chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 29 year old female patient. On 23-AUG-2013, the patient was vaccinated with dose 2 of VARIVAX (Merck) lot# H020250, expiry: 06-NOV-2014 (reported as 18-NOV-2014) 0.5 ml, subcutaneously. On 31-AUG-2013, the patient experienced varicella-like rash. The lesions are itchy and are located on bilateral hands, chest, and between her thighs. The rash was improving without requiring medical treatment. No treatment was received. Patient sought medical attention-office visit. No laboratory tests were performed. The nurse practitioner adds that the patient did not experience adverse symptoms after administration of her first dose of VARIVAX (Merck) 0.5 ml, subcutaneously in November 2012. The therapy was not discontinued. The outcome of varicella-like rash was reported as recovering. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting.
Age: 1.51
Sex: M
Vaccine: HEPA, MMR
Symptoms: Arthralgia, Convulsion, Crying, Insomnia, Rash
Clinical narrative: Not napping, crying/ thrashing fits, suspected joint pain. Rash that I assume to be rubella began 9/9/13.
Age: 1.51
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rubella
Clinical narrative: Not napping, crying/ thrashing fits, suspected joint pain. Rash that I assume to be rubella began 9/9/13.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Redness, tender, warm to touch at injection site from deltoid to elbow. Patient also complains of mild pain. Mother has given patient Benadryl and ice pack.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Neck pain
Clinical narrative: Guillain-Barre Syndrome, paralysis, immunoglobulin treatments all but feet/stamina recovered in about 2 mo w/ therapy. Some lower neck pain, balance, still unrecovered. Feet in constant pain, can't walk as well, balance off.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paralysis, X-ray
Clinical narrative: Guillain-Barre Syndrome, paralysis, immunoglobulin treatments all but feet/stamina recovered in about 2 mo w/ therapy. Some lower neck pain, balance, still unrecovered. Feet in constant pain, can't walk as well, balance off.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Guillain-Barre Syndrome, paralysis, immunoglobulin treatments all but feet/stamina recovered in about 2 mo w/ therapy. Some lower neck pain, balance, still unrecovered. Feet in constant pain, can't walk as well, balance off.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Baseball sized raised red area at injection site- tender and warm to touch: Looks like giant hive.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Baseball sized raised red area at injection site- tender and warm to touch: Looks like giant hive.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch of upper left arm where flu injection was administered.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Anxiety, Asthenia, Blood pressure increased, Convulsion, Dizziness
Clinical narrative: Neck pain, feeling of anxiety, heart raising, increased blood pressure Dizziness, weakness, LOC, seizure. Ambulance had to be called, taken to hospital. Still has intermittent neck pain and feelings of anxiety like another seizure is going to occur.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Electrocardiogram normal, Heart rate increased, Loss of consciousness, Neck pain
Clinical narrative: Neck pain, feeling of anxiety, heart raising, increased blood pressure Dizziness, weakness, LOC, seizure. Ambulance had to be called, taken to hospital. Still has intermittent neck pain and feelings of anxiety like another seizure is going to occur.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, MNQ, RV1
Symptoms: Crying, Screaming, Somnolence
Clinical narrative: Sudden inconsolable screaming followed by extreme sleepiness, gave Tylenol.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations, Tremor
Clinical narrative: Trembling started around 2:00 PM.  When patient stood, he thought his heart pounded a little harder.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Dysgeusia
Clinical narrative: Patient described dizziness starting at 11:30 pm last night (9/9/13) and lasting throughout the night "trouble with equilibrium". He also reported an enhanced sense of taste. "No cognitive compromise whatsoever" per the patient. Today 9/10/13 the dizziness is slowly resolving itself.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 102.9, body aches, vomiting (x3).
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Oedema, Pyrexia, White blood cell count increased
Clinical narrative: Fever, edema, cellulitis in right arm, increased white blood cells 21,000.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Muscle spasms, Pain
Clinical narrative: Shot administered to left deltoid.  Muscle cramping similar to muscle fatigue in upper arms and lower legs (pain scale 1).  Severe muscle cramping of abdomen (7 on pain scale) starting in evening.  Subsided after naproxin 500mg administered and hot bath.
Sex: F
Vaccine: MMR
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: My arm was initially sore after receiving shot on 8/8/13 but a month later pain increase into top shoulder. It's hard to sleep.
