chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis allergic, Eczema, Rash, Rash pruritic, Rash pustular
Clinical narrative: 11/2/03- anthrax #1- no problems 4/14/04- anthrax #2- no problems 4/18/04- developed "rashes" on palms of her hands.  They were "bunch of dots filled with water."  They felt "stinging" but not painful or pruritic.   4/21/04- developed similar appearing pustules on soles of her feet.  They also felt stinging but unlike the rashes on hands, they were mildly pruritic.   4/22/04- was seen by a health care practitioner for her rashes.  By this time, her symptoms had much improved.  She was given Lidex cream for her rashes and was given a diagnosis of "?allergic dermatitis/eczema."   4/26/04- used the Lidex cream as directed for the four three days as directed but her rashes started to worsen.   She also developed a recurrent cold sore on her left lower lip.   4/28/04- again seen by a physician and was given a diagnosis of "dermatitis" for her rashes.  She was also given Acyclovir for her cold sore and a referral to the Regional Vaccine Healthcare Center for her rashes.  By this time, her rashes have much improved and they were present only on her left hand and right foot.  The patient denied having any fever, chills, malaise, headaches, myalgia, arthralgia, or URI sxs, prior to or after the anthrax vaccination.  She stated that her rashes worsened with heat and a cool temperature eased the stinging sensation.  She denied recent use of any new skin products, detergents, or medications.  She stated that she had not had any recent field exposures.  The patient denied having any other blisters in mouth or around her genital area.  She stated that she had no previous history of recurring pruritic rashes and she denied any history of syphilis. 5/27/04- symptoms have now all been resolved.  There are no medical complaints at this time.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer, Syncope
Clinical narrative: Apparent vaccine failure:  patient broke out with lesions late in the day on 5/10/04.  By 5/11/04, I saw evidence of several hundred lesions (over 300) and offered acyclovir.  Patient took acyclovir starting 5/12.  She had two syncopal episodes, on 5/11, and 5/13.  The lesions faded quickly after initiation of acyclovir.  A number of other children who were also vaccinated in the community also developed chicken pox at the same time, according to the patient's family.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Adrenal insufficiency, Adrenocortical insufficiency chronic, Alopecia, Amnesia, Arthralgia
Clinical narrative: Dec 2000 - Pituitary tumor hemmorhaged  Jan 2001 - Surgery to remove "dead tissue" ( Diseeases diagnosed with: Addison's Disease, Adrenal Insufficiency, Pashypothyroidism, Microprolacnomia, Hypertension, Acid Reflux, Diabetes Insipidus   Most common symptoms experiencing (not limited to): chronic "continuos" headaches, constant fatigue, sleep disorders, body temperature changes, joint aches, weak immune system, skin rash (arms/chest/recently feet), memory loss, flu like symptoms (last up to five days at a time), nausea, chronic pnuemonia, body sweats, recent notice of increase hair loss, no testoserone level and low/no sex drive  Current treatments involve follow up visits to specialists: PCM/neurosurgeon/endocrinology/pain management/neurology/yearly MRI  Nurse follow up on 06/14/04 states: "Complete."  Nurse follow up on 06/18/04 states: "Complete."
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Blood testosterone decreased, Diabetes insipidus, Fatigue, Gastrooesophageal reflux disease, Headache
Clinical narrative: Dec 2000 - Pituitary tumor hemmorhaged  Jan 2001 - Surgery to remove "dead tissue" ( Diseeases diagnosed with: Addison's Disease, Adrenal Insufficiency, Pashypothyroidism, Microprolacnomia, Hypertension, Acid Reflux, Diabetes Insipidus   Most common symptoms experiencing (not limited to): chronic "continuos" headaches, constant fatigue, sleep disorders, body temperature changes, joint aches, weak immune system, skin rash (arms/chest/recently feet), memory loss, flu like symptoms (last up to five days at a time), nausea, chronic pnuemonia, body sweats, recent notice of increase hair loss, no testoserone level and low/no sex drive  Current treatments involve follow up visits to specialists: PCM/neurosurgeon/endocrinology/pain management/neurology/yearly MRI  Nurse follow up on 06/14/04 states: "Complete."  Nurse follow up on 06/18/04 states: "Complete."
