chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Corneal disorder, Dry eye, Lacrimal disorder
Clinical narrative: Information has been received from a consumer concerning her approximately 22 year old daughter with no medical history or allergies who in 2002 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. It was reported that the pr experienced dry eyes and a lack of tears which has resulted in scarring of her corneas. The mother noted that she "never had problems like this prior to receiving Recombivax HB vaccine" and that her daughter still suffers from these problems "at the present time". She was considered not recovered. Medical attention was sought. No product quality complaint was involved. Upon internal review, scarring of the cornea was considered an other important medical event (OMIC). Additional information is not expected. Per follow up report received on 06/14/2005:  Patient still had not recovered.
Age: 1.25
Sex: M
Vaccine: FLU3, MMR
Symptoms: Urticaria
Clinical narrative: hives, Benadryl, Zyrtec 2.5ml qd bid, Zantac 1.5ml bid
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Coordination abnormal, Cough, Diarrhoea, Gait disturbance, Hallucination
Clinical narrative: Sept 7th received vaccine soon after developed crampy and pain, diarrhea lasting 3 days. Then cough neck soreness and stiffness, headache. Night sweats, hallucinations concurrently had balance and gait disturbances.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Muscle spasms, Neck pain, Night sweats, Nuchal rigidity
Clinical narrative: Sept 7th received vaccine soon after developed crampy and pain, diarrhea lasting 3 days. Then cough neck soreness and stiffness, headache. Night sweats, hallucinations concurrently had balance and gait disturbances.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Sept 7th received vaccine soon after developed crampy and pain, diarrhea lasting 3 days. Then cough neck soreness and stiffness, headache. Night sweats, hallucinations concurrently had balance and gait disturbances.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site inflammation, Pruritus
Clinical narrative: Entire deltoid inflammed 22 hours post injection. Benadryl administered to control itching
Age: 36.0
Sex: F
Vaccine: MMR, TD
Symptoms: Arthralgia, Nausea, Oedema, Pain
Clinical narrative: Arthralgias and edema x 2 weeks tx prednisone taper, pain and nausea med and DOW
Age: 1.71
Sex: M
Vaccine: DTAP, HBPV, MMR, VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Mild varicella skin lesions, no other symptoms
Age: 1.02
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: 2 chickenpox lesions on forehead  4 on trunk
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives, no other sx
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Pt presented to office with rash to face, torso, all extremities, itching severly
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: Fever to 104.1 rectal, rapid respirations, less than 24 hours after vaccinations
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Chest pain, Chills, Headache, Hypokinesia
Clinical narrative: Chills began, severe lower back pain, arm hurt like if hit with baseball bat, red mark at vax site 3 inches in diameter, fever 102.1 for 2 days. Could not get out of bed, no relief by any pain medication (Percocet) headaches. Saturday and Sunday felt chest pains and tachycardia. By 01/17/05 fever decreased to 100, condition gradually improving. Did not have any problems at 49 years last time received this vax.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Similar reaction on previous exposure to drug, Tachycardia
Clinical narrative: Chills began, severe lower back pain, arm hurt like if hit with baseball bat, red mark at vax site 3 inches in diameter, fever 102.1 for 2 days. Could not get out of bed, no relief by any pain medication (Percocet) headaches. Saturday and Sunday felt chest pains and tachycardia. By 01/17/05 fever decreased to 100, condition gradually improving. Did not have any problems at 49 years last time received this vax.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Chills began, severe lower back pain, arm hurt like if hit with baseball bat, red mark at vax site 3 inches in diameter, fever 102.1 for 2 days. Could not get out of bed, no relief by any pain medication (Percocet) headaches. Saturday and Sunday felt chest pains and tachycardia. By 01/17/05 fever decreased to 100, condition gradually improving. Did not have any problems at 49 years last time received this vax.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Chills began, severe lower back pain, arm hurt like if hit with baseball bat, red mark at vax site 3 inches in diameter, fever 102.1 for 2 days. Could not get out of bed, no relief by any pain medication (Percocet) headaches. Saturday and Sunday felt chest pains and tachycardia. By 01/17/05 fever decreased to 100, condition gradually improving. Did not have any problems at 49 years last time received this vax.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Bronchiolitis, Cough, Headache, Nasal congestion, Pyrexia
