well. RN called parent and let her know that she missed the Dtap, so parent made an appointment to get it the next day. RN also informed parent that she added sterile water to the hib, which is not normally done but will have no adverse effects and dose is still valid. Parent said that was fine. Filled out incident report
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: On 07/31/2024, patient came to pharmacy to receive a vaccine. His immunization consent form indicated he wanted to receive a COVID vaccine. However, the vaccine was processed and administered as an influenza vaccine. On 12/02/2024, patient returned to pharmacy to receive a vaccine. His immunization consent form indicated he wanted to receive the seasonal influenza vaccine and he received intended vaccine. He has not had any adverse effects from receiving duplicate influenza vaccines within the same season.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait disturbance, Posture abnormal
Clinical narrative: Extreme weakness and trouble sitting up and walking, shivering with NO fever, 24 hours
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MMRV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: DISCOVERED BY LOT # THAT MMRV (PROQUAD) WAS GIVEN IN ERROR. VARICELLA WAS REQUESTED, AND MMR WAS ALSO GIVEN RESULTING IN EXTRA DOSE OF MMR, AND INAPPROPRIATE AGE.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus
Clinical narrative: patient came to the office to receive her second dose of the HPV vaccine. Before administration, I asked the patient if she had any problems after the first dose and patient replied, "no".  At 9:43pm last night, mom called our night nurse service to report the patient has itching and redness all over her body. Mom denied hives, swelling of tongue, throat, lips, or face. mom denies fever or respiratory concerns.  Attempted to call mom today for an update but she has not called back yet.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Patient had vasovagal event after influenza immunization was administered. Patient recovered quickly after event and left office after being monitored for a period of time.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Covid vaccine idiicated for age 5-7 was given to child who is 15 years old, making it invalid Covid vaccine indicated for age 12+was given as directed
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a 2nd high dose flu vaccine by mistake. Patient received first vaccine on 10/9/24
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Anion gap, Blood calcium normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: can. No visible vomiting occuring at this time.  Patient is shivering and pale,  is slow to respond to verbal stimuli.  Dr at chairside and advised that  patient had just received covid and flu vaccinations, and immediately became  "centrally contracted, pale, turned head to one side, nonresponsive to verbal  stimuli, then began to vomit into trash can that was placed in front of him".  Was gurgling and may have aspirated post arrival of the response team.  Patient was able to verbalize that this has happened once before in the distant  past when he received a small pox vaccine.  Patient advised that he blacked out,  endorses stomach pain, nausea, shakiness, dizziness, and feeling cold. He has  not eaten today. Was provided water to sip on and graham crackers. Patient  states he is slowly starting to feel better after water and crackers.  Background: Baseline description of patient's status prior to acute change: Upon arriving to  the clinic today for a scheduled appointment with pcp, patient was alert,  oriented, and asymptomatic.  Did not eat this morning, denies GI symptoms prior  to arrival.    Assessment: Description of acute change in patient's status: Upon the response teams arrival,  patient is slow to respond to verbal stimuli,  pallor, and sitting in the exam chair with head over a trash can. C/o  generalized abdominal discomfort and nausea.  Denies chest pain, shortness of  breath or dizziness.  Interventions:   Yes       Other Interventions:     Repositioning, unable to trendelberg due to exam table limits, obtained  glucometer reading, oral hydration and snack.  Obtained a lab draw at chairside.  Completed from Right AC @ 1045.  Patient tolerated without incident. Secured  with gauze and coban.   Outcome: Patient left ambulatory per self after observation and lab draw.  He was  asymptomatic upon discharge. Left to the lobby without incident, gait is steady  without deficits.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Breath sounds abnormal