Age: 37.0
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test, Rubella antibody test
Clinical narrative: This spontaneous report was received from a nurse refers to a 37 years adult female patient. The nurse reported that the patient who might have received M-M-R II (lot # unspecified), (route, dose and location unspecified) as a child. The patient underwent lab to titer for measles, mumps and rubella, which showed the patient had a negative titer for measles. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial 19400 PFU. On an unknown date, unspecified number of patients developed rashes after receiving ZOSTAVAX. The outcome of the event developed rashes was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip blister, Lip discolouration
Clinical narrative: Pt developed small blistering sore on/near lip. Pt had never had anything like this before. Sore did not resolve on it's own so after around 10 days pt began using Abreva. Began to clear - blisters started to go away. Pt stopped TX and reports that while not fully resolved, blisters are gone though some discoloration remains.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: This spontaneous report as received from nurse practitioner (N. P.) refers to a female patient of unknown age. On 04-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (Lot#, dose and route not reported). Concomitant therapy was not reported. On an unknown date the patient experienced a local reaction, two inches in diameter and erythremia around the PNEUMOVAX23 injection site. N. P. reported that there was no drainage at injection site. The patient received the vaccine at an unspecified healthcare provider's office. The patient did not sought medical attention and no treatment was given for the adverse event. The patient's outcome was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Has red spot around injection site on (LA). Pt claims the spot is getting bigger - not smaller. Does not hurt or bother her. Sometimes itchy. At ZOSTAVAX side.
Age: 1.32
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Balance disorder, Fatigue, Pyrexia
Clinical narrative: Fatigue, fever, loss of balance, 2 weeks after vaccine given.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt was given Gardasil #1 at 8:58 AM, was fine immediately after but fainted around 9:06. Pt immediately recovered and was evaluated by physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Back of R arm (at injection site) swelled up, turned red, felt warm to touch, and area felt hard. Patient also states felt feverish and had chills. Went to PCP on 9/10/13 after being referred by pharmacy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Back of R arm (at injection site) swelled up, turned red, felt warm to touch, and area felt hard. Patient also states felt feverish and had chills. Went to PCP on 9/10/13 after being referred by pharmacy.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Abnormal behaviour, Muscle twitching, Pyrexia, Skin warm, Vomiting
Clinical narrative: Twitching during daytime naps only - per mom, dazed out, slight fever (warm to touch) per mom, vomiting. No symptoms observed in office. Mom reports frequency may be decreasing.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage
Clinical narrative: Flu shot administered into left deltoid 9/7/13. Patient bled a little. Bruised immediately around injection site. Three days later bruise healing. No treatment necessary.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain
Clinical narrative: "Flu-like" symptoms at 24-48 hours. Upper left arm (deltoid) sore. Can barely lift arm. No swelling, redness, tingling or numbness. No fever, taking 2 (500 mg) acetaminophen 3 x day as needed. Applying heat. Husband doctor wrote for prednisone. Feeling better.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Antibody test, Rash generalised, Rubella antibody test
Clinical narrative: Rash starting on neck and chest, 2 days ago. Rash spread over entire body. Denies fever.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Pt. developed cellulitis after getting the vaccine. She was treated with IV antibiotic in hospital.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: After injection, patient cannot lift her left arm. It hurts when she tries to lift it. Patient went see her doctor. She might need an MRI.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was here for a M. V vaccine order was in EMR. Correct vaccines were given. But when immz record was pulled up to be printed, it was noted pt had already had those vaccines in 10-4-12. MMR-Varicella-Kinrix. Dr was advised. No adverse effect was noted.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itch and swelling on adminstration site.
Age: 63.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Constipation, Dry mouth, Intestinal obstruction
Clinical narrative: This case was received from a nurse and forwarded by Crucell, No: CVAE-049-2013. An initial report was received from a nurse on 26.Aug.2013 and concerns a 63-year-old male patient who, on 17.Aug.2013, received the first oral administration of VIVOTIF (batch no: not reported). The patient's medical history was reported as insulin-dependent diabetes and post-colorectal cancer. It was noted that on 31.Jul.2013 the patient received ZOSTAVAX. No other concomitant medications were reported. On 19.Aug.2013, following the second oral VIVOTIF administration, the patient developed a very dry mouth and slight constipation. It was noted that the patient continued with the VIVOTIF and completed the course of 4 pills. On 26.Aug.2013 the patient was admitted to hospital because he continued to have bowel blockage. No further information was available. At the date of the report, the outcome of the events was unknown. The events were considered serious (hospitalisation).
