chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash to R arm and neck.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Excessive swelling and redness of left upper arm. Sought treatment from MD; Prednisone prescribed.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Headache, dizziness, nausea, diarrhea.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Red warm area about 3-4 inches wide and about 2/3'ds around arm. Rash below injection site. Spread to below elbow and towards shoulder. KEFLEX antibiotic given 10/24/16 for 7 days.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Odynophagia, Pyrexia, Streptococcal infection, Streptococcus test positive
Clinical narrative: Pt woke next AM w/swollen lymph nodes, fever, pain swallowing to ER - Strep diagnosis. TX w/ABX and steroid, per ER MD flu shot contributing factor.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pyrexia
Clinical narrative: Mom called on 10/20/16 at 12:20 pm and reported child had a fever of 104 at 4 am and wanted the child to be seen. Mom report after TYLENOL the fever broke at 3 pm next day to 99.8. No S&S of infection.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt experienced redness, soreness, hot to the touch and a lump at the injection site of the PNEUMOVAX 23.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: SOB, tightness in chest, difficulty breathing, rapid pulse. ER MD gave - epinephrine and BENADRYL.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: Large red bruise and sore arm for over 7 days.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash erythematous, Skin lesion
Clinical narrative: Pt received varicella vaccine on 10/4/16, red spots appeared on pt's face 5 days after vaccine administration, new lesions gradually over other parts of body, some with watery discharge. Presented in office on 10/21/16 with red bumps on legs, back and face. Mom used Aloe moisturizer, BENADRYL CREAM and CERAVE at home. No medication prescribed. Instructed to use calamine lotion for itchiness.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: 12 x 14 cm erythema, swelling. Tender centrally, itchy. Advised to give BENADRYL.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Haemorrhage subcutaneous, Injection site erythema, Injection site reaction, Vaccination site oedema, Vaccination site pain
Clinical narrative: 2-3 inches below vaccine site, the area was red and edematous painful covering a very large area. After being assessed by a FNP, pt was given antibiotics. Site was back to normal by 10/24/16 except for slight edema. On the 21st before pt. took antibiotics, the site appeared as though there was SQ bleeding below the 2nd day reaction site. Like gravity as though there was bleeding internally.
Age: 23.0
Sex: F
Vaccine: HPV2
Symptoms: Abdominal pain upper, Asthenia, Back pain, Chills, Hot flush
Clinical narrative: Pt given second dose of HPV vaccine (CERVARIX) on 9/15/16. Returned to office on 10/18/16 to report experiencing flu-like symptoms and low grade fever (99/5) for a few days after receiving injection. Felt weak with stomach pain and lower back pain x 3-4 weeks afterward. Also getting hot flashes and chills since receiving vaccine.
Age: 23.0
Sex: F
Vaccine: HPV2
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Pt given second dose of HPV vaccine (CERVARIX) on 9/15/16. Returned to office on 10/18/16 to report experiencing flu-like symptoms and low grade fever (99/5) for a few days after receiving injection. Felt weak with stomach pain and lower back pain x 3-4 weeks afterward. Also getting hot flashes and chills since receiving vaccine.
Age: 48.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Full blood count, Myalgia, Pyrexia
Clinical narrative: Myalgias with fever 10/17/16. Diabetic appt 10/18/16-admins PNEUMOVAX (L) deltoid and Tdap (R) deltoid. Developed 102 fever 10/18/16.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PNEUMOVAX given (L) deltoid 10/19. Redness, warmth, tenderness. 16 x 10cm (L) deltoid. No fever.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Left arm pain continued following vaccine. Pt spoke with MD 7/5/16, instructed to use ASPERCREME and deep massage and expect resolution within a week. 10/18/16 message from pt stating pain is less but still aches all of the time. Pt will see primary care provided and may seek physical therapy.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient developed swelling, redness, warmth, tenderness 9 hrs after vaccine administration in the same area as the vaccine. Patient went to the ER and was diagnosed with cellulitis and was prescribed doxycycline 100 mg BID x 7 days.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Full blood count, Pyrexia, Skin discolouration
Clinical narrative: Fever 101.3. Purple spots on back, belly, legs and arms.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction. KINRIX (given to patient in error).
