chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist called to report a patient received their first dose of GARDASIL 9 in August 2023 (specific date unknown) and has not received their second dose until today July 31, 2024. No symptoms reported. No further information provided. No Additiona; No Additional AE; This spontaneous report was received from a pharmacist and refers to a 15-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in August 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Then, on 31-JUL-2024, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No symptoms reported (no adverse event).   No further information provided.  Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: low-grade fever; redness and soreness at the injection sight; redness and soreness at the injection sight; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0151, Expiration Date: Jul2021) at the age of 62 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression", start date: 01Sep1970 (ongoing), notes: Still taking medication; "Anxiety", start date: Jul2020 (ongoing), notes: Still taking medication; "Allergies" (unspecified if ongoing), notes: I have many allergies; "Allergic to Hornet Family and Ticks" (unspecified if ongoing), notes: Highly allergic; "left arm, elbow and hand have had extensive surgery" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Cortisone, reaction(s): "Drug allergies"; Prednisone, reaction(s): "Drug allergies". Vaccination history included: BNT162b2 (Dose 1: intramuscular upper left arm, Received: 19Mar2021, Lot- EN6204 exp. Jun2021), administration date: 19Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "heat feeling", "weakness", "feel the soreness settle in the surgery areas", "fever-low grade", "extreme soreness and hurting in area"; Tetanus vaccine, administration date: 2017, when the patient was 59 years old, for Immunization, reaction(s): "Reaction", "Drug allergies"; Flu vaccine, for Immunization, reaction(s): "weakness", "soreness", "heat feeling". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "low-grade fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "redness and soreness at the injection sight".  Additional information: the patient reported that she did not repeat the mistake of the first dose. The patient received the second shot in her upper right arm. This time, the patient only experienced low-grade fever, redness and soreness at the injection site. The events lasted approximately 48 hours. The patient state there was "no problem out of the ordinary."
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: low-grade fever; redness and soreness at the injection site; redness and soreness at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FJ8757, Expiration Date: Nov2022) at the age of 63 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "My left arm, elbow and hand have had extensive surgery" (unspecified if ongoing); "Highly allergic to hornet family & ticks" (unspecified if ongoing); "Depression", start date: 09Jan1970 (ongoing), notes: still taking medication for these 2 problems/illness; "Anxiety", start date: Jul2020 (ongoing), notes: still taking medication for these 2 problems/illness. The patient's concomitant medications were not reported. Past drug history included: Tetanus, start date: 2017, stop date: 2017, reaction(s): "Drug allergies: Tetanus"; Cortisone, reaction(s): "Drug allergies: Cortisone"; Prednisone, reaction(s): "Drug allergies: Prednisone". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Pfizer Bio-N-Tech lot: EN6204 expiry: Jun2021 via intramuscular in the left upper arm), administration date: 19Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "heat feeling", "weakness", "feel the soreness settle in the surgery areas"; BNT162b2 (DOSE 1, SINGLE; Pfizer Bio-N-Tech lot: EN6204 expiry: Jun2021 via intramuscular in the left upper arm), administration date: 19Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "fever-low grade"; BNT162b2 (Dose 2, Single via intramuscular in the upper right arm, lot: EW0151, expiry date: Jul2021), administration date: 16Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "redness and soreness at the injection sight", "low-grade fever"; BNT162b2 (Dose 2, Single via intramuscular in the upper right arm, lot: EW0151, expiry date: Jul2021), administration date: 16Apr2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "redness and soreness at the injection sight". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "low-grade fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "redness and soreness at the injection site". The events lasted less than 48 hours.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Paraesthesia, Stomatitis
Clinical narrative: First local redness, warm and sore injection site normal for me with previous shots. Have had at least 5 prior COVID  vaccines. After 3 days my mouth and tongue had sores everywhere and tongue was extremely swollen to the point it was between upper and lower teeth. It tingled  as well. It seemed to resolve after 3 to 4 days. No shortness of breath or other symptoms. But the sores have continued to break out every week tongue and mucus membranes of mouth, some swelling and tingle feeling. Lasts 2 to 3 days goes away then returns. This is still happening now almost 2 months since vaccine administered. Very uncomfortable. It's like the virus has settled in my mouth and flares up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: First local redness, warm and sore injection site normal for me with previous shots. Have had at least 5 prior COVID  vaccines. After 3 days my mouth and tongue had sores everywhere and tongue was extremely swollen to the point it was between upper and lower teeth. It tingled  as well. It seemed to resolve after 3 to 4 days. No shortness of breath or other symptoms. But the sores have continued to break out every week tongue and mucus membranes of mouth, some swelling and tingle feeling. Lasts 2 to 3 days goes away then returns. This is still happening now almost 2 months since vaccine administered. Very uncomfortable. It's like the virus has settled in my mouth and flares up.