chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 20 C, time frame: 24 hours) doses of VARIVAX of lot/batch # L034370 with expiry date 08-SEP-2017 and lot/batch # L042265 with expiry date 26-OCT-2017 (Dose, strength, dose number, vaccination site and route of administration not provided) on unspecified dates. Concomitant therapies were not reported. The previous temperature excursion was reported as 8.2 C for 13 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 01-APR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot number K020214 with expiration date 25-MAR-2016, (dose, anatomical location and route were not reported). There was no concomitant medication reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Skin discolouration
Clinical narrative: Silver dollar sized area of pinkness that is blanchable and indurated but not warm to touch- (L) upper arm.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a male patient of an unknown age. The patient's current conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, route of administration, lot # and expiry date were not provided). Concomitant medications were not reported. After vaccination, the patient fainted. There was no product quality complaint involved. At the time of reporting, the outcome of syncope was unknown. The relatedness between syncope and vaccination with GARDASIL was not provided by the reporter. Additional information is not expected as it is not possible to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of an unknown age and gender. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. 02-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737 (expiry date: 28-JUL-2017) (dosage and route were not reported). Concomitant medication was not reported. No adverse effect reported. The nurse reported a temperature excursion for the GARDASIL 9. No further details provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions were not reported. On 13-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number not provided) (Strength and route were not reported). Concomitant medication was not reported. Then, on an unknown date, it was noticed that the product was expired as of March 2016. Additional information is not expected because no contact details were provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 03-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012480 exp date 10-APR-2017) that was exposed to 11 degrees C for 38.5 hours and 0 degrees C for 269.16 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to 8 unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L019835 exp date 23-MAR-2017) (dose and route not reported) that were exposed to 11 degrees C for 38.5 hours and 0 degrees C for 269.16 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer, referring on herself, an 81 year old female patient. The patient's medical history included hip replacement, knee surgery (left knee) and heart surgery. Current conditions included hypertension and hypothyroidism. The patient did not have any drug allergy or drug reactions. On 21-MAR-2016, the patient was vaccinated a first dose of ZOSTAVAX, subcutaneously (dose, frequency, anatomical location, lot # and expiry date were not reported). Concomitant therapies included atenolol, SYNTHROID, simvastatin (manufacturer unknown), warfarin and amlodipine. After vaccination, the patient experienced an injection site reaction of pain, swelling and redness in her arm. It was reported that the effects had slowly resolved over time and symptoms had subsequently resolved. On approximately 30-MAR-2016, reported as within the past 5 or 6 days, the patient began to experience pain in her thigh; the patient attributed that pain to the bad weather as she has had a knee and hip surgery. The pain has increased and exacerbated across her right thigh up to her hip (arthralgia). It was reported that she was on severe pain and took TYLENOL as a treatment; however, the pain was not relieved. the patient was unable to use other painkillers due to her heart surgery. Laboratory test were not performed. It was reported that the patient was seen by the doctor on 05-APR-2016, to discuss the matter. There was no product quality complaint involved. The patient recovered from the injection site reaction, pain, swelling and redness in her arm. Nevertheless, at the reporting time pain in thigh and hip was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist regarding a patient of unknown age and unknown gender. The patient's medical history or concurrent conditions were not provided. On 13-APR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number reported as 1603AA, expiration date 13-JAN-2013) route and anatomical location were not provided). Concomitant medications were not provided. No adverse effect was reported. A product quality complaint (PQC) was reported and filed. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Injection site swelling which turned into rash and itching on 04/13/2016. The area of rash was 4 1/8" by 5" which extended down the arm. Took Benadryl as instructed by the administering NP.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Rapid heart rate from 11:00PM until 1:10PM when I went to bed. Recorded heart rate above 140 to 151 consistantly for 2 hours, occasionally irregular. Went to bed, awoke at 8:30 AM, heart rate was regular again.
