chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Eosinophil count normal, Eosinophil percentage, Glomerular filtration rate decreased, Glucose urine absent, Glycosylated haemoglobin normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Granulocyte count, Granulocyte percentage, Haematocrit decreased, Haemoglobin decreased, High density lipoprotein decreased
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Low density lipoprotein normal, Lymphocyte count decreased, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Nitrite urine absent
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Platelet count decreased, Prostatic specific antigen normal, Protein total normal, Protein urine absent, Red blood cell count decreased
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Red cell distribution width normal, Specific gravity urine normal, Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Urobilinogen urine decreased, Wheezing, White blood cell count normal, pH urine normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 3-13-17 0850: 21 yr old, patient presented to the clinic for TD booster. She received a TDaP vaccine in 2006. TD vaccine not available at the time. BOOSTRIX is to be given in place of TD vaccine during shortage. 855: BOOSTRIX vaccine administered into left deltoid muscle. 900: Pt stated, "Is this supposed to be itching like this where you give me that shot?" Lifted patient's sleeve and found 3 in x 4 in erythema area, warm to touch. Pt alert and oriented. No respiratory distress noted no other complaints. 901: Notified nurse. Administered BENADRYL 25 mg PO per protocol at 0905 am. 905: Vitals 104/73, 109, 16, 94%/. Pt sitting up in chair alert and oriented. 915: Pt alert and oriented. Remains sitting up in chair. Denies itching. Erythema area non measuring 2 in x 3 in. No respiratory distress noted. RR 16. 930: Vitals 109/62, 90, 16, 96%. No physical distress noted. Pt states, "It's not itching anymore and not near as red. 3-13-17 0935: Ambulated out of clinic with no physical distress noted. Pt stated, "I will call you as soon as I get home." 955: Received phone call from patient stating, "I've made it home and I feel fine. It's not even red anymore. Thank you for everything!" 1200: Notified staff. 1210: Notified staff. 12:15: Notified nurse.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Headache, Influenza B virus test positive, Pyrexia
Clinical narrative: Patient started with a fever and headache on 3-9-17. Patient tested positive for flu B on 3/10/17.
Age: 29.0
Sex: M
Vaccine: FLUX, TYP, FLUX, TYP
Symptoms: Back injury, Fall, Fatigue, Muscular weakness, Paraesthesia
Clinical narrative: Developed fatigue, UE and LE weakness, paresthesias of arms "about a month after late 2008 or early 2009 immunizations for deployment. Evaluation shows symptoms caused by back trauma from a fall, TMJ disorder.
Age: 29.0
Sex: M
Vaccine: FLUX, TYP, FLUX, TYP
Symptoms: Temporomandibular joint syndrome
Clinical narrative: Developed fatigue, UE and LE weakness, paresthesias of arms "about a month after late 2008 or early 2009 immunizations for deployment. Evaluation shows symptoms caused by back trauma from a fall, TMJ disorder.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Fever, blister like rash 15-16 days post 1st dose varicella vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Left deltoid became red and swollen about 12 hours after IM immunization with KINRIX. Not painful. No fever. Seen back in same office 3/8/17 and diagnosed with arthus phenomenon. Patient was already improving so no intervention done.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: 13 yr. old pt. given PROQUAD and Varicella vaccine. MMR was read on PROQUAD vaccine but not Varicella. "PROQUAD" Label not clearly visible on vial. Pt. was prescribed TYLENOL for possible fever.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Injection site pain, Mass, Neuralgia
Clinical narrative: The pt states she has pain down her (R) arm from her shoulder and a lump up by the clavicle nerve type pain. (Can not work).