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Hyperhidrosis, Hypothyroidism, Immune system disorder, Influenza like illness, Libido decreased
Clinical narrative: Dec 2000 - Pituitary tumor hemmorhaged  Jan 2001 - Surgery to remove "dead tissue" ( Diseeases diagnosed with: Addison's Disease, Adrenal Insufficiency, Pashypothyroidism, Microprolacnomia, Hypertension, Acid Reflux, Diabetes Insipidus   Most common symptoms experiencing (not limited to): chronic "continuos" headaches, constant fatigue, sleep disorders, body temperature changes, joint aches, weak immune system, skin rash (arms/chest/recently feet), memory loss, flu like symptoms (last up to five days at a time), nausea, chronic pnuemonia, body sweats, recent notice of increase hair loss, no testoserone level and low/no sex drive  Current treatments involve follow up visits to specialists: PCM/neurosurgeon/endocrinology/pain management/neurology/yearly MRI  Nurse follow up on 06/14/04 states: "Complete."  Nurse follow up on 06/18/04 states: "Complete."
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Neoplasm, Pneumonia, Rash, Sleep disorder
Clinical narrative: Dec 2000 - Pituitary tumor hemmorhaged  Jan 2001 - Surgery to remove "dead tissue" ( Diseeases diagnosed with: Addison's Disease, Adrenal Insufficiency, Pashypothyroidism, Microprolacnomia, Hypertension, Acid Reflux, Diabetes Insipidus   Most common symptoms experiencing (not limited to): chronic "continuos" headaches, constant fatigue, sleep disorders, body temperature changes, joint aches, weak immune system, skin rash (arms/chest/recently feet), memory loss, flu like symptoms (last up to five days at a time), nausea, chronic pnuemonia, body sweats, recent notice of increase hair loss, no testoserone level and low/no sex drive  Current treatments involve follow up visits to specialists: PCM/neurosurgeon/endocrinology/pain management/neurology/yearly MRI  Nurse follow up on 06/14/04 states: "Complete."  Nurse follow up on 06/18/04 states: "Complete."
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Eyelid oedema, Face oedema, Pruritus
Clinical narrative: Approximately 5 to 10 minutes after receiving injections, child began to have swelling of her lips, ears, upper eyelids, palms and soles as well as pruritis.  She never developed respiratory symptoms.   She received 0.25 mg of Epinephrine IM and 18.75 mg of Benadryl orally. Blood pressure, and respiratory rate remained stable over the next hour and swelling and pruritis diminished in all areas except eyelids.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Ejaculation disorder, Spermatozoa abnormal
Clinical narrative: The anthrax shots has affected my sperm production and ejaculatory process and I also have a daughter born with a short Femur after receiving shot.
Age: 2.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Chills, Oedema, Pyrexia, Swelling
Clinical narrative: Cellulitis after administration in Left Tricep.  Sx developed with 48 hours of administration.  Patient with edema, soft tissue swelling, fever and chills, tachycardia.
Age: 2.0
Sex: M
Vaccine: ANTH
Symptoms: Tachycardia
Clinical narrative: Cellulitis after administration in Left Tricep.  Sx developed with 48 hours of administration.  Patient with edema, soft tissue swelling, fever and chills, tachycardia.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Myalgia, Pain
Clinical narrative: pt c/o calf pain/myalgias, bilaterally sine Td booster on 3/23/04. No prior intolerance of Td booster. Denies weakness/paresthesias/strength changes.  to see PMD for hypothyroid w/u May 2004.
Sex: M
Vaccine: DTAP
Symptoms: Autism
Clinical narrative: This case was reported by an attorney and described the occurrence of autism spectrum disorder in a male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified the report. The attorney stated that on 5/3/98, the patient received Engerix B (lot # ENG4248A2). On 7/10/98, the patient received Infanrix (lot # DTPA852A2), on 9/3/98, the patient received Infanrix (lot # DTPA860A2). On 11/6/98, the patient received Infanrix (lot DTPA916A2). At an unknown time after receiving Engerix B and Infanrix vaccines, the patient developed autism spectrum disorder. The event was attributed to exposure to thimerosal from the vaccine. This case was assessed as medically serious (OMIC).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test abnormal, Sarcoma, Skin nodule
Clinical narrative: 1/20/04 Annual physician examination. Received pneumococcal vaccine polyvalent pneumovax 23 on the left upper arm. 1/21/04 Morning, noticed a mass of quarter size on the left side under jaw bone area. Rapidly expanding to tail of the parotid gland, painless, mobile. 3/16/04: Diagnosis: Myxofibrosarcomo intermediate grade, (also known as myxoid variant of malignant fibrous histocytoma).
