chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route of administration were not reported) lot # K007828; expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effect reported. There was not a product quality involved. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot #, expiration date and anatomical location were not provided). The reporter stated, that the patients had an increase in injection site reactions during the summer months after ZOSTAVAX administration on multiple unspecified dates. It was unknown if the treatment was given for adverse events. The outcome of the events and causality assessment were not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX (lot # K008820, expiration date 19-JUN-2016, dose and route unknown). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 30-JUN-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L048468, expiration date 02-DEC-2017, dose and route unknown). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Varicella, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 04 year old female patient. None pertinent medical history, drug reactions/ allergies and concomitant medication. On 14-DEC-2012, the patient was vaccinated with first dose of VARIVAX, lot# h010558 (expiry date: 24-MAY-2014), subcutaneously. On 10-NOV-2015, patient was vaccinated with second dose of VARIVAX, lot# 1023589 (expiry date: 26-JUN-2017), subcutaneously (Inappropriate schedule of vaccine administered). On 23-JUN-2016, when she sought medical attention for chickenpox from her healthcare professional, tested positive for varicella zoster (chickenpox). The patient received unspecified treatment for the event. No Product Quality Complaint (PQC) was involved. The outcome of the event (chickenpox) was resolving. The reporter did not provide any causality assessment between event (chickenpox) and VARIVAX. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash, itchy on 7/24/16. C/O rash erythematous, non painful, "tad itchy" mom first noticed yesterday, slightly larger today, never hard or painful, more "annoying" was in the sun most of the day and has hx of eczema. Located about 1 inch from injection site on left arm, rash is more over bicep than deltoid. Had MENVEO on Friday.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Applied hydrocortisone cream and 3 days later area was clear. Urticaria pruritus and red, warm swollen at injection site four inches in diameter. Hydrocortisone apply TID.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 19-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, expiration date 31-JAN-2016 (dose, dosage number, route of administration and lot # were not reported). No concomitant medications were reported. No adverse event were reported. Additional information is not expected because no authorization was given to contact the primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with two doses of ZOSTAVAX within the same 24 hour period (dose, dosage number, route of administration, expiration date and lot # were not reported). No concomitant medications were reported. No adverse event were reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, lot number was L016125 and expiration date of 06-MAY-2017 (strength, route of administration and dose were not reported), which was stored at 6 Celsius Degree for 179 hours and 30 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a male patient over 50 years old. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a single dose of ZOSTAVAX, administered by an unspecified route (dose number and lot number were not provided). The pharmacist reported that on an unknown date the patient developed a large red bump for 2 weeks after receiving the dose of ZOSTAVAX. Although no treatment was given, at the time of reporting the patient was recovered from the adverse event. The causality assessment was not provided. 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 physician refers to a unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (dose, dosage number, route of administration, lot # and expiration date were not reported). No concomitant medications were reported. No adverse events or product quality complain were involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Pt-presented with redness and warmth to injection site. Reported low grade temp.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 25-JUL-2016, the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5 ml, 0.5 ml once, intramuscular (dose number, anatomical location, lot # and expiration date were not reported). No other suspect therapies or concomitants were reported. It was stated that VAQTA experienced temperature of 46.8F for a time frame of 20 minutes. There were, reportedly, no previous temperature excursions. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. Additional information had been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, Needle issue, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date,  the patient was vaccinated with GARDASIL (dose, dosage number, route of administration, lot # and expiration date were not reported) it was also stated that the vaccine was administered with an improperly gauge needle. No concomitant medications were reported. No averse reaction was reported. No adverse effects and no product quality complain were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical Assistant via Pfizer refers to a 66 year old male patient. The pertinent medical history was not provided. The patient's concurrent conditions included blood pressure management. On 15-JUN-2016 the patient was vaccinated with PREVNAR 13 0.5 ml, intramuscularly in the right deltoid muscle, instead of PNEUMOVAX 23. Concomitant therapies included lisinopril (manufacturer unknown) and unspecified multivitamins. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were  not reported. In July 2013 (reported as "3 years ago"), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported). Since an unknown date, the patient experienced a shingles outbreak every 6-8 weeks. It was  unknown if the pharmacist would be interested in varicella zoster virus (VZV) analysis by polymerase chain reaction (PCR). The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L036437 with expiration date 18-MAY-2017; dose and route were not reported). No adverse symptoms was reported. 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 healthcare worker refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history, drug allergies, and concomitant medications were not reported. On 14-JUL-2016 the patient received an improperly dose of PROQUAD (lot # L031601, expiry date 18-FEB-2017) (dose and route were unknown ). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored GARDASIL 9 (lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored PEDVAXHIB (lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored ROTATEQ (lot # and expiration date were not reported) orally. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (strength, dose and route of administration were unknown). The lot number and expiration date were either L045955 with expiration date of 17-NON-2017 or an unspecified lot number with an unknown expiration date. There were no concomitant therapies nor adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unknown number of patient of unknown age and gender. On unknown dates incorrectly stored doses of VAQTA (lot # M009786 and M003025; exp date: 26-MAY-2017), could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with a highest temperature of 48.6 degree F. Temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. 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 physician assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 07-JUN-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and route of administration were unknown). The lot number was L046900 with an expiration date of 23-FEB-2017. There were no concomitant therapies nor adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L048849 expiration date 04-FEB-2018 (dose, dosage number and route of administration were not reported). No concomitant medications were reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to one unspecified patients of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 14-JUL-2016 the patient received an improperly stored dose of VARVIAX (lot # L046888, expiry date 23-NOV-2017) (dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: No known.
