chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 673521), concerning an 11 years old male patient. The patient had no concurrent conditions or medical history. On 16-DEC-2016, the patient was vaccinated with his first dose of GARDASIL 9, lot # M023169, in the left arm for prophylaxis (route of administration and expiration date were unknown). On the same date, he was also vaccinated with MENACTRA (dose 1, lot # U5392AC, in the right arm, route and expiration date unknown); ADACEL (dose 1, lot # U5477CA, in the right arm, route and expiration date unknown) and FLUZONE (dose 1, lot # U1709AB, in the left arm, route and expiration date unknown), as well for prophylaxis. Concomitant medications were not reported. On 17-DEC-2016, the patient experienced a large local reaction, erythema and induration at the injection site of 8 x 5 cm (injection site erythema, injection site induration). At the time of reporting, the patient had recovered from the local reaction, the injection site induration and the injection site erythema. The causality assessment between the local reaction, the injection site induration, the injection site erythema and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the regulatory authority.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Gait disturbance, Pain, Pruritus, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 678606), concerning an 11 years old male patient. The patient's medical history and concurrent conditions were not reported. The patient's historic vaccinations included an unspecified influenza (seasonal vaccine) in approximately 2011 (reported as "5-6 years ago"). On 11-JAN-2017, the patient was vaccinated with his first dose of GARDASIL 9, lot # M036059, intramuscularly in the left leg, for prophylaxis (expiration date was unknown). On the same date, he was also vaccinated with ADACEL (lot # U5552AA, intramuscularly in the right leg, dose number and expiration date were unknown); MENACTRA (dose 1, lot # U5508AA, intramuscularly in the left leg, expiration date unknown) and FLUZONE (lot # UI658AB, intramuscularly in the right leg, dose number and expiration date were unknown). Concomitant medications were not reported. On 11-JAN-2017 in the morning (reported as "AM"), the patient had vaccines-soreness. Then, on the same date in the afternoon (reported as "PM"), the patient was very sore and had difficulty to walk with the right (R) leg. On 12-JAN-2017, the patient experienced swelling and redness, increased soreness and received treatment with BENADRYL. On 13-JAN-2017, the patient had redness from the knee to the hip, swelling and itching, and received treatment with BENADRYL. On an unspecified date, the patient had an office visit (also reported as "emergency visit"), and received treatment with BENADRYL and ORAPRED, and was given a prescription for cephalexin for 10 days. At the time of reporting, the outcome of erythema, swelling, pruritus, pain and gait disturbance was unknown. The causality assessment between erythema, swelling, pruritus, pain and gait disturbance with GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679086) under the Freedom of Information Act referring to an 11 year old male patient. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the left arm, intramuscularly (lot # M031557, expiration date was not provided), for prophylaxis.  Other suspect therapies included BOOSTRIX and MENVEO. It was stated that the patient's mother called an unspecified clinic to report that the patient had the right arm where he received vaccine was swollen, red and hot and he had pain. Furthermore, the patient could not move his arm much. Therefore the patient was taken to the emergency room.  The patient received antibiotics and intravenous anti-inflammatory medication for two days. On 23-JAN-2017, the patients mother called to follow up and referred the patient had recovered from the events, with movement and without pain, however he still on prescribed medication.  The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679086) under the Freedom of Information Act referring to an 11 year old male patient. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the left arm, intramuscularly (lot # M031557, expiration date was not provided), for prophylaxis.  Other suspect therapies included BOOSTRIX and MENVEO. It was stated that the patient's mother called an unspecified clinic to report that the patient had the right arm where he received vaccine was swollen, red and hot and he had pain. Furthermore, the patient could not move his arm much. Therefore the patient was taken to the emergency room.  The patient received antibiotics and intravenous anti-inflammatory medication for two days. On 23-JAN-2017, the patients mother called to follow up and referred the patient had recovered from the events, with movement and without pain, however he still on prescribed medication.  