chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Orthostatic hypotension, Respiratory disorder, Respiratory tract infection, Scan brain, Seizure
Clinical narrative: Information has been received from the patient's husband referring to his 52 year old wife, a female patient who was immunocompromised. The patient had no pertinent medical history. On 01-MAY-2011 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose, route not reported). Concomitant therapies included gabapentin, lidocaine (manufacturer unknown) and unspecified thyroid medication. On around 08-MAY-2011 the patient experienced muscle weakness, seizures, vision problems, breathing problems, bowels problems, stomach problems, bladder stop working, passing out, acute respiratory tract infection (ARTI), orthostatic hypotension, heart issue, and her blood work results issues while on PNEUMOVAX23. The patient had been in many unspecified hospitals on several unspecified dates with the latest being at an unspecified hospital for 13 days and "currently" the patient was at an unspecified clinic. Unspecified treatment was given for the events. Unspecified brain scans, unspecified blood work, spinal taps, seizure studies and electrocardiogram (EKGs) were performed and the results were not provided. Outcome of the events was reported as not recovered. The causality was not provided. Upon internal review, seizures was determined to be medically significant. additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: Information has been received from the patient's husband referring to his 52 year old wife, a female patient who was immunocompromised. The patient had no pertinent medical history. On 01-MAY-2011 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose, route not reported). Concomitant therapies included gabapentin, lidocaine (manufacturer unknown) and unspecified thyroid medication. On around 08-MAY-2011 the patient experienced muscle weakness, seizures, vision problems, breathing problems, bowels problems, stomach problems, bladder stop working, passing out, acute respiratory tract infection (ARTI), orthostatic hypotension, heart issue, and her blood work results issues while on PNEUMOVAX23. The patient had been in many unspecified hospitals on several unspecified dates with the latest being at an unspecified hospital for 13 days and "currently" the patient was at an unspecified clinic. Unspecified treatment was given for the events. Unspecified brain scans, unspecified blood work, spinal taps, seizure studies and electrocardiogram (EKGs) were performed and the results were not provided. Outcome of the events was reported as not recovered. The causality was not provided. Upon internal review, seizures was determined to be medically significant. additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse event was experienced.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Injection site discolouration, Mobility decreased, Pain
Clinical narrative: Injection site turned black and blue. Arm was swollen and Wednesday 2/11/15 arm was swollen and red almost down to my elbow.  Whole arm and hand was swollen.  When had lab work done on Friday 2/6/15 white blood count was high enough for doctor to call and have me report to immediate care. I was told it was Cellulitis and given an antibiotic.  However by Friday 2/6/15 the three fingers on that left arm are so painful and unable to make a fist are painful to touch and painful to use them.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Tenderness, White blood cell count increased
Clinical narrative: Injection site turned black and blue. Arm was swollen and Wednesday 2/11/15 arm was swollen and red almost down to my elbow.  Whole arm and hand was swollen.  When had lab work done on Friday 2/6/15 white blood count was high enough for doctor to call and have me report to immediate care. I was told it was Cellulitis and given an antibiotic.  However by Friday 2/6/15 the three fingers on that left arm are so painful and unable to make a fist are painful to touch and painful to use them.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: A few hours after I returned home my collar bone and neck started hurting.  This lasted for a few weeks. About a month ago it started hurting again.
Age: 17.0
Sex: F
Vaccine: HEPA, HPVX, MEN
Symptoms: Eye movement disorder, Headache, Moaning, Pain in extremity, Syncope
Clinical narrative: Pt said she felt pain moving down her arm, then she felt it in her head. Her eyes rolled back and she began groaning and collapsed. She experienced psychedelic visions while out. Also received HepA and Meningoccocal.
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Vaccination site oedema
Clinical narrative: EDEMA AND REDNESS AT VACCINATION SITE (RIGHT AND LEFT ARM).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with M-M-R II (route, dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been 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 nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (route, dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with VAQTA (route, dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been 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 healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored, oral, ROTATEQ (Lot number, expiry date and dose were not reported) oral. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
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. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB, intramuscular (dose and frequency were not provided). No symptoms were reported. This is one of several reports received from the same reporter. Follow-up information has been received from a receptionist on 03-JUN-2015. The reporting medical assistant was no longer at the facility. The receptionist was familiar with the vaccine storage issue and would forward the request for patient identifiers, lot numbers and dates of vaccination to a new office manager. Additional information has been requested. AEs and the narrative have been updated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date the patients were vaccinated with improperly stored (Merck) PROQUAD, .5 ml, subcutaneous. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. 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 regarding an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, .5 ml, subcutaneous. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. 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 was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored RECOMBIVAX HB (Lot number, expiry date, dose and route of administration were not reported). No adverse events were reported. This is one of the several reports 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 healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (strength, lot#, expiration date, dose and route were unknown). The temperature excursion for GARDASIL was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports 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 nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with ROTATEQ orally (dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (strength, lot#, expiration date, dose and route were unknown0. the temperature excursion for M-M-R II was not supported with in-house stability data. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site cellulitis, Local reaction, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 1st of 6 reports. A 65 or older patient of an unspecified ethinicity and gender received PREVNAR 13, (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on 27May2015. The patient medical history was unknown. The patient's concomitant medications were unknown. On 27May2015 the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The patient recovered. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: She had a seizure that lasted 15 minutes.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patients of unknown demographics. Relevant medical history and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date unspecified. No adverse effect was 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: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (dose strength, route unspecified). No adverse effects reported. Follow up information has been received from the pharmacist who provided additional information. It was reported that a current 57 year old patient (gender not provided) received a dose of ZOSTAVAX Lot # K021953, expiry date on 10-FEB-2016, that was inappropriately storage. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (Lot number, expiry date. dose and route of administration were not reported). No adverse events were reported. This is one of the several reports from the same reporter. 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 healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients was vaccinated with an improperly stored VARIVAX (Merck) (Lot number, expiry date, dose and route of administration were not reported). No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-MAY-2015, the patient was vaccinated with an improperly stored M-M-R II (lot number, expiry date, dose and route of administration were not reported). No adverse events were reported. This is one of several reports from the same reporter. 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 registered nurse regarding an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL, 120 Y(DF), injection. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. 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 an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (strengtth, dose, lot# and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional, via company representative, refers to her son of unknown age. On an unspecified dates, the patient received the first three doses of GARDASIL. On 28-MAY-2015, the patient was vaccinated with the fourth dose of GARDASIL (lot #, dose, route and site of administration were not reported). No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (strength, does, lot# and route not provided) (incorrect product storage). No adverse effects 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: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (strength, dose and lot# not provided) orally (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored COMVAX (strength, dose, lot# and route not provided) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (strength, does, lot# and route not provided) (incorrect product storage). No adverse effects 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: This spontaneous report as received from a health care professional refers to a unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (dose, route and frequency unspecified). No medical history and concomitant medications were provided. It was reported that the doses administered on an unknown date to an unspecified number of patients may have been improperly stored doses of either GARDASIL or ROTATEQ or improperly stored doses of both GARDASIL and ROTATEQ. No adverse effects reported. The outcome of the medication error was unknown. No product quality complaint involved. This is one of several reports received from the same source. 