chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPVX
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history. On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who had children who had had similar experiences as her daughter (MARRS number: 1703USA003781). The experiences reported included:  pyrexia, helicobacter infection, leg pain, feeling abnormal, neuralgia, body temperature fluctuation, hypoaesthesia, neuropathy peripheral, fatigue, muscular weakness, abasia, paraesthesia, vomiting, nausea, stomach pain and influenza. The outcome of the events and the relatedness between the events and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the abasia and the helicobacter infection were considered as medically significant events.  This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004619.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, lot number and expiration date unknown) for prophylaxis. Data logger issue was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005357: US-009507513-1702USA010273.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, lot number and expiration date unknown) for prophylaxis. Data logger issue was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005356: US-009507513-1702USA010273.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of VARIVAX, lot numbers M020899 with expiration date 27-APR-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were previously exposed to temperature excursion of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 6 hours in November 16 (year unspecified) additionally, the vaccine was exposed to temperature excursion (unspecified dates) of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 12 hours; however, no patient was vaccinated with the last temperature excursion reported.  The call was because "data logger". No adverse effects were noted. This is one of two reports from the same source Additional information has been requested. Sender's Comments:  US-009507513-1703USA004386.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX (lot# M037014 with expiration date 22-NOV-2017; concentration, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at more than minus 15 Celsius degree (C) but less than minus 10 C for 1 hour 38 minutes. The data logger was involved. There was no previous temperature excursion. No product quality complaint was involved. Lot number M037014 has been verified to be a valid lot number for zoster vaccine live. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005922: US-009507513-1702USA012153.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (lot# M012986 with expiration date 12-SEP-2017; concentration, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at more than minus 15 Celsius degree (C) but less than minus 10 C for 1 hour 38 minutes. The data logger was involved. There was no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA012153: US-009507513-1703USA005921.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored RECOMBIVAX HB (lot# M037248, expiry date: 21-FEB-2019; lot# L033343, expiry date: 13-SEP-2017) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006087: US-009507513-1703USA000376: US-009507513-1703USA006086.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored PEDVAXHIB (lot# M036058, expiry date: 19-MAY-2019) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000376: US-009507513-1703USA006087: US-009507513-1703USA006085.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored ROTATEQ (lot# M038846, expiry date: 26-APR-2018; lot# M031807, expiry date: 02-APR-2018) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006086: US-009507513-1703USA000376: US-009507513-1703USA006085.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Stridor, Tremor
Clinical narrative: Shortly after being vaccinated, pt started to shake and was told to lie down. Staff started to take vital signs. During examination, stridor was noticed by staff and pt confirmed shortness of breath. Epi pen and 50 mg of IM Benadryl was administered. Stridor continued but pt started breathing easier. Staff continued to take vitals and observe pt until ambulance arrived.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reaction to site includes redness, tenderness, warmth and swelling. The patient developed a fever with chills that evening.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Reaction to site includes redness, tenderness, warmth and swelling. The patient developed a fever with chills that evening.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M035145, expiration date 30-JAN-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit ( >14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006255: US-009507513-1703USA006257: US-009507513-1703USA006254: US-009507513-1703USA006256.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 12 unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable VARIVAX (lot# M035140, expiration date 03-AUG-2018) (strength, dose, frequency, route of administration and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion greater than 5 and less than 14 degrees Fahrenheit (also reported as ">-15 but <-10 degrees Celsius") for 1 hour and 40 minutes and 2 hours in two different time frames; digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000959.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 06-MAR-2017 from a medical assistant via a company representative regarding unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, unspecified patients were administered improperly stored GARDASIL (lot # M036059, expiration date 03-JUN-2019) and ROTATEQ (lot # M038846, expiration date 26-APR-2018). Temperature : 0 degrees Celsius to 2 degrees Celsius for 2 hours and 30 minutes; also >8 degrees Celsius but < 25 degrees Celsius for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as over three years ago), the patient was vaccinated with a first dose of GARDASIL 9 (lot # and expiration date were not reported) prophylaxis. The patient missed two doses of GARDASIL 9. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient had an unspecified antibody test performed that revealed low titers. The outcome of the adverse event was not provided. The relatedness between the adverse event and RECOMBIVAX HB was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. The nurse reported that on unspecified dates, multiple unspecified patients received improperly stored doses of the following vaccines: VARIVAX (lot # M006156 and expiration date: 05-FEB-2018, lot # M033213 and expiration date: 13-JUL-2018) (strength, dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature between -15 degrees Celsius and -10 degrees Celsius for 40 minutes, on an unknown date and previous temperature excursion included -15 degrees Celsius and -10 degrees Celsius during a time frame of 4 hours 20 minutes, 1 hour 40minutes and 63 hours and -10 degrees Celsius and 8 degrees Celsius during a time frame of 3 hours 40 minutes and 13 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts on 10-MAR-2017 to obtain follow-up information had been unsuccessful. General, product, events and narrative were updated.; Sender's Comments: US-009507513-1612USA010400:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M035145, expiration date 30-JAN-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit ( >14 but <16 degreesFahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursionn of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006257: US-009507513-1703USA006256: US-009507513-1702USA010414: US-009507513-1703USA006255:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M014908, expiration date 25-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit (>14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006257: US-009507513-1703USA006256: US-009507513-1703USA006254: US-009507513-1702USA010414.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M014908, expiration date 25-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit (>14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006257: US-009507513-1702USA010414: US-009507513-1703USA006254: US-009507513-1703USA006255.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M014908, expiration date 25-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit (>14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA010414: US-009507513-1703USA006256: US-009507513-1703USA006254: US-009507513-1703USA006255:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients may have received an unknown number of improperly stored doses of GARDASIL 9 (dose, route of administration, lot numbers and expiration dates were not reported) for prophylaxis. There were no adverse effects reported in any patients. Administered doses of GARDASIL 9 were exposed to a temperature excursion of below 32°F/0°C for 105 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA010265: US-009507513-1703USA006287.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients may have received an unknown number of improperly stored doses of PNEUMOVAX 23 (dose, route of administration, lot numbers and expiration dates were not reported) for prophylaxis. There were no adverse effects reported in any patients. Administered doses of PNEUMOVAX 23 were exposed to a temperature excursion of below 32°F/0°C for 105 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA010265: US-009507513-1703USA006286.
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Bronchitis, Chest pain, Nasal operation, Nasal polyps
Clinical narrative: This is a Spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00377203) from a non-contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date a year before this report for immunization. Since being vaccinated, she has experienced pain in her chest area. She developed bronchitis on an unknown date and she has had surgery on an unknown date on her nose to remove nasal polyps. She also had chronic asthma. The outcome of the events was unknown. Therapeutic measures were taken as a result of she has had surgery on an unknown date on her nose to remove nasal polyps. Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt. Please note that this information has not been reported to the FDA.
Sex: F
Vaccine: PNC13
Symptoms: Surgery
Clinical narrative: This is a Spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00377203) from a non-contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date a year before this report for immunization. Since being vaccinated, she has experienced pain in her chest area. She developed bronchitis on an unknown date and she has had surgery on an unknown date on her nose to remove nasal polyps. She also had chronic asthma. The outcome of the events was unknown. Therapeutic measures were taken as a result of she has had surgery on an unknown date on her nose to remove nasal polyps. Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt. Please note that this information has not been reported to the FDA.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 (lot R28321, expiry date Mar2018) via an unspecified route of administration in the arm on an unspecified date in 2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and warmth at the injection site on an unspecified date in 2017. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017108573 Same reporter/product/events, different patient.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: This is probably just a coincidence, but I'm reporting it in an abundance of caution. My left shoulder began hurting at the time the shot was administered & has continued to hurt on & off since. I've had physical therapy for that shoulder in the past, but it had cleared up in the past year.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Exposure during pregnancy
