chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Abdominal pain lower
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 15 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-MAY-2017, the patient received the first dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for immunization (prophylaxis). On 25-MAY-2017 at 07:30, the patient experienced severe pain in lower abdomen area that was described as stabbing and pressure. The patient did not received treatment for the event, and no laboratory diagnostics were performed. At the time of reporting, the outcome of the event was not recovered. The causal relationship between the event and GARDASIL 9 was not reported. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Underdose
Clinical narrative: Administered vaccine into left arm and had resistance, unable to administer entire vaccine.
Age: 42.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt c/o pain at the injection site. Next day c/o rush of fever, nausea and vomiting.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: FLU LIKE ILLNESS FOR 5 DAYS, MYALGIAS AND HEADACHE, LOW GRADE TEMP.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Electromyogram, Musculoskeletal pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe pain in right shoulder blade, arm and hand. Continued throughout morning. Went to Urgent Care Center and was prescribed ibuprophen, cyclobenzaprine and ice packs.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, Fatigue, Injection site nodule, Injection site swelling
Clinical narrative: Initial unsolicited report received from nurse on 17-May-2017. This case involves a female patient (age not reported) who was vaccinated with unknown dose of ADACEL batch number- U5542AA in left arm and MENACTRA batch number- U5567CA arm right (expiration date, dose in series, route were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patients had left arm was swollen with a knot and fatigue in arm when lifting and reaction got worse in both arms. It was also a case of actual medication error due to inappropriate age at vaccine administration. Laboratory examinations were not reported. Corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Limb mass, Local swelling, Pain
Clinical narrative: Arm hurt the day given. Started with a little Redness at injection site 2 days later that spread down arm. Area was warm, swollen and very painful. Developed fever 3rd and 5th days. Still have firm lump, tender and redness to arm. Will be 2 weeks tomorrow.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Arm hurt the day given. Started with a little Redness at injection site 2 days later that spread down arm. Area was warm, swollen and very painful. Developed fever 3rd and 5th days. Still have firm lump, tender and redness to arm. Will be 2 weeks tomorrow.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Nausea, Vomiting
Clinical narrative: Uncontrollable vomiting 10-12 episodes 2-2.5 hours after admin of vaccines. Reglan giving to aid with nausea/vomiting.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient experienced swelling and redness around the injection site. The patient reported to an unspecified hospital. The patient was fine and was not admitted to the hospital. The patient returned to the pharmacy on an unspecified date, complaining of not having been told of the potential adverse experience. The outcome of the events was not reported. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 0.17
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 a 9 weeks infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-SEP-2016, the patient was vaccinated with an improperly stored dose 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. 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-009507513-1705USA004961: US-009507513-1705USA004964: US-009507513-1705USA004973: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1705USA004967: US-009507513-1705USA004963: US-009507513-1705USA004960: US-009507513-1705USA004965: US-009507513-1705USA004962:
Age: 0.5
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 a 6 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-SEP-2016, the patient was vaccinated with an improperly stored dose 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. 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-009507513-1705USA004973: US-009507513-1608USA012794: US-009507513-1705USA004967: US-009507513-1705USA004965: US-009507513-1705USA004962: US-009507513-1705USA004960: US-009507513-1705USA004952: US-009507513-1705USA004964: US-009507513-1705USA004961: US-009507513-1705USA004963.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date about 12 months later, the patient received the second dose of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unspecified date in April 2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L037924 with expiration date: 22-JUN-2017 and lot # M002254 with expiration date: 15-NOV-2017, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 12.7 Celsius degrees for 2 hours and 15 minutes. There were no previous temperature excursions reported. Data logger was involved. No symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site 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. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's current illnesses, history and prior vaccinations were not reported. On 27-DEC-2016, the patient was vaccinated intramuscularly in the left arm with unknown dose of GARDASIL 9 (lot # M030380, expiry date 01-FEB-2019) and intramuscularly in the right arm with unknown doses of BOOSTRIX (lot # 7RJ9B) and MENVEO (M16004). There were no other medications. On 28-DEC-2016, the patient experienced redness and swelling around injection site on the right arm. There was no lab data. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as no follow up information could be obtained from the Agency.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Rash
