chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: REDNESS, SWELLING, HIVE-LIKE REACTION IMMEDIATELY BELOW SITE OF INJECTION.  SIGNIFICANT IN SIZE - ABOUT 3" X 2" AREA.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Abnormal behaviour, Body temperature increased, Choking, Irritability, Respiration abnormal
Clinical narrative: In the afternoon he started having a low grade temp what I know is normal. I gave him 0.4 mL of Infant Tylenol at around 4 PM. Later on that evening he started to be more fussy. At around 11:30 PM he suddenly projectile vomitited. He fell asleep soon after that. The next morning on 12/03 he ate some breakfast and while I was holding him he again suddenly projectile vomited all over. That was more than I've ever seen. He also had a temp of 102 most of the day. In the evening I took him to the ER and they sent us back home after some observation. That night he seemed to not be able to breathe right and choke on himself. He was sleepy and just not as happy as usual.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Somnolence, Vomiting projectile
Clinical narrative: In the afternoon he started having a low grade temp what I know is normal. I gave him 0.4 mL of Infant Tylenol at around 4 PM. Later on that evening he started to be more fussy. At around 11:30 PM he suddenly projectile vomitited. He fell asleep soon after that. The next morning on 12/03 he ate some breakfast and while I was holding him he again suddenly projectile vomited all over. That was more than I've ever seen. He also had a temp of 102 most of the day. In the evening I took him to the ER and they sent us back home after some observation. That night he seemed to not be able to breathe right and choke on himself. He was sleepy and just not as happy as usual.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Throat tightness
Clinical narrative: Fast heart rate, chills, throat closure.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Computerised tomogram normal, Ear pain, Eye oedema, Eyelid ptosis, Hypoaesthesia
Clinical narrative: Bell's Palsy - symptom of pain behind ear started 11/30/11. Eye edema numbness, tingling of face 12/1/11. 12/2/11 seen in E.D., acyclovir and prednisone admin. Recovering - still has mouth -eye drooping.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia, VIIth nerve paralysis
Clinical narrative: Bell's Palsy - symptom of pain behind ear started 11/30/11. Eye edema numbness, tingling of face 12/1/11. 12/2/11 seen in E.D., acyclovir and prednisone admin. Recovering - still has mouth -eye drooping.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in jaw, Pyrexia, Retching
Clinical narrative: Initial case was received on 23 September 2010 from a healthcare professional. A 69 year old female patient received on 20 September 2010 a right deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3617AA). A few hours after the vaccination the patient experienced a "headache, dry heaves, pain in jaw and slight fever." The patient had no illness at the time of the vaccination. Her pre-existing medical conditions included asthma. She had no known allergies. Her concomitant medications included "PULMACORT" and other unspecified medications. She had received "FLUZONE" on an unspecified date "in the past"." The patient's recovery status was unknown. Follow-up information was received from a health care professional on 18 October 2010. The patient had no reported adverse events following prior vaccinations. The patient was reported to be "50%" better in 12 hours and recovered in 48 hours. This case is linked to 2010-05340 by the reporter. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Sore Throat, Nasal congestion, Body aches, x 3 days, headache x 2weeks  Fatigue x approx 10 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Mother noticed arm red, swollen, and warm to the touch yesterday. Called MD. Has been given pt Benadryl, Tylenol, and ice pack to site.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Aunt stated client developed a fever, nausea, redness and swelling at the injection site on Saturday morning.
Sex: U
Vaccine: FLUX
Symptoms: Muscular weakness
Clinical narrative: This literature report (initial receipt 18-Nov-2011) concerns a healthy patient aged in the mid 40's. The patient received trivalent inactivated influenza vaccine and developed neuromuscular weakness one day later. The event outcome was not reported.
