chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.31
Sex: F
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 3 month old female patient. On 28-AUG-2015 the patient was vaccinated with VAQTA (K026529, expiry date 28-AUG-2016) and PNEUMOVAX 23 (K005402, expiry date 28-AUG-2016). When the error occurred, the patient did not have RECOMBIVAX HB, for which the patient was indicated. At this time of report the patient had no adverse event. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscle spasms
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of spasms in a 47-year-old male patient who received FLUARIX (batch number 2F5P4, expiry date 30th June 2016). On 15th October 2015, the patient received FLUARIX .5 ml. On 15th October 2015, 5 min after receiving FLUARIX, the patient experienced spasms and injection site pain. On 15th October 2015, the outcome of the spasms and injection site pain were recovered/resolved. It was unknown if the reporter considered the spasms and injection site pain to be related to FLUARIX. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a pharmacist, who himself was the patient. No concomitant medications were reported. The healthcare professional stated that 5 minutes after receiving the vaccine, the patient experiences spasms in the other arm (not the vaccinated arm) above the elbow which was about a 2 inch section. The spasm resolved soon after it occurred. On 15th October 2015, less than a day, after receiving the vaccine, the patient also experienced pain at the injection site that lasted for a minute.
Age: 53.0
Sex: M
Vaccine: FLU3, HEP, PNC13
Symptoms: Drug administered to patient of inappropriate age, Paraesthesia
Clinical narrative: Gave PCV13 to 53 yr old diabetic - should have been PPSV23 only for his age. Was reading the recommended adult IZ schedule for 2015, but was considering him immunocompromised and should have read further where it specifically addressed diabetic - upon talking with pt today 10/26/15, pt.  has had some  on and off tingling ring finger, middle finger and under arm L. No other symptoms will check out with provider if continues.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Flu shot R arm 2 weeks ago shoulder is sore.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Skin discolouration, Swelling
Clinical narrative: 10/9 Presented with large area bruised swollen and discolored - pt states painful. Rph recommended MD visit. Pt made appt and was seen. MD advised symptom care, time, no further attn unless continues to worsen.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Contusion, Mobility decreased, Swelling
Clinical narrative: Patient experienced bruising and she could not move her arms at first, but now she can, is getting better slowly. Was also swollen.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypoaesthesia, Injection site bruising, Injection site hypoaesthesia, Pain
Clinical narrative: Patient experienced bruising and she could not move her arms at first, but now she can, is getting better slowly. Was also swollen.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Muscle spasms, Nausea, Vertigo
Clinical narrative: Woke up with a severe headache, nausea, diarrhea. Also experienced horrible leg cramps. Vertigo and head spinning when down from bed. Recovering.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Inflammation, Injection site pain
Clinical narrative: Pt has been experiencing pain in injection site area for the last month. She was concerning area for the last month. She was concerned and went to her primary MD, who believes that injection was given to high and burst Bursa sack causing inflammation and pain.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the patients were vaccinated with GARDASIL (dose, strength and route were not provided) that was improperly stored. Co-suspect or concomitant therapies were not reported. No adverse effects were reported. The lot number reported for GARDASIL were: L012190 with expiration date on 13-APR-2017, K006960 with expiration date on 19-FEB-2017 and K023432 with expiration date on 18-JUN-2016. Follow up information has been received from the certified medical assistant on 06-OCT-2015. It was reported that, two doses of improperly stored GARDASIL, were administered to two patients. This case was concerning a 11 year old patient of unknown gender. On 19-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # L012190, expiry date: 13-APR-2017) (dose, strength and route were not provided) which experienced 46.9 degrees Fahrenheit for 20 minutes before administered. The patient was safe with the vaccines given. This is one of several reports from the same source. Additional information. Patient's information, therapy information and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored (incorrect product storage) oral, ROTATEQ lot# K023537 and expiry date of 22-JUN-2016 and Lot# K024700, with an expiry date of 30-JUL-2016). No adverse events were reported. No product quality complaint was reported. This is one of the several reports 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 as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date multiple unspecified patients were vaccinated with improperly stored VAQTA lot# K012457 and expiry date 04-JUN-2017 and Lot# L002717, with an expiry date of 02-JUN-2017. No adverse events were reported. The outcome of events were unknown. No product quality complaint reported. This is one of the several reports 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 as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date the multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot# L004754 and expiry date of 10-NOV-2016. No adverse events were reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. On 13-OCT-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (lot # K010439, expiration date, dose, dose number and route were unspecified) instead of the intended dose of ZOSTAVAX. No adverse events were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Immunology test abnormal, Measles, Measles antibody positive, Polymerase chain reaction positive
