chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Electrocardiogram, Full blood count, Hypotension, Hypoxia
Clinical narrative: Felt faint, short of breath with hypoxia, hypotension, tachycardia, and nauseated.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Metabolic function test, Nausea, Tachycardia
Clinical narrative: Felt faint, short of breath with hypoxia, hypotension, tachycardia, and nauseated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, heat, itching/burning.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Chicken Pox vaccine. Large red bump appeared at injection site 15 days after vaccination. Tiny red bumps in the middle of back. Complaining that her back was "itchy."
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC13, VARCEL
Symptoms: Injection site mass, Rash, Vaccination complication
Clinical narrative: Pt. came in with 2 lumps on his thigh and a rash on 4/18/12. Pt. saw Dr. who believed the lumps to be a reaction to the vaccines he received. They were not painful to the pt. She also "believed the rash to be secondary to the varicella vaccine".
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Pt described having an injection site reaction: about a 4 inch diameter swollen area, with redness, feeling of warmth, & itching/irritation. She also felt a little feverish but had not measured her temperature yet.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Pt described having an injection site reaction: about a 4 inch diameter swollen area, with redness, feeling of warmth, & itching/irritation. She also felt a little feverish but had not measured her temperature yet.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomited every time they were given  some of vaccine.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Urticaria
Clinical narrative: Pt received Tdap BOOSTRIX IM in (L) deltoid at a Public Health Clinic at approx 0930 on 4-19-12. On 4-21-12 in the a.m pt. developed hives over the entire body. Guardian tx with BENADRYL, but as of 4-23-12 the hives have not resolved. Guardian to call pt's MDfor f/u.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Skin lesion, Swelling face, VIIth nerve paralysis, Varicella post vaccine
Clinical narrative: The patient received catch up vaccines (MMR & Var) on 4-13-12. She developed few lesions on 4-19-12 and was seen on 4-20-12 in the office and Dxed with viral exanthem (suspected Varicella). Developed high fever on 4-21-12 and facial swelling on 4-22-12 and seen at clinic on 4-22-12. Seen in office on 4-23-12 and dxed with Bell's Palsy. Referred to Neurologist. Pt. clinically well.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral rash
Clinical narrative: The patient received catch up vaccines (MMR & Var) on 4-13-12. She developed few lesions on 4-19-12 and was seen on 4-20-12 in the office and Dxed with viral exanthem (suspected Varicella). Developed high fever on 4-21-12 and facial swelling on 4-22-12 and seen at clinic on 4-22-12. Seen in office on 4-23-12 and dxed with Bell's Palsy. Referred to Neurologist. Pt. clinically well.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: Child received TDAP, Varicella #2 and GARDASIL #1 on 4/11/12 at the Pediatric office - tolerated vaccines well, child went home, slept fine overnight. The following morning child awoke and child told his parents "my face feels slower on the lf. side, especially around my lf. eye". Child has Htx of eye twitching in the past - Dad feels that child has experienced this (eye twitching) in the past when child has been fatigued. Dad and pt. state that child lf. side of face appeared "somewhat slack and droopy" 2 days following his vaccine administration - child noted having difficulty closing his lf. eyelid and smiling on the lf. side of his face. These symptoms became progressively worse on 4/12/12. Dad recognized child's symptoms as being "Bell's Palsy" (Dad experienced Bell's Palsy in 2007 - rt. side of Dad's face, unknown cause). Dad feels that child lf. side of face is less slack in nature today - child is able to somewhat close his lf. eye on his own but is unable to smile using the lf. side of his mouth. Child does have feeling (sensation to touch and pain) on the lf. side of his face. Normal facial pigmentation. No htx of chest pain. No htx of SOB. No htx of smoking/drinking or drug usage. Normal taste sensation on his tongue. No htx of LOC. No word slurring noted. Child has been able to carry on daily activities appropriately. No htx of fever. Sleeping well. No rashes report. No joint pain or joint swelling. No head trauma. No rapid heart rate/no palpitations noted.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eyelid function disorder, Hypoaesthesia, Sensory disturbance, VIIth nerve paralysis
