chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Restlessness, Sleep disorder
Clinical narrative: 8/3 started feeling severe fatigue- rest and given pain medication 8/6 noticed fatigue and spots on chest and back- bath, rest, pain medication 8/8 More spots on chest and abdomen and back and pain in shoulder and back that ran down the back to hip. Restless/sleepless night with severe abdominal pain, nausea, and chills- pain and fever medication, bath, rest 8/9 Doctor visit with fatigue and trunk pain, sore muscles- legs, chest and hurt to take deep breaths. Shifted to bladder and discomfort sleeping
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after administration of Gardasil vaccine, patient had a syncopal event (lost consciousness, became weak). She was laid back on exam table with feet up and immediately regained consciousness. She remained supine with an ice pack for 20 minutes, drank a full juice and water and was then back to baseline.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Cold sweat, Death, Dyspnoea, Feeling abnormal
Clinical narrative: On 7/23/23 at approximately 0050 CNA called this writer to resident's room. CNA asked if resident had seizures. Resident was unable to roll onto her side and her eyes rolled upwards. Resident was very pale and lips were white colored. Eyes were wide open and breaths were 7 per minute. Writer attempted to check O2 sat, but it did not register. VS taken 96-45-7-91/70. Resident's limbs were flaccid and initially did not respond to verbal stimuli. After approximately 2 minutes resident was able to make eye contact with writer and talk, but skin remains cool and clammy. VS 98.1-45-12-108/56 O2 92% RA. Resident stated she was feeling better. Neuro check completed and intact.  Resident reports she can not breathe. O2 concentrator brought to the room. Started at 2LPM via N/C, but sats would not maintain 90%. Increased to 3LPM with improvement to 95%-96%, however resident states she is still feeling terrible and can not catch her breath. Cannula moved to the oral cavity as resident is breathing heavily from her mouth only. Writer stayed with resident. When turning onto her side per request, resident couldn't lift her arm as was weak, so writer turned resident. Skin is cool and clammy still, but resident stated she felt hot and did not want blankets on her. Writer asked resident if she felt she needed to go to the ER and resident said "Yes, I can't do this". Son, called and given an update. Son supported resident being taken to the ER. He is out of town and will notify his local brother of the transfer. Call placed to ER and spoke with nurse as well as doctor on call Dr. Condition update given. Dr. gave the order for resident to be transferred to ER via ambulance. Ambulance arrived at 0210 and resident was assisted onto the gurney and transferred to the ER.On 7/23/23 at 0510 call received from Hospital from RN reporting that resident passed away. Stated her family was there with her when she passed.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Gaze palsy, Hypotonia, Lip discolouration, Mobility decreased
Clinical narrative: On 7/23/23 at approximately 0050 CNA called this writer to resident's room. CNA asked if resident had seizures. Resident was unable to roll onto her side and her eyes rolled upwards. Resident was very pale and lips were white colored. Eyes were wide open and breaths were 7 per minute. Writer attempted to check O2 sat, but it did not register. VS taken 96-45-7-91/70. Resident's limbs were flaccid and initially did not respond to verbal stimuli. After approximately 2 minutes resident was able to make eye contact with writer and talk, but skin remains cool and clammy. VS 98.1-45-12-108/56 O2 92% RA. Resident stated she was feeling better. Neuro check completed and intact.  Resident reports she can not breathe. O2 concentrator brought to the room. Started at 2LPM via N/C, but sats would not maintain 90%. Increased to 3LPM with improvement to 95%-96%, however resident states she is still feeling terrible and can not catch her breath. Cannula moved to the oral cavity as resident is breathing heavily from her mouth only. Writer stayed with resident. When turning onto her side per request, resident couldn't lift her arm as was weak, so writer turned resident. Skin is cool and clammy still, but resident stated she felt hot and did not want blankets on her. Writer asked resident if she felt she needed to go to the ER and resident said "Yes, I can't do this". Son, called and given an update. Son supported resident being taken to the ER. He is out of town and will notify his local brother of the transfer. Call placed to ER and spoke with nurse as well as doctor on call Dr. Condition update given. Dr. gave the order for resident to be transferred to ER via ambulance. Ambulance arrived at 0210 and resident was assisted onto the gurney and transferred to the ER.On 7/23/23 at 0510 call received from Hospital from RN reporting that resident passed away. Stated her family was there with her when she passed.