Age: 65.0
Sex: F
Vaccine: PER
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Swelling, itching, soreness, fatigue, muscle pain injection sight. Body ache, chills, fever, headache.
Age: 65.0
Sex: F
Vaccine: PER
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Swelling, itching, soreness, fatigue, muscle pain injection sight. Body ache, chills, fever, headache.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Chills, Crying, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Fever 102.7, heavy fast breathing, lethargy, chills, extreme fussiness, crying in pain for extended time, swollen painful injection site.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Lethargy, Pain, Pyrexia, Respiratory rate increased
Clinical narrative: Fever 102.7, heavy fast breathing, lethargy, chills, extreme fussiness, crying in pain for extended time, swollen painful injection site.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Monoplegia, Muscular weakness, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Right Arm Pain. Right Arm Weakness. Right Arm Paralysis.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Facial pain, Fatigue, Headache, Laboratory test
Clinical narrative: Dizzy, almost fainting spells, sensitivity to lights, headaches and facial pain, exhaustion, lightheadedness.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia, Syncope
Clinical narrative: Dizzy, almost fainting spells, sensitivity to lights, headaches and facial pain, exhaustion, lightheadedness.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache
Clinical narrative: Headaches, chills.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Patient complains of swelling and redness left arm at site of PCV-13 vaccine injection given yesterday. Also felt fatigue and chills.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored GARDASIL (Lot # K011562; expiration date: 08-APR-2017) (dose and route not provided). No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F doe 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (Lot # L013204; expiration date: 28-JAN-2017) and (Lot # L027070; expiration date: 30-APR-2017) (dose not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F for 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. 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 concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (Lot # L038018; expiration date: 13-SEP-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F for 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. 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 nurse concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored VAQTA (Lot # L045713; expiration date: 14-JAN-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F for 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. 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 10 patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # L033138, expiration date: 31-AUG-2017; dose and route of administration were not provided). No adverse symptoms were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAS23 (lot # L013428, expiration date: 30-FEB-2017), (lot # L019835; expiration date: 23-MAR-2017) and (Lot # L040456; expiration date: 10-MAY-2017)(dose and route not provided). Concomitant therapies were not provided. NO adverse effect was reported. It was reported the following temperature excursion to be administered vaccines, high temperature: 49.1 for 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. 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 medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date: 06-OCT-2018; dose and route of administration were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 4 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. 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 medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified date, the patients were vaccinated were vaccinated with improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; dose and route of administration were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 4 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several 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 medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L027070, expiration date: 30-APR-2017; dose was not provided) orally. The vaccine was exposed to temperature of 32 degrees Fahrenheit for 4 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reported 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 nurse concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients received an improperly stored dose of GARDASIL 9 (Lot # L016429; expiration date: 09-AUG-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: 50 F for 4 hours and 6 minutes. No previous temperature excursion was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of GARDASIL 9 with a lot # L011846 and expiration date of 16-JUN-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients received an improperly stored dose of M-M-R II (Lot # L004656; expiration date: 11-FEB-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: 50 F for 4 hours and 6 minutes. No previous temperature excursion was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of VARIVAX with a lot # L001327 and expiration date of 13-JAN-2017, lot # L026411 and expiration date of 15-FEB-2017, lot # L038132 and expiration date of 01-OCT-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue 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 has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of VAQTA with a lot # L004439 and expiration date of 15-FEB-2016, lot # L022259 and expiration date of 06-APR-2017, lot # L013380 and expiration date of 04-NOV-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several 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 has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of ROTATEQ with a lot # K016314 and expiration date of 05-JUN-2016, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue 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 has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of RECOMBIVAX with a lot # K023863 and expiration date of 03-APR-2016, lot # L001626 and expiration date of 06-OCT-2016, lot # L016959 and expiration date of 12-MAR-2018, lot # L044707 and expiration date of 06-OCT-2018, lot # L045117 and expiration date of 06-OCT-2018, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Urticaria
Clinical narrative: The child has developed urticaria around 3/17/16 of unclear etiology, still going into April.  Seems to be heading toward chronic urticaria.  Possibly an immune reaction triggered by immunizations?
