chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Laboratory test, Peripheral swelling, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. The patient's medical history included hypoglycaemia. The patient's drug reactions or allergies were not reported. On 11-MAY-2016, the patient was vaccinated with her first dose of GARDASIL 9 (lot # L036245 and expiration date 09-FEB-2018, dose and route of administration were not reported). Concomitant therapy was not reported. On 11-MAY-2016, the patient fell and hit her head, then had one seizure and developed a skin rash across her chest, along with swelling of both feet. Both of her feet turned purple in color. the patient sought medical attention and on 11-MAY-2016, she was hospitalized. It was stated that they tested all of her systems. On the same day, the patient was released from the hospital. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review the event of seizure was considered as medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Skin discolouration
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. The patient's medical history included hypoglycaemia. The patient's drug reactions or allergies were not reported. On 11-MAY-2016, the patient was vaccinated with her first dose of GARDASIL 9 (lot # L036245 and expiration date 09-FEB-2018, dose and route of administration were not reported). Concomitant therapy was not reported. On 11-MAY-2016, the patient fell and hit her head, then had one seizure and developed a skin rash across her chest, along with swelling of both feet. Both of her feet turned purple in color. the patient sought medical attention and on 11-MAY-2016, she was hospitalized. It was stated that they tested all of her systems. On the same day, the patient was released from the hospital. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review the event of seizure was considered as medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to an unspecified number of an unspecified patients of an unknown age and gender. On an unknown date, an unspecified number of an unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L011846 (expiry date: 16-JUN-2017) and lot# L036245 (expiry date: 09-FEB-2018) (dosage not reported). Temperature excursion reported was 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Nephrolithiasis, Seizure, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative and through an unspecified reporter of an online post. The post refers to a 15 year old female patient, whose current conditions and medical history was not known. On an unknown date the patient was vaccinated with GARDASIL (dosage details and lot number were not reported). Concomitant medications were not reported. On an unknown date, as the patient was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she had been taking to try to control the seizures caused her to develop kidney stones. Patient was rushed to the emergency room and was hospitalized. The outcome of the events was not known. Kidney stone was considered to be not related to GARDASIL since it was due to the medication that the patient was taking for seizures, while causality assessment for seizures and abdominal pain was not reported. The physician was concerned about GARDASIL due to this online post as he had vaccinated his wife, daughter and his patients. The reporter (from the online post) considered the events to be serious due to hospitalization. Upon internal review, seizure and kidney stone (nephrolithiasis) was considered to be medically significant. The case is linked to 1605MYS009749 (same reporter). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Anaphylactic reaction, General physical condition abnormal
Clinical narrative: Information was received from a physician via an Internet article regarding cases in litigation concerning seven women of unknown ages, who say they have suffered various physical problems, including anaphylaxis and miscarriages (dates of events unknown) after receiving GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). The details of the pregnancies were not reported. The outcome of the various physical problems, miscarriages and anaphylaxis is unknown. Upon internal review, miscarriages and anaphylaxis were determined to be medically significant. this is one of several reports from the same source. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 29 year-old female patient who was 28 weeks pregnant. The patient's medical history and concurrent conditions were not reported. On 04-MAY-2016 the patient was inadvertently vaccinated with GARDASIL 9 (lot # L045711; expiry date: 08-MAY-2017) at a dose of 0.5 ml, once via intramuscular route. The reporter stated that the patient was doing fine. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. Physician assistant reported that patient was administered the series of GARDASIL outside the recommended dosing schedule. The first dose of GARDASIL (unspecified lot, expiration date, dose and route were unspecified) was administered on 20-APR-2015. The second dose of GARDASIL (unspecified lot, expiration date, dose and route were unspecified) was administered on 22-MAY-2015 and the third dose of GARDASIL (unspecified lot expiration date, dose and route were unspecified) was administered on 23-JUN-2015. No adverse experience has been reported. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 45 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a pharmacist concerning 1500 patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. In 1996 (reported as occurred approximately 20 years ago), 1900 patients were vaccinated with RECOMBIVAX HB (strength, dose, route and lot # not provided) in an immunization program where the pharmacist was working in. The patients' titers were tested later at an unspecified time. Only 400 patients had positive titers. At the time of reporting, the outcome of hepatitis B surface antibody negative was unknown. The causality was not provided. Additional information is not expected as the reporter did not wish further contact.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # and expiration date was not reported) 1 ml, intramuscularly (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This report was received from a medical assistant (patient's mother) regarding 1 year old female patient as a part of Market Research. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration and lot # were not reported). On an unknown date, the patient got shingles as a result of receiving the VARIVAX. The patient's outcome was reported as recovered/resolved with sequelae (on an unknown date). The reporter considered the event to be related to the VARIVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 61 years old female patient without any drug reaction/allergy. At the beginning of April 2016 the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not reported), 0.65 ml, subcutaneous. The patient was on unspecified concomitant medications. On the next day of vaccination, the patient developed redness and swelling around the injection site. The patient reported the events to the reporter on the phone on an unknown date in 2016. The patient recovered on an unknown date in 2016 (reported as within a week). The causality was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Localized edema, pain, and redness at injection site. Fever (103 F) and vomiting about 12:00 PM same day. Removed from daycare.
