chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives, trunk area, ZYRTEC 10 mg QD and to force fluids.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Patients reports swelling of injection site up to 8 days after vaccine was administered.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediate soreness at injection site which has persisted for >6 weeks, limited range of motion.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Fall, Feeling abnormal
Clinical narrative: Patient went to lab to draw blood and while was sitting in the chair started to feel faint, and looked pale and was slipping out of lab chair. Pt was raised into chair. BP had dropped and FS 88. Eyes were open and he was responsive and was given fluids, apple juice and allowed to lie down. Pt was observed for over 1 hour and recovered and was discharged home. On f/u call 12/28/16 to see how patient is, mother reports child is still not himself, had a headache, sore throat, and slight temperature for past few days. So mother was recommended to bring child to ER now for further evaluation.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Headache, Oropharyngeal pain, Pallor, Pyrexia
Clinical narrative: Patient went to lab to draw blood and while was sitting in the chair started to feel faint, and looked pale and was slipping out of lab chair. Pt was raised into chair. BP had dropped and FS 88. Eyes were open and he was responsive and was given fluids, apple juice and allowed to lie down. Pt was observed for over 1 hour and recovered and was discharged home. On f/u call 12/28/16 to see how patient is, mother reports child is still not himself, had a headache, sore throat, and slight temperature for past few days. So mother was recommended to bring child to ER now for further evaluation.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced redness, swelling, itching, and pain at the injection site.
Age: 38.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: AN ASSOCIATE HAS A RASH AND ITCHING ALL OVER THE BODY ABOUT ONE HOUR AFTER ADMINISTERING THE VACCINES BOOSTRIX AND FLUARIX QUAD. THERE WAS NO PAIN OR ITCHING IN THE AREA OF VACCINE ADMINITRATION. 50 MG OF LIQUID BANOPHEN(DIPHENHYDRAMINE)WAS GIVEN ORALLY.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Upper Deltoid on-going pain for three weeks continuous.  Limited movement and range of motion for shoulder.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Facial Hives, patient was given Benadryl by mouth.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone normal, Electrocardiogram normal, Full blood count normal, Herpes zoster
Clinical narrative: Markedly elevated BP, left side facial and neck rash consistent with Herpes zoster.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Rash, Urine analysis normal
Clinical narrative: Markedly elevated BP, left side facial and neck rash consistent with Herpes zoster.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Urticaria
Clinical narrative: Developed redness, firmness, tenderness at injection site and developed hives.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Discomfort, Impaired work ability, Insomnia, Joint crepitation
Clinical narrative: I was unable to lift my arm for normal daily ADL's. I was put on 3 rounds of steroids and called into work in between the doses. It was all under workmans competition. Yet I was fired due to calling in. I was caused great pain, and discomfort for over 6 months. Getting dressed and sleeping became impossible. I still have tingling in my hand from time to time. And discomfort lifting certain ways. My arm now clicks with movement.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Loss of employment, Mobility decreased, Pain, Paraesthesia
Clinical narrative: I was unable to lift my arm for normal daily ADL's. I was put on 3 rounds of steroids and called into work in between the doses. It was all under workmans competition. Yet I was fired due to calling in. I was caused great pain, and discomfort for over 6 months. Getting dressed and sleeping became impossible. I still have tingling in my hand from time to time. And discomfort lifting certain ways. My arm now clicks with movement.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Lethargic, no appetite, fever 12/25-12/28. 12/28 she woke up with a rash at het hairline that spread along her whole body by 1:00pm. Rash is itchy, red spots.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Lethargic, no appetite, fever 12/25-12/28. 12/28 she woke up with a rash at het hairline that spread along her whole body by 1:00pm. Rash is itchy, red spots.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling, extending to elbow.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. has red, warm, raised area approx. 4 cm x 6 cm circumference at injection site (posterior RUA).
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Skin eruption, 4cm x 7cm, at inj site.