Clinical narrative: can. No visible vomiting occuring at this time.  Patient is shivering and pale,  is slow to respond to verbal stimuli.  Dr at chairside and advised that  patient had just received covid and flu vaccinations, and immediately became  "centrally contracted, pale, turned head to one side, nonresponsive to verbal  stimuli, then began to vomit into trash can that was placed in front of him".  Was gurgling and may have aspirated post arrival of the response team.  Patient was able to verbalize that this has happened once before in the distant  past when he received a small pox vaccine.  Patient advised that he blacked out,  endorses stomach pain, nausea, shakiness, dizziness, and feeling cold. He has  not eaten today. Was provided water to sip on and graham crackers. Patient  states he is slowly starting to feel better after water and crackers.  Background: Baseline description of patient's status prior to acute change: Upon arriving to  the clinic today for a scheduled appointment with pcp, patient was alert,  oriented, and asymptomatic.  Did not eat this morning, denies GI symptoms prior  to arrival.    Assessment: Description of acute change in patient's status: Upon the response teams arrival,  patient is slow to respond to verbal stimuli,  pallor, and sitting in the exam chair with head over a trash can. C/o  generalized abdominal discomfort and nausea.  Denies chest pain, shortness of  breath or dizziness.  Interventions:   Yes       Other Interventions:     Repositioning, unable to trendelberg due to exam table limits, obtained  glucometer reading, oral hydration and snack.  Obtained a lab draw at chairside.  Completed from Right AC @ 1045.  Patient tolerated without incident. Secured  with gauze and coban.   Outcome: Patient left ambulatory per self after observation and lab draw.  He was  asymptomatic upon discharge. Left to the lobby without incident, gait is steady  without deficits.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: C-reactive protein normal, Carbon dioxide normal, Chills, Dizziness, Feeling cold
Clinical narrative: can. No visible vomiting occuring at this time.  Patient is shivering and pale,  is slow to respond to verbal stimuli.  Dr at chairside and advised that  patient had just received covid and flu vaccinations, and immediately became  "centrally contracted, pale, turned head to one side, nonresponsive to verbal  stimuli, then began to vomit into trash can that was placed in front of him".  Was gurgling and may have aspirated post arrival of the response team.  Patient was able to verbalize that this has happened once before in the distant  past when he received a small pox vaccine.  Patient advised that he blacked out,  endorses stomach pain, nausea, shakiness, dizziness, and feeling cold. He has  not eaten today. Was provided water to sip on and graham crackers. Patient  states he is slowly starting to feel better after water and crackers.  Background: Baseline description of patient's status prior to acute change: Upon arriving to  the clinic today for a scheduled appointment with pcp, patient was alert,  oriented, and asymptomatic.  Did not eat this morning, denies GI symptoms prior  to arrival.    Assessment: Description of acute change in patient's status: Upon the response teams arrival,  patient is slow to respond to verbal stimuli,  pallor, and sitting in the exam chair with head over a trash can. C/o  generalized abdominal discomfort and nausea.  Denies chest pain, shortness of  breath or dizziness.  Interventions:   Yes       Other Interventions:     Repositioning, unable to trendelberg due to exam table limits, obtained  glucometer reading, oral hydration and snack.  Obtained a lab draw at chairside.  Completed from Right AC @ 1045.  Patient tolerated without incident. Secured  with gauze and coban.   Outcome: Patient left ambulatory per self after observation and lab draw.  He was  asymptomatic upon discharge. Left to the lobby without incident, gait is steady  without deficits.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Glomerular filtration rate, Hyporesponsive to stimuli, Nausea, Pallor, Posture abnormal
Clinical narrative: can. No visible vomiting occuring at this time.  Patient is shivering and pale,  is slow to respond to verbal stimuli.  Dr at chairside and advised that  patient had just received covid and flu vaccinations, and immediately became  "centrally contracted, pale, turned head to one side, nonresponsive to verbal  stimuli, then began to vomit into trash can that was placed in front of him".  Was gurgling and may have aspirated post arrival of the response team.  Patient was able to verbalize that this has happened once before in the distant  past when he received a small pox vaccine.  Patient advised that he blacked out,  endorses stomach pain, nausea, shakiness, dizziness, and feeling cold. He has  not eaten today. Was provided water to sip on and graham crackers. Patient  states he is slowly starting to feel better after water and crackers.  Background: Baseline description of patient's status prior to acute change: Upon arriving to  the clinic today for a scheduled appointment with pcp, patient was alert,  oriented, and asymptomatic.  Did not eat this morning, denies GI symptoms prior  to arrival.    Assessment: Description of acute change in patient's status: Upon the response teams arrival,  patient is slow to respond to verbal stimuli,  pallor, and sitting in the exam chair with head over a trash can. C/o  generalized abdominal discomfort and nausea.  