Clinical narrative: Information has been received from the author (physician) of a published article, concerning a 48 year old female patient, who also was a nurse. The patient had documentation of receipt of 2 doses of MMR (manufacturer unknown) (lot #, dose, frequency and route not reported) in 1991 and 1992, respectively. In 2006, the patient had received negative measles immunoglobulin (Ig) G serology test results: however, according to recommendations of the Advisory Committee on Immunization Practices, she received two MMR (manufacturer unknown) doses. On 11-JAN-2015, the nurse had contact with a patient with laboratory-confirmed measles associated with an outbreak. On 21-JAN-2015, she developed a fever (103 F [39.4 C]), and on 23-JAN-2015 she experienced cough and coryza. On the same day, the nurse was identified as suspected measles. On 24-JAN-2015, she developed a rash. The patient was instructed to isolate herself at home. On 26-JAN-2015, serum, a nasopharyngeal swab, and a urine specimen were collected. The following day on 27-JAN-2015, measles infection was diagnosed by real time reverse transcription polymerase chain reaction testing of the nasopharyngeal swab and urine specimen and by detection of measles-specified IgM and IgG in serum by enzyme-linked immunosorbent assay. Because of her symptoms and laboratory results, the patient was considered to be infectious. The presence of measles IgG (index standard ratio=8.2, with more than or equal to 1.1 considered seropositive) 2 days after rash onset suggested secondary vaccine failure (waning of vaccine-induced immunity, rather than failure to develop an immune response to administered vaccine [i.e. primary vaccine failure]). The outcome of the events was unknown. The reporter considered events to be related to MMR (manufacturer unknown). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rhinitis, Vaccination failure
Clinical narrative: Information has been received from the author (physician) of a published article, concerning a 48 year old female patient, who also was a nurse. The patient had documentation of receipt of 2 doses of MMR (manufacturer unknown) (lot #, dose, frequency and route not reported) in 1991 and 1992, respectively. In 2006, the patient had received negative measles immunoglobulin (Ig) G serology test results: however, according to recommendations of the Advisory Committee on Immunization Practices, she received two MMR (manufacturer unknown) doses. On 11-JAN-2015, the nurse had contact with a patient with laboratory-confirmed measles associated with an outbreak. On 21-JAN-2015, she developed a fever (103 F [39.4 C]), and on 23-JAN-2015 she experienced cough and coryza. On the same day, the nurse was identified as suspected measles. On 24-JAN-2015, she developed a rash. The patient was instructed to isolate herself at home. On 26-JAN-2015, serum, a nasopharyngeal swab, and a urine specimen were collected. The following day on 27-JAN-2015, measles infection was diagnosed by real time reverse transcription polymerase chain reaction testing of the nasopharyngeal swab and urine specimen and by detection of measles-specified IgM and IgG in serum by enzyme-linked immunosorbent assay. Because of her symptoms and laboratory results, the patient was considered to be infectious. The presence of measles IgG (index standard ratio=8.2, with more than or equal to 1.1 considered seropositive) 2 days after rash onset suggested secondary vaccine failure (waning of vaccine-induced immunity, rather than failure to develop an immune response to administered vaccine [i.e. primary vaccine failure]). The outcome of the events was unknown. The reporter considered events to be related to MMR (manufacturer unknown). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old male patient. There was no information about patient's concomitant medications, concurrent condition and medical history reported. On 16-OCT-2015, the patient was vaccinated with a first, 0.6 ml dose of expired dose of ZOSTAVAX lot # K008078, expiry date 03-SEP-2015, subcutaneously (site of administration was not reported) for prevention of shingles. No adverse events were reported. The patient's laboratory data was unknown. The pharmacist queried if she should revaccinate the patient. 