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Muscle twitching
Clinical narrative: Twitching during daytime naps only (per mom). No symptoms in office. Mom reports frequency maybe decreasing.
Age: 1.32
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Measles post vaccine, Oral mucosal erythema, Rash generalised, Rash maculo-papular
Clinical narrative: Patient presented with maculopapular rash over most of body and redness in mouth 14 days after receiving vaccinations - Diagnosed with uncomplicated measles.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Breast pain, Burning sensation, Herpes zoster, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from an approximately 63 year old female patient without any pertinent medical history or drug reactions/allergies. About seven years ago, in 2006 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant therapies included LYRICA. About six years after getting the vaccine of ZOSTAVAX, in approximately 2012 the patient was diagnosed with shingles after receiving the ZOSTAVAX vaccine. The patient experienced pain and lesinos on the right side of her buttock. The patient stated, "Within four to five weeks, the lesions on buttock were gone". Three weeks after that episode, the patient developed a burning, stabbing pain in the fold of her left breast. Physician told her it was post-herpetic neuralgia (PHN) from having the shingles. The patient had visited many physicians (names not provided) and had tried many pain medicaitons (VALTREX and prednisone mentioned but others not specified) for relief but still continued to have pain. There were no lesions present at this time. There was Magnetic resonance imaging (MRI) and bloodwork performed without results. At the time of reporting, the patient had not recovered from adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Skin lesion
Clinical narrative: This spontaneous report as received from an approximately 63 year old female patient without any pertinent medical history or drug reactions/allergies. About seven years ago, in 2006 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant therapies included LYRICA. About six years after getting the vaccine of ZOSTAVAX, in approximately 2012 the patient was diagnosed with shingles after receiving the ZOSTAVAX vaccine. The patient experienced pain and lesinos on the right side of her buttock. The patient stated, "Within four to five weeks, the lesions on buttock were gone". Three weeks after that episode, the patient developed a burning, stabbing pain in the fold of her left breast. Physician told her it was post-herpetic neuralgia (PHN) from having the shingles. The patient had visited many physicians (names not provided) and had tried many pain medicaitons (VALTREX and prednisone mentioned but others not specified) for relief but still continued to have pain. There were no lesions present at this time. There was Magnetic resonance imaging (MRI) and bloodwork performed without results. At the time of reporting, the patient had not recovered from adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No medical history or drug reactions/allergies were reported. On 28-SEP-2012, the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not provided) and on 30-AUG-2013, the patient received second dose of GARDASIL (lot#, dose and route not provided). The patient did not get the third dose. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: This spontaneous report as received from a 48 year old female patient with none of pertinent medical history and none of drug reactions/allergies. On 04-SEP-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (strength, dose and lot # were not provided) and FLUVIRIN. The patient experienced fever and couldn't lift arm after receiving the second dose of PNEUMOVAX23 and FLUVIRIN. The patient was given ALEVE (dosage unspecified) and TYLENOL (dosage unspecified) for the events. None lab diagnostics studies performed. No sought medical attention. The patient did not plan to get any future doses of PNEUMOVAX23. The outcome of events was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients. As unknown number of patients may have received improperly stored GARDASIL (strength, dose and lot # were not provided) RECOMBIVAX HB (strength, dose and lot # were not provided) and VAQTA (strength, dose and lot # were not provided) since 20-JUL-2013 to present (05-SEP-2013), (exact date of administration unspecified). No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4, PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route and frequency were not reported). Other suspect therapies included GARDASIL and PEDVAXHIB. On an unknown date, an improperly stored PNEUMOVAX23, GARDASIL, and PEDVAXHIB that was exposed to a temperature of 33F for an unspecified amount of time had been administered. PNEUMOVAX23, GARDASIL, and PEDVAXHIB had been stored at 34F for "years" because her clinic was under the impression by the Vaccines for Children Program (VFC) that 34F was proper storage range for the PNEUMOVAX23, GARDASIL, and PEDVAXHIB. The nurse stated that "other" clinics in her area were also under the impression that 34F is proper storage range for "refrigerated vaccines". No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Antibody test negative, Hepatitis viral test negative, Vaccination failure