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: On 7/23/23 at approximately 0050 CNA called this writer to resident's room. CNA asked if resident had seizures. Resident was unable to roll onto her side and her eyes rolled upwards. Resident was very pale and lips were white colored. Eyes were wide open and breaths were 7 per minute. Writer attempted to check O2 sat, but it did not register. VS taken 96-45-7-91/70. Resident's limbs were flaccid and initially did not respond to verbal stimuli. After approximately 2 minutes resident was able to make eye contact with writer and talk, but skin remains cool and clammy. VS 98.1-45-12-108/56 O2 92% RA. Resident stated she was feeling better. Neuro check completed and intact.  Resident reports she can not breathe. O2 concentrator brought to the room. Started at 2LPM via N/C, but sats would not maintain 90%. Increased to 3LPM with improvement to 95%-96%, however resident states she is still feeling terrible and can not catch her breath. Cannula moved to the oral cavity as resident is breathing heavily from her mouth only. Writer stayed with resident. When turning onto her side per request, resident couldn't lift her arm as was weak, so writer turned resident. Skin is cool and clammy still, but resident stated she felt hot and did not want blankets on her. Writer asked resident if she felt she needed to go to the ER and resident said "Yes, I can't do this". Son, called and given an update. Son supported resident being taken to the ER. He is out of town and will notify his local brother of the transfer. Call placed to ER and spoke with nurse as well as doctor on call Dr. Condition update given. Dr. gave the order for resident to be transferred to ER via ambulance. Ambulance arrived at 0210 and resident was assisted onto the gurney and transferred to the ER.On 7/23/23 at 0510 call received from Hospital from RN reporting that resident passed away. Stated her family was there with her when she passed.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 18.0
Sex: M
Vaccine: IPV, MNQ, YF
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Client passed out falling off the exam table to the floor, striking his forehead on the floor.  He was rolled over onto his back, his mother cradled his head in her lap.   Ice pack was placed on his head, he was given a juice box to drink.  Client stayed on the floor for 15 minutes until he felt good enough to sit up.  He then sat in a chair for 5 minutes before he left with his mother.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Myocardial ischaemia, Organ failure, Sepsis
Clinical narrative: DEMAND ISCHEMIA 4/1/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Dizziness, Hypertension
Clinical narrative: diziness, high blood pressure
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Blood pressure increased, Blood test, Cardiac disorder, Chest pain, Dizziness
Clinical narrative: diziness, high blood pressure
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Haemoglobin normal, Hypertension
Clinical narrative: diziness, high blood pressure
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypertension, Hypotension, Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/26/2023 HTN (HYPERTENSION) HYPOTENSION 4/26/2023 HTN (HYPERTENSION) ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/26/2023 HTN (HYPERTENSION)  HYPOXIA 4/26/2023 HTN (HYPERTENSION)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/26/2023 HTN (HYPERTENSION) HYPOTENSION 4/26/2023 HTN (HYPERTENSION) ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/26/2023 HTN (HYPERTENSION)  HYPOXIA 4/26/2023 HTN (HYPERTENSION)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic kidney disease, Deep vein thrombosis, Glomerular filtration rate
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/26/2023 CKD STAGE 3A (GFR 45-59) ACUTE DVT, UNSPECIFIED VEIN 3/19/2023 CKD STAGE 3A (GFR 45-59) ACUTE DVT OF LEFT FEMORAL VEIN 3/28/2023 CKD STAGE 3A (GFR 45-59)
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: hives
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Provider prescribed/ordere Bexcero Men B vaccine for patient, MA cancelled order because that vaccine not carried in clinic and placed an order for MEN ACYW Vaccine. Showed Provider who did looked at label for expiration, there was no communication on the switch, and provider did not see the difference in name. Vaccine administered. This would be the 3rd dose of MEN acwy for this patient. MA team caught error after and reported it to provider who called patient and let them know they received incorrect vaccine and an incident report was filed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling at injection site s/p 8 hours after injection, treated with oral benadryl at moms discretion resulting in waxing/waning of swelling. Patient presented 2 days following injection, physical exam noted mild erythema with minimal localized swelling, no warmth, no tenderness, and no change in gait.
