chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pyrexia, Rash, Rash macular
Clinical narrative: 9-06-15 "Low fever" per grandmother. 9-07-15 T 104 degrees - sore throat - swollen gland - dr - family physician - dx "tonsillitis" - rx ZITHROMAX but wrote bronchitis on script. 9-08 to 9-10-15 T 102 degrees - rash torso, face blotchy - no sore throat GM D/C ZITHROMAX. Returned to dr (date unknown) rx amox 9-17-15 afebrile but rash continues.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Streptococcus test negative, Tonsillitis
Clinical narrative: 9-06-15 "Low fever" per grandmother. 9-07-15 T 104 degrees - sore throat - swollen gland - dr - family physician - dx "tonsillitis" - rx ZITHROMAX but wrote bronchitis on script. 9-08 to 9-10-15 T 102 degrees - rash torso, face blotchy - no sore throat GM D/C ZITHROMAX. Returned to dr (date unknown) rx amox 9-17-15 afebrile but rash continues.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding 1 of two patients and this report concerns a female patient of unknown age. No information about medical history, concurrent conditions were reported. The pharmacist had provided the consumer, the patient's husband with the Merck Global Safety phone number and directed him to call regarding  his wife and her shingles experience following vaccination with ZOSTAVAX. The Consumer was provided the Privacy disclosure statement and was asked if Merck would be able to send him/his wife correspondence to obtain wife's treating physician full contact information for which the consumer agreed. He stated that on an unknown date in 2015, his wife received ZOSTAVAX (lot# and expiry not reported). Since receiving that vaccination his wife has had shingles twice on an unknown date approximately in 2015. She was currently under the care of her physician (current treatment for her Shingles was unknown) and the condition was ongoing. The outcome of first occurrence of shingles was unknown. Causality was not reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. No concurrent conditions and medical history were reported. On 21-SEP-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB 2.5/0.5 (lot # J001836, Expiry date 01-FEB-2015) 0.5 ml, intramuscularly (dosing regimen and frequency unknown). No concomitant medications were reported. A product quality issue was reported. No adverse effects were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient seen in office on 9/29/15 for physical. Provider did not see the prior date of 1/28/15 which showed that patient had already received this vaccine. Patient informed.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: Mom called clinic 9/29/2015 to report on 9/28/2015 patient started having generalized hives all over and slight wheezing. Advised mom to take to PCP or ER.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 12-AUG-2015, the nurse reported that the patient possibly received a dose of improperly stored VARIVAX (dose, frequency and route were unknown), lot# L008272, expiration date 11-MAR-2017. No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Pt. reports feeling feverish and HA and chills. Onset 1 day after vaccination lasting 2 days. With spont. resolve.
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia, Injection site bruising, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. The patient's medical history and concurrent conditions were not provided. On 17-SEP-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous route in the arm. The patient reported that after receiving the injection, he noticed some bruising at the injection site, which was painful to touch. The patient also reported that "hair on his arm also fell off" around the injection site. The patient did not seek medical attention (did not see his physician). No treatment was given for the adverse events. The outcome of the events alopecia, injection site pain and injection site bruising was reported as not recovered/not resolved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy. Product quality complaint (PQC) was not reported. Additional information is not expected, no contact details were provided.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Haematuria
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 16 year old female patient. No medical history and concomitant medications were reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose 1) (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patient experienced haematuria. It was reported that the patient sought medical attention and saw an unspecified urologist. The urologist determined that the hematuria was vaccine related. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of haematuria was unknown. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child began to complain of localized pain, swelling, redness at the site of varicella injection on 9/17/15. Parent's gave her BENADRYL (oral) for several days with no relief. On 9/23/15 child had increased swelling and warmth and parent instructed to see physician. Child was instructed to apply topical hydrocortisone to the area and return if any streaking noticed.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 17 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 28-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, lot # K023432, expiration date 18-JUN-2016; dose and route were not reported), which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Body temperature increased, Chest pain, Dizziness, Nausea
Clinical narrative: Developed rash, weakness, dizziness, mild chest pain, nausea, temp approx 100 degree * 1 week.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Developed rash, weakness, dizziness, mild chest pain, nausea, temp approx 100 degree * 1 week.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema
Clinical narrative: Client presented with edema and redness to (R) upper arm. Mother states she gave the client MOTRIN for an elevated temp this morning.