Age: 9.0
Sex: F
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: No known.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Tooth fracture
Clinical narrative: HPV9, TDAP and MCVP vaccines admin. 10-15 min after patient stood up, then passed out, falling to floor, breaking both top incisors. Immediately seen by dentist for emergency care.
Age: 26.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Anxiety, Dizziness, Eye pruritus, Urticaria
Clinical narrative: Hep B and TDAP given this am - pt developed acute hives across (B) UE and torso approximately 5 1/2 inches after immunizations. Associated dizziness, N, anxiety, peri orbital itching.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient noticed a circular rash (1 1/2 - 2 inches in diameter) at injection site. Redness and slight warm to touch. Patient advised to try BENADRYL, ice to site, and follow up with Dr. next day if no improvement. No swelling.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, MENB
Symptoms: Feeling hot, Injection site erythema, Pain
Clinical narrative: Developed arm redness around injection on 7-7-16 to maximum 4 x 5 inch. No fever. No hives. Localized pain and warmth. Seen at urgent care and placed on antibiotic. Better within 4 days. ? Whether to give 2nd and 3rd dose.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Peripheral coldness
Clinical narrative: Vaccine given (R) arm IM-immediately stated "feels like cold going down arm". C/o numbness ("Icy/hot feeling)-Numbness and cold. -Lasted greater than 30 mins. inner portion of (R) arm form-Axilla and decreased thru fingers.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient requested ZOSTAVAX as per PCP and CDC recommended for adult 65 y.o and older. The screening questionnaire was answered with NO for all questions. on 7/28/16, Pharmacist was informed by patient POP that patient ha shingles and has been treated with Acyclovir with no severe symptoms.
Age: 52.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Injection site vesicles, Palpitations
Clinical narrative: Approximately 24 hrs. after receiving vaccination ZOSTAVAX, pt. developed blisters, reddened, swollen skin around the injection site. Area was swollen "like a bee sting" but not itchy or sore. Pt. also said she developed chest pain/palpitations during this time as well. The rash seemed to get worse from Wednesday to Thursday when I spoke with her. She called Dr. and was going to see her PCP on Friday.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient ordered VARICELLA dose # 1 ZOSTAVAX vaccine was administered Lot M017294 NDC 0006-4963-01 Exp 6/28/17.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Pallor
Clinical narrative: Patient got HPV shot at 10am, at 10:05am patient got very pale and said he did not feel well. We laid him down on the table and he passed out right after. He came back around after a minute.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swollen.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Mild erythema and noted edema to left deltoid area. Right deltoid hot to touch, erythematous and edematous. Mild firmness noted at site. Area approx. 10 cm in length. BENDARYL 25mg q 6-8 hours prn, prednisone 20mg BID x3 days and continue ice packs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Hard, red and swollen area at site, 1.5 in and 1 in treated 3 days after im w/KEFLEX for cellulitis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gaze palsy, Pyrexia, Tonic posturing
Clinical narrative: Patient received vaccines in the morning. In the evening she developed tactile fever and became tonic > 10 mn with eyes deviation. Called 911 then went to ER.
Sex: U
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: This spontaneous report was received from a nurse via field representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with oral ROTATEQ, (lot #, expiry date, dose and frequency not reported). After giving oral ROTATEQ, the patient almost immediately started projectile vomiting. The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA pediatric (25/0.5 unit unknown, lot# L023232, expiration date 25-FEB-2017, route not reported). The vaccine was improperly stored in 12 Celsius degree for 8 hours and 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K003520, expiration date: 20-NOV-2016, 0.5 ml, once, intramuscularly (dose number was not reported). There was no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient was vaccinated with her first dose of GARDASIL 9 and her second dose of GARDASIL 9, following the recommended vaccination schedule (dose, route of administration, lot # and expiration date were not reported for both doses). Then, one week after the second dose, she received her third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. The patient's medical history an concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB injection (dose, lot number, expiration date, route and anatomical location of administration were not reported, which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-health care professional (patient) on 6 October 2015. This case involves a 75 years old female patient whose was vaccinated with a dose of FLUZONE HS (batch number, dose, dose number were unknown) via intramuscular route in right arm on 26 September 2015. Patient's medical history includes low blood pressure and lung cancer and concomitant medications was not reported. It was reported that, on 27 September 2015 (1 day after vaccination), patient developed very painful at right arm and felt very difficult using arm. It was reported that the patient required ER/doctor visit. Lab data was reported as unknown and corrective treatment was not reported. The outcome of the events were unknown at the time of this report. Follow-up information received from a health-care professional on 23 November 2015. Tha patient had received first dose of FLUZONE HD (batch number: UI457AA, expiry date: 22 April 2016) in right deltoid. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Dysphagia, Flushing, Hypoaesthesia oral, Throat tightness
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional on 5 October 2015. This case involves a 57-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI459AA, expiration date: 30 April 2016, dose, dose number and site of administration were not reported) intramuscularly on 29 September 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was none reported. The patient did not had illness at time of vaccination. Concomitant medication was not reported. On 29 September 2015, three hours following the vaccination, the patient's lips became numb, her throat tightened and it became difficult to swallow, and she was flushed. It was a case of inappropriate age at vaccine administration. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient was recovered from all the events. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Cellulitis, Erythema, Malaise, Pain in extremity, Skin induration
Clinical narrative: In March I went to the ER for pain that was making me sick my arm was swelling. I was having
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: X-ray
Clinical narrative: In March I went to the ER for pain that was making me sick my arm was swelling. I was having
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Malaise, Pain, Peripheral swelling
Clinical narrative: In March I went to the ER for pain that was making me sick my arm was swelling. I was having
Age: 77.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 77 year old male consumer referring to himself. The patient's pertinent medical history included cataract and prostate surgeries. The patient was allergic to SULFA drugs. On an unknown date, he took some SULFA drugs and they almost killed him. He did no remember the names of the SULFA drugs. On 26-APR-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot# and frequency unknown) by intravenous route for pneumonia vaccination. Concomitant therapies included ibuprofen, aspirin(manufacturer unknown) and alprazolam. On 26-APR-2016 while on PNEUMOVAX 23, the patient developed redness, itchiness, puffiness and blisters on his skin in the areas of his back, arms and shoulders. He was still developing more blisters on his fingers. Some of his skin in these areas was only red and itchy with no blisters. It was also reported that the suspect therapy was discontinued. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the patient denied consent to contact physician for further information.
Age: 77.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: This spontaneous report was received from a 77 year old male consumer referring to himself. The patient's pertinent medical history included cataract and prostate surgeries. The patient was allergic to SULFA drugs. On an unknown date, he took some SULFA drugs and they almost killed him. He did no remember the names of the SULFA drugs. On 26-APR-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot# and frequency unknown) by intravenous route for pneumonia vaccination. Concomitant therapies included ibuprofen, aspirin(manufacturer unknown) and alprazolam. On 26-APR-2016 while on PNEUMOVAX 23, the patient developed redness, itchiness, puffiness and blisters on his skin in the areas of his back, arms and shoulders. He was still developing more blisters on his fingers. Some of his skin in these areas was only red and itchy with no blisters. It was also reported that the suspect therapy was discontinued. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the patient denied consent to contact physician for further information.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Severe pain, swelling and inflammation below site of injection extending to forearm-skin color evolved from red to blue, purple and yellow. Treated by physician with Prednisone - Injectable and oral x 5 days.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: Severe pain, swelling and inflammation below site of injection extending to forearm-skin color evolved from red to blue, purple and yellow. Treated by physician with Prednisone - Injectable and oral x 5 days.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Altered state of consciousness, Eye movement disorder, Muscle contractions involuntary, Seizure
Clinical narrative: Patient had received her hepatitis A vaccine and also her HPV vaccine. She then had a syncopal spell on when she was lying down and subsequently had a seizure. Estimated less than 30 seconds was witnessed by mom. Observing for about 30 minutes that patient left without any complications.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Seizure, Syncope
Clinical narrative: Patient had received her hepatitis A vaccine and also her HPV vaccine. She then had a syncopal spell on when she was lying down and subsequently had a seizure. Estimated less than 30 seconds was witnessed by mom. Observing for about 30 minutes that patient left without any complications.
Age: 0.51
Sex: F
Vaccine: DTAP
Symptoms: Dermatitis diaper, Head banging, Injection site mass, Rash
Clinical narrative: Severe rash on belly and in diaper area (never had this previously), large lump in thigh where shot was administered, and banging head on mattress and against mother's chest.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 05 October 2015. This case is linked to 2015SA154152, 2015SA154153, 2015SA154190 (same reporter, different patients). This case involves a female (age not reported) patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Quadrivalent influenza vaccine) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date (over the week end). Previously patient received unspecified vaccine for the last couple of years with no ill effect. Medical history was not reported. Concomitant medication was not reported. On an unspecified date, the patient experienced little soreness that usually. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a consumer on 5 October 2015. This case linked to 2015SA154146, 2015SA154153 and 2015SA154190 (same reporter). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (batch number, dose, route and site of administration was not reported) on an unspecified date (over the week end). It was reported that the patient received the vaccine from the clinic for the last couple years and did not experience any illness. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed little soreness (that usually comes from getting a shot). Lab data and corrective treatments were not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a Consumer (patient's father) on 05-Oct-2015. This case was linked to 4 other cases with ids 2015SA154152, 2015SA154146, and 2015SA154190 (same reporter and vaccine). This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Quadrivalent Influenza Vaccine) (manufacturer: unknown, batch number, expiry date route and site of administration was not reported) on unspecified date over the week end. Medical history and concomitant medications were not reported. On unspecified date, patient had experienced little soreness after shot. Patient had received Quadrivalent Influenza Vaccine last year with no ill effect. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer on 05-Oct-2015. This case involves a 92 years old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route in the right shoulder (batch number, expiry date were not reported) on an unspecified date in Sep 2015. Previous dose was reported as yes. The patient had no illness at time of vaccination. There was no known allergy and he had arthritis in the hands. Concomitant medications were not reported. On unspecified date in Sep 2015, one day post vaccination, the patient developed pain at site, it was reported that the vaccine was given in her shoulder, not the deltoid. The pain had persisited with "ten on a scale of ten at times". She was seen by her orthopedist who stated the pain was due to the vaccine. The patient stated she cannot move her arm the full ROM (Range Of Motion), she was unable to play tennis and could not get dressed without help. The patient took tylenol (Over The Counter) as corrective treatment. Laboratory tests were not reported. She required ER/doctor visit. The patient had not yet recovered from the above mentioned events. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Injection site discharge, Injection site haemorrhage, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's friend) on 5 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced pain upon vaccination and when needle withdrawn had bleeding and small drop of clear fluid at site. It was reported that, the patient went for FLUZONE HD vaccination but was not sure which flu vaccine he received and he also thought that it looked like more than 0.5 ml dose. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain, Injection site pruritus, Platelet count
Clinical narrative: Initial unsolicited report received from a consumer who was also a physician on 6 October 2015. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration not reported) on an unspecified date. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as NKA(no known allergy), none, Illness at time of vaccination was none and concomitant medications were reported as none. On 6 October 2015, about 2 weeks after the vaccination the patient had experienced large hematoma at the site with pain and itching without rash. The patient also reported that the hematoma was 7 inches by 6 inches approximately The patient required ER/doctor visit. Laboratory investigations includes platelet count and corrective treatments were not reported. The final outcome for the events was reported as not recovered. Documents held by sender: none
