chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: EE states she developed an achy arm/shoulder the same day of the shot and it is still present of 12/02/2013. States she believes the shot "got close to a nerve".
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatofibrosarcoma protuberans, Injection site mass, Spindle cell sarcoma, Subcutaneous biopsy abnormal
Clinical narrative: Employee reported on 1/11/2013 that she developed a non- painful lump to injection site approximately one month after receiving the flu vaccine. She was referred to a Worker's Compensation provider. Biopsy on the lump was performed on 8/29/13. The diagnosis was: atypical dermal and subcutaneous spindle cell neoplasm C/W dermatofibrosarcoma protuberans.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Chills, Hyperhidrosis
Clinical narrative: Severe chills w/ teeth chattering, sweats.  Hair loss reported to start 10/15/2013, dermatologist told patient that may be due to preservative in vaccine.
Age: 28.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Chills, Cough, Decreased appetite, Headache, Pain
Clinical narrative: Body aches, loss of appetite, chills, headache, rhinorrhea, cough.
Age: 28.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Rhinorrhoea
Clinical narrative: Body aches, loss of appetite, chills, headache, rhinorrhea, cough.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: Received vaccine 10/24/2013 and about a week later developed pain in arm with "moving elbow away from body." Reported to employee health 11/12/13 after about 2 weeks of discomfort. Continues discomfort today (12/4/13).
Age: 52.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Middle insomnia, Pain
Clinical narrative: Received vaccine 10/24/2013 and about a week later developed pain in arm with "moving elbow away from body." Reported to employee health 11/12/13 after about 2 weeks of discomfort. Continues discomfort today (12/4/13).
Age: 52.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: Recieved Flu vaccine in L Deltoid on Oct 24th.  By the first of November I noticed my L shoulder was painful when lifting elbow laterally.  At the time of this report, shoulder is still painful and sometimes aches at night enough to awaken me.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Middle insomnia, Pain
Clinical narrative: Recieved Flu vaccine in L Deltoid on Oct 24th.  By the first of November I noticed my L shoulder was painful when lifting elbow laterally.  At the time of this report, shoulder is still painful and sometimes aches at night enough to awaken me.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dr.: Mother and Father returned with the patient about 20 minutes after the immunizations noting swelling and redness of the left thigh. This was the location of the Varicella and MMR immunization. The child was evaluated and did have an area of swelling and erythema measuring about 2 inch in diameter. Ice was placed and 1/4 cc of Benadryl at 12.5 mg/5cc was given. Ice was applied. Patient was monitored for another 25 minutes. The area of swelling decreased, vitals was stable, respirations were normal. Patient was discharged in good condition. Our office will call mother/father back later today to check the status. Benadryl advised tonight at the same dose as above. Ibuprofen dosed based on weight recommended for any fever pain. Parents understood, all questions were answered. Dr. also evaluated the patient. Please check on patient this afternoon.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dr.: Mother and Father returned with the patient about 20 minutes after the immunizations noting swelling and redness of the left thigh. This was the location of the Varicella and MMR immunization. The child was evaluated and did have an area of swelling and erythema measuring about 2 inch in diameter. Ice was placed and 1/4 cc of Benadryl at 12.5 mg/5cc was given. Ice was applied. Patient was monitored for another 25 minutes. The area of swelling decreased, vitals was stable, respirations were normal. Patient was discharged in good condition. Our office will call mother/father back later today to check the status. Benadryl advised tonight at the same dose as above. Ibuprofen dosed based on weight recommended for any fever pain. Parents understood, all questions were answered. Dr. also evaluated the patient.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: Swelling of vaccine site, vomiting, fever.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Hyperventilation, Pruritus, Throat irritation
Clinical narrative: Developed hyperventilating, itchy/red chest, "catch" in throat; able to breathe easily. No tongue swelling. No SOB. Took OTC meds on own. No hives noted. Irritated cough. Refused to be seen in ER, though agreed to go if worsened.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient called the doctor on 11127/2013, after receiving her flu shot in the clinic on 11/26/2013. She had a rough night with nausea, vomiting, and diarrhea. She was working hard to stay hydrated and was already in the recovery phase of this acute illness when she called the Doctor. She assured the doctor she was going to be okay. She has not had this sort of reaction from the flu shot in the past, so this may be coincedental. Patient wanted to report this to the Doctor.
Age: 64.0
Sex: M
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Cellulitis, Inflammation
Clinical narrative: Patient came for a doctor's visit on 12/02/2013 and came to the clinic for a lab appointment on 12/04/13. The patient voiced the inflammation on his left arm has been spreading. PCP, assessed area as cellulitis and prescribed antibiotics. Patient to go to E.R. if gets worse.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase, Blood test, Muscle spasms, Neuralgia, Pain in extremity
Clinical narrative: Leg pain which increased in intensity over the next two weeks. Muscle spasms in legs, cramping in calves, nerve pain in lower legs. Treated with prednisone and pain medication. Day 18, pain started to subside.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count
Clinical narrative: Leg pain which increased in intensity over the next two weeks. Muscle spasms in legs, cramping in calves, nerve pain in lower legs. Treated with prednisone and pain medication. Day 18, pain started to subside.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Felt dull joint pain when she gave me the shot. It was the worst pain I have ever felt! Not a slight burn as she had warned me about. Still cannot use my arm completely.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Influenza like illness, Injection site pain, Malaise
Clinical narrative: PATIENT REPORTS A BURNING SENSATION DURING VACCINATION.  PATIENT FELT VERY SICK WITH FLU LIKE SYMPTOMS FOR TWO DAYS AFTER VACCINATION AND MISSED TWO DAYS OF WORK.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea and vomiting, and lethargy.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Rash, Wheezing
Clinical narrative: Itching which progressed to rash, then within next 2 days to wheezing and shortness of breath.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Headache, Local swelling, Pain in extremity
Clinical narrative: Arm was swollen and very painful. By 12;00 PM began to run fever. Chills, headache arm hurt more. At 5:00 Pm Dr sent out an antibiotic and had us circle the area. He told us to go to emergency if the redness went out of the circle.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product contamination, Pyrexia
Clinical narrative: Arm was swollen and very painful. By 12;00 PM began to run fever. Chills, headache arm hurt more. At 5:00 Pm Dr sent out an antibiotic and had us circle the area. He told us to go to emergency if the redness went out of the circle.
Age: 67.0
Sex: F
Vaccine: DPP, FLUX, IPV, PPV, SMALL, VARZOS
Symptoms: Amnesia, Asthenia, Bedridden, Concussion, Contusion
Clinical narrative: Received a pneumonia and shingles vaccines on the same visit. That evening, I felt weakness and a paralyzing feeling in my extremities. I was very weak, had loss of coordination and attempted to get to my bedroom. I fainted and sustained total upper body bruising and a concussion. I also have had amnesia, as my room was torn up and I have no recollection of how this happened. I was bed ridden for one week then began to feel my muscle strength come back. I still have problems with days of the week, but am improving. I was too weak to call 911, as I said I felt paralyzed.
Age: 67.0
Sex: F
Vaccine: DPP, FLUX, IPV, PPV, SMALL, VARZOS
Symptoms: Coordination abnormal, Paralysis, Syncope
Clinical narrative: Received a pneumonia and shingles vaccines on the same visit. That evening, I felt weakness and a paralyzing feeling in my extremities. I was very weak, had loss of coordination and attempted to get to my bedroom. I fainted and sustained total upper body bruising and a concussion. I also have had amnesia, as my room was torn up and I have no recollection of how this happened. I was bed ridden for one week then began to feel my muscle strength come back. I still have problems with days of the week, but am improving. I was too weak to call 911, as I said I felt paralyzed.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Papule rash pruritic scattered on abdomen, face, hands/arms, legs/feet. Given PRN Benadryl and hydrocortisone cream 2.5% for itching.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Oropharyngeal pain, Pain, Pallor, Rash erythematous, Rash maculo-papular
Clinical narrative: Yellow fever vaccine given 11/23/13. Pine mono papular non-pruritic rash noticed on 12/2/13. Perio-lesion pallor prominent. Very "viral" looking. Associated with mild sore throat and achiness, which both improved by 12/4. No fever. No other meals or vaccine prior to rash eruptions.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Cold agglutinins negative, Full blood count normal, Metabolic function test normal
Clinical narrative: Had onset of severe myalgias lasting about 10 days, beginning 36 hours after flu vaccine. No arthralgias, joint swelling, rash, fever.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: Had onset of severe myalgias lasting about 10 days, beginning 36 hours after flu vaccine. No arthralgias, joint swelling, rash, fever.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient is complaining of pain for 2 weeks. No heat or swelling. Complaining the pain is in the joint.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pruritus
Clinical narrative: 48 hrs post injection pt came in, observation injection site warm to touch, pt states itchy off and on, pt followed up with observation was improved pt called 3wks later, complaint of stiffness.
Age: 49.0
Sex: F
Vaccine: FLUR3
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Itching burning all over hives arms, legs, back.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: To unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 15-NOV-2013 the patient was vaccinated with improperly stored M-M-R II (lot# J003791, exp. 28-MAR-2015), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011616, 1311USA011615, 1311USA011617, 1311USA011619). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist who learned about the case through an unspecified pharmacy costumer who was a friend of the patient via a company representative refers to an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number were not reported). Concomitant medication was not reported. On an unknown date, the patient experienced severe swelling around the injection site after receiving PNEUMOVAX23. The outcome of severe swelling around the injection site was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 64 year old female patient. Medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, concentration and dose were not reported). No concomitant therapy was reported. On an unknown date the patient developed lesions on her hands and feet. On unspecified dates, the patient went to a dermatologist and physician and she received unspecified medications to treat the adverse symptoms. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Nurse reported that the patient received a first dose of CERVARIX (lot number and expiration date not reported) on 26-MAY-2013, and might be in the office to receive a dose of GARDASIL (dose, route, lot number and expiration date not reported) on 21-NOV-2013 as next dose in HPV series because office did not have CERVARIX in stock. No adverse event was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Decreased appetite, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Anorexia; sudden fever = 24 hours later = 102-103. Vomiting x 2 and arm soreness.
Age: 41.0
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist via an other company refers to a 41 year old patient. In January 2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose, route and indication not reported). In April 2013, the patient got pneumonia. The outcome of the event was unknown. The reporter also asked "how long after receiving PNEUMOVAX23 may a patient receive PREVNAR 13)". Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatinine increased
Clinical narrative: This spontaneous report as received from a 75 year old female retired nurse (who was also the patient) with MACRODANTIN reaction/allergy, possibly narcotics reaction/allergy, elevated blood pressure, elevated cholesterol, osteoarthritis, might possibly have rheumatoid arthritis, urinary tract infection (began prior to receiving ZOSTAVAX). Her primary physician prescribed BACTRIM but she had not taken if yet and high creatine level (unspecified what her usual level is). The patient's medical history included insulin resistance, shingles and double coronary artery bypass grafting (CABG) in 2005. On 18-NOV-2013, the patient creatine was 1.18 (the lab that ran the test said their "normal range" was 0.5 to 1.10) (ordered by her primary physician). On 19-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported) at an unspecified pharmacy. Concomitant therapies included acetaminophen (manufacturer unknown), TYLENOL Extended Release, aspirin (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), LOVAZA, magnesium (manufacturer unknown), metoprolol (manufacturer unknown), NIASPAN, nitroglycerin (manufacturer unknown), omeprazole (manufacturer unknown), potassium chloride (manufacturer unknown) and vitamin D (manufacturer unknown). On 21-NOV-2013, the patient creatinine level increased, her creatinine was 1.7 (the lab that ran the test said their "normal range" was 0.7 to 1.2) (ordered by her rheumatologist). The patient sought for medical attention (phone call). No treatment given for the events. The outcome of creatinine level increased was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatinine increased, Injection site erythema
Clinical narrative: This spontaneous report as received from a 75 year old female retired nurse (who was also the patient) with MACRODANTIN reaction/allergy, possibly narcotics reaction/allergy, elevated blood pressure, elevated cholesterol, osteoarthritis, might possibly have rheumatoid arthritis, urinary tract infection (began prior to receiving ZOSTAVAX). Her primary physician prescribed BACTRIM but she had not taken if yet and high creatine level (unspecified what her usual level is). The patient's medical history included insulin resistance, shingles and double coronary artery bypass grafting (CABG) in 2005. On 18-NOV-2013, the patient creatine was 1.18 (the lab that ran the test said their "normal range" was 0.5 to 1.10) (ordered by her primary physician). On 19-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported) at an unspecified pharmacy. Concomitant therapies included acetaminophen (manufacturer unknown), TYLENOL Extended Release, aspirin (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), LOVAZA, magnesium (manufacturer unknown), metoprolol (manufacturer unknown), NIASPAN, nitroglycerin (manufacturer unknown), omeprazole (manufacturer unknown), potassium chloride (manufacturer unknown) and vitamin D (manufacturer unknown). On 21-NOV-2013, the patient creatinine level increased, her creatinine was 1.7 (the lab that ran the test said their "normal range" was 0.7 to 1.2) (ordered by her rheumatologist). The patient sought for medical attention (phone call). No treatment given for the events. The outcome of creatinine level increased was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 19-NOV-2013 the patient was vaccinated with improperly stored M-M-R II (lot# J006954, exp. 07-JUN-2015), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011616, 1311USA011615, 1311USA011617, 1311USA011618). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot #, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 20-SEP-2013 the patient was vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011616, 1311USA011615, 1311USA011618, 1311USA011619). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning 2 patients. On 19-SEP-2013 the two patients were vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011615, 1311USA011617, 1311USA011618, 1311USA011619). Additional information has been received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 17-SEP-2013 the patient was vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information has been received.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site dermatitis, Injection site dryness, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2013US084023, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493487) website on 06 Aug 2013 with a follow up received from Quality Assurance (QA ref: 246024) department on 27 Nov 2013. This report refers to 17-year-old female patient. Her medical history included exercise induced asthma and iron deficiency anemia. Her concomitant medication included ciprofloxacin, ferrous sulfate, docusate, beclomethasone, albuterol, acetaminophen, and ibuprofen. On 08 Feb 2011, she was vaccinated with MENVEO (batch number: M12004, Expiry date: Sep 2014) intramuscularly in the right arm, ADACEL (batch number: U4395AA) and GARDASIL (batch number: H017698) both intramuscularly in the left arm. On 11 Feb 2013, she experienced vaccination site reactions like skin warmth, dryness, rash, erythema, and hive like rash in the right deltoid area about 1 cm from the vaccination site. It was reported that the site of vaccination was tender and the area of vaccination was slightly raised. Primary encounter diagnosis was cellulitis. She visited the emergency room. She was also diagnosed with dermatitis allergic. The event outcome was reported as completely recovery as of 05 Jun 2013. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the MENVEO vaccine (batch number: M12004) was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Follow-up received from Quality Assurance Department (reference number: 246024) on 27 Nov 2013: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Case number PHHY2013US084023, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493487) website on 06 Aug 2013 with a follow up received from Quality Assurance (QA ref: 246024) department on 27 Nov 2013. This report refers to 17-year-old female patient. Her medical history included exercise induced asthma and iron deficiency anemia. Her concomitant medication included ciprofloxacin, ferrous sulfate, docusate, beclomethasone, albuterol, acetaminophen, and ibuprofen. On 08 Feb 2011, she was vaccinated with MENVEO (batch number: M12004, Expiry date: Sep 2014) intramuscularly in the right arm, ADACEL (batch number: U4395AA) and GARDASIL (batch number: H017698) both intramuscularly in the left arm. On 11 Feb 2013, she experienced vaccination site reactions like skin warmth, dryness, rash, erythema, and hive like rash in the right deltoid area about 1 cm from the vaccination site. It was reported that the site of vaccination was tender and the area of vaccination was slightly raised. Primary encounter diagnosis was cellulitis. She visited the emergency room. She was also diagnosed with dermatitis allergic. The event outcome was reported as completely recovery as of 05 Jun 2013. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the MENVEO vaccine (batch number: M12004) was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Follow-up received from Quality Assurance Department (reference number: 246024) on 27 Nov 2013: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dermatitis allergic, Injection site cellulitis, Injection site dryness, Injection site urticaria, Injection site warmth
Clinical narrative: Case number PHHY2013US084023, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493487) website on 06 Aug 2013 with a follow up received from Quality Assurance (QA ref: 246024) department on 27 Nov 2013. This report refers to 17-year-old female patient. Her medical history included exercise induced asthma and iron deficiency anemia. Her concomitant medication included ciprofloxacin, ferrous sulfate, docusate, beclomethasone, albuterol, acetaminophen, and ibuprofen. On 08 Feb 2011, she was vaccinated with MENVEO (batch number: M12004, Expiry date: Sep 2014) intramuscularly in the right arm, ADACEL (batch number: U4395AA) and GARDASIL (batch number: H017698) both intramuscularly in the left arm. On 11 Feb 2013, she experienced vaccination site reactions like skin warmth, dryness, rash, erythema, and hive like rash in the right deltoid area about 1 cm from the vaccination site. It was reported that the site of vaccination was tender and the area of vaccination was slightly raised. Primary encounter diagnosis was cellulitis. She visited the emergency room. She was also diagnosed with dermatitis allergic. The event outcome was reported as completely recovery as of 05 Jun 2013. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the MENVEO vaccine (batch number: M12004) was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Follow-up received from Quality Assurance Department (reference number: 246024) on 27 Nov 2013: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2013US084023, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493487) website on 06 Aug 2013 with a follow up received from Quality Assurance (QA ref: 246024) department on 27 Nov 2013. This report refers to 17-year-old female patient. Her medical history included exercise induced asthma and iron deficiency anemia. Her concomitant medication included ciprofloxacin, ferrous sulfate, docusate, beclomethasone, albuterol, acetaminophen, and ibuprofen. On 08 Feb 2011, she was vaccinated with MENVEO (batch number: M12004, Expiry date: Sep 2014) intramuscularly in the right arm, ADACEL (batch number: U4395AA) and GARDASIL (batch number: H017698) both intramuscularly in the left arm. On 11 Feb 2013, she experienced vaccination site reactions like skin warmth, dryness, rash, erythema, and hive like rash in the right deltoid area about 1 cm from the vaccination site. It was reported that the site of vaccination was tender and the area of vaccination was slightly raised. Primary encounter diagnosis was cellulitis. She visited the emergency room. She was also diagnosed with dermatitis allergic. The event outcome was reported as completely recovery as of 05 Jun 2013. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the MENVEO vaccine (batch number: M12004) was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Follow-up received from Quality Assurance Department (reference number: 246024) on 27 Nov 2013: Updated batch review report.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Case number PHEH2013US017567 is a combined initial and follow up spontaneous report received from a pharmacist on 15 Aug 2013 with a follow up information received from a pharmacist on 22 Nov 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. Pharmacist gave a dose of MENVEO (batch number: unknown) at a dose of 0.5 ml subcutaneously (wrong route), and then she gave a second dose of MENVEO (batch number: unknown) by the correct route (intramuscular) on 15 Aug 2013. She was under the impression that administration by the subcutaneous route would make it inactive, which was why she administered a second dose. She later learned that the vaccine should not have been a second time. On 16 Aug 2013, he experienced headache, fever, chills, fatigue and soreness at the site of administration of vaccine. It was reported that the patient visited the local emergency room, but was not admitted to the hospital. The events completely recovered 7 days later. The pharmacist reported the events as medically significant. The causality was not reported. No further information was provided. Follow up information received from a pharmacist on 22 Nov 2013: Patient demographics (age and date of birth), dose and date of vaccination, events (headache, fever, chills, fatigue and soreness), outcome of seriousness updated.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Chills, Fatigue, Headache, Incorrect dose administered, Incorrect route of drug administration
Clinical narrative: Case number PHEH2013US017567 is a combined initial and follow up spontaneous report received from a pharmacist on 15 Aug 2013 with a follow up information received from a pharmacist on 22 Nov 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. Pharmacist gave a dose of MENVEO (batch number: unknown) at a dose of 0.5 ml subcutaneously (wrong route), and then she gave a second dose of MENVEO (batch number: unknown) by the correct route (intramuscular) on 15 Aug 2013. She was under the impression that administration by the subcutaneous route would make it inactive, which was why she administered a second dose. She later learned that the vaccine should not have been a second time. On 16 Aug 2013, he experienced headache, fever, chills, fatigue and soreness at the site of administration of vaccine. It was reported that the patient visited the local emergency room, but was not admitted to the hospital. The events completely recovered 7 days later. The pharmacist reported the events as medically significant. The causality was not reported. No further information was provided. Follow up information received from a pharmacist on 22 Nov 2013: Patient demographics (age and date of birth), dose and date of vaccination, events (headache, fever, chills, fatigue and soreness), outcome of seriousness updated.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Case number PHEH2013US017567 is a combined initial and follow up spontaneous report received from a pharmacist on 15 Aug 2013 with a follow up information received from a pharmacist on 22 Nov 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. Pharmacist gave a dose of MENVEO (batch number: unknown) at a dose of 0.5 ml subcutaneously (wrong route), and then she gave a second dose of MENVEO (batch number: unknown) by the correct route (intramuscular) on 15 Aug 2013. She was under the impression that administration by the subcutaneous route would make it inactive, which was why she administered a second dose. She later learned that the vaccine should not have been a second time. On 16 Aug 2013, he experienced headache, fever, chills, fatigue and soreness at the site of administration of vaccine. It was reported that the patient visited the local emergency room, but was not admitted to the hospital. The events completely recovered 7 days later. The pharmacist reported the events as medically significant. The causality was not reported. No further information was provided. Follow up information received from a pharmacist on 22 Nov 2013: Patient demographics (age and date of birth), dose and date of vaccination, events (headache, fever, chills, fatigue and soreness), outcome of seriousness updated.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Haemorrhage, Head injury, Syncope
Clinical narrative: Case number PHHY2013US127844 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 500307) web site on 11 Nov 2013, with a follow up received from the QA department (QA reference number: 264295) on 29 Nov 2013. This report refers to a 19-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12009) intramuscularly in arm on 09 Aug 2013. He fainted within minutes of vaccination and hit his head. He was bleeding and was taken to the emergency room of area hospital. He was treated and released. The outcome of the events was reported as complete recovery as of 16 Aug 2013. The causality was not reported. Based on the batch review, it was stated that the concerned MENVEO batch number A12009 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Significant follow up received from the QA department on 29 Nov 2013: Updated Batch report.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Allodynia, Arthralgia, Asthenia, Back pain, Complex regional pain syndrome
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dysstasia, Gait disturbance, Muscle atrophy, Neuropathy peripheral, Small fibre neuropathy
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tremor
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Allodynia, Arthralgia, Asthenia, Balance disorder
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy skin, Blood test, Borrelia test, Computerised tomogram, Dysphagia
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Electromyogram, Fall, Guillain-Barre syndrome, Hyperaesthesia
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscle atrophy, Muscular weakness, Nerve conduction studies, Neuropathy peripheral