The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dry skin, Erythema, Rash, Rash erythematous, Rash macular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID #681952) referring to a 13 year old female patient with no current illness and no known drug allergies. On 08-FEB-2017, the patient was vaccinated with GARDASIL 9 (lot # M034780, expiration date not provided) dose 1, intramuscularly in the left arm. After receiving immunization, on 08-FEB-2017, the patient broke out in blotchy red rash on bilateral arms. Rash was raised and rough like sandpaper. Denied itchiness, difficulty breathing or swallowing. Face red and blotchy. Given BENADRYL in office. The outcome of the dry skin, erythema, rash, rash erythematous, and rash macular is unknown. Causality was not assessed by the agency. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dry skin, Erythema, Rash erythematous, Rash macular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID #681952) referring to a 13 year old female patient with no current illness and no known drug allergies. On 08-FEB-2017, the patient was vaccinated with GARDASIL 9 (lot # M034780, expiration date not provided) dose 1, intramuscularly in the left arm. After receiving immunization, on 08-FEB-2017, the patient broke out in blotchy red rash on bilateral arms. Rash was raised and rough like sandpaper. Denied itchiness, difficulty breathing or swallowing. Face red and blotchy. Given BENADRYL in office. The outcome of the dry skin, erythema, rash, rash erythematous, and rash macular is unknown. Causality was not assessed by the agency. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 683045) form the 18.0 year old female patient. She had no current illness and she had prior vaccinations before. On 16-FEB-2017, the patient was vaccinated with third dose of GARDASIL 9 (lot # M017983, 1 dose form, intramuscular, on right arm) for prophylaxis. Other suspect therapies included second dose of MENVEO(Intramuscular, lot# M16005, on left arm), second dose of HAVRIX(Intramuscular, lot#4RX3D, on left arm) and first dose of BEXSERO(Intramuscular, lot# 156701, on right arm). On the same day, the patient felt nausea and tired, then went to bed. She woke up next morning with nausea, temperature of 99 (unit unknown), also feeling weak and tired. She also stated her right arm felt numb and weak. The outcome of events was reported as unknown. The causality between GARDASIL 9 and events was not reported. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, DTAPIPVHIB, HEP, PNC13
Symptoms: Pain in extremity, Screaming
Clinical narrative: Unknown if adverse event day after vaccine provided pt. would grab extremity (foot, hand) stop what doing and scream. Possible joint pain. Labs ordered. Mother aware. Not completed.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received on 09May2017 PREVNAR 13 (lot number R49357, expiration date May2018, NDC number 00005197101) at 0.5 ml single dose intramuscular in the left arm to prevent pneumonia. Medical history included cholesterol, blood pressure and hyperthyroidism, all ongoing. Concomitant medications included LIPITOR for cholesterol, metoprolol tartrate for blood pressure, DYAZIDE for blood pressure and diuretic, thiamazole for hyperthyroidism, all since an unknown date and ongoing. On 12May2017, in the evening, the patient had arm red and swollen. It started as a small spot and was now getting larger and worse. On 16May2017 the patient had also itchiness (during night). On 17May2017, the patient came back and the pharmacist saw that the arm was red and swollen. Treatment was provided and included IBUPROFEN and BENADRYL. Outcome was not recovered. The pharmacist supposed that the patient had an allergic reaction.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received on 09May2017 PREVNAR 13 (lot number R49357, expiration date May2018, NDC number 00005197101) at 0.5 ml single dose intramuscular in the left arm to prevent pneumonia. Medical history included cholesterol, blood pressure and hyperthyroidism, all ongoing. Concomitant medications included LIPITOR for cholesterol, metoprolol tartrate for blood pressure, DYAZIDE for blood pressure and diuretic, thiamazole for hyperthyroidism, all since an unknown date and ongoing. On 12May2017, in the evening, the patient had arm red and swollen. It started as a small spot and was now getting larger and worse. On 16May2017 the patient had also itchiness (during night). On 17May2017, the patient came back and the pharmacist saw that the arm was red and swollen. Treatment was provided and included IBUPROFEN and BENADRYL. Outcome was not recovered. The pharmacist supposed that the patient had an allergic reaction.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report was received from a doctor of pharmacy referring to a 57 year old female patient. The patient's medical history was not reported. The patient's concurrent conditions included migraines, menopause and "pain in unspecified limb". Drug reactions or allergies were reported as "none". On 17-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot # M040146 with expiration date of 26-DEC-2017; strength, dose, route and anatomical location were not provided), for prevention of shingles. Other suspect therapies included sterile diluent (manufacturer unknown) (strength, dose, route, lot number, expiration date and indication were not provided) administered on the same date. Concomitant therapies included cyclobenzaprine hydrochloride, dicyclomine hydrochloride, docusate sodium, pregabalin (LYRICA) and unspecified hormones. In May 2017, the patient experienced redness around the injection site with some blisters. It