chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 57 year old female patient with no medical history or drug reactions/allergies. On 23-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot# K020801, expire date 31-JAN-2016) subcutaneously in the left arm as routine vaccination. There was no concomitant medication. On 23-JAN-2015, after receiving ZOSTAVAX the patient experienced swelling, redness, and warmth at the injection site in her left arm. No treatment was given for these adverse events. There was no lab diagnosed studies performed. The outcome of these events was reported as recovered in January 2015. The patient did not seek medical attention. There was no product quality complaint (PQC) involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse via a field representative concerning a patient of unknown age and gender. On 10-FEB-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot # J011799 that had expired on 09-FEB-2015 (dose and route not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) for prophylaxis that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) for prophylaxis that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Discomfort, Dizziness
Clinical narrative: After I reeived the booster shot, I went home and prepared for a nap, as I had to work the night shift that night. I laid down and noted that I was dizzy and had a headache. When I woke up four hours later, the headache I had was excruciating. I could not focus and felt nauseous as a result. I went to work, and by 2100, I thought that I was hungry, which could have been to blame for my lightheadedness, headache and bubbly stomach. I ate chicken enchiladas. By 2330, I was pacing the room, unable to find comfort. I felt the need to vomit, and my abdomen was severely cramping. I have given birth naturally, five times. The cramping I experienced was on par with contractions experienced. I had severe diarrhea, which is a classy word for what I experienced. I threw up violently, no less than 5 times. These symptoms lasted through the remainder of my shift, and through the next day. I was able to sleep it off, and within 18 hours I was feeling like myself again. I know this boosters gain outweigh this risk, and I wont have to receive it for another ten years, but it was absolutely horrible.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Hunger, Nausea, Vision blurred, Vomiting
Clinical narrative: After I reeived the booster shot, I went home and prepared for a nap, as I had to work the night shift that night. I laid down and noted that I was dizzy and had a headache. When I woke up four hours later, the headache I had was excruciating. I could not focus and felt nauseous as a result. I went to work, and by 2100, I thought that I was hungry, which could have been to blame for my lightheadedness, headache and bubbly stomach. I ate chicken enchiladas. By 2330, I was pacing the room, unable to find comfort. I felt the need to vomit, and my abdomen was severely cramping. I have given birth naturally, five times. The cramping I experienced was on par with contractions experienced. I had severe diarrhea, which is a classy word for what I experienced. I threw up violently, no less than 5 times. These symptoms lasted through the remainder of my shift, and through the next day. I was able to sleep it off, and within 18 hours I was feeling like myself again. I know this boosters gain outweigh this risk, and I wont have to receive it for another ten years, but it was absolutely horrible.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Pain, Pain in extremity
Clinical narrative: Increasing arm pain next two days, the pain remains the same after 11 days. It feels like the bicep muscle locks up, severe stabbing pain when lifting, raising or contracting the muscle. Extremely painful from the shoulder joint and down near the elbow. Expect some pain after but not this long or severe.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Culture, Culture urine, Feeling cold, Influenza virus test
Clinical narrative: Began to feel extremely cold and couldn't stop shaking.  Took a two hour nap and woke up with a fever of 104.6.  Showered and the fever dropped to 102.4.  Took Tylenol and Motrin and fever broke about three hours later.  The fevers continued and I was admitted back into the hospital for four days.  Tylenol and Motrin worked to break the fever, but the fever would come back once the medicine wore off.  Fevers fluctuated between 99.6 and 102.4 for more than a week.  The blood cultures taken showed that my white blood cell count was elevated, but they couldn't not find an infection.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Physical breast examination, Pyrexia, Tremor, Ultrasound scan vagina
Clinical narrative: Began to feel extremely cold and couldn't stop shaking.  Took a two hour nap and woke up with a fever of 104.6.  Showered and the fever dropped to 102.4.  Took Tylenol and Motrin and fever broke about three hours later.  The fevers continued and I was admitted back into the hospital for four days.  Tylenol and Motrin worked to break the fever, but the fever would come back once the medicine wore off.  Fevers fluctuated between 99.6 and 102.4 for more than a week.  The blood cultures taken showed that my white blood cell count was elevated, but they couldn't not find an infection.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count increased
Clinical narrative: Began to feel extremely cold and couldn't stop shaking.  Took a two hour nap and woke up with a fever of 104.6.  Showered and the fever dropped to 102.4.  Took Tylenol and Motrin and fever broke about three hours later.  The fevers continued and I was admitted back into the hospital for four days.  Tylenol and Motrin worked to break the fever, but the fever would come back once the medicine wore off.  Fevers fluctuated between 99.6 and 102.4 for more than a week.  The blood cultures taken showed that my white blood cell count was elevated, but they couldn't not find an infection.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Back pain, C-reactive protein increased, Electromyogram, Fatigue, Insomnia