Age: 1.25
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: See progress note DOS 2/7/17.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: Case number PHHY2015US060340, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS ID 568660) on 12 May 2015 with a follow up information received from the quality assurance department (QA reference number: 371804) on 21 May 2015 with a follow up information received from the quality assurance department on 16 Jun 2015. This report refers to an 11-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14070, expiry date: Nov 2015) onto his right arm (right deltoid), GARDASIL (other manufacturer, batch number: K006960) onto his right arm, FLUARIX (other manufacturer, batch number: 9954H) onto his left arm and BOOSTRIX (other manufacturer, batch number 932Z9) onto his left arm; all vaccines administered on 03 Mar 2015. On 04 Mar 2015 after the vaccinations he had erythema and cellulitis at the site of vaccine. He was treated with KEFLEX and mupirocin. The final outcome of the events was unknown. The events were reported as non-serious, but the event cellulitis at the site of vaccination was upgraded based on available information in the source document. The causality of the event was not reported. Based on the documents review performed, it was concluded that the MENVEO batch M14070 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from the quality assurance department on 21 May 2015: QA reference number updated. Follow up information received from the quality assurance department on 16 Jun 2015: Batch summary and expiry date updated. On 20th February 2017, after GSK internal review, the suspect vaccine FLUARIX was changed into FLUARIX QUADRIVALENT.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza, Influenza A virus test positive, Influenza B virus test, Influenza virus test negative
Clinical narrative: Case number PHHY2016US177900, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 655234) website on 21 Dec 2016. This report refers to a 57 years old male patient. Past medical history was not reported. Concomitant medications included as BYSTOLIC, LIVALO, gemfibrozil, DEXILANT, amlodipine, CoQ10, magnesium, fish oil, B12 and D3. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into the left arm on 21 Sep 2016. On 23 Sep 2016, the patient experienced fever (reported as 101 to 102 degree), aches, headache and flu symptoms. He visited urgent care clinic (emergency room) and was tested positive for influenza A and negative to B. The patient was prescribed TAMIFLU. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event Influenza A virus test positive was upgraded (medically significant) based on the information available in the source document. Upon confirmation with Quality Assurance department regarding the batch number, it was identified that the earlier reported batch number (Q2037) is not a valid batch number for FLUVIRIN. Follow up report received from a quality assurance department on 01 Feb 2017: The Quality Assurance department confirmed that the earlier reported batch number (Q2037) is not a valid batch number for FLUVIRIN.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHHY2016US177900, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 655234) website on 21 Dec 2016. This report refers to a 57 years old male patient. Past medical history was not reported. Concomitant medications included as BYSTOLIC, LIVALO, gemfibrozil, DEXILANT, amlodipine, CoQ10, magnesium, fish oil, B12 and D3. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into the left arm on 21 Sep 2016. On 23 Sep 2016, the patient experienced fever (reported as 101 to 102 degree), aches, headache and flu symptoms. He visited urgent care clinic (emergency room) and was tested positive for influenza A and negative to B. The patient was prescribed TAMIFLU. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event Influenza A virus test positive was upgraded (medically significant) based on the information available in the source document. Upon confirmation with Quality Assurance department regarding the batch number, it was identified that the earlier reported batch number (Q2037) is not a valid batch number for FLUVIRIN. Follow up report received from a quality assurance department on 01 Feb 2017: The Quality Assurance department confirmed that the earlier reported batch number (Q2037) is not a valid batch number for FLUVIRIN.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-MAR-2017, the patient was vaccinated with an expired dose of GARDASIL lot # K006191, expiration date 02-FEB-2017; (strength and dose number unspecified) 0.5 ml via intramuscular route for prophylaxis. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging
Clinical narrative: Multiple Sclerosis diagnosis.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy
Clinical narrative: Diarrhea.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 26-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB, 5 mg / 0.5 ml (pediatric dose), (route, anatomical location, lot# and expiration date were not provided). Then, on an unknown date, the patient was vaccinated with a second dose of RECOMBIVAX HB, 5 mg / 0.5 ml (pediatric dose), (route, anatomical location, lot number and expiration date were not provided), for prophylaxis. The reporter stated that the patient received the third dose of RECOMBIVAX HB on an unknown date in an adult formulation. No adverse effects were reported. The reporter also stated that the patient "will be getting titers in 2 months". Product quality complain (PQC) was not involved. No other suspect or concomitant therapies were reported. Follow up information was received on 28-FEB-2017 from the registered nurse. She stated, that she was unaware of any adverse effects reported regarding the administration of RECOMBIVAX HB. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discolouration, Rash, Rash erythematous
