chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium normal, Blood chloride increased, Blood cholesterol increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood triglycerides increased, Blood urea nitrogen/creatinine ratio
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urea normal, Blood urine absent, C-reactive protein normal, Carbon dioxide normal, Chest X-ray abnormal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chromaturia, Computerised tomogram head normal, Cough, Differential white blood cell count, Diplopia
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug screen negative, Eosinophil count normal, Eosinophil percentage increased, Full blood count, Glomerular filtration rate normal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Glucose urine absent, Haematocrit normal, Haemoglobin normal, High density lipoprotein normal, Low density lipoprotein normal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean platelet volume decreased, Monocyte count normal, Monocyte percentage increased, Neutrophil count decreased, Neutrophil percentage decreased
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nitrite urine absent, Nuclear magnetic resonance imaging brain abnormal, Opiates negative, Platelet count normal, Protein total normal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Protein urine absent, Red blood cell count normal, Red blood cell nucleated morphology, Red blood cell sedimentation rate normal, Red blood cells urine negative
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Red cell distribution width normal, Specific gravity urine normal, Ultrasound Doppler, Ultrasound scan normal, Urine amphetamine negative
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine ketone body absent, Urine leukocyte esterase positive, Urobilinogen urine decreased, Very low density lipoprotein normal, Visual field defect
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count decreased, White blood cells urine negative, pH urine normal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersomnia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 7x9 cm erythematous, warm to touch, tender, mildly edematous area on left shoulder where shin grid was injected 48 hours ago (this was written by Minute Clinic on 3/16/2019). Skin is warm and dry. There is erythema. I had chills and slept a lot the day after the shot. On 3/18/2019 I still have rash and arm still sore and now itchy, but I feel better.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Pruritus, Rash
Clinical narrative: 7x9 cm erythematous, warm to touch, tender, mildly edematous area on left shoulder where shin grid was injected 48 hours ago (this was written by Minute Clinic on 3/16/2019). Skin is warm and dry. There is erythema. I had chills and slept a lot the day after the shot. On 3/18/2019 I still have rash and arm still sore and now itchy, but I feel better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red, raised rash at the site of injection traveling down arm. Size about 5 inches in length, and 3 inches in width.
Age: 72.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Ophthalmic herpes zoster, Rash
Clinical narrative: Patient called the pharmacy today to report that three days after she had gotten the SHINGRIX shot, she began to break out on her face, eyes and around her trunk.
Age: 72.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Blood test, Headache, Herpes zoster, Injection site swelling, Ophthalmic herpes zoster
Clinical narrative: Patient called the pharmacy today to report that three days after she had gotten the SHINGRIX shot, she began to break out on her face, eyes and around her trunk.
Age: 72.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Ophthalmological examination, Pain, Peripheral swelling, Visual impairment
Clinical narrative: Patient called the pharmacy today to report that three days after she had gotten the SHINGRIX shot, she began to break out on her face, eyes and around her trunk.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Hot flush, Nausea, Respiratory tract congestion, Vomiting
Clinical narrative: Received SHINGRIX vaccine 03/14/19. Pt experienced nausea, vomiting, diarrhea, hot flashes and congestion to the heart around 10 or 11 pm that night. As up to today (03/18/19) pt still has diarrhea.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: TD was expired in Jan 2019. I didn't realize this when it was given. Expired vaccine was in the Refrigerator.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Flu injection was given in my left arm. Since the injection on my arm is still hurting deep in area. I am have difficulty raising my arm and using my left arm. Also pain in the arm with decreased range of motion. Came over in Feb 2019. Staff member was unable to find the form. Informed me to come back.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Pt felt dizzy after the administration of the injection; He was placed in Trendelenburg position, given po water, VS remained stable and recovered completely after a few minutes. Dizziness.
Age: 0.5
Sex: F
Vaccine: PPV, RV5
Symptoms: Band neutrophil count decreased, Culture throat negative, Erythema, Full blood count, Haemoglobin
Clinical narrative: 7-31-18 -Started with a blotchy rash from head to toe, gave BENADRYL, by 8-1-18 at 7:57am rash was better, still a little blotchy. Rash completely resolved by 8/4/18. Rash: Erythema on arms and legs; splotchy on face, neck, trunk.