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 care professional refers to a unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with, Oral, ROTATEQ (dose, route and frequency unspecified). No medical history and concomitant medications were provided. It was reported that the doses administered on an unknown date to an unspecified number of patients may have been improperly, stored doses of either GARDASIL or ROTATEQ or improperly stored doses of both GARDASIL. No adverse effects reported. The outcome of the medication error was unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a physician via a company representative concerning a male patient of unknown age. On unspecified date in 2014 (reported as "about one year ago"), the patient was vaccinated with his second dose of GARDASIL (dose, strength and route were not reported). On an unknown date the patient developed dizziness and sweating. The patient had sought unspecified medical attention. The outcome of the events was reported as recovered on unspecified date. Additional information is not expected because the physician did not want to be contacted.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner through a Pfizer Hospital representative. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced cellulitis at the injection site on an unspecified date. The event was reported as serious due to hospitalization. At hospital, the patient received unspecified IV antibiotic. The outcome of the event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse concerning unspecified number of patients of unknown demographics. On unspecified dates since 05-FEB-2015, unspecified patients were vaccinated with VARIVAX (1. lot number: K003412, expire date: 06-MAR-2016; 2. lot number: K005427, expire date: 15-APR-2016; 3. lot number: K006138, expire date: 29-APR-2016; 4. Lot number: K007981, expire date: 03-JUN-2016; 5. Lot number: K010440, expire date: 22-JUL-2016; 6. Lot number: K015971, expire date: 23-SEP-2016; 7. Lot number: K021484, expire date: 03-NOV-2016; 8. Lot number: K026387, expire date: 15-DEC-2016; 9. lot number: L001335, expire date: 13-JNA-2017, dose and route unspecified), which were previously exposed to temperatures outside of the recommended range. No adverse effect had been observed or reported. Additional information has been requested.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for her mother. A 96-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The reporter mentioned that on an unknown date the patient "was much dying of the shot over a while, she ended up sleeping for about a week, she was very very tired for a couple of weeks, her arms got sore for almost 3 weeks (she has never recovered from it) and she had bad breathing, poor oxygen and she got worse". Patient not recovered from "arms got sore" and "bad breathing"; the final outcome of the other events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 2nd of 6 reports. An elderly patient of an unspecified age, ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. On an unknown date the area became hot, hard and red (generally a large portion of the arm, not localized to injection site, a more perfused area). Events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth, Local reaction, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 2nd of 6 reports. An elderly patient of an unspecified age, ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. On an unknown date the area became hot, hard and red (generally a large portion of the arm, not localized to injection site, a more perfused area). Events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 1st of 6 reports. A 65 or older patient of an unspecified ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth, Local reaction, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 1st of 6 reports. A 65 or older patient of an unspecified ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Coccydynia
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with unspecified food allergies. The patient had no medical history. On 26-JAN-2011, the patient was vaccinated with her first dose of GARDASIL (0.5 ml, once, intramuscular). On 12-APR-2013 and 30-APR-205, the patient was vaccinated with her second and third dose of GARDASIL respectively (inappropriate schedule of vaccine administered). No concomitant therapy was reported. On 01-MAY-2015, the patient developed pain in her tailbone when rising from a lying position to a sitting position. The patient did not experience the pain on ambulation. The physician would be scheduling an office evaluation in her near future. No treatment was given for the event. No lab diagnostics studies were performed. The physician had sought medical attention by contacting the physician via phone. The tailbone pain was not recovered at the time of reporting. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer Sales Representative. The nurse reported similar events for six patients, who experienced the same issues over the past 3 months before this report. This is the 6th of 6 reports. An elderly patient of an unspecified ethnicity and gender received on unknown date a single dose of PREVANR 13 (Expiry date and NDC # Unknown) subcutaneous in arm (unknown of which one). Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The outcome of the events was unknown. Laboratory tests performed were unknown. The patient was treated with antibiotics for cellulitis.