Age: 49.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 49 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 69 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2106, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 18 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # and expiration date was not reported) 1 ml, intramuscularly, into a left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with PNEUMOVAX 23. The pharmacist reported that the patient was receiving a dose every three years since an unspecified date. No adverse effect was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant therapy provided. On 06-MAY-2016, the patient was vaccinated with an expired dose of M-M-R II (route and dose not reported, lot # K005110, expiration date 04-APR-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a 65 year old female patient, regarding herself via company representative. Patient's pertinent medical history included Hashimoto's disease, brain aneurysm, high blood pressure and colon surgery. Patient's drug reactions/allergies included an unspecified pain pills when she had during her colon surgery. Approximately in September 2015 (reported as "last fall"), the patient was vaccinated with 1 dose of ZOSTAVAX, intramuscularly (IM) (strength, lot number and expiration date was not provided). Concomitant therapies included thyroid medication, statin. Approximately in September 2015 (reported as since receiving the vaccine), the patient had experienced shingles. The patient had stated that she had experienced shingles 3 times after getting the ZOSTAVAX vaccine. She also stated that "she knows it was coming because she feels the itching, burning feeling. The patient sought medical attention for the events via telephone. Patient was treated for the events. The outcome of shingles was reported as not recovered. The causality of the events was not reported. No product quality complaints (PQC) was reported. Additional information is not expected as the reporter refused to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative referring to a female patient of unknown age. Current or historical conditions were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneously, lot number and expired date were not provided). Concomitant medication was not provided. The next day after vaccination, the patient experienced "extreme" inflammation at the injection site and pain from shoulder to the elbow in the same arm that ZOSTAVAX was administered. No treatment was given. The outcome of the events was reported as recovered. This is one of 2 reports received from the same reporter. Additional information is not expected as we have no consent to contact the pharmacist.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a currently 4 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated a dose of VARIVAX (via subcutaneous route, dose and lot # were not reported). It was reported that the patient's mother could not remember if her daughter had received a VARIVAX injection. On an unknown date, the patient was diagnosed with chickenpox by her physician. On 13-MAY-2016 (reported as today), the patient's mother came to a pharmacy with an unspecified prescription to treat her daughter's chickenpox. The patient's outcome was reported as recovering/resolving. The relatedness between the event and the therapy with VARIVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown demography. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with PROQUAD (Merck) (dose and route unknown) lot # L041629 with expiration date of 22-APR-2016 which was improperly stored. The vaccine was exposed to a temperature of -7.1 degree Celsius for 3 hours and 18 minutes, and the data logger was involved. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: Information has been received from a healthcare worker referring to a 41 year old female patient. On an unknown date the patient was vaccinated with M-M-R II (strength, dosage, frequency and route unspecified) "as a child". On an unknown date the patient had titers drawn which showed she was positive for immunity to rubella but negative for immunity to measles and mumps. As a result, the patient was administered another dose of M-M-R II on an unspecified date. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot# reported as L045956 with expiration date of 17-NOV-2017; strength dosage, frequency and route unspecified) (incorrect product storage). No adverse effect was reported. There was no previous temperature excursion. Temperature was 14.63 F with time frame of 4 minutes. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Information on their concurrent condition, medical history and drug allergies were not reported. On 12-APr-2016, 18-APR-2016 and 21-APR-2016 unspecified patients were vaccinated with improperly stored 1 dose of PEDVAXHIB, on 13-APR-2016 with 3 doses, on 19-APR-2016 with 2 doses and on 20-APR-2016 with 4 doses of PEDVAXHIB lot # L035878, expiry date 11-AUG-2018, (dose number, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse events reported. There was no product Quality Complaint (PQC) involved. The vaccine administered was maintained at a temperature of 58 degree Fahrenheit for a time frame of 1.5 hours. This case is also linked to MARRS#1604USA015519 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Information on their concurrent condition, medical history and drug allergies were not reported. On 11-APR-2016, unspecified patients were vaccinated with 2 doses of improperly stored GARDASIL 9 and on 12-APR-2016, 13-APR-2016 and 18-APR-2016 with 1 dose and on 20-APR-2016 with 3 doses of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017, (dose number, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse events reported. There was no product quality complaint (PQC) involved. The vaccine administered was maintained at a temperature of 58 degree Fahrenheit for a time frame of 1.5 hours. This case is also linked to MARRS#1605USA009599 (same reporter link). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse via pharmacist via office manager refers to a 11 year old female patient. The patient's relevant medical history and concurrent condition were not reported. On an unknown date, patient was vaccinated with first dose of GARDASIL 9 (lot number and dosage not reported). On 28-APR-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L018351 (expiry date: 11-AUG-2017) (dosage not reported), which had previously undergone a supported temperature excursion. Concomitant therapies were not reported. It was unknown if there was any relevant laboratory data. As of 04-MAY-2016, it was unknown if the patient continued to take GARDASIL 9 and the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-MAY-2016 (reported as "today"), the patient was administered, by an unspecified nurse, an expired dose of ZOSTAVAX lot # L003216, expiration date 30-APR-2016 (dose and route of administration not reported). It was reported that an unspecified physician prescribed ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report has been received from a nurse via field representative referring to a 12 month-old patient of unknown gender. The patient's medical history and current condition was not reported. The patient experienced an unspecified adverse reaction after administration of VARIVAX and MMR II on unspecified date. No detail information was provided about the vaccination. The outcome of the adverse event was unknown. The causality as reported was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to an unspecified number of an unspecified patients of an unknown age and gender. On an unknown date, an unspecified number of an unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 injection 25/0.5 y (unspecified units) prefilled syringes lot # K020800 (expiry date: 05-JUN-2016) (dosage not reported). Temperature excursion reported was 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to an unspecified number of patients of an unknown age and gender. On an unknown date, an unspecified number of an unspecified patients were vaccinated with improperly stored VAQTA lot # K018531 (expiry date: 28-APR-2017) (dosage not reported). Temperature excursion reported was 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea started at 6:30, Vomiting started at 7:30.  Still vomiting today, May 20 at 11am.  Fever started 5/19.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to an unspecified number of an unspecified patients of an unknown age and gender. On an unspecified date, an unspecified number of an unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot # K021581 (expiry date 24-OCT-2016) (dosage not reported). Temperature excursion reported as 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness in area of injection, some swelling, some itching.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states that after receiving BEXSERO vaccine her left arm was painful and she has difficulty moving it.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information was received from a physician via an internet article regarding cases in litigation concerning female patients of unknown age, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010 (exact dates not provided), there were reported to be 25 cases of Guillain-Barre Syndrome that occurred after GARDASIL vaccination. The outcome of the 25 cases of Guillain-Barre Syndrome was not provided. Upon internal review, 25 cases of Guillain-Barre Syndrome was determined to be medically significant. This is one of several reports from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information was received from a physician via an Internet article regarding cases in litigation concerning 789 females of unknown age, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010, there were 789 reports of "serious" adverse reactions (not further specified) that occurred after GARDASIL vaccinations. The outcome of the "serious" adverse reactions was not reported. Upon internal review, 789 reports of "serious" adverse reactions was determined to be medically significant. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative referring to unspecified patients of unknown age and gender. Current or historical conditions were not provided. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, route and lot number unknown). Concomitant medication was not provided. On unspecified dates, the patients had developed inflammation at the injection site after receiving a dose of ZOSTAVAX. The outcome of injection site inflammation was not provided. This is one of 2 reports received from the same source. Additional information is not expected as we have no consent to the pharmacist.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash papular, Urticaria