Clinical narrative: This spontaneous report has been received from a physician's office nurse via company representative referring to a male patient of unknown age. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was unknown by the reporter. On an unknown date, reported as "a few years ago," the patient was vaccinated with VARIVAX, (route of administration, dose, frequency, strength, lot#, and expiration date were unknown by the reporter) for routine vaccination. On the same date, the patient developed a black and blue reaction at the injection site and, after 2-3 days the patient developed red rash on the arm that he was vaccinated. It was unknown by the reporter if the patient sought medical attention, if laboratory diagnostic studies were performed or if treatment was given for the adverse events. At the time of reporting the outcome of black and blue reaction at the injection site and red rash on the arm was reported as recovered on an unknown date. The relatedness between the events and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (dose, lot number and expiration date unknown) for prophylaxis. Data logger issue was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005357: US-009507513-1703USA005356.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 22-FEB-2017, the patient was vaccinated with an expired dose of PROQUAD (dose and route unknown; lot # L023114 with 24-DEC-2016) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to unknown number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date, the patients were vaccinated with improperly stored PROQUAD (lot # M003436, therapy type: RHA, expiration date: 19-JUL-2017; lot# M015698, therapy type: RHA, expiration date: ,26-SEP-2017; lot# M017334, therapy type: RHA, expiration date: 05-OCT-2017; lot# M023932, therapy type: RHA, expiration date: 09-NOV-2017; lot# M035689, therapy type: RHA, expiration date: 06-FEB-2018; lot# M037651, therapy type: RHA, expiration date: 28-FEB-2018; lot# M038227, therapy type: RHA, expiration date: 06-MAR-2018; lot# M039448, therapy type: RHA, expiration date: 20-MAR-2018; lot# M041082, therapy type: rha, expiration date: 04-APR-2018; lot# M042499, therapy type: RHA, expiration date: 17-APR-2018; lot# M018635, therapy type: RHA, expiration date: 11-OCT-2017; lot# M029598, therapy type: RHA, expiration date: 10-DEC-2017; lot# L034930, therapy type: RHA, expiration date: 03-MAR-2017; lot# L039269, therapy type: RHA, expiration date: 05-APR-2017; lot# L041626, therapy type: RHA, expiration date: 20-APR-2017; lot# L042817, therapy type: RHA, expiration date: 26-APR-2017; lot# L046510, therapy type: RHA, expiration date: 19-MAY-2017; lot# reported as "L047375", expiration date: 23-MAY-2017; lot# L050907, therapy type: RHA, expiration date: 14-JUN-2017; lot# L051101, therapy type: RHA, expiration date: 17-JUN-2017; lot# reported as " K012930", expiration date: 27-JUN-2017; lot# M001152, therapy type: RHA, expiration date: 05-JUL-2017; lot# M004892, therapy type: RHA, expiration date: 25-JUL-2017; lot# M010475, therapy type: HSA, expiration date: 01-SEP-2017; lot# M010478, therapy type: HSA, expiration date: 01-SEP-2017; lot# M011663, therapy type: RHA, expiration date: 08-SEP-2017; lot# M012987, therapy type: HSA, expiration date: 12-SEP-2017; lot# M015699, therapy type: RHA,  expiration date: 26-SEP-2017; lot# M017337, therapy type: RHA, expiration date: 05-OCT-2017; dose and route unknown) for prophylaxis. The PROQUAD was stored at 10 Fahrenheit for 3024 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same source. Lot number L047375 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. Lot number K012930 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA002612:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored VARIVAX (lot# M008171 with expiration date 16-FEB-2018; concentration, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at more than minus 15 Celsius degree (C) but less than minus 10 C for 1 hour 38 minutes. The data logger was involved. There was no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005921: US-009507513-1703USA005922.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant and an office manager, referring to an unspecified number of patients of unknown age and gender. The patients' current condition, concomitant medication and medical history were not provided. On unspecified dates between 23-JAN-2017 and 21-FEB-2017, the patients received unspecified doses of improperly stored PROQUAD (concentration, frequency and route were unknown; lot # M023931 with expiration date 09-NOV-2017, lot# M038861 with expiration date 13-MAR-2018 and lot# M035690 with expiration date 06-FEB-2018, respectively) for prophylaxis. No adverse effects were reported. PROQUAD was stored between 5 Fahrenheit degree (F) and 14 F for 18 hour 40 minutes, and between 14 F and 46 F for 4 hour 30 minutes. There was no previous temperature excursion, and the data logger was involved. Lot number lot# M038861 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested. Sender's Comments: US-009507513-1703USA006076.