Clinical narrative: Patient experienced high fever (3 days), severe headache, congestion, cough and bronchial irritation/burning.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Pyrexia, Vomiting
Clinical narrative: I got a influenza shot on 1/18/05 @ hospital @ about 2:50 pm and woke up @ 10:00 pm that night sick, with fever and chills and severe vomiting, then again around midnight and 3:00 am. The next day I had dizziness, fever, chills and weakness and the smell or mention of food made me want to vomit even more, I had a bowl of soup and water only all day. Now day 3 I feel like a new man healhy but a bit weak understandably so but I have to wonder if the flu shot actualey gave me the flu? I have not felt this sick in years and this was the first time I ever got the shot.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Urticaria, Vaccine positive rechallenge
Clinical narrative: Patient experienced a rash and urticaria on arms and back after the administration of Pneumovax.  The patient had no other problems prior to this.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Dyspnoea, Hyperglycaemia, Hypersensitivity, Laboratory test abnormal
Clinical narrative: Pt admitted s/p an allergic rxn to flu vaccine.  She experienced sudden onset shortness of breath and wheezing.  She was transferred from the nursing home to emergency room, where, despite corticosteroid injection, epinephrine inj and aerosol treatments, she was still wheezing and somewhat sob.  It was decided to admit her.  Her O2 sats remained above 90% during this, and there was no respiratory arrest.  During her stay, she gradually improved and was discharged back to the nursing home 12/17/04. Discharge summary states Bronchitis. msv
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Leukocytosis, Wheezing
Clinical narrative: Pt admitted s/p an allergic rxn to flu vaccine.  She experienced sudden onset shortness of breath and wheezing.  She was transferred from the nursing home to emergency room, where, despite corticosteroid injection, epinephrine inj and aerosol treatments, she was still wheezing and somewhat sob.  It was decided to admit her.  Her O2 sats remained above 90% during this, and there was no respiratory arrest.  During her stay, she gradually improved and was discharged back to the nursing home 12/17/04. Discharge summary states Bronchitis. msv
Age: 1.4
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Bronchiolitis, Face oedema, Parotitis
Clinical narrative: Patient received the MMR, DT, Hib, and influenza vaccinations on 01/12/05.  The patient returned on 01/13/05 with the left side of her face swollen - diagnosed as parotitis.  No treatment was given.  Patient was also diagnosed with Bronchiolitis that same visit and was treated with xopenex nebs at home via a home nebulizer.
Age: 1.55
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Coma, Convulsion, Depressed level of consciousness, Dizziness, Hemiplegia
Clinical narrative: Infant given vaccine on 1/11. On the morning of 1/12, mother found child unresponsive in crib. Taken to ER and admitted. having continual focal seizures. Currently in ICU and on IV Dilantin, Phenobarbital, and Acyclovir. Still obtunded. Occasional seizure. LP with clear CSF. NL protein. MRI: diffuse inflammatory changes mostly white matter. HSV PCR negative. Routine cultures negative. Viral cultures pending. Follow up 01/25/05: Patient currently in hospital in ICU and under the care of a neurologist. Follow up 03/29/05: Patient has not recovered from the adverse event(s), she has left hemiparesis, seizures and significant loss of developmental skills. Does not ambulate, verbalize or interact with people. Per follow up report recieved on 06/14/2005:  Patient still has no use of left side and is approximately 7 months of age mentally.  Per physical, occupational, and speech therapist believes she has years of therapy ahead of her. Per follow up report: seizure disorder, recent prolonged seizure, Left hemiplegia, in physical and occupational therapy, developmental delay. Still non verbal.  Per follow up report-Patient still has no use of her left arm and she cannot speak.