Age: 48.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Induration, Mass, Tenderness
Clinical narrative: Firmness of soft tissue, tender, redness, and a 3 1/2 cm lump.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Patient developed small bruising/red area which progressed over 24 hrs to 1/2/ dollar size. Then progressed again to 2" wide by 4" long, 3/10 soreness, hot, sm swelling, itchy.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient developed small bruising/red area which progressed over 24 hrs to 1/2/ dollar size. Then progressed again to 2" wide by 4" long, 3/10 soreness, hot, sm swelling, itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella-like rash.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 16 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 25-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, lot # K023432, expiration date 18-JUN-2016; dose and route were not reported, which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning multiple patients of unknown age and gender. No concurrent conditions or medical history were reported. On 21-SEP-2015, multiple unspecified patients were vaccinated with an improperly stored dose of ROTATEQ (Lot # L008034 Expiration date: 05-AUG-2016) (dose, route and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning multiple patients of unknown age and gender. No concurrent conditions or medical history were reported. On 21-SEP-2015, multiple unspecified patients were vaccinated with an improperly stored dose of GARDASIL (Lot # K010215 Expiration date: 05-MAY-2017) (dose, route and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. 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 registered nurse (R.N.) concerning multiple patients of unknown age and gender. No concurrent conditions or medical history were reported. On 21-SEP-2015, multiple unspecified patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot # K018180 Expiration date: 17-SEP-2016) (dose, route and anatomical location of adminstration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 13-AUG-2015, the nurse reported that the patient possibly received a dose of improperly stored (Oka/Merck) VARIVAX (dose, frequency and route were unknown), lot# L008272, expiration date 11-MAR-2017. No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 3 patients of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 14-AUG-2015, the nurse reported that the patients possibly received a dose of improperly stored VARIVAX (dose, frequency and route were unknown), lot# L008272, expiration date 11-MAR-2017. No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Irritability, Pyrexia
Clinical narrative: Fussy, low grade fever for 2 nights 100-101? Slept almost constantly, voiding, stooling and nursing okay.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a licensed practitioner nurse concerning an 11 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 14-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016 (dose and route were not reported), which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 15 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 28-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL injection (lot # K023432, expiration date 18-JUN-2016; dose and route were not reported), which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: 6 days after injection: Pt here for another appt today in clinic. Reports left arm is swollen, red and warm to touch after PREVNAR 13 injection 4-30-15. Will alert PCP to evaluate while in clinic today.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 84 patients of unknown age and gender. The patients' medical history and drug reactions or allergies were not reported. On unknown dates since January 2015, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX (dose, route, lot# and expiry date were not reported). Concomitant medications were not reported. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No demographic information was available. On 29-SEP-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # K008883, expiration date: 20-SEP-2015, route of administration was not provided. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that on 23-SEP-2015, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006382, expiration date 25-MAY-2016) (Dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from same source. Additional information is not expected because the pharmacist decline to provide patient's or physician's information at this time.