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 nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On approximately 15-OCT-2015 (date estimated based on "one week ago"), the patient was vaccinated with the first dose of pneumococcal vaccine (manufacturer unknown), (dose, route of administration, injection site, lot number and expiration date were not reported). On approximately 22-OCT-2015 (date estimated based on "one week later"), the patient received the second dose of pneumococcal vaccine (manufacturer unknown), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report has been received from a physician via company representative referring to unspecified patients of unknown age. On unknown dates the patients were vaccinated with unspecified HPV vaccine (manufacturer unknown) (dose, frequency, route and lot# not reported) (cannot rule out GARDASIL or GARDASIL 9). The patients had other types of unspecified warts that were not genital warts prior to administering the HPV vaccine. The unspecified dermatologist stated that the warts that the patients had "went away" after vaccinating the patient with an HPV vaccine. The outcome of therapeutic response unexpected was unknown. It was unknown if the patient sought any medical attention. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patient of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with less than a full adult dose of RECOMBIVAX HB lot # L014418, expiry date 13-APR-2017. No adverse reactions have been reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Information was received from a 78 year old female patient with anxiety, asthma, high blood pressure, benign thyroid nodules and no known drug allergies. The patient reported that 3 to 4 years ago, she was vaccinated with ZOSTAVAX 0.65 ml, once, (lot number not provided) subcutaneously for prevention of shingles. Concomitant therapies included gabapentin and montelukast sodium (manufacturers unknown). In the middle of September 2015, the patient developed shingles, located on the right side of her buttocks and they itch. She had an office visit with her physician and was treated with valacyclovir and BACTRIM. The outcome of her shingles was reported as not recovered. No further information was provided. The relatedness of the shingles to ZOSTAVAX was not provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 14 year old female patient with none drug reactions/allergies. The patient's medical history included unspecified thyroid level abnormalities since 2013. On 02-SEP-2014 the patient was vaccinated with her first dose in the vaccine series of GARDASIL (injection, lot # K008335, expired date as 23-JUN-2016, dose and route were unspecified). No concomitant therapy was taken. On 03-SEP-2014, "1 day later", the patient developed hives all over her body. The physician reported that the hives lasted 1 day and then the patient fully recovered (date unspecified). Physician also reported that no medical treatment was sought because the patient's mother never told the physician that her daughter developed the hives until a year later when the patient's mother came in for an appointment for herself. No lab diagnostics studies was performed and no treatment was give for the event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On the night of 19-OCT-2015, the PNEUMOVAX 23 was improperly exposed to 48F for 8 hours. On 20-OCT-2015, the patient was vaccinated intramuscularly with a dose of this improperly exposed PNEUMOVAX 23 (lot number L021367 and expiration date 05-NOV-2016; dose was not reported). Concomitant therapy was not reported. There was no adverse effects reported. 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 pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 01-NOV-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported). On 08-JAN-2015, the patient was vaccinated with the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 07-APR-2015, earlier than recommended, the patient received the third dose of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse reactions were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, 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 pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 08-OCT-2015 the patient was vaccinated with expired dose of PNEUMOVAX 23 0.5 mL, lot # K010016 with an expiry date of 05-AUG-2015, intramuscularly. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. 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 pharmacist refers to one unspecified patient of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with improperly stored ZOSTAVAX lot # K024031, expiry date 20-FE-2016, (dose and frequency not provided). No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 19-OCT-2015, the patient was accidentally vaccinated with doses of PNEUMOVAX 23, (dose, route of administration, injection site, lot number and expiration date were not reported) and PREVNAR 13 (manufacturer unspecified), (dose, route of administration, injection site, lot number and expiration date were not reported), both indicated. No adverse effects were reported. 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 nurse and refers to unspecified patients of unknown age and gender. Information regarding the patients' relevant medical history and concomitant medications were not reported. On unknown dates, the patients received ten doses of improperly stored oral, ROTATEQ route of administration defaulted to oral, lot # K024700, expiration date 30-JUL-2016 (dose was not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Disorientation, Syncope
Clinical narrative: Patient had an episode of syncope about 15 min after HPV was administered, he was disoriented (lasted about 15 to 30 seconds) he completely recovered after 30 to 50 mins with stable vital signs. All precautions and care were observed.
