chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dose, dose#, route and vaccination site was unknown). Concomitant therapies included prednisone (manufacturer unknown). On an unknown date the patient developed shingle after receiving ZOSTAVAX. The patient sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: Alopecia
Clinical narrative: Case number PHEH2015US016660, is an initial spontaneous report from a pharmacist received on 21 August 2015. This report refers to an adult middle aged female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received MENVEO, (batch number: not reported) on an unknown date in late Feb 2015. On an unknown date subsequent to the vaccination the patient was losing hair. Final outcome, seriousness and causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness postural, Heart rate increased
Clinical narrative: Case number PHEH2015US008747, is an initial spontaneous report from a consumer (patient's parent) received on 04 May 2015. This report refers to an 11 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: unknown) intramuscularly on 23 Apr 2015. On the same day, one hour after vaccination, the patient felt dizzy. The episodes of dizziness occur when he was standing up or sitting up, along with an increased heart rate. The only relief he gets from the dizziness was when he was laying down. He characterizes the dizziness as "rocking back and a forth in a boat". Outcome of the events was recovered. Seriousness and causality of the events were not reported.
Sex: U
Vaccine: MMR
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of MMR II, (lot #, expiry date and route of administration not reported). On an unknown date, the patient experienced "redness, rash, a low grade fever for two days, and dots on his face" after administration of MMR II. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was reported. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Information has been received from a pharmacist via company representative referring to a patient of unknown age and gender. On an unknown date, a couple of months ago the patient was vaccinated with PNEUMOVAX 23 (route, dose, strength and lot were unknown). On an unknown date the patient experienced some pain that was not typical injection site pain. The patient also experienced some loss of mobility of an unspecified extremity, and that the patient consulted an unspecified healthcare provider. The unspecified healthcare provider told the patient that the loss of mobility was not related to the vaccine. The outcome of the events was unknown. The causality between some pain and the vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates the patients were administered improperly stored oral, ROTATEQ (lot # L013192, expiration date 19-JAN-2017) (dosage and strength unknown) following a temperature excursion on 07-JAN-2016 (temperature 32.2 degree F, time frame 40 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose and frequency were not reported, lot # L014415, expiry date: 25-JUL-2017). No adverse events were reported. No further information was provided. Product quality complaint was not filed. This case is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. On 12-FEB-2016 the patient was inadvertently administered an expired dose of RECOMBIVAX HB (expired product administered) injection (lot # K009505, expiry date 07-FEB-2016) parenterally (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of event was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not known. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (strength, dose and frequency were not reported, lot # L030871, expiry date: 10-JUN-2018). No adverse events were reported. No further information was provided. Product quality complaint was not filed. This case is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On an unknown date in September 2014 the patient was vaccinated with the first dose in the series of RECOMBIVAX HB (strength 2.5/0.5 DF), intramuscularly and second dose in the series on an unknown date in September 2015 (dose, frequency, lot# and expiration date unknown). The third dose in the series of RECOMBIVAX HB (lot# L019299 and expiration date 14-APR-2017) was on 05-FEB-2016 (inappropriate schedule of drug administration). No adverse effects were reported. The outcome of inappropriate schedule of drug administration was unknown. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an approximately 14 month old male patient. It was reported that the patient did not have any concurrent condition or medical history. On 04-FEB-2016 the patient was vaccinated with VARIVAX (Merck) (lot # L034370, expiry date unknown) injection (dosing regimen and frequency unknown). The patient was not on any concomitant medications. On 06-FEB-2016 (also reported 2 days later) the patient experienced chicken pox (varicella). On approximately 08-FEB-2016 the patient's chicken pox was severe and had over 100 lesions. This had prompted an office visit with the patient's physician. There was no lab diagnostics studies performed. It was reported that the patient was treated with an unspecified anti itch cream. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of varicella was reported as recovering. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On multiple unspecified dates the patient were vaccinated with improperly stored GARDASIL lot # K008931; expiry: 04-MAR-2017 (dose, route and frequency unspecified). No further information was available. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates in 2016 the patients were administered improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017) (dosage, strength and route unknown) following a temperature excursion on 07-JAN-2016 (temperature 32.2 degree F, time frame 40 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates in 2016 the patients were administered improperly stored GARDASIL 9 (lot # L020015, expiration date 16-AUG-2017) (dosage, strength and route unknown) following a temperature excursion on 07-JAN-2016 (temperature 32.2 degree F, time frame 40 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 17 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 19-MAR-2014, the patient was vaccinated with first dose of GARDASIL (lot# H021346, expiry date: 01-OCT-2015), on 16-MAY-2014 second dose of GARDASIL (Lot# J015378, expiry date: 09-APR-2016) and with third dose of GARDASIL on 19-SEP-2014 (lot# K001631, expiry date: 06-NOV-2016). On 11-JAN-2016 the patient was vaccinated with GARDASIL 9. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates the patients were administered improperly stored VAQTA (lot # L002717, expiration date 02-JUN-2017) (dosage, strength and route unknown) following a temperature excursion on 23-NOV-2015 and 07-JAN-2016 (32.2 degree F for 1 hour and 10 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # L013203 with expiration date: 28-JAN-2017, lot# K010755 with expiration date: 19-MAY-2016, oral, dose was unknown) (incorrect product storage). The vaccine was excursion to -3.8 degree centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a female pharmacist of unknown age via a company representative referring to herself. Pertinent medical history and drug reactions/allergies were not reported. In December 2015 the patient was vaccinated with ZOSTAVAX (route, dose, lot# and expiration date were not reported). Concomitant drug was not reported. Following the vaccination, on an unknown date the patient experienced a little rash at the injection site. The patient did not seek medical attention. The patient recovered on an unknown date. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L036300, expiration date: 04-NOV-2016, route and dose were unknown). The vaccine was excursion to -3.8 degree centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 2 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored dose of ZOSTAVAX (lot#, dose, dose# and route unknown). No adverse effect reported. Additional information is not expected since there was no consent for follow up contact.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of VAQTA (exact dose and route were not reported, lot # L039659, expiration date 15-MAR-2017), that experienced a temperature excursion of 32.7 degrees Fahrenheit for 3 hours and 49 minutes. No adverse events were reported. Additional information has been requested. It has been determined that case # US-009507513-1602USA0005212 is a duplicate of case # US-009507513-1602USA004961. The case # US-009507513-1602USA004961 has the earlier aware date 08-FEB-2016. There fore, case # US-009507513-1602USA005212 is being deleted from our files and the cases are consolidated into case # US-009507513-1602USA004961.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, improperly stored PEDVAXHIB (lot # L012838, expiration date 10-MAR-2018) (dosage, strength and route unknown) (temperature: low 32.2 degree F, time frame: 53 hours 25 minutes) were administered to the patients. There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, improperly stored RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016 and lot # L019298, expiration date 22-JUN-2017) (dosage, strength and route unknown) (temperature: low 32.2 degree F, time frame: 53 hours and 25 minutes) were administered to the patients. There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L020015, expiration date: 16-AUG-2017, route and dose were unknown). The vaccine was excursion to -3.8 degree centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215, expiration date: 05-MAY-2017, route and dose were unknown) (incorrect product storage). The vaccine was excursion to -3.8 degree Centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 10-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 39 year old patient of unknown gender, who on 09-DEC-2051, was vaccinated with a dose of ZOSTAVAX unknown administration route, lot # L032402, expiration date 26-NOV-2016. The pharmacist also reported that the patient had a history of previous shingles outbreaks prior to vaccination. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse (medical assistant) referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 10-FEB-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) injection (lot # K007451 with expiration date 21-NOV-2015; dose, route and albumin status were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Somnolence
