chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139494, is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number 504888) on 25 Nov 2013. The author described a prospective cohort study which was conducted to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome between Oct 2009 and Aug 2012. Out of 1032 subjects available for analysis, 841 women were exposed to a pH1N1-containing vaccine in pregnancy and 191 women were unexposed to any influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 vaccine (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a neonate by unknown delivery method and the baby had congenital anomaly and was born with femoral artery deficiency (see related case number: PHHY2013US135820). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of maternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy; however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ratio (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139498 is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number: 504891) on 25 Nov 2013. The author described a prospective study which was conducted to evaluated the foetal risk and relative safety of the H1N1 vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome. Out of 1032 subjects available for analysis, 841 women were exposed to a H1N1 -containing vaccine in pregnancy and 191 women were unexposed to an influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a neonate by unknown delivery method and the baby had congenital anomaly and was born with stenosis of pulmonary artery (see related case number: PHHY2013US135827). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of meternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy, however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ration (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was  demonstrated.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139500, is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number 504894) on 25 Nov 2013. The author described a prospective cohort study which was conducted to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome between Oct 2009 and Aug 2012. Out of 1032 subjects available for analysis, 841 women were exposed to a pH1N1-containing vaccine in pregnancy and 191 women were unexposed to any influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 vaccine (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a neonate by unknown delivery method and the baby had congenital anomaly and was born with bilateral congenital club foot (see related case number: PHHY2013US135831). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of maternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy; however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ratio (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Age: 4.0
Sex: M
Vaccine: SMALL, TD
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was received on 13 March 2014 via a third party query tool search on the VAERS database, under reference number 515464. A four year old male patient received the following vaccines on 20 November 2013: a right arm injection reported as "Smallpox vaccine" (lot number, site and manufacturer unknown) and a left arm injection reported as "Tetanus and Diphtheria vaccine" (lot number, route and manufacturer unknown). One day later on 21 November 2013 the patient's left arm around the shot was "very swollen, hot to the touch, hard and itchy". The mother gave him BENADRYL and called the doctor. The doctor advised her to take her son to the ER. She was told that the child had the beginnings of cellulitis and was prescribed cephalexin. The patient's lab data and other medications were not reported. The patient's current illnesses were reported as no. The patient has a history of fish and soy allergies and asthma. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLUX, HEPA, TYP, YF
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2014US043603, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519292) website on 08 Apr 2014. This report refers to a 59-year-old female patient. She was allergic to eggs. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) along with yellow fever vaccine (other manufacturer, batch number: not reported), typhoid Vi vaccine (other manufacturer, batch number: not reported) and hepatitis A vaccine (other manufacturer, batch number: not reported) on an unknown date in 2010. On an unknown date, after vaccination the patient experienced anaphylactic reaction. The outcome and causality of the event was not reported. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 19.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Case number PHHY2014US054821, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523110) website on 06 May 2014. This report refers to a 19-year-old female patient. Past medications included penicillin. No concomitant medication was reported. She was vaccinated with H1N1 (batch number: 105050P1) on 13 Mar 2010. On the same day immediately after vaccination, she experienced swelling of throat, face and hands. Also she experienced numbness in arms and legs, dizziness and fatigue. The outcome of the events was unknown. The events were reported as non-serious; however the events swelling of throat; face; were considered as medically significant by the agency. Causality was not reported.