Age: 25.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever as high as 101 degrees. Redness, swelling, warmth at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: On 10/14/15 noticed itching at inj. site - saw red raised rash approx 2" x 3" at site. Over next 4 day increased to 3" x 4.5" was painful to pressure with pruritus. Then began to fade. Is still pink 10/21/15 - itchy 1" x 1" - fading. During inj. initially felt a lot of stinging - lasted 2 hr after.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt states the site of the injection is very painful, tender to the touch, red warm to the touch and feels like there is a lumb at the site.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic, Varicella post vaccine
Clinical narrative: Rash on body x 5 days, began on trunk and has spread to limbs and scalp. Rash very pruritic dx of varicella, uncomplicated.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a nurse reporting on a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 18-AUG-2015, the patient was vaccinated with MMR II (dose, route, lot # and expiration date were not reported) and (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported). On the same date, the patient had tuberculosis (TB) skin test performed. On an unknown date in 2015, the patient developed a flat, red rash bilaterally on his arms, anterior thighs, neck and trunk. The nurse reported that the patient was in her office at the time of the report, but she could not provide the details about his adverse events as "he needed to go back to work". The outcome of rash was reported as not recovered. The relatedness between the event and MMR II (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Mobility decreased
Clinical narrative: Pt said day after couldn't get out of bed, couldn't breathe, got ambulance went to hospital.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PPV
Symptoms: Rash papular, Skin hyperpigmentation, Skin plaque
Clinical narrative: This literature marketed report was received from the authors of the published article entitled as stated above regarding a 13-month old girl with inoculation pigmenti (IP). As a neonate, her initial IP lesions involved the left thigh, extending to the groin, and her left flank. After the vesiculobullous stage, she maintained stable whorled hyperpigmented patches for months, with slightly atropic area interspersed with prominent vasculature. Mild ocular findings were noted, which were checked regularly by the patient's ophthalmologist. The patient's mother had a personal history of IP and currently presented with both hyper- and hypo pigmented patches on her torso and left thigh. On 11-DEC-2012, the patient had her 12-month immunization with MMR II (manufacturer unknown); HIB (manufacturer unknown); and pneumococcal conjugate vaccine (manufacturer unknown) (doses, routes of administration, lot # were not provided). On an unknown date in December 2012, in the 2 weeks after immunization, the patient presented to the Dermatology Clinic with erythematous, vesicular plaques consistent with IP which developed on the patient's left hand and right foot. The first vesiculobullous lesions to appear had, according to the mother's report, subsequently transformed into verrucous papules. According to the patient's mother, her previous immunizations had not resulted in similar lesions. The mother also denied that the patient had recent infections or fevers. Examination of the left thigh and flank found slightly hyperpigmented, whorled patches, with prominent vasculature. No diagnostic tests were ordered because she already carried a biopsy-supported diagnosis of IP completed at birth, and the classic appearance of the reactivation lesions was sufficient to make the diagnosis. Reactivation of IP after 12-month immunizations was diagnosed. The outcome of IP reactivation was not reported. The reporter considered that there might have been a link between the event and administration of MMR II (manufacturer unknown), HIB (manufacturer unknown); and pneumococcal conjugate vaccine (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. Information regarding the patient's relevant medical history and concomitant medications was not reported. On an unknown date, the patient received improperly stored one dose of M-M-R II lot # K022285, expiration date: 12-NOV-2016, (exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Inconsolable crying for 3 hours.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Contusion, Decreased appetite, Erythema, Fatigue
Clinical narrative: Arm was red, hot and swollen, bruised 9-12-15 to 9-22-15 chills, no appetite, fatigue general ill feeling  9-12 - 9-22 itching 9-22-15 to present, not as severe as at beginning.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm was red, hot and swollen, bruised 9-12-15 to 9-22-15 chills, no appetite, fatigue general ill feeling  9-12 - 9-22 itching 9-22-15 to present, not as severe as at beginning.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Exercise tolerance decreased, Fatigue, Hypoaesthesia, Laboratory test, Limb discomfort
Clinical narrative: Progressive fatigue, numbness and sensation of heaviness in lower extremities and upper extremities, decreased exercise tolerance.