Clinical narrative: This spontaneous report was received from a female registered nurse of unknown age refers to herself. Nurse stated that on unknown dates she had received three doses in a series of an unspecified Hepatitis vaccine; unspecified if it was hepatitis A or B, unspecified as to the manufacturer of the vaccine. Cannot rule out VAQTA or RECOMBIVAX HB. No administration route or lot # were reported. Nurse states that the "series of unspecified hepatitis vaccines" were administered over 3 years ago on unspecified dates. Titers were drawn as evidence of immunity after the administration of the vaccine series and the titers were negative on an unspecified date. Nurse felt this was vaccine failure. Outcome of events was unknown.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, FLUX, HIBV, PPV, RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Local reaction
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female subject who was vaccinated with ROTARIX. Concurrent vaccination included Hib vaccine; manufacturer unspecified; unknown; right anterior thigh given on 8 August 2012; DTaP/IPV-HepB; GlaxoSmithKline; unknown given on 8 August 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 8 August 2012. On August 8 2012 at 11:00 the subject received 1st dose of ROTARIX (1 ml, intramuscular right thigh) and experienced inappropriate route of vaccination. The subject received ROTARIX intramuscularly instead of orally as indicated. The healthcare professional also reported that another 2-month-old baby had received ROTARIX intramuscularly and experienced inappropriate route of vaccination. See case id A0989008A for more details on this subject. On 09 August 2012, follow-up was received from a consumer reporter (the mother of the subject). She reported that the subject (her daughter) had been given rotavirus (intramuscularly instead of orally on 08 August 2012. The mother had contact the CDC and the prescribing physician. At the time of this report, the subject's only local reaction since administration the day before, was a pinpoint red dot at injection site. The mother also reported that the subject received 1st dose of flu vaccine (details unknown) as a concurrent vaccine on 08 August 2012.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Sudden hearing loss
Clinical narrative: Suddenly unable to hear from right ear.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Speech disorder, Trismus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 years old male patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient had presented to the emergency room at her facility with "lock jaw and could not talk." The patient had not been admitted to the hospital. The pharmacist noted that the patient's mother stated that "the only thing that was different, was that he had been administered GARDASIL. It was unspecified how many doses of GARDASIL the patient had been administered. The reporter considered that the patient cannot talk as disability. The outcome of lock jaw and cannot talk was reported as not recovered/not resolved. The relationship between the GARDASIL and the events was not reported. Follow up information has been received concerning the 16 year, male student patient. No medical history or drug allergies/reactions were reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On 18-AUG-2013, the patient experienced lock jaw and rash that required emergency room/doctor visit. At the time of the report, the outcome of lock jaw and rash was unknown. Causality between the events and GARDASIL was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash, Speech disorder, Trismus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 years old male patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient had presented to the emergency room at her facility with "lock jaw and could not talk." The patient had not been admitted to the hospital. The pharmacist noted that the patient's mother stated that "the only thing that was different, was that he had been administered GARDASIL. It was unspecified how many doses of GARDASIL the patient had been administered. The reporter considered that the patient cannot talk as disability. The outcome of lock jaw and cannot talk was reported as not recovered/not resolved. The relationship between the GARDASIL and the events was not reported. Follow up information has been received concerning the 16 year, male student patient. No medical history or drug allergies/reactions were reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On 18-AUG-2013, the patient experienced lock jaw and rash that required emergency room/doctor visit. At the time of the report, the outcome of lock jaw and rash was unknown. Causality between the events and GARDASIL was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Malaise
Clinical narrative: I had FLUVIRIN and ZOSTAVAX on Aug. 29th. ZOSTAVAX swelled very red and sore then on 9/1 I suffered a seizure (tonic/clonic). Now I have to take Keppra.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Laboratory test abnormal, Vaccination complication
Clinical narrative: I had FLUVIRIN and ZOSTAVAX on Aug. 29th. ZOSTAVAX swelled very red and sore then on 9/1 I suffered a seizure (tonic/clonic). Now I have to take Keppra.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Grand mal convulsion, Injection site erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: I had FLUVIRIN and ZOSTAVAX on Aug. 29th. ZOSTAVAX swelled very red and sore then on 9/1 I suffered a seizure (tonic/clonic). Now I have to take Keppra.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Scan brain
