chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dark circles under eyes, Diarrhoea, Injected limb mobility decreased, Injection site rash, Malaise
Clinical narrative: This spontaneous report as received from a 66 year old female patient reporting on herself. The patient's concurrent conditions included unspecified allergy and drug reactions or allergies to myacins and zinc eye drops. On 01-JUN-2016, the patient was vaccinated with a dose PNEUMOVAX 23 injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided. Concomitant medication included ARMOUR THYROID tablets. On 01-JUN-2016, after the patient received the injection, she rotated her arm to circulate the vaccine. The patient explained, that she could only lift her arm one third of a normal rotation for the first 24 hours after injection. The patient further explained, that she experienced nausea, a rash at the injection site down to the elbow, diarrhea and severe pain after receiving PNEUMOVAX 23, on 01-JUN-2016. The patient tried to get medical attention, but the physician's office could not fit her in for an appointment. When the symptoms did not resolve, the patient called the physician's office again at an unspecified time and the "on-call" physician told her to use an unspecified dose of BENADRYL. She took the BENADRYL for five days. The patient stated it took her 10 days to "feel human again". At the time of the report, the patient still had dark circles under her eyes and did not "feel 100 percent" (details were unspecified). She also stated, that at the time of the report, it was almost two weeks later and she still was not perky. The outcome of dark circles under eyes and feeling abnormal was reported as not recovered/not resolved. The outcome of the other events was not provided. Causality assessment was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain
Clinical narrative: This spontaneous report as received from a 66 year old female patient reporting on herself. The patient's concurrent conditions included unspecified allergy and drug reactions or allergies to myacins and zinc eye drops. On 01-JUN-2016, the patient was vaccinated with a dose PNEUMOVAX 23 injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided. Concomitant medication included ARMOUR THYROID tablets. On 01-JUN-2016, after the patient received the injection, she rotated her arm to circulate the vaccine. The patient explained, that she could only lift her arm one third of a normal rotation for the first 24 hours after injection. The patient further explained, that she experienced nausea, a rash at the injection site down to the elbow, diarrhea and severe pain after receiving PNEUMOVAX 23, on 01-JUN-2016. The patient tried to get medical attention, but the physician's office could not fit her in for an appointment. When the symptoms did not resolve, the patient called the physician's office again at an unspecified time and the "on-call" physician told her to use an unspecified dose of BENADRYL. She took the BENADRYL for five days. The patient stated it took her 10 days to "feel human again". At the time of the report, the patient still had dark circles under her eyes and did not "feel 100 percent" (details were unspecified). She also stated, that at the time of the report, it was almost two weeks later and she still was not perky. The outcome of dark circles under eyes and feeling abnormal was reported as not recovered/not resolved. The outcome of the other events was not provided. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 21 year old female patient who was not pregnant a the time of the report. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On an unknown date the, patient was vaccinated intramuscularly with the first dose of GARDASIL. On unknown dates 2 and 6 months after the initial dose, she received booster doses of GARDASIL (dose, lot# and expiration dates were not provided). The patient has all three doses of GARDASIL, but on an unknown date, she showed positive for either HPV 16 or HPV 18. The nurse could not remember which strain. No treatment was given for the adverse event. The patient sought medical attention via visiting the nurse on an unknown date. The nurse said that the patient had no intercourse prior to starting the vaccine. However it was not certain whether or not she became sexually active during the vaccination period. The outcome of the adverse event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients received improperly stored various unspecified doses of M-M-R II, (lot # L012480, expiration date 10-APR-2017; lot # L024268, expiration date 01-JUL-2017; lot# L023181 (not valid), expiration date 25-AUG-2017), (dose, frequency and route not reported) on 16-JUN-2016 and 17-JUN-2016. The vaccines were exposed to temperature 70 F for 45 minutes due to power outage. There was no previous temperature excursion. No adverse reactions were 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 nurse referring to unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. The unspecified patients received improperly stored unspecified doses of GARDASIL 9, (lot # L043213, expiration date 28-AUG-2017; lot # M003659, expiration date 20-SEI-2017), (dose, frequency and route not reported) on 16-JUN-2016 and 17-JUN-2016. The vaccines were exposed to temperature 70 F for 45 minutes. There was no previous temperature excursion. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient had swelling at injection site (golf ball size or larger) for one week. Swelling then resolved without treatment.