Age: 1.84
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Mom noticed several red bumps on child's trunk anterior and posterior. Also on both arms and legs.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Aching with low grade temp initially with swelling and redness and pain at the (10 cm diameter) site of injection without blister formation. Treated with cephalexin 250mg every 6 hours for 5 days. Cool compresses for 10-15 minutes 3x/day.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other healthcare professional refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 23-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (lot# reported as L022446, expiration date 14-FEB-2017, dose was not reported; orally). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with a history of unspecified tetracycline allergy and possible allergy to doxycycline. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and site of administration, lot# and expiry date were not reported). The patient used many unspecified medications. On an unknown date, the patient experienced pain in her arm all day long and a red line. The outcome of the events was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Pain
Clinical narrative: Pain on the evening of injection, next day had hives, redness, itching, heat at injection site, patient did not document a fever pt took BENADRYL and applied cortisone cream.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date since 06-OCT-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot# K002527 exp. 18-FEB-2016 and lot# K14833 exp. 14-SEP-2016). There was no concomitant medication described. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site infection, Swelling
Clinical narrative: Pt reports she developed a severe infection at the injection site beginning a few days after the vaccination. She had severe swelling and redness and temperature over 102 degrees. She sought care for this reaction from another physician whose name she would not provide. On 10/26 she still had swelling, pain and superficial erythema x 3 cm.
Age: 56.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, warmth, edema of injection site right deltoid. Covered one-third of upper arm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm red, raised, warm to touch at injection site. Given methylprednisone, CLARITIN OTC.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (R) arm red, raised, warm to touch. Started 24 hours after inj. Given KEFLEX.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Pain of skin, Pruritus, Urticaria
Clinical narrative: C/O hives, itching, skin sore to the touch. Taking ZYRTEC and was seen by PCP and put on steroids.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling and erythema of right arm - upper arm. This occurred two days after injection (Tdap) was administered in right arm.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Mass, Pain, Pruritus, Swelling
Clinical narrative: Severe bruising, itchy, swelling, lump, very sore.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: Pt came back to pharmacy with a scarlet red reaction about 4-5 in long x 2 inches wide on right arm. Also arm had a bump at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Muscular weakness
Clinical narrative: Patient experienced severe fatigue and muscle weakness of 2.5 days was unable to work.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 8 cm red/warm swelling at site of injection/mild tenderness.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Breath holding, Eye movement disorder, Joint hyperextension, Musculoskeletal stiffness
Clinical narrative: After administration varicella, MMR and Hep A, pt had possible body stiffening with arms flexed up and eyes rolled up for 5 seconds. In setting of charge and breath holding. Pt returned to neurologic borderline immediately.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. Information regarding the patients' relevant medical history and concomitant medications was not reported. On unknown dates, the patients received improperly stored GARDASIL two doses of lot # H021861, expiration date 09-OCT-2015 and 14 doses of lot # K016966, expiration date: 10-MAY-2017 (doses, routes of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This spontaneous report as received from company representative from a physician. It was reported that the physician stated that anytime he or his staff administer GARDASIL, or GARDASIL 9, to an unspecified number of patients, the patients immediately complain of burning or tingling at the onset of administration up to two minutes after. Even if the patients are getting other vaccines they can identify that it is GARDASIL being administered, due to the burning. No further information was provided. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Back pain, Flank pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back pain (with radiation) in a 58-year-old female patient who received TWINRIX adult (batch number B457F, expiry date 25th September 2015). On 7th September 2015, the patient received the 1st dose of TWINRIX adult .5 ml. On 23rd September 2015, 16 days after receiving TWINRIX adult, the patient experienced back pain (with radiation). On an unknown date, the outcome of the back pain (with radiation) was not recovered/not resolved. It was unknown if the reporter considered the back pain (with radiation) to be related to TWINRIX adult. Additional details were provided as follows: This case was reported to a doctor. The reported injection site was right deltoid. The patient experienced pain in her side that moved to her back after receiving 1st dose of TWINRIX adult. For tolerance to 2nd vaccination, refer case US2015GSK152583.
