chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus
Clinical narrative: Increasing redness at injection site with itching then tiny, itchy blisters formed. This lasted for two weeks. I treated it with OTC cortisone cream. That site by injection cleared up and now it has moved (the tiny, itchy blisters) to under my left arm with redness since August 25, 2016. I'm treating that with OTC cortisone. I had a flu shot given at the same time as the Shingles vaccine at the Pharmacy.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Pt received HPV #1 and Hep A #2. Pt was checked after 15 min wait and c/o  bad headache, dizziness and weakness.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Pt had swelling at injection sight & developed a fever evening of injection, got to 101'F, had chills and wrapped in a blanket all next day, fever came back 2nd night. Pt did not seek medical treatment or report taking any medications.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Barium enema abnormal, Intussusception, Irritability, Vomiting
Clinical narrative: Vomiting and abdominal pain and fussiness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash appeared on Thursday, by Sunday rash spread up trunk of body and on face on Monday started running fever.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Acute onset of high fever (102-103), extreme fussiness.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation
Clinical narrative: Localized inflammation to the flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash generalised
Clinical narrative: Received FLUZONE High-Dose and PREVNAR 13 on 8/29/16. Couple hours later, patient broke out in a rash all over body. Came back to pharmacy on 8/30/16. Recommended BENADRYL.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 103.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema
Clinical narrative: It began with redness that rapidly progress and ultimately, on the date seen (8/24/2016) was 17cm X 12 cm and most consistent with cellulitis. 99F temp, no fevers, chills, vomiting, diarrhea, or limp.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Acute disseminated encephalomyelitis, Coma, Seizure
Clinical narrative: Seizure, 3 week Coma, ADEM diagnosis, steroids.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site has painful radiating pain/increased swelling/redness.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Rubella antibody negative, Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a nurse refers to a 43 year old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, "as a child", the patient received two doses of M-M-R-II (strength, dosing details, anatomical location, lot# and expiration date were unknown). The nurse stated that there was no documented doses of M-M-R II in the patient's medical record but she is assuming the patient received them. On an unknown date in 2008, the patient was diagnosed with Lupus. On an unknown date the patient had titers drawn (antibody test), which showed she was positive for immunity to measles and mumps, but negative for immunity to rubella. The reporting nurse was not positive whether the patient has ever received M-M-R II, but since she stated that she was assuming, she reported this adverse event to be filed as a precaution. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review the event systemic lupus erythematosus was considered to be medically significant. Addition information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Noninfective encephalitis, Paralysis, Seizure, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a physician via company representative who provided the media report concerning 15037 female patients of unknown age, whose concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patients were vaccinated with unknown number of doses of GARDASIL (details not known). It was reported that "so far 15037 girls had reported adverse events from the vaccine which include: Guillain Barre Syndrome (paralysis lasting for years, or permanently- sometimes eventually causing suffocation), lupus, seizures, blood clots, and brain inflammation. It was also reported that 44 girls who were officially known to have died from GARDASIL. (Case reported in MARRS # 1608USA012148). Upon internal review, all of the events, besides blood clots were considered to be medically significant. This is one of the several reports received from the same reporter. Additional information is not expected as the physician does not want to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis
Clinical narrative: This spontaneous report was received from a physician via company representative who provided the media report concerning 15037 female patients of unknown age, whose concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patients were vaccinated with unknown number of doses of GARDASIL (details not known). It was reported that "so far 15037 girls had reported adverse events from the vaccine which include: Guillain Barre Syndrome (paralysis lasting for years, or permanently- sometimes eventually causing suffocation), lupus, seizures, blood clots, and brain inflammation. It was also reported that 44 girls who were officially known to have died from GARDASIL. (Case reported in MARRS # 1608USA012148). Upon internal review, all of the events, besides blood clots were considered to be medically significant. This is one of the several reports received from the same reporter. Additional information is not expected as the physician does not want to be contacted.