Clinical narrative: Child received TDAP, Varicella #2 and GARDASIL #1 on 4/11/12 at the Pediatric office - tolerated vaccines well, child went home, slept fine overnight. The following morning child awoke and child told his parents "my face feels slower on the lf. side, especially around my lf. eye". Child has Htx of eye twitching in the past - Dad feels that child has experienced this (eye twitching) in the past when child has been fatigued. Dad and pt. state that child lf. side of face appeared "somewhat slack and droopy" 2 days following his vaccine administration - child noted having difficulty closing his lf. eyelid and smiling on the lf. side of his face. These symptoms became progressively worse on 4/12/12. Dad recognized child's symptoms as being "Bell's Palsy" (Dad experienced Bell's Palsy in 2007 - rt. side of Dad's face, unknown cause). Dad feels that child lf. side of face is less slack in nature today - child is able to somewhat close his lf. eye on his own but is unable to smile using the lf. side of his mouth. Child does have feeling (sensation to touch and pain) on the lf. side of his face. Normal facial pigmentation. No htx of chest pain. No htx of SOB. No htx of smoking/drinking or drug usage. Normal taste sensation on his tongue. No htx of LOC. No word slurring noted. Child has been able to carry on daily activities appropriately. No htx of fever. Sleeping well. No rashes report. No joint pain or joint swelling. No head trauma. No rapid heart rate/no palpitations noted.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular
Clinical narrative: Generalized papular erythematous rash with low grade fever starting 11 days after immunization with multiple vaccines including MMR.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness at vaccine area, about 1 hour later, radies at area of vaccine, breathing problems. Went back to Clinic was told to go to ER. Methylprednisolone 4mg dose pack 21s, Doxycycline Hyclate 100mg, Ranitidine 150 mg, Q-DRYL 25 mg.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: Redness at vaccine area, about 1 hour later, radies at area of vaccine, breathing problems. Went back to Clinic was told to go to ER. Methylprednisolone 4mg dose pack 21s, Doxycycline Hyclate 100mg, Ranitidine 150 mg, Q-DRYL 25 mg.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site reaction
Clinical narrative: Redness at vaccine area, about 1 hour later, radies at area of vaccine, breathing problems. Went back to Clinic was told to go to ER. Methylprednisolone 4mg dose pack 21s, Doxycycline Hyclate 100mg, Ranitidine 150 mg, Q-DRYL 25 mg.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large red area (L) upper leg.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Injection site urticaria
Clinical narrative: Within 5 mins of receiving MMR vaccine, to right thigh, SQ,  pt developed a dime sized whelp at the site of injection.  Pt was treated w/ benadryl and tylenol, by weight.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain requiring treatment.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 73 year old female who in 2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). The physician reported patient who had been given ZOSTAVAX (Merck) in 2007 was presently hospitalized in an unspecified hospital with shingles and encephalitis. Patient was still hospitalized. The date of hospitalization was unspecified. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site oedema
Clinical narrative: Pt had significant erythema, edema & warmth to upper arm (injection site) systemic symptoms included fever chills, HA, myalgias, fatigue starting the day after injection until today.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Pt had significant erythema, edema & warmth to upper arm (injection site) systemic symptoms included fever chills, HA, myalgias, fatigue starting the day after injection until today.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Flat macular (L) 11's x 10 cm erythema (R) thigh 9x8 cm w/ warmth CT AB, no respiratory distress.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Dysphonia, Oedema mouth, Urticaria
Clinical narrative: Information has been received from a physician concerning a 56 year old female patient with drug reactions/allergies to lidocaine and no other pertinent medical history, who on 07-FEB-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, site and lot number not reported). Concomitant therapy included vitamin D (unspecified). The patient experienced anaphylactic reaction after receiving PNEUMOVAX 23. Patient experienced generalized hives all over the body and swelling of the mouth and her voice became hoarse. The patient went to ER for adverse reactions but she was not admitted. No lab diagnostic studies were performed. The patient was given epinephrine injection and antihistamine as treatment for the adverse event. At the time of the report, the patient outcome was unknown. The events were considered to be other important medical events, by the physician, because of the treatment with epinephrine injection. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, TYP, YF
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: 4-23-2012. Flu like sx; achy, tired. Low grade fever 100.2.
