chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Malaise, Musculoskeletal stiffness, Nausea
Clinical narrative: Approximately 2 1/2 - 3 hours following vaccination of MCV4 patient stated he noted neck stiffness, dizziness, sore throat, nausea without vomiting, diaphoretic, generalized malaise.  Patient states he felt like he had fever but did not check temperature.  Patient reported he slept on an off the following day with symptoms continued.  Approximately 48 hours post vaccination patient stated most symptoms had subsided.  Stiff neck with night sweats remained 6 days post vaccination otherwise must better. No treatment reported by patient.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Night sweats, Oropharyngeal pain, Pyrexia
Clinical narrative: Approximately 2 1/2 - 3 hours following vaccination of MCV4 patient stated he noted neck stiffness, dizziness, sore throat, nausea without vomiting, diaphoretic, generalized malaise.  Patient states he felt like he had fever but did not check temperature.  Patient reported he slept on an off the following day with symptoms continued.  Approximately 48 hours post vaccination patient stated most symptoms had subsided.  Stiff neck with night sweats remained 6 days post vaccination otherwise must better. No treatment reported by patient.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal dreams, Cataplexy, Hallucination, auditory, Hallucination, visual, Muscular weakness
Clinical narrative: Shortly after my last vaccine I began experiencing muscle weakness in my face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). Also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy has recently been found to be an autoimmune disease sometimes caused by a virus or vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Narcolepsy, Sleep paralysis, Somnolence, Syncope
Clinical narrative: Shortly after my last vaccine I began experiencing muscle weakness in my face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). Also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy has recently been found to be an autoimmune disease sometimes caused by a virus or vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal dreams, Cataplexy, Condition aggravated, Hallucination, auditory, Hallucination, visual
Clinical narrative: Shortly after my last vaccine I began experiencing muscle weakness in my face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). Also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy has recently been found to be an autoimmune disease sometimes caused by a virus or vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Narcolepsy, Sleep paralysis, Somnolence, Syncope
Clinical narrative: Shortly after my last vaccine I began experiencing muscle weakness in my face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). Also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy has recently been found to be an autoimmune disease sometimes caused by a virus or vaccine.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: No adverse events noted per parent.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abnormal behaviour, Apparent life threatening event, Blood gases, Chest X-ray normal, Crying
Clinical narrative: Mother called office @2:45 pm. Mom was changing diaper after nap, child was very pale and blue around nose and lips.  Baby was breathing, but "out of it" per mom.  Did pink up with stimulation & cry - episode lasted 1 - 2 minutes. Mom called primary care physician office and was sent to Emergency room. After evaluation at emergency room admitted to Hospital, admitting diagnosis apparent life threatening event.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Cyanosis, Full blood count, Laboratory test normal, Metabolic function test, Pallor
Clinical narrative: Mother called office @2:45 pm. Mom was changing diaper after nap, child was very pale and blue around nose and lips.  Baby was breathing, but "out of it" per mom.  Did pink up with stimulation & cry - episode lasted 1 - 2 minutes. Mom called primary care physician office and was sent to Emergency room. After evaluation at emergency room admitted to Hospital, admitting diagnosis apparent life threatening event.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: ROUND RED, WARM SPOT SIZE OF HALF DOLLAR AT INJECTION SITE. PERSISTED FOR 6 DAYS.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Local rash at injection site to pneumonia vaccine.
Age: 62.0
Sex: M
Vaccine: HEPAB
Symptoms: Bone pain, Cardiac flutter, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient stated he had heart flutters, nausea and vomiting, diarrhea, and "aching in bones."
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Headache, Syncope
Clinical narrative: Patient was administered vaccine and had no reaction at time of administration, but upon leaving the office, fainted and hit his head on the waiting room floor. The doctor was summoned and checked him over and took BP. Brought back to exam room by wheelchair, observed, administered ibuprofen for head pain, but recovered fully and allowed to leave the office.