Sex: F
Vaccine: HPV2
Symptoms: Joint swelling, Local swelling, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of neck swelling in a 14-year-old female patient who received CERVARIX (batch number BF7A2, expiry date 28th May 2016). On an unknown date, the patient received CERVARIX .5 ml. On 15th October 2015, an unknown time after receiving CERVARIX, the patient experienced neck swelling and swelling arm. On an unknown date, the patient experienced swollen joints. On an unknown date, the outcome of the neck swelling, swollen joints and swelling arm were unknown. The reporter considered the neck swelling, swollen joints and swelling arm to be almost certainly related to CERVARIX. Additional details were provided as follows: The patient received CERVARIX vaccine in the left deltoid. The patient experienced multiple adverse events which included neck swelling, shoulder swelling and arm swelling.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Local swelling, Rash, Rash erythematous, Throat irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 64-year-old female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). On 19th September 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 30th September 2015, 11 days after receiving BOOSTRIX, the patient experienced local swelling and irritative cough. On an unknown date, the outcome of the local swelling and irritative cough were not recovered/resolved. It was unknown if the reporter considered the local swelling and irritative cough to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient experienced red bumps on both legs and also she experienced a cough and tickling in her throat. The patient followed up with her doctor and was referred to her pharmacy where she received the vaccine.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sweating in a 58-year-old female patient who received TWINRIX adult (batch number HZ9Z9, expiry date 13th March 2017). Previously administered products included TWINRIX adult with an associated reaction of back pain (1st dose received on 7th September 2015, see case US2015148849). On 9th October 2015, the patient received the 2nd dose of TWINRIX adult .5 ml. On 10th October 2015, 1 days after receiving TWINRIX adult, the patient experienced sweating. On an unknown date, the outcome of the sweating was recovered/resolved. The reporter considered the swelling to be almost certainly related to TWINRIX adult. Additional details were provided as follows: This case was previously reported to a doctor. The reported injection site was left deltoid. The reported batch number (HZ929) of TWINRIX adult did not exist and was updated to HZ9Z9 as per sales database.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative concerning an unspecified adult male patients greater than 26 years old (specific ages were not provided). Patients' concurrent conditions and medical history were not provided. On an unknown date, the patients who are greater than 26 years of age were vaccinated with GARDASIL 9 (dose, route, frequency, Lot No. and expiration date not provided). There was no concomitant medication described. No adverse symptoms were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse referring to a current 66 year old patient of unknown gender. No pertinent or historical conditions were reported. In 2013, the patient was vaccinated with immunization series of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. On an unknown date the patient had antibody testing completed and the results showed negative titers. The patient was visiting office to received additional dose of RECOMBIVAX HB as treatment and dose had not yet been administered at the time of reporting. The outcome of the event and causality were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored GARDASIL 9, (dose and route not provided) (lot number # L019286, expiration date: 14-NOV-2017 or lot number # L011846, expiration date 16-JUN-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) referring to a 4-year-old child with unknown gender. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that on 07-OCT-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K007797 with expiration date 29-NOV-2015, dose and route were not provided). There was no concomitant medication reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Croup infectious, Decreased appetite, Dizziness