Clinical narrative: Muscles aches, Fatigue and Sleep problems and extreme back pain started after injections of series of 6 anthrax injections. Also thyroid nodule developed along with nerve pain in bilateral legs. Pulmonary embolism.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Neuralgia, Pulmonary embolism, Red blood cell sedimentation rate increased, Sleep study
Clinical narrative: Muscles aches, Fatigue and Sleep problems and extreme back pain started after injections of series of 6 anthrax injections. Also thyroid nodule developed along with nerve pain in bilateral legs. Pulmonary embolism.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Thyroid neoplasm
Clinical narrative: Muscles aches, Fatigue and Sleep problems and extreme back pain started after injections of series of 6 anthrax injections. Also thyroid nodule developed along with nerve pain in bilateral legs. Pulmonary embolism.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Food allergy, Haematochezia, Rash erythematous, Rash generalised
Clinical narrative: Suddenly allergic to soy. If soy is eaten, will get bloody poo or red prickly rash all over body. There was previously no allergy to soy at all, and patient never had an allergic reaction to anything prior to receiving vaccine.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Paralysis, Pyrexia, Tremor
Clinical narrative: HEADACHE, WHEEZING, FEVER, COUGHING, PARALYSIS, UNCONTROLLABLE SHAKING. I am a LVN so I treated myself with 800 mg of ibuprofen and started Tamiflu 75 mg the following day.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: HEADACHE, WHEEZING, FEVER, COUGHING, PARALYSIS, UNCONTROLLABLE SHAKING. I am a LVN so I treated myself with 800 mg of ibuprofen and started Tamiflu 75 mg the following day.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, CSF culture negative, CSF glucose decreased
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Carbon dioxide decreased, Cerebellar ataxia
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Computerised tomogram, Computerised tomogram head normal, Differential white blood cell count, Drug screen negative, Full blood count
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Gram stain negative, Haematocrit normal, Haemoglobin normal, Laboratory test, Lumbar puncture
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Lymphocyte percentage increased, Monocyte count, Nasopharyngitis, Neutrophil count, Paralysis
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Platelet count normal, White blood cell count normal
Clinical narrative: Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Parotid gland enlargement, Pyrexia, Testicular pain
Clinical narrative: Noticed bilateral parotid gland swelling, fussiness, fever up to 101.5. Later noticed testicular tenderness.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Eye swelling, Lacrimation increased, Pyrexia, Rash
Clinical narrative: Fever, Cough, Rash covering torso and face, swollen and watery eyes.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Arthralgia, Joint stiffness, Neck pain, Pain in extremity, Upper respiratory tract infection
Clinical narrative: Neck pain, feet pain, knee pain, upper respiratory infection, joint stiffness.
Age: 30.0
Sex: F
Vaccine: FLUC3
Symptoms: Fear, Mental disorder, Panic reaction, Suicidal ideation
Clinical narrative: PSYCHOLOGICALLY UNPLEASANT, PANIC, FEAR AND SUICIDAL THOUGHT.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: RED HOT WELT, SIZE OF QUARTER AT 2PM, BECAME LARGER THROUGHOUT THE DAY AND THE FAMILY BROUGHT THEIR SON IN FOR THIS.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Crying, Diarrhoea, Hypohidrosis, Infantile colic
Clinical narrative: Rash, fever, irritability, waking up 4-5 times a night with fits of crying like in pain, excessive itching, sun-burned skin, lack of sweating, excessive thirst, colic behaviors, loose bowels, clingy behaviors-wants to be held all day.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Middle insomnia, Pain, Pruritus, Pyrexia
Clinical narrative: Rash, fever, irritability, waking up 4-5 times a night with fits of crying like in pain, excessive itching, sun-burned skin, lack of sweating, excessive thirst, colic behaviors, loose bowels, clingy behaviors-wants to be held all day.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash, Sunburn, Thirst
Clinical narrative: Rash, fever, irritability, waking up 4-5 times a night with fits of crying like in pain, excessive itching, sun-burned skin, lack of sweating, excessive thirst, colic behaviors, loose bowels, clingy behaviors-wants to be held all day.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referrng to multiple unspecified patients of unknown age and gender. On an unknown date, these patients were vaccinated with ROTATEQ (strength, lot number, expiry date, route and dose were not reported) post supported excursion. No adverse effects were reported. This is one of two reports received from the same reporter (linked to 1502USA0007950). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006588, 1502USA006589, 1502USA006590). This is one of several reports from the same source. 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 concerning unspecified patients of unknown age and gender. Nurse reported that since 30-JUL-2014, improperly stored M-M-R II (therapy type, lot#, dose, route and duration were unspecified) were administered to unspecified patients. No adverse effects were noted. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has bene received from a nurse referring to a male patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006587, 1502USa006589, 1502USA006590). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006587, 1502USA006588, 1502USA006589). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. On an unknown date, unspecified patients were vaccinated with multiple doses of PROQUAD (Merck) (0.5 ml, subcutaneous) which were all post supported temperature excursion. No adverse effects were reported by any patient. This is one of the several reports from the same reporter. (Linked to MARRS# 1502USA006586). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare worker via a field employee referring to a patient of unknown age and gender. Patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of MMR II (lot#, expiration date, route, dosage and dose in series unspecified). On an unknown date, 4 days post vaccination, the patient developed hives. The field employees stated per the healthcare worker that "hives that developed were not diagnosed as measles, mumps or rubella by physician". The outcome of hives was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown gender in greater than 18 years old. The patients' relevant medical history was not reported. On unknown dates, the patients were vaccinated with M-M-R II (lot# K005109, expiration date 04-APR-2016) (dose, dose number and route not reported) which were improperly stored. Information about concomitant medication was not reported. The temperature excursion for M-M-R II was not supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. The registered nurse provided that there had been no adverse events reported following the administration of the vaccinations and on need for revaccination. PQC (product quality complaint) was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006587, 1502USA006588, 1502USA006590). This is one of several reports from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Feeling abnormal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of strange taste in a 35-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 12 August 2014, at 3.47 PM, the subject received unspecified dose of FLUARIX (.5 ml, unknown injection site, right arm). On 12 August 2014, less than one day after vaccination with FLUARIX, the subject experienced funny taste in mouth and feeling funny in the top lip. At the time of reporting, the outcome of the events were unspecified.
Age: 54.0
Sex: U
Vaccine: FLU4
Symptoms: Feeling abnormal, Feeling hot, Flushing, Hyperchlorhydria, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tongue thick in a 54-year-old patient who received FLULAVAL QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). The patient's past medical history included rectal carcinoma (2000 and 2008 rectal cancer) and cervical cancer (2002 and 2010 cervical cancer). Previously administered products included sulfa (throat swelling, hives, redness and hot, tongue swelling) and epinephrine (throat swelling, hives, redness and hot, tongue swelling). Concurrent medical conditions included familial adenomatous polyposis (remission and monitored) and diverticulum (monitored). On 5th November 2014, the patient received the 1st dose of FLULAVAL QUADRIVALENT (injection). On 5th November 2014, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced tongue thick, nausea ,feeling bad, sour stomach, feeling hot, hand swelling, throat swelling, flushing and limbs stiffness. On an unknown date, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the tongue thick, nausea, throat swelling and flushing were recovered/resolved and the outcome of the feeling bad, sour stomach, feeling hot, hand swelling and limbs stiffness were not recovered/not resolved and the outcome of the inappropriate preparation of medication was unknown. The reporter considered the tongue thick, nausea, feeling bad, sour stomach, feeling hot, hand swelling, throat swelling, flushing and limbs stiffness to be possibly related to FLULAVAL QUADRIVALENT. Additional information received: Caller reports that product was not shaken prior to administration. She states it appeared to be a large doe but not sure of the exact dose given. Caller states product was pulled from a Multidose vial. She experienced side effects similar to other drug reactions she has had. She was seen at the local Emergency room, administered IV fluids, BENADRYL and released. She continues to have some issues. Caller states her skin on her left arm was pinched and the vaccine was administered. She was not able to provide the complete address of the facility but notes the reason for the vaccination was for employment at the facility which was a new job,
Age: 54.0
Sex: U
Vaccine: FLU4
Symptoms: Nausea, Peripheral swelling, Pharyngeal oedema, Tongue disorder, Wrong technique in drug usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tongue thick in a 54-year-old patient who received FLULAVAL QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). The patient's past medical history included rectal carcinoma (2000 and 2008 rectal cancer) and cervical cancer (2002 and 2010 cervical cancer). Previously administered products included sulfa (throat swelling, hives, redness and hot, tongue swelling) and epinephrine (throat swelling, hives, redness and hot, tongue swelling). Concurrent medical conditions included familial adenomatous polyposis (remission and monitored) and diverticulum (monitored). On 5th November 2014, the patient received the 1st dose of FLULAVAL QUADRIVALENT (injection). On 5th November 2014, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced tongue thick, nausea ,feeling bad, sour stomach, feeling hot, hand swelling, throat swelling, flushing and limbs stiffness. On an unknown date, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the tongue thick, nausea, throat swelling and flushing were recovered/resolved and the outcome of the feeling bad, sour stomach, feeling hot, hand swelling and limbs stiffness were not recovered/not resolved and the outcome of the inappropriate preparation of medication was unknown. The reporter considered the tongue thick, nausea, feeling bad, sour stomach, feeling hot, hand swelling, throat swelling, flushing and limbs stiffness to be possibly related to FLULAVAL QUADRIVALENT. Additional information received: Caller reports that product was not shaken prior to administration. She states it appeared to be a large doe but not sure of the exact dose given. Caller states product was pulled from a Multidose vial. She experienced side effects similar to other drug reactions she has had. She was seen at the local Emergency room, administered IV fluids, BENADRYL and released. She continues to have some issues. Caller states her skin on her left arm was pinched and the vaccine was administered. She was not able to provide the complete address of the facility but notes the reason for the vaccination was for employment at the facility which was a new job,