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative, regarding to her two sons of unknown age. The patients medical history, drug reactions or allergies were not provided. Approximately in 2014 (reported as approximately one year ago), the patients received their first dose of GARDASIL (dose, route, lot number and expiration date were not provided). Approximately in 2015 (reported as recently), the boys received a dose of GARDASIL 9 (dose, route, lot number and expiration date were not provided). No adverse effects reported. At the time of the report, the patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot, batch # L015414, expiry date 01-AUG-2016, dose, strength, dose number, vaccination site, route of administration unspecified) since 01-SEP-2015. Concomitant medications were not provided. No adverse events were reported. No additional information was provided. The outcome of the reported events was unknown. Product quality complaint (PQC) was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding a 4 year old patient of unknown gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. There was no concomitant medication reported. On 07-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot number L011080, expiration date 01-OCT-2016, (dose and route were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot, batch # J012772, expiry date 09-OCT-2015, lot, batch # L002216, expiry date 21-JAN-2017, dose, strength, dose number, vaccination site, route of administration unspecified) since 01-SEP-2015. Concomitant medications were not provided. No adverse events were reported. No additional information was provided. The outcome of the reported events was unknown. Product quality complaint (PQC) was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 55-year-old female patient who received BOOSTRIX. On 22nd July 2015, the patient received BOOSTRIX (intramuscular) .5 ml. On 22nd July 2015, 2 hours after receiving BOOSTRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovering/resolving. The reporter considered the injection site tenderness to be probably related to BOOSTRIX. Additional details provided were as follows: The patient received BOOSTRIX in left arm. On 22nd July 2015, about 2 hours after receiving the BOOSTRIX vaccine, the patient experienced tenderness in her arm. The tenderness was slowly getting better, but it still bothered the patient while she drives for half an hour or when the patient lifts her arm above her head.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 55-year-old female patient who received BOOSTRIX. On 22nd July 2015, the patient received BOOSTRIX (intramuscular) .5 ml. On 22nd July 2015, 2 hours after receiving BOOSTRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovering/resolving. The reporter considered the injection site tenderness to be probably related to BOOSTRIX. Additional details provided were as follows: The patient received BOOSTRIX in left arm. On 22nd July 2015, about 2 hours after receiving the BOOSTRIX vaccine, the patient experienced tenderness in her arm. The tenderness was slowly getting better, but it still bothered the patient while she drives for half an hour or when the patient lifts her arm above her head.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: PREVNAR 13 redness of upper arm; C/o of redness on left upper arm from Pneumococcal PCV 13 (PREVNAR 13), he denies pain or itching at the site, denies fever and his wife is retired nurse and reports that she has been monitoring his the redness and applying cold compresses to the site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients 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 patients might have been vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # L010144, expiration date 24-MAR-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same source. 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 registered nurse refers to multiple unspecified patients 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 patients might have been vaccinated with improperly stored doses of PROQUAD (Merck) lot # K020748, expiration date 30-APR-2016 (dose and route of administration were not reported). There was no advere effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Body temperature increased, Dermatitis allergic, Dizziness, Erythema, Nausea