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Body temperature increased, Erythema, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from Consumer on 06-Oct-2015. This case involves a 70-year-old male patient who was vaccinated with a sixth dose of FLUZONE HD (batch number was not available, expiry date and route of administration were not reported) in left deltoid and first dose of PREVNAR 13 (manufacturer: Pfizer, batch number was not available, expiry date and route of administration were not reported) in right deltoid on unspecified date in Sep-2014. Patient had not received any other vaccinations four weeks prior. It was reported that patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On unspecified date in September immediately after vaccination, patient had swelling of his left arm with redness warmth and pain it extended down to his mid forearm. He also had expected side effects of temp of 100.5F and body aches. It was reported that both PREVNAR 13 and FLUZONE HD were given on the same day and the patient was not sure which arm the vaccines were given and felt that the Pharmacy may have them mixed up. No Lab test had been performed. Patient was treated the swelling and pain with ice and OTC medications. On unspecified date, patient gradually got better and was recovered from the events in a week or so. Documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from Consumer on 06-Oct-2015. This case involves a 70-year-old male patient who was vaccinated with a sixth dose of FLUZONE HD (batch number was not available, expiry date and route of administration were not reported) in left deltoid and first dose of PREVNAR 13 (manufacturer: Pfizer, batch number was not available, expiry date and route of administration were not reported) in right deltoid on unspecified date in Sep-2014. Patient had not received any other vaccinations four weeks prior. It was reported that patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On unspecified date in September immediately after vaccination, patient had swelling of his left arm with redness warmth and pain it extended down to his mid forearm. He also had expected side effects of temp of 100.5F and body aches. It was reported that both PREVNAR 13 and FLUZONE HD were given on the same day and the patient was not sure which arm the vaccines were given and felt that the Pharmacy may have them mixed up. No Lab test had been performed. Patient was treated the swelling and pain with ice and OTC medications. On unspecified date, patient gradually got better and was recovered from the events in a week or so. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Initial unsolicited report received from a non healthcare professional on 06-Oct-2015. This case involves a 40 years old male patient who was vaccinated with a dose of INFLUENZA VACCINE (INFLUENZA VACCINE) via intramuscular route (manufacturer: unknown, batch number, expiry date, site of administration were not reported) on 16-Sep-2015. The patient had no illness at time of vaccination. There was no known allergy. Birth defects and medical conditions were reported as none. Concomitant medications were not reported. On 19-Sep-2015, three days post vaccination, the patient began itching and broke out in a rash on his forearms. Symptoms progressed to uticaria all over his body. She required Emergency Room/doctor visit for the events. The patient took two courses of Solumedrol dose pack as corrective treatment with little improvement. No laboratory tests were done. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Blood test, Chills, Computerised tomogram abdomen, Hyperhidrosis
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 6 October 2015. This case involves a 61-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza) (batch number U53388A, route, dose and site of administration was not reported) 3 October 2015 at 10:00 AM. Patient medical history and concomitant medications were not reported. On 3 October 2015 at 5:00 PM, seven hours following the vaccination, the patient experienced chills, body aches and muscle tightness and same day at 11:00 PM, 13 hours following vaccination the patient experienced severe sweating, body aches, muscle tightness, arm tingling and stomach pain or soreness. On 3 October 2015, same day the patient also experienced rash at injection site. The patient required emergency room or doctor visit. Lab data included blood work, urinalysis, x-ray and CAT scan of abdomen. Corrective treatments were not reported. The patient was recovered from the events. List of documents held by sender: none. Follow-up information received from non-healthcare professional in the United States on 01 December 2015. No further information available.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site rash, Muscle tightness, Pain, Paraesthesia, Urine analysis
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 6 October 2015. This case involves a 61-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza) (batch number U53388A, route, dose and site of administration was not reported) 3 October 2015 at 10:00 AM. Patient medical history and concomitant medications were not reported. On 3 October 2015 at 5:00 PM, seven hours following the vaccination, the patient experienced chills, body aches and muscle tightness and same day at 11:00 PM, 13 hours following vaccination the patient experienced severe sweating, body aches, muscle tightness, arm tingling and stomach pain or soreness. On 3 October 2015, same day the patient also experienced rash at injection site. The patient required emergency room or doctor visit. Lab data included blood work, urinalysis, x-ray and CAT scan of abdomen. Corrective treatments were not reported. The patient was recovered from the events. List of documents held by sender: none. Follow-up information received from non-healthcare professional in the United States on 01 December 2015. No further information available.