Clinical narrative: Prolonged somnolence unable to wake up for 5 hours followed by high pitched cry for 2 hours.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Parkinson's disease, Parkinsonism
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received BOOSTRIX. On 3rd June 2015, the patient received BOOSTRIX .5 ml. On 3rd June 2015, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the patient experienced parkinsonism. On an unknown date, the outcome of the injection site pain was not recovered/no resolved and the outcome of the parkinsonism was unknown. The reporter considered the injection site pain and parkinsonism to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient reported that, he experienced left arm pain after receiving BOOSTRIX vaccine. On an unknown date, the patient was diagnosed with Parkinson's disease.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from patient's mother refers to a 12 month old patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 10-FEB-2016 (reported as yesterday), the patient was vaccinated with two 0.5 ml doses of VARIVAX (Merck), during a doctor's visit. No adverse effect was reported. Additional information has been requested.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blister, Injection site induration, Local reaction
Clinical narrative: Mild local reaction with vesicles, a few generalized vesicles on trunk, back and neck (approximately 10 total), induration around site of injection.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2015US022692, is an initial spontaneous report from a nurse received on 03 Nov 2015. This report refers to an 11 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO, (batch number: M15023) at a dose of 0.5 ml into the left arm on 02 Nov 2015. On 03 Nov 2015 the patient experienced swelling, redness and pain at the injection site. The had applied ice to site, no other intervention were taken. No further information was reported regarding the events. Outcome of the events was reported as condition unchanged (unresolved). Events were reported to be non-serious and causality of the events was not reported.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a consumer, via Pfizer (Mfr. Control N 2016076426) referring to a female patient of unknown age with chronic obstructive pulmonary disease (COPD), she never smoked but she also had emphysema and bronchitis. In February 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot#, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. On 22-DEC-2015, the patient experienced pneumonia. The outcome and causality of pneumonia was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: 5 inch - orange sized - hardened red area that occurred next day. Itching - no pain.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 15-FEB-2016, the patient was vaccinated with an expired dose of VAQTA expiration date: 15-JAN-2016 (Lot#, dose and route of administration were not reported). No adverse effects were reported. There was no product quality involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with rash "on his belly". The patient's medical history was not provided. On 30-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route were not reported) and then the pharmacist noticed the patient had a rash "on his belly". The pharmacist stated that the patient said that he had developed the rash prior to being vaccinated (drug maladministration). The pharmacist stated also that the patient did not mention this to him prior to vaccination. The pharmacist stated that he did not know if the rash was related to shingles. Follow up information has been received from the pharmacist on 15-FEB-2016, regarding to a 65 year old male patient with possible shingles. The patient's medical history was not reported. On 30-DEC-2015 at 11:00 hours, the patient was vaccinated with the first dose of ZOSTAVAX lot # L016283, subcutaneous, in the right arm. Concomitant therapy was not reported. The pharmacist reported that the patient said that on an unspecified date, after giving vaccination he had rash. Therefore the pharmacist looked at it and it was under a belly fold. Subsequently the patient was advised to go to the emergency room. The outcome of rash was reported as recovered on an unknown date. Additional information is not expected because all the follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from health care worker referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-FEB-2016, the patient was vaccinated with an expired dose of M-M-R II albumin status RHA (route, dose and anatomical site were not reported) lot # J013069, expiration date 16-OCT-2015, also the reporter stated that the M-M-R II vaccine did not had any previous temperature excursions. No adverse symptoms were reported and no product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Inflammation, Injection site pain, Mass, Myalgia
Clinical narrative: Prolonged dull pain in muscle between left shoulder and elbow as well as in muscle between elbow and wrist. Pain level 2-3 on a scale of 1 thru 10, with 10 being severe. Loss of strength in left dominant arm. Can't pick up a gallon of milk or water without use of other hand. Small lump under skin.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Tendonitis