Age: 27.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Asthenia, Back pain, Chills, Mobility decreased, Musculoskeletal pain
Clinical narrative: Chills, fever, vomiting, nausea, weakness, severe unbearable pain from arm/shoulder/neck and upper back. Stiff shoulder, limited mobility. Treatment - morphine, VICODIN, ibuprofen, ICY HOT, BEN GAY, ice packs, heat packs.
Age: 27.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, vomiting, nausea, weakness, severe unbearable pain from arm/shoulder/neck and upper back. Stiff shoulder, limited mobility. Treatment - morphine, VICODIN, ibuprofen, ICY HOT, BEN GAY, ice packs, heat packs.
Age: 27.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Vomiting
Clinical narrative: Chills, fever, vomiting, nausea, weakness, severe unbearable pain from arm/shoulder/neck and upper back. Stiff shoulder, limited mobility. Treatment - morphine, VICODIN, ibuprofen, ICY HOT, BEN GAY, ice packs, heat packs.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, RV5
Symptoms: Irritability
Clinical narrative: Mother noted the baby to be cranky/fussy/six hours after vaccinations were given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb mass, Pruritus, Skin warm
Clinical narrative: Right arm red, hot, itchy with a large area of redness and a lump 2"x1".
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report was received from a consumer (patient's  daughter) and refers to a 58 year old (also reported as 78 year old) female patient enrolled in a market research. The patient's concurrent conditions and medical history were not reported. On an unknown date in March 2016 (reported as in the spring of this year), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date in 2016, 3 weeks after vaccination with ZOSTAVAX, the patient got shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to an multiple unknown patients of unknown age and gender. It was reported that the multiple patients were vaccinated with PROQUAD (Dose, frequency were not reported) (Lot numbers: 042818, Expiry date: 26-APR-2017; lot: M026879, Expiry date: 27-NOV-2017; lot: M031566, expiry date: 24-DEC-2017, lot: M004897, Expiry date: 26-JUL-2017) which were improperly stored on multiple dates. The reported vaccine was stored at -13.1 degree C for 10 hours. No adverse effects reported. There was no previous excursion. This is one of the two reports received from the same reporter. Additional information was requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-SEP-2016, the patient was vaccinated with improperly stored ROTATEQ lot # L027719, expiry date 28-APR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, red, burning, itch, sensitivity around injection site - per patient. Vaccine was not given by us.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided. On an unspecified date in 2014, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route, lot # and expiration date were unknown). On 17-OCT-2016, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (dose, route, lot # and expiration date were unknown) (extra dose administered). No adverse effect was reported. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPAB, MMR, TDAP
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Pt got Guillain-Barre Syndrome diagnosis 10 days after vaccination. Seen in ER and admitted to hospital to intensive care.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient complained of red swollen, hot arm after her PNEUMOVAX 23 shot. I recommended to apply ice, take BENADRYL and try anti-inflammatory. Pt. went to ER where they gave BENADRYL and applied ice and gave anti-inflammatory.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Erythema, Mass, Pruritus, Swelling
Clinical narrative: Immunized on 10/17/16. Redness and swelling that evening with discomfort. Progress to lump under skin with the swelling. Warm soaks and TYLENOL for comfort. 10/21 - still complains of itching, cont. to have lump under skin - redness improving.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medication were not provided. On 30-SEP-2016, the patient was vaccinated with and expired dose of PNEUMOVAX 23 injection (lot # L002310, expiration date 08-JUL-2016). Strength, route of administration and dose number were not reported. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: 11 yr wcc. Pt is a 11 year old female. Source of patient information was mother. Takes BENADRYL 10mL once daily at bedtime for urticaria - seems to help as preventative, is followed by allergist - ordered blood testing, no skin testing, mom has not yet gone for labs.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies, drug reactions or allergies provided. On an unknown dates, reported as several years ago, the patient was vaccinated with 3 doses series of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, anatomical location, lot # and expiration date were not reported). On an unknown date, reported as recently, the patient had titers drawn for nursing school and the titers came back for Hepatitis B as low. The outcome of titers coming back for Hepatitis B as low was reported as not recovered. The relatedness between the event and hepatitis B vaccine (recombinant) (manufacturer unknown) was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to six female patients of unknown age. The medical history, concurrent condition and concomitant therapies of the six patients were not reported. On an unknown date, the six patients were vaccinated with ZOSTAVAX (lot number, expiration date and route of administration were not reported). On an unknown date, after getting ZOSTAVAX, the patients experienced herpes zoster. The outcome of the herpes zoster was not reported. The causal relationship between ZOSTAVAX and the event was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner concerning an unspecified number of patients below the age of 50 years old. The gender of these patients were unknown. On unknown dates the patients received a dose of ZOSTAVAX (dosage, route and frequency were unknown) (Lot Number and expired date were known). No adverse effects reported. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 85 year old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. The pharmacist reported that on 14-SEP-2016, the patient might have received ZOSTAVAX (strength, indication, expiry and lot# were not reported). The pharmacist also reported that on 13-OCT-2016, the patient had received a possible second dose of ZOSTAVAX lot# L044528; expiry on 09-FEB-2017. No adverse events were reported. There were no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On approximately 11-OCT-2016 (reported as a week ago), the patient was vaccinated subcutaneously with ZOSTAVAX (dose, lot number and expiration date were not reported) that was reconstituted with sodium chloride (dose was not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reported refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 03-OCT-2016, the patient was inadvertently administered improperly stored of ZOSTAVAX (lot number M028799 with expiration date 08-AUG-2017; strength, dose, frequency and route were unknown). The product was exposed to temperature 34.9 F for 65 hours. There was no data logger. The temperature was back in range. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L029615, expiry date: 15-MAY-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: 9C and Time: 30 minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M017294, expiry date: 28-JUN-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: -13C and Time: 30 Minutes, Temperature: -11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiry date: 17-DEC-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: 9C and Time: 30 minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site urticaria, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient's current conditions included abnormal blood pressure and blood cholesterol. Patient was not allergic to any medication. On 06-OCT-2016 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # L044529, expiry date: 09-FEB-2017), once subcutaneously. Patient's concomitant medications included, unspecified blood pressure medicine and unspecified cholesterol medicine. The reporter stated that that patient immediately after vaccination experienced arm swelling and was painful. As of 2 days ago (on 16-OCT-2016), the welt-hard area continues on the left arm injection-site. The patient received treatment for the events. The pain went away the following day. The outcome of peripheral swelling is unknown. The outcome of injection site mass was reported as not recovered/not resolved. The reporter did not provided the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker referring to a 21 year old female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was previously vaccinated with her first dose of (Oka/Merck) VARIVAX (start date, lot#, expiration date, dose and route were not reported). On 10-OCT-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot # M013377, expiration date 25-MAY-2017; dose not reported), intramuscularly, instead of a second dose of (Oka/Merck) VARIVAX (Wrong drug administered, incorrect route of drug administration and inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018, dose and route were not reported). The vaccine had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to his significant other, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date in 2008, reported as " in approximately 2008", the patient was vaccinated with ZOSTAVAX (lot number, expiration date and route of administration were not reported). Approximately in 2013, reported as "within 5 to 6 years of receiving vaccine", the patient developed a severe case of shingles. The patient was treated by an unspecified dermatologist and received a course of acyclovir. The Herpes zoster lasted approximately 6 weeks. At the time of the report, the patient was recovered. The causal relationship between Herpes zoster and vaccination with ZOSTAVAX was not provided. This is one of the several reports received from the same source. 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 medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M013156, expiry date: 15-OCT-2017). No adverse effects were reported. Excursion information: Time: 30 Minutes, Temperature: 9C and Time: 30 Minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling from injection site, left deltoid, to the elbow.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that 2 out of 3 patients who received BEXSERO, experienced high fevers (103 to 104 degree F). No further information was available or provided regarding the event. This case has been linked with US2016GSK155329, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure to communicable disease, Extra dose administered