Clinical narrative: None stated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of ZOSTAVAX (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 5 degrees Fahrenheit and 14 degrees Fahrenheit for 60 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006712: US-009507513-1702USA006713: US-009507513-1702USA006714.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to her sister, a 48 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that the patient was going to start taking an unspecified medication for severe allergies which can suppress one's immune system. On an unknown date, as a part of the therapy with the unspecified allergy medication, the patient received a dose of ZOSTAVAX 0.65 ml (route of administration, lot number and expiration date were not provided) at age 48 years old (inappropriate schedule of drug administration) prior to start taking the unspecified allergy medication as a precaution (product use in unapproved indication). There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from the patient's friend, referring to a patient of unknown gender and age. Information on medical history, concomitant medication and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date unknown) for prevention of shingles. On an unknown date, the patient experienced pain and swelling after receiving the ZOSTAVAX injection. The outcome of the events was unknown. The causality assessment was not provided. Additional information is not expected as the reporter did not consent to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017; lot# M022924, expiration date: 24-JAN-2018; dose and route unknown) for prophylaxis. From 14-OCT-2016 to 04-NOV-2016, the VAQTA of lot# M022924 was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for totally 45 hours. The VAQTA of lot# M022924 was stored under temperature between 46 Fahrenheit and 77 Fahrenheit for totally 31.5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005337: US-009507513-1703USA005338:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 02-MAR-2017 from a medical assistant who reported that a patient (age and gender not reported) received an expired dose of VAQTA (lot# L042039, expiration 14-JAN-2017) 1.0 ml, once, intramuscular on 28-FEB-2017. A physician continued the call and reported that the patient had no adverse effects. Reason for escalation: expired product was not on post expiry memo. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to patient of unknown age.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via company representative regarding a male patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date at the age of 69-year-old, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (dose,  anatomical location, lot number and expiration date were not reported) for prevention of shingles. On unspecified date about 1 year after vaccination, the patient got "a very bad shingles outbreak" (herpes zoster). At the time of the report, the outcome of the herpes zoster was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# M004116 with expiration date: 12-OCT-2017, lot# M013636 with expiration date: 15-FEB-2018 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005129: US-009507513-1703USA000842: US-009507513-1703USA005126: US-009507513-1703USA005127:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ liquid, orally, lot# M014318, expiration date: 30-SEP-2017 (dose was not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000842: US-009507513-1703USA005126: US-009507513-1703USA005127: US-009507513-1703USA005128:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 09-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX vial (strength, dose, and route were not reported) (lot number L044529, expiration date: 09-FEB-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to female patient of unknown age.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to male patient of unknown age.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to patient of unknown age and gender.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Cough, Erythema, Influenza like illness, Malaise, Pruritus
Clinical narrative: ON 3/3/17 FLU LIKE SYMPTOMS, FEVER, MALAISE, COUGH. ON  3/13/17 IN AM NOTED RED RAISED PUSTULES TO NECK AND CHEST, BOTH ARMS, STOMACH AND BACK WITH ITCHING.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Pyrexia, Rash pustular
Clinical narrative: ON 3/3/17 FLU LIKE SYMPTOMS, FEVER, MALAISE, COUGH. ON  3/13/17 IN AM NOTED RED RAISED PUSTULES TO NECK AND CHEST, BOTH ARMS, STOMACH AND BACK WITH ITCHING.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt had swollen and painful arm, and even until now, her arm is still sore and a little bit swollen. No fever, no other complaint otherwise.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive, Pus in stool
Clinical narrative: Blood and pus to stool x2 stools, otherwise asymptomatic. No treatment.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Menstruation delayed
Clinical narrative: Mom states that each time patient would get the HPV shot, her menses would delay for 1 - 2 months.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Employee began to complain of nausea, weakness, and dizziness. Employee felt better when she laid down but would complain of feeling as if she would vomit upon movement. This occurred over a period of fifteen minutes. Patient recovered on her own and was sent home for the day.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dermatitis contact, Drug eruption, Oedema, Rash, Rash erythematous