Age: 19.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Case number PHHY2014US054821, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523110) website on 06 May 2014. This report refers to a 19-year-old female patient. Past medications included penicillin. No concomitant medication was reported. She was vaccinated with H1N1 (batch number: 105050P1) on 13 Mar 2010. On the same day immediately after vaccination, she experienced swelling of throat, face and hands. Also she experienced numbness in arms and legs, dizziness and fatigue. The outcome of the events was unknown. The events were reported as non-serious; however the events swelling of throat; face; were considered as medically significant by the agency. Causality was not reported.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). Concurrent medical conditions included diabetes, hypertension, osteoarthritis and hyperlipidemia. Concomitant products included AMARYL, Aspirin, gabapentin, HYZAAR, JANUMET, VIAGRA and ZOCOR. On 22nd October 2014 09:14, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 mg. On an unknown date, the dose was an unknown dose. On 23rd October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability). On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional information was provided: Medical assistant reported a patient who has been experiencing significant pain at the injection site starting the day after his FLUARIX QUADRIVALENT vaccination. The pain is still ongoing and hasn't improved. The patient was not ill at the time of the injection.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX, MEN
Symptoms: Rash, Rash erythematous, Rash pruritic, Viral infection
Clinical narrative: Little red bumps all over the arms, torso, thighs and back of knees. Bumps were extremely itchy and got worse with time.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Chills, Gait disturbance, Musculoskeletal pain
Clinical narrative: Loss of muscle strength, difficulty walking, pain in joints, chills, pain in muscles, pain in shoulders, pain in forearms, loss of muscle strength in arms.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Loss of muscle strength, difficulty walking, pain in joints, chills, pain in muscles, pain in shoulders, pain in forearms, loss of muscle strength in arms.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain when lifting arm. Pain is limiting mobility and seems to be getting worse each day. Took 400mg Ibuprofen for pain this morning with minimal affect. Some pain in muscle where vaccine received.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Injection site became hot, raised like a welt and splotchy.  The area covered the backside of my arm. The red raised area became sore like a burn and itchy. Any type of contact with the site is painful even soft cloth covering my arm irritates the area. Periodic stabbing prickly pain in the injection site. Any pressure contact such as leaning against car seat or sofa results brings great discomfort.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Urticaria
Clinical narrative: Injection site became hot, raised like a welt and splotchy.  The area covered the backside of my arm. The red raised area became sore like a burn and itchy. Any type of contact with the site is painful even soft cloth covering my arm irritates the area. Periodic stabbing prickly pain in the injection site. Any pressure contact such as leaning against car seat or sofa results brings great discomfort.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Haemorrhage, Headache, Nausea
Clinical narrative: Severe headaches, nausea, abdominal pain, chills, and profuse bleeding.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Induration, Injection site bruising, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: EMPLOYEE STATED THAT HE IS EXPERIENCING CRAMPING AND PAIN ALL THE WAY UP THE RIGHT ARM. ALSO STATED THAT ARM IS SWOLLED AND VERY HARD TO THE TOUCH. ARM DID APPEAR TO BE SWOLLEN WITH SOME BRUISING AT THE INJECTION SITE AND ALSO SOME HARDNESS.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: EMPLOYEE STATED THAT HE IS EXPERIENCING CRAMPING AND PAIN ALL THE WAY UP THE RIGHT ARM. ALSO STATED THAT ARM IS SWOLLED AND VERY HARD TO THE TOUCH. ARM DID APPEAR TO BE SWOLLEN WITH SOME BRUISING AT THE INJECTION SITE AND ALSO SOME HARDNESS.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 78 year old male patient regarding himself. Patient's concurrent conditions included diabetes, hydrocephalus, prostate and bladder problems. The patient's medical history included heart attack and shingles. On an unknown date in April 2013 the patient was vaccinated with ZOSTAVAX (1 dose, once), subcutaneous. Concomitant medications included unspecified medications for blood pressure and diabetes. On 27-DEC-2014 the patient experienced shingles after receiving ZOSTAVAX. The patient received treatment with unspecified pills. The outcome of shingles was reported as recovering/resolving. The causality of the event with ZOSTAVAX was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Respiratory tract congestion, Respiratory tract infection, Splenectomy, Wheezing