Age: 1.55
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Mental retardation severity unspecified, Oedema
Clinical narrative: Infant given vaccine on 1/11. On the morning of 1/12, mother found child unresponsive in crib. Taken to ER and admitted. having continual focal seizures. Currently in ICU and on IV Dilantin, Phenobarbital, and Acyclovir. Still obtunded. Occasional seizure. LP with clear CSF. NL protein. MRI: diffuse inflammatory changes mostly white matter. HSV PCR negative. Routine cultures negative. Viral cultures pending. Follow up 01/25/05: Patient currently in hospital in ICU and under the care of a neurologist. Follow up 03/29/05: Patient has not recovered from the adverse event(s), she has left hemiparesis, seizures and significant loss of developmental skills. Does not ambulate, verbalize or interact with people. Per follow up report recieved on 06/14/2005:  Patient still has no use of left side and is approximately 7 months of age mentally.  Per physical, occupational, and speech therapist believes she has years of therapy ahead of her. Per follow up report: seizure disorder, recent prolonged seizure, Left hemiplegia, in physical and occupational therapy, developmental delay. Still non verbal.  Per follow up report-Patient still has no use of her left arm and she cannot speak.
Age: 1.55
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Antisocial behaviour, Convulsion, Hemiplegia, Irritability
Clinical narrative: Infant given vaccine on 1/11. On the morning of 1/12, mother found child unresponsive in crib. Taken to ER and admitted. having continual focal seizures. Currently in ICU and on IV Dilantin, Phenobarbital, and Acyclovir. Still obtunded. Occasional seizure. LP with clear CSF. NL protein. MRI: diffuse inflammatory changes mostly white matter. HSV PCR negative. Routine cultures negative. Viral cultures pending. Follow up 01/25/05: Patient currently in hospital in ICU and under the care of a neurologist. Follow up 03/29/05: Patient has not recovered from the adverse event(s), she has left hemiparesis, seizures and significant loss of developmental skills. Does not ambulate, verbalize or interact with people. Per follow up report recieved on 06/14/2005:  Patient still has no use of left side and is approximately 7 months of age mentally.  Per physical, occupational, and speech therapist believes she has years of therapy ahead of her. Per follow up report: seizure disorder, recent prolonged seizure, Left hemiplegia, in physical and occupational therapy, developmental delay. Still non verbal.  Per follow up report-Patient still has no use of her left arm and she cannot speak.
Age: 1.46
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Cyanosis, Loss of consciousness, Tremor
Clinical narrative: Seizure face and lips blue, had + LOC, body shook, lasted only minutes.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swelling, redness, pain x 2 days, Right deltoid, Right arm. Cont to use warm towel every 4 hrs.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Chest discomfort, Injection site reaction, Muscle contractions involuntary, Pyrexia, Skin discolouration
Clinical narrative: Symptoms started at 4AM, he felt as though someone had struck him in the chest. Low grade temp of 99.6. He also had involuntary muscle jerking, at the injection site he had a bulls eye effect and white in middle with red around.
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Demyelination, Fatigue, Multiple sclerosis, Myalgia
Clinical narrative: We received the following information: On 22Dec03 reporter was bitten on the hand by a raccoon as he attempted to get the animal off his dogs. In the ensuing struggle, he killed the raccoon with a stick. He then went to the local ER where the wound was cleansed and he was given a tetanus. He was told the protocol was to test the animal first prior to determining if the rabies Pet regimen in needed. On 23Dec03 he received a call stating that the animal was rabid and that he needed prophylaxis. He was given HRIG (based on weight) and he thinks it was given into the arms and legs but not sure as well as RabAvert x 5 doses in the shoulders and gluteal areas- although he is not sure about the exact location of HRIG and rabies vaccinations. Somewhere around mid-end January he noted that his usual strength as a metalworker artist had diminished greatly and he was very fatigued. He discussed this with the ER doctor and the DHEC and was told since it was flu season that he could have the flu and was questioned about contact with tics (lyme disease). He was told to continue with PET because he could live with sore muscles, but he could not live with rabies. By the 4th rabies vaccination he again pursued his symptoms with another ER doctor who said he may serum sickness and when the doctor looked it up in his palm computer, it was not mentioned as a side effect of RabAvert. On 06Feb04 he saw his general doctor, had a neurologic exam and was hospitalized due to a concern about having live rabies.  He was air helicoptered to university with an admitting diagnosis of acute serum sickness, R/O rabies. A spinal fluid test showed a pressure of 26 then, but he does not recall that other parameters were measured. He had a reaction to the spinal tap necessitating a blood patch be applied. He decribes IVIG therapy being administered during his hospitalization. After this, he felt better for months. It was also at this time that he was told that no rabies was found in the raccoon and he didn't need to have the PET regimen. In the past 2 months, he says all his symptoms have worsened necessitating a neurologic evaluation locally where he was told that he might have multiple sclerosis or CIDP (chronic inflammatory demyelinating polyradiculoneuropathy). A brain MRI and another spinal tap are scheduled this week. He was also given SoluMedrol x3 days. He has a follow up appointment on 14Jan05. Preliminary company assessment: Seriousness criteria: hospitalization lasting damage.