Clinical narrative: I had FLUVIRIN and ZOSTAVAX on Aug. 29th. ZOSTAVAX swelled very red and sore then on 9/1 I suffered a seizure (tonic/clonic). Now I have to take Keppra.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anger, Disorientation, Somnambulism
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 14 year old daughter with allergies to dogs and dust and no drug reactions/allergies. On 26-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration, route, dose frequency unspecified). No concomitant medication. On 26-AUG-2013 at first she had pain at the injection site but that went away. On 27-AUG-2013 (the next day) the patient was demonstrating behavior that was unusual for her. She was angry and frustrated and throwing things around. By the afternoon the reporter thought that her daughter may be hot and they went to a hotel to stay where it was cooler. The daughter had difficulty knowing how to open the car door and how to fasten the seat belt. At the hotel she was asking her mother questions that made no sense. The patient sat and stared and didn't have much to say. On 28-AUG-2013 (the next day) when they were at home the daughter reported to her mother that she had no recall of going to the hotel. The mother thought the daughter had a "complex partial seizure" as a result of the GARDASIL. No lab diagnostics studies performed. The patient sought medical attention via called the physician assistant. The patient would be getting blood work on 29-AUG-2013 ("today"). Therapy with GARDASIL was discontinued. The patient was recovered on 27-AUG-2013. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Activities of daily living impaired, Anger, Frustration, Injection site pain
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 14 year old daughter with allergies to dogs and dust and no drug reactions/allergies. On 26-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration, route, dose frequency unspecified). No concomitant medication. On 26-AUG-2013 at first she had pain at the injection site but that went away. On 27-AUG-2013 (the next day) the patient was demonstrating behavior that was unusual for her. She was angry and frustrated and throwing things around. By the afternoon the reporter thought that her daughter may be hot and they went to a hotel to stay where it was cooler. The daughter had difficulty knowing how to open the car door and how to fasten the seat belt. At the hotel she was asking her mother questions that made no sense. The patient sat and stared and didn't have much to say. On 28-AUG-2013 (the next day) when they were at home the daughter reported to her mother that she had no recall of going to the hotel. The mother thought the daughter had a "complex partial seizure" as a result of the GARDASIL. No lab diagnostics studies performed. The patient sought medical attention via called the physician assistant. The patient would be getting blood work on 29-AUG-2013 ("today"). Therapy with GARDASIL was discontinued. The patient was recovered on 27-AUG-2013. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Staring
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 14 year old daughter with allergies to dogs and dust and no drug reactions/allergies. On 26-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration, route, dose frequency unspecified). No concomitant medication. On 26-AUG-2013 at first she had pain at the injection site but that went away. On 27-AUG-2013 (the next day) the patient was demonstrating behavior that was unusual for her. She was angry and frustrated and throwing things around. By the afternoon the reporter thought that her daughter may be hot and they went to a hotel to stay where it was cooler. The daughter had difficulty knowing how to open the car door and how to fasten the seat belt. At the hotel she was asking her mother questions that made no sense. The patient sat and stared and didn't have much to say. On 28-AUG-2013 (the next day) when they were at home the daughter reported to her mother that she had no recall of going to the hotel. The mother thought the daughter had a "complex partial seizure" as a result of the GARDASIL. No lab diagnostics studies performed. The patient sought medical attention via called the physician assistant. The patient would be getting blood work on 29-AUG-2013 ("today"). Therapy with GARDASIL was discontinued. The patient was recovered on 27-AUG-2013. This is one of several reports from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Swollen arm at injection site.  Large Red Lump.  103+ fever.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Congestion, body aches, sore throat, cough, headache which is gotten progressively worse over the past week since receiving the vaccine that is required by employer.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: NAUSEA, BODY ACHES AND PAINS, FATIGUE.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, pain, swelling, and warm to touch of right upper arm. Patient also complaint of itching of right upper arm, states symptoms started on 8/26/13. Swelling and redness approx. 20 mm, small amount of swelling of left upper arm.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: 9/4 Redness, swelling, hot feeling at site. No evidence of fever. Arm was swollen according to pt. 9/6 Pt states swelling down but today swelling worse. Pt started on cephalexin 500 mg BID for cellulitis of the arm.  Right arm (Zostavax site).
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site rash, Injection site warmth, Nausea
Clinical narrative: Patient stated he had flu and PNEUMOVAX on 9/6/13 and they were both put in right arm side by side. He states he was nauseous, and had diarrhea all weekend. Also has a red rash by the site and redness the size of a fist some warmth to touch. No fever. Instructed to draw line on edge and to call back if redness goes outside line.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Axillary pain, Injection site discolouration, Injection site reaction, Scab, Spinal pain
Clinical narrative: 25 Aug when he was 2 weeks post smallpox immunization was for concern regarding the (expected) black crusting at the site. He had significant pain 6/10 in left axilla and spine. No headache, fever, chest pain, SOB. Person confirmed that on 30 Aug the patient was much better with only axillary pain 2/10.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dysarthria, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a consumer on 30 August 2013. A 4-year-old male child had received the following vaccinations on 28 August 2013: a dose 5 left deltoid intramuscular injection of DAPTACEL (lot number C4345AA) and a dose 4 left arm subcutaneous injection of IPOL (lot number J1406). On 29 August 2013, 1 day later, the patient presented with left upper arm red, swollen, hard, warm to touch, and slurring words and lethargic. the patient had no fever and no tingling. The patient took prednisolone (15mg/5ml) 15 mg daily for three days. The patient also took BENADRYL twice daily. The patient had a history of laryngomalacia. The patient had no illness at time of vaccination. The patient had no diagnostic or lab testing. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy
Clinical narrative: Initial report was received from a consumer on 30 August 2013. A 4-year-old male child had received the following vaccinations on 28 August 2013: a dose 5 left deltoid intramuscular injection of DAPTACEL (lot number C4345AA) and a dose 4 left arm subcutaneous injection of IPOL (lot number J1406). On 29 August 2013, 1 day later, the patient presented with left upper arm red, swollen, hard, warm to touch, and slurring words and lethargic. the patient had no fever and no tingling. The patient took prednisolone (15mg/5ml) 15 mg daily for three days. The patient also took BENADRYL twice daily. The patient had a history of laryngomalacia. The patient had no illness at time of vaccination. The patient had no diagnostic or lab testing. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Malaise
Clinical narrative: Initial report was received from a healthcare professional on 29 August 2013. A 49-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL (lot number C4432AB) on 27 August 2013 at 14:50 PM. The patient had Td vaccine in 1994. This was the first time with Tdap. The patient left the clinic without symptoms. The patient did not feel well "during the evening" (onset date reported as 28 August 2013). 911 was called and the patient was taken to the emergency room (ER). The ER reported anaphylaxis and gave the patient epinephrine. The patient was discharged and went home and was doing well. The patient had no illness at the time of vaccination but did have a toe injury. The patient had no allergies and no health problems. The reporter was getting information third hand. She had no further description of the symptoms. The patient's outcome was recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial report was received 28 August 2013 from a health care professional. A 60-year-old female patient had received an intramuscular right deltoid injection of ADACEL, lot number U4655AA on 24 August 2013, and two days later, the patient returned to the office to be evaluated for "cellulitis" at the vaccine injection site. She received corrective treatment with Cefotaxime. At the time of the report, outcome was unknown. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Haemorrhage, Loss of consciousness, Pallor, Seizure like phenomena
Clinical narrative: Pt in for required vaccine and PPD. Gave all vaccines. Brought pt and family out front to give copy of record. Noted PPD site was bleeding a little. Had pt come back to exam room to clean off site. Pt stated that he felt "dizzy" then pt collapsed. RN caught pt and lowered to floor. Pt then had "seizure-like" movements. Pt. regained consciousness and was placed on exam table were he passed out again and had seizure like movements. Pt was very pale called EMS squad to have patient evaluated.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt in for required vaccine and PPD. Gave all vaccines. Brought pt and family out front to give copy of record. Noted PPD site was bleeding a little. Had pt come back to exam room to clean off site. Pt stated that he felt "dizzy" then pt collapsed. RN caught pt and lowered to floor. Pt then had "seizure-like" movements. Pt. regained consciousness and was placed on exam table were he passed out again and had seizure like movements. Pt was very pale called EMS squad to have patient evaluated.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from an unknown age female consumer refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route, indication not reported). On an unknown date the patient experienced pain and swelling at the injection site. The outcome of the events was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt. came in Saturday afternoon 9/7/13, presented with redness, soreness, hardness around injection site. RPh on duty advised ice, 20 min on, 20 min off. Then pt. called again and was told to use heat 20 min on , 20 min off. Pt. was contacted on Sun 9/8 bu RPh and she reported that her arm was "better" but still a little bit red and hard. Pt. came into pharmacy Mon 9/9/13 and shoed RPh her arm. She said it is better (still a bit red and hard).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Swelling and tenderness/warmth (8x8cm) about 2 inches below injection site Lt deltoid.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: Patient developed "bumps" that itched on her hand. These continued to increase in numbers and developed over her whole body. They itch and some are pus-like filled, others are hard/solid she has been taking BENADRYL as she suspected an allergic reaction.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Rash generalised, Rash vesicular
Clinical narrative: Patient developed "bumps" that itched on her hand. These continued to increase in numbers and developed over her whole body. They itch and some are pus-like filled, others are hard/solid she has been taking BENADRYL as she suspected an allergic reaction.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Given 8/29/13. Pain, swelling and redness at site. Occurred later in evening of same day of vaccination. Patient advised to take BENADRYL and apply cool pack to area. Still sore and red on 9/1/13.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red and swollen below administration site(s). Dx cellulitis w/fever >101 degrees. Rx Cephalexin and SMZ/TMP.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Local swelling, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: Night of shot - flet like flu (Friday) went to football game. Sat - sick to stomach, swelling of arm, pain in arm at vaccine site. Sunday - Swelling moves up neck and glands, called local physician told to take Benadryl 50 mg - started Benadryl Monday afternoon.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Patient stated hives, redness, hot around injection site. Went to Dr. he thought she might have infection. Got antibiotic. Got flu shot same night-no problem.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pain, Pyrexia, Rash generalised
Clinical narrative: Had the shot Saturday 6:00 pm 9/7/13. Had fever of 99.5 and 99.7 with a flush face some redness on Sunday 9/8/13 Monday a little redness on face but body and arms ached all day woke up Tuesday 9/10/11 with a rash on arms, shoulders, legs no fever woke up today Wednesday 9/11/13 with rash all over, chest, back, arms, legs, no fever. Went to doctor at 9:30 AM this morning. They told me to take ZYRTEC and see tomorrow how rash is.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Local swelling, Rash, Skin warm
Clinical narrative: Large bumps. Warm. Swelling. Hot to touch. In right arm only.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Rash
Clinical narrative: Pt developed rash and redness speading approx 5 inch - also said she developed 2 hard nodule.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. The patient was vaccinated with GARDASIL, intramuscularly (lot# and dose unspecified) on 08-MAY-2013, 06-JUN-2013 and on 29-AUG-2013. No known adverse effects. It was unspecified whether the patient sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 29-AUG-2013 the patient was vaccinated with a 0.5 ml dose of expired PNEUMOVAX23 (lot # 1071AA, expired on 20-MAR-2013) (route not reported). No adverse effect reported. This is one of several reports received from the same source. It was linked to MARRS#1309USA001808. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 28-AUG-2013 the patient was vaccinated with a 0.5 ml dose of expired PNEUMOVAX23 (lot # 1071AA, expired on 20-MAR-2013) (route not reported). No adverse effect reported. This is one of several reports received from the same source. It was linked to MARRS#1309USA004457. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (lot #, dose, route not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot#, expiration date not reported). The patient experienced syncope about 12 hours later. The patient did not seek medical attention. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The healthcare worker reports that an improperly stored RECOMBIVAX HB (lot #, expiry not reported) that was exposed to a temperature of 27F for 1 hour may have been administered. The healthcare worker did not have patient or physician details available at the time of the call since it was unknown to her whether or not the vaccine had been administered. No adverse effect reported. The healthcare worker also reported that the vaccines were stored as low as 33 F for up to 225 hours. This excursion was supported so there was no adverse event. This is 1 of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site warmth
Clinical narrative: 5.5 cm x 5.5 cm of induration/erythema site warm to the touch.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The healthcare worker reports that an improperly stored VAQTA (lot#, expiry not reported) that was exposed to a temperature of 27F for 1 hour may have been administered. The healthcare worker did not have patient or physician details available at the time of the call since it was unknown to her whether or not the vaccine had been administered. No adverse effect reported. The healthcare worker also reported that the vaccines were stored as low as 33 F for up to 225 hours. This excursion was supported so there was no adverse event. This is 1 of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: 2nd day after vaccination patient experienced pain, rash and itching approximately 2 inches around vaccination site and appears to be spreading. Treated w/Ibuprofen but symptoms persisted.