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: REACTION UNEVALUABLE
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Crying, Irritability, Ocular hyperaemia, Pyrexia, Rhinorrhoea
Clinical narrative: 5/20/04 Vomited x 10 through night. Shaking. Fever- mom says yes but not taken. Tylenol prn. 5/20/04 no further vomiting (4A). Crying, fussy. Eyes red, nose running clear. Injection site okay. Already had runny nose. 5/21 mom states he just has a cold. No more vomiting.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Tremor, Vomiting
Clinical narrative: 5/20/04 Vomited x 10 through night. Shaking. Fever- mom says yes but not taken. Tylenol prn. 5/20/04 no further vomiting (4A). Crying, fussy. Eyes red, nose running clear. Injection site okay. Already had runny nose. 5/21 mom states he just has a cold. No more vomiting.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Right deltoid sore, red and swollen. Temperature 98.5 sore to touch. Full range of motion in right arm and shoulder.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Facial palsy
Clinical narrative: Bell's palsy staring 13 days (3/3/04) after immunization of 02/19/2004
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: A five year old boy, broken out with generalized hives, throughout, welts, raised bumps, red and pt complained of itching. Mom denies any SOB, dyspne, nor any temperature. Still ongoing during report.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: fever up to 104x24hrs then 102x48hrs. Vomited x 12hrs. Lethargic x 3days.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Eye disorder, Pallor, Pyrexia, Urinary tract infection
Clinical narrative: Within 15 min after receiving vaccine, child became frightened and scared. Child requested to stay in nurse office. Vaccine given at school. Within 1 hour child became pale. Glassy eyes. Temp 104: mother took child to emergency room at 3:15PM-- stayed in ER till 9:00 PM and diagnosed with UTI.
Age: 1.9
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia, Rash
Clinical narrative: Child presented with rash on face, stomach, arms and legs since 05/24/2004 in arm. Fever two days ago up to 102.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Pain
Clinical narrative: Client presented at PH office on 05/17/04. Received adult td on 04/28/04 right deltoid. C/o sharp shooting pain right arm/ shoulder area, approx 2 weeks post injection. No redness, pain, drainage, post injection. No muscle  atrophy noted on 05/17/2004.
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Convulsion, Dyskinesia, Dyspnoea, Somnolence, Vomiting
Clinical narrative: Probable generalized seizure during sleep. Pt put down for her AM nap and fell asleep, started gasping for air, spit up some milk and was picked up by mom. Fell back asleep for 30 min and began to have jerking movements, first right hand, then left. Then both arms. Then whole body intermittent x 2hrs. Seemed groggy for 20-30 minutes when woke up.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Localized reaction left leg.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: DTaP given on 7/28/03: left arm upper red, swollen 7"x5".