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Fever, headache, fatigue, dizziness, left upper arm redness, left upper arm swelling, left upper arm induration, enlarged lymph nodes to left axilla and left collar bone, decreased active ROM left upper extremity.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, headache, fatigue, dizziness, left upper arm redness, left upper arm swelling, left upper arm induration, enlarged lymph nodes to left axilla and left collar bone, decreased active ROM left upper extremity.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult dose Hep A administered to a 2 year old child.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Hypersensitivity, Hyperventilation, Injection site erythema, Injection site pain
Clinical narrative: Swelling, redness and pain to left upper arm started around 1:30 PM; within half hour she was starting to hyperventilate and her fingers were tingling; seen in ER at 5:30 PM, hyperventilation and tingling feelings resolved by then, only left upper arm was red hot and swollen; ER diagnosed as allergic reaction vs early cellulitis, and prescribed Keflex.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Swelling, redness and pain to left upper arm started around 1:30 PM; within half hour she was starting to hyperventilate and her fingers were tingling; seen in ER at 5:30 PM, hyperventilation and tingling feelings resolved by then, only left upper arm was red hot and swollen; ER diagnosed as allergic reaction vs early cellulitis, and prescribed Keflex.
Age: 85.0
Sex: U
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Pyrexia, Tremor
Clinical narrative: FLUZONE High Dose was administered IM into left arm of patient at 12:30 pm 8/29/16. Beginning around 2:30 pm same day. patient had chills and "shakes", developed a fever of a 100 F, and blood pressure increased (SBP) to approximately 150. Pt went to ER in evening and returned to pharmacy next day.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism, Coeliac disease, Lactose intolerance, Sensory processing disorder
Clinical narrative: Information has been received from a consumer concerning her currently 4 years old grandson. The patient had no concurrent conditions, medical histories, drug reactions or allergies and concomitant therapies. On an unknown date in April 2013, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route were unknown). On an unknown date, while on M-M-R II, the patient was diagnosed with autism sensory perception disorder. The patient lost his ability to talk, became lactose intolerant and developed celiac disease (dates unspecified). The patient visited the doctor for medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient did not recover from the events. No product quality complaint (PQC) was involved. The causal relationship between M-M-R II and the events was not provided. Upon internal review, autism and celiac disease were considered to be medically significant. Additional information is not expected as the reporter did not want to be contacted.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Client felt dizzy after receiving vaccines and sat on the floor in the main lobby of the facility. Complained of nausea, dizziness, noted diaphoresis. EMS assessed client, client's parents declined transfer to hospital. EMT assessed client and declared vital signs stable. Client admitted to eating not eating since breakfast and was very nervous before receiving the vaccines.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Fatigue, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Low grade fever, headache, fatigue started in the evening on 8/24/16. Left arm red, swollen, headache, fatigue continued on 8/25/16. Headache, fatigue, left arm redness continued on 8/26/16.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Pt started to itch at injection site and progressively over the weekend the area became inflamed, red, and spread to cover the top part of the left deltoid.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary pain, Fatigue, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Swollen arm at site of injection, under arm pain, cannot raise arm, body aches, fatigue.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swollen arm at site of injection, under arm pain, cannot raise arm, body aches, fatigue.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea that lasted three days until 6/29/2016. And this happened last year as well but I was not sure of the cause last year. But since same thing happened this year reaction was confirmed.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Headache, Nausea, Neck pain, Pyrexia
Clinical narrative: Pt c/o headache, neck ache fever and nausea, temp of 101F.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Blister, Erythema, Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Has patch on her back by scapula that is bright red, blotchy. Also red swollen at injection site on left thigh. Mom does not think it looks infected, no blisters, No sign of bite. Not peeling. Was the size of mom's thumb, but now the size of her hand. On 05/11/2016 mother called back and pt has fluid filled blisters all over her body. States siblings have gotten chicken pox from vaccine and have had them multiple times, so strong family history.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting x 7 overnight.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Biopsy lymph gland abnormal, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram abnormal, Computerised tomogram pelvis