Age: 23.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Adverse events: syncope (10 seconds); Nausea and constant vomiting (20 minutes then transported to hospital via EMS)
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product administration duration, No adverse event
Clinical narrative: no adverse effect. but patient was given a dose that was past the discard after date. the vaccine was stored in the fridge with a discard after date of 7/13/23 but administered on 8/4/23. it was discovered today on 8/10/23 that the box of moderna doses of that batch were not discarded.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Vaccination site mass, Vaccination site nodule
Clinical narrative: The patient called into the clinic's nurse line on 8/9/23 reporting a persistent sore left arm and possible small "knot" at site where Gardasil was injection on 7/20/23. She reports she had no soreness until about 2 days after she received the Gardasil injection and it has been sore since. The soreness never worsened, it has just been persistent. Denied rash, nausea, vomiting, fever, chills, warmth/redness at site, systemic signs of an allergic reaction (hives, pruritis, anaphylactic-type reaction), or other symptoms. She declined a same-day appointment for evaluation due to work, but accepted an appointment today, 8/10/23.  Today CRNP evaluated patient in the office. Per evaluation notes, skin is clear. A palpable vaccine lump or nodule is noted. Some concern for inflammation or bursitis but difficult to assess. Should see PCP, recommended ice and Motrin, and return in 6 weeks to reassess.  The patient is scheduled for an appointment on 9/21/23 per her preference for reevaluation of site prior to receiving Gardasil dose #2.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: No symptoms at the time of occurrence. Client did wait 15 min in the lobby.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Cough, Influenza like illness, Injection site rash, Malaise
Clinical narrative: The initial burn felt like a staple was injected into my arm.  For the next week, I had a round red rash which was painful at injection site. I had a cough, felt like I had the flu and after 8+ weeks, still not feeling well. The injection site aches everytime I feel under the weather, or sneeze or cough.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash erythematous
Clinical narrative: The initial burn felt like a staple was injected into my arm.  For the next week, I had a round red rash which was painful at injection site. I had a cough, felt like I had the flu and after 8+ weeks, still not feeling well. The injection site aches everytime I feel under the weather, or sneeze or cough.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Fear, Hypotension, Loss of consciousness, Pallor
Clinical narrative: 14 year old F who experienced a vasovagal syncopal event following administration of her vaccine. Patient was sitting in her exam room chair and slid to the ground when mother alerted staff that patient had passed out. Patient came regained consciousness in less than 1 minute. While unconscious patient was noted to be breathing at a normal rate and her pulse was palpable. As patient regained consciousness, she was alert but scared and was not altered. She was placed in her exam chair and patient had set of vitals which were concerning for hypotension and pallor on examination. EMS was called and dispatched. They were given an assessment of the patient by writing provider. The patient was evaluated by EMS and had normalized vitals. No additional concerns at this time. Mother was fully informed via translator that patient would not require additional treatment or transport to the hospital. Patient was given anticipatory guidance regarding vasovagal syncope and discharged home with mother.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: 14 year old F who experienced a vasovagal syncopal event following administration of her vaccine. Patient was sitting in her exam room chair and slid to the ground when mother alerted staff that patient had passed out. Patient came regained consciousness in less than 1 minute. While unconscious patient was noted to be breathing at a normal rate and her pulse was palpable. As patient regained consciousness, she was alert but scared and was not altered. She was placed in her exam chair and patient had set of vitals which were concerning for hypotension and pallor on examination. EMS was called and dispatched. They were given an assessment of the patient by writing provider. The patient was evaluated by EMS and had normalized vitals. No additional concerns at this time. Mother was fully informed via translator that patient would not require additional treatment or transport to the hospital. Patient was given anticipatory guidance regarding vasovagal syncope and discharged home with mother.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: Patient received vaccine after BUD
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: Patient received vaccine after BUD
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per assessment of RN  Patient?s medical problem is:  Redness and swelling to L thigh on 8/7/23.since 8/7/23 S/P immunization  Symptoms:  Per mom: Patient has redness and swelling to the L thigh since 8/7, after she received her vaccine. Denies pain , redness or itching. Denies fever  or any other symptoms . Patient s able to walk Med: none
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Fatigue, Hyperhidrosis, Mydriasis
