chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration, Injection site reaction, Mobility decreased, Oedema
Clinical narrative: 31 yo healthy male who was referred to agency for adverse reaction to anthrax vaccine #7 reports severe edema, erythema, tenderness, induration and pruritus onset 1 day after vaccine receipt on 23 AUG. Pain was as high as 4/10. affected function, difficulty lifting his arm, although no weakness. He was seen by clinic and treated with prednisone and BENADRYL. Site is greatly improved, most erythema resolved, minimal pruritus, pain now 1/10, normal ROM.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pruritus, Tenderness
Clinical narrative: 31 yo healthy male who was referred to agency for adverse reaction to anthrax vaccine #7 reports severe edema, erythema, tenderness, induration and pruritus onset 1 day after vaccine receipt on 23 AUG. Pain was as high as 4/10. affected function, difficulty lifting his arm, although no weakness. He was seen by clinic and treated with prednisone and BENADRYL. Site is greatly improved, most erythema resolved, minimal pruritus, pain now 1/10, normal ROM.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. Since 19-JUN-2016, the patients' were vaccinated with improperly stored doses of PNEUMOVAX 23 from lot # L019836 with expiry date of 24-MAR-2017 and from lot # L013428 with expiry date of 03-FEB-2017 (dose and route not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Feeling hot, Injection site mass, Injection site swelling, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received BEXSERO (batch number 154101, expiry date 31st May 2017). On 18th August 2016, the patient received BEXSERO .5 ml. In August 2016, less than a week after receiving BEXSERO, the patient experienced tiredness. On 18th August 2016, the patient experienced injection site lump, fever, feeling unwell, feeling hot and injection site swelling. In August 2016, the outcome of the injection site lump and injection site swelling were recovered/resolved. On 20th August 2016, the outcome of the fever, feeling unwell and feeling hot were recovered/resolved. On an unknown date, the outcome of the tiredness was unknown. the reporter considered the injection site lump, fever, feeling unwell, feeling hot, injection site swelling and tiredness to be almost certainly related to BEXSERO. Additional details were provided as follows: the patient received BEXSERO vaccine in the right deltoid. the patient experienced multiple symptoms which included swelling at injection site, hot to touch, fever (103.5 degrees F), malaise and was just not feeling well. On 19th August 2016, the patient went to the emergency room experiencing the same symptoms from the day before. On 20th August 2016, the patient went to the physician's office with swelling at injection site, but fever had gone away and overall he was feeling better. On 23rd August 2016, the patient's mom stated that the patient felt tires, but all symptoms had gone away. the healthcare professional had pictures documented if the safety department wanted to see those.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received BEXSERO (batch number 154101, expiry date 31st May 2017). On 18th August 2016, the patient received BEXSERO .5 ml. In August 2016, less than a week after receiving BEXSERO, the patient experienced tiredness. On 18th August 2016, the patient experienced injection site lump, fever, feeling unwell, feeling hot and injection site swelling. In August 2016, the outcome of the injection site lump and injection site swelling were recovered/resolved. On 20th August 2016, the outcome of the fever, feeling unwell and feeling hot were recovered/resolved. On an unknown date, the outcome of the tiredness was unknown. the reporter considered the injection site lump, fever, feeling unwell, feeling hot, injection site swelling and tiredness to be almost certainly related to BEXSERO. Additional details were provided as follows: the patient received BEXSERO vaccine in the right deltoid. the patient experienced multiple symptoms which included swelling at injection site, hot to touch, fever (103.5 degrees F), malaise and was just not feeling well. On 19th August 2016, the patient went to the emergency room experiencing the same symptoms from the day before. On 20th August 2016, the patient went to the physician's office with swelling at injection site, but fever had gone away and overall he was feeling better. On 23rd August 2016, the patient's mom stated that the patient felt tires, but all symptoms had gone away. the healthcare professional had pictures documented if the safety department wanted to see those.
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Feeling cold, Pyrexia, Rash papular
Clinical narrative: This spontaneous report was received from a patient's parent referring to her son, a 14 year old male patient. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 04-AUG-2016 (reported as "on Thursday late afternoon"), the patient was vaccinated with second dose of GARDASIL 9 (route, strength, lot # and expiration date were not reported). On 05-AUG-2016, the patient experienced chills, feeling abnormal and pyrexia (reported as "low-grade fever, chills and generally felt poor"). On 06-AUG-2016, the patient recovered from the aforementioned events as the fever subsided and his energy returned. In August 2016 (referred as "this weekend"), the patient experienced rash papular (referred as "bumps on his fingers primarily on the skin between the cuticle and first finger joint. On his little fingers, the bumps run higher up and cover most of the tip of the pinky"). It was also stated that the "bumps" did not appear to be on the palm side of his fingers. They are not red or itchy, just a raised rash of sorts on the first finger join of all fingers. The outcome of this event was unknown at the time of reporting. The reporter did not know whether the events were related to the use of GARDASIL 9, but it was not something the patient experienced before. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient in his 70's. The patients' medical history and concurrent conditions were not reported. On an unspecified date in 2011, the patient was vaccinated with the first dose of ZOSTAVAX from and unspecified healthcare provider, (lot number, expiration date, concentration, via, dose and frequency were not reported). Information regarding concomitant medication was not provided. In August 2016, the primary reporter stated that the patient experienced an 'achy" feeling on the right side of his body. He also had some redness on the right side of his chest and the right side of his back. He went to the emergency room and was diagnosed with shingles. At the time of the report, the outcome of shingles was reported as not recovered. The causality between ZOSTAVAX and shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple 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 improperly stored doses of GARDASIL 9 lot # L037554, expiry date 25-DEC-2016) (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of -0.17 degrees Celsius for 1 hour 15 minutes. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. This report is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple 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 improperly stored doses of RECOMBIVAX HB (lot # L048236, expiry date 31-MAR-2018) (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of -0.17 degrees Celsius for 1 hour 15 minutes. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. This report is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 31-AUG-2016, the patient was orally vaccinated with an expired dose of ROTATEQ oral liquid (lot# K024700, expiry date 30-JUL-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.), referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 12-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml, intramuscularly, lot # M011117 and exp. date 07-DEC-2016. Anatomical location was not provided. No adverse effects were reported. It was not a product quality complaint involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 27-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K020214, expiration date 25-MAR-2016 (strength, dose, route of administration and anatomical location were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified 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 possibly vaccinated with improperly stored doses of ZOSTAVAX lot # L024999, expiration date 06-OCT-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 48 hours. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of ROTATEQ (lot number K013408 and expiration date 20-FEB-2016, orally dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown date, patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number L022261 and expiration date 01-APR-2016, lot number K018180 and expiration date 17-SEP-2016, dose and route of administration were not reported). Concomitant therapy were not reported. No adverse effect was reported. No product quality complaint (PQC) 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL (lot number K016966 and expiration date 10-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number L013429 and expiration date 21-JUL-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses VARIVAX (lot number L041206 and expiration date 20-OCT-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reaction or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored of VAQTA (lot number L013380 and expiration date 04-NOV-2017, lot number L043209 and expiration date 17-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to an unknown number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. The consumer reported about another parent's children who on an unknown date were vaccinated with a doses of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown dates, the patients experienced health problems (unspecified). The outcome of adverse event was unknown. The relatedness between vaccination with GARDASIL and the event was not reported. This is one of 3 reports from the same reporter. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary mass, Axillary pain, Immediate post-injection reaction, Injection site discomfort, Injection site mass
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL intramuscularly (dose, lot# and expiration date were not reported). The patient had no concomitant medications. The nurse reported that the patient experienced discomfort at the injection site immediately after vaccination. On 21-JUL-2016 (reported as "the following day"), a lump formed at the injection site. The patient was seen by her primary care physician on 26-JUL-2016. The nurse stated that it took two weeks that lump went down and then on an unspecified date in approximately August 2016 (reported as "6 days after the lump went away"), there was a painful 1 inch in diameter lump at the left clavicle and another painful 1 inch in diameter lump in the left axilla. The patient did not receive treatment for the events. The lump at the injection site resolved on an unknown date in 2016. The outcome of the discomfort at the injection site and painful 1 inch in diameter lump at the left clavicle and another painful 1 inch in diameter lump in the left axilla was reported as recovering. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Mass, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL intramuscularly (dose, lot# and expiration date were not reported). The patient had no concomitant medications. The nurse reported that the patient experienced discomfort at the injection site immediately after vaccination. On 21-JUL-2016 (reported as "the following day"), a lump formed at the injection site. The patient was seen by her primary care physician on 26-JUL-2016. The nurse stated that it took two weeks that lump went down and then on an unspecified date in approximately August 2016 (reported as "6 days after the lump went away"), there was a painful 1 inch in diameter lump at the left clavicle and another painful 1 inch in diameter lump in the left axilla. The patient did not receive treatment for the events. The lump at the injection site resolved on an unknown date in 2016. The outcome of the discomfort at the injection site and painful 1 inch in diameter lump at the left clavicle and another painful 1 inch in diameter lump in the left axilla was reported as recovering. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: ER reported lump at the injection site and red lines going from it. Also reported rash, fever, chills, immunization reaction, and cellulitis of R arm.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: ER reported lump at the injection site and red lines going from it. Also reported rash, fever, chills, immunization reaction, and cellulitis of R arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # 1019989, expiry date: 01-JUN-2017 (dosing details were not reported). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. 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 as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K016966, expiry date: 10-MAY-2017 or GARDASIL 9 lot # K016966, expiry date: 10-MAY-2017 (dosing details were not reported). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a physician, via a company representative, referring to two unspecified patients of unknown patients of unknown age and gender. The patients' medical history, concomitant condition and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (strength, dose, route, lot# and expiration date were not reported). The reporting physician stated that while on RECOMBIVAX HB, the patients did not seroconvert. The patients did not seek medical attention. At the time of reporting, the patients were not recovered from the event. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored ZOSTAVAX (batch number # reported as M011665, expiration date 17-MAY-2017, dose not provided), subcutaneously. No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Adverse reaction
Clinical narrative: Within 15 minutes of reaction symptoms appeared. Patient was transferred to local ER per ambulance. Follow up call to patient he states received IV steroids reaction improved and he left the ER about an hour after arriving.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored (Oka/Merck) VARIVAX (batch/lot number # L019999, expiration date 02-JUN-2017, batch/lot number # L035127, expiration date 14-SEP-2017, batch/lot number # L046885, expiration date 23-NOV-2017, batch/lot number # M006729, expiration date 05-FEB-2018, dose and route not provided). No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored PROQUAD (batch/lot number # L045676, expiration date 09-MAY-2017, batch/lot number # M007961, expiration date 15-AUG-2017, dose and route not provided). No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager  referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-AUG-2016, The patient received an expired dose of M-M-R II injection,by subcutaneous,lot number:k011188,expiration date:12-AUG-2016(Strength,dose were not reported). There was no concomitant medications reported. No adverse events were reported and no product quality complain was involved. Additional information is not expected as the reporter did not consent for new follow up attempts.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Food allergy, Herpes simplex test positive, Injection site reaction, Oral disorder, Rash vesicular
Clinical narrative: 21 year old patient received Smallpox vaccine and anthrax vaccine on 31 July 2016. On post vaccination day 21 the patient developed a generalized popular and vesicular dermatitis with popular lesions to both arms, legs and trunk. Pt also reported he has lesions on his fingers and palms. On post vaccination day 22 patient developed oral vesicular lesions. He was seen at a community ER and prescribed a pain relieving mouthwash. Overall the patient feel well. Patient has history of a similar rash with the oral lesions last summer (2015) and did not receive vaccine at that time. He has no medical history, surgical history, and does not smoke or drink. He reports he gets oral vesicular lesions, and one identified trigger is consumption of peanut butter. He cannot identify an new exposures such as foods, medications or topicals. The inoculation site had an intact eschar, is healing well and has no peripheral induration or vesicles. He is unsure how many doses of anthrax he has previously received.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Vaccination site eschar
Clinical narrative: 21 year old patient received Smallpox vaccine and anthrax vaccine on 31 July 2016. On post vaccination day 21 the patient developed a generalized popular and vesicular dermatitis with popular lesions to both arms, legs and trunk. Pt also reported he has lesions on his fingers and palms. On post vaccination day 22 patient developed oral vesicular lesions. He was seen at a community ER and prescribed a pain relieving mouthwash. Overall the patient feel well. Patient has history of a similar rash with the oral lesions last summer (2015) and did not receive vaccine at that time. He has no medical history, surgical history, and does not smoke or drink. He reports he gets oral vesicular lesions, and one identified trigger is consumption of peanut butter. He cannot identify an new exposures such as foods, medications or topicals. The inoculation site had an intact eschar, is healing well and has no peripheral induration or vesicles. He is unsure how many doses of anthrax he has previously received.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning to her husband (unknown age). The patient concurrent conditions included "tends to be easily injured, muscle twitches, spasms and dry eye". The patient's pertinent medical history was not reported. On an unspecified date in 2012, reported as "four years ago", the patient was administered a dose of ZOSTAVAX (lot #, expiration date, concentration, dosage and therapy route were not provided). Concomitant therapies included simvastatin (manufacturer unknown) tablets administered per oral route (lot #, expiration date, concentration, dose and indication were not provided); ranitidine (lot #, expiration date, concentration, dose, therapy route and indication were not provided); RESTASIS (lot #, expiration date, concentration, dose, therapy route and indication were not provided); and "over the counter eye" vitamins (unspecified) (lot #, expiration date, concentration, dose, therapy route and indication were not provided). The pharmacist reported that on an unknown date her husband has had three mild outbreaks of shingles starting "2 1/2 years, approximately in 2016, after" receiving ZOSTAVAX and at the time of the report, her husband had another outbreak. The pharmacist stated that the outbreaks of shingles were "incredibly uncomfortable and affecting his quality of life". The patient sought medical attention by visiting the physician and he received unspecified treatment for the events. There were no diagnostic laboratory tests performed. The outcome of the three outbreaks of shingles was recovered and for the current outbreak of shingles was not recovered at the time of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Flat red rash at site of injection. Patient noticed it 6 days after injection. No itching, pain or open sores.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt denied redness until day 2, large red raised area below injection site, rt deltoid BENADRYL advised.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Defaecation urgency, Dizziness, Electrocardiogram, Hyperhidrosis
Clinical narrative: Patient received Tdap, became immediately dizzy, diaphoretic had syncopal episode. Vitals taken, patient placed in supine position w/legs elevated. She developed emesis, abd camping, urge to defecate. Pt declined EMS transport, she was watched in the clinic for an hour, returned to baseline and picked up by a friend who stayed with her overnight.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Patient received Tdap, became immediately dizzy, diaphoretic had syncopal episode. Vitals taken, patient placed in supine position w/legs elevated. She developed emesis, abd camping, urge to defecate. Pt declined EMS transport, she was watched in the clinic for an hour, returned to baseline and picked up by a friend who stayed with her overnight.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema to R thigh, site warm to touch- Day (1) 3"x3" (8/30/16). Day 2 (8/31/16) spread outside of original markings and wraps around posterior to thigh.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 8/26/16 patient received vaccines. 8/27/16 patient presented to ER with urticaria.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: (R) deltoid swollen, red and warm to touch. Pain reported by patient.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Pt started to see blurry spots, then finished. Pt was caught by her father and helped to a chair. Vitals were taken. Pt was brought to an exam room to rest BS was checked. Juice was provided as well as cold packs to the head until pt. recovered.
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Dermatitis, Rash papular, Rash pruritic, Skin lesion
Clinical narrative: 31 yo healthy female who received SPV and anthrax #2 vaccine 11 days ago with a dermatitis (onset day 10) to arms, legs, buttocks, and a few lesions to chest and abdomen. The lesions are fine papular, very pruritic, and non-painful. She is feeling well. Lesions are discrete, no vesicles or pustules or bruising. The lesions do not come and go and have improved since onset. No lesions to her palms or soles. ROS otherwise unremarkable. No history of eczema, atopic dermatitis, asthma or allergic rhinitis. Photos were sent and reviewed. The dermatitis is not consistent with a concerning adverse event such as generalized vaccinia, and is most are suggestive of an immune mediated dermatitis particularly nonviral pustulosis, and the onset is within the typical timeframe, and she has no systemic symptoms and feels well.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching (L) deltoid. Ibuprofen and BENADRYL.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cold sweat, Influenza like illness, Injection site cellulitis, Injection site rash
Clinical narrative: This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a 'reaction to PNEUMOVAX 23'-she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was not known. Causality assessment was not provided. Follow-up information has been received from the physician on 29-AUG-2016 and refers to a 68-year-old female patient. The patient's concurrent conditions included gastroesophageal reflux disease, seasonal allergies and anxiety disorder. No adverse events occurred after previous vaccination and there was no illness at the time of vaccination. On 02-JUN-2016, the patient received her first dose of PNEUMOVAX 23, lot # M005287, intramuscular in left arm (expiration date was not reported). On the same day, the patient experienced muscle pain at the site of injection and chills on the following morning. On approximately 06-JUN-2016 (reported as 4 days later), there was a redness at the injection site which progressed to area 4 x 8 cm of redness, tenderness and warmth. A cellulitis was diagnosed. No laboratory tests were performed. The patient was treated with KEFLEX 500mg twice daily for 7 days. By 13-JUN-2016, the cellulitis was mostly resolved. The outcome of cellulitis was reported as recovered on the same day. The reporter considered cellulitis and muscle pain to be medically significant, as it required medical or surgical intervention to prevent a serious outcome. Additional information is not expected because all the information was obtained.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Cold sweat, Influenza like illness, Injection site cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a 'reaction to PNEUMOVAX 23'-she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was not known. Causality assessment was not provided. Follow-up information has been received from the physician on 29-AUG-2016 and refers to a 68-year-old female patient. The patient's concurrent conditions included gastroesophageal reflux disease, seasonal allergies and anxiety disorder. No adverse events occurred after previous vaccination and there was no illness at the time of vaccination. On 02-JUN-2016, the patient received her first dose of PNEUMOVAX 23, lot # M005287, intramuscular in left arm (expiration date was not reported). On the same day, the patient experienced muscle pain at the site of injection and chills on the following morning. On approximately 06-JUN-2016 (reported as 4 days later), there was a redness at the injection site which progressed to area 4 x 8 cm of redness, tenderness and warmth. A cellulitis was diagnosed. No laboratory tests were performed. The patient was treated with KEFLEX 500mg twice daily for 7 days. By 13-JUN-2016, the cellulitis was mostly resolved. The outcome of cellulitis was reported as recovered on the same day. The reporter considered cellulitis and muscle pain to be medically significant, as it required medical or surgical intervention to prevent a serious outcome. Additional information is not expected because all the information was obtained.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Vaccination complication
Clinical narrative: This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a 'reaction to PNEUMOVAX 23'-she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was not known. Causality assessment was not provided. Follow-up information has been received from the physician on 29-AUG-2016 and refers to a 68-year-old female patient. The patient's concurrent conditions included gastroesophageal reflux disease, seasonal allergies and anxiety disorder. No adverse events occurred after previous vaccination and there was no illness at the time of vaccination. On 02-JUN-2016, the patient received her first dose of PNEUMOVAX 23, lot # M005287, intramuscular in left arm (expiration date was not reported). On the same day, the patient experienced muscle pain at the site of injection and chills on the following morning. On approximately 06-JUN-2016 (reported as 4 days later), there was a redness at the injection site which progressed to area 4 x 8 cm of redness, tenderness and warmth. A cellulitis was diagnosed. No laboratory tests were performed. The patient was treated with KEFLEX 500mg twice daily for 7 days. By 13-JUN-2016, the cellulitis was mostly resolved. The outcome of cellulitis was reported as recovered on the same day. The reporter considered cellulitis and muscle pain to be medically significant, as it required medical or surgical intervention to prevent a serious outcome. Additional information is not expected because all the information was obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Chills, Extra dose administered, Fatigue, Headache
Clinical narrative: Information has been received from a physician via the patient's mother referring to a 17 years old male patient. Patient's current condition included asthma, allergic rhinitis. Concomitant therapy included albuterol, SINGULAIR and ZYRTEC. The patient was allergy to AUGMENTIN and he also had unknown seasonal allergies. The patient received GARDASIL (strength, dose, frequency and route unknown) on 02-AUG-2011, 13-OCT-2011 and 07-MAR-2012. On 04-AUG-2016, the patient inadvertently received GARDASIL 9 (strength and frequency unknown; reporter reports GARDASIAL 9 with Lot # M01363 which was not valid for GARDASIL 9. However, lot# M01363 is valid for GARDASIL) 0.5ml (Product lot number issue), intramuscularly (Extra dose administered). After the vaccination, the patient immediately experienced pain at the injection site of the left upper arm, where he received GARDASIL 9. Twelve hours after receiving GARDASIL 9, the patient experienced feeling feverish, chills, headache, feeling weak, complained of myalgia and fatigue. There was no treatment was given to the patient. There was no lab diagnostics studies performed. The patient felt better by the morning of 06-AUG-2016 and was back to baseline on 08-AUG-2016. The causal relationship between GARDASIL 9, GARDASIL and the events was not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician via the patient's mother referring to a 17 years old male patient. Patient's current condition included asthma, allergic rhinitis. Concomitant therapy included albuterol, SINGULAIR and ZYRTEC. The patient was allergy to AUGMENTIN and he also had unknown seasonal allergies. The patient received GARDASIL (strength, dose, frequency and route unknown) on 02-AUG-2011, 13-OCT-2011 and 07-MAR-2012. On 04-AUG-2016, the patient inadvertently received GARDASIL 9 (strength and frequency unknown; reporter reports GARDASIAL 9 with Lot # M01363 which was not valid for GARDASIL 9. However, lot# M01363 is valid for GARDASIL) 0.5ml (Product lot number issue), intramuscularly (Extra dose administered). After the vaccination, the patient immediately experienced pain at the injection site of the left upper arm, where he received GARDASIL 9. Twelve hours after receiving GARDASIL 9, the patient experienced feeling feverish, chills, headache, feeling weak, complained of myalgia and fatigue. There was no treatment was given to the patient. There was no lab diagnostics studies performed. The patient felt better by the morning of 06-AUG-2016 and was back to baseline on 08-AUG-2016. The causal relationship between GARDASIL 9, GARDASIL and the events was not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Information has been received from a physician via the patient's mother referring to a 17 years old male patient. Patient's current condition included asthma, allergic rhinitis. Concomitant therapy included albuterol, SINGULAIR and ZYRTEC. The patient was allergy to AUGMENTIN and he also had unknown seasonal allergies. The patient received GARDASIL (strength, dose, frequency and route unknown) on 02-AUG-2011, 13-OCT-2011 and 07-MAR-2012. On 04-AUG-2016, the patient inadvertently received GARDASIL 9 (strength and frequency unknown; reporter reports GARDASIAL 9 with Lot # M01363 which was not valid for GARDASIL 9. However, lot# M01363 is valid for GARDASIL) 0.5ml (Product lot number issue), intramuscularly (Extra dose administered). After the vaccination, the patient immediately experienced pain at the injection site of the left upper arm, where he received GARDASIL 9. Twelve hours after receiving GARDASIL 9, the patient experienced feeling feverish, chills, headache, feeling weak, complained of myalgia and fatigue. There was no treatment was given to the patient. There was no lab diagnostics studies performed. The patient felt better by the morning of 06-AUG-2016 and was back to baseline on 08-AUG-2016. The causal relationship between GARDASIL 9, GARDASIL and the events was not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician via the patient's mother referring to a 17 years old male patient. Patient's current condition included asthma, allergic rhinitis. Concomitant therapy included albuterol, SINGULAIR and ZYRTEC. The patient was allergy to AUGMENTIN and he also had unknown seasonal allergies. The patient received GARDASIL (strength, dose, frequency and route unknown) on 02-AUG-2011, 13-OCT-2011 and 07-MAR-2012. On 04-AUG-2016, the patient inadvertently received GARDASIL 9 (strength and frequency unknown; reporter reports GARDASIAL 9 with Lot # M01363 which was not valid for GARDASIL 9. However, lot# M01363 is valid for GARDASIL) 0.5ml (Product lot number issue), intramuscularly (Extra dose administered). After the vaccination, the patient immediately experienced pain at the injection site of the left upper arm, where he received GARDASIL 9. Twelve hours after receiving GARDASIL 9, the patient experienced feeling feverish, chills, headache, feeling weak, complained of myalgia and fatigue. There was no treatment was given to the patient. There was no lab diagnostics studies performed. The patient felt better by the morning of 06-AUG-2016 and was back to baseline on 08-AUG-2016. The causal relationship between GARDASIL 9, GARDASIL and the events was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anxiety, Aphasia, Arteriogram carotid, Computerised tomogram head, Dizziness
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 25 August 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, one day following vaccination, patient had stoke and patient was taken to hospital. On an unspecified date, following vaccination, patient was not able to use their right side. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented not medically confirmed case in which stroke is reported after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Electrocardiogram, Facial paralysis, Headache, Heart rate increased, Hemiplegia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 25 August 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, one day following vaccination, patient had stoke and patient was taken to hospital. On an unspecified date, following vaccination, patient was not able to use their right side. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented not medically confirmed case in which stroke is reported after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.