Clinical narrative: Vaccine had been administered in left deltoid. Patient subsequently developed enlarged lymph nodes along the left side of his neck. One enlarged node was noticed on Friday August 19th and another noted Sunday August 21st. They were tender to touch. By Monday morning August 21st 3 supraclavicular nodes were noted and the largest measured 1.5 cm. He was seen by a physician 8/21 where diagnostic labs and imaging were performed.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram thorax, Laboratory test, Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccine had been administered in left deltoid. Patient subsequently developed enlarged lymph nodes along the left side of his neck. One enlarged node was noticed on Friday August 19th and another noted Sunday August 21st. They were tender to touch. By Monday morning August 21st 3 supraclavicular nodes were noted and the largest measured 1.5 cm. He was seen by a physician 8/21 where diagnostic labs and imaging were performed.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, Swelling at Injection Site. Was in ER 8/29/16 and dx with Cellulitis. Tx with Bactrim BID x 10 days.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Erythema, Nasal congestion, Oral mucosal eruption, Rash pustular, Rhinorrhoea
Clinical narrative: Per the pt.'s mom: the pt's nose was  red, swollen, and had nasal discharge on 8/25/16. On 8/30/16 mom noticed that there was dry pussy discharge from nose and a rash around the pts mouth.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Large red bumps around site on the site and under the site.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Gastritis, Injected limb mobility decreased, Injection site pain, Neuralgic amyotrophy
Clinical narrative: Patient received Vaccinia vaccine in his left upper arm. Within 2 days, patient developed significant left shoulder pain. Pain intensity was rated as 6-7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient self treated with Ibuprofen 1200 mg without significant improvement. He later treated with Hydrocodone with minimal relief. Patient denied fever, but had experience brief episode of "chills". He denied chest pain, palpitations, shortness of breath, and pedal edema. He also denied significant fatigue, headaches, rashes, nausea/vomiting, and generalized body aches. Patient denied significant reaction surrounding vaccination site. He denied weakness and numbness/tingling of left upper extremity. Patient denied recent trauma to left upper extremity. He had left shoulder surgery (rotator cuff repair) in 2010. By 2200, patient was not able to go to sleep due to pain. After speaking to DHA Immunization Healthcare Support Center, he sought evaluation at local emergency room, where he was given Toradol injection. According to the ER physician, patient's exam was unremarkable. Patient's pain significantly decreased after Toradol, but returned the following morning. No additional symptoms reported, just continued, constant left shoulder pain. Patient called IHB Immunization Healthcare Support Center and was advised to seek evaluation with local PCM or urgent care. Patient self treated with Ibuprofen until he started experiencing symptoms of gastritis. He sought evaluation at St. Luke's on 20 Aug 2016. The pain continued and interfered with his sleep and limited his range of motion and function. The vaccination site had a robust take several days after pain started. Differential per MD was Brachial Plexus Neuritis. He was treated with oral steroids and narcotics with improvement over the next 24-48 hours.  By 24 Aug 2016, pain had completely resolved.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Robust take following exposure to vaccinia virus, Sleep disorder
Clinical narrative: Patient received Vaccinia vaccine in his left upper arm. Within 2 days, patient developed significant left shoulder pain. Pain intensity was rated as 6-7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient self treated with Ibuprofen 1200 mg without significant improvement. He later treated with Hydrocodone with minimal relief. Patient denied fever, but had experience brief episode of "chills". He denied chest pain, palpitations, shortness of breath, and pedal edema. He also denied significant fatigue, headaches, rashes, nausea/vomiting, and generalized body aches. Patient denied significant reaction surrounding vaccination site. He denied weakness and numbness/tingling of left upper extremity. Patient denied recent trauma to left upper extremity. He had left shoulder surgery (rotator cuff repair) in 2010. By 2200, patient was not able to go to sleep due to pain. After speaking to DHA Immunization Healthcare Support Center, he sought evaluation at local emergency room, where he was given Toradol injection. According to the ER physician, patient's exam was unremarkable. Patient's pain significantly decreased after Toradol, but returned the following morning. No additional symptoms reported, just continued, constant left shoulder pain. Patient called IHB Immunization Healthcare Support Center and was advised to seek evaluation with local PCM or urgent care. Patient self treated with Ibuprofen until he started experiencing symptoms of gastritis. He sought evaluation at St. Luke's on 20 Aug 2016. The pain continued and interfered with his sleep and limited his range of motion and function. The vaccination site had a robust take several days after pain started. Differential per MD was Brachial Plexus Neuritis. He was treated with oral steroids and narcotics with improvement over the next 24-48 hours.  By 24 Aug 2016, pain had completely resolved.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypoaesthesia, Laryngeal oedema, Malaise, Panic attack