Clinical narrative: This spontaneous report was received from a 56 year old female patient who is also a nurse. Concurrent conditions, medical history and allergies were not reported. On an unknown date in 2010 (4 years ago) the patient was vaccinated with PNEUMOVAX 23, (strength, dose, frequency, route, anatomical location and lot number were not reported). Concomitant therapies included losartan potassium (manufacturer unknown). The patient inquired if she could receive revaccination and booster for PNEUMOVAX 23 that she received 4 years ago. On an unknown date the patient's spleen was removed (indication was not reported), the patient indicated that she had 3 separate respiratory infections, the first two on an unknown dates in 2014, the last incident started on 12-DEC-2014 in which case she had not recovered at the time of this report, she was taking antibiotics amoxicillin 100mg twice daily and was using an unspecified inhaler. On an unknown date in December 2014 the patient was experiencing congestion and wheezing and had not recovered. The patient sought medical attention in an urgent care on an unknown date and various unspecified tests were perform. The outcome of the patient who is without spleen and she has separated respiratory infections in 2014 was unknown. The outcome of she has separate respiratory infections, the last incident started in 12-DEC-2014, wheezing and congestion was reported as not recovered/not resolved. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site oedema, Pyrexia, Ultrasound scan abnormal, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient went to ER on 11/07/14 for severe pain and swelling at site of vaccines. Fever > 102 F. Ultrasound of site performed and subcutaneous edema is identified without evidence of mass, lesion, or focal fluid collection.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Liquid product physical issue, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist of unknown age reporting on himself. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, via subcutaneous route. It was reported that increased pressure irregularity with a ZOSTAVAX vial caused the vaccine to drip on to his skin just past his protective gloves. Also reported contracting "chicken pox". Cancer and overdose was not reported. The outcome of the event contracting "chicken pox" was reported as recovering/resolving. The outcome of increased pressure irregularity with a ZOSTAVAX vial caused the vaccine to drip on to his skin just past his protective gloves and vaccine drip on to his skin is unknown. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture negative, Convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Seizure.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope
Clinical narrative: Patient was appeared fine after vaccine.  She walked to her care with mom and seemed to have fainted. No one is sure if she lost consciousness. Pulse 92, respirations 20, B/P 120/60. She complained of headache and was transported via EVAC to hospital.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Allergy to vaccine, Pruritus, Rash generalised
Clinical narrative: All over body rash that has yet to resolve on 1/2/2015. Was seen by provider who deemed it allergic rx to nasal vaccine. Extreme itching.
Age: 29.0
Sex: M
Vaccine: FLU3, HEPA, PPV
Symptoms: Pain, Pyrexia, Rash, Vision blurred
Clinical narrative: Fever 102, body aches, rash, vision blurriness after pna, flu and hep a vaccines.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness at injection site, initially. Soreness, Redness, and Warmth increased over the next 5 days.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from parents via a consumer who read on epilepsy website refers to about 50 female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (dose, route, lot # not reported). On an unknown date the patients started to experience seizures after receiving GARDASIL. The outcome of seizures was unknown. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of seizures was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Generalised tonic-clonic seizure, Pain in extremity, Paraesthesia
Clinical narrative: Grand Mal seizures and hospitalization due to continued seizure, placed on anti seizure medicine due to continued seizure activity.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Posture abnormal, Seizure like phenomena, Syncope, Tremor
Clinical narrative: Grand Mal seizures and hospitalization due to continued seizure, placed on anti seizure medicine due to continued seizure activity.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood test normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging
Clinical narrative: Grand Mal seizures and hospitalization due to continued seizure, placed on anti seizure medicine due to continued seizure activity.