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Oedema, Pain, Pain in extremity, Paraesthesia
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash, Seizure like phenomena, Small fibre neuropathy, Tremor, Ultrasound scan
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: GBS-like symptoms, pain began in back, legs, knees, feet etc. January 2012 pain increased, edema, shiny rash on legs, muscle atrophy/weakness/tingling & numbness in upper & lower extremities/sensitivity to touch, difficulty breathing. Feb-March 2012 pain increased and leg weaknes worsened. He could not attend a full day of school.  Difficulty swallowing. March 12, 2012 ceased pt due to onset of seizure-like tremors, balance issues, falling, absolutely no pain relief, April 2012 Dx Allodynia, bilateral peripheral neuropathy (axonal) both legs, & small fiber neuropathy 8/2012 large fiber neuropathy.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Dermatitis contact, Fall, Feeling abnormal
Clinical narrative: This spontaneous report as received from a patient, as part of a marketing research program, refers to himself or herself. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (lot #, expiration date, dose, route not reported). The patient felt on 26-OCT-2013 injuring by left shoulder and arm. The patient went to the doctor and at that time did not have a rash on the patient's arm, just pain in the shoulder joint and upper arm area. The patient was given pain medications and told that the patient had pulled muscles. On 31-OCT-2013 ("five days later"), the patient developed a red rash, then fluid filled pus pockets beginning at my shoulder going down to the hand and into fingers. The patient went to doctor on 02-NOV-2013 ("Sunday") and was told that it was contact dermatitis and if it was the shingles it was to late to begin viral medications. The patient was given prednisone shot and pills to take. On 05-NOV-2013 morning ("Tuesday morning") the patient woke up with severe shoulder joint pain, more blisters, and swollen arm, the patient went to the regular doctor was told the patient had full blown shingles and the doctor wanted the patient to stop the prednisone and wrote prescription for a viral medication to begin taking immediately and stronger pain medications. The patient was at home resting and felt terrible. The doctor was hoping that the viral medications will help. The outcome of the event was unknown. Follow up information has been received from the patient, as part of a marketing research program, refers to himself/herself. The patient stated he/she had been suffering from shingles on and off for 39 years. Even after the vaccine he/she was still getting them. At the time of the report, the outcome of the patient was unknown. Additional information has been requested. It has been determined that initial receipt date of MARRS # 1311USA002469 shoulder be 05-NOV-2013, but entered as 06-NOV-2013 by mistake. Therefore, that MARRS # 1311USA002469 is being deleted from our files and the cases consolidated into MARRS # 1312USA000882.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Joint injury, Limb injury, Local swelling, Muscle strain
Clinical narrative: This spontaneous report as received from a patient, as part of a marketing research program, refers to himself or herself. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (lot #, expiration date, dose, route not reported). The patient felt on 26-OCT-2013 injuring by left shoulder and arm. The patient went to the doctor and at that time did not have a rash on the patient's arm, just pain in the shoulder joint and upper arm area. The patient was given pain medications and told that the patient had pulled muscles. On 31-OCT-2013 ("five days later"), the patient developed a red rash, then fluid filled pus pockets beginning at my shoulder going down to the hand and into fingers. The patient went to doctor on 02-NOV-2013 ("Sunday") and was told that it was contact dermatitis and if it was the shingles it was to late to begin viral medications. The patient was given prednisone shot and pills to take. On 05-NOV-2013 morning ("Tuesday morning") the patient woke up with severe shoulder joint pain, more blisters, and swollen arm, the patient went to the regular doctor was told the patient had full blown shingles and the doctor wanted the patient to stop the prednisone and wrote prescription for a viral medication to begin taking immediately and stronger pain medications. The patient was at home resting and felt terrible. The doctor was hoping that the viral medications will help. The outcome of the event was unknown. Follow up information has been received from the patient, as part of a marketing research program, refers to himself/herself. The patient stated he/she had been suffering from shingles on and off for 39 years. Even after the vaccine he/she was still getting them. At the time of the report, the outcome of the patient was unknown. Additional information has been requested. It has been determined that initial receipt date of MARRS # 1311USA002469 shoulder be 05-NOV-2013, but entered as 06-NOV-2013 by mistake. Therefore, that MARRS # 1311USA002469 is being deleted from our files and the cases consolidated into MARRS # 1312USA000882.