Clinical narrative: Shortness of breath, swellling of vocal chords, numbness in legs, panic attack.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient said the injection site was red and felt like a blister. In addition, the site itched. This occurred Monday evening when the patient received the immunization for the flu shot. The patient is presently taking an antihistamine and the site is still the same (but has not become worse).
Age: 0.92
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site nodule, Injection site reaction, Rash erythematous
Clinical narrative: Red bumps on skin of left thigh and also one larger nodule below skin.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen red larger patches in multiple locations on the arm.
Age: 26.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Local reaction, Local swelling, Mobility decreased, Pain
Clinical narrative: Localized swelling.  Localized pain.  Localized restriction of motion.  Localized reaction: left upper arm.  Fever, apex 101.0F.  Treated self with acetaminophen and sought treatment in hospital environment on 8/27/2016.  Patient experienced mild tapering of symptoms 8/28/2016 and symptoms largely resolved by 8/29/2016.  Patient still experiencing mild aching pain with full range of motion in upper left arm as of 8/30/2016.
Age: 26.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Localized swelling.  Localized pain.  Localized restriction of motion.  Localized reaction: left upper arm.  Fever, apex 101.0F.  Treated self with acetaminophen and sought treatment in hospital environment on 8/27/2016.  Patient experienced mild tapering of symptoms 8/28/2016 and symptoms largely resolved by 8/29/2016.  Patient still experiencing mild aching pain with full range of motion in upper left arm as of 8/30/2016.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Angioedema, Dyspnoea, Eye pruritus, Speech disorder, Swelling face
Clinical narrative: Facial swelling and hives, itching eyes, angioedema of mouth, tongue, and lips, truncal and extremity hives. Trouble breathing and talking.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Facial swelling and hives, itching eyes, angioedema of mouth, tongue, and lips, truncal and extremity hives. Trouble breathing and talking.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site rash, Rash, Skin warm
Clinical narrative: Her arm is red and warm. The rash started right around the area of injection but has spread over most of her arm.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching and erythema around (mostly distal) injection site.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Lymph node pain, Speech disorder, Urticaria
Clinical narrative: Difficulty speaking/swallowing, hives, painful lymph nodes.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus
Clinical narrative: Increased temeperature and redness around the injection site, which spread all over the upper arm and became itchy after 2-3 days. As of the date of reporting it is getting better.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Pt recieved a flu shot and called us about an hour later complaining of itchy skin. pt had no injection site reaction or rash/hives she just said her skin felt itchy. Pt also stated this had happened 2 other times in the last 6 months and she is curious if it is food related but she has yet to pinpoint a cause. at this time we are unsure if it is flu shot related. Pt took Benadryl and called back an hour later and itching had subsided.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: The skin area where patient received Pneumovax vaccine became red and inflamed a few hours after the patient came home from pharmacy. Patient put ice on the area but area did not resolved. Patient called pharmacy next evening 8/29/16 @ 6 PM and was instructed by pharmacist to take Benadryl and ibuprofen. Pharmacy called patient on 8/30/16 and patient reported redness improving.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Fatigue, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate large, red itchy bump formed.  White center with red the size of arm where injection was given. This followed by headache and stomach ache. The next morning very tired and sore muscle type pain in body.  Arm still itchy night of day 2.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Immediate large, red itchy bump formed.  White center with red the size of arm where injection was given. This followed by headache and stomach ache. The next morning very tired and sore muscle type pain in body.  Arm still itchy night of day 2.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Antibody test negative, Cytomegalovirus test, Epstein-Barr virus antibody, Full blood count normal, Oral pain
Clinical narrative: Mouth sores and pain for 3 weeks. Better with steroids.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Red blood cell sedimentation rate increased, Stomatitis
Clinical narrative: Mouth sores and pain for 3 weeks. Better with steroids.