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone cancer, Bone pain, Injection site joint pain, Insomnia, Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with osteoporosis and thyroid disorder and without drug reactions or allergies. On 09-OCT-2014, patient was vaccinated with ZOSTAVAX subcutaneous, lot # K008880, expiry date 09-SEP-2015). On an unknown date approximately in 2014, 4 weeks prior to administration of ZOSTAVAX, the patient was administered with a dose of an unspecified influenza virus vaccine (manufacturer unknown), in an unspecified arm. Concomitant medication reported was unspecified osteoporosis and thyroid medication. Patient began to experience severe pain in the elbow of her injection arm, on an unspecified date, following the vaccination. Pharmacist reports that the patient could not sleep because of the pain. Also the patient clarified that she was not actually having pain in her elbow, she believes that she could pinpoint the nerve in which she felt the pain. The patient was seen by unspecified physician on an unspecified date due to the severe elbow pain. The physician administered, on an unknown date, a cortisone (manufacturer unknown) injection into the patient's elbow to treat the pain and also had an x-ray of her elbow performed. Pharmacist reported that the cortisone (manufacturer unknown) injection did nothing to treat the patient's pain (captured into MARRS #1411USA012759) and nothing was found on the x-ray. The patient had not recovered from the adverse events. Follow up information had been received on 11-FEB-2015 from the pharmacist who stated that the patient was been diagnosed recently (date not reported) with bone cancer and that was the reason for the bone pain, not from the vaccination with ZOSTAVAX. Upon internal review Bone cancer was considered as an important medical event. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray limb normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with osteoporosis and thyroid disorder and without drug reactions or allergies. On 09-OCT-2014, patient was vaccinated with ZOSTAVAX subcutaneous, lot # K008880, expiry date 09-SEP-2015). On an unknown date approximately in 2014, 4 weeks prior to administration of ZOSTAVAX, the patient was administered with a dose of an unspecified influenza virus vaccine (manufacturer unknown), in an unspecified arm. Concomitant medication reported was unspecified osteoporosis and thyroid medication. Patient began to experience severe pain in the elbow of her injection arm, on an unspecified date, following the vaccination. Pharmacist reports that the patient could not sleep because of the pain. Also the patient clarified that she was not actually having pain in her elbow, she believes that she could pinpoint the nerve in which she felt the pain. The patient was seen by unspecified physician on an unspecified date due to the severe elbow pain. The physician administered, on an unknown date, a cortisone (manufacturer unknown) injection into the patient's elbow to treat the pain and also had an x-ray of her elbow performed. Pharmacist reported that the cortisone (manufacturer unknown) injection did nothing to treat the patient's pain (captured into MARRS #1411USA012759) and nothing was found on the x-ray. The patient had not recovered from the adverse events. Follow up information had been received on 11-FEB-2015 from the pharmacist who stated that the patient was been diagnosed recently (date not reported) with bone cancer and that was the reason for the bone pain, not from the vaccination with ZOSTAVAX. Upon internal review Bone cancer was considered as an important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: This spontaneous report as received from a clinical medical assistant via a company representative refers to a 11 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies and no concomitant medications. On 19-JAN-2015, the patient was vaccinated with the first dose of GARDASIL (dose: 0.5 ml, route intramuscular, lot # K008931, expiration date 04-MAR-2017). On 19-JAN-2015, within 15 min of receiving GARDASIL, the patient fell forward off examination table. The patient bruised her head, chipped a tooth and had concussion-like behavior. On the same day, the patient had also received ADACEL and MENACTRA. The patient sought for medical attention and was seen at physician's office. There was no lab diagnostics and studies performed. The patient did not receive any treatment. The patient's outcome was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Concussion, Contusion, Fall, Tooth fracture
Clinical narrative: This spontaneous report as received from a clinical medical assistant via a company representative refers to a 11 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies and no concomitant medications. On 19-JAN-2015, the patient was vaccinated with the first dose of GARDASIL (dose: 0.5 ml, route intramuscular, lot # K008931, expiration date 04-MAR-2017). On 19-JAN-2015, within 15 min of receiving GARDASIL, the patient fell forward off examination table. The patient bruised her head, chipped a tooth and had concussion-like behavior. On the same day, the patient had also received ADACEL and MENACTRA. The patient sought for medical attention and was seen at physician's office. There was no lab diagnostics and studies performed. The patient did not receive any treatment. The patient's outcome was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX , (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she