Age: 61.0
Sex: U
Vaccine: FLUX
Symptoms: Central nervous system inflammation, Condition aggravated
Clinical narrative: This literature report (initial receipt 18-Nov-2011) concerns a 61-year old patient, who had unknown past medical history. The patient received AFLURIA and developed an exacerbation of idiopathic inflammation disease of CNS (central nervous system) 10 days later. The event outcome was not reported. Reporter's comments: The reporter considered event to be unlikely in relation to the suspect drug.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles, Pruritus
Clinical narrative: Rectangular rash 6 x 14 cm at injection site 2 days after administration oval central raised granular texture/early flat coalesced vesicles. Pruritic.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Maternal exposure during pregnancy, Rash
Clinical narrative: Pt reports she developed, rash and shortness of breath. Presented to Emergency Room where she was treated, and then sent to L & D for monitoring.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF culture negative, Diplopia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Diplopia began approximately 2 days after flu shot with progressive weakness. Admitted to hospital on 11/28/11 with 6th cranial nerve palsy, right sided facial droop. Motor strength 4/5 upper & lower extremities. She received IVIG therapy. Discharged after 5 day inpatient visit with plan for outpatient PT & OT.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis, VIth nerve paralysis
Clinical narrative: Diplopia began approximately 2 days after flu shot with progressive weakness. Admitted to hospital on 11/28/11 with 6th cranial nerve palsy, right sided facial droop. Motor strength 4/5 upper & lower extremities. She received IVIG therapy. Discharged after 5 day inpatient visit with plan for outpatient PT & OT.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Cerebral ataxia, Nuclear magnetic resonance imaging, Viral infection
Clinical narrative: Received FLUMIST. Next day or so developed viral symptoms. 3 days later developed cerebellar ataxia.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Delayed muscle pain, especially at site of injection.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Feeling abnormal, Limb discomfort, Nausea
Clinical narrative: Pt called to let us know that approx 6 hrs after shot he experienced chills, nausea, diarrhea, fat "bad" arm swelling & discomfort.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Pt called to let us know that approx 6 hrs after shot he experienced chills, nausea, diarrhea, fat "bad" arm swelling & discomfort.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: (R) deltoid area has area of redness initially w/ "little fine bumps". Today is just slightly red, not raised, not itchy (it was). Approx 60 mm across in size.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: After receiving vaccine booster, patient ended up going to ED for a local reaction. Swelling and pain at site of injection. Dx'd as mild allergic reaction, discharged to home with allergy treatment plan.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Blood test, Diplopia, Eye pain, Lumbar puncture
Clinical narrative: Within three weeks of a herpes zoster vaccination, patient suffered binocular diplopia involving right cranial nerve palsy and severe periorbital pain around the right eye. Extensive tests eliminated other causes for this adverse event.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Within three weeks of a herpes zoster vaccination, patient suffered binocular diplopia involving right cranial nerve palsy and severe periorbital pain around the right eye. Extensive tests eliminated other causes for this adverse event.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash erythema on site of vaccination, given IPV and DTaP at site LRI thigh. Patient was given Rx for BENADRYL & BACTRIM.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema, Pain, Skin warm
Clinical narrative: Received vaccines 11/22/11 at 7pm, awoke with redness and pain, seen in UC 11/25/11 with 9 x 13 cm erythema with edema, warm to touch. Tx'd with KEFLEX for cellulitis ED 11/27 & 11/28 abx changed to clindamycin wound responding.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count normal, Wound
Clinical narrative: Received vaccines 11/22/11 at 7pm, awoke with redness and pain, seen in UC 11/25/11 with 9 x 13 cm erythema with edema, warm to touch. Tx'd with KEFLEX for cellulitis ED 11/27 & 11/28 abx changed to clindamycin wound responding.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash generalised, Skin exfoliation
Clinical narrative: Woke up morning after immunization with sensation of itching. By 11/18/2011 face was swollen, erythematous, itching. Doctor diagnosed allergic reaction. Returned to doctor on 11/21/2011 with full body rash, peeling skin on face and hands. Per patient, doctor diagnosed Stevens-Johnson reaction.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Stevens-Johnson syndrome, Swelling face
Clinical narrative: Woke up morning after immunization with sensation of itching. By 11/18/2011 face was swollen, erythematous, itching. Doctor diagnosed allergic reaction. Returned to doctor on 11/21/2011 with full body rash, peeling skin on face and hands. Per patient, doctor diagnosed Stevens-Johnson reaction.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Injection site erythema, Injection site haematoma, Injection site reaction, Injection site swelling
Clinical narrative: Severe arm muscle pain, Excruciating shoulder pain, severe swelling, redness, bruising, and hot to the touch at injection site, muscle weakness in arm - can't lift or grasp anything, fatigue...all symptoms remaining still 7 days later.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site warmth, Muscular weakness, Musculoskeletal pain, Myalgia
Clinical narrative: Severe arm muscle pain, Excruciating shoulder pain, severe swelling, redness, bruising, and hot to the touch at injection site, muscle weakness in arm - can't lift or grasp anything, fatigue...all symptoms remaining still 7 days later.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives with urticaria over extremities that extended to trunk.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Swelling around the right upper collar bone and neck.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Reaction to preservatives
Clinical narrative: Itching and it increased from the site of the injection to just below the elbow. The site was red and swollen. Dr. informed patient that she is allergic to thimerosal. Dr. perscribed smoothing cream to help with the itching.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Hives/red raised bumps on chest and both arms. Tried to see Dr., they informed her to take Benadryl.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood iron decreased, Blood test abnormal, C-reactive protein increased, Computerised tomogram abnormal
Clinical narrative: Extreme pain in legs, back of knees, thighs, hips, low-grade fever.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyrexia, Red blood cell count decreased
Clinical narrative: Extreme pain in legs, back of knees, thighs, hips, low-grade fever.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Extreme pain in legs, back of knees, thighs, hips, low-grade fever.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatinine normal, Blood glucose normal, Borrelia test negative
Clinical narrative: Rapid onset aching, pain in all 4 extremities and hips. Intermitent extreme pain, fatigue. Unable to work. All testing negative. Diagnosed with Fibromyalgia on 11/30/2011.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Electromyogram normal, Fatigue, Fibromyalgia, Full blood count normal
Clinical narrative: Rapid onset aching, pain in all 4 extremities and hips. Intermitent extreme pain, fatigue. Unable to work. All testing negative. Diagnosed with Fibromyalgia on 11/30/2011.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Liver function test normal, Metabolic function test normal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Rapid onset aching, pain in all 4 extremities and hips. Intermitent extreme pain, fatigue. Unable to work. All testing negative. Diagnosed with Fibromyalgia on 11/30/2011.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Renal function test normal, Rheumatoid factor negative
Clinical narrative: Rapid onset aching, pain in all 4 extremities and hips. Intermitent extreme pain, fatigue. Unable to work. All testing negative. Diagnosed with Fibromyalgia on 11/30/2011.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Rash
Clinical narrative: Rash on torso, felt hot.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Poor quality sleep
Clinical narrative: Patient reported that she is still experiencing aching pain at injection site. It wakes her up at night all she can take is ibuprofen/Naproxen. No insurance can not see Dr.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Patient call center and reports shortness of breath, and "tightness in her chest". Patient sent to emergency room.
Age: 1.34
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt developed an approx 10 x 10 cm area of erythema surrounding the injection sites with a single wheal on it. No apparent dyspnea, no tachypnea. No facial swelling & no wheezing. Chest sounded CTAB. Left thigh only.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Pt with redness no warmth at site of vaccine administration.
Age: 3.0
Sex: U
Vaccine: FLUN3
Symptoms: Erythema, Oedema peripheral, Pruritus, Swelling face
Clinical narrative: Child received FLUMIST #2 on 11/28/11. Swelling of face, hands, itching. Redness of cheeks evening of vaccine. Seen by M.D. on 12/1/11. Sx resolving duration days.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local swelling
Clinical narrative: Pt. returned for booster 11-30-11 & reported localized swelling "golf ball size" with redness, firmness, & tenderness at injection site. Swelling persisted x 1 week - tenderness x 2 weeks.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receiving flu vaccine (R) shoulder and arm swelled became red and warm. BENADRYL & ibuprofen given and helped.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Onset of rash 2-3 days after vaccine admin. Progressing from thighs to abdomen/under breast & to bilat arms. No pruritus. No burning sensation. Given DEPO MEDROL 80 mg IM today. TMC 0.1% BID cream to involved areas. ZYRTEC 10 mg PO QD x 7 day.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Injection site erythema, Nausea, Pyrexia, Vision blurred
Clinical narrative: A few hours after vaccination c/o nausea and fever. Left work early. Later noted red arm from injection site down to forearm. At 2am 11/30/11 c/o increased heart rate (30bpm), blurry vision and persisting fever & nausea. Called her primary MD at the time but felt better later. No MD visit.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Fever started 2 days following vaccine and lasted 3 days - fever was controllable with MOTRIN. Today client has red welts that itch on (R) arm, chest abdomen and both legs. (R) hand is swollen and red. OBGYN advised her to follow-up with primary physician.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Fever started 2 days following vaccine and lasted 3 days - fever was controllable with MOTRIN. Today client has red welts that itch on (R) arm, chest abdomen and both legs. (R) hand is swollen and red. OBGYN advised her to follow-up with primary physician.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth, Joint range of motion decreased
Clinical narrative: Pt. received flu shot at mass flu clinic on 10/25/11. Saw PMD on 11/1/11 with c/o sore arm. MD documented (lt) upper arm with 2" x 3" raised, firm nodule, sl. wm to touch, mild erythema. ROM shoulder with decreased flexion secondary stiffness, can lift arm above head, grip strong, no arm/finger tenderness. Pt was given MEDROL dose pk & LORTAB for pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Pain in extremity
Clinical narrative: Pt. received flu shot at mass flu clinic on 10/25/11. Saw PMD on 11/1/11 with c/o sore arm. MD documented (lt) upper arm with 2" x 3" raised, firm nodule, sl. wm to touch, mild erythema. ROM shoulder with decreased flexion secondary stiffness, can lift arm above head, grip strong, no arm/finger tenderness. Pt was given MEDROL dose pk & LORTAB for pain.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Irritability
Clinical narrative: Fever developed the same day shots were given. Then blister formed on arm and popped, which drained clear fluid. Area is red, swollen, and warm to the touch. Pt is also irritable. Mom doesn't measure fever, just gives ibuprofen & TYLENOL when pt feels warm. Treat with BENADRYL, hot packs and cephalexin 250mg/5mL to 5 mL PO every 8 hrs x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever developed the same day shots were given. Then blister formed on arm and popped, which drained clear fluid. Area is red, swollen, and warm to the touch. Pt is also irritable. Mom doesn't measure fever, just gives ibuprofen & TYLENOL when pt feels warm. Treat with BENADRYL, hot packs and cephalexin 250mg/5mL to 5 mL PO every 8 hrs x 10 days.
Age: 49.0
Sex: M
Vaccine: DTP
Symptoms: Injected limb mobility decreased, Injection site anaesthesia, Injection site nodule, Pain, Rash
Clinical narrative: Reports that after his Td shot on Sept 22 the site of the injection still numb and with a knot that bothers him to raise his arm. He also report breaking down in a rash. He reports that he has taken Tetanus shots before and had never cause him any problems. He said that the rash has subsided and gone but his Rt deltoid area is sore. Denies any fever or chills.
Age: 1.36
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Dyskinesia, Febrile convulsion, Gaze palsy, Urine analysis normal
Clinical narrative: On 5/18/11 1938 pt was seen at Hospital for febrile seizure (1st seizure) occurred at 18:45. Mom noticed eyes rolled back hands & leg shaking ambulance transferred to hospital.
Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Flushing, Lacrimation increased, Myalgia
Clinical narrative: Within minutes of receiving flu shot developed itching feet, watery eyes runny nose, chills, sore sinuses. C/O burning sensation & muscle soreness. Nausea & vomiting 48 hrs later. At OV 10/17/11 noted to have flushed, warm face, mild erythema of oropharynx 98 degree temp. Tx with prednisone 10 mg 6 day dose pack. Full recovery.
Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Pharyngeal erythema, Pruritus, Rhinorrhoea, Sinus headache
Clinical narrative: Within minutes of receiving flu shot developed itching feet, watery eyes runny nose, chills, sore sinuses. C/O burning sensation & muscle soreness. Nausea & vomiting 48 hrs later. At OV 10/17/11 noted to have flushed, warm face, mild erythema of oropharynx 98 degree temp. Tx with prednisone 10 mg 6 day dose pack. Full recovery.
Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Skin warm, Vomiting
Clinical narrative: Within minutes of receiving flu shot developed itching feet, watery eyes runny nose, chills, sore sinuses. C/O burning sensation & muscle soreness. Nausea & vomiting 48 hrs later. At OV 10/17/11 noted to have flushed, warm face, mild erythema of oropharynx 98 degree temp. Tx with prednisone 10 mg 6 day dose pack. Full recovery.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Numbness to (L) arm from injection site to wrist. Symptoms resolved by appt with is on 11-10-11 at 9:30 am.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Cough, Dyspnoea, Wheezing
Clinical narrative: Wheeze, cough, SOB. Pt has egg white allergy but parent didn't note on FLUVAX form.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Pt has rash & itching (L) arm 5 1/2 cm x 3 cm reddened & swollen area around injection site - hurts under (L) arm - instructed pt to go PMD or ER.
Age: 11.0
Sex: M
Vaccine: DT, MNQ
Symptoms: Metabolic function test, Unevaluable event
Clinical narrative: Patient had 2 vaccines administered on 11-28-11 MENACTRA and adult Td (DECAVAC).
Age: 44.0
Sex: M
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Injection site pain
Clinical narrative: Pain with injection subsided then 4 days later pain at site last for approximately 4 week still tender never had redness - Lt deltoid.
Age: 86.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Cough, Headache, Hypoaesthesia, Increased upper airway secretion
Clinical narrative: Vaccine given at 3P Nov 17 - arm numb & sore. Nov 18 fever 100.6, sore back, very sore left thigh, legs very weak, headache, phlegm with cough. Nov 20 temp. normal, legs still weak & arm still sore.
Age: 86.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Vaccine given at 3P Nov 17 - arm numb & sore. Nov 18 fever 100.6, sore back, very sore left thigh, legs very weak, headache, phlegm with cough. Nov 20 temp. normal, legs still weak & arm still sore.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Pt called on 11-29-11 stating he had reaction 2 days after injection - 11-29-11 was day 7. Pt c/o numbness, pain in arm starting at elbow and traveling to pointer and middle finger.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Eye irritation
Clinical narrative: 24 hrs after vaccination developed "deep cough, chills, eye burning", stayed in bed for 3-4 days. Feeling fine now. Never checked temperature.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test negative, Paraesthesia, Tremor
Clinical narrative: 4 days after vaccination c/o hands shaking, body shaking, tingling.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Wife called 9/27/11 to report that he had a fever (101.4) in AM, legs aching on 9/25/11. Referred to MD. 12/2/11 I called to follow up, wife did not remember this episode, husband is fine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: 4 or 5 hrs after vaccination - fever 103 degrees, chills, headache, joint pain lasting 24 hrs.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Discomfort, Erythema, Pain in extremity, Staphylococcal infection
Clinical narrative: Father states that child voiced discomfort and sore arm at school on Friday. No swelling or redness noted. Seen by school nurse and received Tylenol. On Friday evening, elevated temperature noted.  Seen by physician on Saturday after parent noted a "saucer sized reddened area on Lt arm.  Dx of staph infection' and antibiotics prescribed.  Father states that redness is decreasing and child is back in school today.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in left arm after shot. During the night I got a sharp pain in my hip that went away with Advil. But the next day I got pain in my left calf that lasted 1 month, got better for 3 weeks and has returned. I cannot stretch or even bend down without an increase in pain.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Computerised tomogram, Computerised tomogram head, Dizziness, Headache, Hearing impaired
Clinical narrative: Ongoing dizziness, headache, visual and auditory sensitivity with facial numbness with scalp sensitivity and headache.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypoaesthesia, Pain of skin, Visual impairment
Clinical narrative: Ongoing dizziness, headache, visual and auditory sensitivity with facial numbness with scalp sensitivity and headache.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Left arm pain from neck to wrist.  Unable to move arm at all X 2 days.
Age: 29.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Rash
Clinical narrative: Patient noted rash on trunk.  No itching.  Rash still apparent on Monday 12/5 when he returned to health dept for evaluation.  Rash has not gotten worse since first noted.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Heart rate increased, Swelling, Urticaria
Clinical narrative: Patient reported "hives on shoulder and into the inside of arm. Also rapid heart beat upon exertion". She took Benadryl, called the Nurse. Then followed recommedations to apply ice.  The rapid heart beat resolved. Redness and swelling persisted at original hive sites.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm sore, red and swollen at injection site. Went to Urgent Care twice and Dr. once for pain. Antibiotics and Benadryl.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: L deltoid hard, red and hot ~ 2 to 2.5 inches x 4 to 4.5 inches, fatigue, body aches.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: I had my flu shot and developed bad joint pain the day after and over the last two days, I have developed neck, hand, and foot pain.  My hands and feet develop numbness and tingling through the night and are swollen by the morning.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: I had my flu shot and developed bad joint pain the day after and over the last two days, I have developed neck, hand, and foot pain.  My hands and feet develop numbness and tingling through the night and are swollen by the morning.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Swelling face
Clinical narrative: Lips blue, face swollen. went to the Dr. put on medication, did know know the name.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Feeling abnormal, Injection site warmth, Pyrexia, Rash
Clinical narrative: INJECTION SITE WARM TO TOUCH.  FEVER, FUZZINESS, AND RASH.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Immediately and shortly after injection pt. had pain in her left arm. She had trouble moving her arm and had been to the ER three times and received treatment with cold and warm packs, ibuprofen, antibiotics and Benadryl.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP
Symptoms: Neisseria test positive, Pneumonia
Clinical narrative: Visit sickcall for afebrile pneumonia.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: Mmuscle weakness in upper arm where shot was injected -- weakness is still present 6 weeks later.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Infection, Pain, Swelling
Clinical narrative: Red, swollen, sore, got infected and was put on antibiotics, steroids and took Benadryl for the itching.
Age: 25.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: It began in the morning with muscle aches, which progressed to chills and a 102 degree fever in the evening.  The fever came down to a low grade (around 100 degrees) by the morning of 10/31/11 with repeated doses of acetaminophen.  The right arm, which is the arm in which the Pneumovax was given, was sore, red, and swollen.  Symptoms completely resolved by the morning of 11/1/11.
Age: 25.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: It began in the morning with muscle aches, which progressed to chills and a 102 degree fever in the evening.  The fever came down to a low grade (around 100 degrees) by the morning of 10/31/11 with repeated doses of acetaminophen.  The right arm, which is the arm in which the Pneumovax was given, was sore, red, and swollen.  Symptoms completely resolved by the morning of 11/1/11.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen, pain.
Age: 38.0
Sex: M
Vaccine: ANTH, RAB, SMALL
Symptoms: Chest pain, Chills, Echocardiogram abnormal, Electrocardiogram abnormal, Myalgia
Clinical narrative: Pericarditis with chest pain, EKG changes, and echocardiogram abnormalities in addition to fevers, rigors and systemic myalgias.
Age: 38.0
Sex: M
Vaccine: ANTH, RAB, SMALL
Symptoms: Pericarditis, Pyrexia
Clinical narrative: Pericarditis with chest pain, EKG changes, and echocardiogram abnormalities in addition to fevers, rigors and systemic myalgias.
Age: 28.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site mass, Paraesthesia oral, Pruritus, Vaccination site warmth
Clinical narrative: Client states she felt a slight tingling in her lips on her drive home. She took Zyrtec 10mg @ HS. In AM had Silver dollar size lump at vaccine site which was red and warm to touch. States she had itching on her face and back and took Benadryl 25 mg and Zyrtec 10mg which relieved most of her symptoms. States she still has a little bit of itching and the lump has gone down in size.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Shoulder (joint) and arm pain. Shooting pain when lifting arm, or crossing the body with arm. Ongoing since time of flu shot on November 4, 2011. Starting physical therapy 12/7/11.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Pain in extremity, Skin discolouration, Ultrasound scan
Clinical narrative: 2 days after getting the flu vaccination arm started hurting.  She looked at arm and it was black and blue and there was a big lump the size of a tangerine. She went to the doctor and they did an ultrasound to R/O blood clot.  She is fine now but still has a lump but it is smaller the size of a golfball.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture negative, Computerised tomogram abdomen normal, Headache, Hypotension, Lumbar puncture normal
Clinical narrative: Fever, headache, stiff neck, hypotension, arm pain within 4 hours of vaccination with Fluzone High Dose -Lot UH488AC- Sanofi- admitted to her local hospital-had multiple normal cultures and LP - all no growth - needed Levophed for BP - Covered with IV Zosyn - fully recovered and discharged on Day 4.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Fever, headache, stiff neck, hypotension, arm pain within 4 hours of vaccination with Fluzone High Dose -Lot UH488AC- Sanofi- admitted to her local hospital-had multiple normal cultures and LP - all no growth - needed Levophed for BP - Covered with IV Zosyn - fully recovered and discharged on Day 4.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Oedema peripheral, Pain, Tenderness
Clinical narrative: Increased swelling of arm and tenderness.  Currently golf ball sized lump approximately two inches below injection site.  Painful to move arm.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: Body rash, observed overnight at ER. Diagnosed w/ shingles.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Pyrexia
Clinical narrative: Initial report was received on 05 October 2010 from a health care professional which involved a cluster of four patients who experienced adverse events after receiving FLUZONE, lot number UT3570DA. This report represents one patient and other three patients have been captured in case numbers 2010-05758, -05759, and -05760. An eight-month-old female patient had received a first dose intramuscular injection of FLUZONE, lot number UT3570DA on 21 September 2010, and an unspecified amount of time later on the day of vaccination, the patient developed a fever of 102 and was cranky. The patient had not previously received any INFLUENZA vaccinations. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2010-05761.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: Initial report received from a company representative who had received the original report from a nurse on 16 November 2010. A 6-year-old male patient had received a 0.5 mL dose of FLUZONE (lot number U3744AA) from a multi-vial bottle on 08 November 2010. Approximately 5 days post-vaccination, the parents noticed a facial muscle "tick" in the patient. It was not reported whether the patient required medical evaluation or treatment. The patient's recovery status was not reported. Follow-up information was received from a health care professional on 28 December 2010. The event recovered on an unspecified date. No additional information was reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Emotional distress, Polyarthritis
Clinical narrative: Very aggressive polyarthritis that has lasted around 6 months, although it is currently much better.  This caused significant mental trauma and hindered my ability to work.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor positive
Clinical narrative: Very aggressive polyarthritis that has lasted around 6 months, although it is currently much better.  This caused significant mental trauma and hindered my ability to work.
Age: 0.43
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Febrile convulsion
Clinical narrative: Prolonged seizure fever (approximately 30 minutes) associated with a very high fever (>104 degrees).
Age: 0.43
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count normal, Metabolic function test, Metabolic function test normal, Pyrexia
Clinical narrative: Prolonged seizure fever (approximately 30 minutes) associated with a very high fever (>104 degrees).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching at injection site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Furuncle
Clinical narrative: Several boils - one under each arm. (1) day after the shot & 2nd three days later > not at inj site under arm. Took an antibiotic clindamycin 150 TID x 5d.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching on injection site. Treatment (BENADRYL, TYLENOL).
Age: 0.59
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Urticaria
Clinical narrative: Patient received influenza vaccine 10/26/11. 2 hours after patient received vaccine, hives developed generalized to body and swelling to periorbital area relieved within 36 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular, Scab
Clinical narrative: 1 week after getting vaccine developed a rash left side of neck at hairline. In linear distribution craniocaudal cluster of approximately 6 lesions maculopapular with central scabbed area.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Chills/nausea/vomit - 8 PM. Passed out.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness on left arm, hot to touch.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Rash, Urticaria
Clinical narrative: 12/5/2011 Received shingles vac 11/29/2011. Started to break out with rash in Right Lumbar 1 dermatome. Started to blister approximately 48-72 hours ago and started having pain last night. No fever or other alert symptoms. No immunocompromise risk factors. Well nourished, healthy appearing, no distress. Has red welts band-like fashion right Lumbar 1 dermatome--very confluent and starting to breakout in multiple blisters.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Arm very sore, couldn't lift it 5 days after injection. Went to ER. Dr did MRI & concluded that pt suffered a deep muscle contusion due to allergic reaction to vaccine component. Pt given pain meds & told to not lift heavy items for 2-3 days & will be sore for 2-3 weeks.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Muscle injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Vaccination complication
Clinical narrative: Arm very sore, couldn't lift it 5 days after injection. Went to ER. Dr did MRI & concluded that pt suffered a deep muscle contusion due to allergic reaction to vaccine component. Pt given pain meds & told to not lift heavy items for 2-3 days & will be sore for 2-3 weeks.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Multi-organ failure
Clinical narrative: This literature report (initial receipt 18-Nov-2011) concerns a 77 year old patient, who had a past medical history of Factor V Leiden deficiency, hyperlipidemia, diabetes, obesity and hypertension. The patient received trivalent inactivated influenza vaccine (TIV), yellow fever vaccine and a combined tetanus toxoid; reduced diphtheria toxoid and acellular pertussis vaccine. The patient developed multisystem organ failure 5 days later. The event outcome was not reported.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Asthenia, Death, Drug administered to patient of inappropriate age, Multi-organ failure, Nausea
Clinical narrative: This literature report (initial receipt 18-Nov-2011) concerns a 77 year old patient, who had a past medical history of Factor V Leiden deficiency, hyperlipidemia, diabetes, obesity and hypertension. The patient received trivalent inactivated influenza vaccine (TIV), yellow fever vaccine and a combined tetanus toxoid; reduced diphtheria toxoid and acellular pertussis vaccine. The patient developed multisystem organ failure 5 days later. The event outcome was not reported.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Off label use, Pyrexia, Septic shock
Clinical narrative: This literature report (initial receipt 18-Nov-2011) concerns a 77 year old patient, who had a past medical history of Factor V Leiden deficiency, hyperlipidemia, diabetes, obesity and hypertension. The patient received trivalent inactivated influenza vaccine (TIV), yellow fever vaccine and a combined tetanus toxoid; reduced diphtheria toxoid and acellular pertussis vaccine. The patient developed multisystem organ failure 5 days later. The event outcome was not reported.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAP, HEP, IPV, PPV, RVX
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: 3 weeks straight of screaming and crying (abnormally so).
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAP, HEP, IPV, PPV, RVX
Symptoms: Crying, Screaming
Clinical narrative: 3 weeks straight of screaming and crying (abnormally so).
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abasia, Asthenia, Blood culture positive, Injection site erythema, Myalgia
Clinical narrative: PATIENT PHONED ON 10/03/2011 STATED SYMPTOMS CAME ON AFTER INJECTION AND LASTED FOR 7 HOURS. FEELING BETTER AS OF 10/3/2011
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pallor, Pyrexia, Streptococcus test positive, Urticaria
Clinical narrative: PATIENT PHONED ON 10/03/2011 STATED SYMPTOMS CAME ON AFTER INJECTION AND LASTED FOR 7 HOURS. FEELING BETTER AS OF 10/3/2011
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture positive, Chills, Hypokinesia, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT PHONED ON 10/03/2011 STATED SYMPTOMS CAME ON AFTER INJECTION AND LASTED FOR 7 HOURS. FEELING BETTER AS OF 10/3/2011
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myalgia, Pyrexia, Streptococcus test positive, Tremor
Clinical narrative: PATIENT PHONED ON 10/03/2011 STATED SYMPTOMS CAME ON AFTER INJECTION AND LASTED FOR 7 HOURS. FEELING BETTER AS OF 10/3/2011
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Activated partial thromboplastin time, Chest X-ray, Chills, Ecchymosis, Full blood count
Clinical narrative: PT experienced fever, chills, and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extrimities set in.  PT was medevac'd to Hospital and spent 2 days in the hospital DX with vasculitis.  Released 29 Nov 11 Fit for Full Duty Asymptomatic.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Oedema, Pain in extremity, Prothrombin time, Pyrexia, Ultrasound scan
Clinical narrative: PT experienced fever, chills, and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extrimities set in.  PT was medevac'd to Hospital and spent 2 days in the hospital DX with vasculitis.  Released 29 Nov 11 Fit for Full Duty Asymptomatic.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Vasculitis
Clinical narrative: PT experienced fever, chills, and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extrimities set in.  PT was medevac'd to Hospital and spent 2 days in the hospital DX with vasculitis.  Released 29 Nov 11 Fit for Full Duty Asymptomatic.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Malaise, Myalgia, Paraesthesia
Clinical narrative: Severe Diarrhea, Muscle Soreness, Malaise, bilateral arms tingling.
Age: 2.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Sudden high fever, leading to a febrile seizure/convulsions, vomiting, trip to the ER by 3:00 AM 12/4/2011, at the ER, high doses of Tylenol and Motrin were given to resolve the fever.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal, Paraesthesia
Clinical narrative: Tingling in hands & feet, went to ER, diagnosed with Guillain-Barre, admitted to hospital for 5 days, received IVIG.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient exhibits redness and swelling on left arm at injection site, site feels warm and hard. Pt used ibuprofen and BENADRYL without symptom relief.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Heart rate increased, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, tenderness at injection site, mild reaction headache, achy, heart beating fast. TYLENOL for fever, monitor blood sugars (DM II).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 11/25/11 fever 103.5 ; rash on face, torso - "small red dots" developed 11/27/11 lasting at 48 hours. 12/3/11 - Rash reappeared face, torso, diaper area no fever.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in a 45-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to CIPRO and penicillin allergy. There were no concurrent medications. On 5 January 2011 the subject received 3rd dose of TWINRIX in the left arm. On 6 January 2011, 1 day after vaccination with TWINRIX, the subject experienced itching followed shortly by hives. The subject contacted the office on the day of reporting stating that the condition had worsened and she was advised to go to the emergency room. It was not known if the subject had done so. The subject was administered the first two doses of the TWINRIX series without incident. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The healthcare professional considered the events were possibly related to vaccination with TWINRIX. Follow up information was received on 27 January 2011 via healthcare professional. The onset of the subject's hives and itching was 06 January 2011 and resolved on an unspecified date with ZYRTEC treatment. The reporting healthcare professional did not consider the event serious. Linked cases for this subject include A0853360A, A0853363A and A0900430A.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This study was received from the investigator on 21 November 2011. A 24 year-old male subject with a history of high blood pressure and a family history of elevated cholesterol and DM (diabetes mellitus) was found to have an chest pain, unspecified 11 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 18 March 2009. The subject was evaluated in the ER (emergency room) and was hospitalized (dates not reported). The subject's discharge diagnosis was myocarditis. Relevant laboratory data on 29 March 2009 included: an abnormal Troponin I with the highest recorded value of 6.19, a normal ECG and a normal Echocardiogram. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.