was reported that the patient did not received any treatment. At the time of reporting, the patient did not recover from the vaccination site vesicles and vaccination site erythema. The causal relationship between the events with ZOSTAVAX and sterile diluent (manufacturer unknown) was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report was received from a doctor of pharmacy referring to a 57 year old female patient. The patient's medical history was not reported. The patient's concurrent conditions included migraines, menopause and "pain in unspecified limb". Drug reactions or allergies were reported as "none". On 17-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot # M040146 with expiration date of 26-DEC-2017; strength, dose, route and anatomical location were not provided), for prevention of shingles. Other suspect therapies included sterile diluent (manufacturer unknown) (strength, dose, route, lot number, expiration date and indication were not provided) administered on the same date. Concomitant therapies included cyclobenzaprine hydrochloride, dicyclomine hydrochloride, docusate sodium, pregabalin (LYRICA) and unspecified hormones. In May 2017, the patient experienced redness around the injection site with some blisters. It was reported that the patient did not received any treatment. At the time of reporting, the patient did not recover from the vaccination site vesicles and vaccination site erythema. The causal relationship between the events with ZOSTAVAX and sterile diluent (manufacturer unknown) was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site abscess
Clinical narrative: Local Abscess formation at injection site.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Chills, Feeling abnormal, Headache, Mobility decreased, Pain
Clinical narrative: Limited ability to move or raise arm, severe headache, chills, body aches, swelling in arm, brain fog, fever. Symptoms slowly resolved started 3 days after vaccination.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Limited ability to move or raise arm, severe headache, chills, body aches, swelling in arm, brain fog, fever. Symptoms slowly resolved started 3 days after vaccination.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a an improperly stored dose of VAQTA (lot number M047658, expiration date 28-OCT-2017) or RECOMBIVAX HB (lot number M042322, expiration date 21-FEB-2019) or GARDASIL 9 (lot number M036059, expiration date 03-JUN-2019) or ROTATEQ (orally, lot number M038846, expiration date 26-APR-2018) (strength, doses and routes were not reported) all of them for prophylaxis. The duration of temperature excursion with the vaccines previously mentioned was 8 hours at 21.4  Fahrenheit degrees. The temperature excursions were detected by a data logger. No previous temperature excursion was performed. No product quality complaint (PQC) was involved. 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 medical assistant and 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 GARDASIL 9 (lot number: M009378 with an expiration date of 23-APR-2018; dose regimen details were not provided) for prophylaxis. The vaccine had been improperly stored on an unspecified date: Temperature: -1°C or colder (-9°C) Time frame: 8 hours, Temperature: -1°C or colder (-15°C) Time frame: 12 hours. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to a 50-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 08-MAY-2017, the patient was inadvertently vaccinated with PROQUAD (lot number M037011 with an expiration date of 21-FEB-2018; dose regimen details were not provided) in the left arm for prophylaxis, instead of the intended dose of VARIVAX and M-M-R II. The physician reported that the mistake was due to human error. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Age: 1.75
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 21 month old patient, who was vaccinated with improperly stored doses of RECOMBIVAX HB on 16-AUG-2016. Reporting nurse did know why the temperature excursions occurred but there were no further excursions.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1705USA004965: US-009507513-1608USA012908: Original case: 1608USA012916 US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004953: Original Case: 1608USA012916 US-009507513-1705USA004952: Original case 1608USA012916 US-009507513-1705USA004967: US-009507513-1705USA004954:
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 9 week old patient, who was vaccinated with improperly stored doses of RECOMBIVAX HB and ROTATEQ (lot # L046319, expiry date: 28-SEP-2017, dose and route of administration were not reported) on 16-AUG-2016. Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1608USA012908: Original case: 1608USA012916 US-009507513-1705USA004965: US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004953: Original Case: 1608USA012916 US-009507513-1705USA004952: Original case 1608USA012916 US-009507513-1705USA004967: US-009507513-1705USA004954:
Age: 0.58