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain, Vaccination site injury
Clinical narrative: Pain on movement of left arm. Pain starting in shoulder and radiating down left arm. I believe this represents SIRVA, resulting from inadvertent injection into the subdeltoid bursa. Pain improved but not resolved with ibuprofen.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Local swelling, Pain, Skin warm
Clinical narrative: Pain, localized swelling in deltoid which later moved to biceps, triceps, and forearm.  Pain was intense first 24 hrs.  "8 on a scale of 1-10"  Area was warm and flushed. Doctor was called.  Advised ice and ibuprofen. Some swelling and ache persisted for about a week.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Hypersensitivity, Pyrexia, Urticaria, Vision blurred
Clinical narrative: HIVES, FEVER, WEAKNESS, BLURRY VISION.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Paraesthesia, Rash pruritic
Clinical narrative: The patient received a shingles vaccine and reported that 12 days later she broke out in an itch/prickly rash over her body. There was a red spot over where the vaccine was adminstered. She stated that taking diphenhydramine and topical hydrocortisone have help treat the symptoms. The spots have seemed to improve over past several days, but are still present.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Extreme burning pain in right shoulder, not able to sleep because of pain, no relief with over the counter medication, intensifies in evening hours, no relief from Dr prescribed prednisone 20mg of a 5 day course. Heat and or ice minimal relief!
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Acidosis, Base excess decreased, Blood bicarbonate decreased, Blood pH decreased, Carbon dioxide normal
Clinical narrative: Fever up to 104 then on 3/30 became more lethargic with altered mental status, severe acidosis, poor po intake. This required intubation for airway protection and IV fluid hydration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Endotracheal intubation, Human rhinovirus test positive, Hypophagia, Lethargy, Lumbar puncture normal
Clinical narrative: Fever up to 104 then on 3/30 became more lethargic with altered mental status, severe acidosis, poor po intake. This required intubation for airway protection and IV fluid hydration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Mental status changes, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Toxicologic test
Clinical narrative: Fever up to 104 then on 3/30 became more lethargic with altered mental status, severe acidosis, poor po intake. This required intubation for airway protection and IV fluid hydration.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Upper extremity mass
Clinical narrative: Received TDAP injection and still have lump in upper arm about the size of a quarter.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Irritability, Pyrexia, Screaming
Clinical narrative: Inconsolable crying for 2.5 hours. Shot at 1:30pm, left office went home, changed had a bottle and went to sleep until he woke up with a blood curdling scream that he would not calm down for 2.5 hours. When he did finally calm down he was still fussing and irritable and even while eating or sleeping continued to let out high pitched screams for hours. Ran a slight fever for 24 hours. 2 days later he seems to be recovering, but still fussy.