Clinical narrative: This spontaneous report as received from a male patient in his sixties via a company representative refers to himself. The patient's concurrent conditions included diabetes, hypertension, and hyperlipidaemia. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unknown date in 2009 (reported as "eight years ago"), the patient was vaccinated with the first dose of ZOSTAVAX (route of administration, lot# and expiration date were unknown), reconstituted with sterile diluent (STERILE DILUENT) (lot# and expiration date were unknown) to prevent shingles. On an unknown date, the patient developed zoster rash outbreak. The outbreak was treated with a booster dose of ZOSTAVAX (lot# and expiration date were not provided) given on an unknown date. On an unknown date, the patient developed neurophaty and received a variety of unspecified steroids and antivirals. The patient sought medical attention. It was unknown if any lab diagnostic studies were performed. At the time of the report, the patient did not recover from zoster rash outbreak and neuropathy. The relatedness between the adverse events and ZOSTAVAX was not provided. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA014929:
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to her mother, a currently 71 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date (reported as "years ago"), the patient was vaccinated with PNEUMOVAX23 (lot#, dose, frequency and route of administration were unspecified) for routine vaccination (prophylaxis). On an unknown date, after receiving PNEUMOVAX23, the patient developed a big bump on her arm at a department of health. It was stated that the big bump (injection site mass) lasted a week. It was also reported that it was not necessary intervention to prevent serious criteria, that the adverse event was not significant disability or incapacity or life threatening, and that the patient was not hospitalized. The relatedness assessment between PNEUMOVAX23 and injection site mass was not provided. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014939: US-009507513-1705USA014940:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a consumer and refers to herself, an approximately 60 year old female patient with immunodeficiency, allergies to sulfonamide and alfuzosin hydrochloride and a history of lymphoma treated with unspecified chemotherapy. On 13-FEB-2017, the patient was vaccinated with ZOSTAVAX, (dose, lot number and expiration date were not reported) subcutaneously for prophylaxis. Concomitant therapies included CLARITIN, ZYRTEC and an unspecified nasal spray. In approximately MAR-2017, (reported as "about 6 to 8 weeks ago"), the patient developed "small bumps that look like blisters" periodically on her "arms, back of legs and ankles". Also the patient stated that "the bumps would go away eventually but would take a very long time to heal" and "usually when one bump would heal another bump would appear somewhere else on [her] body". The patient also described the "small bumps" as "looking like mosquito bites but when [she] scratched them the top of skin comes right off". It was reported that the patient previously had "lymphoma" and had finished her treatments of chemotherapy "sometime last year". The patient then stated that although her lymphoma had "cleared up" (unspecified date) her primary physician considered her to be "immunocompromised". On 17-MAY-2017, the patent reported that she met with a physician about her experience with the small bumps on her body and was going to see another physician on 19-MAY-2017 for this same event. At the time of this report, no treatment was given for the event. The patient underwent "standard blood test" (results not provided). The outcome of small bumps that looked like blisters was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Contraindication to vaccination, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a consumer and refers to herself, an approximately 60 year old female patient with immunodeficiency, allergies to sulfonamide and alfuzosin hydrochloride and a history of lymphoma treated with unspecified chemotherapy. On 13-FEB-2017, the patient was vaccinated with ZOSTAVAX, (dose, lot number and expiration date were not reported) subcutaneously for prophylaxis. Concomitant therapies included CLARITIN, ZYRTEC and an unspecified nasal spray. In approximately MAR-2017, (reported as "about 6 to 8 weeks ago"), the patient developed "small bumps that look like blisters" periodically on her "arms, back of legs and ankles". Also the patient stated that "the bumps would go away eventually but would take a very long time to heal" and "usually when one bump would heal another bump would appear somewhere else on [her] body". The patient also described the "small bumps" as "looking like mosquito bites but when [she] scratched them the top of skin comes right off". It was reported that the patient previously had "lymphoma" and had finished her treatments of chemotherapy "sometime last year". The patient then stated that although her lymphoma had "cleared up" (unspecified date) her primary physician considered her to be "immunocompromised". On 17-MAY-2017, the patent reported that she met with a physician about her experience with the small bumps on her body and was going to see another physician on 19-MAY-2017 for this same event. At the time of this report, no treatment was given for the event. The patient underwent "standard blood test" (results not provided). The outcome of small bumps that looked like blisters was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-MAY-2017, the patient was vaccinated with ZOSTAVAX  (K003601 exp: March 2015) that was reconstituted with STERILE WATER DILUENT ( M031575 exp: March 2019).  On an unspecified date, it was reported  the injection site was "red, hard, and bumpy." No additional information provided. The outcome of injection site erythema, expired product administered, injection site mass and injection site induration is unknown. Lot number M031575 has been verified to be a valid lot number for sterile diluent. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive
Clinical narrative: This spontaneous retrospective report was received from the registered nurse and refers to a 15-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in 2002, the patient received the first dose of GARDASIL 9 (lot#, expiration date, dose, frequency and route of administration were not reported) for HPV prevention. On 28-FEB-2017, the patient received second dose of GARDASIL 9 lot# M034780 (expiration date, dose, frequency and route of administration were not reported). On 28-FEB-2017, at the time of office visit, the patient was discovered to be pregnant. The nurse completed pregnancy test to the patient and the results came back positive. The nurse stated that the last menstruation period (LMP) might have been on 27-FEB-2017 (the patient was still bleeding, as in routine menstrual cycle at the time of administration of GARDASIL 9 so it was hard to pinpoint an actual date of LMP). The patient was instructed to follow up with the office which did not happen. The patient's mother contacted the office at an unspecified time for unspecified information and advised nurse that the patient would follow up with an unspecified family doctor. The nurse stated that there was no contact from the patient or the patient's mother, therefore it was possible that the pregnancy was no longer viable. The nurse reviewed the assumption of abortion with the pregnancy registry web site. The outcome of the events: abortion and vaginal bleeding was unknown. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of abortion was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 66 year old female patient with drug reaction/allergy to nitrofurantoin (manufacturer unknown) (linked case 1705USA014917). Concomitant therapies included estrogens, conjugated (PREMARIN) and multivitamins (manufacturer unknown). On 19-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscular in the right deltoid, for prophylaxis, lot # M039060 with expiration date of 22-MAY-2018 (dose and frequency were not reported). It was reported that, on an unknown date in May 2017, the patient developed a rash on her right inner arm above the elbow, but not at the injection site, it was described as red, raised, hot to the touch, and itchy. The patient sought medical attention, however, treatment was not given, no laboratories diagnostics were performed, no intervention to prevent seriousness criteria was performed, no significant disability or incapacity occurred, no life threatening happened and no hospitalization was needed.   At the time of reporting the rash had not grown in size, but also had not improved (not recovered). The causality between rash, rash papular, skin warm, rash pruritic and rash erythematous with PNEUMOVAX23 was not reported. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014917:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M036543, (dose, dose number, albumin status, injection site, route of administration and expiration date were not provided) for prophylaxis. The dose of the vaccine was reconstituted with properly stored sterile diluent injection. It was also stated that the vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 11-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 12-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660.
Age: 1.33
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 16 month old male patient. The patient administered the vaccine on 13-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old female patient. The patient administered the vaccine on 18-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old female patient. The patient administered the vaccine on 20-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in April 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # M043424 with expiration date: 20-JUN-2018 and lot # M037533 with expiration date: 17-MAY-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 12.7 Celsius degrees for 2 hours and 15 minutes. There were no previous temperature excursions reported. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA006461: US-009507513-1705USA014914:
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis, only 3 months after she received PREVNAR 13 (dose, frequency and route of administration were unspecified) also for prophylaxis. On an unknown date, the patient developed a big bump at her injection site for PNEUMOVAX 23, so much so that she could not move her arm "anymore". However, it was also reported that the injection site mass lasted about a week. The relatedness assessment between PNEUMOVAX 23 and injection site mass was not provided. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA009926: US-009507513-1705USA014940.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. The pharmacist stated that injection site adverse experiences are common with PNEUMOVAX 23. Additionally, she stated that she told her patients that there may be inflammation and pain. At the time of the report, the outcome of injection site reaction was not reported. The relatedness assessment between PNEUMOVAX 23 and injection site reaction was considered as related. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA014939: US-009507513-1705USA009926.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacy technician and a contactable pharmacist via a Pfizer representative. This physician reported similar events for 3 patients, this is the first of three reports. An elderly female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling of injection site and itching all on an unspecified date with outcome of unknown. The swelling of injection site got worse and the patient had to go to the doctor for an antibiotic to reduce the swelling. The reporter stated she thought the swelling worsened because the patient was itching it and that made it worse. The patient was treated for both the events. Sender's Comments: Linked Report(s): US-PFIZER INC-2017231547 Same reporter/ product, similar events, different patients; US-PFIZER INC-2017231548 Same reporter/ product, similar events, different patients.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacy technician and a contactable pharmacist via a Pfizer representative. This physician reported similar events for 3 patients, this is the second of three reports. A female patient over 65 years old of unknown ethnicity received PREVNAR 13 for Protection against pneumococcal pneumonia via an unspecified route at single dose on unknown date. Relevant medical history and concomitant medication were unknown. On unknown date the patient experienced swelling of injection site. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017231461 Same reporter/ product, similar events, different patients; US-PFIZER INC-2017231548 Same reporter/ product, similar events, different patients.