Age: 1.71
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion, Mental status changes
Clinical narrative: Had 2 complex febrile seizures 1st about 17 hrs and 2nd 24 hours after vaccine given. Next day some mental status changes.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Aspiration joint normal, Blood culture negative, Injection site reaction, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: (L) Thigh myositis near injection site. Blood culture negative.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine TRUMENBA (Lot# L13514, expires 7/20/16) on 8/1/16. Tolerated well, no adverse reaction. Report of vaccination error.
Age: 73.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Leukocytosis
Clinical narrative: Right arm cellulitis. Leukocytosis likely secondary to cellulitis and history of myelofibrosis. Treated with IV clindamycin, Vancomycin -> BACTRIM PO.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Peripheral swelling, Rash macular
Clinical narrative: Achy body, swollen arm, upper arm red spotches.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Adverse reaction, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever 101 degree F, headache, sore arm.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Back pain, Blood urine present, Decreased appetite, Fatigue, Insomnia
Clinical narrative: Pt complained of arm pain, lower back pain, fatigue, decreased appetite, difficult time sleeping. Pt went to doctor had blood and protein in urine, was given antibiotic injection and PYRIDIUM.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in extremity, Protein urine present
Clinical narrative: Pt complained of arm pain, lower back pain, fatigue, decreased appetite, difficult time sleeping. Pt went to doctor had blood and protein in urine, was given antibiotic injection and PYRIDIUM.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Body temperature decreased, Chills, Decreased appetite, Eating disorder, Fatigue
Clinical narrative: Pt complained of arm pain, lower back pain, fatigue, decreased appetite, difficult time sleeping. Pt went to doctor had blood and protein in urine, was given antibiotic injection and PYRIDIUM.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Haemorrhage, Injection site pain, Nausea, Pallor, Renal pain
Clinical narrative: Pt complained of arm pain, lower back pain, fatigue, decreased appetite, difficult time sleeping. Pt went to doctor had blood and protein in urine, was given antibiotic injection and PYRIDIUM.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MENB
Symptoms: Erythema, Injected limb mobility decreased, Pain, Rash
Clinical narrative: 8-19-2016 4:26pm PC from grandma, client reports left upper very sore; can hardly move it with rash red et raise et one dollar in size; afebrile; reddened area to the front et outer aspect of left forearm well below injection site; s/s started one day before; advised to seek medical care; evaluated by Emergency on 8/19/2016 at 4:56pm; client prescribed ZYRTEC 10mg po daily for 3 days et to follow with primary physician.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: 8-19-2016 4:26pm PC from grandma, client reports left upper very sore; can hardly move it with rash red et raise et one dollar in size; afebrile; reddened area to the front et outer aspect of left forearm well below injection site; s/s started one day before; advised to seek medical care; evaluated by Emergency on 8/19/2016 at 4:56pm; client prescribed ZYRTEC 10mg po daily for 3 days et to follow with primary physician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. swelling to left anterior lateral thigh extending to left inner thigh. Area tender and warm. Improved with KEFLEX. No improvement in first 24-48 hrs with BENADRYL
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PREVNAR 13 (Aug 23, 2016) (L) arm IM, red and tender area, bit painful no bleeding, no fever, no itchy, no rash elsewhere.