Clinical narrative: Vasovagal episode-dizzy, brief (<5 seconds)seizure like activity, dilated pupils, sweaty, clammy, pale, and c/o being tired. First responders contacted, VS obtained, water given. Able to answer questions. Reports not eating anything today.  From time of vaccine given til patient left=30 minutes.  Pulse 58reg, BP 100/70, SaO2 99% Mother refused ER visit/exam. Child laughing and joking with brother as they left appointment.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Presyncope, Seizure like phenomena
Clinical narrative: Vasovagal episode-dizzy, brief (<5 seconds)seizure like activity, dilated pupils, sweaty, clammy, pale, and c/o being tired. First responders contacted, VS obtained, water given. Able to answer questions. Reports not eating anything today.  From time of vaccine given til patient left=30 minutes.  Pulse 58reg, BP 100/70, SaO2 99% Mother refused ER visit/exam. Child laughing and joking with brother as they left appointment.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PT did not provide a full record at the time of vaccination and this resulted in the PT receiving dose 2 of HEP A too early. Advised patient to return in 6 months from 7/26/23 to complete HEP A series.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Erythema, Heart rate irregular, Pain, Swelling
Clinical narrative: :30am Donor called post vaccination, off-site, to report soreness, redness, swelling and abdominal pains and off/on fast heart beats, that started about 3 am this morning. Donor was advised to apply cool compress to area, for 10-20 minutes at a time. Put a thin cloth between the ice and her skin. Seek medical care if any of these symptoms increase or cant move arm.  Donor advised to seek urgent/ER care as soon as possible to evaluate the heart rate.  3pm Donor was called to Follow up. She stated she went to ER  at 10am and was told she was experiencing normal side effects.  Donor also reported that all symptoms had subsided by the time she got to ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Throat tightness, Urticaria
Clinical narrative: Throat tightness, trouble breathing, racing heart, hives
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Adverse drug reaction, Allergy test, Anaphylactic reaction, X-ray
Clinical narrative: Side effects/anaphylaxis; This spontaneous report was received from a nurse and refers to an unspecified patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On an unknown date, the patient was vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, albumin status rHA lot #U025199, expiration date not reported but upon internal validation established as 13-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced side effects. At the time of reporting, the outcome of the side effects was not known.   The causal relationship between side effects and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  This is a non-valid case due to lack of patient's identifiers.  Follow-up was received from a consumer on 03-AUG-2023 referring to the 21-year-old female patient. The patient had no pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications (reported as "none"). She was not ill at the time of vaccination.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the left deltoid, corresponding to the third dose of the vaccine. Additionally, the patient was also vaccinated with an unspecified varicella vaccine (manufacturer unknown) (reported as "varicella") lot # reported as "W006413" with expiration date reported as "23-FEB-2024", subcutaneously in the left arm, for prophylaxis (strength and dose were not provided). The vaccines were administered as private doctor's office/hospital.   On 28-APR-2023, the patient experienced anaphylaxis. The patient's mother took her to the emergency room (ER) and a allergy testing was done (results not provided). She required X-ray (result not provided) and was treated with intravenous medications and with epinephrine, methylprednisolone sodium succinate (SOLUMEDROL), famotidine (PEPCID) and ammonium chloride (+) diphenhydramine hydrochloride (BENADRYL). She also received oral antihistamines and steroids at home. The patient responded to treatment and recovered from the event on 27-JUN-2023. The rechallenge and rechallenge results were reported as positive for the suspect vaccines.  The reporter considered the event to be related to the suspect vaccines.  The reporter considered anaphylaxis to be a life-threatening event and also a medically significant event.  Follow-up information provided patient's identifiers, therefore, the case was considered as a valid case.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I am currently 29 years old and have received one dose of Gardasil 4; No other AE.; This spontaneous report was received from a Consumer and refers to a currently 29-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (anatomical location) strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No other adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report temperature excursion for VARIVAX in which it was administered.; This spontaneous report was received from a pharmacist 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 an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number X000100 (is not valid for varicella virus vaccine live (Oka/Merck) (VARIVAX)), 0.5 milliliter for prophylaxis (dose number, route and site of administration and expiration date were not provided) (product storage error and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC.; Nurse reported AE related to improperly stored and administered PROQUAD; This spontaneous report was received from a Licensed Practical Nurse (LPN) and referred to a patient of unspecified age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 19-JUL-2023, the patient was vaccinated with an one (1) improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live s (rHA [recombinant Human albumin]) (PROQUAD) injection (strength, dosage, vaccination scheme frequency, dose number, route of administration and anatomical site of application were not reported; lot number W029543 with an expiration date reported and established as 14-MAR-2024) (product storage error) for prophylaxis.  