Sex: F
Vaccine: PNC13
Symptoms: Sinus disorder
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 at 0.5 ml, single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, one month after the vaccination, in 2017, the patient experienced sinus issue. The patient recovered from the adverse event on an unspecified date.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a female patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not provided. The reporting nurse stated that the patient's mother said that the patient experienced fever last time she had vaccination with PREVNAR 13 and other unspecified vaccines. Event outcome was unknown. The patient's mother decided not to vaccinate the patient with more than one vaccine at the time.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, Branded and Unbranded Quant GM. A contactable 70 years old female consumer received PREVNAR 13 on an unspecified date at single dose for immunisation. The consumer medical history and concomitant medications were not reported. The consumer experienced pneumonia on an unspecified date with unknown outcome. The consumer stated that it was probably more due to being diagnosed with lupus than the vaccine. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the limited information available pneumonia is possibly related to patient underlying medical condition of lupus.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable Pharmacist received via a Pfizer sales representative. A 75-years-old female patient of an unspecified ethnicity received PREVNAR 13, intramuscular in the arm on 15May2017 at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 within couple of hours after vaccination the patient experienced a bout of vomiting with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A patient of unspecified age, gender and race/ethnicity received PREVNAR 13 on an unknown date, in arm (unspecified), at single dose, for immunization. Medical history and concomitant medications were not provided. The patient's arm swelled for 3 days, it was abnormal swelling. The final event outcome was not provided.
Age: 58.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Malaise, Pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect" received from a contactable pharmacist. This pharmacist reported 2 reports for different patients (mother and son). This is the 1st of 2 reports. A 58-year-old female patient of unspecified race/ethnicity received TRUMENBA (NDC# 00005010005, Exp date Jul2017, Lot# N16808 or NI6808), via an unspecified route of administration in left arm, on 23May2017, at single dose, for immunisation. Patient was vaccinated at the pharmacy/drug store. Relevant medical history and concomitant medications were not provided. The patient experienced did not feel good, body aches, pain in arm, malaise, cold and sweating all in May2017. After vaccination the patient was good. Several hours after vaccination, around midnight or 2:00 AM the following morning, she woke up and did not feel good. She had body aches, pain in her arm, malaise, was cold and had sweats. Therapeutic measures were taken as a result of body aches and pain in arm and included treatment with Naproxen, Tylenol or some kind of NSAID. The events recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017236185 Same reporter/drug/event, different patient.
Age: 58.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect" received from a contactable pharmacist. This pharmacist reported 2 reports for different patients (mother and son). This is the 1st of 2 reports. A 58-year-old female patient of unspecified race/ethnicity received TRUMENBA (NDC# 00005010005, Exp date Jul2017, Lot# N16808 or NI6808), via an unspecified route of administration in left arm, on 23May2017, at single dose, for immunisation. Patient was vaccinated at the pharmacy/drug store. Relevant medical history and concomitant medications were not provided. The patient experienced did not feel good, body aches, pain in arm, malaise, cold and sweating all in May2017. After vaccination the patient was good. Several hours after vaccination, around midnight or 2:00 AM the following morning, she woke up and did not feel good. She had body aches, pain in her arm, malaise, was cold and had sweats. Therapeutic measures were taken as a result of body aches and pain in arm and included treatment with Naproxen, Tylenol or some kind of NSAID. The events recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017236185 Same reporter/drug/event, different patient.
Age: 31.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Malaise, Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [Pfizer First Connect]. A contactable pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A 31-year-old male patient of an unspecified race received TRUMENBA (lot N16808 or NI6808, NDC number: 00005010005, Expiry Date: Jul 2017) for Immunization via intramuscular route in the left arm, at 0,5ml single dose on 23May2017. No medical history was reported. concomitant tm medications were unknown. On unknown date the patient experienced did not feel good, body aches, pain in arm, malaise, cold and sweating. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017236106 same reporter/drug/event, different patient.
Age: 31.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [Pfizer First Connect]. A contactable pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A 31-year-old male patient of an unspecified race received TRUMENBA (lot N16808 or NI6808, NDC number: 00005010005, Expiry Date: Jul 2017) for Immunization via intramuscular route in the left arm, at 0,5ml single dose on 23May2017. No medical history was reported. concomitant tm medications were unknown. On unknown date the patient experienced did not feel good, body aches, pain in arm, malaise, cold and sweating. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017236106 same reporter/drug/event, different patient.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Awoke with redness, swelling, achiness and slight itching of L arm. Massaged the arm and symptoms worsened, with redness extendng down arm and warm to touch. 10x8cm area of mild erythema and edema. No tenderness or induration with palpation.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12-year-old male patient. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 24-APR-2017, the patient was vaccinated with GARDASIL intramuscularly (dose, lot# and expiration date were not reported) and GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported), both vaccines were administered during the same vaccination session. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender (reported as baby). No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patient was vaccinated with a improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported) lot # M031574, expiration date: 11-NOV-2018. There were no adverse effects reported. The vaccine was stored in a temperature between 47 and 77 degrees Fahrenheit for 18 hours. It was detected by a 'Digital Data Logger'. There were no previous temperature excursions. Additional information has been requested.
Age: 0.17
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 a 9 week old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine 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. 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-009507513-1608USA012794:
Age: 0.17
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 a 8 week old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine 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. 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-009507513-1608USA012794:
Age: 0.33
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 a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine 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. 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-009507513-1608USA012794.