Age: 19.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Patient reported redness, (+) warm, discomfort injection site right deltoid.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness on the injection site. Started with a small redness about 3cm diameter then slowly progressed to about 6-8cm after few days. As of July 5, the area oo about 6-8cm is still red but not sore.
Age: 0.25
Sex: F
Vaccine: DTAP, RVX
Symptoms: Abnormal behaviour, Crying, Loss of consciousness, Posture abnormal, Screaming
Clinical narrative: It was approximately 15 minutes after vaccine was given that my daughter began screaming and crying hysterically. We were driving and I pulled over as soon as it was safe. She did not calm at all and screamed bloody murder for 20 minutes straight until she passed out. I called the doctors office and they said to call back if it started again but didn't seem concerned. I was also hysterically crying because I have NEVER ever heard a child scream and cry like that. I was terrified and on the verge of calling 911. She didn't act like herself for a week or so. She wasn't holding her head up alr cooing like she had done previously. It was the scariest thing I've ever seen with my children. She appears frontage outside to have made a full recovery but I wonder if there was any internal damage that isn't seen.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dysphagia, Herpes zoster, Immunodeficiency, Laparoscopic surgery
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old male patient. Medical history and concurrent conditions were not reported. On 18-MAY-2012 the patient was vaccinated with ZOSTAVAX, 1 shot subcutaneous. Lot number and expiration date were not provided. Approximately, on 15-JUN-2016 ("two weeks ago") the patient broke out in a significant case of Shingles; the outbreak appeared on his left groin to his back, where he developed blisters (Herpes zoster). The reporter stated that the patient was currently immunocompromised, but was not at the time of vaccination. Additionally, the patient recently had a laparoscopic surgery for dysphagia and was under stress. He was not hospitalized and was on an unspecified treatment regimen. The outcome of immunodeficiency was reported as not recovered, the outcome of Herpes zoster was reported as recovering and the outcome of dysphagia and stress was unknown. The causality between the events and the therapy with ZOSTAVAX was not reported. Upon internal review immunodeficiency was considered to be medically significant event. Additionally, dysphagia was considered to be medically significant event since a laparoscopic surgery was required. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Stress
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old male patient. Medical history and concurrent conditions were not reported. On 18-MAY-2012 the patient was vaccinated with ZOSTAVAX, 1 shot subcutaneous. Lot number and expiration date were not provided. Approximately, on 15-JUN-2016 ("two weeks ago") the patient broke out in a significant case of Shingles; the outbreak appeared on his left groin to his back, where he developed blisters (Herpes zoster). The reporter stated that the patient was currently immunocompromised, but was not at the time of vaccination. Additionally, the patient recently had a laparoscopic surgery for dysphagia and was under stress. He was not hospitalized and was on an unspecified treatment regimen. The outcome of immunodeficiency was reported as not recovered, the outcome of Herpes zoster was reported as recovering and the outcome of dysphagia and stress was unknown. The causality between the events and the therapy with ZOSTAVAX was not reported. Upon internal review immunodeficiency was considered to be medically significant event. Additionally, dysphagia was considered to be medically significant event since a laparoscopic surgery was required. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. In approximately January 2012 (reported as "4 1/2 years ago"), the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, frequency, route, lot# and expiration date were not reported). In May 2016 (reported as "one month ago") the patient received a second dose ZOSTAVAX (inappropriate dose of vaccine administered). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist via company representative referring to a patient of unknown age and gender. In about 2011 (reported as "more than 5 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, route, lot# and expiration date were not reported). On an unknown date the patient received a second dose of ZOSTAVAX (strength, route, lot# and expiration date were not reported). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. The reporter refused to answer information regarding the patient's medical history, drug reaction or allergies. On different unknown dates, the patient was vaccinated with the three doses of GARDASIL (route, lot #, and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, and after completion of the schedule of vaccination, the patient was diagnosed with high risk human papilloma virus (HPV) non 16/18. Product quality complaint was not involved. At the time of reporting the outcome of high risk HPV non 16/18 was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected because the nurse practitioner did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On an unknown date in 2001, patient was administered with first dose of VARIVAX and on an unknown date in 2016, 2nd dose of VARIVAX was administered (lot and expiry date were not reported) subcutaneously (inappropriate schedule of drug administration). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concerns (PQC) involved. Additional information is not expected as there was no reporter consent for follow up.