Age: 0.12
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Continuous crying for over 4 hours.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Lumbar puncture abnormal, Myelitis transverse, Neurological examination abnormal, Paralysis
Clinical narrative: Became paralyzed from waist down. It came on very suddenly. I was subsequently diagnosed with transverse myelitis.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Movement disorder, Multiple sclerosis
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of difficulty moving arm in a 33-year-old male subject who was vaccinated with FLUARIX 2011-12 season (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and falciform anemia. Concurrent medical included COPAXONE. On 8 March 2012 at 09:34 the subject experienced unspecified dose of FLUARIX 2011-12 season in an unknown arm. On 16 March 2012, 8 days after vaccination with FLUARIX 2011-12 season, the subject experienced difficulty moving arms and legs and fatigue. It was reported that the symptoms mimicked the symptoms of multiple sclerosis. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events was unspecified. The lot number was reported as AFWA614BA from the reporter; however; however, based on GlaxoSmithKline sales data review, the lot number was corrected to AFLUA614BA.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Approximately 2 hrs after immunization, pt began with itching of his neck.
Age: 0.28
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Grunting, Pain, Pallor, Skin warm
Clinical narrative: About 5 hours (340) after receiving immunizations mom states child became very pale and was making "grunting noises." Mom states child seemed bothered when she moved his legs. Mom did not check temp but stated child "felt a little warm". Mom states after about 20 min child "seemed more himself". During that time mom put child in a cooler environment. She gave water & TYLENOL at 420pm.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: - Pt complains of severe joint/muscle pain all over body. Says can not get out of bed.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site haematoma, Mood altered, Somnolence
Clinical narrative: Per note at Office visit on 5/24/12 at 4:40 PM- Mom said cried for an hour, could not be consoled. No known fever. Noticed redness of both legs extending thigh to foot, red & bruised appearing (3PM). Slept a lot of the day but did feed a couple of times. Legs much less red at office visit - no swelling of extremities. Bilat exterior legs & abdomen are somewhat pinker than surrounding skin and the intensity of pink tone varied during the exam - Brisk capillary refill. To use APAP UAD PRN for fussiness, cool compresses to legs. If inconsolable or other concerns go to ER. To call tomorrow if further problems. I tried calling mom & also sent postcard to obtain info on recovery. No return call. 6-4-12 at 2:10 pm. Mom returned call and said pinkness dissipated that evening and except for being somewhat moody the rest of the week he was fine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Mother called 225 pm. States child has rash. Called and left message (urgent for mom to bring child to office at 228/pm. ? Allergy to vaccine. Called mom 330/pm. Stated child broke out in hives. Mother gave BENADRYL. VIS sheets were given prior to vaccine for reading. Asked mother if allergic to yeast. Mom said yes. Mom to continue BENADRYL over next 24 hours. See sooner if worsens per nurse in am if needed 5/30/12.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Allergy to vaccine, Rash, Urticaria
Clinical narrative: Mother called 225 pm. States child has rash. Called and left message (urgent for mom to bring child to office at 228/pm. ? Allergy to vaccine. Called mom 330/pm. Stated child broke out in hives. Mother gave BENADRYL. VIS sheets were given prior to vaccine for reading. Asked mother if allergic to yeast. Mom said yes. Mom to continue BENADRYL over next 24 hours. See sooner if worsens per nurse in am if needed 5/30/12.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Face injury, Fall, Haemorrhage
Clinical narrative: Told Mom and patient were getting MENACTRA and GARDASIL shots. After patients get vaccinations had to stay in room because could get dizzy from GARDASIL. After GARDASIL was administered, leaned table so patient could lay down. Patient was sitting on exam table when I turned around for 1 second to grab my notepad. Patient fell face forward on floor and was bleeding. She had a seizure for less than a minute.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Generalised erythema, Pruritus, Rash generalised, Vaccination complication
Clinical narrative: Pt called and reported experiencing ADR to the vaccine he received on 5/4/12. Pt reported redness all over his body, all body rash, itchy. Pt denied blisters fever, pain.