Clinical narrative: Runny nose, sinus pain, headache, sore throat, croupy cough, weakness, generalized body ache, light headedness, malaise, loss of appetite: most sym. much improved in 2 wks. Saw doctor on 10-15-15. TYLENOL, pseudoephedrine, DELSYN, guaifenesin, then antibiotic on 10-15.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Runny nose, sinus pain, headache, sore throat, croupy cough, weakness, generalized body ache, light headedness, malaise, loss of appetite: most sym. much improved in 2 wks. Saw doctor on 10-15-15. TYLENOL, pseudoephedrine, DELSYN, guaifenesin, then antibiotic on 10-15.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus headache, Streptococcus test negative
Clinical narrative: Runny nose, sinus pain, headache, sore throat, croupy cough, weakness, generalized body ache, light headedness, malaise, loss of appetite: most sym. much improved in 2 wks. Saw doctor on 10-15-15. TYLENOL, pseudoephedrine, DELSYN, guaifenesin, then antibiotic on 10-15.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis
Clinical narrative: Acute left shoulder pain and mobility restriction. Radiating down to forearm.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: X-ray normal
Clinical narrative: Acute left shoulder pain and mobility restriction. Radiating down to forearm.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bone marrow oedema, Bursitis, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Acute left shoulder pain and mobility restriction. Radiating down to forearm.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Oedema, Pain in extremity, Tenosynovitis
Clinical narrative: Acute left shoulder pain and mobility restriction. Radiating down to forearm.
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Formication, Headache, Herpes zoster, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report was received from a male patient of unknown age (who was also a company representative) reporting on himself. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, lot #, expiration date and route of administration were not reported). On 30-SEP-2015, after vaccination, the patient experienced shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient of unknown age (who was also a company representative) reporting on himself. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, lot #, expiration date and route of administration were not reported). On 30-SEP-2015, after vaccination, the patient experienced shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Has existing bilateral tinnitus. After FLUZONE shot has noticeable hearing loss in right ear with increased ringing. Given steroids at urgent care and referred to an ENT doctor.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Has existing bilateral tinnitus. After FLUZONE shot has noticeable hearing loss in right ear with increased ringing. Given steroids at urgent care and referred to an ENT doctor.
Age: 63.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Pyrexia, Rash macular, Tremor
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old patient of unknown gender. The patient was allergic to egg erythromycin and codeine. The patient did not have pertinent medical history. On 13-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX23, lot # K008927 (dose not reported), expiration date 17-MAR-2016, intramuscularly. The patient did not take concomitant therapy. On an unknown date in October 2015, the patient experienced a rash at the injection site on left tricep, sized at 12 cm x 13 cm, which was red and diagnosed as cellulitis. The patient also complained of chills, body aches on an unspecified date in October 2015. The patient contacted the office to seek medical attention on 15-OCT-2015 (today), and was seen by a clinician in the office. Doxycycline was given for the event. No lab diagnostics were performed. The outcome of the events was unknown. This is one of three reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old patient of unknown gender. The patient was allergic to egg erythromycin and codeine. The patient did not have pertinent medical history. On 13-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX23, lot # K008927 (dose not reported), expiration date 17-MAR-2016, intramuscularly. The patient did not take concomitant therapy. On an unknown date in October 2015, the patient experienced a rash at the injection site on left tricep, sized at 12 cm x 13 cm, which was red and diagnosed as cellulitis. The patient also complained of chills, body aches on an unspecified date in October 2015. The patient contacted the office to seek medical attention on 15-OCT-2015 (today), and was seen by a clinician in the office. Doxycycline was given for the event. No lab diagnostics were performed. The outcome of the events was unknown. This is one of three reports received from the same source. Additional information has been requested.