Age: 4.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 4 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-JUN-2016 the patient was inadvertently vaccinated with ZOSTAVAX lot # L034724, expiration date 09-DEC-2016. Dose and route were not provided. Additionally, the patient was also vaccinated with VARIVAX, lot # L026410, expiration date 15-FEB-2017. Dose and route were not provided. No other suspect or concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Lethargy, Pain, Pyrexia, Vomiting
Clinical narrative: 3 hr after injections, patient had fever >103 degrees F with chills, vomiting, body aches and lethargy.
Age: 1.1
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash
Clinical narrative: Left thigh rash 1 wk. after vaccines were administered.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Lip blister
Clinical narrative: Broke out on lip with blisters also hair loss both shot times.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Myalgia, Paraesthesia, Peripheral coldness
Clinical narrative: Pt came to clinic for day 3 RPtP. Reports muscle aches after day 0 shot. Day 3 RABAVERT shot given (L) deltoid without issue pt. took well. Approx. 2 hrs. later pt. called in to report (L) arm, finger and up to cheek cold, tingling, fell asleep. Advised to call her MD. As of 6/29/16- pt. states has some feeling in (L) arm, Not worse, MD advised to go to ER if gets worse. Pt to receive monitoring at hosp. ER in controlled setting.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Pt came to clinic for day 3 RPtP. Reports muscle aches after day 0 shot. Day 3 RABAVERT shot given (L) deltoid without issue pt. took well. Approx. 2 hrs. later pt. called in to report (L) arm, finger and up to cheek cold, tingling, fell asleep. Advised to call her MD. As of 6/29/16- pt. states has some feeling in (L) arm, Not worse, MD advised to go to ER if gets worse. Pt to receive monitoring at hosp. ER in controlled setting.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, warmth, itchy around injection sites the night after he was given the injection.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Otitis media, Varicella post vaccine
Clinical narrative: Pt's mom had shingles around 6-1-16. Pt had VARICELLA vaccine on 6-8-16. Pt Dx with chickenpox on 6-29-16.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Local injection site reaction, warm, red told to try Ibuprofen and BENADRYL.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Headache, Pain in extremity
Clinical narrative: Patient felt dizzy and fell down 5 min after receiving immz. He felt light headache and mild pain on (L) arm.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Chest X-ray normal, Injection site pain, Muscular weakness, Pain
Clinical narrative: Pt had Td vaccine on 4/7/16. Soreness after vaccine then developed pain/weakness. She continues with (R) shoulder pain/arm pain as well as (R) shoulder/arm weakness. Treated with PT, oral steroids, pain medications, NSAID's, gabapentin. Still pending EMG and eval at neurology as well as MRI of C-spine now approved by insurance.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Pt had Td vaccine on 4/7/16. Soreness after vaccine then developed pain/weakness. She continues with (R) shoulder pain/arm pain as well as (R) shoulder/arm weakness. Treated with PT, oral steroids, pain medications, NSAID's, gabapentin. Still pending EMG and eval at neurology as well as MRI of C-spine now approved by insurance.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction, Nasal congestion
Clinical narrative: 6/3/16- MENACTRA admin RA/IM at 2:17pm. That eve pt developed local itchiness, started scratching site over next day cont'd scratching, developed swelling, redness at site. Mom took to ER 6/4/16 night. ER tx'd for cellulitis and local rxn. 06/03/2016 c/o stuffy nose and sore throat. HPV and MCV due now. Other Imms UTD for age incl 2015 Flu Vac and TDaP. 06/06/2016 Walk in: Mom present swelling on his right arm. Imms UTD for age incl 2015 Flu, and TDaP. HPV #3 due 10/2016. 06/13/2016 Follow up: Local vaccine reaction and cellulitis. Imm's UTD for age incl 2015 Flu, TDaP, MENACTRA.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Oropharyngeal pain, Pruritus