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears, tinnitus.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Patient vomitted 10 minutes after receiving the vaccine. He sat, rested and drank a little water then go home with his parent.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Injection site discolouration, Injection site reaction, Malignant melanoma stage II, Neoplasm skin
Clinical narrative: IT STARTED WITH BROWN SPOT IN THE PLACE OF THE INJECTION THE SAME MONTH OF THE VACCINATION (JAN 2022); BEGINNING OF 2024 MY FATHER NOTICED THE SPOT BECAME DARKER (SMALL SPOT OF LESS 1/4 INCH); BY JUNE 2024 THERE WAS BLACK GROWTH ON THE SKIN; IN JULY THE BIOPSY WAS TAKEN FROM THAT SPOT AND MY FATHER WAS DIAGNOSED WITH MELANOMA CANCER OF STAGE II.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy liver, Blood test, Cerebrovascular accident, Cholangiocarcinoma, Metastatic malignant melanoma
Clinical narrative: IT STARTED WITH BROWN SPOT IN THE PLACE OF THE INJECTION THE SAME MONTH OF THE VACCINATION (JAN 2022); BEGINNING OF 2024 MY FATHER NOTICED THE SPOT BECAME DARKER (SMALL SPOT OF LESS 1/4 INCH); BY JUNE 2024 THERE WAS BLACK GROWTH ON THE SKIN; IN JULY THE BIOPSY WAS TAKEN FROM THAT SPOT AND MY FATHER WAS DIAGNOSED WITH MELANOMA CANCER OF STAGE II.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin test
Clinical narrative: IT STARTED WITH BROWN SPOT IN THE PLACE OF THE INJECTION THE SAME MONTH OF THE VACCINATION (JAN 2022); BEGINNING OF 2024 MY FATHER NOTICED THE SPOT BECAME DARKER (SMALL SPOT OF LESS 1/4 INCH); BY JUNE 2024 THERE WAS BLACK GROWTH ON THE SKIN; IN JULY THE BIOPSY WAS TAKEN FROM THAT SPOT AND MY FATHER WAS DIAGNOSED WITH MELANOMA CANCER OF STAGE II.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic, Skin warm
Clinical narrative: 2 hours after shot, red, large itchy rash formed, hot to touch.  Went to PCP 7/30 and received RX for Cephalexin
Age: 17.0
Sex: M
Vaccine: HPV9, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: THE PATIENT WAS ADMINISTERED AN EXPIRED MMR VACCINE WITH EXPIRATION DATE 6/202024.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Patient fainted when walking back to the waiting room. Slowly fell to ground with each step losing consciousness for very brief moment. She came to as quickly as I reached her and spoke to her. Drink and snack provided while patient sat on floor until she recovered enough to comfortably stand by herself.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Expired product administered
Clinical narrative: THE PATIENT WAS ADMINISTERED AN EXPIRED MMR VACCINE. EXPIRATION DATE: 6/202024.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: only the diluent was administered, it was not reconstituted
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Gait disturbance, Rash, Skin exfoliation
Clinical narrative: She developed a skin rash all over her body where her skin was peeling off. She said she could hardly walk. It is finally getting better, but she says she really suffered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Localised infection, Peripheral swelling
Clinical narrative: Arm was swollen and red, presented signs of infection. Pt went to the dr and received cephalexin.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Cardiac arrest and died 4 days later
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: 12 year old male patient was here for vaccination. Pt received Hep A IM, HPV IM, IPV IM, MCV-4, Tdap IM and Varicella. At 10:05 am during observation, patient felt nauseous and vomited. At 10:10 AM BP 127/74 HR 96 O2 98% TEMP 97.5. At 10:15 AM BP 107/71 HR 97 O2 99%. At 10:25 AM BP 108/76 HR 89 O2 98%. Provider was contacted at 10:26 am. The patient was not complaining of any other symptoms. Patient was alert and oriented times four. Patient's mom refused ambulance transport for her child. Patient was advised to stay with us for 15 more minutes for observation. After 15 minutes, the patient stated that he felt fine and had no other symptoms. BP 102/78 HR 85 O2 99% patient was stable
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Blood glucose normal, Dizziness, Unresponsive to stimuli
Clinical narrative: Patient reports feeling dizzy. Lowered himself to the ground. Then found by co-worker laying on the ground in aircraft hanger with eyes closed; patient did not respond to name, patient did respond to touch. Assessment after event: no injury to head. Patient transported to ED via supervisor
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: received flu vaccine in right deltoid on 8/2/24- woke up with his right deltoid swollen and red, lethargy and metallic taste.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site paraesthesia, Loss of personal independence in daily activities
Clinical narrative: I'm experiencing extreme constant pain, weakness, numbness, limited motion and restricted use of my right arm, tingling from my shoulder into all 5 fingers to the tips, and arm  soreness. It affects my daily limitations of use washing hair, picking up things and stiffness ect..