Sex: M
Vaccine: RAB
Symptoms: Neuropathy, Serum sickness
Clinical narrative: We received the following information: On 22Dec03 reporter was bitten on the hand by a raccoon as he attempted to get the animal off his dogs. In the ensuing struggle, he killed the raccoon with a stick. He then went to the local ER where the wound was cleansed and he was given a tetanus. He was told the protocol was to test the animal first prior to determining if the rabies Pet regimen in needed. On 23Dec03 he received a call stating that the animal was rabid and that he needed prophylaxis. He was given HRIG (based on weight) and he thinks it was given into the arms and legs but not sure as well as RabAvert x 5 doses in the shoulders and gluteal areas- although he is not sure about the exact location of HRIG and rabies vaccinations. Somewhere around mid-end January he noted that his usual strength as a metalworker artist had diminished greatly and he was very fatigued. He discussed this with the ER doctor and the DHEC and was told since it was flu season that he could have the flu and was questioned about contact with tics (lyme disease). He was told to continue with PET because he could live with sore muscles, but he could not live with rabies. By the 4th rabies vaccination he again pursued his symptoms with another ER doctor who said he may serum sickness and when the doctor looked it up in his palm computer, it was not mentioned as a side effect of RabAvert. On 06Feb04 he saw his general doctor, had a neurologic exam and was hospitalized due to a concern about having live rabies.  He was air helicoptered to university with an admitting diagnosis of acute serum sickness, R/O rabies. A spinal fluid test showed a pressure of 26 then, but he does not recall that other parameters were measured. He had a reaction to the spinal tap necessitating a blood patch be applied. He decribes IVIG therapy being administered during his hospitalization. After this, he felt better for months. It was also at this time that he was told that no rabies was found in the raccoon and he didn't need to have the PET regimen. In the past 2 months, he says all his symptoms have worsened necessitating a neurologic evaluation locally where he was told that he might have multiple sclerosis or CIDP (chronic inflammatory demyelinating polyradiculoneuropathy). A brain MRI and another spinal tap are scheduled this week. He was also given SoluMedrol x3 days. He has a follow up appointment on 14Jan05. Preliminary company assessment: Seriousness criteria: hospitalization lasting damage.
Age: 19.0
Sex: F
Vaccine: BCG, MEN
Symptoms: Anxiety, Chest discomfort, Chest pain, Cough, Dyspnoea
Clinical narrative: From initial information received on 05/10/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received her first dose of Menomune A/C/Y/W-135, lot number UE111AA, administered subcutaneously in the right arm on 05/05/04 at 10:00 AM. 16 hours later, on 05/06/04 at 2:00 AM, the patient developed shortness of breath, cough and non radiating chest pain. The patient had a doctor appointment at 10:00 AM that same day. Reportedly, the symptoms continue and the patient did not recover from the events. The patient's pre-existing medical conditions include sports related asthma and anxiety attacks. From additional information received on 05/14/04 through a telephone call to the reporter, it was reported that the patient has a history of sports related asthma, but was on no concomitant medications at the time of vaccination. Reportedly, the patient did not require an emergency room visit when she experienced the reaction and was not seen by a physician until 10:AM on 05/06/04. The patient was not treated with epinephrine or other medications to the reporter's knowledge. The reporter stated that she spoke with the patient's mother recently and was informed that the patient continues to have symptoms, which are described as chest tightness. The reporter also stated that the patient is about to graduate from high school and begin college and that her mother and the reporter both feel that her reaction may more likely be a form of an anxiety attack. From additional information received on 06/04/04 from the initial reporter, the patient was not taking any other medications at the time of vaccination. It was not reported whether the patient recovered. From additional information received on 09/07/04 from a health care professional, it was reported that the patient was found to have mononucleosis which likely is responsible for the symptoms. The patient has recovered. No further information is anticipated, this case is considered closed.