It was stated that the suspect vaccine had a temperature excursion of 6.93 degree Fahrenheit (F) with a time frame of 1 hour 13 minutes. Also experienced a previous temperature excursions of  52.01 F with a time frame of 2 hours and 6 minutes; and 9.74 F with a time frame of 4 hours and 34 minutes.  No additional adverse event (AE) was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: 06/20/2023: 34.9F for 6 hours 34 minutes 0 seconds; This spontaneous report was received from a customer (also reported as type "other") and referred to a patient of unspecified age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2023, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dosage of 2 ml administered orally (strength, vaccination scheme frequency, and dose number were not reported; lot number 1968385 with an expiration date reported and established as 22-MAY-2024) (product storage error) for prophylaxis.  It was stated that the suspect vaccine had the following previously temperature excursions: 34.9 degree Fahrenheit (F) with a time frame of 6 hours and 34 minutes (on 20-JUN-2023); 51.4 F with a time frame of 7 hours and 33 minutes (on 03-JUL-2023); 51.1 F with a time frame of 24 hours (on 04-JUL-2023); and 50.7 F with a time frame of 9 hours and 27 minutes (on 05-JUL-2023).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009703: US-009507513-2307USA009726: US-009507513-2307USA010639: US-009507513-2307USA009739: US-009507513-2307USA009675: US-009507513-2307USA009613: US-009507513-2307USA009752: US-009507513-2307USA009715: US-009507513-2307USA009717: US-009507513-2307USA009693: US-009507513-2307USA009646: US-009507513-2307USA009646: US-009507513-2307USA009916: US-009507513-2307USA009764: US-009507513-2307USA010119: US-009507513-2307USA009734: US-009507513-2307USA009695: US-009507513-2307USA009885: US-009507513-2307USA009993: US-009507513-2307USA009743: US-009507513-2307USA009605: US-009507513-2307USA009630: US-009507513-2307USA009885:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of product administration; This spontaneous report was received from nurse and refers to an 1-day-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-APR-2023 and 26-JUN-2023, the patient received doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate vaccination schedule).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2307USA010202:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: NO adverse effect; both vaccines PROQUAD & VARIVAX were inadvertently administered to a patient at the same time on 07/27/2023.; This spontaneous report was received from a health care professional (HCP) referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions, and allergies were not reported.  On 27-JUL-223, the patient was inadvertently vaccinated at the same time with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection (strength and route of administration not reported, lot # X000996, expiry date: 08-JUL-2024), and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength and route of administration not reported, lot # X002100, expiry date: 19-JAN-2025) for prophylaxis (accidental overdose). The patient did not experience any symptoms. No additional adverse event (AE) (no adverse event).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Call transferred from specialist with a pediatric patient's mother on the back line. The caller reported that her 4 year old daughter received PROQUAD that was expired on 06/09/2023 and administered on 08/01/2023. Caller declined to; This spontaneous report was received from a pediatric patient's mother referring to her 4-year-old daughter. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 01-AUG-2023, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, expiration date: 09-JUN-2023, administered as prophylaxis (strength, dose, lot #, and route of administration were not provided) (expired product administered). There was no additional adverse event (AE).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: chicken pox rash; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was unknown by the reporter.  On an unknown date, when the patient was 12-month-old, he was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, once, administered as routine vaccination (prophylaxis) (route of administration, lot number, and expiration date were not reported).  On an unknown date in 2023 (also reported as last week), he experienced chicken pox rash (varicella) which was initially thought to be a chiggers rash or poison oak rash since the patient was on a camping trip. On 02-AUG-2023, it was confirmed by the health care professional (HCP) that he patient experienced varicella. It was not reported if the patient received any treatment, or if he had laboratory diagnostics or studies performed for this adverse event. At the reporting time, the patient had not been vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).  The outcome of the event, and the causal relationship between the event and the suspect vaccine were not reported.