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I'm experiencing extreme constant pain, weakness, numbness, limited motion and restricted use of my right arm, tingling from my shoulder into all 5 fingers to the tips, and arm  soreness. It affects my daily limitations of use washing hair, picking up things and stiffness ect..
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cardiac imaging procedure, Chronic kidney disease, Echocardiogram, Electrocardiogram
Clinical narrative: 01/12/2022 Major vertigo event lasting several hours ? this initiated several months of severe health problems rendering me non-functioning.  05/03/22 Kidney Disease, Stage 3b, (44-30% kidney function), No cause was provided until I saw a new Nephrologist on 05/20/24!
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Renal function test, Renal impairment, Vertigo, Visual impairment
Clinical narrative: 01/12/2022 Major vertigo event lasting several hours ? this initiated several months of severe health problems rendering me non-functioning.  05/03/22 Kidney Disease, Stage 3b, (44-30% kidney function), No cause was provided until I saw a new Nephrologist on 05/20/24!
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site warmth, Paraesthesia, Urticaria
Clinical narrative: reported hives on face and tingling/numbness of fingers/toes after second dose. She also reported warmness of the arm at site of injection. Patient took Benadryl to treat side effects. Pharmacist told patient to go to urgent care or emergency room if side effects are moderate or severe. Told patient to have someone take her to and from the doctor office. Called patient's PCP on 8/2/24; pharmacist informed office of patient's reaction to shingles vaccine. Pharmacist also called patient on 8/2/24 to follow up. Patient states she still had reaction but not getting worse. She was still taking generic Benadryl.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My right ring finger went numb.  This lasted about 90 minutes and improved when heat was applied.  This happened once before as well after a COVID vaccine.
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 22.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Cyanosis, Generalised tonic-clonic seizure, Pyrexia, Respiratory arrest, Seizure
Clinical narrative: Fever of 102. Grand Mal seizures 8 days after vaccines. Doctor said ALL children will get a fever from MMR about a week later. But my child stopped breathing, lips turned blue, had to havr oxygen and be brought to the hospital by ambulance.
Age: 50.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Rash
Clinical narrative: Rash on left outer thigh (injection site)
Age: 60.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Injection site rash
Clinical narrative: 7/31 (date of immunization): small injection site rash --- 8/3: reported rash has gotten bigger (described as 3in x 5in) --- 8/4: reported no improvement
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Addison's disease, Arthritis, Asthma, Dyspnoea, Hypertension
Clinical narrative: Began to get sick within 7 days and have never recovered in fact all systems of my body have been affected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pneumonia
Clinical narrative: Began to get sick within 7 days and have never recovered in fact all systems of my body have been affected
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive flu vaccine, but instead received Boostrix. Patient did have a reaction thus far, was just given incorrect vaccine and incorrect vaccine for patient age. Pediatrician on call was notified and said pt should be fine, just will not need any additional Tdap/Dtap vaccines.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash
Clinical narrative: Shingles rash and eruptions on V1 distribution and frontal headache
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, X-ray normal
Clinical narrative: patient says arm has been very sore since the vaccine was given over a month ago.  worse at night and seems to be getting worse not better
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness
Clinical narrative: Patient called the morning of 8/4/24 to report that she experienced dizziness following a vaccine administered at 11:05AM on 8/3/24. The patient was at an outdoor festival around 6:00PM when the symptoms began. She did not seek medical care. She still reported being dizzy and having chills today.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Oropharyngeal pain
Clinical narrative: Itchy rash on arm,  pain (day 3) at injection site, nausea, vomiting, diarrhea, HEADACHE, mild runny nose, mild sore throat, chills (on day 2).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Rhinorrhoea, Vomiting
Clinical narrative: Itchy rash on arm,  pain (day 3) at injection site, nausea, vomiting, diarrhea, HEADACHE, mild runny nose, mild sore throat, chills (on day 2).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Blood creatinine, Blood thyroid stimulating hormone, Differential white blood cell count, Electrophoresis protein
Clinical narrative: Peripheral neuropathy which has worsened per the patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Neuropathy peripheral, Vitamin B12, Vitamin D
Clinical narrative: Peripheral neuropathy which has worsened per the patient
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Patient stated swelling and redness. Also tender and painful at spot of immunization
Age: 58.0
Sex: M
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Patient stated swelling and redness in right arm. Also tender and painful at spot of immunization
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, UNK
Symptoms: Memory impairment
Clinical narrative: Patient is experiencing memory issues since having the last vaccine.  Started appearing in approximately March where I was having issues recalling name's of people ,pla.ces and dates