Age: 72.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asphyxia
Clinical narrative: I received information from the insurance. The patient did not call the pharmacy. The patient went to his doctor next day of the vaccines because of asfixia. The third day went to emergency room.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reaction at injection site on Right arm, red, swollen and warm to touch. Redness and swollen line of demarcation just below injection site and extends 6 inches down and around entire arm.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 15-DEC-2016, the patient was vaccinated with ZOSTAVAX, intramuscular route for prophylaxis (dosing details not provided). It was reported that, the patient's under part of the arm got swollen after the administration of vaccine on the same day (15-DEC-2016). The patient did not seek medical attention. The outcome of the event was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not involved. No further information was available. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 15-DEC-2016, the patient was vaccinated with ZOSTAVAX, intramuscular route for prophylaxis (dosing details not provided). It was reported that, the patient's under part of the arm got swollen after the administration of vaccine on the same day (15-DEC-2016). The patient did not seek medical attention. The outcome of the event was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not involved. No further information was available. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site discomfort, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of two reports. A 78-year-old male patient received PREVNAR 13; (lot number N97935, expiration date, Dec2017), intramuscularly, in the left deltoid, on 09Dec2016, at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On Dec092016, the patient experienced injection site discomfort; on 14Dec2016 the patient experienced pain in joint/shoulder. Clinical details were reported as follows: The patient initially reported discomfort at the injection site but that went away. Then several days later, the patient reported shoulder/joint pain, in the same arm the injection was given in. This pain started after the patient received the injection and does not seem to be improving. It gets better throughout the day but then starts back the next morning. The outcome of injection site discomfort was recovered in Dec2016; the outcome of pain in joint/shoulder was not recovered. The reported states that the causality does seem to be related, there doesn't seem to be any other explanation for the pain. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596497 same reporter/vaccine/event, different patient.
Age: 78.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injection site discomfort
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of two reports. A 78-year-old male patient received PREVNAR 13; (lot number N97935, expiration date, Dec2017), intramuscularly, in the left deltoid, on 09Dec2016, at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On Dec092016, the patient experienced injection site discomfort; on 14Dec2016 the patient experienced pain in joint/shoulder. Clinical details were reported as follows: The patient initially reported discomfort at the injection site but that went away. Then several days later, the patient reported shoulder/joint pain, in the same arm the injection was given in. This pain started after the patient received the injection and does not seem to be improving. It gets better throughout the day but then starts back the next morning. The outcome of injection site discomfort was recovered in Dec2016; the outcome of pain in joint/shoulder was not recovered. The reported states that the causality does seem to be related, there doesn't seem to be any other explanation for the pain. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596497 same reporter/vaccine/event, different patient.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injection site discomfort, Joint range of motion decreased
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients.  This is the second of two reports. A 75-year-old female patient received PREVNAR 13; (lot number N97935, expiration date, Dec2017), intramuscularly, in the left deltoid, on 09Dec2016, at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On Dec092016, the patient experienced injection site pain; on 15Dec2016 the patient experienced pain in joint/shoulder. Clinical details were reported as follows: The patient initially reported pain at the injection site but that went away. Then several days later, the patient reported shoulder/joint pain, in the same arm the injection was given in. This pain started after the patient received the injection and does not seem to be improving. It gets better throughout the day but then starts back the next morning. The patient still does not have full motion in the affected arm. The outcome of injection site pain was recovered in Dec2016; the outcome of pain in joint/shoulder was recovering. The reported states that the causality does seem to be related, there doesn't seem to be any other explanation for the pain. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596551 same reporter/vaccine/event, different patient.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients.  