Clinical narrative: 6/3/16- MENACTRA admin RA/IM at 2:17pm. That eve pt developed local itchiness, started scratching site over next day cont'd scratching, developed swelling, redness at site. Mom took to ER 6/4/16 night. ER tx'd for cellulitis and local rxn. 06/03/2016 c/o stuffy nose and sore throat. HPV and MCV due now. Other Imms UTD for age incl 2015 Flu Vac and TDaP. 06/06/2016 Walk in: Mom present swelling on his right arm. Imms UTD for age incl 2015 Flu, and TDaP. HPV #3 due 10/2016. 06/13/2016 Follow up: Local vaccine reaction and cellulitis. Imm's UTD for age incl 2015 Flu, TDaP, MENACTRA.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Joint swelling, Muscle spasms, Rash pruritic
Clinical narrative: "Itchy" rash and slight swelling on Right knee cap (vaccinated 6/8/16). 6/9/16 pen-like cramping across my chest.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Colonoscopy, Endoscopy
Clinical narrative: Abdominal pain, joint pain, headaches, nausea, cannot sleep, visual disturbances, hot flashes, cognitive memory issues. All occurring after vaccine given. Been to many doctors.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Hot flush, Insomnia, Memory impairment, Nausea
Clinical narrative: Abdominal pain, joint pain, headaches, nausea, cannot sleep, visual disturbances, hot flashes, cognitive memory issues. All occurring after vaccine given. Been to many doctors.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Visual impairment, X-ray
Clinical narrative: Abdominal pain, joint pain, headaches, nausea, cannot sleep, visual disturbances, hot flashes, cognitive memory issues. All occurring after vaccine given. Been to many doctors.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Computerised tomogram, Migraine, Nausea, Pyrexia
Clinical narrative: Migraine, fever and nausea (7-1-16) (Sat-Sun) 24 hrs after injection.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local reaction, Local swelling, Skin warm
Clinical narrative: 48 post vac., localized reaction raised, red and hot to touch. 72 hrs. urgent care. Signs of cellulitis. Script for antibiotic and steroid. Mon. stayed home from work. Home early on Tues. minimal swelling.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Mom called office 6/30 to report redness/swelling on L thigh at vaccine injection site. Pt examined by ARNP. Large area (approximately 10 cm x 12 cm) of soft edema and blanchable erythema L anteromedial thigh. No tenderness or induration. TX with antihistamine and cool compress.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Swelling face, Throat tightness
Clinical narrative: Pt experienced facial swelling, throat closing and rash to face and arms. This took place later in the day after vaccine. Also pt had been playing and holding a cat. (Which mom states pt has played with cats before). BENADRYL was given and pt fine next day
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Pt was given vaccine on 6/28 and called 7-2-16 stating his arm was swollen down to above elbow and hard and red. Pt did not come in for eval.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: Shot given in March. Still have, after 3 months, swelling, major joint pain and I can't lift my arm even waist high or reach out or up with it without experiencing shooting pains in arm. Doctor told me I'd just have to wait for it to wear off.
Age: 18.0
Sex: F
Vaccine: DTAPIPV, HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 18 year old female patient. There was no information about the patient's concurrent condition, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the second dose of unidentified MERCK hpv vaccine administered (name and lot number not provided) intramuscularly (exact dose, expiration date and intervals were not provided). In approximately MAY 2016 (reported as "about a month ago"), the patient experienced injection site arm soreness. The reporter stated, that the event had persisted for over thirty days following the second dose administration of unidentified MERCK hpv vaccine. It was also reported that the event had not recovered, on an unspecified date. Treatment was not given for adverse event. The outcome of injection site arm soreness was unknown. Causality assessment was not provided. Additional information is not expected as the reporter refused additional contact.