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 7 month old patient, who was vaccinated with improperly stored doses of RECOMBIVAX HB and ROTATEQ (lot # L046319, expiry date: 28-SEP-2017, dose and route of administration were not reported) on 16-AUG-2016. Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1705USA004965: US-009507513-1608USA012908: Original case: 1608USA012916. US-009507513-1705USA004967: US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004952: Original case 1608USA012916 US-009507513-1705USA004954: US-009507513-1705USA004953: Original Case: 1608USA012916.
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Dyspnoea, Generalised erythema, Pharyngeal oedema
Clinical narrative: This spontaneous report has been received from a nurse practitioner and referred to a 16-year-old female patient. The patient's relevant medical history, concurrent conditions and concomitant therapies, were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. Subsequently, on an unknown date, she received the second dose of GARDASIL (dose, frequency, route, lot number and expiration date were not reported) and the first dose of VARIVAX (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The patient did not present any adverse symptoms after this vaccinations. Then on an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis and a dose of VARIVAX (dose, frequency, route, lot number and expiration date were not reported). Then, 15 minutes after the vaccination, the patient developed throat swelling, redness on her body, and shortness of breath. The patient had to remain in the facility for approximately 30 minutes after the vaccination, and the patient returned to normal on an unknown date. The Causality assessment between dyspnea, generalised erythema, and pharyngeal oedema with GARDASIL, GARDASIL 9, and VARIVAX was not reported. Additional information is not expected as there was no contact consent provided.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner and referred to a 17-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions drug, reactions/allergies, and concomitant therapies were not reported. On an unknown (at the age of 17), the patient was vaccinated with a dose of PROQUAD subcutaneously (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis that was reconstituted with a sterile diluent (MRK). There were no side effects reported and no product quality complaints. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently administered an expired single dose of VARIVAX injection (lot # L006384 with expiration date at 25-FEB-2017; exact dose, route of administration and anatomical location were not reported), for prophylaxis, which was reconstituted with sterile diluent (STERILE DILUENT) single dose (lot # M024782 with expiration date at 23-FEB-2019; strength and exact dose were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-MAY-2017, the patient was vaccinated with an expired first dose of M-M-R II (lot # M032153 exp date 22-APR-2017) (dose and route not reported) reconstituted with sterile diluent that was not expired. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Renal transplant
Clinical narrative: This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, and drug reactions or allergies was provided. Concomitant therapies included prednisone.  On an unknown date in the past, the patient was vaccinated with PNEUMOVAX23 for prophylaxis (the lot #, expiration date, route, dose, and strength were not provided). In April 2016, the patient underwent a kidney transplant which outcome was unknown. Upon internal review the event of kidney transplant was considered to be medically significant. The causal relationship between the event and the vaccine was not provided. Additional information is not expected because there was no consent to contact physician.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Information has been received from a physician via a company representative, referring on herself, a 61 year old patient. The patient's concurrent conditions and concomitant therapies were not reported. As medical history was reported drug reactions/allergies to penicillin (unspecified), aspirin (manufacturer unknown) and acetaminophen. On an unknown date in April 2017 (reported as in the "beginning of April" of this year (2017)), the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (strength, anatomical location, lot number and expiration date were not reported) and also received the sterile diluent (manufacturer unknown) subcutaneously (dose, anatomical location, lot number and expiration date were not reported) both products for shingles prevention. On an unspecified date in 2017,  after the patient received the ZOSTAVAX, she developed an allergic reaction that mainly consisted of symptoms where she had shortness of breath and difficulty breathing. It was confirmed that the patient did not seek medical attention, however she took an unspecified therapies as treatment for the adverse events. The outcome of the allergic reaction and the shortness of breath/difficulty breathing was reported as recovered and the causality between the events and the vaccination with ZOSTAVAX and the diluent (manufacturer unknown) was not reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same patient. Additional information is not expected because there was no consent to contact for follow-up.; Sender's Comments: US-009507513-1705USA011368:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Dime sized red mark an injection site on right leg, no itching, fussines, or pain.