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth, Local reaction, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer Sales Representative. The nurse reported similar events for six patients, who experienced the same issues over the past 3 months before this report. This is the 6th of 6 reports. An elderly patient of an unspecified ethnicity and gender received on unknown date a single dose of PREVANR 13 (Expiry date and NDC # Unknown) subcutaneous in arm (unknown of which one). Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The outcome of the events was unknown. Laboratory tests performed were unknown. The patient was treated with antibiotics for cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 28-MAY-2015 the patient was vaccinated with the first dose of ZOSTAVAX (dose, lot #, route and application site were not reported). On 28-MAY-2015 the patient was inadvertently administered a second dose of ZOSTAVAX (dose, lot #, route and application site were not reported). No adverse effects reported. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 6th of 6 reports. An elderly patient of an unspecified age, ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. On an unknown date the area became hot, hard and red (generally a large portion of the arm, not localized to injection site, a more perfused area). Events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth, Local reaction, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 6th of 6 reports. An elderly patient of an unspecified age, ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. On an unknown date the area became hot, hard and red (generally a large portion of the arm, not localized to injection site, a more perfused area). Events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (L.V.N) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 20-MAY-2015 the patient was vaccinated with a dose of incorrect stored RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016. concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was unspecified if the patient sought any medical attention. 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 was received from a health care professional refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with GARDASIL injection lot # K006960; expiry: 19-FEB-2017 (dose, route and frequency unspecified). On an unknown date, the patients were administered GARDASIL 9 that had been improperly stored. No adverse effects reported. No further information provided. The outcome of incorrect product storage and no adverse event is unknown. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (L.V.N.) referring to a patient of unknown age and gender. History medication and drug allergies were not reported. On 19-MAY-2015 the patient was vaccinated with a dose of incorrect stored RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016). Concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was reported if the patient sought any medical attention. 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 Licensed Vocational Nurse (L.V.N) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 16-MAY-2015 the patient was vaccinated with a dose of incorrect stored ECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016). Concomitant drug was no reported. At the time of reporting, no adverse effects was reported and it was unspecified if the patient sought any medical attention. 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 Licensed Vocational Nurse (L.V.N.) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 18-MAY-2015 the patient was vaccinated with a dose of incorrect storage RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016). Concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was unspecified if the patient sought any medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 04-MAY-2015 the patient were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot# reported as K011979 with expiration date: 21-AUG-2016, lot#K026384 with expiration date: 15-DEC-2016, lot# K021487 with expiration date 30-NOV-2016 respectively; strength, dosage, frequency and route unspecified). No adverse experience was 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: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 04-MAY-2015 the patients were vaccinated with doses of improperly stored (Merck) PROQUAD, (lot# reported as L005293 with expiration date: 17-AUG-2016; strength, dosage, frequency and route unspecified). No adverse experience was 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 healthcare professional refers to 2 unspecified patients. On 11-MAY-2015, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (lot # L002419, expiration date 27-JUL-2016, dose, route and site of administration were not reported). The temperature excursion was supported with in-house instability data. No adverse symptoms were reported. Additional information has been requested.
Age: 1.43
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt developed rash approximately 2-3 hours after receiving MMR/Varivax/PCV13. A fine erythematous rash on trunk and upper extremities with some patches on face. No rash present at injection sites.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Dyspnoea, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Pt had onset of soreness and increased pain to injection site. Progressed the next day to: Increased pain and swelling to injection site; urticaria to left upper arm; lethargy; muscle pain to left upper am; tachyarrhythmia; chest pain; difficulty breathing at night; expiratory wheezing was worse; mental status alteration.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Mental status changes, Myalgia, Tachyarrhythmia, Urticaria, Wheezing