Clinical narrative: This is a spontaneous report by a contactable 58 year-old female consumer reported for herself. This 58-year-old female patient received PREVNAR 13 at 0.5 ml single in the left arm on 22Sep2015 at 12:00 noon and QUADRIVALENT FLU SHOT at 1 DF single in the right arm on 22Sep2015. Medical history included hypertension from 2010 and ongoing, neoplasm malignant from 2012 and ongoing (Reporter verbalized she was immunocompromised), splenectomy from May2012 to an unknown date indicates she had this done related to the cancer, ongoing blood cholesterol increased 3-4 years ago, ongoing diabetes mellitus (Reporter was pre-diabetic for a while, diagnosed as diabetic 3-4 years ago). Concomitant medication included lisinopril 15mg every night for hypertension, atorvastatin 10mg once a day for cholesterol, glipizide 5mg in the morning, 5mg at night, for diabetes, ADVIL. The patient experienced cellulitis on an unspecified date with outcome of unknown, swollen arm on 22Sep2015 at 18:00 with outcome of not recovered, elevated temperature on 22Sep2015 at 16:00 with outcome of recovering, chills on 22Sep2015 16:00 with outcome of unknown, sweats on 22Sep2015 16:00 with outcome of unknown, hot arm on 22Sep2015 18:00 with outcome of recovering, nausea on 22Sep2015 18:00 with outcome of recovering, lightheadedness on 22Sep2015 18:00 with outcome of recovering, needlepoint is black and blue on 23Sep2015 12:00 with outcome of not recovered, redness of arm on 22Sep2015 18:00 with outcome of not recovered, bumps on redness of arm on an unspecified date with outcome of not recovered, when she took the needle out, blood came out when they took the needle out from giving her the PREVNAR 13 shot on 22Sep2015 with outcome of unknown, pain in arm on 22Sep2015 18:00 with outcome of not recovered, tired and achy on an unspecified date with outcome of unknown, arm is fairly immobile on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown. The event swollen arm was described as total size of one mid-sized grapefruit on her arm, from her elbow to shoulder; elevated temperature: reported noticing increased temperature by 4pm on 22Sep2015, clarifies she had chills and sweats by 4pm on 22Sep2015, indicates she felt worse the next morning. Temperature read at doctor's appointment on 23Sep2015 was 99.9 or 100 degrees Fahrenheit; needlepoint is black and blue. Reported that the injection seemed to be administered correctly, and it was not administered near a joint. The patient underwent lab tests and procedures which included (CBC) full blood count: normal (about a month ago). Reporter verbalized the doctor thinks it looks like a severe allergic reaction, but she (reporter) also looked online and thinks it may be cellulitis.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report by a contactable 58 year-old female consumer reported for herself. This 58-year-old female patient received PREVNAR 13 at 0.5 ml single in the left arm on 22Sep2015 at 12:00 noon and QUADRIVALENT FLU SHOT at 1 DF single in the right arm on 22Sep2015. Medical history included hypertension from 2010 and ongoing, neoplasm malignant from 2012 and ongoing (Reporter verbalized she was immunocompromised), splenectomy from May2012 to an unknown date indicates she had this done related to the cancer, ongoing blood cholesterol increased 3-4 years ago, ongoing diabetes mellitus (Reporter was pre-diabetic for a while, diagnosed as diabetic 3-4 years ago). Concomitant medication included lisinopril 15mg every night for hypertension, atorvastatin 10mg once a day for cholesterol, glipizide 5mg in the morning, 5mg at night, for diabetes, ADVIL. The patient experienced cellulitis on an unspecified date with outcome of unknown, swollen arm on 22Sep2015 at 18:00 with outcome of not recovered, elevated temperature on 22Sep2015 at 16:00 with outcome of recovering, chills on 22Sep2015 16:00 with outcome of unknown, sweats on 22Sep2015 16:00 with outcome of unknown, hot arm on 22Sep2015 18:00 with outcome of recovering, nausea on 22Sep2015 18:00 with outcome of recovering, lightheadedness on 22Sep2015 18:00 with outcome of recovering, needlepoint is black and blue on 23Sep2015 12:00 with outcome of not recovered, redness of arm on 22Sep2015 18:00 with outcome of not recovered, bumps on redness of arm on an unspecified date with outcome of not recovered, when she took the needle out, blood came out when they took the needle out from giving her the PREVNAR 13 shot on 22Sep2015 with outcome of unknown, pain in arm on 22Sep2015 18:00 with outcome of not recovered, tired and achy on an unspecified date with outcome of unknown, arm is fairly immobile on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown. The event swollen arm was described as total size of one mid-sized grapefruit on her arm, from her elbow to shoulder; elevated temperature: reported noticing increased temperature by 4pm on 22Sep2015, clarifies she had chills and sweats by 4pm on 22Sep2015, indicates she felt worse the next morning. Temperature read at doctor's appointment on 23Sep2015 was 99.9 or 100 degrees Fahrenheit; needlepoint is black and blue. Reported that the injection seemed to be administered correctly, and it was not administered near a joint. The patient underwent lab tests and procedures which included (CBC) full blood count: normal (about a month ago). Reporter verbalized the doctor thinks it looks like a severe allergic reaction, but she (reporter) also looked online and thinks it may be cellulitis.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Body temperature increased, Cellulitis, Chills, Dizziness, Erythema
Clinical narrative: This is a spontaneous report by a contactable 58 year-old female consumer reported for herself. This 58-year-old female patient received PREVNAR 13 at 0.5 ml single in the left arm on 22Sep2015 at 12:00 noon and QUADRIVALENT FLU SHOT at 1 DF single in the right arm on 22Sep2015. Medical history included hypertension from 2010 and ongoing, neoplasm malignant from 2012 and ongoing (Reporter verbalized she was immunocompromised), splenectomy from May2012 to an unknown date indicates she had this done related to the cancer, ongoing blood cholesterol increased 3-4 years ago, ongoing diabetes mellitus (Reporter was pre-diabetic for a while, diagnosed as diabetic 3-4 years ago). Concomitant medication included lisinopril 15mg every night for hypertension, atorvastatin 10mg once a day for cholesterol, glipizide 5mg in the morning, 5mg at night, for diabetes, ADVIL. The patient experienced cellulitis on an unspecified date with outcome of unknown, swollen arm on 22Sep2015 at 18:00 with outcome of not recovered, elevated temperature on 22Sep2015 at 16:00 with outcome of recovering, chills on 22Sep2015 16:00 with outcome of unknown, sweats on 22Sep2015 16:00 with outcome of unknown, hot arm on 22Sep2015 18:00 with outcome of recovering, nausea on 22Sep2015 18:00 with outcome of recovering, lightheadedness on 22Sep2015 18:00 with outcome of recovering, needlepoint is black and blue on 23Sep2015 12:00 with outcome of not recovered, redness of arm on 22Sep2015 18:00 with outcome of not recovered, bumps on redness of arm on an unspecified date with outcome of not recovered, when she took the needle out, blood came out when they took the needle out from giving her the PREVNAR 13 shot on 22Sep2015 with outcome of unknown, pain in arm on 22Sep2015 18:00 with outcome of not recovered, tired and achy on an unspecified date with outcome of unknown, arm is fairly immobile on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown. The event swollen arm was described as total size of one mid-sized grapefruit on her arm, from her elbow to shoulder; elevated temperature: reported noticing increased temperature by 4pm on 22Sep2015, clarifies she had chills and sweats by 4pm on 22Sep2015, indicates she felt worse the next morning. Temperature read at doctor's appointment on 23Sep2015 was 99.9 or 100 degrees Fahrenheit; needlepoint is black and blue. Reported that the injection seemed to be administered correctly, and it was not administered near a joint. The patient underwent lab tests and procedures which included (CBC) full blood count: normal (about a month ago). Reporter verbalized the doctor thinks it looks like a severe allergic reaction, but she (reporter) also looked online and thinks it may be cellulitis.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Fatigue, Full blood count normal, Hyperhidrosis, Hypersensitivity, Injected limb mobility decreased
Clinical narrative: This is a spontaneous report by a contactable 58 year-old female consumer reported for herself. This 58-year-old female patient received PREVNAR 13 at 0.5 ml single in the left arm on 22Sep2015 at 12:00 noon and QUADRIVALENT FLU SHOT at 1 DF single in the right arm on 22Sep2015. Medical history included hypertension from 2010 and ongoing, neoplasm malignant from 2012 and ongoing (Reporter verbalized she was immunocompromised), splenectomy from May2012 to an unknown date indicates she had this done related to the cancer, ongoing blood cholesterol increased 3-4 years ago, ongoing diabetes mellitus (Reporter was pre-diabetic for a while, diagnosed as diabetic 3-4 years ago). Concomitant medication included lisinopril 15mg every night for hypertension, atorvastatin 10mg once a day for cholesterol, glipizide 5mg in the morning, 5mg at night, for diabetes, ADVIL. The patient experienced cellulitis on an unspecified date with outcome of unknown, swollen arm on 22Sep2015 at 18:00 with outcome of not recovered, elevated temperature on 22Sep2015 at 16:00 with outcome of recovering, chills on 22Sep2015 16:00 with outcome of unknown, sweats on 22Sep2015 16:00 with outcome of unknown, hot arm on 22Sep2015 18:00 with outcome of recovering, nausea on 22Sep2015 18:00 with outcome of recovering, lightheadedness on 22Sep2015 18:00 with outcome of recovering, needlepoint is black and blue on 23Sep2015 12:00 with outcome of not recovered, redness of arm on 22Sep2015 18:00 with outcome of not recovered, bumps on redness of arm on an unspecified date with outcome of not recovered, when she took the needle out, blood came out when they took the needle out from giving her the PREVNAR 13 shot on 22Sep2015 with outcome of unknown, pain in arm on 22Sep2015 18:00 with outcome of not recovered, tired and achy on an unspecified date with outcome of unknown, arm is fairly immobile on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown. The event swollen arm was described as total size of one mid-sized grapefruit on her arm, from her elbow to shoulder; elevated temperature: reported noticing increased temperature by 4pm on 22Sep2015, clarifies she had chills and sweats by 4pm on 22Sep2015, indicates she felt worse the next morning. Temperature read at doctor's appointment on 23Sep2015 was 99.9 or 100 degrees Fahrenheit; needlepoint is black and blue. Reported that the injection seemed to be administered correctly, and it was not administered near a joint. The patient underwent lab tests and procedures which included (CBC) full blood count: normal (about a month ago). Reporter verbalized the doctor thinks it looks like a severe allergic reaction, but she (reporter) also looked online and thinks it may be cellulitis.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site swelling, Nausea, Pain
Clinical narrative: This is a spontaneous report by a contactable 58 year-old female consumer reported for herself. This 58-year-old female patient received PREVNAR 13 at 0.5 ml single in the left arm on 22Sep2015 at 12:00 noon and QUADRIVALENT FLU SHOT at 1 DF single in the right arm on 22Sep2015. Medical history included hypertension from 2010 and ongoing, neoplasm malignant from 2012 and ongoing (Reporter verbalized she was immunocompromised), splenectomy from May2012 to an unknown date indicates she had this done related to the cancer, ongoing blood cholesterol increased 3-4 years ago, ongoing diabetes mellitus (Reporter was pre-diabetic for a while, diagnosed as diabetic 3-4 years ago). Concomitant medication included lisinopril 15mg every night for hypertension, atorvastatin 10mg once a day for cholesterol, glipizide 5mg in the morning, 5mg at night, for diabetes, ADVIL. The patient experienced cellulitis on an unspecified date with outcome of unknown, swollen arm on 22Sep2015 at 18:00 with outcome of not recovered, elevated temperature on 22Sep2015 at 16:00 with outcome of recovering, chills on 22Sep2015 16:00 with outcome of unknown, sweats on 22Sep2015 16:00 with outcome of unknown, hot arm on 22Sep2015 18:00 with outcome of recovering, nausea on 22Sep2015 18:00 with outcome of recovering, lightheadedness on 22Sep2015 18:00 with outcome of recovering, needlepoint is black and blue on 23Sep2015 12:00 with outcome of not recovered, redness of arm on 22Sep2015 18:00 with outcome of not recovered, bumps on redness of arm on an unspecified date with outcome of not recovered, when she took the needle out, blood came out when they took the needle out from giving her the PREVNAR 13 shot on 22Sep2015 with outcome of unknown, pain in arm on 22Sep2015 18:00 with outcome of not recovered, tired and achy on an unspecified date with outcome of unknown, arm is fairly immobile on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown. The event swollen arm was described as total size of one mid-sized grapefruit on her arm, from her elbow to shoulder; elevated temperature: reported noticing increased temperature by 4pm on 22Sep2015, clarifies she had chills and sweats by 4pm on 22Sep2015, indicates she felt worse the next morning. Temperature read at doctor's appointment on 23Sep2015 was 99.9 or 100 degrees Fahrenheit; needlepoint is black and blue. Reported that the injection seemed to be administered correctly, and it was not administered near a joint. The patient underwent lab tests and procedures which included (CBC) full blood count: normal (about a month ago). Reporter verbalized the doctor thinks it looks like a severe allergic reaction, but she (reporter) also looked online and thinks it may be cellulitis.