got vaccinated, since on an unknown date in September 2014, she started to experienced paresthesia as she reported that she was experiencing prickling, tingly, burning stabbing all over her body; it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, it first it lasted for 2 weeks and she recovered, but, since on an unknown day in November 2014, it came back with a vengeance, the only time she had relief is at night when she used less clothing, but during the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results not provided). The patient was prescribed DOXEPIN 10 mg capsule for the event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX , (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she got vaccinated, since on an unknown date in September 2014, she started to experienced paresthesia as she reported that she was experiencing prickling, tingly, burning stabbing all over her body; it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, it first it lasted for 2 weeks and she recovered, but, since on an unknown day in November 2014, it came back with a vengeance, the only time she had relief is at night when she used less clothing, but during the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results not provided). The patient was prescribed DOXEPIN 10 mg capsule for the event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Knee operation, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX , (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she got vaccinated, since on an unknown date in September 2014, she started to experienced paresthesia as she reported that she was experiencing prickling, tingly, burning stabbing all over her body; it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, it first it lasted for 2 weeks and she recovered, but, since on an unknown day in November 2014, it came back with a vengeance, the only time she had relief is at night when she used less clothing, but during the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results not provided). The patient was prescribed DOXEPIN 10 mg capsule for the event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX , (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she got vaccinated, since on an unknown date in September 2014, she started to experienced paresthesia as she reported that she was experiencing prickling, tingly, burning stabbing all over her body; it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, it first it lasted for 2 weeks and she recovered, but, since on an unknown day in November 2014, it came back with a vengeance, the only time she had relief is at night when she used less clothing, but during the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results not provided). The patient was prescribed DOXEPIN 10 mg capsule for the event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Feeling abnormal, Knee operation
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX , (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she got vaccinated, since on an unknown date in September 2014, she started to experienced paresthesia as she reported that she was experiencing prickling, tingly, burning stabbing all over her body; it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, it first it lasted for 2 weeks and she recovered, but, since on an unknown day in November 2014, it came back with a vengeance, the only time she had relief is at night when she used less clothing, but during the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results not provided). The patient was prescribed DOXEPIN 10 mg capsule for the event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Paraesthesia, Urine analysis
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX , (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she got vaccinated, since on an unknown date in September 2014, she started to experienced paresthesia as she reported that she was experiencing prickling, tingly, burning stabbing all over her body; it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, it first it lasted for 2 weeks and she recovered, but, since on an unknown day in November 2014, it came back with a vengeance, the only time she had relief is at night when she used less clothing, but during the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results not provided). The patient was prescribed DOXEPIN 10 mg capsule for the event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Electrocardiogram, Loss of consciousness
Clinical narrative: Information has been received from an office administrator via a field representative referring to a 16 year old female patient. No relevant medical history and drug allergy were reported. On 10-FEB-2015 the patient was vaccinated with her first dose of GARDASIL (lot# unknown), 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. Prior to receiving the GARDASIL, the patient was in good health. When the dose of GARDASIL was administered to the patient, she felt dizzy or light-headed. Seven minutes later, the patient lost consciousness for approximately 20 minutes. The facility performed the following intervention to prevent serious criteria: they called 911, and the paramedics provided the intravenous fluid as treatment, and they also performed an electrocardiogram (EKG) as a diagnostic test (result unspecified). The patient was transported by the paramedics to an unspecified hospital on 10-FEB-2015. The representative did not know if the patient was observed overnight or admitted to the hospital. On 12-FEB-2015, the patient had an appointment to be examined by a Physician. The physician was reluctant to give her more doses of GARDASIL, so the representative did not know if the GARDASIL series were discontinued. The events of dizzy or light-headed and lost consciousness were reported to be serious as other medical significant. The outcome of feeling dizzy or light-headed was unknown. The relationship of the adverse events and GARDASIL was not reported. Additional information has been requested.