Age: 5.0
Sex: U
Vaccine: DT, TD
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 29 July 2014. A '5-year-old' patient (no other information was provided regarding patient) had received a dose of TENIVAC and a dose of DT vaccine on an unspecified date. I.E. inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Initial report received from Health care professional on 30 July 2014. A '40-year-old' female patient, whose concomitant medication were not reported, had received a dose of TD (Lot number, Expiration date, and site of vaccination were not reported) on an unspecified date and patient had experienced fever, malaise and generalized body aches. It was advised that not to take this TD vaccine again. The laboratory details and corrective treatment were not reported. The outcome of the event was resolved on an unspecified date. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: TD
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 01 July 2014. A 24-month-old (2-year-old) patient received first dose of TD who was an unvaccinated child (No other information was provided regarding the patient). Thus wrong vaccine administered. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Erythema, Local swelling, Peripheral swelling, Skin warm
Clinical narrative: Initial information received from another manufacturer on 18 July 2014 with additional information received from a consumer who is also the patient. A female patient was vaccinated on an unknown date with Tetanus, diphtheria toxoid on an unreported date 10 to 15 years ago, (manufacturer, route, site and batch not reported). An unspecified time later, the patient experienced side effects arm and neck swelling that was red and hot. The patient was treated with steroids. The patient was not hospitalized for the event. The patient has a medical history of spinal stenosis, degenerative disc disease, herniated discs, cervical and lumbar radiculopathy, fibromyalgia, hypercholesterolemia, GERD, HTN (hypertension), asthma, arthritis, cauda equina syndrome, sleep apnea, plantar fasciitis, endometriosis, acute renal failure, pulmonary edema, mild bronchiectasis, chronic sinusitis, colonic adenocarcinoma, gestations diabetes, osteoporosis, cysto with fulguration of the bladder in 1975, tonsillectomy in 1976, cesarean in 1989, tubal ligation in 1990, extradural cyst excision with near total laminectomy T-12-L2; placement 2 metal aneurysm clips for wound closure in 1993, colon resection 2003, bilat oophorectomy, appendectomy, excision of lymph node chain and artery supplying 1/2 foot section of colon, right shoulder arthroscopy, bursectomy, numerous epidural, trigger and facet joint steroid injections, L5-S1 lt microdiscectomy in 2001. She has a family history of cancer and drinks alcohol 1-2 drinks a year and caffeine use, one glass of tea a day. Current meds on 18 June 2014 were: LASIX 80 mg tablet twice a day, omeprazole 50 mg capsule delayed released 1 capsule in morning 1 QHS, ABILIFY 2 mg tablet daily, CYMBALTA 30 mg 3 once a day at breakfast, LYRICA 75 mg capsule qhs, methadone HCL, 5 mg tablet, e tablets every 12 hours, pravastatin sodium 20 mg tablet 1 tablet every other day, COREG 25 mg tablet, 1 tablet with food twice a day, clonidine HCl, 0.1 mg tablet qhs, estradiol 1 mg tablet Q?OD, KLOR-CON M20 20 MEQ tablet extended release tablet Qday PRN, Lisinopril 10 mg tablet a day, dronabinol 5 mg tablet twice a day prn, tizanidine HCl 6 mg capsule TID, tramadol HCl 50 mg tablet as needed every 6 hours. Her allergies are BACTRIM: anaphylaxis, topiramate - hives, fire ants - anaphylaxis, adhesives - hives, baclofen - anaphylaxis, LIPITOR - shortness of breath, BENADRYL - rash, pseudoephedrine cold - allergy, side effects, KEPPRA - side effects, codeine phosphate - side effects, hydrocodone bitartrate - side effects, erythromycin - stomach upset, MRI steel aneurysm clips on spinal cord - contraindication. The patient outcome was recovered. According to the patient, she did not know the name of who administered the vaccine and did not have any further information to provide. Documents held by sender: medical assessment records.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (Pharmacist) on 17 March 2014. An expire dose of TENIVAC (batch number U4173AA and expired date 17 March 2014) was administered on an unknown date. No adverse event was reported. List of documents held by sender: None.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 March 2014. A male patient received an expired dose of TD vaccine of unknown brand (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: TD