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: prescribed or given GARDASIL 9 um for a patient for secondary prevention of genital warts for a patient who already had genitall warts, prior to vaccination. So the patient, or this person already has had previously been exposed um to HPV. So he was; This spontaneous report was received from a physician and refers to a male patient of unknown age.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included  genital wart.  On an unknown date, the patient was vaccinated with 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). The reporter prescribed or given this vaccine to a patient for secondary prevention of genital warts, but the patient already had genital warts prior to vaccination (Off label use ).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after Shingrix). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2023 The reporter was questioning the efficacy of Shingrix as the patient returned to him with shingles shortly after receiving the Shingrix vaccination. The reporter consented to follow up. This case is linked with US2023AMR107644, by same reporter.; Sender's Comments:  US-GSK-US2023AMR107644:Same reporter, same product, different patients.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered 7/28/2023; Extra dose administered on 6/01/2023; This non-serious case was reported by a consumer and described the occurrence of extra dose administered in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 13 June 2019,received 2nd dose), Shingrix (on 13 March 2019, received 1st dose), Zostavax (on 01 January 2008, received 2nd dose) and Zostavax (on 01 February 2007, received 1st dose). Concurrent medical conditions included dementia.   On 28-JUL-2023, the patient received the 4th dose of Shingrix. On 01-JUN-2023, the patient received the 3rd dose of Shingrix. On 01-JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered on 6/01/2023). On 28-JUL-2023, the patient experienced extra dose administered (Verbatim: Extra dose administered 7/28/2023). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: Receipt Date: 02-AUG-2023 The reporter mother was having dementia . The reporter just learned that the administration of two Shingrix injection to his/ her mother in last few months without the reporter consent as medical power of attorney. The reporter concern was that the patient already had 4 prior Shingrix injection prior to the last two administered. The reporter needed to speak to someone that could explain the health consequences associated with taking this many Shingrix. The patient received 2 more dose of Shingrix, which led to extra dose administered. The reporter was requested for follow up.
Sex: U
Vaccine: MENB, MENB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero so that was an error; doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero so that was an error; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number GP8621, expiry date 02-AUG-2025) for prophylaxis.   On 28-JUL-2023, the patient received Bexsero (intramuscular, right deltoid) .5 ml and the 1st dose of TRUMENBA (intramuscular, left deltoid) .5 ml. On 28-JUL-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero so that was an error) and accidental overdose (Verbatim: doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero so that was an error). The outcome of the wrong vaccine administered and accidental overdose were 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: 03-AUG-2023 The reporter stated that the issue was that she knew in a true adverse event if the patient had a reaction and the patient not had a reaction so was reporting the doctor ordered Trumenba and Menactra and the staff member gave the patient Bexsero and Trumenba at the same time and the patient had these administered.  The patient had no reactions. It was their annual physical for the patient and at certain times according to age you give certain vaccines and the doctor decided since the patient was age 16, wanted to prescribe for the patient the Trumenba and Menactra for the yearly annual physical. For the Menactra, had no information to provide or lot, expiry date or NDC as it was not given to the patient. There was nothing at this time that needed to say regarding this.  No treatment for the reported event. The doctor was going to have to give a call or the medical director was going to call the patient's parents and obviously the Menactra would still have to be given when they decide a good time to give that. It had documented this with Bexsero, Pfizer, their own facility and the CDC and the doctor would have to decide guessed to stick with Trumenba and to give the 2nd shot in 6 months of the Trumenba because it was a 2 shot series. The adverse event was that the doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero so that was an error, which led to wrong vaccine administered and accidental overdose.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, 24 hrs after receiving Pediarix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was resolved.   It was unknown if the reporter considered the fever to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the fever to be related to Pediarix and Pediarix 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: 31-JUL-2023 The reporter reported that the patient received Pediarix vaccine and 24 hours after received vaccine patient experienced fever. The reporter stated that the fever had resolved now. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site after the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site after the first dose). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023106303   Additional Information: Receipt Date: 04-AUG-2023 The patient reported after administration of first dose of Shingrix she had soreness at the injection site. The reporter consented to follow up with health care profession. For tolerance of 2nd dose, refer case US2023106303, reported by same reporter.; Sender's Comments:  US-GSK-US2023106303:Same reporter, same patient, different dose