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: DTaP given on 06/02/2003, left upper arm red, swollen, warm to touch 6"x4" redness on 06/04/2003.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: DTaP (Daptacel) given in left arm on 02/05/2004. 3" x 6" red, swollen upper arm. Mild fever- 100 degrees. Cool compress Atarine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: DTaP given on 10/16/2003 left upper arm, red, firm, swollen 2.5x3.5 area on 10/17/2003. (ice, Motrin and Tylenol prn).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: DTaP given on 08/21/2003 4"x5" red, swollen, warm to touch reaction left upper arm (ice, benadryl prn)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site swelling, Oedema
Clinical narrative: Left arm started afternoon of day received vaccine with redness and raised area size of quarter and increased in size of warmth each day. Seen in office 05/12/2004 5x10cm area of erythema. 2cm central darker erythema and warmth + underlying edema--though to be large local reaction to DTaP--started on Atarax 10mg every 4 hours PRN.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Contusion, Erythema, Feeling hot, Injection site induration, Malaise
Clinical narrative: Localized burning, redness, swelling, warmth. General malaise 1-2 days after vaccine administration. Marble size lump at injection site. 7 days post vaccine-lump, bruising red, swelling.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Skin burning sensation, Swelling
Clinical narrative: Localized burning, redness, swelling, warmth. General malaise 1-2 days after vaccine administration. Marble size lump at injection site. 7 days post vaccine-lump, bruising red, swelling.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Pruritus
Clinical narrative: Injection site shows 8cmx8cm area of redness, slightly warm area scattered through out area. Pt complained of itching earlier but no itching now.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: #5 DTaP. #2 MMR, #4 IPV administered- child began itching and began to develop urticaria within 1 minute after the last immunization- epi & Benadryl adminstered per ER protocol child went to ER in ambulance.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: #5 DTaP. #2 MMR, #4 IPV administered- child began itching and began to develop urticaria within 1 minute after the last immunization- epi & Benadryl adminstered per ER protocol child went to ER in ambulance.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Injection site reaction, Rash
Clinical narrative: Received MMR and PPD on 5/10/04. PPD read as "OMM" negative on 5/12/04; no complaints. On 5/23/04 pt seen in ER for "rash to bilateral upper extremities, upper body and face. "Also states "some shortness of breath- mild." Diagnosed in ER with "adverse reaction to MMR." Taking Prednisone now for next 6 days.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Convulsion, Diarrhoea, Dyskinesia, Injection site reaction
Clinical narrative: Had shot on 5/18/04. Symptoms started within 72 hours. Fever greater than 104 degrees/ chills. Seizure-like activity (jerking of limbs, no loc). Lethargy. Facial rash. Nausea/vomiting/Diarrhea. Mom verbalized reaction to vacc. on the 26th, pt already recovering. She did not bring the pts in for treatment.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Had shot on 5/18/04. Symptoms started within 72 hours. Fever greater than 104 degrees/ chills. Seizure-like activity (jerking of limbs, no loc). Lethargy. Facial rash. Nausea/vomiting/Diarrhea. Mom verbalized reaction to vacc. on the 26th, pt already recovering. She did not bring the pts in for treatment.
Age: 0.92
Sex: F
Vaccine: DTAP, IPV
Symptoms: Blister, Erythema, Rash, Skin nodule
Clinical narrative: Development of 2 little red dots on face Thursday night. Friday-rash around mouth- Blister on lips. Friday night went to ER. Amoxil 1 tsp prescribed by ER physician.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin nodule
Clinical narrative: 2 in x 2 in- redness 1 cm x 1 cm knot.
Age: 0.42
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Convulsion
Clinical narrative: Had a seizure 5/23/04 went to ER- Hospital.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Injection site pain, Oedema
Clinical narrative: Immunizations received 5-27-04. Redness & swelling to left arm 5-29-04 with pain at site. Benadryl 12.5 mg given IM.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site inflammation, Oedema, Pyrexia
Clinical narrative: Left leg swollen, large, red, inflammed area. Ran fever within 6 hours of vaccine for 24 hours.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Pt. began to cry 4 hours after vaccine adminstration. Crying loudly over 1 1/2 hours. Pt. was given Tylenol 1 hour into period. Followed up with parent who reported back to.
Age: 7.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Erythema, Feeling hot, Skin nodule
Clinical narrative: Pt. received Td on 03/02/04 and Hep A. parent calls in to report large erythematous and indurated area in left arm (where Td was administered) on 03/04/04 states it is warm to the touch and spreading into the pts back. Referred to local urgent care.
Age: 18.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Cellulitis, Medication error
Clinical narrative: Pt inadvertently received PPV 23 instead of Meningoccal vaccine. Error was realized and Meningococcal was also give. On 5/27/04 we got a report of cellulitis on this girl. She's being treated with Keflex.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Crying, Dyspnoea, Hypokinesia, Pyrexia
Clinical narrative: 5/25/04- Vaccines given, later that evening pt began to run fever 102.2 was given Motrin and came down. Child woke up 3:30 am 5/25 crying a lot and gasping for air- Temp 104.3 given Motrin & tepid bath, temp came down. 5/24/04 7:00 am Temp = 98.9 no complaints since other than being less active than usual. Parent called to office 5/25/04 at 11:30.