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 February 2014. The cases were received on 21 March 2014. A male patient received two doses of TENIVAC at one time (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from health care professional (nurse) on 20 February 2014. It was reported that patient had received 2 days ago TD vaccine (Manufacturer-unknown) instead of ADACEL on an unspecified date. Patient had received vaccine under dose. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Underdose, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional (Nurse) on 22 August 2013. The cases were received on 21 March 2014. A patient had received Td vaccine (unknown MFR) instead of ADACEL. It was vaccine underdose. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: DT, DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 19 Aug 2013. This is an invalid case as no patient identifiers were reported. It was reported that on 1 Aug years not specified the temperature of ADACEL, MENACTRA, TUBERSOL, DAPTACEL, IPOL, PENTACEL, DT Pediatric, FLUZONE was 26F (Fahrenheit) leading to incorrect storage conditions of drugs. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 March 2014. The patient (No information was provided regarding the patient) had received expired dose of TD vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DT, DTAP, FLU3, HIBV, IPV, MNQ, TD, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 6 February 2014. An unknown patient had received FLUZONE, DAPTACEL, IPOL, ACT-HIB, MENACTRA, ADACEL, TENIVAC and DT which was stored at 82F for unknown time period, possibly 40 plus hours. It was an incorrect storage of vaccine. No adverse event was reported. List of documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Injection site pain, Muscle spasms, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Diagnosis = post vaccinal brachial plexus neuritis by Neurologist. Had flu shot 10/4/14 - felt pain on injection site, then 2 days after 10/6/14 progressed to tingling, spasm and electrical shooting pain radiating to fingers on left upper extremity. Treatment - gabapentin, ROBAXIN, Prednisone. Spasm on left upper back. Saw Neurologist started 12/9/14.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Diagnosis = post vaccinal brachial plexus neuritis by Neurologist. Had flu shot 10/4/14 - felt pain on injection site, then 2 days after 10/6/14 progressed to tingling, spasm and electrical shooting pain radiating to fingers on left upper extremity. Treatment - gabapentin, ROBAXIN, Prednisone. Spasm on left upper back. Saw Neurologist started 12/9/14.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Insomnia
Clinical narrative: Insomnia.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dysphagia, Heart rate irregular, Injected limb mobility decreased
Clinical narrative: Difficulty swallowing, vomited contents of stomach, developed severe chills that lasted throughout the night, soreness at injection site with inability to lift left arm higher than shoulder height, erratic heartbeat, leg joints mildly ached, stuffy head.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Sinus congestion, Vomiting
Clinical narrative: Difficulty swallowing, vomited contents of stomach, developed severe chills that lasted throughout the night, soreness at injection site with inability to lift left arm higher than shoulder height, erratic heartbeat, leg joints mildly ached, stuffy head.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt said arm was swollen, hot, hard and painful. Also said slight stiff neck and said was careful of using arm.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test abnormal, Polycystic ovaries
Clinical narrative: Development of PCOS.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Patient complains of fever developing the night after vaccination and rash appeared around injection site 3 days later after fever has lowered.  Rash was warm to touch.  No signs of difficult breathing, severe allergy reaction or other discomfort.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on face arms chest.  Patient presented 3 days following vaccine administration to ED.  Prescribed Pepcid AC 10mg tablet by mouth two times a day, Orapred 15 mg/5 ml- 10 ml by mouth two times a day, Hydroxyzine hydrochloride 10 mg/5 ml - give 7.5 ml by mouth PRN up to 4 times daily.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Blood glucose normal, Dyskinesia, Loss of consciousness, Neurological examination normal
Clinical narrative: Brief loss of consciousness and jerking movements lasting about 15 seconds. Then patient became responsive. Patient received O2, MD conducted neuro exam which was normal and obtained finger stick blood glucose which was normal. Patient was sent home. Gardasil was added to allergy list. This was the patient's second dose of HPV vaccine. She tolerated the first dose well.
Age: 30.0
Sex: F
Vaccine: TD, YF
Symptoms: Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: High Fever, Chills, dizziness, weakness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: 12/30/14 site was red and swollen in a 6 inch diameter, hot to touch, itchy, felt sick all week.