Age: 5.0
Sex: F
Vaccine: IPV, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to upper arm per Dr.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Oedema peripheral, Rash, Rash pustular
Clinical narrative: Large rash, cellulitis, swollen arm, pustules.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dry mouth, Paraesthesia
Clinical narrative: 510 pm dizzy after vaccine was given, arm felt like its asleep, dry mouth water was given BP taken at 5:30 much improved.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dry mouth, Hypoaesthesia
Clinical narrative: 510 pm dizzy after vaccine was given, arm felt like its asleep, dry mouth water was given BP taken at 5:30 much improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Rash macular
Clinical narrative: Patient had swelling of (L) leg that started 24-30 hours after the injections were given. Reports "blotchy" in appearance on leg - reports swelling of (L) leg twice the size of (R) leg. "Unable to see knee cap bones." Swelling reported knee to hip. Went to urgent care - evening of 5/22/12.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Fatigue, Headache, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Swelling & pain at injection site ((L) arm), difficulty moving (L) arm, malaise, myalgia, fatigue, dyspnea, headache, flu-like symptoms, mild fever (100 degrees F).
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Malaise, Myalgia, Pyrexia
Clinical narrative: Swelling & pain at injection site ((L) arm), difficulty moving (L) arm, malaise, myalgia, fatigue, dyspnea, headache, flu-like symptoms, mild fever (100 degrees F).
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site swelling, Irritability, Pain, Screaming
Clinical narrative: Child received vaccines at 0938. Fell asleep until 12:00. Woke, fed, then began crying/screaming uncontrollably. Mom gave dose of TYLENOL at 1230 & checked babies legs. (Rt) leg swollen. Child screams when moving it. 1430 mom states TYLENOL has not helped. Advised mom to try ice pack & return to clinic if not better in 4-6 hrs. 6/11/12 1445 Child's leg remained swollen throughout weekend & child remained fussy, per mom Swelling resolved in 48 hours & child returned to normal disposition. No fever noted throughout course of reaction.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Nausea, Pain
Clinical narrative: Abdominal pain, right mid and upper abdominal pain and right mid and upper back pain, nausea, minimal vomiting, body aches.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Abdominal pain, right mid and upper abdominal pain and right mid and upper back pain, nausea, minimal vomiting, body aches.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: VAR vaccine (R) arm, local reaction 15cmx45cm Red, Denies pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt given Tdap 6-4-12 & mom called 6-7-12 with c/o upper (L) arm very red & swelling & now redness spreading downward. Pt came in to have arm looked at by Dr..
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: 6/8/12 received immunizations. 6/10/12 developed fever, & hives on hands & feet,. Mom gave child BENADRYL. 6/11/12 called health dept. Symptoms gone 6/10/12.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Golf ball size swelling & redness at injection site - no fever - itchy.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Measles, Measles antibody positive, Polymerase chain reaction
Clinical narrative: Confirmed case of measles, H2d classic clinical presentation followed by confirmatory buccal swab. PCR confirmed vaccine related, not wild type.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dysphagia, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: 06/03/2012 mild other. On the evening of 6/3/2012, client had nausea and a headache. On 6/4 the headache continued and he had a low grade fever of 99, sore throat, & complained that it hurt to swallow. Saw doctor on 6/5 for strep throat test that was (-) initially, but got official lab results on 6/6/12.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Streptococcus test negative
Clinical narrative: 06/03/2012 mild other. On the evening of 6/3/2012, client had nausea and a headache. On 6/4 the headache continued and he had a low grade fever of 99, sore throat, & complained that it hurt to swallow. Saw doctor on 6/5 for strep throat test that was (-) initially, but got official lab results on 6/6/12.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: 3 days after administration of ADACEL pt felt warm & soreness at site at 1 cm x 3/4 cm of injection Pt to apply ice/BENADRYL at hs prn.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported light-headedness on day of vaccine administration (6/8/12) and the day following administration. On the day following vaccine administration, patient developed redness at injection site which eventually progressed to a quarter-sized area with swelling/itching 3 days post-administration (6/11/12).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Arthritis, Joint swelling, Laboratory test, Limb discomfort
Clinical narrative: Legs felt silly, c/o Rt knee pain with swelling. Pt was given NAPROSYN.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: X-ray
Clinical narrative: Legs felt silly, c/o Rt knee pain with swelling. Pt was given NAPROSYN.
Age: 1.21
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Cough, Injection site rash, Nasopharyngitis
Clinical narrative: 06/02/102 Mild Other small, pinpoint size bumps near all injection sites. Mom states that client also has had a bad cold and cough.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: High fever x 2 days.