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle soreness  only with the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (In february2023, received 1st dose and it broke up in pox, refer case US2023106949).   In JUL-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle soreness (Verbatim: muscle soreness  only with the 2nd dose). The outcome of the muscle soreness was resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     It was unknown if the company considered the muscle soreness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023106949   Additional Information: Receipt date: 07-AUG-2023 The patient self-reported this case. The patient received the 2nd dose of Shingrix vaccine 10 days ago from reporting, last week of July 2023. The reporter reported that he did not have pox reaction and had muscle soreness only with the 2nd dose. Not all information was available, reporter did not provide injection site or lot numbers or expiration dates for neither one of the doses. The reporter did consent to follow up with healthcare professional.; Sender's Comments:  US-GSK-US2023106949:case created 2 doses
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Hot flush, Hyperhidrosis, Pruritus
Clinical narrative: itching; Rapid heartbeat; sweats; very tiredness; hot flashes; This non-serious case was reported by a consumer and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: itching), heartbeats increased (Verbatim: Rapid heartbeat), sweating (Verbatim: sweats), tiredness (Verbatim: very tiredness) and hot flashes (Verbatim: hot flashes). The outcome of the pruritus, heartbeats increased, sweating, tiredness and hot flashes were not reported.   It was unknown if the reporter considered the pruritus, heartbeats increased, sweating, tiredness and hot flashes to be related to Shingrix.     It was unknown if the company considered the pruritus, heartbeats increased, sweating, tiredness and hot flashes to be related to Shingrix.   Additional Information: Receipt date: 06-AUG-2023 The patient reported that he/she had bad effects from the Shingrix shots. Rapid heartbeat, sweats, very tiredness, itching, hot flashes.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Underdose
Clinical narrative: APRN administered the above vaccines to the patient on 8/9/23. Patient left clinic without side effects or reactions. APRN realized later that evening that she had inadvertently given the pediatric 0.5 mL dose of Engerix Hep B rather than 1.0 mL adult dose.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Additional dose of Hepatitis B vaccine given instead of Dtap.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Cellulitis, Fatigue, Injection site erythema, Rash
Clinical narrative: Patient developed rash, redness on injection site. Felt tired  and weak for 2-3 days. Suspected cullilistis , patient went to PCP and was prescribed  with Cephalexin
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient's arm has been hurting since 6/10/23 beyond the usual soreness.  He says it's difficult for him to lift his arm since getting vaccinated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood creatine phosphokinase, Cardiac arrest, Catatonia, Coronary artery disease
Clinical narrative: On January 12, 2022, patient visited primary health provider. Complained of "tingling sensation in different parts of his body, arms, abd that comes and goes."  (This is a quote from the health provider notes in the patient's medical records."  Received 2nd dose of Pfizer/BioNTech shot on the same day.  Lot number EK9231. Site of injection is not recorded in the medical records.  Altogether, patient received a total of five Pfizer shots and one flu shot between 12/22/2020 and 9/16/2022. Here is the info for these additional shots: January 12, 2021; Pfizer/BioNTech; Lot EK9231 September 29, 2021; Pfizer/BioNTech; Lot 3014SB4 April 10, 2022; Pfizer/BioNTech; Lot FP4554 September 16, 2022; Pfizer/BioNTech Bivalent: Lot GH9694
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Paraesthesia, Rhabdomyolysis
Clinical narrative: On January 12, 2022, patient visited primary health provider. Complained of "tingling sensation in different parts of his body, arms, abd that comes and goes."  (This is a quote from the health provider notes in the patient's medical records."  Received 2nd dose of Pfizer/BioNTech shot on the same day.  Lot number EK9231. Site of injection is not recorded in the medical records.  Altogether, patient received a total of five Pfizer shots and one flu shot between 12/22/2020 and 9/16/2022. Here is the info for these additional shots: January 12, 2021; Pfizer/BioNTech; Lot EK9231 September 29, 2021; Pfizer/BioNTech; Lot 3014SB4 April 10, 2022; Pfizer/BioNTech; Lot FP4554 September 16, 2022; Pfizer/BioNTech Bivalent: Lot GH9694