Age: 48.0
Sex: F
Vaccine: FLU3, MMR, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling and redness and pain.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Child developed urticaria after Flu Mist. Treatment: Diphenhydramine Elixir.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reports swelling, redness, soreness, warm to the touch at injection site. No fever, growth in size, streaking reported. Denied s/s of serious allergic reaction.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy left side facial paralysis.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle soreness.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Fatigue, nausea, fever, diarrhea, body aches, headache, loss of appetite.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue, nausea, fever, diarrhea, body aches, headache, loss of appetite.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: I woke up with extreme pain in the left arm.  I had no fever or other symptoms, but the pain worsened throughout the day.  I sought treatment from my doctor as soon as I could get an appointment the next week.  He did an xray which showed no shoulder damage, and prescribed a round of cortisone.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Headache, Lacrimation increased, Productive cough
Clinical narrative: I started coughing and it immediately went deep - hacking and wheezing and coughing up phlegm. Headache, other mucous symptoms including watery and swollen eyes. Heartrate was around 150 bpm. Went to Urgent Care center where they checked vitals. BP 147/83 HR 87. They suggested that symptoms were subsiding but could worsen. Prescribed an epi-pen and sent me home with instructions to use it and call 911 if symptoms worsened.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: I started coughing and it immediately went deep - hacking and wheezing and coughing up phlegm. Headache, other mucous symptoms including watery and swollen eyes. Heartrate was around 150 bpm. Went to Urgent Care center where they checked vitals. BP 147/83 HR 87. They suggested that symptoms were subsiding but could worsen. Prescribed an epi-pen and sent me home with instructions to use it and call 911 if symptoms worsened.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Zostavax injection site redness. Patient was told to try Benadryl if she wanted and to wait a few days, then follow up if redness persists.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: This spontaneous report as received from a health professional refers to a 10 week old female patient. Medical history and current conditions were not reported. On 09-DEC-2014, the patient was vaccinated with the first dose of ROTATEQ, 2 ml, orally (lot number reported as: K010755, expiration date: 19-MAY-2016). Concomitant medication was not reported. On 23-DEC-2014, the patient's mother called the office and was advised to go to the emergency room at the hospital. The patient then was diagnosed with intussusception, was hospitalized and had a surgery to correct it. The outcome of intussusception was unknown. The reporter considered the event to be life threatening. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a office manager refers to a 6 month old female patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient completed the first and two doses in series of ROTATEQ oral (dose, lot number and expiry date were not provided). There was no concomitant medication reported. On 15-DEC-2014, the patient sought medical attention, was admitted to an unknown hospital and diagnosed with intussusception. Patient was discharged (in December 2014) and followed up with physician on 29-DEC-2014. The patient received unspecified treatment. The outcome of diagnosed with intussusception was reported as recovering. Relatedness between the therapy with ROTATEQ and the event: diagnosed with intussusception was not reported. Additional information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received on 02 December 2013 from nurse. A child patient whose gender, age, medical history and concomitant medications were not reported, received a dose of DAPTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. Administered extra dose of DAPTACEL to child who had incomplete vaccine record. Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 March 2014. A patient had received an intramuscular dose of YF-Vax on an unspecified date. No adverse events were reported. List of documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Headache, Malaise
Clinical narrative: Case number PHHY2013US122311, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 497409) web site on 15 Oct 2013. The report refers to a 38-year-old female patient. Her medical history included drug allergy to BACTRIM, SOMA, melatonin and abnormal response to PAXIL and PROZAC, cerebral palsy and endometriosis. Concomitant drugs included ZOLOFT, LOSEASONIQUE and baclofen. On an unknown date in 2009, the patient received H1N1 (manufacturer and batch number: not reported, so conservatively coded as Pandemic Influenza vaccine INN). On an unknown date, after vaccination she experienced headaches and general weakness with malaise. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unknown number of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of ZOSTAVAX (dose, route, lot numbers and expiration dates were not provided), that underwent a temperature excursion, were administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On 05-AUG-2012, the patient was vaccinated with a first dose of GARDASIL, (route, lot number and expiration date were not provided). It was reported that in August 2013, the patient received a second dose of GARDSAIL, (route, lot number and expiration date were not provided. Additional information is not expected since physician would not like to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unknown number of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of PROQUAD (Merck) (dose, route, lot numbers and expiration dates were not provided), that underwent a temperature excursion, were administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Neuralgia