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Graves' disease, Injection site pain, Injection site swelling, Sleep disorder, Vitiligo
Clinical narrative: I received a flu shot at the same time in the same arm. That night and for a couple days after, my upper arm was incredibly swollen and tender. I couldn?t even sleep on that side. Two months later, I noticed that a part of my skin on my right hand looked lighter. I also started having symptoms of hyperthyroidism. I went to see my endocrinologist and he diagnosed me with vitiligo and Graves? disease.
Age: 70.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Deafness unilateral, Vertigo
Clinical narrative: Patient stated that she has been experiencing vertigo and hearing lost in her left ear beginning three days after  receiving the immunizations..
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Intensive care, Intestinal operation, Intussusception, Laparotomy, Wound closure
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Abdominal X-ray, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bicarbonate increased, Blood lactic acid
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Blood pH decreased, C-reactive protein increased, Endotracheal intubation, Enteral nutrition, Gastrointestinal tube insertion
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Infant irritability, Intensive care, Intestinal operation, Intussusception, Laparotomy
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Lethargy, Oedema, Pallor, Platelet count increased, Poor feeding infant
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Procalcitonin, Respiratory pathogen panel, Shock, Small intestinal obstruction, Vomiting
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: White blood cell count decreased, Wound closure, X-ray abnormal
Clinical narrative: Patient words: 13-week-old male presenting with mom for transition into care after hospitalization for intussusception and shock requiring exploratory laparotomy and subsequent PICU stay with endotracheal intubation and wound VAC. 2 days after 7.5 wk well visit, developed fussiness and decreased feeding, although was consolable and able to feed enough to maintain hydration, without stool changes.  Parents brought him to local ER on 7/6 when he suddenly became pale and lethargic, and was transferred to another ER. At ER he had a negative respiratory pathogen panel, PIV was started, and initial labs were remarkable for AST 139, ALT 198, CRP 159, procalcitonin >100, pH 7/26, bicarb 38, lactate 3.9, plt 663, WBC 4.77. Abdominal XR showed small bowel obstruction. The decision was made to transfer, and ETT was placed. He was given Unasyn and INVnz, and was transferred by air to a third hospital.   At hospital, he developed emesis, and had ex lap with reduction of intussusception. Due to edema and critical status, wound vac was placed, and patient was stabilized in PICU. He subsequently had secondary wound closure in OR, with no ultimate need for bowel resection. He was discharged on 7/20 with NG-tube for feeds as needed while working back toward full oral feeds.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cognitive disorder, Disturbance in attention, Drug ineffective
Clinical narrative: Psoriasis; This is a spontaneous report received from a Physician.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 53 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Hashimoto's/Hashimoto's thyroiditis" (ongoing); "Rheumatoid arthritis" (ongoing); "depression anxiety", start date: 1965 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); ROPINIROLE oral taken for depression (ongoing); METHIMAZOLE oral taken for autoimmune thyroiditis (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). Vaccination history included: moderna (Dose: 1, Arm, Intramuscular, Batch/Lot number: 011J20A), administration date: 23Dec2020, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Arm, Intramuscular, Batch/Lot number: EW0177), administration date: 04Aug2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 2022, outcome "not recovered".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400099201 Same reporter/patient/vaccine; different dose/event;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Memory impairment, Post-acute COVID-19 syndrome, Reading disorder
Clinical narrative: Psoriasis; This is a spontaneous report received from a Physician.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 53 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Hashimoto's/Hashimoto's thyroiditis" (ongoing); "Rheumatoid arthritis" (ongoing); "depression anxiety", start date: 1965 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); ROPINIROLE oral taken for depression (ongoing); METHIMAZOLE oral taken for autoimmune thyroiditis (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). Vaccination history included: moderna (Dose: 1, Arm, Intramuscular, Batch/Lot number: 011J20A), administration date: 23Dec2020, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Arm, Intramuscular, Batch/Lot number: EW0177), administration date: 04Aug2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 2022, outcome "not recovered".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400099201 Same reporter/patient/vaccine; different dose/event;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis; This is a spontaneous report received from a Physician.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 53 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Hashimoto's/Hashimoto's thyroiditis" (ongoing); "Rheumatoid arthritis" (ongoing); "depression anxiety", start date: 1965 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); ROPINIROLE oral taken for depression (ongoing); METHIMAZOLE oral taken for autoimmune thyroiditis (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). Vaccination history included: moderna (Dose: 1, Arm, Intramuscular, Batch/Lot number: 011J20A), administration date: 23Dec2020, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Arm, Intramuscular, Batch/Lot number: EW0177), administration date: 04Aug2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 2022, outcome "not recovered".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400099201 Same reporter/patient/vaccine; different dose/event;