Clinical narrative: Assessment & Plan (3/14/2017 12:58 PM). Pustular rash (782.1 | L08.0) Story: Patient received TDAP and PNEUMOVAX yesterday as well as beginning diclofenac and developed pustular, erythematous rash on both wrists with edema as well as scattered lesions on her arms and trunk. She also has a contact dermatitis from her bilateral knee braces. Impression: I sent pictures to Dermatology resident. He felt this was consistent with an eczematous drug eruption and for us to treat with prednisone 40 mg now and every morning x 5 days. We could stop then. He felt that it was likely though that she would flare again and would need a 3 week taper in total, 40 mg, 30 mg, 20 mg. He also recommended a fluorinated steroid. We gave her fluocinonide twice daily and told her to stop diclofenac.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Rash pustular, Skin lesion
Clinical narrative: Assessment & Plan (3/14/2017 12:58 PM). Pustular rash (782.1 | L08.0) Story: Patient received TDAP and PNEUMOVAX yesterday as well as beginning diclofenac and developed pustular, erythematous rash on both wrists with edema as well as scattered lesions on her arms and trunk. She also has a contact dermatitis from her bilateral knee braces. Impression: I sent pictures to Dermatology resident. He felt this was consistent with an eczematous drug eruption and for us to treat with prednisone 40 mg now and every morning x 5 days. We could stop then. He felt that it was likely though that she would flare again and would need a 3 week taper in total, 40 mg, 30 mg, 20 mg. He also recommended a fluorinated steroid. We gave her fluocinonide twice daily and told her to stop diclofenac.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. 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-009507513-1703USA006323: US-009507513-1703USA006327: US-009507513-1703USA006325: US-009507513-1703USA006326: US-009507513-1703USA006322: US-009507513-1703USA006324:
Sex: U
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: Information was received on 03-MAR-2017 from  a physician via a field employee. The physician reported "that she read an article about a patient who had persistent entire body muscle aches after receiving GARDASIL 9 a year a go." (no dose, route, site, lot or expiration reported). No patient details or medical history, concomitant medications or allergies were reported. The outcome of the event is unknown. There was no further information to provide. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M018810, expiration date: 28-MAY-2018; dose and route unknown) for prophylaxis. From 14-OCT-2016 to 06-DEC-2016, the GARDASIL 9 was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for totally 135.5 hours. The GARDASIL 9 was stored under temperature between 46 Fahrenheit and 77 Fahrenheit for totally 40.5 hours. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012145: US-009507513-1703USA005337:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. 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-009507513-1703USA000892:
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 an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. 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-009507513-1703USA000892:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. 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-009507513-1703USA000892:
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 (lot R28321, expiry date Mar2018) via an unspecified route of administration in the arm on an unspecified date in 2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and warmth at the injection site on an unspecified date in 2017. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017108571 Same reporter/product/events, different patient.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of arm.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: MMR vaccine administered was expired by 9 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Injection site urticaria
Clinical narrative: Mom contacted office after leaving appt, child with swollen eyes, was told to come back to office. Swelling of B/L eyes, could barely open eyes.  One hive noted at injection site of MMR.  Pt was given oral Benadryl and depo Medrol 40 mg IM.  Pt was monitored for 30 mins, with eye swelling reduced but not resolved when they left the office. No difficulty with breathing or tongue swelling.
Age: 0.25
Sex: M
Vaccine: RVX
Symptoms: Allergy test, Diarrhoea, Diarrhoea haemorrhagic, Food allergy, Stool analysis
Clinical narrative: Started having diarrhea, 12+ stools per day. 2 weeks later started having bloody diarrhea. Persisted for 2 months through maternal elimination diet of dairy, soy, gluten, corn, nuts, and eggs, finally started to subside after maternal total elimination diet of eating same few foods. Slowly was able to add more foods back, still reacts to meat at 14 months old.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Computerised tomogram normal, Diarrhoea, Dizziness, Hepatobiliary scan normal
Clinical narrative: Diarrhea, vomiting, dry heaves, dizziness, severe abdominal pain for 1-2 hrs. 2 days later severe abdominal pain, took to ER. 1 week later same symptoms. 1 more week later same symptoms went to ER again. 4 weeks later stomach hurts every day and dizziness continues. No health problems prior to contracting the flu and taking this drug.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Oesophagogastroduodenoscopy normal, Retching, Ultrasound scan normal, Vomiting
Clinical narrative: Diarrhea, vomiting, dry heaves, dizziness, severe abdominal pain for 1-2 hrs. 2 days later severe abdominal pain, took to ER. 1 week later same symptoms. 1 more week later same symptoms went to ER again. 4 weeks later stomach hurts every day and dizziness continues. No health problems prior to contracting the flu and taking this drug.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Peripheral swelling, Pyrexia, Swelling face, Vomiting
Clinical narrative: Swelling and redness of cheeks, hands and feet. Vomiting and fever.