Clinical narrative: This spontaneous report was received from a male consumer in his 80's years of age concerning himself. The patient's medical history included prostate cancer in approximately 2004 (reported as 10 years ago), the patient had no drug reaction or allergies. On an unspecified date in approximately 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (manufacturer unknown), (strength, dose, route, anatomical location, lot number and expiration date were not reported) in the physician's office, the patient was not able to identify if the vaccine was ZOSTAVAX or another vaccine. Concomitant therapies included steroids unspecified and tramadol hydrochloride. On an unknown date soon after the patient developed a case of shingles from which he was still experiencing nerve pain. The patient seek medical attention through office visit, the patient was given gabapentin as treatment for the event. Quarterly unspecified lab test were performed. No further information was provided. The outcome of shingles and nerve pain was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: YF
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27-Aug-2013. The case was received on 21-Mar-2014. This is an invalid case as individual patient identifiers are not reported. The patient had received unstable YF vaccine. This one gave a dose of YF vaccine 2 weeks post MMR. Now she wants to give another dose of YF vaccine much earlier than the 28 days. According to the CDC if the 2 live vaccines are not administered the same day there is a 28 day waiting pd. This is in the CDC yellow book and the gen rec immuniz. Administration of a live-virus vaccine stimulates not only specific immune responses but also non-specific responses, such as increased levels and activity of interferon. This interferon can impair responsiveness to another live virus vaccine if given before the interferon settles down. So, wait at least 28 days between live virus vaccines. If injectable or nasally administered live vaccines are separated by <4 weeks, the second vaccine administered should not be counted as a valid dose and should be repeated. The repeat dose should not be administered greater than or equal to 4 weeks after the last invalid dose. I do not have anything from CDC advocating 4 days earlier. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Blood test normal, Fatigue, Liver function test, Malaise, Pain
Clinical narrative: Initial report received on 06 December 2013 from consumer. A 25 year old female patient whose medical history included Addison's disease and celiac disease within the past year and concomitant medication was hydrocortisone 20 mg, received a dose of YF Vaccine (route, lot number, expiration date and site of vaccination was not reported) on an unspecified date. She reported that began to have moderately severe aches, malaise, fatigue and felt like she had fever; temp was taken several times in the evening, and fever was not documented. She has had normal LFTs twice, other normal blood work. Event were recovering at the time of report. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia
Clinical narrative: Initial report received on 06 December 2013 from consumer. A 25 year old female patient whose medical history included Addison's disease and celiac disease within the past year and concomitant medication was hydrocortisone 20 mg, received a dose of YF Vaccine (route, lot number, expiration date and site of vaccination was not reported) on an unspecified date. She reported that began to have moderately severe aches, malaise, fatigue and felt like she had fever; temp was taken several times in the evening, and fever was not documented. She has had normal LFTs twice, other normal blood work. Event were recovering at the time of report. List of documents held by sender: none.
Age: 10.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 November 2013. A 10-year-old patient (gender was not reported) received a dose of DAPTACEL. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous repot as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 22-DEC-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and lot number were not provided). The expiration date was reported as 26-SEP-2014. Additional information is not expected since reporter would not like to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unknown number of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of (Oka/Merck) VARIVAX (dose, route, lot numbers and expiration dates were not provided), that underwent a temperature excursion, were administered to an unspecified amount of patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (strength and lot # were not reported) which had been exposed to temperatures outside of recommended condition. No adverse events were reported. Additional information has been requested.