This is the second of two reports. A 75-year-old female patient received PREVNAR 13; (lot number N97935, expiration date, Dec2017), intramuscularly, in the left deltoid, on 09Dec2016, at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On Dec092016, the patient experienced injection site pain; on 15Dec2016 the patient experienced pain in joint/shoulder. Clinical details were reported as follows: The patient initially reported pain at the injection site but that went away. Then several days later, the patient reported shoulder/joint pain, in the same arm the injection was given in. This pain started after the patient received the injection and does not seem to be improving. It gets better throughout the day but then starts back the next morning. The patient still does not have full motion in the affected arm. The outcome of injection site pain was recovered in Dec2016; the outcome of pain in joint/shoulder was recovering. The reported states that the causality does seem to be related, there doesn't seem to be any other explanation for the pain. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596551 same reporter/vaccine/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Seizure, Syncope
Clinical narrative: Syncope and seizure.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse via Poison & Drug Center and refers to a 16 month old male patient. The patient's relevant medical history included otitis media and he had "no active problems". The patient's concomitant medications included a course of amoxicillin started on 21-NOV-2016 for otitis media. On 28-NOV-2016, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneously, once, lot # M028546, expiration date 07-JUN-2018 (anatomical location was not reported), for routine health care. The dose of vaccine had undergone a temperature excursion on an unknown date. The patient had no relevant laboratory values. The patient did not experience an adverse reaction and no treatments were provided. At the time of the report, it was unknown if the patient continued to receive VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000108: US-009507513-1612USA000174.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse via Poison & Drug Center referring to a 4 year old female patient. The patient's medical history included a 10-day antibiotic course completed on an unknown date over 5 weeks before her visit to the clinic for an unknown indication. On 25-NOV-2016, the patient was vaccinated with a dose of PROQUAD 0.5 ml, subcutaneously, lot # M022402, expiration date 01-NOV-2017 (anatomical location was not reported), for routine health care. The dose of vaccine had undergone a temperature excursion. The patient had no concomitant medications. The patient had no laboratory values. The patient did not experience an adverse reaction and no treatments were provided. At the time of 29-NOV-2016, it was unknown if the patient continued to receive VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA000108: US-009507513-1612USA000002: US-009507513-1612USA000174:
Sex: U
Vaccine: VARCEL
Symptoms: Secondary transmission
Clinical narrative: This spontaneous report was received from a consumer and refers to three patients of unknown gender and age. The patients' pertinent medical history and concomitant therapies were not reported. On 19-NOV-2016, the 5 year old male, who was a son of the reporter, was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported). On 30-NOV-2016, also reported as approximately 10 days after receiving the vaccine, the patient transmitted the vaccine strained virus to three patients, who were household family members. The outcome of the event and the causality between the event and VARIVAX were not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report regarding a 77 years old female patient was received from the patient's daughter. The patient's medical history and concurrent conditions were not reported. On 02-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for prevention of shingles (dose number, lot number and expiration date were unknown). On the same date, she was also vaccinated with an unspecified influenza virus vaccine. Concomitant medications were not reported. On the same date, the patient developed a fever. At the time of reporting, the patient had recovered from the fever. The causality assessment between the fever and ZOSTAVAX was not provided. Additional information is not expected as the patient did not wish to provide healthcare professional (HCP) contact details.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 17-NOV-2016, the patients were vaccinated with improperly stored doses of VAQTA lot # L015460, Expiration date: 20-JUL-2017 and Lot# M036459, Expiration date:18-JAN-2018 for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014191: US-009507513-1612USA014190: US-009507513-1612USA014189.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L031068, expiration date: 18-AUG-2017 for prophylaxis, which was exposed to 18F for 30.5 hours. It was reported that the vaccine doses did not have previous temperature excursion. No product quality complaint was involved. Additional information is not expected as the reporter did not consent for follow up attempts.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # K008873 with expiration date on 06-FEB-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour. There was a previous excursion of 33 degrees Fahrenheit for 74 hours reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1605USA003943.