Clinical narrative: This spontaneous report was received from a male physician of unknown age referring to himself. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient received one dose of ZOSTAVAX (lot number, expiration date and route of administration were not reported). On an unspecified date, the patient received a booster of ZOSTAVAX (lot number, expiration date and route of administration were not reported) because his significant other had developed active shingles. The patient stated "he did not feel that his prior ZOSTAVAX dose would provided him with proper immunity". The outcome of the events was unknown. This is one of the 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 medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # L041629, expiry date: 22-ApR-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: -13C and Time: 30 minutes, Temperature: -11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 55-year-old female patient who received ENGERIX B (batch number L4DF7, expiry date 15th January 2019). On 14th October 2016, the patient received the 1st dose of ENGERIX B (intramuscular) 1 ml. On 14th October 2016, less than a day after receiving ENGERIX B, the patient experienced injection site itching, injection site erythema, adult use of a child product, wrong injection technique and off label use. On an unknown date, the outcome of the injection site itching and injection site erythema were unchanged and the outcome of the adult use of a child product, wrong injection site technique and off label use were unknown. The reporter considered the injection site itching and injection site erythema to be probably related to ENGERIX B. Additional details were provided as follows: This case was not previously reported to anyone. On Friday, at 11:00, the patient received ENGERIX B on left deltoid. The reporter reported that two, 0.5 ml doses of the paediatric strength were drawn up into one syringe and injected into the adult patient. The patient received a total of 1 ml of product. This led to an off label use, inappropriate age at vaccine administration and wrong injection technique. On the same day, the patient experienced localized itching and erythema approximately one inch around the injection site. The reporter indicated that the patient sent her a picture of the injection site and would be glad to send it.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On 13-OCT-2016, "a week ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in October 2016, the patient complained of redness, soreness and itching at the injection site. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild redness and swelling on left thigh around injection site, day after injection. Ice packs, diphenhydramine and ibuprofen as needed.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # reported as M036301 with expiration date 20-DEC-2017; lot# M013636 with expiration date 15-MAR-2018; lot# L036301 with expiration date 20-DEC-2017, dose and route were not reported). The vaccine had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. Lot number M036301 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse, referring to a female patient (also a nurse) of unknown age who was not pregnant. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was administered a dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown). On an unknown date after receiving the vaccine, the patient developed a rash. The outcome of rash was unknown. The causality assessment between the rash and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to an multiple unknown patients of unknown age and gender. It was reported that the multiple patients were vaccinated with (Oka/Merck) VARIVAX (Dose, frequency were not reported) (Lot numbers: L050956, Expiry date: 17-DEC-2017; lot L035126, Expiry date: 14-SEP-2017; lot L021214, expiry date: 10-JUN-2017, lot: L048468, Expiry date: 02-DEC-2017) which were improperly stored on multiple dates (incorrect product storage). The reported vaccine was stored at -13.1 degree C for 10 hours. No adverse effects reported. There was no previous excursion. This is one of the two reports received from the same reporter. Additional information was requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L046318 with expiration date 28-SEP-2017, lot# M007125 with expiration date 06-OCT-2017, lot# M002252 with expiration date 28-FEB-2017, dose not reported) orally. The vaccines had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # M030598 with expiration date 13-OCT-2017, dose and route were not reported). The vaccine had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient's not reported. The patient was vaccinated with GARDASIL 9 first dose on 12-JUL-2016 and second dose on 21-SEP-2016 (dose, route and site of administration was not reported for both doses). The third dose of GARDASIL 9 (lot # M023169, expiration date 13-JUN-2018; dose, route and site of administration was not reported) was administered earlier than recommended - on 18-OCT-2016 (also reported as 18-OCT-2018). No adverse event was reported. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (lot #, expiration date, dose and route were unknown). On an unspecified date after administration, the patient reported an injection site reaction, which was described as being a rash and redness around the injection site that lasted for an unspecified amount of time. The outcome of the events and the causality were not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a male patient of unknown age. The patient did not have any pertinent medical history, drug reactions and allergies. On 16-APR-2008, the patient was vaccinated with M-M-R II (dose and route were not reported). The patient did not take any concomitant medications. On an unknown dates in 2008, after receiving the initial dose of M-M-R II the patient experienced chronic fevers that lasted for about 4 days and developed every 3-4 weeks. This last for one year before he stopped developing fevers. Treatment was given for the event and no lab lasts tests were performed. The patient sought medical attention and spoke to the physician. The outcome of pyrexia was reported as recovered/resolved. The causal relationship between M-M-R II and chronic fever was not reported. Additional information is not expected as there is no consent to contact the physician.