Age: 19.0
Sex: F
Vaccine: BCG, MEN
Symptoms: Monocytosis, Urinary tract infection
Clinical narrative: From initial information received on 05/10/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received her first dose of Menomune A/C/Y/W-135, lot number UE111AA, administered subcutaneously in the right arm on 05/05/04 at 10:00 AM. 16 hours later, on 05/06/04 at 2:00 AM, the patient developed shortness of breath, cough and non radiating chest pain. The patient had a doctor appointment at 10:00 AM that same day. Reportedly, the symptoms continue and the patient did not recover from the events. The patient's pre-existing medical conditions include sports related asthma and anxiety attacks. From additional information received on 05/14/04 through a telephone call to the reporter, it was reported that the patient has a history of sports related asthma, but was on no concomitant medications at the time of vaccination. Reportedly, the patient did not require an emergency room visit when she experienced the reaction and was not seen by a physician until 10:AM on 05/06/04. The patient was not treated with epinephrine or other medications to the reporter's knowledge. The reporter stated that she spoke with the patient's mother recently and was informed that the patient continues to have symptoms, which are described as chest tightness. The reporter also stated that the patient is about to graduate from high school and begin college and that her mother and the reporter both feel that her reaction may more likely be a form of an anxiety attack. From additional information received on 06/04/04 from the initial reporter, the patient was not taking any other medications at the time of vaccination. It was not reported whether the patient recovered. From additional information received on 09/07/04 from a health care professional, it was reported that the patient was found to have mononucleosis which likely is responsible for the symptoms. The patient has recovered. No further information is anticipated, this case is considered closed.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Musculoskeletal stiffness
Clinical narrative: From initial information received on 02Aug04 from a public health professional regarding an adverse event occurring, it was reported that an 18 year old female pt received a first dose of Menomune A/C/Y/W-135, administered SC at an unspecified site on 27Jul04. The lot number was reported as unk. One day after receiving the vaccine, the pt complained of chills, weakness, aches, tightness and soreness of her neck and pain in her upper chest. The pt was evaluated by a nurse practitioner, who assessed clicking in the right side. The pt had a chest x-ray which appeared clear. At the time of the report, the pt was still being evaluated and had not recovered from these events. From additional information received on 25Oct05 the pt's date of birth was provided. It was also reported that the pt received the Menomune A/C/Y/W-145 vaccination, lot number UE157AA administered in the left deltoid.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Myalgia, Neck pain
Clinical narrative: From initial information received on 02Aug04 from a public health professional regarding an adverse event occurring, it was reported that an 18 year old female pt received a first dose of Menomune A/C/Y/W-135, administered SC at an unspecified site on 27Jul04. The lot number was reported as unk. One day after receiving the vaccine, the pt complained of chills, weakness, aches, tightness and soreness of her neck and pain in her upper chest. The pt was evaluated by a nurse practitioner, who assessed clicking in the right side. The pt had a chest x-ray which appeared clear. At the time of the report, the pt was still being evaluated and had not recovered from these events. From additional information received on 25Oct05 the pt's date of birth was provided. It was also reported that the pt received the Menomune A/C/Y/W-145 vaccination, lot number UE157AA administered in the left deltoid.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Dysphonia
Clinical narrative: Dizzy Hoarse voice Physician notified by phone 11:30AM on 01/01/2005.  No local reaction noted.  Advised to call primary doctor if increased dizziness advised to gargle with salt water.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Cough, Dyspnoea, Hypersensitivity, Pruritus, Throat tightness