Age: 18.0
Sex: M
Vaccine: HPV9, MMR, MNQ
Symptoms: Chest X-ray, Chills, Cough, Glossitis, Pyrexia
Clinical narrative: About 6d after MMR pt developed low grade fever, chills, congestion, cough, glossitis.
Age: 18.0
Sex: M
Vaccine: HPV9, MMR, MNQ
Symptoms: Respiratory tract congestion
Clinical narrative: About 6d after MMR pt developed low grade fever, chills, congestion, cough, glossitis.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site
Clinical narrative: Imm was given in a incorrect site for an IM injection. Site was approximately 4 inches below deltoid.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3 inch wide x 31/2 in long area swollen hard to touch, red - Center around injection site darker red 1in x 11/2 inch - painful itching.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Localized swelling with erythema and induration 75cm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site rash, Sleep disorder
Clinical narrative: Pt reports extreme soreness and rash near injection site and edema. Soreness kept her awake X 2 nights.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Mom phoned BOH states patient has itching and mild swelling in (L) arm at insertion site. Sent picture to BOH. Hive like swelling noted, mom said it looked like the size of a Snickers bar. Encouraged BENADRYL and TYLENOL. Continue to watch for increase in size or reaction.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Fall, Presyncope
Clinical narrative: Pt had near syncopal event Kw/in 5 min of receiving injection fell to floor but did not lose consciousness. VS pulse Ox and Bl. glucose of nl. HR did go from 80 to 59 but slowly recovered. Pt awake, alert and O x3. Rested in exam room x 20 min. Left in stable condition.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Muscle tightness, Paraesthesia, Tinnitus
Clinical narrative: Began feeling lightheaded, ears ringing, arms tingling, jaw tight. Lasted ten minutes before resolving.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a medical assistant via field representative refers to a 66 year old female patient. The patient's pertinent medical history included hypertension and drug allergies were not reported. On 10-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (one time injection) (lot # M018766 and expiry date: 15-OCT-2017). Concomitant medications were unknown. On 11-AUG-2016, the patient experienced fever, red, hot, swollen and painful arm. The patient sought medical attention and treatment was provided for the events. The outcome the events was unknown (action taken was also reported as withdrawn). The relatedness of the events with PNEUMOVAX 23 was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Infertility female, Vaccination complication
Clinical narrative: This solicited report received from the consumer and refers to a female patient in her teens as a part of a market research program. The patient's concurrent conditions, medical history, concomitant medications and past drugs were not reported. The reporter referred to the daughter (patient) of a parent in her church. On an unknown date in 2007 (approximately 9 years ago), when the patient was in her teens, she was vaccinated with GARDASIL. The patient's mother was reported to have gotten the patient vaccinated for HPV after finding out that the patient was sexually active. On an unspecified date, the patient had a bad reaction (details unspecified) to the vaccine (which made the reporter skeptical of the vaccine). After vaccination, the patient had an issue (details unspecified) 'that seemed to have been directly related that caused the doctors to think that she may be unable to bear children in the future' (female infertility). It was reported that patient had since had her first child (date unspecified). The outcome of event bad reaction to the vaccine was not reported. Action taken with the vaccine due to the events was not reported. The reporter considered infertility female to be related to GARDASIL. The causality of the event bad reaction to the vaccine with GARDASIL was not reported. Upon internal review, event infertility female was considered to be medically significant. Additional information is not expected since reporter not willing to contact further.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9, injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). The patient's mother reported, that on an unknown date, her son would miss the second dose of GARDASIL 9. Additional information is not expected due to lack of the reporter's contact details.