Sex: F
Vaccine: HPV9
Symptoms: Dysphagia, Nausea, Pharyngeal oedema
Clinical narrative: Information has been received from the patient's father referring to his 17 year old daughter. The patient had no medical history, concomitant medication or drug reactions/allergies. On 20-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (dose and route unknown). On 21-AUG-2016, the patient experienced swelling in her throat, had difficulty swallowing, and experienced nausea. The patient had visited the doctor to seek medical attention. No treatment was given for the events and no lab was performed. The patient was fully recovered from the events at present. The causal relationship between the events and GARDASIL 9 was unknown. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: The patient experienced "redness, pain, and swelling as a hole was starting to develop around the injection site for GARDASIL 9, the patient also experienced "a swollen injection site that was developing blisters and bubbles from the VAQTA [injection site swelling]. Information has been received from a physician via a company representative referring to a 14 years old female non-pregnancy patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose unknown) intramuscularly in one arm and VAQTA (dose unknown) intramuscularly in the other arm. On an unknown date, the patient experienced redness, pain, and swelling as a hole was starting to develop around the injection site for GARDASIL 9. The patient also experienced a swollen, purple injection site that was developing blisters and bubbles from the VAQTA. The patient had sought the physician twice and treatment had been given for the events. The causal relationship between the events and GARDASIL 9, VAQTA was unknown. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Excessive eye blinking
Clinical narrative: Seen in office 10/12/16 complaining of exacerbated eye blinking x 4 days. Resolved at visit 10/18/16.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Patient got the PNEUMOVAX 23 shot in the morning 11:24 am and came back to the pharmacy around 6 pm with swollen arm (red and inflamed).
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Irritability, Pyrexia, Restlessness, Screaming
Clinical narrative: Rash on right and left lateral thigh. Mother states baby very restless and started with screaming type cry in the evening of 10-17-16 which lasted approximately 3 hrs. States fever of 100 degrees axillary, gave TYLENOL at 4:30pm, fever cont, so used MOTRIN cont. with fussiness.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Allergy to vaccine, Blood pressure decreased, Vaccination complication
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 15 year old male patient. Patient's pertinent medical history, concurrent conditions and drug reactions allergies were unknown by the reporter. On 05-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 (Lot #, expiration date, strength and dose were not reported), via intramuscular. Patient's concomitant therapies included VAQTA. On 05-JUN-2016, the patient had a severe allergic reaction to GARDASIL 9. The physician stated that the patient was in the office when the allergic reaction happened, and the patient's blood pressure dropped. When the allergic reaction started, the patient was rushed to an unspecified Emergency room (ER) and was discharged later. Afterward the patient followed-up with his physician. It was unknown if lab diagnostics studied were performed to the patient. An unspecified treatment was given for the adverse event. The outcome of allergy to vaccine and blood pressure decreased was reported as recovered on an unknown date in 2016. The reporter considered the allergy reaction to be related to GARDASIL 9. However, the causality between blood pressure decreased and GARDASIL 9 was not provided. The reporter considered the events to be life threatening. A product quality complaint was not involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Pyrexia, Status epilepticus
Clinical narrative: Information has been received from an unspecified reporter referring to a 2 year old male patient. The patient's medical history included atypical febrile seizure. The patient's concurrent condition and concomitant therapy were not provided. On 28-JUL-2016 at 14:30, the patient was vaccinated with the third dose of PEDVAXHIB (lot # M010439, intramuscular, in the left thigh, expiration date and dose unknown) and the second dose of VARIVAX (lot # L032391, subcutaneous, in the left thigh, expiration date and dose unknown), in a community clinic. On 01-AUG-2016 four days after vaccination, the patient experienced fever (104 (unit unspecified)) followed by status epilepticus. Outcome of the events was unknown. Causality was not reported. Upon internal review, status epilepticus was considered to be medically significant. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.