Clinical narrative: There were no seriousness criteria reported. Based upon appropriate medical judgement this case was considered as important medical event (OMIC). From initial information received on 7/7/04 from a health care professional regarding an adverse event occurring in the USA< it was reported that an 18 year old male patient received his first dose of MENOMUNE, lot number UE112AB, administered SC in an unspecified site on 7/1/04 at 3:30 PM. 85 minutes later, at 4:55 PM, the patient developed shortness of breath and itching and felt as if his throat was closing. He was taken to the hospital emergency room and was diagnosed with systemic allergic reaction secondary to vaccination. Reportedly, the patient is highly allergic to peanuts and did admit to having a cupcake with peanut butter icing the day of vaccination at 11:30 AM. It was reported that the patient recovered from the events. From additional information received on 8/19/04, it was reported that the patient had a cookie with peanut butter icing not a cupcake as previously reported. The patient's full name and address was provided as well as the county where the product was administered. It was also reported that the patient was vaccinated at a university health center and the vaccine was purchased with private funds. No additional relevant information has been obtained for the adverse experiences; this follow up report is not submitted to health authorities. From a telephone call received on 9/13/04 from the initial reporter, any additional information requested for this case will be in the emergency room records, which the reporter does not have. She provided the name and address of the hospital where these records could be obtained. No new medical information was reported at this time. No additional relevant information has been obtained for the reported adverse events; this follow up is not submitted to health authorities. From additional information received on 10/11/04 from the treating facility, it was reported that approximately 45 minutes after receiving the vaccine (previously reported as 85 minutes), the patient experienced throat swelling with increased difficulty of breathing, itchy hands, generalized hives and a non-productive cough. A chest x-ray, neck x-ray and electrocardiogram were within normal limits. The patient was treated with Benadryl, Solu-Medrol, and Zantac. He was placed on supplemental oxygen at 2 liters per minute via nasal cannula. The patient recovered from these events. No further information is anticipated; this case is considered closed. (OMIC)
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: There were no seriousness criteria reported. Based upon appropriate medical judgement this case was considered as important medical event (OMIC). From initial information received on 7/7/04 from a health care professional regarding an adverse event occurring in the USA< it was reported that an 18 year old male patient received his first dose of MENOMUNE, lot number UE112AB, administered SC in an unspecified site on 7/1/04 at 3:30 PM. 85 minutes later, at 4:55 PM, the patient developed shortness of breath and itching and felt as if his throat was closing. He was taken to the hospital emergency room and was diagnosed with systemic allergic reaction secondary to vaccination. Reportedly, the patient is highly allergic to peanuts and did admit to having a cupcake with peanut butter icing the day of vaccination at 11:30 AM. It was reported that the patient recovered from the events. From additional information received on 8/19/04, it was reported that the patient had a cookie with peanut butter icing not a cupcake as previously reported. The patient's full name and address was provided as well as the county where the product was administered. It was also reported that the patient was vaccinated at a university health center and the vaccine was purchased with private funds. No additional relevant information has been obtained for the adverse experiences; this follow up report is not submitted to health authorities. From a telephone call received on 9/13/04 from the initial reporter, any additional information requested for this case will be in the emergency room records, which the reporter does not have. She provided the name and address of the hospital where these records could be obtained. No new medical information was reported at this time. No additional relevant information has been obtained for the reported adverse events; this follow up is not submitted to health authorities. From additional information received on 10/11/04 from the treating facility, it was reported that approximately 45 minutes after receiving the vaccine (previously reported as 85 minutes), the patient experienced throat swelling with increased difficulty of breathing, itchy hands, generalized hives and a non-productive cough. A chest x-ray, neck x-ray and electrocardiogram were within normal limits. The patient was treated with Benadryl, Solu-Medrol, and Zantac. He was placed on supplemental oxygen at 2 liters per minute via nasal cannula. The patient recovered from these events. No further information is anticipated; this case is considered closed. (OMIC)
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal pain
Clinical narrative: From initial information received on 11/24/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received a dose of Menomune A/C/Y/W-135, lot number UB487AA, administered subcutaneously in her left arm on 10/23/2003. One hour after receiving the vaccine, the patient complained of abdominal pain. She was seen by a physician and a chemistry screen and complete blood count were normal. Reportedly, the patient recovered from this event. From additional information received on 02/23/04 form the initial reporter, the case was reviewed and no additional information is available at this time. No further information is anticipated, this case is considered closed.