Age: 18.0
Sex: F
Vaccine: DTAPIPV, HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 18 year old female patient. There was no information about the patient's concurrent condition, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the second dose of unidentified MERCK hpv vaccine administered (name and lot number not provided) intramuscularly (exact dose, expiration date and intervals were not provided). In approximately MAY 2016 (reported as "about a month ago"), the patient experienced injection site arm soreness. The reporter stated, that the event had persisted for over thirty days following the second dose administration of unidentified MERCK hpv vaccine. It was also reported that the event had not recovered, on an unspecified date. Treatment was not given for adverse event. The outcome of injection site arm soreness was unknown. Causality assessment was not provided. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates during the past three months in 2016 the patients were vaccinated with improperly stored VARIVAX (lot #, expiration date, dose, frequency and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer referring to her daughter, a 12 year old female patient enrolled in a market research. On unknown dates in October 2014 and October 2015 the patient was vaccinated with GARDASIL dose 1 and dose 2 respectively (which were 12 months apart) (inappropriate schedule of drug administration). The outcome was unknown. Additional information is not expected as the reporter was not willing to be contacted.
Sex: M
Vaccine: FLUX, MMR, FLUX, MMR, TD
Symptoms: Condition aggravated, Pneumonia, Sickle cell anaemia
Clinical narrative: This spontaneous case, initially received on 01-Jul-2016, was reported by a health professional and concerns a(n) male patient. Weight: not provided; Height: not provided. Past medical history included Measles at the age of six years (without any prior immunization). Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for Indication not reported in Nov2010. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. Non-company suspect drugs: MMR II (MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE), Indication: Indication not reported, received in Nov-2010. Adverse reactions/events and outcomes: On Dec-2010, the patient experienced Pneumonia (Hospitalized, outcome: Not Reported), Relapse of sickle cell (Hospitalized, outcome: Not Reported). The patient was hospitalized in Dec-2010 with relapse of sickle cell and pneumonia. The patient received unspecified pneumonia vaccine while hospitalization. No immunological testing was completed on the patient but may happen in the future. The patient was now 25 years old and was doing great. Sender's Comments: Company comment: Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine, Relapse of sickle cell(anaemia) and chest infection are unlisted. Causality: Not related. Sickle-cell disease is autosomal recessive inherited illness characterised by relapses. There are several triggering factors which include infection, dehydration but in most instances, there is no identifiable predisposing cause. Acute chest symptoms with symptoms very similar to pneumonia (chest pain, fever, pulmonary infiltrate or focal abnormality) is also well known complication. Causality is considered unrelated for both events and most likely that patient immunocompromised state from underlying illness (sickle cell disease) is most likely causal factor.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates during the past three months in 2016 the patients were vaccinated with improperly stored PROQUAD (lot #, expiration date, strength, dose, frequency and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Blood glucose fluctuation, Blood glucose increased, Blood pressure fluctuation, Blood pressure increased
Clinical narrative: Information has been received from a male patient of unknown age. The patient's medical history included heart issues and shingles. The patient's concurrent condition included diabetes. The patient was allergic to several drugs. On 16-JUN-2016 (reported as "last Thursday") the patient received ZOSTAVAX (dose, Lot#, Expiration date and route not reported) and pneumococcal 13v conj vaccine (PCV 13)(dose, Lot#, Expiration date and route not reported) in the back of his right arm. Since the patient received the vaccines, he had been very weak and his blood pressure and sugar had been up an down. The patient did see his HCP on 19-JUN-2016 (reported as "yesterday") and was advised his blood pressure was too high and his sugar was up to 500 (unit unknown) and the patient also had low sodium. No treatment was given for the adverse events. The outcome of the events was unknown. Reporter's causality was not provided. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood sodium decreased, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a male patient of unknown age. The patient's medical history included heart issues and shingles. The patient's concurrent condition included diabetes. The patient was allergic to several drugs. On 16-JUN-2016 (reported as "last Thursday") the patient received ZOSTAVAX (dose, Lot#, Expiration date and route not reported) and pneumococcal 13v conj vaccine (PCV 13)(dose, Lot#, Expiration date and route not reported) in the back of his right arm. Since the patient received the vaccines, he had been very weak and his blood pressure and sugar had been up an down. The patient did see his HCP on 19-JUN-2016 (reported as "yesterday") and was advised his blood pressure was too high and his sugar was up to 500 (unit unknown) and the patient also had low sodium. No treatment was given for the adverse events. The outcome of the events was unknown. Reporter's causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The nurse reported that the patient received three doses of GARDASIL 9 outside of recommended dosing interval. On 04-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L014198, route and expiration date were not reported). The second dose of GARDASIL 9 (lot # L045700, expiration date 22-FEB-2018, route unknown) was administered on 24-MAY-2016. The third dose of GARDASIL 9 (lot # L045700, expiration date 22-FEB-2018, route unknown) was administered on 28-JUN-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 09-JUN-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # K007981, expiration date 03-JUN-2016, exact dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age. On 22-JUN-2016 the patient was vaccinated with VARIVAX and PROQUAD (lot #/expiration date unknown) together (overdose). No adverse effects reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Arthralgia, Back pain, Chills, Nausea, Vomiting
Clinical narrative: Around 3:30 PM the client's employer called and reported that patient was having chills, lower back pain, nausea, and joint pain. They reported that she had vomited one time. They checked her BP and her temp and reported that she did not have a fever or any abnormal BP values. Writer spoke with client and she reported that she did not have any rashes and was not having any difficulty breathing.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via company representative referring to a 68 years old female patient. On 20-FEB-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). In 2016 (reported as "about a year after receiving ZOSTAVAX") the patient experienced shingles. On 20-JUN-2016 the patient went to her physician's office where it was confirmed the patient had developed shingles. The outcome of the adverse event was unknown. Reporter's causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 16-JUN-2016 the patient received a dose of improperly stored M-M-R II (Lot # L032044, expiration date 24-AUG-2017, dose unknown) intramuscularly (Drug use via unapproved administration route). Concomitant therapy was not reported. The M-M-R II was improperly stored under 49.3 Fahrenheit degree for 20 hours on 06-MAY-2016, 48.88 Fahrenheit degree for 22 minutes on 12-MAY-2016 and 47.04 Fahrenheit degree for 37 minutes on 02-JUN-2016. Cumulatively, the vaccine was stored in maximum temperature 49.3 Fahrenheit degree for 20 hours 59 minutes. Date logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L025208, expiration date 07-JUL-2017, lot # M004662, expiration date 27-JAN-2018, strength, dose, frequency and route were not reported). The vaccine has been stored under temperature of -10.6 degree for 30 hours. Data logger has been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a nurse practitioner via a sales representative refers to an 86 year old female patient with hypertension, diabetes mellitus, asthma, chronic obstructive pulmonary disease (COPD), coronary heart disease (CHD) and drug hypersensitivity to nitrofurantoin. On 01-MAY-2012, the patient was vaccinated with a dose of ZOSTAVAX, 1 DF, subcutaneously, (dosage, lot # and expiry date were not provided). Concomitant therapies included losartan potassium (manufacturer unknown), gabapentin, CALAN, CELEBREX and zoledronic acid.  It was reported that on 27-APR-2016 the patient was diagnosed with an outbreak of shingles. She was later diagnosed with postherpetic neuralgia on 11-MAY-2016. The patient was treated with LIDODERM patches to use for 12 hours a day. On unknown date in 2016, the patient was subsequently recovered fully. The causal relationship between the events and suspect therapy was not provided. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (5/0.5 microgram/ml, second dose, lot # K011239 with expiry date 11-JUN-2016), intramuscularly. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified amount of patients of unknown age and gender. There was no information on the patients' concurrent conditions, medical history and concomitant medications. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ orally, lot # L033543, expiry date 30-MAY-2017. There was temperature excursion of 32.9F for 4 hours (supported). No adverse effects were reported. Additional information had been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II lot# L032181 with expiration date: 25-AUG-2017 (dose and route of administration were not reported). Administered dose of M-M-R II underwent temperature excursion at 77 Fahrenheit degrees, for 1 hour. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This solicited report as received from a patient's mother, as a part of market research program refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL(dose, lot #, expiration date and route of administration were not reported). On an unknown date, after the patient received the third dose of GARDASIL (dose, lot #, expiration date and route of administration were not reported), she passed out. The outcome of the vent was not reported. The relatedness between the event and GARDASIL was not provided. Additional information is not expected as there was no consent for further contact.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Dizziness, Mass, Pain, Pallor