Age: 35.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: CD4 lymphocytes increased
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 35 year old male patient. The patient's medical history, drug reactions/allergies, meanwhile, the patient's concurrent conditions included Human Immunodeficiency Virus (HIV). It was reported that, in April 2016, the patient had a CD4 count which result was 186 (units not provided). Later, on 12-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX23 lot number reported as: L7332, expiration date: July 2017, (strength, dose, frequency and route of administration were not reported) and PREVNAR 13 (Lot number, expiration date, strength, dose, frequency and route of administration were not reported); both for prophylaxis. No concomitant medications were reported. In June 2016, the patient had another CD4 count and the result was 312 (units not provided). Additionally, in July 2016 (reported as one month later), the patient received another dose of PREVNAR 13. No product quality complaints were involved. At the time of reporting, the outcome of the events was unknown. The Causality between the events with  PNEUMOVAX23) and PREVNAR 13 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner via a field representative referring to a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history were unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot # and expiration date  were not reported) for prophylaxis. After receiving ZOSTAVAX, the patient started to get swelling and rash around the injection site. The outcome of the events was unknown. The causality between ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2014, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). Then, on 28-JUL-2016, they received a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unknown dates, the patients were administered improperly stored doses of VARIVAX (dose and route unknown, lot # M023384, expiration date: 05-NOV-2018) for prophylaxis. The vaccines were exposed to 7 Fahrenheit degree for 30 minutes. These temperatures were not logged with a data logger and there were no prior excursions. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014050.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received via company representative from a female patient of unknown age reporting on herself. The patient's medical history included breakout of rashes "every year or so" which upon getting routine testing, occurred to be shingles. On an unknown date in September 2016, the patient was vaccinated, in a pharmacy, with the first dose of ZOSTAVAX injection (dose, site and route of administration, lot# and expiry date were not reported) for prevention of shingles. There was no information about the patient's concomitant medications reported. On an unknown date in 2016, the patient "broke out in a good size rash on her buttocks". The patient sought medical attention. Unspecified treatment was given for the adverse event. The patient recovered from the event on an unknown date in 2016. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. On an unknown date, the unspecified patient was administered the second dose of ZOSTAVAX (dose, frequency and route were unknown, lot# M036297, expiration date 14-NOV-2017) "one year" after his first dose for prophylaxis (unapproved dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, medical history, drug reactions or allergies provided. On 15-DEC-2016, the patient was vaccinated with GARDASIL 9 injection, intramuscularly, lot # M005714, expiration date: 03-OCT-2017 (dose was not reported) which was improperly-stored. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to a 58 year old female patient. Information about concomitant medication, pertinent medical history or drug reactions/allergies was unknown. On an unknown date in 2014 (reported as 2 years ago) the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot#, expiration date and route unknown) for prophylaxis. The Nurse Practitioner stated that the patient started a "methylprednisolone (MEDROL) Dose Pack" for unknown reasons, one day after the injection. No side effects reported. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored doses of ROTATEQ oral liquid (orally) for prophylaxis. (Strength, dose number, lot number and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013215: US-009507513-1612USA013214.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 22-DEC-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K021950, expiration date: 10-NOV-2016 (strenght, dose, frequency and route of administration were not reported ) for prophylaxis, by a physician. No adverse events were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored doses of PEDVAXHIB intramuscular injection, for prophylaxis. (Strength, route, dose number, lot number and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013215: US-009507513-1612USA011668.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 17-NOV-2016, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035510, Expiration date: 13-MAY-2017, orally for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003501: US-009507513-1612USA014191: US-009507513-1612USA014189.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 17-NOV-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K016965, Expiration date: 20-JUL-2017, Lot# M032147, Expiration date: 14-NOV-2019 and Lot# L009649, Expiration date: 29-NOV-2017 for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014190: US-009507513-1612USA014189: US-009507513-1612USA003501.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-DEC-2016 (reported as today at the time of the report), the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot #K018960, expiration date: 15-OCT-2016, dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP, HIBV, IPV, PNC13, TDAP
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for a 24 year-old female patient of an unspecified race and ethnicity who received in Apr2016 for immunization a single dose of PREVNAR 13, a dose of TDAP, a dose of haemophilus influenza type b vaccine, a dose of recombinant hepatitis b vaccine and a dose of poliovirus vaccine. Medical history included ongoing immunosuppression, concomitant medications were not reported. On an unspecified date in 2016 she had a very robust response to the vaccines with fever. Outcome was unknown. They would continue to hold off on further vaccinations as at the present time the patient remained immunosuppressed in treatment with prednisone and subcutaneous Ig.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 4 patients. This is the 3rd of 4 reports. An adult patient (over 60) of unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in the days before report (Dec2016), at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. The patient was treated in an urgent care center. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595831 Same reporter/drug/event, different patient; US-PFIZER INC-2016595836 Same reporter/drug/event, different patient; US-PFIZER INC-2016595837 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative, who reported similar events for four patients. This is the fourth of four reports. An adult patient of an unspecified gender who was over 60 years, received a single dose of PREVNAR 13, in Dec2016 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. Patient was taken to Urgent care center and it was unknown if was hospitalized or received treatments. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595828 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative, who reported similar events for four patients. This is the first of four reports. An adult patient of an unspecified gender, who was over 60 years, received a single dose of PREVNAR 13, in Dec2016 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. Patient was taken to Urgent care center and it was unknown if was hospitalized or received treatments. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595828 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 4 patients. This is the 2nd of 4 reports. An adult patient (over 60) of unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in the days before report (Dec2016), at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. The patient was treated in an urgent care center. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595828 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a medical assistant reporting on behalf of a physician. This Medical assistant reported similar events for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date as single dose for immunization. The patients medical history and concomitant medications were not reported. The patient experienced fever and swelling on an unspecified date. The outcome of fever and swelling was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596236 similar events and product, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a medical assistant reporting on behalf of a physician. This Medical assistant reported similar events for two patients. This is the second of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date as single dose for immunization. The patients medical history and concomitant medications were not reported. The patient experienced swelling on an unspecified date. The outcome of swelling was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596207 Similar events and product, different patient.