Clinical narrative: Right upper thigh mother reports welts pink popular rash x 2 days after vaccination.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Client call and complained of nausea and vomiting x 7, after ingesting 3rd dose of Typhoid vaccine that started 5/9/16. On 5/10/16 client had a fever and headache. Nurse advised client to stop vaccine and start taking flds. and food in small amounts.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Oxygen saturation decreased, Stridor, Urticaria
Clinical narrative: Ten minutes following injection: shortness of breath, stridor, (oxygen saturation 86% sacral urticaria. Prompt improvement with epinephrine
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Injection site redness, warmth, and swelling approximately 4.5 inches by 2.5 inches (measured by patient) with tenderness extending into neck and armpit.
Age: 36.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Pyrexia, Seizure, X-ray
Clinical narrative: Fever 102 F, seizure.
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 47 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 24 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 70 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MMR, TD
Symptoms: Asthenia, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, weakness, arm pain at site of injection.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Asthenia, Decreased appetite, Glassy eyes, Headache, Injection site pain
Clinical narrative: Fever, weakness, pain throughout body, loss of appetite, pain at injection site, nausea, headache, glassy eyes.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, weakness, pain throughout body, loss of appetite, pain at injection site, nausea, headache, glassy eyes.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Asthenia, Blood test normal, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: Within a few hours, patient started to feel extreme fatigue. The next day, she had diffuse myalgias, right arm swelling. This was followed by several days of weakness, numbness, and tingling. Now with persistent fatigue and myalgias (3 weeks into vaccine).
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Within a few hours, patient started to feel extreme fatigue. The next day, she had diffuse myalgias, right arm swelling. This was followed by several days of weakness, numbness, and tingling. Now with persistent fatigue and myalgias (3 weeks into vaccine).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist 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 14-MAY-2016, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (dose and route were not reported, lot # K002924 with expiration 26-FEB-2016. The patient had not reported any adverse effects. The reporter also stated that (Oka/Merck) VARIVAX did not have any previous temperature excursions. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 34.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 34 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers 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 07-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 28-APR-2016, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX in error (expiration date 11-APR-2016) (dosing details, anatomical location and lot# unknown). No known adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Left upper posterior arm edema with swelling, and redness in area where vaccine was administered. Active ROM LUE as directed. Temp. 98.8 (ear), (+) radial brachial pulse. Telephone f/u 5/23/16.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Rash, redness, itching, light swelling.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, 24 hours after administration of BEXSERO, the patient experienced severe pain at the injection site and the patient had trouble in lifting her arm where she got the injection. The reporter did not have any further information. This case has been linked with US2016067076 reported by same reporter.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Sat 5/14: Vaccine administered, slight redness, raised skin at injection site. Sun 5/15: Sore arm, headache; itching, raised, red injection site. Mon 5/16; Lump noticed red and itching injection site, seek medical help - prescribed anti itch steroid cream.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Sat 5/14: Vaccine administered, slight redness, raised skin at injection site. Sun 5/15: Sore arm, headache; itching, raised, red injection site. Mon 5/16; Lump noticed red and itching injection site, seek medical help - prescribed anti itch steroid cream.
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness
Clinical narrative: Case number PHEH2014US016306 is an initial spontaneous report received from a nurse on 11 Aug 2014, with the follow-up received from physician on 19 Aug 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of MENVEO  (batch number: not reported) intramuscularly on an unknown date. It was reported that after vaccination, she complained of throat closing up and she was transported to the emergency room. The event outcome was unknown. The seriousness and causality were not reported. Upon the follow-up, physician reported that, patient did not receive the MENVEO. The patient received Sanofi Aventis product MENACTRA. Therefore case would be deactivated. Follow-up received from physician on 19 Aug 2014: Upon the follow-up, physician reported that, patient did not received the MENVEO. The patient received Sanofi Aventis product MENACTRA. Therefore the case would be deactivated.
Age: 55.0
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003602, is an initial spontaneous report from a pharmacist received on 21 Feb 2014. This report refers to a patient of unknown gender and over 55 years of age. Past medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with MENVEO (batch number: not reported) intramuscularly on undetermined date in Dec 2013. No adverse reactions had occurred since the maladministration (inappropriate age at vaccine administration).
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood test normal, CSF test normal, Computerised tomogram head normal, Febrile convulsion
Clinical narrative: COMPLEX FEBRILE SEIZURE.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Agitation, Feeling abnormal, Hyperventilation, Immediate post-injection reaction
Clinical narrative: Started to feel "weird" right after shot given. Hyperventilated, very agitated for 90 minutes.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Agitation, Anxiety, Feeling abnormal, Hyperventilation
Clinical narrative: Started to feel "weird" right after shot given. Hyperventilated, very agitated for 90 minutes.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria
Clinical narrative: RED WELT AT SITE OF INJECTION (QUARTER SIZED) PINK AREA ABOUT BASEBALL SIZED SURROUNDING RED WELT; BURNING LIKE A SUNBURN, PER PT.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Dyskinesia, Pain
Clinical narrative: Pt reported body aches and dizziness. Also had a few episode of jerking per mother. Tylenol was administered.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient and 2 other new hires in her group received the Tdap (Adacel-lot #UI543AA) and each deltoid of these persons were red/pink and raised, also warmer than surrounding skin.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: On Tues 05/17/16 in evening developed soreness, on Wed 05/18/16 developed swelling in left upper arm, warmth to touch and more pain in her arm, Fri "feels like she is coming down with FLU".
Age: 1.26
Sex: F
Vaccine: FLU3, MMR
Symptoms: Allergy test, Autism, Coma, Developmental delay, Food allergy
Clinical narrative: Child had MMR and Flu vaccine 11-1-13 she developed a fever and had a seizure with coma - adm PICU 11-8-13.
Age: 1.26
Sex: F
Vaccine: FLU3, MMR
Symptoms: Intensive care, Pyrexia, Seizure
Clinical narrative: Child had MMR and Flu vaccine 11-1-13 she developed a fever and had a seizure with coma - adm PICU 11-8-13.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Injection site pain, Pain in extremity
Clinical narrative: Patient started complaining that his leg was hurting. It got progressively worse, until he couldn't walk on his leg and I couldn't touch anywhere from his hip to his knee on the leg where he got the injection. Throughout the night, if the sheet even brushed his leg, he would wake up screaming in pain.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Haemoptysis, Headache, Hyperaesthesia
Clinical narrative: Severe body aches and sensitivity to touch (unable to get out of bed or walk without assistance). Sore throat. Coughing up blood and mucus. Progressing to severe headache (worst ever). Reoccurring fever. Sweating. Chills. Cellulitis on arm near but not on injection site that spreads in size over time. 5/17/2016-5/20/2016 (still dealing with side effects).
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pain, Productive cough, Pyrexia
Clinical narrative: Severe body aches and sensitivity to touch (unable to get out of bed or walk without assistance). Sore throat. Coughing up blood and mucus. Progressing to severe headache (worst ever). Reoccurring fever. Sweating. Chills. Cellulitis on arm near but not on injection site that spreads in size over time. 5/17/2016-5/20/2016 (still dealing with side effects).
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Walking aid user
Clinical narrative: Severe body aches and sensitivity to touch (unable to get out of bed or walk without assistance). Sore throat. Coughing up blood and mucus. Progressing to severe headache (worst ever). Reoccurring fever. Sweating. Chills. Cellulitis on arm near but not on injection site that spreads in size over time. 5/17/2016-5/20/2016 (still dealing with side effects).
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Red, swollen 4-5 inches below injection site.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Immediate post-injection reaction
Clinical narrative: As per employee felt dizzy and a brief period of shortness of breath for approximately 10 seconds. Employee states symptoms subsided immediately after walking. Employee was directed to sit down by medical staff and stated symptoms had subsided before getting to medical office. No treatment required as employee denies symptoms at time of monitoring by medical staff.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Swelling, red, 3-4 inches below and anterior of injection site. Md diagnosed pt w/ cellulitis, prescribed antibiotic (Bactrim) and steroid(Medrol dose pack).
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Skin warm
Clinical narrative: As per employee felt dizzy, warmth to head, and nausea. Employee states symptoms subsided approx 1 hour after onset of symptoms. Employee states she was escorted to medical office to sit down and was provided with an ice compress.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypopnoea, Injection site erythema, Injection site pain, Laryngitis, Oropharyngeal pain
Clinical narrative: 5/18/2016 1545: Pt presents in office with her father. Reports wheezing, shallow breathing, sore throat, and laryngitis last night as well hives, redness and soreness at the MENACTRA injection site on her right upper arm. Dad reports he had her do a nebulizer treatment and do an albuterol nebulizer treatment and the symptoms. Wheezing, shallow breathing, sore throat, laryngitis and hives resolved. I noted redness, swelling and slight warmth around the Menactra injection site on her upper right arm. O2 Sat 97% on room air, P 71, respirations are even and unlabored. 1400: Patient's PCP, PA-C, advised of above. No further treatment advised, reports patient has these symptoms routinely regardless of proximity to immunization. Ok to continue both HV and MENACTRA immunizations.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria, Wheezing
Clinical narrative: 5/18/2016 1545: Pt presents in office with her father. Reports wheezing, shallow breathing, sore throat, and laryngitis last night as well hives, redness and soreness at the MENACTRA injection site on her right upper arm. Dad reports he had her do a nebulizer treatment and do an albuterol nebulizer treatment and the symptoms. Wheezing, shallow breathing, sore throat, laryngitis and hives resolved. I noted redness, swelling and slight warmth around the Menactra injection site on her upper right arm. O2 Sat 97% on room air, P 71, respirations are even and unlabored. 1400: Patient's PCP, PA-C, advised of above. No further treatment advised, reports patient has these symptoms routinely regardless of proximity to immunization. Ok to continue both HV and MENACTRA immunizations.
Age: 0.97
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rash erythematous, Urticaria, Viral rash
Clinical narrative: Had subjective fever on 5/16, 5/17, and 5/18, no fever on 5/19, developed erythematous rash on 5/20 - viral exanthema versus hives, no other associated symptoms.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral, Pharyngeal disorder
Clinical narrative: FACE FELT TINGLING AND NUMB. TONGUE AND THROAT FELT FUNNY. GAVE 25MG BENADRYL. THEN PT STATED SHE HAD RECEIVED STEROID SHOT AND HAD MISSED HER BLOOD PRESSURE MEDICATION. SHE WAS GIVEN CARTIA 24OMG HER USUAL DOSE OF BLOOD PRESSURE MEDICATION.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site urticaria
Clinical narrative: 1/4 inch welt pt noticed below skin 1/2 inch under tattoo on her left deltoid arm.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 102.5 F.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Eye swelling
Clinical narrative: Patient reported slight peri-orbital ap swelling 48 hours after injection.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pain, Screaming
Clinical narrative: Severe pain and screaming for 7 hours until dusky. Non responsive to Tylenol. Leg with injection swollen 50%.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Discomfort, Nausea, Rhinorrhoea, Sneezing
Clinical narrative: As per employee felt nausea, sneezing and nasal discharge. Employee stated discomforts subsided next day.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint injury, Tendon disorder, Ultrasound joint
Clinical narrative: Right shoulder pain and limited range of motion immediately after a "too high" influenza vaccine injection.  Pain has improved but is still present 7 months later. Diagnosis is Shoulder Injury Related to Vaccine Administration (SIRVA)