Age: 1.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Continuous positive airway pressure
Clinical narrative: Baby was a 30 wk preemie, now 38+5 wks on HFNC 2 liter flow/room air. Had is 2mo immunizations on 4/16 at 11am and required PPV for apnea in the eve of 4/16. He is okay now.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with a dose of improperly stored M-M-R II (dosing details were not reported) (Lot # L040960 with expiry date of 16-OCT-2017). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse regarding a 4 month old patient. The patient's medical history and concurrent conditions were not reported. On 11-APR-2016, the patient was inadvertently administered with an expired dose of ROTATEQ (lot # K006455, expiry date 10-FEB-2016) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in March 2016, (also reported as unspecified date last week) the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported), intramuscularly. The patient was not using any medication concomitantly. On an unknown date in March 2016, 4 minutes after vaccination the patient fainted. The patient was still in the office and needed no follow up medical attention. The patient did not receive any treatment for the event. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. This is one of the two reports received from the same reporter (1604USA010554). Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in March 2016, (also reported as unspecified date last week) the patient was vaccinated with second dose of GARDASIL 9 (dosing details were not reported), intramuscularly. The patient was not using any medication concomitantly. On an unknown date in March 2016, 15 minutes after vaccination the patient fainted. The reporter stated that the patient had no issue after the first dose in the immunization series. The patient was still in the office and needed no follow up medical attention. The patient did not receive any treatment for the event. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. This is one of the two reports received from the same reporter (1604USA006593). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 55 year old female patient referring to herself. The patient had high blood pressure, depression and allergy to sulfa, doxycycline, and antibiotics. On 08-APR-2016 the patient was vaccinated with her first dose of ZOSTAVAX (lot number reported as "L040442" with expiration date 15-JAN-2017, strength, dose and route were unknown) in the left arm. Concomitant therapies included CYMBALTA, CELEXA, SINOPRIL and SINGULAR and aniprazol. On 09-APR-2016, the patient experienced a "raised red area, that feels hot", at the site of insertion on her left arm, about the size of "her hand". The outcome of was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Malaise, Pain in extremity
Clinical narrative: Information has been received from a 55 year old female patient referring to herself. The patient had high blood pressure, depression and allergy to sulfa, doxycycline, and antibiotics. On 08-APR-2016 the patient was vaccinated with her first dose of ZOSTAVAX (lot number reported as "L040442" with expiration date 15-JAN-2017, strength, dose and route were unknown) in the left arm. Concomitant therapies included CYMBALTA, CELEXA, SINOPRIL and SINGULAR and aniprazol. On 09-APR-2016, the patient experienced a "raised red area, that feels hot", at the site of insertion on her left arm, about the size of "her hand". The outcome of was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a 55 year old female patient referring to herself. The patient had high blood pressure, depression and allergy to sulfa, doxycycline, and antibiotics. On 08-APR-2016 the patient was vaccinated with her first dose of ZOSTAVAX (lot number reported as "L040442" with expiration date 15-JAN-2017, strength, dose and route were unknown) in the left arm. Concomitant therapies included CYMBALTA, CELEXA, SINOPRIL and SINGULAR and aniprazol. On 09-APR-2016, the patient experienced a "raised red area, that feels hot", at the site of insertion on her left arm, about the size of "her hand". The outcome of was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot # L023387 with expiration date 22-JUN-2017, strength, dose and route were unknown) that were improperly stored. No adverse effects reported. 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 an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patients was vaccinated with PNEUMOVAX 23 (lot # L031459 with expiration date 30-APR-2017 and lot # L019835 with expiration date 23-MAR-2017, strength, dose and route were unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with VAQTA (lot # L045713 with expiration date 14-JAN-2017, strength, dose and route were unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (lot # L037339 with expiration date 09-FEB-2018, strength, dose and route were unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a patient's mother refers to a male patient of an unknown age. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 08-APR-2016, the patient was vaccinated with GARDASIL (lot number, expiration date, dose and route of administration were not reported) or GARDASIL 9 (lot number, expiration date, dose and route of administration were not reported). It could not be confirmed whether the vaccine was received by the patient. On an unknown date in April 2016, the patient experienced two swollen lymph nodes after receiving the vaccine. There was no product quality complaint. The outcome of the event was not reported. The relatedness between the event and the vaccines was not reported. Additional information is not expected as the reporter declined to participate in answering questions within this adverse event report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Death, Dizziness, Dysarthria