Age: 25.0
Sex: F
Vaccine: FLUX, HEP, HEPA, MEN, TYP
Symptoms: Headache, Injection site swelling, Lymphadenitis, Pain, Pruritus
Clinical narrative: From initial information received on 01/28/04 from another manufacturer ( case number A0442068A) regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 25 year old female patient received Menomune A/C/Y/W-135, lot number not reported, administered in the left arm; Typhim VI, lot number not reported, administered in the right arm; Influenza Vaccine, lot number not reported, manufacturer unknown, administered in the left arm; a first dose of Engerix B, lot number ENG5460A (lot number incomplete), manufacturer GlaxoSmithKline, administered in the right are; all on 11/28/03. Later taht evening th patient developed a headache, low grade fever and achiness. The following day, on 11/29/03, the patient developed hives and itching on her torso and other parts of her body. On 11/30/03, the patient developed a swollen lymph node (site not reported), and a raised wheal at the injection site of her left arm. As of 12/03/03, the hives and itching have improved. The patient's recovery status was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX, HEP, HEPA, MEN, TYP
Symptoms: Pyrexia, Urticaria
Clinical narrative: From initial information received on 01/28/04 from another manufacturer ( case number A0442068A) regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 25 year old female patient received Menomune A/C/Y/W-135, lot number not reported, administered in the left arm; Typhim VI, lot number not reported, administered in the right arm; Influenza Vaccine, lot number not reported, manufacturer unknown, administered in the left arm; a first dose of Engerix B, lot number ENG5460A (lot number incomplete), manufacturer GlaxoSmithKline, administered in the right are; all on 11/28/03. Later taht evening th patient developed a headache, low grade fever and achiness. The following day, on 11/29/03, the patient developed hives and itching on her torso and other parts of her body. On 11/30/03, the patient developed a swollen lymph node (site not reported), and a raised wheal at the injection site of her left arm. As of 12/03/03, the hives and itching have improved. The patient's recovery status was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: From initial information received on 01/29/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 45 year old female patient received a second dose of Menomune A/C/Y/W-135, lot number UE110AA, administered subcutaneously in the left arm at 1:05 PM on 01/22/04. Approximately five hours later, at 6:00 PM, the patient developed redness, itching and swelling at the injection site. The patient was treated initially with Benadryl and was also given intravenous and or antibiotics, as well as Percocet for pain. Reportedly the patient recovered from this experience. The patient had previously experienced injection site redness at the age of 42 years following the receipt of Menomune, TD and Pnemo.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal discomfort, Chills, Headache, Malaise, Pain
Clinical narrative: From initial information received on 01/16/04 and additional information received on 01/18/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received he first dose of Menomune A/C/Y/W-135, lot number UE471AA, administered subcutaneously on 01/07/04. The site of administration was not reported. The following day on 01/08/04, the patient developed a sore throat and gastrointestinal upset. The next day , the patient still had a sore throat and also developed a fever, headache, body aches and chills. She was seen by the physician on 01/10/04 and continued to have body aches, as well as malaise ( onset date not reported) and a temperature of 101.5 degrees Fahrenheit. Upon examination, her pulse was 100 and her pharynx was negative. At 8:00 PM that evening, the reporter contacted the patient's mother by phone and was advised that the patient's fever had decreased. It was not reported whether the patient recovered from these events. From additional information received on 11/08/04 from the initial reporter, the patient's address and telephone number were provided. Vaccine administrators name was also provided. It is unknown whether the patient recovered from the events.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: From initial information received on 01/16/04 and additional information received on 01/18/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received he first dose of Menomune A/C/Y/W-135, lot number UE471AA, administered subcutaneously on 01/07/04. The site of administration was not reported. The following day on 01/08/04, the patient developed a sore throat and gastrointestinal upset. The next day , the patient still had a sore throat and also developed a fever, headache, body aches and chills. She was seen by the physician on 01/10/04 and continued to have body aches, as well as malaise ( onset date not reported) and a temperature of 101.5 degrees Fahrenheit. Upon examination, her pulse was 100 and her pharynx was negative. At 8:00 PM that evening, the reporter contacted the patient's mother by phone and was advised that the patient's fever had decreased. It was not reported whether the patient recovered from these events. From additional information received on 11/08/04 from the initial reporter, the patient's address and telephone number were provided. Vaccine administrators name was also provided. It is unknown whether the patient recovered from the events.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Back pain, Headache, Laboratory test abnormal, Malaise