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored VAQTA (lot# M039202, expiry date: 11-MAR-2018) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006086: US-009507513-1703USA006087: US-009507513-1703USA006085.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 12 month-old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies or concomitant medications were not reported. On 21-FEB-2017, the patient was subcutaneously vaccinated, at the same time, with a dose of PROQUAD  (0.5 ml once) lot # M041084 with expiration date of 04-APR-2018, and a dose of VARIVAX (0.5 ml once) lot # reported as M039318 with expiration date of 20-SEP-2018. No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 37 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (reported as "during a recent office visit"), the patient was vaccinated with a dose of PROQUAD (dose, route, site of administration, lot # and expiration date were not reported) for prophylaxis. The patient was outside of the recommended age group for receiving this vaccine. No adverse effects were reported in the patient. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Appendicectomy, Axillary pain, Back pain, Blister
Clinical narrative: This spontaneous report was received from an approximately 75 year old male patient. The patient's concurrent conditions included blood pressure abnormal, diabetes (unspecified), a sinus disorder and other unspecified medical conditions. The patient had shingles around March 2014 (reported as ''about 3 years ago''). The patient did not have allergies or drug reactions. In approximately March 2015 (reported as ''about 2 years ago''), the patient was vaccinated with ZOSTAVAX dose 1 (dose, frequency, route of administration, lot # and expiration date were unknown) for prophylaxis. The patient reported that it was other-than-indicated in the Prescribing Information, however it was not specified. Concomitant medication included unspecified blood pressure and unspecified sinus medication and other unspecified medications. In January 2016, the patient underwent a colonoscopy and it was discovered that he had three polyps at unspecified locations and one polyp on the appendix. Subsequently, in the same month he was admitted in the hospital and he had a surgery to remove his "appendix and part of his small colon" (appendectomy and Small intestine operation). The day after the surgery, the place where the patient was operated on, ruptured (postoperative wound complication). Therefore the patient went through another surgery and he was placed in a medically induced coma and he was in a coma during almost 3 weeks. On an unspecified date in 2016, the patient was revived from coma and was hospitalized for another 3 weeks. Then he started and indeterminate rehabilitation. Consequently, after 5 1/2 weeks in hospital the patient's lung collapsed (Pneumothorax) and he acquired pneumonia. He stayed in hospital for 3 other weeks. On an unknown date in 2016, the patient recovered from pneumothorax and pneumonia and patient was discharged from hospital. In November 2016, the patient developed shingles as he experienced chills, a blister feeling, and shooting pains in the chest, back, under arm, around his stomach that felt "like someone sticking an ice pick into him, reportedly. At the time of this report he had not recovered from shingles. At the reporting time, the outcome of appendectomy, small intestine operation, polyps and postoperative wound complication was unknown. Upon internal review, appendectomy, postoperative wound complication, small intestine operation pneumothorax and pneumonia were considered to be medically significant events. No causal relationship was provided between vaccination with ZOSTAVAX and the events. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Colon operation, Colonoscopy abnormal, Herpes zoster
Clinical narrative: This spontaneous report was received from an approximately 75 year old male patient. The patient's concurrent conditions included blood pressure abnormal, diabetes (unspecified), a sinus disorder and other unspecified medical conditions. The patient had shingles around March 2014 (reported as ''about 3 years ago''). The patient did not have allergies or drug reactions. In approximately March 2015 (reported as ''about 2 years ago''), the patient was vaccinated with ZOSTAVAX dose 1 (dose, frequency, route of administration, lot # and expiration date were unknown) for prophylaxis. The patient reported that it was other-than-indicated in the Prescribing Information, however it was not specified. Concomitant medication included unspecified blood pressure and unspecified sinus medication and other unspecified medications. In January 2016, the patient underwent a colonoscopy and it was discovered that he had three polyps at unspecified locations and one polyp on the appendix. Subsequently, in the same month he was admitted in the hospital and he had a surgery to remove his "appendix and part of his small colon" (appendectomy and Small intestine operation). The day after the surgery, the place where the patient was operated on, ruptured (postoperative wound complication). Therefore the patient went through another surgery and he was placed in a medically induced coma and he was in a coma during almost 3 weeks. On an unspecified date in 2016, the patient was revived from coma and was hospitalized for another 3 weeks. Then he started and indeterminate rehabilitation. Consequently, after 5 1/2 weeks in hospital the patient's lung collapsed (Pneumothorax) and he acquired pneumonia. He stayed in hospital for 3 other weeks. On an unknown date in 2016, the patient recovered from pneumothorax and pneumonia and patient was discharged from hospital. In November 2016, the patient developed shingles as he experienced chills, a blister feeling, and shooting pains in the chest, back, under arm, around his stomach that felt "like someone sticking an ice pick into him, reportedly. At the time of this report he had not recovered from shingles. At the reporting time, the outcome of appendectomy, small intestine operation, polyps and postoperative wound complication was unknown. Upon internal review, appendectomy, postoperative wound complication, small intestine operation pneumothorax and pneumonia were considered to be medically significant events. No causal relationship was provided between vaccination with ZOSTAVAX and the events. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Large intestine polyp, Medical induction of coma, Pain, Pneumonia, Pneumothorax
Clinical narrative: This spontaneous report was received from an approximately 75 year old male patient. The patient's concurrent conditions included blood pressure abnormal, diabetes (unspecified), a sinus disorder and other unspecified medical conditions. The patient had shingles around March 2014 (reported as ''about 3 years ago''). The patient did not have allergies or drug reactions. In approximately March 2015 (reported as ''about 2 years ago''), the patient was vaccinated with ZOSTAVAX dose 1 (dose, frequency, route of administration, lot # and expiration date were unknown) for prophylaxis. The patient reported that it was other-than-indicated in the Prescribing Information, however it was not specified. Concomitant medication included unspecified blood pressure and unspecified sinus medication and other unspecified medications. In January 2016, the patient underwent a colonoscopy and it was discovered that he had three polyps at unspecified locations and one polyp on the appendix. Subsequently, in the same month he was admitted in the hospital and he had a surgery to remove his "appendix and part of his small colon" (appendectomy and Small intestine operation). The day after the surgery, the place where the patient was operated on, ruptured (postoperative wound complication). Therefore the patient went through another surgery and he was placed in a medically induced coma and he was in a coma during almost 3 weeks. On an unspecified date in 2016, the patient was revived from coma and was hospitalized for another 3 weeks. Then he started and indeterminate rehabilitation. Consequently, after 5 1/2 weeks in hospital the patient's lung collapsed (Pneumothorax) and he acquired pneumonia. He stayed in hospital for 3 other weeks. On an unknown date in 2016, the patient recovered from pneumothorax and pneumonia and patient was discharged from hospital. In November 2016, the patient developed shingles as he experienced chills, a blister feeling, and shooting pains in the chest, back, under arm, around his stomach that felt "like someone sticking an ice pick into him, reportedly. At the time of this report he had not recovered from shingles. At the reporting time, the outcome of appendectomy, small intestine operation, polyps and postoperative wound complication was unknown. Upon internal review, appendectomy, postoperative wound complication, small intestine operation pneumothorax and pneumonia were considered to be medically significant events. No causal relationship was provided between vaccination with ZOSTAVAX and the events. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Polyp, Postoperative wound complication, Surgery
Clinical narrative: This spontaneous report was received from an approximately 75 year old male patient. The patient's concurrent conditions included blood pressure abnormal, diabetes (unspecified), a sinus disorder and other unspecified medical conditions. The patient had shingles around March 2014 (reported as ''about 3 years ago''). The patient did not have allergies or drug reactions. In approximately March 2015 (reported as ''about 2 years ago''), the patient was vaccinated with ZOSTAVAX dose 1 (dose, frequency, route of administration, lot # and expiration date were unknown) for prophylaxis. The patient reported that it was other-than-indicated in the Prescribing Information, however it was not specified. Concomitant medication included unspecified blood pressure and unspecified sinus medication and other unspecified medications. In January 2016, the patient underwent a colonoscopy and it was discovered that he had three polyps at unspecified locations and one polyp on the appendix. Subsequently, in the same month he was admitted in the hospital and he had a surgery to remove his "appendix and part of his small colon" (appendectomy and Small intestine operation). The day after the surgery, the place where the patient was operated on, ruptured (postoperative wound complication). Therefore the patient went through another surgery and he was placed in a medically induced coma and he was in a coma during almost 3 weeks. On an