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: This is a spontaneous report by a contactable 58 year-old female consumer reported for herself. This 58-year-old female patient received PREVNAR 13 at 0.5 ml single in the left arm on 22Sep2015 at 12:00 noon and QUADRIVALENT FLU SHOT at 1 DF single in the right arm on 22Sep2015. Medical history included hypertension from 2010 and ongoing, neoplasm malignant from 2012 and ongoing (Reporter verbalized she was immunocompromised), splenectomy from May2012 to an unknown date indicates she had this done related to the cancer, ongoing blood cholesterol increased 3-4 years ago, ongoing diabetes mellitus (Reporter was pre-diabetic for a while, diagnosed as diabetic 3-4 years ago). Concomitant medication included lisinopril 15mg every night for hypertension, atorvastatin 10mg once a day for cholesterol, glipizide 5mg in the morning, 5mg at night, for diabetes, ADVIL. The patient experienced cellulitis on an unspecified date with outcome of unknown, swollen arm on 22Sep2015 at 18:00 with outcome of not recovered, elevated temperature on 22Sep2015 at 16:00 with outcome of recovering, chills on 22Sep2015 16:00 with outcome of unknown, sweats on 22Sep2015 16:00 with outcome of unknown, hot arm on 22Sep2015 18:00 with outcome of recovering, nausea on 22Sep2015 18:00 with outcome of recovering, lightheadedness on 22Sep2015 18:00 with outcome of recovering, needlepoint is black and blue on 23Sep2015 12:00 with outcome of not recovered, redness of arm on 22Sep2015 18:00 with outcome of not recovered, bumps on redness of arm on an unspecified date with outcome of not recovered, when she took the needle out, blood came out when they took the needle out from giving her the PREVNAR 13 shot on 22Sep2015 with outcome of unknown, pain in arm on 22Sep2015 18:00 with outcome of not recovered, tired and achy on an unspecified date with outcome of unknown, arm is fairly immobile on an unspecified date with outcome of unknown, severe allergic reaction on an unspecified date with outcome of unknown. The event swollen arm was described as total size of one mid-sized grapefruit on her arm, from her elbow to shoulder; elevated temperature: reported noticing increased temperature by 4pm on 22Sep2015, clarifies she had chills and sweats by 4pm on 22Sep2015, indicates she felt worse the next morning. Temperature read at doctor's appointment on 23Sep2015 was 99.9 or 100 degrees Fahrenheit; needlepoint is black and blue. Reported that the injection seemed to be administered correctly, and it was not administered near a joint. The patient underwent lab tests and procedures which included (CBC) full blood count: normal (about a month ago). Reporter verbalized the doctor thinks it looks like a severe allergic reaction, but she (reporter) also looked online and thinks it may be cellulitis.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Crying, Decreased appetite, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle aches and stiffness (besides injection site), nausea, chills, vomiting, loss of appetite, crying for no reason. Arm pain.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Muscle aches and stiffness (besides injection site), nausea, chills, vomiting, loss of appetite, crying for no reason. Arm pain.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Headache, Malaise, Pain
Clinical narrative: Trouble Breathing, Cough, Chest Congestion. 24 hours later: 09/29/2015 9:00 pm: Fever (101.1), Headache, Body Aches, Feeling all over sick - I guess Malaise.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Trouble Breathing, Cough, Chest Congestion. 24 hours later: 09/29/2015 9:00 pm: Fever (101.1), Headache, Body Aches, Feeling all over sick - I guess Malaise.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: My breastfed son feed at 9pm. Woke up around 315a throwing up and a fever of 99.6. Tried to give ibuprofen for fever reduction but emesis occurred immediately afterwards. Provided cool compress to forehead and neck areas until he went to sleep.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Dyspepsia, Fatigue, Feeling cold, Headache, Immediate post-injection reaction