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The patient did not had any pertinent medical history, concomitant medication and drug reaction or allergies. The patient received vaccinations with VARIVAX dose number 1 from lot # L009205 with expiry date of March 2017 on 01-JUN-2016 and received dose number 2 from lot # M004662 with expiry date of January 2018 on 28-JUN-2016, both subcutaneously. On 29-JUL-2016, the patient had her titers checked and they were negative for Varicella. No laboratory tests were performed. She inquired about receiving reimbursement if she had to take titer test they are expensive. The outcome of the event was unknown. Causality was not provided by the reporter. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning to a patient of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not provided. On 22-AUG-2016, the patient was vaccinated with a dose of incorrect stored ROTATEQ (lot # L046320, expiration date 29-SEP-2017, oral). No adverse effects were reported. Temperature: 9.62 degree C. Time frame: 45 minutes. Was it administered? Yes. Was previous temperature excursion? Yes. (6 minutes at 8.91degree C and 13 Minutes at 10. 25 degree C) Was call because of a "data logger"? Yes. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Headache, Measles antibody negative, Mumps antibody test negative, Pain, Parotitis
Clinical narrative: This literature market report has been received from the authors of a published literature article as stated above, concerning a 27 year old female patient, who was a medical student. The patient had no known exposure to the other infected medical student or to any of the undergraduate students involved in the earlier outbreak. She had received 2 childhood MMR (manufacturer unknown) ( lot#, dose and route unspecified) vaccinations. On May 8 (year unspecified), MMR immunoglobulin G (lg G) levels were tested as a prerequisite for an away rotation: her measles and mumps lgG titers were negative (titers were <=0.90) and her Rubella lgG titer -was positive. She consequently received the (wistar ra 27-3) M-M-R II (lot#, expiration date, dose and route unspecified) booster vaccination on May 21 (year unspecified) to fulfill the rotation hospital's requirements. Eighteen days post vaccination, on June 8 (year unspecified), she developed mild generalized headaches and painful swelling under her right mandible. She had no symptoms of fever, coryza, or neck stiffness. At her June 9 appointment, she presented to the clinic and was afebrile with marked right parotitis and laboratory results revealed the following: a conversion to a positive mumps lgG titer of greater than 5 index (positive titer >1.10), a negative mumps lgM titer of less than 1:20, and buccal swab positive for mumps virus ribonucleic acid (RNA) Reverse transcription polymerase chain reaction (RT-PCR). Because the mumps RNA RT-PCR did not differentiate between wild type mumps and vaccination strain mumps, the buccal PCR sample was shipped to the CDC for further analysis. Genotypic analysis, by sequencing the variable region of the shot hydrophobic protein gene, distinguishes the 12 recognized mump strains (A L). Typing of the buccal PCR sample confirmed genotype A, consistent with the Jeryl-Lynn vaccine strain. The patient was self-isolated for 5 days during which time her symptoms completely resolved. Because she was otherwise healthy, a formal work-up for immunodeficiency was not pursued. In this report, through genotypic testing, the parotitis was proved to be vaccine-induced. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same source (linked with MARRS # WAES1608USA014935, WAES1608USA015163 and WAES1608USA015164). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Polymerase chain reaction positive, Rubella antibody positive, Rubulavirus test positive, Swelling
Clinical narrative: This literature market report has been received from the authors of a published literature article as stated above, concerning a 27 year old female patient, who was a medical student. The patient had no known exposure to the other infected medical student or to any of the undergraduate students involved in the earlier outbreak. She had received 2 childhood MMR (manufacturer unknown) ( lot#, dose and route unspecified) vaccinations. On May 8 (year unspecified), MMR immunoglobulin G (lg G) levels were tested as a prerequisite for an away rotation: her measles and mumps lgG titers were negative (titers were <=0.90) and her Rubella lgG titer -was positive. She consequently received the (wistar ra 27-3) M-M-R II (lot#, expiration date, dose and route unspecified) booster vaccination on May 21 (year unspecified) to fulfill the rotation hospital's requirements. Eighteen days post vaccination, on June 8 (year unspecified), she developed mild generalized headaches and painful swelling under her right mandible. She had no symptoms of fever, coryza, or neck stiffness. At her June 9 appointment, she presented to the clinic and was afebrile with marked right parotitis and laboratory results revealed the following: a conversion