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Injection site rash, Rash
Clinical narrative: Rash appeared shortly after receiving PENTACEL on 4/13/12. Rash started on thighs and continued to spread on the inside of thighs, back, and face. Spiked a temperature of 103 and was taken to ER-prescribed BENADRYL. Treated with prednisolone and ATARAX 4/20/2012.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Fever - chills. Myalgia. Headache. Gastric upset. Red raised hot at area of injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Fever - chills. Myalgia. Headache. Gastric upset. Red raised hot at area of injection.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Patient developed dizziness & pallor 10 minutes after vaccination.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Was given a GARDASIL vaccine in (Rt) Delt. stood up to change into clothes from gown and passed out. Pt woke up and was fine. Kept eye on her till she went home.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Pallor, Pruritus, Rash generalised, Tachycardia
Clinical narrative: Shortly after receiving GARDASIL vaccine developed a rash described by parent as diffused with hives, diff. breathing. BENADRYL 50 mg given at home. Pt. seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Given SOLUMEDROL, improved and sent home.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Shortly after receiving GARDASIL vaccine developed a rash described by parent as diffused with hives, diff. breathing. BENADRYL 50 mg given at home. Pt. seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Given SOLUMEDROL, improved and sent home.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Pallor, Pruritus, Rash, Tachycardia
Clinical narrative: Shortly after receiving GARDASIL vaccine developed a rash described by parent as diffused with hives, diff. breathing. BENADRYL 50 mg given at home. Pt. seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Given SOLUMEDROL, improved and sent home.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dyspnoea, Injection site rash, Pain, Rash
Clinical narrative: Parent reports rash (L) sd of body and at injection site, shortness of breath, throat felt as if closing. Body aches & weakness, parent reports s/s resolved spontaneously.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Parent reports rash (L) sd of body and at injection site, shortness of breath, throat felt as if closing. Body aches & weakness, parent reports s/s resolved spontaneously.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Visual impairment
Clinical narrative: Pt received ZOSTAVAX vaccine Sq at clinic states right after giving the vaccine states vision problems states feeling funny took VS Temp 976 Pulse 70 Pulse Ox 98% B/P 120/80 Resp 18 Pt stayed in exam table watched Pt for 45 minutes & Pt states feeling fine will follow with eye doctor.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Fatigue, Induration, Malaise, Pruritus
Clinical narrative: Developed noted scaly, red, lumpy rash and tender induration just inferior to the injection site on the right upper arm. Pruritic. No vesicle/blister. No discharge or crusting. Mild fatigue/malaise. No fever. Self tx'd with BENADRYL cream. Slowly improved over the last 2-3 days. No prior h/o shingles vaccination or disease.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Developed noted scaly, red, lumpy rash and tender induration just inferior to the injection site on the right upper arm. Pruritic. No vesicle/blister. No discharge or crusting. Mild fatigue/malaise. No fever. Self tx'd with BENADRYL cream. Slowly improved over the last 2-3 days. No prior h/o shingles vaccination or disease.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt presented with 5 cm wheel to (L) deltoid.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Oedema peripheral
Clinical narrative: 4-20-12 1100 pt returned to office stating left arm swollen, seen by dr who advised pt to go to urgent care. Pt states was given IV fluids and antibiotics Trimethoprim and Cephalexin was re-examined 4-22-12. Swelling diminished/slight discomfort (per patient).