Clinical narrative: Prolonged dull pain in muscle between left shoulder and elbow as well as in muscle between elbow and wrist. Pain level 2-3 on a scale of 1 thru 10, with 10 being severe. Loss of strength in left dominant arm. Can't pick up a gallon of milk or water without use of other hand. Small lump under skin.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 10-FEB-2016 the patient was vaccinated with improperly stored (30 F for 45 minutes once) ZOSTAVAX (lot # L029484, expiration date 06-NOV-2016, subcutaneous, 0.65 ml) (incorrect product storage). VARIVAX (Merck) was not administered. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash at immunization site. Pt advised to speak w/MD and to use BENADRYL and hydrocortisone cream allergies for profile were also updated.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2015US019626, is an initial spontaneous report received from a physician via sales representative on 29 Sep 2015. This report refers to a 10 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: X14136, expiry date: 31 Oct 2017) in right arm on 12 Sep 2015. The patient was also vaccinated with BOOSTRIX and Varicella in the left arm on 12 Sep 2015. On an unknown date after vaccination, she experienced redness and swollen in the right arm within a 3-4 inch diameter of where the MENVEO vaccine was given. Upon follow up it was reported that swelling and redness had reduced to the size of a mosquito. The outcome of the events was reported as condition improving. Seriousness and causality of the events were not reported. No further information was reported.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 04-FEB-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23, time of frame was 35.5 hours at a temperature of 27F (strength, dose, and frequency were not provided) lot # L040181 and expiration date 18-AUG-2018 and lot # L040178 expiration date 18-AUG-2018. Concomitant therapies were not provided. The nurse did not report adverse symptoms. The nurse was not able to provide the lot # and expiration dates for the PNEUMOVAX 23 was administered to the patient. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine, New daily persistent headache
Clinical narrative: Chronic daily next onset migrainous headache beginning 2 days after HPV #1. No PMhx of recurrent headaches.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2015US004611 is an initial spontaneous report from a physician via GSK company representative received on 05 Mar 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with MENVEO (batch number: M14040) intramuscularly at upper right deltoid on 02 Mar 2015 at 04:30 pm. On the same date, after vaccination the patient experienced redness and swelling at the upper right deltoid and the area was 4 inches by 7 inches. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHEH2015US003423, is an initial spontaneous report received from a nurse on 13 Feb 2015 and with follow-up received from a nurse on 10 Mar 2015. This report refers to a 20 year old male patient. Historical condition and concomitant medication were not reported. His vaccination history included administration of MENACTRA (batch number: not reported, other manufacturer) and was well tolerated. The patient was vaccinated with MENVEO (batch number: M14094) at a dose of 0.5 ml, intramuscularly into left deltoid on 11 Feb 2015. On 13 Feb 2015, he developed swollen lymph nodes under left arm (axilla area) and swelling along left rib cage node measured 2 cm. Outcome of the event was recovered on 17 Feb 2015. Seriousness and causality of the events was not reported. Follow-up received from a nurse on 10 Mar 2015: Patient's demographics (height and weight), vaccination history (MENACTRA), vaccination details (dose and site), outcome and other clinically relevant information updated in the narrative.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and redness with pain same arm as vaccination in < 12 hrs. Treatment - ibuprofen, topical hydrocortisone and oral prednisone.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling and redness with pain same arm as vaccination in < 12 hrs. Treatment - ibuprofen, topical hydrocortisone and oral prednisone.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: Loose stools x 6 days.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Autonomic nervous system imbalance, Muscular weakness, Peripheral coldness
Clinical narrative: Left arm weakness. col to touch; day after vaccination; pt is (R) handed consulted w/Neurology -> suspect autonomic phenomenon.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 03-FEB-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23, time of frame was 35.5 hours at a temperature of 27F (strength, dose, and frequency were not provided) lot # L040181 and expiration date 18-AUG-2018 and lot# L040178 and expiration date 18-AUG-2018. Concomitant therapies were not provided. The nurse did not report adverse symptoms. The nurse was not able to provide the lot # and expiration dates for the PNEUMOVAX 23 was administered to the patient. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since 31-DEC-2015 the patients were vaccinated with improperly stored GARDASIL (lot # J011272 with expiration date of 21-APR-2016, lot# K014191 with expiration date of 10-MAY-2017, dose, strength and route unknown). The vaccines were stored at 10 Celsius degree for 36 minutes. There was no previous temperature excursion. No adverse effects had been reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 28-SEP-2013, 13-NOV-2013, 09-OCT-2014, the patient was vaccinated with the first, the second and the third doses of RECOMBIVAX HB (strength, lot#, expiration date, dose and route were unknown) (inappropriate schedule of drug administration). No adverse events were 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 nurse referring to unspecified number of patients of unknown age and gender. Since 31-DEC-2015 the patients were vaccinated with improperly stored M-M-R II (lot # L000458 with expiration date of 06-JAN-2018, lot # L015282 with expiration date of 30-APR-2017, dose, strength and route unknown). The vaccines were stored at 10 Celsius degree for 36 minutes. There was no previous temperature excursion. No adverse effects had been reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since 31-DEC-2015 the patients were vaccinated with improperly stored PNEUMOVAX 23 SDV (lot# L019835 with expiration date of 23-MAR-2017, lot# L013428 with expiration date of 03-FEB-2017, dose, strength and route unknown). and PNEUMOVAX 23 PFS (lot# L0401478 with expiration date of 18-AUG-2017, dose, strength and route unknown). The vaccines were stored at 10 Celsius degree for 36 minutes. There was no previous temperature excursion. No adverse effects had been reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Skin discolouration, Skin warm
Clinical narrative: Pt was given DTaP on 2/9/16 and was brought in by mother on 2/11/16 because pt's leg was bright pink in color and felt warm at touch.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L044694, expiration date: 04-FEB-2018, route and dose were unknown) (incorrect product storage). The vaccine was excursion to -3.8 degree Centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from Sanofi Pasteur MSD (MFR control number 2016032757) on 28-Jan-2016. Information has been received from an other health professional via Pfizer, Inc on 27-JAN-2016 referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number, expiration date and route were unknown). There were patients allergic to PNEUMOVAX 23 on unknown dates. Outcome of allergic to PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Irritability, Mucous stools, Occult blood positive
Clinical narrative: Copious blood and mucous in stool (documented photographically) along with marked irritability occurring 76 hours after provision of rotavirus vaccine oral (vaccine given 2/12/16; symptoms 2/15/16).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site mass, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: Injection site shows a subdeltoid mass effect of 5-6 cm with moderate tenderness. Pt c/o increased pain with ROM of shoulder. Pt also c/o severe sore throat. Temp of 100.6.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Papule
Clinical narrative: Child had vaccines 2/1/16. On 2/16/16 mom brought child into office with 2 small papules and reddened area on the lt thigh has had x 2 wks. BACTROBAN oint prescribed.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Case number PHEH2015US014708 is an initial spontaneous report from a pharmacist received on 28 Jul 2015. This report refers to a 18-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14133) in her left arm on an unknown date. On an unknown date after the vaccination she had red spot where injection was given on her left upper arm. The outcome of the event was reported as condition unchanged. The seriousness and causality assessment was not reported.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Pain, Pyrexia
Clinical narrative: Dad states baby was fine on day of immunizations - (2/8/16) had fever (104-105) about 40 minutes on 2-10-16. Relieved with TYLENOL. Began inconsolable crying 2-13-16. Acts like he is in pain.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2014US171668, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543913) website on 29 Dec 2014. This report refers to a 56 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1411601) and PNEUMOVAX (other manufacturer, batch number: K004483) intramuscularly in left arm on 12 Sep 2014. On 13 Sep 2014, his arm became swollen (approximately 6 inches), red and hot to touch. Final outcome of these events was reported as condition unchanged. These events were reported as non-serious. Causality of these events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Case number PHHY2014US171268, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543924) web site on 29 Dec 2014. This report refers to a 60 year old female patient. Medical history and concomitant medication were not reported. Concurrent conditions included latex allergy. The patient was vaccinated with FLUVIRIN (batch number: 1413307) intramuscularly in right arm and ZOSTAVAX (other manufacturer, batch number: J014810) subcutaneously in left arm on 09 Sep 2014. On 10 Sep 2014, she developed rash of about 2 inches around vaccination site. Final outcome was unknown. This event was reported as non-serious. Causality of the event was not reported.