to a positive mumps lgG titer of greater than 5 index (positive titer >1.10), a negative mumps lgM titer of less than 1:20, and buccal swab positive for mumps virus ribonucleic acid (RNA) Reverse transcription polymerase chain reaction (RT-PCR). Because the mumps RNA RT-PCR did not differentiate between wild type mumps and vaccination strain mumps, the buccal PCR sample was shipped to the CDC for further analysis. Genotypic analysis, by sequencing the variable region of the shot hydrophobic protein gene, distinguishes the 12 recognized mump strains (A L). Typing of the buccal PCR sample confirmed genotype A, consistent with the Jeryl-Lynn vaccine strain. The patient was self-isolated for 5 days during which time her symptoms completely resolved. Because she was otherwise healthy, a formal work-up for immunodeficiency was not pursued. In this report, through genotypic testing, the parotitis was proved to be vaccine-induced. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same source (linked with MARRS # WAES1608USA014935, WAES1608USA015163 and WAES1608USA015164). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (reported lot # M007764, expiration date: 30-JAN-2018) (strength, dose, frequency and route of administration were not reported). There was no adverse effects reported. Administered doses of GARDASIL 9 experienced the temperature excursion of 38 degrees Fahrenheit for 16 hours. The outcome of the event was not reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot # L044058, expiration date 02-MAY-2017 lot # L009207, expiration date 17-OCT-2016; lot # L023111, expiration date 24-DEC-2016 (exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 13 to 14 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dosing details were not reported). Concomitant medications were unknown. On an unknown date following the administration of the vaccine, the patient experienced severe syncopal episode. The patient sought medical attention (patient was in office) and unknown if treatment was provided for the event. The outcome of the event was unknown. The relatedness of the event with GARDASIL was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 11-JUL-2016, the patient was vaccinated with improperly stored dose of PROQUAD (lot # I017140 and expiry date: 13-NOV-2016). No adverse reactions were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 5 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot number: M000756, expiry date: 06-JAN-2016, route of administration was not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received on 25-AUG-2016 from a registered nurse via Pfizer, Inc. (manufacturer control # 2016394776) referring to an adult patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported) instead of PREVENAR 13 (wrong vaccine administered). The outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 27-MAY-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistences in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, since 09-AUG-2016, the patients were vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016, route of administration and therapy type were not reported). Concomitant therapy was not reported. No adverse effect was reported. M-M-R II was exposed to temperature: 48F for 8 hours. There was no previous excursion. It was not specified if, data logger was in use. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 73-years-old male. The patient had no pertinent medical history and had an allergy to opioid. On 07-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot number: L028286, expiry date: 28-OCT-2016, subcutaneously). There was no concomitant therapy. On an unknown date, reported as: at the end of June 2016, the patient developed pain in his wrists. The joint pain extended to both knees and hips and has subsequently became widespread. The patient sought medical attention (office visit). The patient was treated by his unspecified physician with NAPROSYN and prednisone (manufacturer unknown). At the time of the report, the patient was recovering. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information is not expected, because there is no consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's boyfriend refers to female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, route and site of administration, lot # and expiry date were not reported). On an unknown date, the patient was diagnosed with a moderate case of shingles after receiving ZOSTAVAX. The patient received unspecified treatment for the event. The outcome of herpes zoster was unknown at the time of the report. The patient sought medical attention via contacting the physician. The relatedness between the event and ZOSTAVAX was not provided. Additional information is not expected, as the reporter refused to provide any contact details.