Age: 43.0
Sex: F
Vaccine: YF
Symptoms: Headache, Injection site reaction, Nausea
Clinical narrative: Local reaction, nausea & headache.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Injection site reaction, Nausea
Clinical narrative: Local reaction and nausea.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: One day following the vaccine, the patient developed erythema, swelling, and induration in a 4 inch diameter around the injection site.  He also developed a few linear vesicles over the site.  The area was tender and mildly pruritic.  He was treated with atarax, antibiotics, and icepacks.  He is scheduled to follow up in 1-2 days.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: One day following the vaccine, the patient developed erythema, swelling, and induration in a 4 inch diameter around the injection site.  He also developed a few linear vesicles over the site.  The area was tender and mildly pruritic.  He was treated with atarax, antibiotics, and icepacks.  He is scheduled to follow up in 1-2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: Left upper arm swollen, red, warm to touch apporx 24 hours after injection.  Swelling and redness resolved 5 days later.  No fever reported. Possible arthus reaction
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Erythema, Nausea, Pruritus, Rash
Clinical narrative: This is a 28 year old male Caucasian who was in his usual state of health until 05/22/04, 8 days following his primary smallpox and 15 days following his 6th anthrax vaccination. On 5/22/04 the client relates that he developed episodic nausea and dizziness. He denies any fever, chills, vomiting, diarrhea, constipation, chest pain or dyspnea. He states that these symptoms were transient and last only a day or two.  On 05/26/04, 12 days following his primary smallpox vaccination and 19 days following his anthrax vaccination, the client reports that he noted upon waking, a bright red rash on his bilateral arms, legs, torso and to a lesser extent his face. He reported to the immunization clinic and was referred to the Vaccine Healthcare Center (VHC) for further evaluation. The client stated  that as the day progressed his rash became lighter and lighter, and itched less.   He presented to the VHC at approximately 1430 hours and was evaluated.  At that time, his raise was barely visible and spotty on his arms and two or three probable lesions on his back. He stated that he thought maybe it was going to go away. The possibility of this presentation being a non-viral pustulosis was discussed with the client and his spouse. He and his family were reassured that this was not a contagious condition, which was there main concern. He was prescribed Benadryl® 25-50mg q 6 hours PRN itching and Motrin® 600mg po TID PRN for discomfort and anti-inflammatory properties of the medication.   On 05/27/04, the client's spouse notified the VHC that the client had been seen in the emergency department the previous evening for reoccurrence of his rash and severe itching. The client's spouse stated, "the rash had severe whelping, like poison ivy". The client reportedly was given Zantac® in addition to the Benadryl® and placed sick in quarters for the remainder of the night. The client was still sleeping when the spouse called and the NP was unable to speak with him at that time.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Skin ulcer
Clinical narrative: This is a 28 year old male Caucasian who was in his usual state of health until 05/22/04, 8 days following his primary smallpox and 15 days following his 6th anthrax vaccination. On 5/22/04 the client relates that he developed episodic nausea and dizziness. He denies any fever, chills, vomiting, diarrhea, constipation, chest pain or dyspnea. He states that these symptoms were transient and last only a day or two.  On 05/26/04, 12 days following his primary smallpox vaccination and 19 days following his anthrax vaccination, the client reports that he noted upon waking, a bright red rash on his bilateral arms, legs, torso and to a lesser extent his face. He reported to the immunization clinic and was referred to the Vaccine Healthcare Center (VHC) for further evaluation. The client stated  that as the day progressed his rash became lighter and lighter, and itched less.   He presented to the VHC at approximately 1430 hours and was evaluated.  At that time, his raise was barely visible and spotty on his arms and two or three probable lesions on his back. He stated that he thought maybe it was going to go away. The possibility of this presentation being a non-viral pustulosis was discussed with the client and his spouse. He and his family were reassured that this was not a contagious condition, which was there main concern. He was prescribed Benadryl® 25-50mg q 6 hours PRN itching and Motrin® 600mg po TID PRN for discomfort and anti-inflammatory properties of the medication.   On 05/27/04, the client's spouse notified the VHC that the client had been seen in the emergency department the previous evening for reoccurrence of his rash and severe itching. The client's spouse stated, "the rash had severe whelping, like poison ivy". The client reportedly was given Zantac® in addition to the Benadryl® and placed sick in quarters for the remainder of the night. The client was still sleeping when the spouse called and the NP was unable to speak with him at that time.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Irritability, Pruritus, Skin ulcer
Clinical narrative: Suspect varicella with vaccination.  5-12-04 cranky, 5-13-04 papules - primarily upper trunk, neck and face. puritis - changing to vesicles - possible pustules - lesions cratered with scratching.
Age: 0.3
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Cough, Erythema, Oedema peripheral, Pain, Pruritus
Clinical narrative: On 5/24 mother reports that child was wheezing, coughing, and had pain.  On 5/25/04 mother states that childs left arm was swollen all of the way to the wrist, with redness, itching, and pain.  Mother took child to physician on 5/26/04 and child started on antibiotics.
Age: 0.3
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Wheezing
Clinical narrative: On 5/24 mother reports that child was wheezing, coughing, and had pain.  On 5/25/04 mother states that childs left arm was swollen all of the way to the wrist, with redness, itching, and pain.  Mother took child to physician on 5/26/04 and child started on antibiotics.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia
Clinical narrative: Fever up to 104F (maximun), fever lasting 4 days
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Acne, Chills, Headache, Influenza like illness, Pain
Clinical narrative: This is a 30 year old male Caucasian who had been in his usual health until 05/29/04. He received his primary smallpox vaccination on 05/21/04 in his left deltoid area. He completed all required briefing and screening prior to vaccination. He also received his second Anthrax on 05/17/2004. Upon waking on 05/29/04 he felt like he had the flu, i.e. fever (subjective), chills, body aches (8/10) and headache (9/10).  He described the headache as feeling like someone was constantly applying pressure. The symptoms did not resolve until 06/01/04.  Later in the evening of 05/29/04, the client noticed "pimple" like eruptions in his hairline and forehead, which was painful to touch. He treated it with tea-tree oil, without relief. These eruptions eventually spread to back, chest, abdomen and upper arms. He was referred to the Vaccine Healthcare Center (VHC) for further evaluation and treatment.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: This is a 30 year old male Caucasian who had been in his usual health until 05/29/04. He received his primary smallpox vaccination on 05/21/04 in his left deltoid area. He completed all required briefing and screening prior to vaccination. He also received his second Anthrax on 05/17/2004. Upon waking on 05/29/04 he felt like he had the flu, i.e. fever (subjective), chills, body aches (8/10) and headache (9/10).  He described the headache as feeling like someone was constantly applying pressure. The symptoms did not resolve until 06/01/04.  Later in the evening of 05/29/04, the client noticed "pimple" like eruptions in his hairline and forehead, which was painful to touch. He treated it with tea-tree oil, without relief. These eruptions eventually spread to back, chest, abdomen and upper arms. He was referred to the Vaccine Healthcare Center (VHC) for further evaluation and treatment.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Pt presented with erythema multiforme type rash 2wks after vaccine
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Anaphylactic reaction, Erythema, Face oedema, Hypoventilation, Mental impairment
Clinical narrative: Minutes after vaccine-facial swelling, rash, vomiting, loss of consciousness-shock.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Rash, Stupor, Tachycardia, Vasodilatation, Vomiting
Clinical narrative: Minutes after vaccine-facial swelling, rash, vomiting, loss of consciousness-shock.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Face oedema, Loss of consciousness, Rash, Shock, Vomiting
Clinical narrative: Minutes after vaccine-facial swelling, rash, vomiting, loss of consciousness-shock.
Age: 5.0
Sex: M
Vaccine: DTAP, MEN, MMR, DTP, IPV, MMR
Symptoms: Dyspnoea, Erythema, Flushing, Pruritus, Wheezing
Clinical narrative: Minutes after vaccine, facial swelling, rash, vomiting, loss of consciousness, and shock.