Age: 28.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US171350, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543960) website on 06 Jan 2015. This report refers to a 28 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145233) intramuscularly in right arm, MENACTRA (other manufacturer, batch number: U4686AA) intramuscularly in left arm and PNEUMOVAX (other manufacturer, batch number: K004483) intramuscularly in right arm on 11 Sep 2014. On 12 Sep 2014 (around 09:00 PM), he developed redness, swelling and warm to the touch on his right arm where FLUVIRIN and PNEUMOVAX was administered. Final outcome of these events was reported as complete recovery. Events were reported as non-serious. Causality of these events was not reported.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Lethargy, Listless, Myalgia
Clinical narrative: Case number PHHY2014US171191, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543961) website on 29 Dec 2014. This report refers to a 75 year old male patient. Medical history was not reported. Concurrent conditions included blood pressure high (hypertension). Concomitant medications included TOVAIA ER and doxazosin. The patient was vaccinated with FLUVIRIN (batch number: 1410901) intramuscularly in right arm on 12 Sep 2014. On the same day after vaccination, he experienced rash all over body, extreme soreness of muscles in back of neck and down the back, loss of appetite, lethargy and listlessness. On 14 Sep 2014, he felt faint after a walk. Final outcome of these events was reported as complete recovery. Events were reported as non-serious. Causality of those events was not reported.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US171191, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543961) website on 29 Dec 2014. This report refers to a 75 year old male patient. Medical history was not reported. Concurrent conditions included blood pressure high (hypertension). Concomitant medications included TOVAIA ER and doxazosin. The patient was vaccinated with FLUVIRIN (batch number: 1410901) intramuscularly in right arm on 12 Sep 2014. On the same day after vaccination, he experienced rash all over body, extreme soreness of muscles in back of neck and down the back, loss of appetite, lethargy and listlessness. On 14 Sep 2014, he felt faint after a walk. Final outcome of these events was reported as complete recovery. Events were reported as non-serious. Causality of those events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US171677, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543991) website on 29 Dec 2014. This report refers to a 62 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145603) intramuscularly in left arm and PNEUMOVAX (other manufacturer, batch number: K005797) intramuscularly in right arm on 16 Sep 2014. On the same day after vaccination, she developed injection site swelling and hot to touch. Final outcome of these events was reported as complete recovery. These events were reported as non-serious. Causality of these events was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2014US171686, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 544093) website on 29 Dec 2014. This report refers to a 37 year old female patient. Her historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1411001) via intramuscular route in right arm on 16 Sep 2014. On 17 Sep 2014, she developed numbness and tingling at right hand/fingers. She was taken to emergency room for medical support. Final outcome of these events was unknown. These events were reported as non-serious. Causality of these events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia
Clinical narrative: Case number PHHY2014US171693, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 544110) website on 29 Dec 2014. This report refers to a 58 year old female patient. Her historical condition was not reported. Concomitant medications included omeprazole, metformin and TOPROL. The patient was vaccinated with FLUVIRIN (batch number: 1410901) via intramuscular route in right arm and ZOSTAVAX (other manufacturer, batch number: J012658) via subcutaneous route in left arm both on 30 Aug 2014. On 02 Sep 2014, she developed joint pain in left hand and on 04 Sep 2014, she developed joint pain in right knee. Final outcome of these events was unknown. These events were reported as non-serious. Causality of these events was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US171071, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544139) website on 29 Dec 2014. This report refers to a 24-year-old female patient. The patient had no allergies or medical conditions. Concomitant medications included WELLBUTRIN, birth control pills and Vitamin D. She was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly into the left arm on 17 Sep 2014. On the same day after vaccination, the patient experienced egg shaped and egg size local reaction at injection site described as red, swollen, warm and tender. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.