Clinical narrative: I began feeling a little nauseous right after getting the injection. Over the course of the last 12 hours I've had increasing nausea and digestive problems. I feel fatigued, cold, and sore all over my body. The injection site is particularly painful. I've had a headache since shortly after receiving the shot and I still have it. I feel like vomiting.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: I began feeling a little nauseous right after getting the injection. Over the course of the last 12 hours I've had increasing nausea and digestive problems. I feel fatigued, cold, and sore all over my body. The injection site is particularly painful. I've had a headache since shortly after receiving the shot and I still have it. I feel like vomiting.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Fatigue, Malaise, Nausea, Pain
Clinical narrative: I began feeling a little nauseous right after getting the injection. Over the course of the last 12 hours I've had increasing nausea and digestive problems. I feel fatigued, cold, and sore all over my body. The injection site is particularly painful. I've had a headache since shortly after receiving the shot and I still have it. I feel like vomiting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: This spontaneous report was received from an approximately 63 year old female nurse practitioner, reporting on herself. No information on patient's medical history and concurrent conditions was reported. On unspecified date in November 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapy was not reported. Approximately in 2014, 10-12 days after vaccination, the patient experienced right trigeminal mandibular pain that was lasting for 4 weeks. Dental cause was ruled out. The persistent pain relieved after ibuprofen was administered. The outcome of pain in jaw was reported as recovered/resolved, on an unknown date. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. The event of right trigeminal mandibular pain required medical/surgical intervention to prevent one of the serious criteria as the patient went to dentist and was considered to be medically significant by the reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Full blood count, Lymphocyte count
Clinical narrative: This literature marketed report was received from a physician refers to a 2 year old female patient with Wolf-Hirschhorn syndrome. The patient's medical history included transient hypogammaglobulinaemia of infancy, routine viral illness and recurrent otitis media, but no other recurrent viral, bacteria, fungal or autoimmune diseases. The patient's drug history included oral rotavirus live virus vaccine with demonstrated adequate humoral response noted at 1 year of age with tetanus and diphtheria antibodies present at appropriate levels. On an unspecified date patient was vaccinated with VARIVAX (Merck) (manufacture unknown). Concomitant medications were not reported. On an unspecified date (3 days after vaccination) the patient developed fever to 100.4 degree F associated with bilateral otorrhea. The patient was treated with acetaminophen and ofloxacin drops. On day 3 of fever the patient was presented to outpatient clinic for initial evaluation. On examination the patient had purulent drainage from the ears with debris preventing effective drop administration and the patient external auditory canals were cleared and the treatment with otic antibiotic drops was recommended. The otorrhea was resolved. On day 10 of fever the patient had rash, the rash started at left thigh near the vaccine administration and the rash spread by the initial onset of lesions to the abdomen, back, neck, face, extremities and it was diagnosed as atypical varicella (varicella post vaccine and vaccination failure) and the patient was admitted to the inpatient pediatric ward, the patient was treated with intravenous acyclovir therapy. Laboratory test were performed to evaluate current immunologic functions included complete blood count, immunoglobulin levels, mitogen and antigen lymphocyte studies. On hospital day 1, the patient was removed from the intravenous access and treated with oral acyclovir until the lesion to resolve. The following day the patient appeared well, maintaining adequate oral intake and fever had decreased so the patient was discharged from the hospital. The outcome of the event atypical varicella (varicella post vaccine) was reported as recovering. The reporter assessed the events atypical varicella (varicella post vaccine and vaccination failure) to be related to the suspect therapy. The event atypical varicella (varicella post vaccine) was considered serious due to hospitalization. Additional information has been requested.