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report was received from a healthcare professional on 10 April 2012. The reporter for this case is the same as case number: 2012-03810 and 2012-03811. A 63-year-old female patient received a right deltoid (RD) intramuscular injection (dose one) of ADACEL, sanofi pasteur Ltd., lot number C4101AA on 22 March 2012. The patient's past medical history was reported as hypothyroid, arthritis, and hypertension. The patient denied any known drug allergies and denied illness at time of vaccination. Other vaccinations within four weeks prior to date of vaccination were reported as none. Concomitant medications included: SYNTHROID, CELEXA, AMBIEN, K-DUR, LASIX, ULTRAM, PRILOSEC, and FLONASE. "Seven days after vaccination" on questionably 29 March 2012, the patient presented with "cellulitis" at injection site, requiring a doctor visit. The patient experienced redness, induration, and swelling at injection site with fever, numbness and tingling of arm. She was treated with an antibiotic. The patient had not returned to office or reported persistent or further symptoms. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 10 April 2012. The reporter for this case is the same as case number: 2012-03810 and 2012-03811. A 63-year-old female patient received a right deltoid (RD) intramuscular injection (dose one) of ADACEL, sanofi pasteur Ltd., lot number C4101AA on 22 March 2012. The patient's past medical history was reported as hypothyroid, arthritis, and hypertension. The patient denied any known drug allergies and denied illness at time of vaccination. Other vaccinations within four weeks prior to date of vaccination were reported as none. Concomitant medications included: SYNTHROID, CELEXA, AMBIEN, K-DUR, LASIX, ULTRAM, PRILOSEC, and FLONASE. "Seven days after vaccination" on questionably 29 March 2012, the patient presented with "cellulitis" at injection site, requiring a doctor visit. The patient experienced redness, induration, and swelling at injection site with fever, numbness and tingling of arm. She was treated with an antibiotic. The patient had not returned to office or reported persistent or further symptoms. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Cervical incompetence, Cervix cerclage procedure, Infection, Maternal exposure during pregnancy
Clinical narrative: Initial report was received from a health care professional on 22 December 2011. A 20-year-old pregnant female patient had received an intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3984AA) on 22 December 2011. The date of the patient Last Menstrual Period was not reported. Estimated Date of Delivery was reported as 19 August 2012. The patient did not experience an adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The outcome was reported as unknown. Follow-up information was received from a health care professional on 16 April 2012. Based upon this new information, the event has been upgraded to serious and a separate case has been created to capture the fetal death in case number 2012-04016. The patient received the dose two of ADACEL in the left deltoid. The patient had one previous dose of ADACEL. The patient had an incompetent cervix and had a cervical cerclage on 25 March 2012. The patient got an infection, was in the hospital and on intravenous (IV) antibiotics (dates not reported). The patient had a miscarriage on 08 April 2012. Prior to the miscarriage, the patient's health status was good and had no family history of congenital abnormalities. The patient had no previous pregnancies and received no treatment for infertility. The patient has no adverse events following prior vaccinations. The patient's concomitant medications included prenatal vitamins. The patient's outcome remained unknown. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Nodule, Tenderness
Clinical narrative: Initial report was received from a health care professional on 17 April 2012, which also involved a case of misuse (wrong route of administration). This reporter also reported another adverse event which was captured in case number 2012-04057. A 57-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4051AA, and an intramuscular injection in the left deltoid of TUBERSOL, sanofi pasteur Ltd., lot number C3763AA, on 14 April 2012. Within 24 hours, the patient complained of left upper arm redness and pain at the injection site. The patient also complained of tenderness in left axillary area with a large palpable nodule. The patient was diagnosed with cellulitis secondary to injection site. The patient denied any illness at the time of vaccination, any other vaccinations within four weeks of ADACEL and TUBERSOL and past medical history. The patient had no known allergies (NKA). The patient's outcome was recovered. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Pt was given Menactra in his left arm then Pt was given HPV vaccine in his right arm. He then experienced a syncope tonic clonic reaction. This lasted for approx 20-30 sec. His vitals were stable post event. He had not eaten breakfast so he was given a complex carb and a drink. He quickly recovered. He was monitored for 1 hour and discharged home. A call was placed to check on patient the next day and he was doing well. Sibling has similar reaction.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Oral herpes
Clinical narrative: Cold sore outbreak, continues monthly as of 04/24/2012.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation, Scab
Clinical narrative: Appearance of round crusted lesion consistent with auto-inoculation at distant site.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation, Scab, Skin lesion
Clinical narrative: Appearance of round crusted lesion consistent with auto-inoculation at distant site.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: Fussy, crying non-stop.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, heat, swelling and soreness around whole arm where injection given.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Dry mouth, Fall, Injected limb mobility decreased, Injection site pain
Clinical narrative: RHD beneficiary who developed right upper arm pain within 24 hours following receipt of Tdap (right arm) and PNEUMOVAX (left arm) vaccines on 18 APR 2012. Previous Td vaccine received on 3/19/2007. Patient denies anything unusual about vaccine administration technique, and dose not recall unusual pain during vaccine administration. Patient denies any unusual or persistent bruising, redness, swelling, or warmth at vaccination site. On day of vaccine receipt, noted "usual" aching pain in right deltoid area. Patient often experiences that type of pain after vaccinations and tries to "work it out". The day following vaccinations her right shoulder became more painful with a "constant throbbing" pain reaching a pain intensity of about 8/10. The pain sometimes is triggered by palpation to the right pectoral area and sometimes is noted in her right scapula and up into her neck. Sometimes it feels like a "vise" and other times it is so intense that it is like an "electric shock". She denies any numbness/tingling or weakness or her right upper extremity. Her pain increases with any movement - writing, opening a jar, turning door handle and when she used her left arm to cover a sneeze, she experienced pain in her right upper extremity. Pain leading to limitations with ADLs and interfering with sleep. Patient has not self treated as she is already taking a number of medications for arthritis/symmetric polyarticular inflammation, including ibuprofen 400 mg three times per day. Patient sought evaluation last p.m.; she said the evaluating provider was not sure what was causing the pain, but prescribed PERCOCETS as needed until patient could be evaluated by her Rheumatologist. Patient denies similar pain affecting her right upper extremity and shoulder. She denies recent trauma, except she recently fell in the garden and hit her right knee; does not think she caught herself using her upper extremities. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions except short-lived aching at vaccination site. Patient denies any angioedema, rashes, cardiorespiratory, or GI symptoms. She has noted a "dry mouth" over the past 2 days (onset prior to initiation of PERCOCET.), otherwise no other new symptoms. Patient reports allergies to Sulfa, AUGMENTIN, ACTONEL and FOSAMAX (itching, rashes or both). She does not tolerate NAPROSYN. EXAM per Rheumatologist on 23 APR: Musculoskeletal system: General/bilateral - Musculoskeletal system: Skin overlying bilateral shoulder and chest without erythema or warmth. No notable swelling of bilateral shoulders or anterior chest wall. However, fullness and TTP of (R) trapezius, (R) deltoid and (R) pectoralis muscle. Pain limiting (R) shoulder abduction, flexion, internal and external rotation. Positive liftoff, Neer's Hawkins, Jobe's.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site reaction, Joint injury, Muscle swelling, Musculoskeletal pain, Neck pain
Clinical narrative: RHD beneficiary who developed right upper arm pain within 24 hours following receipt of Tdap (right arm) and PNEUMOVAX (left arm) vaccines on 18 APR 2012. Previous Td vaccine received on 3/19/2007. Patient denies anything unusual about vaccine administration technique, and dose not recall unusual pain during vaccine administration. Patient denies any unusual or persistent bruising, redness, swelling, or warmth at vaccination site. On day of vaccine receipt, noted "usual" aching pain in right deltoid area. Patient often experiences that type of pain after vaccinations and tries to "work it out". The day following vaccinations her right shoulder became more painful with a "constant throbbing" pain reaching a pain intensity of about 8/10. The pain sometimes is triggered by palpation to the right pectoral area and sometimes is noted in her right scapula and up into her neck. Sometimes it feels like a "vise" and other times it is so intense that it is like an "electric shock". She denies any numbness/tingling or weakness or her right upper extremity. Her pain increases with any movement - writing, opening a jar, turning door handle and when she used her left arm to cover a sneeze, she experienced pain in her right upper extremity. Pain leading to limitations with ADLs and interfering with sleep. Patient has not self treated as she is already taking a number of medications for arthritis/symmetric polyarticular inflammation, including ibuprofen 400 mg three times per day. Patient sought evaluation last p.m.; she said the evaluating provider was not sure what was causing the pain, but prescribed PERCOCETS as needed until patient could be evaluated by her Rheumatologist. Patient denies similar pain affecting her right upper extremity and shoulder. She denies recent trauma, except she recently fell in the garden and hit her right knee; does not think she caught herself using her upper extremities. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions except short-lived aching at vaccination site. Patient denies any angioedema, rashes, cardiorespiratory, or GI symptoms. She has noted a "dry mouth" over the past 2 days (onset prior to initiation of PERCOCET.), otherwise no other new symptoms. Patient reports allergies to Sulfa, AUGMENTIN, ACTONEL and FOSAMAX (itching, rashes or both). She does not tolerate NAPROSYN. EXAM per Rheumatologist on 23 APR: Musculoskeletal system: General/bilateral - Musculoskeletal system: Skin overlying bilateral shoulder and chest without erythema or warmth. No notable swelling of bilateral shoulders or anterior chest wall. However, fullness and TTP of (R) trapezius, (R) deltoid and (R) pectoralis muscle. Pain limiting (R) shoulder abduction, flexion, internal and external rotation. Positive liftoff, Neer's Hawkins, Jobe's.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: RHD beneficiary who developed right upper arm pain within 24 hours following receipt of Tdap (right arm) and PNEUMOVAX (left arm) vaccines on 18 APR 2012. Previous Td vaccine received on 3/19/2007. Patient denies anything unusual about vaccine administration technique, and dose not recall unusual pain during vaccine administration. Patient denies any unusual or persistent bruising, redness, swelling, or warmth at vaccination site. On day of vaccine receipt, noted "usual" aching pain in right deltoid area. Patient often experiences that type of pain after vaccinations and tries to "work it out". The day following vaccinations her right shoulder became more painful with a "constant throbbing" pain reaching a pain intensity of about 8/10. The pain sometimes is triggered by palpation to the right pectoral area and sometimes is noted in her right scapula and up into her neck. Sometimes it feels like a "vise" and other times it is so intense that it is like an "electric shock". She denies any numbness/tingling or weakness or her right upper extremity. Her pain increases with any movement - writing, opening a jar, turning door handle and when she used her left arm to cover a sneeze, she experienced pain in her right upper extremity. Pain leading to limitations with ADLs and interfering with sleep. Patient has not self treated as she is already taking a number of medications for arthritis/symmetric polyarticular inflammation, including ibuprofen 400 mg three times per day. Patient sought evaluation last p.m.; she said the evaluating provider was not sure what was causing the pain, but prescribed PERCOCETS as needed until patient could be evaluated by her Rheumatologist. Patient denies similar pain affecting her right upper extremity and shoulder. She denies recent trauma, except she recently fell in the garden and hit her right knee; does not think she caught herself using her upper extremities. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions except short-lived aching at vaccination site. Patient denies any angioedema, rashes, cardiorespiratory, or GI symptoms. She has noted a "dry mouth" over the past 2 days (onset prior to initiation of PERCOCET.), otherwise no other new symptoms. Patient reports allergies to Sulfa, AUGMENTIN, ACTONEL and FOSAMAX (itching, rashes or both). She does not tolerate NAPROSYN. EXAM per Rheumatologist on 23 APR: Musculoskeletal system: General/bilateral - Musculoskeletal system: Skin overlying bilateral shoulder and chest without erythema or warmth. No notable swelling of bilateral shoulders or anterior chest wall. However, fullness and TTP of (R) trapezius, (R) deltoid and (R) pectoralis muscle. Pain limiting (R) shoulder abduction, flexion, internal and external rotation. Positive liftoff, Neer's Hawkins, Jobe's.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling
Clinical narrative: Increased swelling in joints, most pronounced in DIP joints of fifth fingers bilaterally.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Full blood count normal, Headache, Local swelling
Clinical narrative: Fever 102, local erythema/swelling, diffuse myalgias & joint pain, headache.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test normal, Myalgia, Pyrexia
Clinical narrative: Fever 102, local erythema/swelling, diffuse myalgias & joint pain, headache.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: Vaccine administered. Pt. called 25-30 minutes after he left clinic. Pt. said his chest was tight and he had a little difficulty breathing. Pt went to Dr's office about five minutes away. Pt was treated for an asthma attack and released.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Evening of injection site became raised, warm, red. The following day (L) arm became (painful 6 to 10 rating & redness moved up to shoulder, couldn't raise arm at all. Sx's are somewhat improved today. 4-24-12 arm continues to be hot, red & 4/10 painful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: 3-4" by 1" raised rash migrating from injection site. Pt c/o pruritis associated with rash. MD gave antivirals PO at f/u visit.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Lethargy
Clinical narrative: Received TD left arm on 4/23/12, called at approximately 630 pm 4/24/12 reporting "lethargy", no other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The day after shots both deltoids were very swollen, erythematous and tender. Swelling started decreasing 2 days later. Seen on 3rd day after injections.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (L) arm with nickel size red indurations hot to touch at vaccine site. Give 1 tsp BENADRYL, apply ice & of becomes painful give MOTRIN, to be seen if increased swelling, redness or fever. No fever.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Pt's left arm - swollen & itching 10 days after the vaccination & got better after couple of days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Patient called physician about localized swelling no pain or fever. No treatment was given. Office visit offered patient didn't come in. Occurred next day lasted several days.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram normal, Pericardial disease, Troponin normal
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 28-year-old male subject who had no significant medical history was found to have unspecified disease of pericardium 16 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 April 2009. The subject received the following vaccines on 27 March 2009: Anthrax vaccine (manufacturer and lot number not reported) and Influenza Vaccine (manufacturer and lot number not reported). On 15 April 2009 the subject had a troponin I performed which was normal and an electrocardiogram (ECG) which was normal. An echocardiogram was performed and the results were not available. On 20 April 2009 the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Troponin normal
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 29-year-old male subject who had no significant medical history was found to have chest pain, unspecified 29 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 11 May 2011. On 24 May 2011 the subject had an abnormal electrocardiogram. On 25 May 2011 the subject had a normal troponin I level and a normal echocardiogram. The diagnosis of chest pain, unspecified was made on 09 June 2011. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 22-year-old male subject who had no significant medical history was found to have non-specific myocarditis 15 days after receiving an injection of ACAM2000 (lot of number, route and site of administration not reported) on 07 February 2012. On 17 February 2012 the subject had an abnormal troponin I level of 4.37 and an abnormal electrocardiogram. The subject had an echocardiogram on 19 February 2012 was normal. The diagnosis of non-specific myocarditis was made on 22 February 2012. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Antibody test negative, Blood glucose normal, Chest X-ray, Culture negative, Dehydration
Clinical narrative: Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count normal, Gram stain negative, Headache, Hypotension, Intensive care
Clinical narrative: Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Lumbar puncture normal, Meningococcal infection, Protein total decreased, Pyrexia, Rash erythematous
Clinical narrative: Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Rash generalised, Vomiting, White blood cell count increased
Clinical narrative: Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Laboratory test normal, Lumbar puncture normal, Meningococcal bacteraemia, Protein total increased, Pyrexia
Clinical narrative: Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Rash erythematous, Rash generalised, Vomiting, White blood cell count increased
Clinical narrative: Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Chest X-ray, Dizziness, Electrocardiogram, Excoriation, Full blood count
Clinical narrative: Began with low grade fever about 12:00h, became worse. Got up, very light headed and then had full syncopal event lasting at least 20 to 30 seconds with nasal trauma, lacerations to nose, lips, broken tooth and abrasions to face and chin.  Multiple sutures inside lip, outside lip (was through and through) and to nose. Will require dental prosthetic work.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Injury, Laceration, Lip injury, Pyrexia, Suture insertion
Clinical narrative: Began with low grade fever about 12:00h, became worse. Got up, very light headed and then had full syncopal event lasting at least 20 to 30 seconds with nasal trauma, lacerations to nose, lips, broken tooth and abrasions to face and chin.  Multiple sutures inside lip, outside lip (was through and through) and to nose. Will require dental prosthetic work.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Syncope, Tooth injury
Clinical narrative: Began with low grade fever about 12:00h, became worse. Got up, very light headed and then had full syncopal event lasting at least 20 to 30 seconds with nasal trauma, lacerations to nose, lips, broken tooth and abrasions to face and chin.  Multiple sutures inside lip, outside lip (was through and through) and to nose. Will require dental prosthetic work.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash
Clinical narrative: PATIENT HAS BUMPS ON RIGHT SIDE OF NECK, SHOULDER, HEAD (SMALLPOX GIVEN IN LEFT ARM).
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV, MNQ, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: See attachment
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV, MNQ, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Pallor, Rash erythematous
Clinical narrative: See attachment
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV, MNQ, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: See attachment
Age: 1.07
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever up to 101, redness and swelling at the injection site and slight loss of appetite.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Vomiting
Clinical narrative: Headache that has not gone away; vomiting; diarrhea; fatigue; soreness of the joints.
Age: 1.37
Sex: M
Vaccine: DTAP, FLUX, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme Minor, may be from prior URI, vaccinations or possible HSV.