Denies chest pain, shortness of  breath or dizziness.  Interventions:   Yes       Other Interventions:     Repositioning, unable to trendelberg due to exam table limits, obtained  glucometer reading, oral hydration and snack.  Obtained a lab draw at chairside.  Completed from Right AC @ 1045.  Patient tolerated without incident. Secured  with gauze and coban.   Outcome: Patient left ambulatory per self after observation and lab draw.  He was  asymptomatic upon discharge. Left to the lobby without incident, gait is steady  without deficits.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Red blood cell sedimentation rate normal, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: can. No visible vomiting occuring at this time.  Patient is shivering and pale,  is slow to respond to verbal stimuli.  Dr at chairside and advised that  patient had just received covid and flu vaccinations, and immediately became  "centrally contracted, pale, turned head to one side, nonresponsive to verbal  stimuli, then began to vomit into trash can that was placed in front of him".  Was gurgling and may have aspirated post arrival of the response team.  Patient was able to verbalize that this has happened once before in the distant  past when he received a small pox vaccine.  Patient advised that he blacked out,  endorses stomach pain, nausea, shakiness, dizziness, and feeling cold. He has  not eaten today. Was provided water to sip on and graham crackers. Patient  states he is slowly starting to feel better after water and crackers.  Background: Baseline description of patient's status prior to acute change: Upon arriving to  the clinic today for a scheduled appointment with pcp, patient was alert,  oriented, and asymptomatic.  Did not eat this morning, denies GI symptoms prior  to arrival.    Assessment: Description of acute change in patient's status: Upon the response teams arrival,  patient is slow to respond to verbal stimuli,  pallor, and sitting in the exam chair with head over a trash can. C/o  generalized abdominal discomfort and nausea.  Denies chest pain, shortness of  breath or dizziness.  Interventions:   Yes       Other Interventions:     Repositioning, unable to trendelberg due to exam table limits, obtained  glucometer reading, oral hydration and snack.  Obtained a lab draw at chairside.  Completed from Right AC @ 1045.  Patient tolerated without incident. Secured  with gauze and coban.   Outcome: Patient left ambulatory per self after observation and lab draw.  He was  asymptomatic upon discharge. Left to the lobby without incident, gait is steady  without deficits.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: PATIENT REPORTED SHOULDER PAIN FROM INJECTION GIVEN "TOO HIGH" VIA PHONE CALL ON 10/7/2024
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2  high dose flu vaccines by mistake. First was given on 10/23/24.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Per mom patient's developed a fever of 102 F, running  nose, and tired.  Mom gave her son motrin and he felt better.  The symptom last for one day or less.  She said it's always happened after he received the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: pt developed rash over left upper arm (not itchy or painful)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Condition aggravated, Fatigue, Irritable bowel syndrome
Clinical narrative: Pain after eating, including stomach and severe abdominal pain. Fatigue, aches, etc. This lasted for over two weeks. Increased IBS symptoms and was about to go to urgent care when symptoms finally eased.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain after eating, including stomach and severe abdominal pain. Fatigue, aches, etc. This lasted for over two weeks. Increased IBS symptoms and was about to go to urgent care when symptoms finally eased.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: Vaccine expired yesterday on 12/9/2024
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm pain since  date of injection July 2024, 5 months ago
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NO REACTION AT TIME OF VACCINATION, UPON RECONCILIATION NURSE NOTICED THE LOT # CONSENT WERE FOR THE MODERNA SPIKEVAX FOR AGE 12+. PATIENT IS ON LY 10 YEARS OLD AND SHOULD HAVE RECEIVED THE .25 DOSE FOR AGE 6 MOS - 11 YRS
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate dose of HD flu. She received a dose of flu vaccine in September
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt called saying they wanted the covid shot but were given a flu shot which they had at drs office earlier this year in november.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: pt said they wanted covid shot but flu shot was given instead and already had in early november from physician.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events/outcomes reported. COVID-19 vaccine given 11/07/2024 and 11/12/2024.