unspecified date in 2016, the patient was revived from coma and was hospitalized for another 3 weeks. Then he started and indeterminate rehabilitation. Consequently, after 5 1/2 weeks in hospital the patient's lung collapsed (Pneumothorax) and he acquired pneumonia. He stayed in hospital for 3 other weeks. On an unknown date in 2016, the patient recovered from pneumothorax and pneumonia and patient was discharged from hospital. In November 2016, the patient developed shingles as he experienced chills, a blister feeling, and shooting pains in the chest, back, under arm, around his stomach that felt "like someone sticking an ice pick into him, reportedly. At the time of this report he had not recovered from shingles. At the reporting time, the outcome of appendectomy, small intestine operation, polyps and postoperative wound complication was unknown. Upon internal review, appendectomy, postoperative wound complication, small intestine operation pneumothorax and pneumonia were considered to be medically significant events. No causal relationship was provided between vaccination with ZOSTAVAX and the events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from an administrator, referring to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The reporter stated that, in approximately September 2016 (reported as 6 months ago) the patient received a dose of CERVARIX (strength, dose, anatomical location, lot number and expiration date were not reported) and on 07-MAR-2017, she received a dose of GARDASIL 9 lot # M035486 with an expiration date on 05-JUN-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of ZOSTAVAX, lot numbers M030140 with expiration date 18-AUG-2017and  M041510 with expiration date 27-JUL-2017 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were previously exposed to temperature excursion of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 6 hours in November 16 (year unspecified) additionally, the vaccine was exposed to temperature excursion (unspecified dates) of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 12 hours; however, no patient was vaccinated with the last temperature excursion reported. The call was because "data logger". No adverse effects were noted. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA005912.
Sex: U
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history, On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who said that their child had had seizures (convulsion in childhood) since receiving the unidentified Merck Human Papillomavirus (HPV) vaccine. The outcome of the patients and the relatedness between the seizures and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the convulsion in childhood was considered as medically significant event. This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004620.
Sex: U
Vaccine: HPVX
Symptoms: Abasia, Abdominal pain upper, Body temperature fluctuation, Fatigue, Feeling abnormal
Clinical narrative: Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history. On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who had children who had had similar experiences as her daughter (MARRS number: 1703USA003781). The experiences reported included:  pyrexia, helicobacter infection, leg pain, feeling abnormal, neuralgia, body temperature fluctuation, hypoaesthesia, neuropathy peripheral, fatigue, muscular weakness, abasia, paraesthesia, vomiting, nausea, stomach pain and influenza. The outcome of the events and the relatedness between the events and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the abasia and the helicobacter infection were considered as medically significant events.  This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004619.
Sex: U
Vaccine: HPVX
Symptoms: Helicobacter infection, Hypoaesthesia, Influenza, Muscular weakness, Nausea
Clinical narrative: Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history. On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who had children who had had similar experiences as her daughter (MARRS number: 1703USA003781). The experiences reported included:  pyrexia, helicobacter infection, leg pain, feeling abnormal, neuralgia, body temperature fluctuation, hypoaesthesia, neuropathy peripheral, fatigue, muscular weakness, abasia, paraesthesia, vomiting, nausea, stomach pain and influenza. The outcome of the events and the relatedness between the events and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the abasia and the helicobacter infection were considered as medically significant events.  This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004619.
Sex: U
Vaccine: HPVX
Symptoms: Neuralgia, Neuropathy peripheral, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history. On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who had children who had had similar experiences as her daughter (MARRS number: 1703USA003781). The experiences reported included:  pyrexia, helicobacter infection, leg pain, feeling abnormal, neuralgia, body temperature fluctuation, hypoaesthesia, neuropathy peripheral, fatigue, muscular weakness, abasia, paraesthesia, vomiting, nausea, stomach pain and influenza. The outcome of the events and the relatedness between the events and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the abasia and the helicobacter infection were considered as medically significant events.  This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004619.