Age: 0.5
Sex: F
Vaccine: PPV, RV5
Symptoms: Rash generalised, Rash macular, White blood cell count
Clinical narrative: 7-31-18 -Started with a blotchy rash from head to toe, gave BENADRYL, by 8-1-18 at 7:57am rash was better, still a little blotchy. Rash completely resolved by 8/4/18. Rash: Erythema on arms and legs; splotchy on face, neck, trunk.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Headache, Nausea, Tinnitus
Clinical narrative: The night of administration she complained of severe headaches and ringing in the ears and a burning sensation in the head. She is still at the same level but also now lightheaded and nauseated.
Age: 1.33
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Faint erythematous rash. Near the site of injection. No signs of RDS. Normal vital signs. Did improve without intervention.
Age: 74.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Continuous sore arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia, Skin warm, Vaccination complication
Clinical narrative: Infection. 102.5 Fever, shivering, red swelling around left arm and warm to touch. Treatment: Levofloxacin 500 mg x 10 Days. To Whom It May Concern: I am submitting another VAERS Adverse Reaction Form. My current ID you have on file is ID: 767067. The above case number was on file for my first injection of the Zoster SHINGRIX Vaccination. At that time, it was suggested that I received the Infection due to the Technician not cleaning the Injection Site enough causing a skin infection. Unfortunately, now after having the second dose of the Zoster SHINGRIX Vaccine by a different Technician and different Pharmacy I contracted another Infection of the opposite arm. It is now believed that I have had an adverse reaction to the Vaccine itself. Evidently, there is another ingredient that is not in the original Zoster Vac that must be present in this vaccine. I wish I had listed to my gut instinct and not gone back for the second dose. I have had Shingles 3 times in the last 10 years.
Age: 0.08
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Bradycardia, Continuous positive airway pressure, Cyanosis, Mechanical ventilation
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 8 week old patient of unknown gender. The patient had premature birth. The patient's medical history, previously drug reactions and allergies were not provided. Concomitant therapies included gentamicin, budesonide, multivitamins, penicillin and vancomycin. On 17-FEB-2019, the patient was vaccinated with first dose of LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). Other suspect therapies which were given on the same day included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown, intramuscularly and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apneaic reactions and breathing issues as it relates to sleep apnea. On 18-FEB-2019, the patient experienced bradycardia, desaturation (Oxygen saturation was less than 10%) and no response to stimuli. On an unknown date in 2019, the patient was hospitalized. The patient's heart rate was in 40s (units not provided). The patient was placed on nasal intermittent positive pressure ventilation (NIPPV). Prescription drug treatment was required for the events. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the event bradycardia, desaturation and no response to stimuli was determined to be medically significant. The patient's sister also experienced adverse event which was captured in 1902USA009132. This is one among the two case reported by the reporter. Sender's Comments: US-009507513-1902USA009132.
Age: 0.08
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 8 week old patient of unknown gender. The patient had premature birth. The patient's medical history, previously drug reactions and allergies were not provided. Concomitant therapies included gentamicin, budesonide, multivitamins, penicillin and vancomycin. On 17-FEB-2019, the patient was vaccinated with first dose of LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). Other suspect therapies which were given on the same day included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown, intramuscularly and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apneaic reactions and breathing issues as it relates to sleep apnea. On 18-FEB-2019, the patient experienced bradycardia, desaturation (Oxygen saturation was less than 10%) and no response to stimuli. On an unknown date in 2019, the patient was hospitalized. The patient's heart rate was in 40s (units not provided). The patient was placed on nasal intermittent positive pressure ventilation (NIPPV). Prescription drug treatment was required for the events. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the event bradycardia, desaturation and no response to stimuli was determined to be medically significant. The patient's sister also experienced adverse event which was captured in 1902USA009132. This is one among the two case reported by the reporter. Sender's Comments: US-009507513-1902USA009132.
Age: 0.08
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Bradycardia, Dyspnoea, Intermittent positive pressure breathing, Oxygen saturation decreased, Sleep apnoea syndrome
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 8 week old patient of unknown gender. The patient had premature birth. The patient's medical history, previously drug reactions and allergies were not provided. Concomitant therapies included gentamicin, budesonide, multivitamins, penicillin and vancomycin. On 17-FEB-2019, the patient was vaccinated with first dose of LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). Other suspect therapies which were given on the same day included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown, intramuscularly and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apneaic reactions and breathing issues as it relates to sleep apnea. On 18-FEB-2019, the patient experienced bradycardia, desaturation (Oxygen saturation was less than 10%) and no response to stimuli. On an unknown date in 2019, the patient was hospitalized. The patient's heart rate was in 40s (units not provided). The patient was placed on nasal intermittent positive pressure ventilation (NIPPV). Prescription drug treatment was required for the events. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the event bradycardia, desaturation and no response to stimuli was determined to be medically significant. The patient's sister also experienced adverse event which was captured in 1902USA009132. This is one among the two case reported by the reporter. Sender's Comments: US-009507513-1902USA009132.
Age: 0.08
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 8 week old patient of unknown gender. The patient had premature birth. The patient's medical history, previously drug reactions and allergies were not provided. Concomitant therapies included gentamicin, budesonide, multivitamins, penicillin and vancomycin. On 17-FEB-2019, the patient was vaccinated with first dose of LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). Other suspect therapies which were given on the same day included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown, intramuscularly and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apneaic reactions and breathing issues as it relates to sleep apnea. On 18-FEB-2019, the patient experienced bradycardia, desaturation (Oxygen saturation was less than 10%) and no response to stimuli. On an unknown date in 2019, the patient was hospitalized. The patient's heart rate was in 40s (units not provided). The patient was placed on nasal intermittent positive pressure ventilation (NIPPV). Prescription drug treatment was required for the events. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the event bradycardia, desaturation and no response to stimuli was determined to be medically significant. The patient's sister also experienced adverse event which was captured in 1902USA009132. This is one among the two case reported by the reporter. Sender's Comments: US-009507513-1902USA009132.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Blood pH decreased, Blood potassium increased, Calcium ionised, Chest X-ray abnormal
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Continuous positive airway pressure, Endotracheal intubation, Haematocrit decreased, Haemoglobin decreased, Mechanical ventilation
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased, PCO2 increased, PO2 decreased, Packed red blood cell transfusion, Pulmonary haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Transfusion
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Acute respiratory failure, Bradycardia, Continuous positive airway pressure, Cyanosis, Infantile apnoea
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Neonatal hypoxia, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Dyspnoea, Heart rate decreased, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Pallor, Sleep apnoea syndrome
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a two patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided. On unknown date, the patients were vaccinated with LIQUID PEDVAXHIB 0.5 ml, intramuscularly (lot #R013570, expiration date: 18-MAR-2021) for prophylaxis (anatomical location was not reported). On unknown date, both patients experienced sleep apneic reactions and breathing issues as it relates to sleep apnea (sleep apnoea syndrome). The outcome of the events sleep apnoea syndrome was unknown. The causal relationship between the events and LIQUID PEDVAXHIB therapy was not reported. This case is non-valid due to lack of patient identifier. Upon receiving the follow up information from the pharmacist, the case has become valid due to patient identifier. The pharmacist referred to 8 weeks old female patient. The patient had premature birth (birth weight 1.232kg). The patient's concomitant therapies included budesonide, cefepime, multivitamins, vancomycin, fentanyl and dopamine. On 18-FEB-2019, the patient was given first dose of LIQUID PEDVAXHIB. Other suspect therapies included second dose of PEDIARIX lot/batch# 47495, expiration date: unknown and first dose of pneumococcal 13v conj vaccine (CRM197) (lot# W81747, expiration date: unknown) (strength, dose, frequency, anatomical location were not reported) intramuscularly for prophylaxis. On unknown date in February 2019, the patient experienced sleep apnea. On 18-FEB-2018, the patient became apneic and had changes in vital signs. Her heart rate was 70 (units not reported) and oxygen saturation was 40 to 60%. She was having agonal breathing and was pale colouring of face. Her heart rate and oxygen saturation decreased. The patient was transferred to the hospital on an unknown date in 2019 and got admitted. The patient was placed on ventilator. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, the events apnea, decreased heart rate, decreased oxygen saturation and agonal breathing were determined to be medically significant. Patient's sibling also experienced adverse events with LIQUID PEDVAXHIB which was captured in 1903USA004747.; Sender's Comments: US-009507513-1903USA004747:
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 17-year-old male patient received the second dose of TRUMENBA, (lot number: W95359), intramuscular on 20Feb2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had received one dose of TRUMENBA previously for immunization. Approximately 2-3 hours after receiving second dose of TRUMENBA, the patient came in and was complaining of tachycardia and chest tightness when he would take a deep breath, as well as soreness on his left arm at the injection site. The reporter clarified that the dose of TRUMENBA was administered on 20Feb2019 and later that day was when the adverse events started. The outcome of the events was unknown.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chest discomfort, Injection site pain, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 17-year-old male patient received the second dose of TRUMENBA, (lot number: W95359), intramuscular on 20Feb2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had received one dose of TRUMENBA previously for immunization. Approximately 2-3 hours after receiving second dose of TRUMENBA, the patient came in and was complaining of tachycardia and chest tightness when he would take a deep breath, as well as soreness on his left arm at the injection site. The reporter clarified that the dose of TRUMENBA was administered on 20Feb2019 and later that day was when the adverse events started. The outcome of the events was unknown.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Significant pain at injection site for three days. Intense aches and pain in left side of body, mostly in left leg. It was so bad on the day following the injection that it was difficult to walk or lift my left leg. It lasted until the second day following the injection.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Electrocardiogram normal, Fatigue, Muscular weakness, Neck pain
Clinical narrative: Fatigue, vertigo, night sweats, severe pain at 10/10 from C-7, T-1, radiating down L arm and to 4-3rd fingertips. After two rounds of steroids pain is still disabling as is provoked with chin tilt. Have fine motor weakness L hand.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Pain in extremity, Vertigo
Clinical narrative: Fatigue, vertigo, night sweats, severe pain at 10/10 from C-7, T-1, radiating down L arm and to 4-3rd fingertips. After two rounds of steroids pain is still disabling as is provoked with chin tilt. Have fine motor weakness L hand.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Body temperature increased, Decreased appetite, Fatigue, Irritability, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given 1 year shots at 9 month check up. She developed a low grade temp, fussy and tired, not eating as much as usual. She had no local reaction from where vaccines were given. Provider discussed at length with mother of patient that these vaccines were given early and that this should not cause any long term problems.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Wrong product administered
Clinical narrative: Information has been received from 64 years old female medical assistant referring to herself. Concurrent conditions included diabetes and having trouble hearing. In 2017 (reported as last year), the patient had taken a bad fall and was in rehab. She had never received that vaccine previously. On an unknown date in August 2017 while in rehab, the patient started vaccinated with PNEUMOVAX 23 (dose, frequency, route and strength were not reported) for prophylaxis. She was told at that time that she was supposed to receive PREVNAR 13 a year from there and 5 years later another pneumonia vaccine 23. She was reporting that on an unknown date in February 2019 (reported as last week) she went into her family doctor to get flu shot and the pneumonia shot. They gave her another PNEUMOVAX 23 and she should have received a PREVNAR 13.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Information has been received for an 80 years old male patent referring to himself. The patient's concurrent condition included high blood pressure. The patient's historical condition included appendix removed on 20-NOV-2018. The patient had no drug reactions or allergies. The patient's concomitant medication included many unspecified medications. On unspecified date in 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23 valent) (manufacturer unknown (reported as PNEMOVAX)) (dose, strength, route, lot# and expiration date unknown) for prophylaxis. On 01-MAR-2019, the patient received a "booster" of PNEUMOVAX 23 (dose, lot# and expiration date were unknown) intramuscularly for prophylaxis same day the patient experienced injection site pain and swelling. The next day the patient experienced more swelling accompanied by joint pain from shoulders to hands. 11 days later the patient was still experiencing joint pain in his wrist. All the events caused hospitalization. No treatment was given to the patient. No lab diagnostics or studies was performed recently. The outcome of the events were not recovered. The causality between the events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Veterinarian referring to his granddaughter a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The veterinarian reported that his granddaughter received the first dose of ROTATEQ (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) in December 2018, and the second dose of ROTATEQ (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) on 09-MAR-2019. No adverse effect were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-MAR-2019, the adult patient was vaccinated with a pediatric/adolescent dose of RECOMBIVAX HB injection 5mcg/0.5 ml, intramuscularly, lot # reported as 97Y27, expiry date 05-FEB-2021, (dose not reported) for prophylaxis. The patient experienced no adverse effects. Lot number 97Y27 is an invalid lot number for RECOMBIVAX HB.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In July 2014, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a physician. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2017, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-FEB-2015, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In June 2014, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.