Clinical narrative: Case number PHHY2016US027609, is a spontaneous report initially received from Vaccine Adverse Event Reporting System (VAERS reference number: 614067) website on 29 Feb 2016. This report refers to a 73-year-old female patient. Current condition included multiple myeloma. Concomitant medications included calcium, Acyclovir, Metoprolol and MAG64. The patient was vaccinated with FLUVIRIN (batch number: 1515301) intramuscularly into the left arm on 14 Oct 2015. On 28 Oct 2015, the patient experienced dizziness, slurred speech, weakness to the point of needing assistance and was unbalanced. The patient was hospitalized for seven days and all the tests (not specified) were negative. The outcome of the events was not recovered. On 20 Nov 2015, the patient died. Causality was not reported. Based on the documents review performed, it was concluded that the FLUVIRIN batch 1515301 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up received from Quality Assurance Department (QA, reference number: 1012888) on 03 Mar 2016: Updated QA reference number. Follow up information received via quality assurance department on 04 Apr 2016: Batch summary updated.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal
Clinical narrative: Case number PHHY2016US027609, is a spontaneous report initially received from Vaccine Adverse Event Reporting System (VAERS reference number: 614067) website on 29 Feb 2016. This report refers to a 73-year-old female patient. Current condition included multiple myeloma. Concomitant medications included calcium, Acyclovir, Metoprolol and MAG64. The patient was vaccinated with FLUVIRIN (batch number: 1515301) intramuscularly into the left arm on 14 Oct 2015. On 28 Oct 2015, the patient experienced dizziness, slurred speech, weakness to the point of needing assistance and was unbalanced. The patient was hospitalized for seven days and all the tests (not specified) were negative. The outcome of the events was not recovered. On 20 Nov 2015, the patient died. Causality was not reported. Based on the documents review performed, it was concluded that the FLUVIRIN batch 1515301 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up received from Quality Assurance Department (QA, reference number: 1012888) on 03 Mar 2016: Updated QA reference number. Follow up information received via quality assurance department on 04 Apr 2016: Batch summary updated.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TD, HEPA, IPV, TD, HEPA, IPV, TD
Symptoms: Local swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neck swelling in a 20-year-old female patient who received HAV (HAVRIX adult) (batch number 5D952, expiry date 20th April 2018). Concurrent medical conditions included acne. Concomitant products included MMR, NVS POLIO vaccine and BEYAZ. On 8th April 2016, the patient received the 1st dose of HAVRIX adult (intramuscular) 1 ml. On 9th April 2016, 1 days after receiving HAVRIX adult, the patient experienced neck swelling. On an unknown date, the outcome of the neck swelling was not recovered/not resolved. It was unknown if the reporter considered the neck swelling to be related to HAVRIX adult. Additional details provided were as follows: This case was previously reported to a doctor. Immunization supervisor reported that the patient received HAVRIX adult and began to experience right side neck swelling on the next day in the morning that extended up into her jaw area. No difficulty breathing, disabilities or hospitalization has occurred. The patient's mother was a Nurse Practitioner, per the nurse reporting but no treatment options have been performed up to the time of the phone call to report today. The patient's mother was advised to follow up with the daughter's physician. The nurse reporting believed this was a vaccine naïve patient, as she was home schooled and the patient's mother had denied vaccinations. It was not known for sure, but the nurse reporting believes these might be initial vaccinations received by the patient. She was receiving at this time because she plans to travel. The HAVRIX and Polio vaccine were both given on the left side. The Tetanus was given on the right side. The nurse plans to call Sanofi to notify them as well.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TD, HEPA, IPV, TD, HEPA, IPV, TD
Symptoms: Local swelling, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neck swelling in a 20-year-old female patient who received HAV (HAVRIX adult) (batch number 5D952, expiry date 20th April 2018). Concurrent medical conditions included acne. Concomitant products included MMR, NVS POLIO vaccine and BEYAZ. On 8th April 2016, the patient received the 1st dose of HAVRIX adult (intramuscular) 1 ml. On 9th April 2016, 1 days after receiving HAVRIX adult, the patient experienced neck swelling. On an unknown date, the outcome of the neck swelling was not recovered/not resolved. It was unknown if the reporter considered the neck swelling to be related to HAVRIX adult. Additional details provided were as follows: This case was previously reported to a doctor. Immunization supervisor reported that the patient received HAVRIX adult and began to experience right side neck swelling on the next day in the morning that extended up into her jaw area. No difficulty breathing, disabilities or hospitalization has occurred. The patient's mother was a Nurse Practitioner, per the nurse reporting but no treatment options have been performed up to the time of the phone call to report today. The patient's mother was advised to follow up with the daughter's physician. The nurse reporting believed this was a vaccine naïve patient, as she was home schooled and the patient's mother had denied vaccinations. It was not known for sure, but the nurse reporting believes these might be initial vaccinations received by the patient. She was receiving at this time because she plans to travel. The HAVRIX and Polio vaccine were both given on the left side. The Tetanus was given on the right side. The nurse plans to call Sanofi to notify them as well.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: Got shingles from the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles from the vaccine.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Asthenia, Fatigue, Haemoptysis, Migraine, Mood altered
Clinical narrative: Migraine, Sore Throat, Bad cough, coughing blood, weak & tired, 5 days + so far...