Age: 10.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Mother stated pt. has right upper arm swelling that began 05/23/17 after receiving Td vaccine in arm on 05/22/17. Mother denies any other symptoms, no fever; but states pt.'s swelling at injection site has increased since 05/23/17 and that pt. has pain in arm. RN encouraged mother to start ice packs 10 minutes on and 10 minutes off today and call pt.'s PCP because swelling has increased, mother agreed to this. RN encouraged mother to call back if pt. has new symptoms or mother has questions, mother agreed to this and verbalized understanding and intent to comply.
Age: 0.5
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 6 month old patient, who on 16-AUG-2016 was vaccinated with improperly stored doses of RECOMBIVAX HB and ROTATEQ (lot # L046319, expiry date: 28-SEP-2017, dose and route of administration were not reported). Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1608USA012908: Original case: 1608USA012916 US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1705USA004953: Original Case: 1608USA012916 US-009507513-1705USA004954: US-009507513-1705USA004952: Original case 1608USA012916. US-009507513-1705USA004967: US-009507513-1705USA004960:
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 6 month old patient, who on 16-AUG-2016 was vaccinated with improperly stored doses of ROTATEQ. Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1608USA012794: US-009507513-1705USA004965: US-009507513-1705USA004961:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old female patient allergic to sulfa. The patient's medical history and concomitant therapies were not reported. On 16-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 lot # M041686, expiration date 28-MAY-2018; intramuscularly (anatomical location unknown) for prevention of pneumonia. On 17-MAY-2017, the patient experienced erythema to the left of the injection site and presented at the pharmacy with several red bumps around the injection site. No treatment was given for the adverse events and no laboratory tests were performed. At the time of the report, the patient was not recovered from the adverse events. No product quality complaint was involved. The causal relationship between the adverse events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 3-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 14-MAR-2017, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1705USA010142: US-009507513-1705USA010147.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-MAR-2017, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007310: US-009507513-1705USA010145: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1705USA010142: US-009507513-1705USA010147.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010145: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1705USA010142.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 09-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 29-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative reported for herself. A female patient of unknown age received PREVNAR 13 for immunization at 0.5ml single dose via an unspecified route of administration in the arm on unknown date in 2016. Medical history included ongoing asthma. Concomitant medication were not reported. On unknown date at the end of 2016 the patient experienced redness, swelling, itching, pain in the arm the product was administered and pain that radiated into her shoulder. The patient recovered completely from these events a week later. These events lasted for one week.