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported.  Consent to correspond provided.   No additional AE/No PQC.; HCP called to report a patient was inadvertently administered PROQUAD and VARIVAX.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-JUL-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X020150, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 01-AUG-2025, administered for prophylaxis (strength, dose, and route of administration were not provided); and with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (accidental overdose). No symptoms and no additional adverse event reported (no adverse event).  Lot # is being requested and will be submitted if received.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: swelling at injection site; Warm erythematous skin; erythematous skin; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2024, the patient received Shingrix. On 21-JUL-2024, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at injection site), skin warm (Verbatim: Warm erythematous skin) and skin red (Verbatim: erythematous skin). The outcome of the injection site swelling, skin warm and skin red were not resolved.   It was unknown if the reporter considered the injection site swelling, skin warm and skin red to be related to Shingrix.     It was unknown if the company considered the injection site swelling, skin warm and skin red to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2024 This case was reported by patient itself. The patient experienced warm erythematous skin with swelling at injection site. The reporter reported symptoms was treated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she did not get 2nd dose yet and it has been 7 months now; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 16-DEC-2023).   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: she did not get 2nd dose yet and it has been 7 months now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-JUL-2024 The reported was the husband of the patient. He stated that his wife received 1st dose of Shingrix. The reporter asked if she needs to start the series over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to the follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; I had the injections my face broke out; I have four injections of the shingrix; I have four injections of the shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingrix, the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, Shingrix, Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: I had the injections my face broke out), extra dose administered (Verbatim: I have four injections of the shingrix) and extra dose administered (Verbatim: I have four injections of the shingrix). The outcome of the vaccination failure, facial herpes zoster, extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix, Shingrix, Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix, Shingrix, Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix, Shingrix, Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2024 This case was reported by patient itself. The patient had four injections of the Shingrix not at all one time but after Shingrix injections the patient's face broke out. The patient received third and fourth doses which led to extra dose administration. The patient thinks administration of Shingrix as February and March. The consumer disconnected chat prior to any additional adverse event details could be received. This case was considered as suspected vaccination failure as details regarding 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 is considered related to GSK vaccine Shingrix (4 doses).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she had shills, all the symptoms of covid and also has no appetite; she had shills, all the symptoms of covid and also has no appetite; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had shills, all the symptoms of covid and also has no appetite". Clinical course: Caller stated that her mother had all the vaccinations and the booster shots and she had shills, all the symptoms of covid and also has no appetite. Caller was calling on behalf of her mother and she refused to provide her last name.  Batch/lot number is not provided, and it cannot be obtained.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: HIB portion of the PENTACEL was mixed with sterile water, not the DTaP-IPV solution with no reported adverse event; Initial information received on 26-Jul-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 4-month-old male patient and reporter reported hib portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was mixed with sterile water, not the dtap-ipv solution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 08-Jun-2024, the patient received a 0.5 ml total (dose 1) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (strength, lot number, expiry date: unknown) not reported via intramuscular route in unknown administration site as immunization and hib portion of the pentacel was mixed with sterile water, not the dtap-ipv solution with no reported adverse event (product preparation error) (latency: same day).  Information regarding batch number and expiration date corresponding to the one at time of event was requested  Reportedly, PENTACEL vaccine was administered after improper reconstitution.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.