Clinical narrative: Pt had onset of soreness and increased pain to injection site. Progressed the next day to: Increased pain and swelling to injection site; urticaria to left upper arm; lethargy; muscle pain to left upper am; tachyarrhythmia; chest pain; difficulty breathing at night; expiratory wheezing was worse; mental status alteration.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient was taken to hospital with a 105 degree fever and a febrile seizure.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Rash, Skin discolouration, Swelling
Clinical narrative: Swelling/itchy the next day on the right side like the "egg side" and blue black afterward. But per pt has no fever, only pain, not feel any different.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint dislocation
Clinical narrative: Initial severe pain at injection site. It continued and spread from the left upper arm to the shoulder and upper back. Arm became unusable and was hanging out of the shoulder joint. Still very limited in use and constantly painful, lost muscle in area.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle atrophy
Clinical narrative: Initial severe pain at injection site. It continued and spread from the left upper arm to the shoulder and upper back. Arm became unusable and was hanging out of the shoulder joint. Still very limited in use and constantly painful, lost muscle in area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Dizziness, stiff neck, redness and soreness at site of injection, no fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm, fatigued started TYLENOL the day after received rx for BENADRYL and steroid 3 days after.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Nausea, Throat irritation
Clinical narrative: Pt has itchy throat and was nauseated. Gave EPIPEN and called 911. Ambulance took her to hospital. She received IV BENADRYL and prednisone tablet. She is ok but still weak.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthritis, Bone pain, Influenza, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of arthritis in a adult female patient who received Seasonal Influenza vaccine. Previously administered products included tetanus shot (in 1986) and flu vaccine with an associated reaction of influenza (the patient said that every time she gets a flu shot she gets really sick and also still gets the flu afterward). Concurrent medical conditions included asthma. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced arthritis, sickness, bone pain and influenza. On an unknown date, the outcome of the arthritis,  sickness, bone pain and influenza were recovered/resolved. The reporter considered the arthritis, sickness, bone pain and influenza to be possibly related to Seasonal Influenza vaccine. This was report 1 of the 2 case received from the same reporter. Additional details provided as follows: The reporter stated that the last flu shot she had was in 2007 or 2009 whenever the H1N1 epidemic took place. Also, after this most recent flu shot her bones started aching/felt achy. She thought she had fibromyalgia but got checked out and it was not. She then thought she was getting arthritis. This lasted for about 2 years and she had to go to the doctor quite a bit. The consumer did not know the names of any flu shots she has received.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 35-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 1st June 2015 15:10. The subject's estimated date of delivery was in June 2015. The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided as follows: Concomitant products included minerals nos + vitamins nos (Prenatal Vitamins). The reporter did not have the date of the patient's last menstrual period.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Dizziness, Dizziness postural, Feeling abnormal, Vision blurred
Clinical narrative: After lunch was sitting down and stood up and felt dizzy. Lost focus on vision on right eye. Right side of face was odd, not numb was at home with wife. For 3-4 hours felt really dizzy. Balance was off; wouldn't have been able to drive. Called doctor who told him to call if other symptoms occurred. Today feels fine. Right eye not as focused s left eye but it is improving. Run through the stroke symptoms checklist just in case but no symptoms meet criteria. On 6/3/15 symptoms lasted through suppertime.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with the doses of improperly stored GARDASIL (lot # K008931, expiration date: 04-MAR-2017. doses and routes were not reported and lot # K023432, expiration date: 18-JUN-2016, doses and routes not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal faeces, Cold sweat, Diarrhoea, Hyperhidrosis, Mucous stools
Clinical narrative: This spontaneous report as received from a registered nurse who was the mother of a 12 month old male patient. The patient's medical history included food protein-induced enterocolitis syndrome. No drug allergies was reported. On 08-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (Lot number, dose, unit and route were unspecified). On the same day, the patient was vaccinated with M-M-R II and hepatitis a vaccine (Lot number, dose, unit and route were unspecified) and VAQTA (Lot number, dose, unit and route were unspecified). Concomitant therapies included ZANTAC and PERIACTIN. On 15-MAY-2015, 8 days after onset of therapy the patient experienced pyrexia which she treated with TYLENOL cold sweat, also her son experienced symptoms similar to his preexisting condition (food-protein-induced enterocolitis syndrome) such as diarrhea, mucusy and stringy stool. She also noted that her son has been sleepy, sweaty and clammy although the although the fever had resolved. No lab diagnostics studies were performed. The patient had called pediatrician office and sought medical attention. No product quality complaint involved. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.