Sex: U
Vaccine: PLAGUE
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program.  A contactable consumer of unspecified age and gender received an unspecified pneumococcal vaccine (unknown manufacturer) on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not provided. The consumer got really sick on an unknown date after getting pneumococcal vaccine. Event outcome was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Rash pruritic, Skin warm, Swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co. Inc. (Number: 00454732). A non-contactable Medical Assistant reported that a patient of an unspecified age, gender and race received PREVNAR 13 for Prophylactic vaccination, via an unspecified route at single dose on unknown date. The patient experienced a red, swollen, itchy rash, the medical assistant reported that the rash was warm to the touch and covered "about a quarter" of the patient's arm. The medical assistant did not specify when the rash began or when it resolved. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Diarrhoea, Dizziness, Feeling cold, Laboratory test
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC# 0005-1971-02), via an unspecified route of administration, on 18May2017, at 0.5 ml single, for immunisation. PREVNAR 13 was not prescribed, patient took the vaccine for her own willing. Medical history included polycystic kidney (stage 1). Concomitant medications included VIIBRYD, potassium (unspecified trade name), hydrochlorothiazide (unspecified trade name), VITAMIN D. On an unspecified date the patient experienced vomiting constantly with outcome of recovering, shaking with outcome of unknown, freezing with outcome of unknown, chills with outcome of unknown, dizzy with outcome of unknown, muscle ache with outcome of not recovered, restlessness with outcome of not recovered, diarrhea with outcome of recovering. The patient visited the emergency room on 19May2017 and underwent lab tests and procedures which included lab work.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Myalgia, Restlessness, Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC# 0005-1971-02), via an unspecified route of administration, on 18May2017, at 0.5 ml single, for immunisation. PREVNAR 13 was not prescribed, patient took the vaccine for her own willing. Medical history included polycystic kidney (stage 1). Concomitant medications included VIIBRYD, potassium (unspecified trade name), hydrochlorothiazide (unspecified trade name), VITAMIN D. On an unspecified date the patient experienced vomiting constantly with outcome of recovering, shaking with outcome of unknown, freezing with outcome of unknown, chills with outcome of unknown, dizzy with outcome of unknown, muscle ache with outcome of not recovered, restlessness with outcome of not recovered, diarrhea with outcome of recovering. The patient visited the emergency room on 19May2017 and underwent lab tests and procedures which included lab work.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Decreased appetite, Dehydration, Diarrhoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC# 0005-1971-02), via an unspecified route of administration, on 18May2017, at 0.5 ml single, for immunisation. PREVNAR 13 was not prescribed, patient took the vaccine for her own willing. Medical history included polycystic kidney (stage 1). Concomitant medications included VIIBRYD, potassium (unspecified trade name), hydrochlorothiazide (unspecified trade name), VITAMIN D. On an unspecified date the patient experienced vomiting constantly with outcome of recovering, shaking with outcome of unknown, freezing with outcome of unknown, chills with outcome of unknown, dizzy with outcome of unknown, muscle ache with outcome of not recovered, restlessness with outcome of not recovered, diarrhea with outcome of recovering. The patient visited the emergency room on 19May2017 and underwent lab tests and procedures which included lab work.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC# 0005-1971-02), via an unspecified route of administration, on 18May2017, at 0.5 ml single, for immunisation. PREVNAR 13 was not prescribed, patient took the vaccine for her own willing. Medical history included polycystic kidney (stage 1). Concomitant medications included VIIBRYD, potassium (unspecified trade name), hydrochlorothiazide (unspecified trade name), VITAMIN D. On an unspecified date the patient experienced vomiting constantly with outcome of recovering, shaking with outcome of unknown, freezing with outcome of unknown, chills with outcome of unknown, dizzy with outcome of unknown, muscle ache with outcome of not recovered, restlessness with outcome of not recovered, diarrhea with outcome of recovering. The patient visited the emergency room on 19May2017 and underwent lab tests and procedures which included lab work.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Electroencephalogram normal, Eye movement disorder, Pyrexia, Tremor
Clinical narrative: Low grade fever, 3 events with in 1 hour, eyes rolled back, hands cloded up, pt went back, shaking.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Red knot and swelling at site of injection about the size of a baseball.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever.