chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Male sexual dysfunction, Scrotal pain, Scrotal swelling
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced sexual problems, dysfunction of male organs and/or swollen or painful scrotum. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. 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: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#L018501 exp date 22-JUN-2017, L026599 exp date 22-JUN-2017 and lot #L045117 exp date 06-OCT-2018) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Erectile dysfunction
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced impotence. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from patient's friend refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (lot number and dosage not reported). On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information is not expected, as no contact details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a female consumer of unknown age and another consumer refers to the first reporter. The patient stated that she did have pain which was present prior to vaccination. She would have pain whenever she ate specific foods since 1976 (reported as for 40 years or so). On an unknown date the patient received a dose of ZOSTAVAX (dose, strength, route, lot # and expiration date were not reported). Concomitant drug was not reported. At unspecified time, the customer was seated waiting to pay for the vaccine when she reported loss of consciousness. The patient's husband stated the time for passing out was two or three minutes (it was also reported by the second reporter that it was approximately 30 seconds). The patient stated that she never said she experienced abdominal pain as a result of the vaccine (it was also reported by the second reporter that the patient had abdominal pain). The causality was not reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 week old infant patient of unknown gender.  Patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On 12-APR-2016, the patient was vaccinated with VAQTA (strength, dosing details, anatomical location, lot #and expiration date unknown). No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, anatomical route of vaccination, lot numbers and expiration dates were not provided). It was reported by the registered nurse, that (Oka/Merck) VARIVAX was exposed to a defrost cycle (temperature was not provided). Nonetheless, no adverse effects were reported. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Ear infection
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning a patient of unknown age and gender. The concurrent conditions and medical history were not reported. The reporter stated that on an unknown date in December 2015 at the approximately age of 9 months old, the patient who was three months younger that the minimum age indicated for VAQTA immunization was administered an unknown dose number of the mentioned vaccine (given dose and route of administration were not reported) lot # L039659, expiration date 15-MAR-2017. It was also reported that the nurse noted that several months later (on an unknown date in 2016) the patient was diagnosed with an ear infection, there was not treatment specified. The outcome of ear infection was unknown. The causal relationship was not reported. It was reported that there was not a product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L034381 exp date 21-DEC-2016) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event following immunisation
Clinical narrative: This initial report was received from a consumer, as part of a marketing research and refers to a 2 currently adult female patients. The patients' concurrent conditions and medical history was not reported. There was no concomitant medication reported. On an unknown dates, the patients were vaccinated with GARDASIL (lot number, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patients experienced unspecified adverse events following the immunisation. The outcome of adverse event following immunisation was unknown. The causality assessment between the event and the suspect therapy was not reported. Additional information is not expected as the reporter did not consent for new follow-up attempts.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth to injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Per pt, severe itch, and red patchy spots.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with PROQUAD (dose, anatomical route of vaccination, lot numbers and expiration dates were not provided). It was reported by the registered nurse, that PROQUAD was exposed to a defrost cycle (temperature was not provided). Nonetheless, no adverse effects were reported. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Computerised tomogram, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Injection site became increasing more tender and red. By afternoon injection site had doubled in size and very painful to touch. Began running fever pm 1/16/2015, and over next day pain in entire upper arm with site now quadrupled in size. Went to ER and was admitted with cellulitis of L arm. Was admitted to the hospital with IVs and put on 3 different IV antibiotics, and the cellulitis grew to cover the entire upper left arm and about 4 inches past the elbow. Continued running fever and arm very painful for entire 6 days in hospital even though was on the 3 IV antibiotics. Discharged on 7th day and was put on oral antibiotic for 3 more weeks.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site swelling, Laboratory test, Pain in extremity, Pyrexia, X-ray
Clinical narrative: Injection site became increasing more tender and red. By afternoon injection site had doubled in size and very painful to touch. Began running fever pm 1/16/2015, and over next day pain in entire upper arm with site now quadrupled in size. Went to ER and was admitted with cellulitis of L arm. Was admitted to the hospital with IVs and put on 3 different IV antibiotics, and the cellulitis grew to cover the entire upper left arm and about 4 inches past the elbow. Continued running fever and arm very painful for entire 6 days in hospital even though was on the 3 IV antibiotics. Discharged on 7th day and was put on oral antibiotic for 3 more weeks.
Age: 1.2
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: High fever (4/30-5/1). Measles like rash on legs and feet (5/2-5/6). Measles like rash on torso and back (5/8-today 5/9).
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Nauseous, Sweating, dizziness, severe headache.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Over period of several days, site became red, inflamed, swollen, hot, blisters, painful. Eventual Size: 8" x 4".
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Over period of several days, site became red, inflamed, swollen, hot, blisters, painful. Eventual Size: 8" x 4".
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Injection irritations (redness, pain, swelling on injection site) started few hours after vaccine (on 5/6). Recommended pt to go ER and ER PA gave two doses of TYLENOLl 500mg and ice pack (5/6/16 PM). Patient came back to pharmacy on Sunday (5/8/16;2 days after vaccine and ER visit) and complained for inflammation moved to around arm pit and chest area. Recommended patient to take ibuprofen 600mg Q8H and zyrtec 10mg QAM. Patient came back to pharmacy on Monday (5/9) and told pt is completely recovered from sickness. Patient had 3 days minor sickness after PNEUMOVAX 23 (PPSV23).
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Injection irritations (redness, pain, swelling on injection site) started few hours after vaccine (on 5/6). Recommended pt to go ER and ER PA gave two doses of TYLENOLl 500mg and ice pack (5/6/16 PM). Patient came back to pharmacy on Sunday (5/8/16;2 days after vaccine and ER visit) and complained for inflammation moved to around arm pit and chest area. Recommended patient to take ibuprofen 600mg Q8H and zyrtec 10mg QAM. Patient came back to pharmacy on Monday (5/9) and told pt is completely recovered from sickness. Patient had 3 days minor sickness after PNEUMOVAX 23 (PPSV23).
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Dyspnoea, Neck pain, Pyrexia
Clinical narrative: T/C received from pt on 5/3/16 stating that since vaccination she has had felt pressure in her neck and c/o difficulty breathing sometimes. Reports having had fever after vaccine. Still c/o neck pain and feels as though it's difficult to take a deep breath. Saw PCP on 5/2/16 who told her to contact Imm. Clinic. No treatment.
Age: 1.01
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Irritability, Pyrexia, Rash, Rash vesicular
Clinical narrative: Fever day after vaccines; fussy for a few days and developed rash around nose. Fever again 4/26 -> 4/28/16. Fever again 5/4 -> 5/6/16 associated with vesicular rash - starting in groin, then perianally, posterior neck/upper back, ears, face, elbows, knees, hands, feet. Fever on 5/6/16 close to 106 degrees F.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, Rheumatoid arthritis
Clinical narrative: Pt came in for walk in vaccine. No medical hx or meds on file. 15 days later pt hospitalized for RA. Unbeknownst to our staff pt had RA and was on REMICADE. Receipt of vaccine delayed infusion and as result pt was hospitalized.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Face injury, Fall, Loss of consciousness
Clinical narrative: Pt had LOC post GARDASIL injection causing fall from exam table and facial injury.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old patient of unknown gender. No concurrent condition, medical history and concomitant therapies were reported. On 02-MAY-201 the patient was inadvertently administered 1 dose of (Oka/Merck) VARIVAX (lot#, dosage and route not provided) and 1 dose of (Oka-Merck) PROQUAD (lot#, dosage and route not provided) (overdose). No adverse effect were reported. It was unspecified if the patient sought any medical attention. Additional information is not expected as there was no consent to contact the nurse.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2016US027045 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609777) on 29 Feb 2016. This report refers to a 44 years old female patient. Medical history was not reported. Concurrent condition included asthma. Concomitant medications included NEXIUM, PROZAC, WELLBUTRIN, SEROQUEL and CAMRESE. The patient was vaccinated with FLUVIRIN (batch number: not reported) into right arm and PNEUMOVAX (batch number: L010598, other manufacturer) into left arm; both intramuscularly on 12 Nov 2015. On the same day after vaccination the patient's arm got red, swollen and painful. On 14 Nov 2015 the patient consulted doctor and received antibiotics and pain meds to treat diagnosis of cellulitis. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "cellulitis" was upgraded based on the NVS-IMS list. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow-up information from quality assurance department (QA reference nr. 1012901) received on 03 Mar 2016: Updated QA reference number only. Significant follow up report received from a Quality Assurance Department (QA reference number: 1012901) on 04 Mar 2016: Annual product review summary added, deleted the batch number as it was invalid batch number.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2016US026992 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609924) on 29 Feb 2016. This report refers to a 27 years old female patient. The patient had no medical history and concurrent condition. Concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 12 Nov 2015. On 13 Nov 2015 the patient presented with swollen like rash at injection site which was starting to get infected. The patient was told to keep an eye and apply topical antibiotics. Next day it became a lot worse and larger in the PM. The patient was sent to urgent care and then received oral antibiotics. Outcome of the events was recovered.   The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "vaccination site infection" was upgraded based on the Novartis Important Medical Events list. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow-up information from quality assurance department (QA reference nr. 1012886) received on 03 Mar 2016: Updated QA reference number only. Follow up received from quality assurance department (QA reference number: 1012886) on 04 Mar 2016: Added annual product review investigation summary.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal death, Foetal heart rate abnormal
Clinical narrative: Case number PHHY2016US027240 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610363) website on 29 Feb 2016: This report refers to a 41 years old female who was pregnant with no prior complications. The patient's last menstrual date was not reported. Concomitant medication included prenatal vitamins. She was vaccinated with the FLUVIRIN (batch number: 1517501) on 27 Oct 2015 during her 38th week of gestation. It was reported that, fetus had a pronounced death further reported as fetus heartbeat stopped beating less than 24 hours after she received the flu shot. It was reported that, the patient was hospitalized for 4 days and she recovered physically but the fetus was lost. Causality was not reported. Batch review report reference number (1013409) received from quality assurance department on 25 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1517501) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from a Quality Assurance department (QA reference number: 1013409) on 17 Mar 2016: QA reference number added. Follow up received from quality assurance department (QA reference number: 1013409) on 25 Apr 2016: Added expanded batch review report.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Heart rate decreased, Loss of consciousness, Snoring
Clinical narrative: Case number PHHY2016US029692, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613395) website on 29 Feb 2016. This report refers to a 12-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in arm on 29 Nov 2015. On the same day, the patient passed out and started snoring for 2 seconds. His blood pressure was watched for 15 to 20 minutes. First reading noted blood pressure was 100/60 (units unspecified), and pulse rate was 66 (units unspecified) and second reading noted blood pressure as 107/57 (units unspecified) and pulse rate as 57 (units unspecified). Outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious. Causality of the events was not reported. Seriousness of the events blood pressure decreased, heart rate decreased and loss of consciousness was upgraded to medically significant based on the information available in the source document. The quality assurance (QA) department confirmed that, previously reported batch number 151201 was not a valid FLUVIRIN batch number. Hence, standard QA request would not be investigated. Follow up report received from quality assurance (QA) department on 09 Mar 2016: Added QA comment.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 62 year old female patient. The patient's historical drug included EPIPEN. The patient had no drug reactions or allergies, medical history and concomitant medication. On 29-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L031273, expiry date: 19-NOV-2016; dose not reported) subcutaneous. It was reported that the patient developed a "spot the of an orange, that was red, itchy, and painful like bee sting" following vaccination with ZOSTAVAX on an unknown date in 2016. The patient sought medical attention-contacted pharmacist. No laboratory tests were performed. The pharmacist did not aware of any treatment given to the events. The outcome of events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 62 year old female patient. The patient's historical drug included EPIPEN. The patient had no drug reactions or allergies, medical history and concomitant medication. On 29-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L031273, expiry date: 19-NOV-2016; dose not reported) subcutaneous. It was reported that the patient developed a "spot the of an orange, that was red, itchy, and painful like bee sting" following vaccination with ZOSTAVAX on an unknown date in 2016. The patient sought medical attention-contacted pharmacist. No laboratory tests were performed. The pharmacist did not aware of any treatment given to the events. The outcome of events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal pain, Autopsy, Death
Clinical narrative: Pt vaccinated on 3/18/16. Pt presented to office on 3/23/16 with c/o abdominal pain and fever for 3 days and sore throat as per mother. Temp 99.2, Pulse - 75, Resp 18, and BP 119/76. Pt diagnosed with acute URI and discharged home. Received phone call from M.E. on 3/24/16 that pt had expired.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal pain, Death, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Pt vaccinated on 3/18/16. Pt presented to office on 3/23/16 with c/o abdominal pain and fever for 3 days and sore throat as per mother. Temp 99.2, Pulse - 75, Resp 18, and BP 119/76. Pt diagnosed with acute URI and discharged home. Received phone call from M.E. on 3/24/16 that pt had expired.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Upper respiratory tract infection
Clinical narrative: Pt vaccinated on 3/18/16. Pt presented to office on 3/23/16 with c/o abdominal pain and fever for 3 days and sore throat as per mother. Temp 99.2, Pulse - 75, Resp 18, and BP 119/76. Pt diagnosed with acute URI and discharged home. Received phone call from M.E. on 3/24/16 that pt had expired.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Abnormal behaviour, Headache, Hypersomnia, Irritability, Lethargy
Clinical narrative: Patient developed a very high fever very suddenly and was not acting like herself (not even how she usually acts whenever she is sick with normal illness/fever). She vomitted multiple times and was extremely lethargic sleeping most of the afternoon which she also never does. She also complained about her head hurting. The sickness lasted for almost two days. She was irritable for several days after this.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Patient developed a very high fever very suddenly and was not acting like herself (not even how she usually acts whenever she is sick with normal illness/fever). She vomitted multiple times and was extremely lethargic sleeping most of the afternoon which she also never does. She also complained about her head hurting. The sickness lasted for almost two days. She was irritable for several days after this.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to two unspecified patients patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On multiple unspecified dates, patients were vaccinated with improperly stored (temperature: -8.3 degree Celsus for 11 hours, because of data logger), VARIVAX lot #L019124, expiry date 27-MAY-2017, (dose and frequency not reported). There was no previous temperature excursion. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 06-MAY-2016 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K018183 with expired date of 04-MAY-2016; strength, dosage, frequency and route unspecified). No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 60 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced myelitis transverse. No treatment was given for the adverse event. The patient sought unspecified medical attention. Action taken with ZOSTAVAX was not applicable however it was also reported as continued. The outcome of myelitis transverse was not specified. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of myelitis transverse was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to two unspecified patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On multiple unspecified dates, patients were vaccinated with improperly stored (temperature: -8.3 degree Celsius for 11 hours, because of data logger), PROQUAD (Merck), lot # L050908, expiry date 14-JUN-2017, (dose and frequency not reported). There was no previous temperature excursion reported. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. No further information was provided.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received froma physician referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 22-APR-2016 the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route and lot # were unknown), instead of the intended ZOSTAVAX (dose, route and lot # were unknown) (wrong drug administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to 2 patients of unknown age and gender.  Information regarding the patients current condition and medical history was not provided. On an unknown date (a while ago) the patients were vaccinated with ZOSTAVAX, vial, dose, lot number unspecified. On an unknown date the patients experienced shingles. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was reported as recovered/resolved. The causality assessment was not provided. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-APR-2016 the patient was vaccinated with an improperly stored (30.8 Fahrenheit for 9 hours and 67 Fahrenheit for 9 hours) dose of GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a patient of unknown age and gender. Information regarding the patient's current condition and medical history was not provided. On an unknown date (a while ago) the patient was vaccinated with ZOSTAVAX (vial, dose, lot number unspecified). On an unknown date the patient experienced shingles. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was reported as not recovered/resolved (recurring shingles). The causality assessment was not provided. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphagia, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: This spontaneous report was received from a physician referring to a 12 year old female patient. On 05-APR-2016, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose was not reported, lot # L048237 with 08-MAY-2017). On 05-APR-2016, 10 min after vaccination, the patient experienced swallowing difficulty, which patient described like swallowing blood. Upon examination patient was found to have an erythematous and edematous posterior pharyngeal area. The physician reported that the patient was treated with 25mg of BENADRYL and experienced a complete resolution of symptoms on the same day, within 30 minutes. Physician reported that vital signs were taken at the time of report and were within normal range. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. In June 2013, the patient was vaccinated with the first dose of GARDASIL 4 injection (lot # H021346 with expiry date: 01-OCT-2015) and on 11-AUG-2015, with the second dose of GARDASIL 4 (lot # K016966 with expiry date: 10-MAY-2017). The following vaccination the patient received was a dose of GARDASIL 9 (lot # reported as 1013429 with expiry date: 21-JUL-2017). No concomitant medications were reported. No adverse events were reported. 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 refers to a patient of unknown age. On 04-MAY-2016, the patient was vaccinated with an improperly stored ZOSTAVAX, lot # 1033311, 01-DEC-2016. No adverse effects were reported. Temperature of 30 Fahrenheit, 6 hours. There was no previous temperature excursion. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Heart rate increased, Skin discolouration
Clinical narrative: Received 2 mo Immunes on 5/9/16. Woke from nap on 5/9/16 inconsolable crying, mottled lower extremities. Seen in ER. Afebrile, increased HR to 146. Tyl given after calmed down dischg home. Immune sites clear.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Shoulder pain and weakness started a few weeks after administering soon followed by feet numbness and fatigue. Guillain Barre diagnosed 12/27/2014.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash vesicular, Scab
Clinical narrative: Developed fever (approximately 103.8 at highest point) then rash spread over body.  Concentrated more on legs, arms, and face.  Only small amt on torso (buttocks, groin and neck).  Some sites vesicular and others scabbed over. Presented to clinic for eval on 5/3/2016.  Fever had resolved at that point but rash remained. Areas on face appeared to be infected due to scratching, etc. Mother has been using calamine lotion on sites.  Treated with Loratadine 2.5ml QD, Bactroban ointment bid to infected areas.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Skin infection
Clinical narrative: Developed fever (approximately 103.8 at highest point) then rash spread over body.  Concentrated more on legs, arms, and face.  Only small amt on torso (buttocks, groin and neck).  Some sites vesicular and others scabbed over. Presented to clinic for eval on 5/3/2016.  Fever had resolved at that point but rash remained. Areas on face appeared to be infected due to scratching, etc. Mother has been using calamine lotion on sites.  Treated with Loratadine 2.5ml QD, Bactroban ointment bid to infected areas.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 5-year-old male patient who received PEDIARIX (batch number FY7FK, expiry date 27th May 2016). Concurrent medical conditions included conjunctivitis. Concomitant products included POLYTRIM. On 19th April 2016, the patient received PEDIARIX .5 ml. On 20th April 2016, 1 days after receiving PEDIARIX, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovering/resolving. The reporter considered the hives to be possibly related to PEDIARIX. Additional details provided were as follows: The patient had conjunctivitis at the same time and was given POLYTRIM drops on the vaccination day. The patient developed hives on his abdomen and legs. The physician advised the patient to take BENADRYL and the hives seemed to lessen but were still visible. The reporter stated no respiratory involvement at this time.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a 68 year old female patient, reporting on herself. Her medical history and concurrent conditions were not reported. On 14-APR-2016 (reported as on Thursday), the patient was vaccinated with ZOSTAVAX in unspecified forearm (strength, dose, route and lot number were not reported). Concomitant medications were not reported. On 16-APR-2016 (reported as Saturday), the patient developed a rash around the injection site, the rash looked like a patch and was thick. The patient sought a medical attention via visiting back the physician and received BENADRYL, however, the outcome of injection site rash was unknown. The relatedness between the event and vaccination with ZOSTAVAX was not reported. Additional information is not expected since there was no contact information provided.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse via office manager refers to a 12 month old female patient. The patient's concurrent conditions and medical history were not reported. On 21-APR-2016, the patient was vaccinated with a first dose of (Merck) VARIVAX lot # L035127, expiry date 14-SEP-2017 (route and site of administration were not reported, which had previously undergone a supported temperature excursion. Concomitant therapies included MMR II. It was unknown if there was any relevant laboratory data. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender regarding self. Pertinent medical history, concurrent condition and concomitant medication were not reported. On an unknown date in September 2013 the patient was vaccinated with first dose of GARDASIL injection. On an unknown date in January 2014 the patient was vaccinated with second dose in series and on an unknown date in March 2014, the patient was vaccinated with third dose in series (inappropriate schedule of vaccine administered). Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative 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 an unknown date, the patient was vaccinated with the second dose of varicella vaccine. It was unknown if the vaccine was PROQUAD (Merck) or a monovalent vaccine such as VARIVAX (Merck) (exact dose, intervals, therapy type, lot #, expiration date and route of administration were not reported). On an unknown date, within a week after the second dose of vaccine, the patient developed an undiagnosed case of chickenpox. The outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected due to lack of the reporter's contact details.
Age: 14.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Headache, Pruritus, Pyrexia, Tremor
Clinical narrative: Fever to 103.2 with shaking chills and bad headache. Two and a half hours later developed diffuse itching and a hive of the left arm (mother is a dermatologist).
Age: 14.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Fever to 103.2 with shaking chills and bad headache. Two and a half hours later developed diffuse itching and a hive of the left arm (mother is a dermatologist).
Age: 29.0
Sex: M
Vaccine: JEV1
Symptoms: Rash
Clinical narrative: Rash.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: And red, painful, warm, swollen area around vaccine admin site, extended from shoulder to elbow.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L044055 exp. 02-MAY-2017 or lot # L051102 exp. 17-JUN-2017 (dose, site and route of administration were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of max 10.2 degrees Celsius for 10 hours 45 minutes on an unspecified date. No product quality issue was involved. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX, lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer (the patient's sister) and refers to a female patient in her early 70's. The patient was not smoking. Her concurrent conditions included chronic obstructive pulmonary disease (COPD) and bad allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, injection site, lot # and expiration date were not provided). On an unknown date, a few months after the vaccination the patient developed shingles. The patient sought medical attention. The outcome of the event was reported as recovered, on an unknown date (also reported as "a few years"). The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected because there was no consent to contact with the reporter.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Peripheral swelling, Rash
Clinical narrative: Blisters and rash from shoulders all the way down to my back to coccyx bone all the way around my waist. Rash on right lower leg. And swelling in feet. Went to urgent care. Then went to hospital urgent care.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse via office manager refers to a 12 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L018351, expiry date 11-AUG-2017 (route and site of administration were not reported) which had previously undergone a supported temperature excursion. It was unknown if there was any relevant laboratory data. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Macule, Sinus congestion
Clinical narrative: On day 10- noticed 10 pale pink, non-raised macules on central abdomen only. (Below the skin only). Denies itching/burning. Not spreading- is fading with no additional macules. Denies fever or other illness except "sinus congestion" which is common for this client.   Denies any new foods, soaps, clothes. Client did begin pediatric office observation on day 6/7 post vaccination.
Age: 1.57
Sex: M
Vaccine: DTAP
Symptoms: Abdominal discomfort, Diarrhoea, Irritability, Vomiting
Clinical narrative: Diarrhea began and was followed by 6 loose and watery bowel movmements over the course of the next 30 hours. Also vomited roughly 30 hours after vaccination. Irritability and apparent stomach discomfort for approximately 5 days following vaccination, with occasional loose stools.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Mass, Tenderness
Clinical narrative: Lump appeared on distal end of left clavicle approx 2 1/2 x 1 1/2. Tender to touch. Evaluated on May 2, May 4 and May 10,2016. No change.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin mass, Tenderness
Clinical narrative: Lump appeared on distal end of left clavicle approx 2 1/2 x 1 1/2. Tender to touch. Evaluated on May 2, May 4 and May 10,2016. No change.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a non-pregnant 14 year old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On 28-APR-2016, the patient was vaccinated with the GARDASIL 9 injection, in the upper arm deltoid area, (dose, route of administration, lot number and expiration date were not provided) for routine HPV vaccination. There were no concomitant medications reported. On the same date, the patient experienced swelling in her hand "in the arm where she got the injection". The patient sought medical attention via calling her physician who provided "support over the phone". No laboratory diagnostic studies were performed. It was reported that the physician intended to contact the patient again the next morning (on 29-APR-2016). At the time of the report, it was unknown whether the patient would receive her two remaining doses of GARDASIL 9. The outcome of hand swelling was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.