Age: 44.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient, from a Pfizer-sponsored program, Inbound Call Center for HCPs (IBCC).  A 44-year-old male patient received PREVNAR 13, via an unspecified route of administration in the left arm on 19Dec2016 at a single dose for immunisation. Medical history included drug allergy to many medications and sinus infections.  Concomitant medications included cefuroxime axetil (CEFTIN).  On 20Dec2016, the patient experienced fatigue, headache, fever, chills, muscle pain, and joint pain.  The clinical course was as follows: The headache, fever, and chills started around 4:00 PM on 20Dec2016.  The fever was up to 100 degrees Fahrenheit.  The fever and chills went away around 8:00 PM or 8:30 PM.  The fatigue started around noon on 20Dec2016.  The muscle pain and joint pain started around 7:00 PM on 20Dec2016.  He was so sore when he woke up on 21Dec2016.  The muscle pain and joint pain were the worst it had been.  It hurt when he started moving, but the more he moved around the better it seemed to get.  He stated moving hurt, but it felt better. Therapeutic measures were taken as a result of the fever and included treatment with ibuprofen (ADVIL) which did not work. The clinical outcome of the event, fatigue, was not recovered. The clinical outcome of the events, fever and chills, was recovered on 20Dec2016 at around 8:00PM or 8:30PM. The clinical outcome of the events, headache, muscle pain, and joint pain, was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient, from a Pfizer-sponsored program, Inbound Call Center for HCPs (IBCC).  A 44-year-old male patient received PREVNAR 13, via an unspecified route of administration in the left arm on 19Dec2016 at a single dose for immunisation. Medical history included drug allergy to many medications and sinus infections.  Concomitant medications included cefuroxime axetil (CEFTIN).  On 20Dec2016, the patient experienced fatigue, headache, fever, chills, muscle pain, and joint pain.  The clinical course was as follows: The headache, fever, and chills started around 4:00 PM on 20Dec2016.  The fever was up to 100 degrees Fahrenheit.  The fever and chills went away around 8:00 PM or 8:30 PM.  The fatigue started around noon on 20Dec2016.  The muscle pain and joint pain started around 7:00 PM on 20Dec2016.  He was so sore when he woke up on 21Dec2016.  The muscle pain and joint pain were the worst it had been.  It hurt when he started moving, but the more he moved around the better it seemed to get.  He stated moving hurt, but it felt better. Therapeutic measures were taken as a result of the fever and included treatment with ibuprofen (ADVIL) which did not work. The clinical outcome of the event, fatigue, was not recovered. The clinical outcome of the events, fever and chills, was recovered on 20Dec2016 at around 8:00PM or 8:30PM. The clinical outcome of the events, headache, muscle pain, and joint pain, was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Hypersomnia, Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 60-year-old female patient received pneumococcal 13-val conj vaccine, on 21Dec2016 at 0.5 ml single in right arm as prevention vaccine. Medical history included diabetes mellitus and blood pressure high. Ongoing concomitant medications included metformin for diabetes, estradiol as hormone replacement therapy and metoprolol for blood pressure high . Starting 21Dec2016 patient could not move her right arm due to it being sore. The right arm soreness went from the top of her shoulder to right before her elbow. Since 21Dec2016  she can't move her arm without it hurting, her right arm was more stiff and painful and the shot also made her tired, she slept most of the day after getting it. On 21Dec2016 she also experienced swelling and hard at the injection site on right arm. She took 2 ADVIL as treatment and wondered if she should use hot or warm compresses. It was reported a worsening of the following events: right arm sore, can't move her right arm without it hurting and right arm was more stiff and painful. Fatigue was recovering; outcome of she slept most of the day after vaccination was unknown, while the outcome of the other events was not recovered. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 60-year-old female patient received pneumococcal 13-val conj vaccine, on 21Dec2016 at 0.5 ml single in right arm as prevention vaccine. Medical history included diabetes mellitus and blood pressure high. Ongoing concomitant medications included metformin for diabetes, estradiol as hormone replacement therapy and metoprolol for blood pressure high . Starting 21Dec2016 patient could not move her right arm due to it being sore. The right arm soreness went from the top of her shoulder to right before her elbow. Since 21Dec2016  she can't move her arm without it hurting, her right arm was more stiff and painful and the shot also made her tired, she slept most of the day after getting it. On 21Dec2016 she also experienced swelling and hard at the injection site on right arm. She took 2 ADVIL as treatment and wondered if she should use hot or warm compresses. It was reported a worsening of the following events: right arm sore, can't move her right arm without it hurting and right arm was more stiff and painful. Fatigue was recovering; outcome of she slept most of the day after vaccination was unknown, while the outcome of the other events was not recovered. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician, reporting on his son.  An 18-year-old male patient received the first dose of TRUMENBA, via an unspecified route of administration in the arm on an unknown date in Jun2016 at a single dose for immunization. Medical history was not reported.  There were no concomitant medications.  The patient previously took ZITHROMAX and experienced drug hypersensitivity.  On an unknown date in Jun2016, the same day as the vaccination, the patient experienced fever of 103.5 degrees Fahrenheit and swelling at injection site. The events did require a visit to the physician office; however, there was no visit to the emergency room or hospitalization required.  The clinical outcome of the events, fever of 103.5 degrees Fahrenheit and swelling at injection site, was recovered on an unknown date in Jun2016 after a duration of 2-3 days.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscle twitching, Photopsia
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist.  A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, in the left arm, on an unspecified date, as single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced ocular flashes in eyes, twitches in neck area and headaches.  Clinical details were reported as follows:  The patient received the vaccination and within the same side the patient started getting ocular flashes in the eyes.  The patient also had headaches on the left side.  The outcome of ocular flashes in eyes, twitches in neck area and headaches was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Malaise, Secretion discharge
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient of unspecified age, ethnicity and gender received PREVNAR 13 l(ot number unknown), via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient's medical history included patient had no spleen.  The patient's concomitant medications were not reported.  The patient experienced sick and mucus on an unspecified date. The event was described by patient has been sick ever since and  noted up with mucus after vaccination. The outcome of sick and mucus was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 19-Dec-2016. This case involves a patient (gender and age not reported), who was vaccinated with INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and site of administration not reported) on an unknown date (reported as one month ago). Patient's medical history and concomitant medications were not reported. On an unknown date (reported as one month ago), after the vaccination, patient was sick and missed school for next two weeks. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: DTPHEP
Symptoms: Chest discomfort, Cough, Dyspnoea, Exposure during pregnancy, Influenza like illness
Clinical narrative: Symptoms started with feeling very heavy in top of chest, like bricks then it all locked up and I couldn't breathe. This causes coughing and gasping sometimes vomiting from coughing. After a few days like this, mucus began in chest and nose. A few more days and symptoms become flulike. Then pneumonia style begins. That devastates for a few more days. Then feeling better. Then one day cant breathe agin. The whole thing repeats. Severity has increased. Now there 8s no break for healthy spells. I feel like my child and I are dying. Literally.