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Oropharyngeal pain
Clinical narrative: Migraine, Sore Throat, Bad cough, coughing blood, weak & tired, 5 days + so far...
Age: 2.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 4 days (and still continuing) of random hives with itching, mostly on face and trunk. Given BENADRYL to help itching. Hives come and go with no obvious pattern, but do not remain gone more than a few hours at a time. Have tried environmental and diet changes in case it was contact-related or food related, but none of these changes have helped.
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Based on additional information received on 03 August 2015, this case became medically confirmed. Initial unsolicited report received from consumer on 11 March 2015. A female patient, whose age, medical history and concomitant medication were not reported, had received a dose of ADACEL (batch number, dose, dose in series, expiration date were not reported) via intramuscular route into gluteal on an unspecified date. It was reported that after vaccination patient experienced a 5X7 inch red rash at the injection site on buttock, on an unspecified date. Patient's laboratory investigation and corrective treatment were not reported. It was reported that the patient required ER/ doctor visit. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a consumer on 28 May 2015. It was reported that the patient went to her doctor because the rash increased in side about 5-6 inch in size. Corrective treatment included BENADRYL and some cream. Documents held by sender: none. Follow-up information received from a physician on 03 August 2015. It was reported that the physician had not administered the vaccine but agree with the events. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 12 March 2015. A 60-year-old female patient, had medical history of hyperglycemia, hypertension, asthma and concomitant medications were not reported, had received a dose of ADACEL (Batch number C4714AA, expiry date and dose number was not reported) on 09 March 2015. On 09 March 2015, the patient had experienced body aches, chills, headache and soreness and redness and swelling and warm to touch at injection site on left deltoid. Laboratory investigations were not reported and corrective treatment included ibuprofen and ice pack. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included allergy to ELAVIL and ZYRTEC. The event of body aches, chills and headache was resolved on an unspecified date. The event of soreness and redness and swelling and warm to touch at injection site was not resolved. List of documents held by sender: none. Follow-up information received from a nurses on 16 April 2015. The expiry date of ADACEL was reported as 08 April 2017. At the time of this report, the outcome of all the events was reported as resolved within 1 week of vaccination. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 12 March 2015. A 60-year-old female patient, had medical history of hyperglycemia, hypertension, asthma and concomitant medications were not reported, had received a dose of ADACEL (Batch number C4714AA, expiry date and dose number was not reported) on 09 March 2015. On 09 March 2015, the patient had experienced body aches, chills, headache and soreness and redness and swelling and warm to touch at injection site on left deltoid. Laboratory investigations were not reported and corrective treatment included ibuprofen and ice pack. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included allergy to ELAVIL and ZYRTEC. The event of body aches, chills and headache was resolved on an unspecified date. The event of soreness and redness and swelling and warm to touch at injection site was not resolved. List of documents held by sender: none. Follow-up information received from a nurses on 16 April 2015. The expiry date of ADACEL was reported as 08 April 2017. At the time of this report, the outcome of all the events was reported as resolved within 1 week of vaccination. Documents held by sender: none.