Age: 76.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Hives, swelling of the lips and tongue
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Immediate Pain at injection site, pain has increased over the past 2 weeks, Limited shoulder range of motion when rotating  arm above head. Difficulty sleeping due to pain in the shoulder.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain, Neuralgia, Pain
Clinical narrative: I received a Tdap and shingles  (Shingrix) vaccine from the Pharmacy.  A few days later I started with nerve pain radiating from the injection site to underneath my shoulder blade.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Tremor
Clinical narrative: weakness, shakiness, chills. lasting about 3 days.
Age: 0.42
Sex: M
Vaccine: IPV
Symptoms: Gaze palsy, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: approximately 10 second long self resolving seizure like activity including eye rolling and unresponsiveness without apnea or color change
Age: 58.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Fever, Chills, Extreme body aches, muscle aches, joint pain.  Fatigue.  Fever and chills lasted 3 entire days of in bed feeling like I had a bad case of the flu.  Injection site redness, pain, warmness around the site and hard bump in left arm where Prevnar 20 was administered. The other vaccination was in the right arm (Tdap). Injection site hardness of bump has diminished but is still present after 10 days.
Age: 58.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Fever, Chills, Extreme body aches, muscle aches, joint pain.  Fatigue.  Fever and chills lasted 3 entire days of in bed feeling like I had a bad case of the flu.  Injection site redness, pain, warmness around the site and hard bump in left arm where Prevnar 20 was administered. The other vaccination was in the right arm (Tdap). Injection site hardness of bump has diminished but is still present after 10 days.
Age: 58.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, Chills, Extreme body aches, muscle aches, joint pain.  Fatigue.  Fever and chills lasted 3 entire days of in bed feeling like I had a bad case of the flu.  Injection site redness, pain, warmness around the site and hard bump in left arm where Prevnar 20 was administered. The other vaccination was in the right arm (Tdap). Injection site hardness of bump has diminished but is still present after 10 days.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Facial paralysis, Hemiparesis, Memory impairment
Clinical narrative: "At around 0755 this morning, this LN was informed by PT that resident has sudden slurred speech and left side facial droop while trying to change her clothes. This LN went immediately to check, resident is alert and verbal responsive w/ slurred speech. Alert to self but unable to recall year and place, baseline w/ AOX3. Weakness noted to left side . Resident w/ history of stroke. Called 911 via ambulance, came to pick up resident and left facility at around 0810. Updated POA. Received a call back from NP covering Dr, updated. Resident currently at ER. Awaiting for an update. Endorsed. VS: 113/69-103-18-97.0, O2sat 98%RA." Resident was briefly admitted as hospital inpatient for Neuro work up.  Resident was discharged from hospital and readmitted to  Healthcare center on 12/6/2024 at approximately 6:30pm.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted.  Reporting that patient received an RSV (Abrysvo) vaccine on 10/17/2024 from Pharmacy and the patient received another RSV (Abrysvo) vaccine on 11/5/2024 from Pharmacy.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Allergy to vaccine
Clinical narrative: had an allergic reaction to the gelatin in the vaccine; This spontaneous report was received from a nurse concerning to a 5-year-old (currently 12-year-old) male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.   The reporter called to question about the presence of gelatin in human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 virus like particle (VLP) vaccine (yeast) (GARDASIL 9), as on an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided); and had had an allergic reaction to the gelatin in the vaccine (Allergy to vaccine ).   At the time of reporting, the outcome of the event had not been reported. No other information was available at the time of the call.  The reporter did not provide a causal relationship between the event and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), but per company guidelines it was considered to be related.  Additional information was not expected.