Clinical narrative: This solicited report was received from a patient's mother via market research agency regarding the 12 year old female patient enrolled in a market research program. There were no concurrent conditions or medical history. Concomitant therapy was not reported. On 01-APR-2016 the patient received the first dose of unspecified quadrivalent human papillomavirus vaccine (manufacturer unknown) in the arm shot (dose, route and lot number unknown). On that day the patient had some side effects-bump, pain, dizzy and pale. The events resolved with sequelae on 04-APR-2016 with duration of 3 days. The reporter considered the events to be related to quadrivalent human papillomavirus vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L016429 with and expiration date 09-AUG-2017; lot# L037339 with an expiration date 09-FEB-2018; lot# K005881 with and expiration date 14-JAN-2017; lot# L018351 with and expiration date 11-AUG-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Vomiting
Clinical narrative: Pt went home from visit, c/o headache, took ibuprofen and threw up once. Didn't eat anything prior to the visit or after the vaccine for at least 2 hours. Pt laid down and started to feel better, PNP recommended food and drink and told her to follow up for any further symptoms.
Age: 47.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient states her arm became sore, red and swollen with a welt like lesion at the site where varicella injection was given. Area also became itchy.
Age: 47.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient states her arm became sore, red and swollen with a welt like lesion at the site where varicella injection was given. Area also became itchy.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Deep aching pain in right deltoid and difficulty moving arm in Full ROM.
Sex: U
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient did not have any pertinent medical history, or drug reactions/allergies. There was no concomitant medications administered. On an unknown date the patient was vaccinated with M-M-R II (strength, dose, route, lot # and expiration date were not reported). On an unspecified date, while on M-M-R II the patient experienced a rash at the injection site. The outcome of injection site rash was reported as recovered. There was no lab diagnostics studies performed. The reporter's causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse, refers to multiple unspecified patients of unknown age and gender. There was no information on the patients' concurrent conditions, medical history and concomitant medications. On unspecified dates, the patients were administered doses of improperly stored VAQTA (25/0.25) (lot # M021124, expiry date 02-FEB-2018, via the intramuscular route). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On unknown dates the patients were vaccinated with unknown doses of improperly stored PNEUOMOVAX 23 (sdv)(lot # M006139, expiration date 13-MAY-2017) and PNEUMOVAX 23 (syr) (lot # L049744, expiration date 12-OCT-2017) (dose and route were not reported). Date logger was involved. The vaccine had been stored under temperature of 34.9 Fahrenheit for 13 hours, and then was back in range. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M003435 with expiration date 19-JUL-2017) (strength, dose, frequency and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This report as received from a reporter refers to a female patient of age reported as 11 (units not provided) enrolled in a market research. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown exact date in 2016 the patient was vaccinated with the first dose of GARDASIL (dosage information, route of administration, indication, lot # and expiration date were not reported). It was reported that the child received multiple vaccines on that day. In May 2016 the patient experienced soreness on injection site. The outcome of the event was reported as recovered 3 days after injection. The reporter considered the event to be related to GARDASIL. Action taken with GARDASIL was reported as none. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: Burning and tingling sensation through out my whole body. Extremely painful.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Pyrexia
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Basophil percentage increased, Blood bicarbonate decreased, C-reactive protein increased, Dizziness, Dizziness postural
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Eosinophil percentage, Fatigue, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Lymphocyte percentage decreased, Metabolic function test normal, Monocyte percentage increased, Myalgia, Nausea
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Neutrophil percentage, Pain, Pallor, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Tachycardia, Vomiting, White blood cell count normal
Clinical narrative: Started off with a headache and chills and then progressed a fever of 101.6, severe headache, muscle aches, mile shortness of breath, and dizziness.