Age: 67.0
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Lipoma, Lipoma excision, Pain
Clinical narrative: Soon after receiving the flu shot I noticed a hard lump/bump about 2 1/2-3 inches below the shot site. It continued to be there & cause me pain & discomfort until I had it surgically removed in January 2012. It was diagnosed as a lipoma. Dr. has biopsy report.
Age: 67.0
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Biopsy, Discomfort, Lymphoma, Mass, Pain in extremity
Clinical narrative: Soon after receiving the flu shot I noticed a hard lump/bump about 2 1/2-3 inches below the shot site. It continued to be there & cause me pain & discomfort until I had it surgically removed in January 2012. It was diagnosed as a lipoma. Dr. has biopsy report.
Age: 67.0
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Surgery
Clinical narrative: Soon after receiving the flu shot I noticed a hard lump/bump about 2 1/2-3 inches below the shot site. It continued to be there & cause me pain & discomfort until I had it surgically removed in January 2012. It was diagnosed as a lipoma. Dr. has biopsy report.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath/ no oxygen.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Per father's report - 30 minutes after getting vaccine child had hives, facial swelling and difficulty breathing. Child had to be taken to Emergency Room, parents took child to another facility to ER so we have no visit notes to refer to.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Crying, Dyspnoea, Flank pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 22 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 10-MAY-2012 was vaccinated with the second dose of GARDASIL, intramuscularly (dose and lot number not reported). Concomitant therapy included intravenous vancomycin, ascorbic acid and multivitamins (unspecified). It was reported that, on 10-MAY-2012, the patient experienced panic like attack, with hyperventilation, sweating, trembling and uncontrolled crying that happened in the first several hours after the second dose of GARDASIL was given. It was stated that the patient had had no problems after receiving the first dose of GARDASIL. It was also reported that the patient experienced left side flank pain and lethargy that lasted for 1 week; then the patient experienced pain that went toward the gallbladder area. It was noted that the pain on the left side flank resolved (until approximately 17-MAY-2012), then the patient experienced nausea and then abdominal pain. It was stated that the patient was experiencing occasional panic like attacks, profuse sweating followed by rapid breathing, trouble catching breath and crying which occurred whenever the patient was hyperstimulated (there were a lot of people around or there was a lot going on around the patient). It was reported that the patient was in a long term care facility due to a motorcycle accident (date unknown) "in which the patient had cellulitis" and required long term antibiotic therapy. Laboratory tests included: unspecified scan, complete blood count, basic metabolic panel (dates not provided) and were all reported as "normal". At the time of the report, the patient recovered from left side flank pain and lethargy on approximately 17-MAY-2012 and did not recover from the other symptoms. Panic like attacks add the symptoms were considered disabling by the reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Hyperhidrosis, Hyperventilation, Lethargy, Metabolic function test normal
Clinical narrative: Information has been received from a registered pharmacist concerning a 22 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 10-MAY-2012 was vaccinated with the second dose of GARDASIL, intramuscularly (dose and lot number not reported). Concomitant therapy included intravenous vancomycin, ascorbic acid and multivitamins (unspecified). It was reported that, on 10-MAY-2012, the patient experienced panic like attack, with hyperventilation, sweating, trembling and uncontrolled crying that happened in the first several hours after the second dose of GARDASIL was given. It was stated that the patient had had no problems after receiving the first dose of GARDASIL. It was also reported that the patient experienced left side flank pain and lethargy that lasted for 1 week; then the patient experienced pain that went toward the gallbladder area. It was noted that the pain on the left side flank resolved (until approximately 17-MAY-2012), then the patient experienced nausea and then abdominal pain. It was stated that the patient was experiencing occasional panic like attacks, profuse sweating followed by rapid breathing, trouble catching breath and crying which occurred whenever the patient was hyperstimulated (there were a lot of people around or there was a lot going on around the patient). It was reported that the patient was in a long term care facility due to a motorcycle accident (date unknown) "in which the patient had cellulitis" and required long term antibiotic therapy. Laboratory tests included: unspecified scan, complete blood count, basic metabolic panel (dates not provided) and were all reported as "normal". At the time of the report, the patient recovered from left side flank pain and lethargy on approximately 17-MAY-2012 and did not recover from the other symptoms. Panic like attacks add the symptoms were considered disabling by the reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Panic attack, Respiratory rate increased, Scan normal, Tremor
Clinical narrative: Information has been received from a registered pharmacist concerning a 22 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 10-MAY-2012 was vaccinated with the second dose of GARDASIL, intramuscularly (dose and lot number not reported). Concomitant therapy included intravenous vancomycin, ascorbic acid and multivitamins (unspecified). It was reported that, on 10-MAY-2012, the patient experienced panic like attack, with hyperventilation, sweating, trembling and uncontrolled crying that happened in the first several hours after the second dose of GARDASIL was given. It was stated that the patient had had no problems after receiving the first dose of GARDASIL. It was also reported that the patient experienced left side flank pain and lethargy that lasted for 1 week; then the patient experienced pain that went toward the gallbladder area. It was noted that the pain on the left side flank resolved (until approximately 17-MAY-2012), then the patient experienced nausea and then abdominal pain. It was stated that the patient was experiencing occasional panic like attacks, profuse sweating followed by rapid breathing, trouble catching breath and crying which occurred whenever the patient was hyperstimulated (there were a lot of people around or there was a lot going on around the patient). It was reported that the patient was in a long term care facility due to a motorcycle accident (date unknown) "in which the patient had cellulitis" and required long term antibiotic therapy. Laboratory tests included: unspecified scan, complete blood count, basic metabolic panel (dates not provided) and were all reported as "normal". At the time of the report, the patient recovered from left side flank pain and lethargy on approximately 17-MAY-2012 and did not recover from the other symptoms. Panic like attacks add the symptoms were considered disabling by the reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Chest discomfort, Dyspnoea, Urticaria, Urticaria chronic
Clinical narrative: Information has been received from a medical assistant on behalf of a physician concerning a male patient who in approximately April 2012 (within the last two months), was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Within "a couple of days" of receiving the vaccine the patient developed disseminated (all over the body) hives. The patient was hospitalized on unspecified dates at an unspecified facility for the hives, shortness of breath and an unspecified "chest condition". On an unknown date the patient also developed 2 chronic urticaria with angioedema for 6 weeks. The patient was given 2 months of prednisone. The patient was recently seen and prednisone had helped with resolution of AE (still currently resolving). The physician was still not totally convinced the AE were from the vaccine. It was asked if there was any data on the occurrence of disseminated (all over the body) hives following ZOSTAVAX (Merck) vaccination and persisting for months. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Biopsy, Blood sodium decreased, Herpes zoster, Skin test
Clinical narrative: Information has been received from an approximately 72 year old female patient with very sensitive skin and codeine and morphine allergy who "at least 5 years ago", in approximately 2007 and in January 2011 was respectively vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. Concomitant therapy included prednisone, 5 mg tablet and PROZAC. The patient mentioned that she had received ZOSTAVAX (Merck) "at least five years ago", in approximately 2007 and had developed shingles after had the vaccine. In January 2011, the patient received ZOSTAVAX (Merck). In addition to her developing shingles she explained that "around the time" she received the vaccine she experienced a drop in her blood sodium level, to a level 17, this drop in blood sodium required hospitalization for about a week, with rehab for about 3 weeks. The patient was hospitalized at this time. Unspecified antiviral pills, unspecified ointments and fluororacil (+) mitomycin (+) vincristine sulfate were given for the patient. The patient explained that the only treatment that gave her some relief is the muscle relaxant fluorouracil (+) mitomycin (+) vincristine sulfate, which was mostly because it put her to sleep. Unspecified tests had been performed including a biopsy and an allergy patch test. At the time of the report, the patient was still suffering with severe case of shingles. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from an approximately 72 year old female patient with very sensitive skin and codeine and morphine allergy who "at least 5 years ago", in approximately 2007 and in January 2011 was respectively vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. Concomitant therapy included prednisone, 5 mg tablet and PROZAC. The patient mentioned that she had received ZOSTAVAX (Merck) "at least five years ago", in approximately 2007 and had developed shingles after had the vaccine. In January 2011, the patient received ZOSTAVAX (Merck). In addition to her developing shingles she explained that "around the time" she received the vaccine she experienced a drop in her blood sodium level, to a level 17, this drop in blood sodium required hospitalization for about a week, with rehab for about 3 weeks. The patient was hospitalized at this time. Unspecified antiviral pills, unspecified ointments and fluororacil (+) mitomycin (+) vincristine sulfate were given for the patient. The patient explained that the only treatment that gave her some relief is the muscle relaxant fluorouracil (+) mitomycin (+) vincristine sulfate, which was mostly because it put her to sleep. Unspecified tests had been performed including a biopsy and an allergy patch test. At the time of the report, the patient was still suffering with severe case of shingles. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Lobar pneumonia, Obstruction gastric
Clinical narrative: This report was received from pharmaceuticals and was assigned manufacturer report number A201200985 concerning an approximately 74 year old female patient with paroxysmal nocturnal haemoglobinuria who on an unspecified date was vaccinated with a dose of pneumococcal vaccine, polyval, (Lot #, dose and route not reported). Secondary suspect therapies included SOLIRIS 300 mg, infusion 10 mg/ml IV. Concomitant medications were not reported. On approximately 03-MAY-2012, two weeks prior to reporting, the patient was hospitalized for left lower lobe pneumonia. On 08-MAY-2012, the patient missed her SOLIRIS infusion. On 12-MAY-2012, the patient was discharged from the hospital. Treatment and outcome were not reported. Approximately in May 2012, the patient developed an infection in the arm that the vaccination was given, blockage in her stomach and pneumonia in her right lung. On 16-MAY-2012, the patient was readmitted to the hospital with the arm infection, blockage in her stomach, and pneumonia in her right lung. She was having nothing by mouth (NPO), and was treated with IV hydration and unspecified antibiotics. It was noted that SOLIRIS therapy was held by the physician until the infection resolved. At the time of the report, the patient outcome was unknown. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 64 year old female patient, with penicillin and ALEVE allergy, hypertension and asthma, with a history of chickenpox and with none illness at time of vaccination, who on 26-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670382/0218AA), 0.65ml, SC in the right deltoid. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), CARDURA, sertraline HCl, gabapentin and aspirin ("ASA"). It was reported that on 06-MAY-2012 the patient experienced herpes zoster. The patient had no recent exposure to chickenpox or herpes zoster. On 11-MAY-2012 she presented to office with rash on left arm for 1 week, very painful, extended from left hand to left shoulder. Physician noted as erythematous maculopapular rash in dermatome with distribution over lateral left arm from posterior shoulder to hand - C6C7 distribution, 2-3 areas with drying vesicles tendered to palpation. Pain scale was 7. Patient was treated with VALTREX. At the time of reporting the patient's status was in process of recovering. The reporter considered the herpes zoster was an other important medical event (required medical intervention). This is one of several reports received from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculo-papular, Tenderness
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 64 year old female patient, with penicillin and ALEVE allergy, hypertension and asthma, with a history of chickenpox and with none illness at time of vaccination, who on 26-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670382/0218AA), 0.65ml, SC in the right deltoid. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), CARDURA, sertraline HCl, gabapentin and aspirin ("ASA"). It was reported that on 06-MAY-2012 the patient experienced herpes zoster. The patient had no recent exposure to chickenpox or herpes zoster. On 11-MAY-2012 she presented to office with rash on left arm for 1 week, very painful, extended from left hand to left shoulder. Physician noted as erythematous maculopapular rash in dermatome with distribution over lateral left arm from posterior shoulder to hand - C6C7 distribution, 2-3 areas with drying vesicles tendered to palpation. Pain scale was 7. Patient was treated with VALTREX. At the time of reporting the patient's status was in process of recovering. The reporter considered the herpes zoster was an other important medical event (required medical intervention). This is one of several reports received from the same source. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Rash Lt arm with itching.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Back pain, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: High Fever -105, vomiting, back pain, stomach pain, sore throat, lite rash.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: High Fever -105, vomiting, back pain, stomach pain, sore throat, lite rash.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site nodule, Injection site pain, Injection site swelling, Swelling
Clinical narrative: On 6/1, arm started swelling at injection site.  Got very swollen, hard and painful.  About 7 inches in diameter.  By 6/8, the swelling had gone down significantly but hard knot is still present on 6/12.  On 6/2, it became very swollen under the armpit on the injection side arm. Armpit was swollen and painful until June 7th.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous, Rash vesicular
Clinical narrative: The patient presented to the pharmacy with a red blistering bumpy rash trailing down the outside of her left lateral leg. It appears to be a varicella-like/zoster-like rash.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Cellulitis, Rash, Skin warm
Clinical narrative: Bullseye type rash, warm to touch, low grade temp.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Bullseye type rash, warm to touch, low grade temp.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Contusion, Full blood count, Petechiae
Clinical narrative: Diffuse Petechiae- feet, hands, arms, chest, and upper back.  Several light bruises on extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Enuresis, Gaze palsy, Loss of consciousness, Posture abnormal
Clinical narrative: Patient flexed arms in, eyes rolled back, head extended back, collapsed, and enuresis. No shaking observed. Loss of consciousness for several seconds.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Patient flexed arms in, eyes rolled back, head extended back, collapsed, and enuresis. No shaking observed. Loss of consciousness for several seconds.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Enuresis, Fall, Gaze palsy, Joint contracture, Loss of consciousness
Clinical narrative: Patient flexed arms in, eyes rolled back, head extended back, collapsed, and enuresis. No shaking observed. Loss of consciousness for several seconds.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Posture abnormal, Syncope
Clinical narrative: Patient flexed arms in, eyes rolled back, head extended back, collapsed, and enuresis. No shaking observed. Loss of consciousness for several seconds.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Rash, Swollen tongue
Clinical narrative: Patient called from home stating she has a rash all over her arm that she received the vaccination in. She was instructed to take Benadryl. If she gets worse to go to the emergency room. Patient arrived at the emergency room about an hour later with c/o her tongue swelling. Patient was treated and released.
Age: 1.03
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Ear discomfort, Pyrexia, Rash, Rash vesicular, Vomiting
Clinical narrative: Client arrived at ER 06/01/12 at approximately 4:45pm for a vesicular rash to his feet, legs, arms, back and abdomen since 05/30/12; pulling at ears and vomiting x1 on 06/01/12 and fever of 100.1 on 05/30/12.  Dr. diagnosed client with varicella and client was discharged from ER at 5:50pm with instructions to follow-up with his physician as needed.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Injection site swelling, Pain in jaw, Pyrexia
Clinical narrative: Symptoms started the evening of 6/5/2012 as fever of 102 and pain in left jaw and pain plus swelling of the left arm shot site that made it impossible to sleep on that side. The fever lasted through 6/7/2012 and was treated with Tylenol. I also iced the sore shot site. The swelling is almost gone today 6/12/2012 with a slight amount of pain left. The only other symptom that is persisting is the sore jaw on the left side. I have never had a adverse reaction to a shot before.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Dyskinesia, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: Pt was very anxious about receiving vaccines. RN administered a Tdap IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an HPV an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN had her slide down and rest her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightend out. Her mom got a cool cloth. We assisted her to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER if any concerns. RN gave info on the imms given and where they where given. RN text pt the next morning and she stated that she had just finished basketball pracitce and was feeling fine.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Injection site reaction, Pallor, Syncope
Clinical narrative: Pt was very anxious about receiving vaccines. RN administered a Tdap IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an HPV an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN had her slide down and rest her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightend out. Her mom got a cool cloth. We assisted her to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER if any concerns. RN gave info on the imms given and where they where given. RN text pt the next morning and she stated that she had just finished basketball pracitce and was feeling fine.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Injection site reaction, Pallor
Clinical narrative: Pt was very anxious about receiving vaccines. RN administered a Tdap IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an HPV an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN had her slide down and rest her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightend out. Her mom got a cool cloth. We assisted her to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER if any concerns. RN gave info on the imms given and where they where given. RN text pt the next morning and she stated that she had just finished basketball pracitce and was feeling fine.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Pt was very anxious about receiving vaccines. RN administered a Tdap IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an HPV an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN had her slide down and rest her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightend out. Her mom got a cool cloth. We assisted her to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER if any concerns. RN gave info on the imms given and where they where given. RN text pt the next morning and she stated that she had just finished basketball pracitce and was feeling fine.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: No symptoms developed. We realized that patient was vaccinated incorrectly. Vaccine was diluted with Sterile diluent instead of enclosed diluent.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Barium enema, Barium enema abnormal, Intestinal obstruction, Intussusception, Surgery
Clinical narrative: Intestinal obstruction -> intussusception. Required surgery. Pt admitted to hospital.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: X-ray abnormal
Clinical narrative: Intestinal obstruction -> intussusception. Required surgery. Pt admitted to hospital.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash around waistline, top of legs, left ankle area - no pain, no itching. Patient said she would take BENADRYL 25mg.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea, decreased eating
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Muscular weakness, Thinking abnormal
Clinical narrative: A few hours after receiving vaccine arms and legs were weak, got dizzy, couldn't think clearly. Lasted approx. 12 hrs.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Per pt swelling started the evening of shot. Today, induration 9 x 7 cm and red. 2 x 4 cm very hot, tender to painful at sq injection site. Pt given ZYRTEC, TYLENOL, cool compress, KEFLEX 500 to cont. and f/u 1 wk.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Headache
Clinical narrative: Body shakes 8 hrs. after; headache, nausea, chills; body aches, T-102 degrees - no appetite Sat. & Sun. 6/4/12 Today - weak, no appetite T 101 degrees. Saw Dr. - no treatment.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Tremor
Clinical narrative: Body shakes 8 hrs. after; headache, nausea, chills; body aches, T-102 degrees - no appetite Sat. & Sun. 6/4/12 Today - weak, no appetite T 101 degrees. Saw Dr. - no treatment.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site anaesthesia, Pain, Paraesthesia
Clinical narrative: Body aches, numbness & tingling at injection site. Pain 8/10. Was given prescription for pain at ER.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash macular, Rash pruritic, Vomiting
Clinical narrative: On way home after receiving VARIVAX #2 pt developed blotchy, itchy red rash on face & trunk along with vomiting. Pt called office & was advised to seek medical attention.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Crying, Feeding disorder of infancy or early childhood, Immediate post-injection reaction
Clinical narrative: After vaccines, immediately seemed less interest in her feedings, seemed less happy, less laughing and squealing for a few weeks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large indurated, red, warm area at injection site. CIPRO BID taken for approx. 10 days.
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: 4 hrs after injection to Lt lateral thigh, mother noticed a red dime size swelling lateral to the injection site. That evening the inject site had a palmed size red rash, hard swelling. By exam date 6/7/12 site was 2x2 with soft, hot head.
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: 4 hrs after injection to Lt lateral thigh, mother noticed a red dime size swelling lateral to the injection site. That evening the inject site had a palmed size red rash, hard swelling. By exam date 6/7/12 site was 2x2 with soft, hot head.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: 6/4 - Large red swollen site at injection site 3" x 4" went to hospital ER on 6/4/12. They said reaction to vaccine gave her Z pack & BENADRYL. 6/6 - Went back to ER now she said she has cellulitis.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Aphthous stomatitis, Chills, Fatigue, Lip swelling, Pain
Clinical narrative: Within 24 hrs of injection, developed swollen upper lip, multiple canker sores on lower lip, low-grade fever (didn't take temp, but chills), and generalized achiness & fatigue. BENADRYL and ibuprofen used x 3 days.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Within 24 hrs of injection, developed swollen upper lip, multiple canker sores on lower lip, low-grade fever (didn't take temp, but chills), and generalized achiness & fatigue. BENADRYL and ibuprofen used x 3 days.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain and stiffness starting right side of neck, radiation to mid shoulder blade.  No redness, swelling, pain to site of infection, deltoid or arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Broke out with hives which spread during the course of the next day.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Allergy test, Urticaria
Clinical narrative: 10-15 MINUTES POST VACCINATION, PINPOINT HIVES ON TRUNK AND UPPER EXTREMITIES.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncope episode with jerking movements both sides of body. Lasted 30-45 seconds. Monitored closely after 30-40 minutes.