Sex: U
Vaccine: PNC21
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 6-month-old patient was administered a dose of CAPVAXIVE; no side effects; This spontaneous report was received from a pharmacist referring to a 6-month-old patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, administered by health professional for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No side effects or symptoms were reported (no adverse event).   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No patient symptoms have been reported. No additional AE; Pharmacist called stating a patient received HELPISAV-B on 7/27/2024 as their 1st dose in their hepatitis B series and RECOMBIVAX HB on 9/27/2024 as their 2nd dose. Caller stated no patient symptoms have been reported. No additional AE/no PQC reporte; This spontaneous report was received from Pharmacist regarding a patient of unknown age and gender.   The patientmedical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 27-JUL-2024, the patient was vaccinated with hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) (dose, formulation, lot number, expiration date, route of administration, and indication were not provided) as the patient's first dose in their Hepatitis B series, while on 27-SEP-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, prefilled syringe, administered for prophylaxis (dose and route of administration were not provided; lot Y009436 has been verified to be a valid numbe for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date 12-FEB-2027) as their second dose (Interchange of vaccine products). The reporter stated that no symptoms and no additional adverse event have been reported for the patient.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called regarding T/E for VAXNUEVANCE, and GARDASIL-9. HCP reported that this T/E was previously reported with case number #, however the incorrect time was provided. Outcome for GARDASIL-9 was no longer supported and HCP mentioned that th; This spontaneous report was received from a Nurse Practitioner and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-AUG-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024251, expiration date: 15-MAY-2026, 0.5 milliliter, administered in the left deltoid for prophylaxis (route of administration were not provided).   Administered dose was exposed to temperature excursion from 01-AUG-2024 to 05-AUG-2024, of 60.4 degrees Fahrenheit for 86 hours and 35 minutes (product storage error). No additional adverse event was reported (no adverse event).
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called regarding T/E for VAXNUEVANCE, and GARDASIL-9. HCP reported that this T/E was previously reported with case number #, however the incorrect time was provided. Outcome for GARDASIL-9 was no longer supported and HCP mentioned that th; This spontaneous report was received from a Nurse Practitioner and refers to a 13-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-OCT-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024251, expiration date: 15-MAY-2026, 0.5 milliliter, administered in the left deltoid for prophylaxis (route of administration were not provided).   Administered dose was exposed to temperature excursion from 01-AUG-2024 to 05-AUG-2024, of 60.4 degrees Fahrenheit for 86 hours and 35 minutes (product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer calling to report temperature excursion. She states that the product was administered on 11/21/2024.; This spontaneous report was received from a medical assistant referring to a patient with unknown age and gender. The patient's pertinent medical history and drug reactions/ allergies and concomitant medication were not reported.   On 21-NOV-2024, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) injection, lot #Y013576, expiration date: 03-FEB-2026, administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided) after experiencing a temperature excursion (Temperature 18.4 F; Time frame: 360 hours) (Product storage error). No previous temperature excursion. No additional adverse event (AE) (No adverse event).
Sex: F
Vaccine: UNK
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case, initially received on 27-Nov-2024, was reported by a non health professional and concerns an elderly female patient.  Administration of company suspect drug: On 07-Oct-2024, the patient received Fluad (TIV) for Not reported, Dose regimen: .5 ml, route of administration: not reported, Lot number: No batch number available and would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: Between 28-Oct-2024 and 31-Oct-2024, the patient experienced Bell's Palsy (Medically Significant, outcome: Not recovered/Not resolved).  Patient called to report what patient thinks it was an adverse event. Patient took a flu shot, Fluad trivalent, and after three weeks and a half patient had Bell's Palsy, patient was wondering if it was a common reaction, if it was reported before. Patient takes flu shots for years and never had that. But patient was just curious to know if already received a report on similar reaction.   Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality assessment was not reported.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reportable purpose. Also, considering temporal relationship (after three weeks and a half), the event of Bell's palsy is assessed as related
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose, and Has Not Had The Second Dose; Initial report received on 15-Nov-2024.  A pharmacist reported that a 59-year-old male received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 17-Apr-2024 and was supposed to come back in May for the next dose but did not.  No medical history or concomitant medications were reported.  On 17-Apr-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 943192, expiration date 08-Mar-2026, NDC number 43528-002-01; site not specified)] intramuscularly. The patient was supposed to come back in May-2024 for the next dose but did not return.  On 15-Nov-2024, 212 days receiving the first dose of HEPLISAV-B, the patient was noted to have not returned in May-2024, which was when he was supposed to return.  No additional information was reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Drug maladministration/diluent-only administration; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11-NOV-2024, the patient received Shingles vaccine. On 11-NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced inappropriate preparation of medication (Verbatim: Drug maladministration/diluent-only administration) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-NOV-2024 The patient received diluent only of Shingles vaccine, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: Tiredness). The outcome of the tiredness was not reported.   