Age: 5.0
Sex: M
Vaccine: DTAP, MEN, MMR, DTP, IPV, MMR
Symptoms: Loss of consciousness, Rash, Shock, Swelling face, Vomiting
Clinical narrative: Minutes after vaccine, facial swelling, rash, vomiting, loss of consciousness, and shock.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Abnormal behaviour, Aggression, Cellulitis, Injection site mass, Rash
Clinical narrative: He fell down first day. Rash on 2nd day. Leg swelled up 4th day; huge. After that, growling, hitting me, biting me, not able to remember things at times, regression in speech, no eye contact.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Abnormal behaviour, Fall, Memory impairment, Oedema peripheral, Rash
Clinical narrative: He fell down first day. Rash on 2nd day. Leg swelled up 4th day; huge. After that, growling, hitting me, biting me, not able to remember things at times, regression in speech, no eye contact.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Speech disorder
Clinical narrative: He fell down first day. Rash on 2nd day. Leg swelled up 4th day; huge. After that, growling, hitting me, biting me, not able to remember things at times, regression in speech, no eye contact.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: #5 DTaP, # 2 MMR, #4 IPV administered on 5-21-04. On 5-22-04 mom reports fever of 104 and a "fine sweat rash" to abdomen, legs & arm at time of fever. On 5-23-04 rash & fever resolved. On 5-24-04 am nausea with emesis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: #5 DTaP, # 2 MMR, #4 IPV administered on 5-21-04. On 5-22-04 mom reports fever of 104 and a "fine sweat rash" to abdomen, legs & arm at time of fever. On 5-23-04 rash & fever resolved. On 5-24-04 am nausea with emesis.
Sex: M
Vaccine: FLUX
Symptoms: Arteriosclerosis, Asthenia, Back pain, Bone neoplasm, Cardiac arrest
Clinical narrative: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough."  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.
Sex: M
Vaccine: FLUX
Symptoms: Cholecystitis, Colitis, Coronary artery disease, Cough, Dyspnoea
Clinical narrative: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough."  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.
Sex: M
Vaccine: FLUX
Symptoms: Dysuria, Faecal incontinence, Gait disturbance, Gastrointestinal disorder, Hepatic neoplasm
Clinical narrative: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough."  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Lung neoplasm malignant, Lymphoedema, Myocardial infarction, Thrombosis
Clinical narrative: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough."  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.
Sex: M
Vaccine: FLUX
Symptoms: Vascular anomaly, Wheezing
Clinical narrative: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough."  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.
Sex: M
Vaccine: HEP
Symptoms: Tourette's disorder
Clinical narrative: Information has been received from the mother of a male pt with no allergies and no medical history who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown)(thimerosal containing per mother). Subsequently , the pt was diagnosed with Tourettes's Syndrome. Unspecified medical attention was sought. The mother reported that no direct causality has been associated with the pt's condition and the administration of any vaccine. The reporter noted that the doctor may not be contacted. No product quality complaint was noted. Upon internal review, Tourette's Syndrome was determined to be an other important medical event (OMIC).  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Constant headaches since my 1st shot on 23 Apr 03. Fill out back of 2766C every subsequent shot.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH
Symptoms: Pain
Clinical narrative: Bilateral elbow pain at "points" of elbows starting 3-4 days after first Anthrax injection and seems to have continued and worsened with two subsequent injections. Hot sharp sensation especially weight training.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH
Symptoms: Joint range of motion decreased, Skin burning sensation
Clinical narrative: Bilateral elbow pain at "points" of elbows starting 3-4 days after first Anthrax injection and seems to have continued and worsened with two subsequent injections. Hot sharp sensation especially weight training.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: On 17 May patient states he awoke with stiffness, decrease back to left hip & left side. As the day progressed pt stated sharp pain noted Sat. Pt unable to stand Monday PM & Tuesday (17/18) Tuesday PM pt saw private med doctor. Physician treating accordingly with x-rays and medication therapy. Duration for 4 days.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling, Oedema, Pruritus
Clinical narrative: DTaP given thigh Tues 5/18 with raised red & itching area around injection on Sat- oral Benadryl given with relief & swelling gone by Sun.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Listless, Somnolence
Clinical narrative: Onset of listlessness, sleepiness within 1 hr of vaccine lasting approximately 15 hrs. Would not wake up to eat. Was seen/ evaluated in ER after 10-12 hrs. Kept in ER until she became more arousable/ took Pedialyte.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: Fever starting 24 hrs after immunizations (103) lasting for 48 hrs.