It was unknown if the reporter considered the tiredness to be related to Arexvy.     It was unknown if the company considered the tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-NOV-2024 This case was reported by a patient via interactive digital media. The patient reported that he /she took the Arexvy vaccine and experienced tiredness.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: the patient received the liquid adjuvant without the powder antigen; the patient received the liquid adjuvant without the powder antigen; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-NOV-2024, the patient received Shingrix. On 11-NOV-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the patient received the liquid adjuvant without the powder antigen) and inappropriate dose of vaccine administered (Verbatim: the patient received the liquid adjuvant without the powder antigen). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-NOV-2024 Reporter reported that the patient only received the Shingrix vaccine liquid adjuvant without the powder antigen on 11th November 2024. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed me with shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included polycythemia vera. Additional patient notes included patient was in fairly good health. Concomitant products included hydroxycarbamide (Hydroxyurea).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed me with shingles). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-NOV-2024 The patient self-reported this case. The patient had a fairly good health and had both Shingrix shots about five years ago and took hydroxyurea for polycythemia vera (PV). The patient around 1st August, noticed some spots on his forearm that appeared to be a spider bite.  The patient went to his family doctor and she immediately diagnosed him with shingles and put him on gabapentin, which did not helped much.  The next month was complete misery and the patient never really had itching or an extensive rash, but intense pain and burning developed from the top of his neck down to his left thumb and forefinger.  The patient's wife read that hydroxyurea lowered his immune system, which was probably why he had such a bad case of shingles despite the Shingrix shots. The patient's cousin was a retired anesthesiologist and he recommended an epidural steroid injection (ESI) that would help him immediately.  The patient had the injection and within 24 hours he had an 80 percent improvement in his pain level.  Over the next month, the pain decreased another 10 percent to 15 percent and the patient went from being almost incapacitated to being able to live again in 24 hours nd the outcome was life-changing. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had shingles 3 times since vaccine; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles 3 times since vaccine). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-DEC-2024 This case was reported by the patient via interactive digital media. The reporter reported that he/she had shingles 3 times since vaccine, never before. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-DEC-2024 This case was reported by a patient via interactive digital media. The patient got shingles two days after getting the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pateint did not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09-APR-2024).   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: pateint did not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-NOV-2024 The patient had not yet gotten her second dose of Shingrix and it had been more than 6 months since her first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: accidentally administered a dose of Infanrix that expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-month-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 11-NOV-2024, the patient received the 4th dose of Infanrix. On 11-NOV-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: accidentally administered a dose of Infanrix that expired). 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: 11-NOV-2024 The nurse reported, the patient was accidentally administered a dose of Infanrix which was expired, which led expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get the 3rd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose in 2013) and Twinrix (2nd dose in 2013).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: did not get the 3rd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-NOV-2024 The patient received 1st and 2nd dose and did not get the 3rd dose till the time of reporting which led incomplete course of vaccination.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Sleep disorder
Clinical narrative: can't sleep, pain wakes her up throughout the night; pain in the right side of her face; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included shingles (6 years ago). Concomitant products included acyclovir.   On an unknown date, the patient received the 2nd dose of Shingrix. In NOV-2024, an unknown time after receiving Shingrix, the patient experienced facial pain (Verbatim: pain in the right side of her face). On an unknown date, the patient experienced pain (Verbatim: can't sleep, pain wakes her up throughout the night). The outcome of the facial pain and pain were not resolved.   It was unknown if the reporter considered the facial pain and pain to be related to Shingrix.     It was unknown if the company considered the facial pain and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-NOV-2024 The reporter states she had shingles on the right side of her face 6 years ago (she did not remember the dates but thinks it was July 2019) She states shortly after recovering from shingles she got the 2 doses of Shingrix. She has been experiencing pain in the right side of her face for the last week. She states the patient cannot sleep, pain wakes her up throughout the night and she uses a heating pad for pain relief. The health care professional prescribed acyclovir which she has been using daily for almost a week, last dose was today. She states there was no rash, but the pain has not gone away. The reporter did not consent to follow-up.