Clinical narrative: From initial information received on 06/25/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received a Menomune A/C/Y/W-135 vaccination in the right deltoid on 06/23/04. Two hours later, the patient developed nausea, vomiting and lower back pain. on 06/24/04, she was seen at the doctor's office with continued nausea, vomiting and lower back pain. She was seen again in the doctor's office on 06/25/04, where she continued to complain of nausea and weakness and had a temperature of 100 degrees Fahrenheit. Her vomiting had resolved. She was treated with Advil and advised to increase her fluids. It is unknown if the patient recovered from these events. From additional information received on 08/27/04 from the initial reporter and through a telephone contact, additional patient, vaccine, adverse event and lab information was provided. The Menomune A/C/Y/W-135 vaccination was given subcutaneously in the right arm ( previously reported as intra-muscularly in the right deltoid). The patient also received a Tubersol 5 TU skin test, lot number C1677AA, administered intra dermally in the left arm on 06/23/04. It was also reported that the patient developed malaise and headache after receiving the Menomune vaccine (exact date not reported. The patient's recovery status was noted to be "feeling better." On 08/30/04, a fax was sent to the reporter's office requesting the patient's recovery status. From additional information received on 08/31/2004 from a fax received from the reporter's facility, it was reported that the patient is doing well and has recovered from the adverse reactions. No further information is anticipated, this case is considered closed.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: From initial information received on 06/25/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received a Menomune A/C/Y/W-135 vaccination in the right deltoid on 06/23/04. Two hours later, the patient developed nausea, vomiting and lower back pain. on 06/24/04, she was seen at the doctor's office with continued nausea, vomiting and lower back pain. She was seen again in the doctor's office on 06/25/04, where she continued to complain of nausea and weakness and had a temperature of 100 degrees Fahrenheit. Her vomiting had resolved. She was treated with Advil and advised to increase her fluids. It is unknown if the patient recovered from these events. From additional information received on 08/27/04 from the initial reporter and through a telephone contact, additional patient, vaccine, adverse event and lab information was provided. The Menomune A/C/Y/W-135 vaccination was given subcutaneously in the right arm ( previously reported as intra-muscularly in the right deltoid). The patient also received a Tubersol 5 TU skin test, lot number C1677AA, administered intra dermally in the left arm on 06/23/04. It was also reported that the patient developed malaise and headache after receiving the Menomune vaccine (exact date not reported. The patient's recovery status was noted to be "feeling better." On 08/30/04, a fax was sent to the reporter's office requesting the patient's recovery status. From additional information received on 08/31/2004 from a fax received from the reporter's facility, it was reported that the patient is doing well and has recovered from the adverse reactions. No further information is anticipated, this case is considered closed.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria, Wheezing
Clinical narrative: From initial information received on 07/15/04 from a nurse regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received her first dose of Menomune A/C/Y/W-135 lot number Ue111AA, subcutaneously in the right arm on 07/12/04. Three days later, the patient developed generalized hives and wheezing. Reportedly, the patient used a steroid inhaler. Her parent called the doctor's office and set up an appointment that same day. The patient has a pre-existing history of cystic fibrosis and multiple medication allergies. Recovery status was not reported. From additional information received on 07/19/04 through a telephone call to the reporter, it was verified that the patient does have a history of cystic fibrosis. It was reported that on 07/12/04, the patient also received a dose of Tubersol 5 TU, lot number C1954AA, which was read as negative. Route and sit of administration were not reported. The reporter stated that on follow up visit on 07/15/04, hives were almost gone and the patient had improved. It was also reported that the patient was prescribed an EPI pen. From additional information received on 09/09/04 from a health care professional, it was reported that the patient recovered from these events. The following patient medical history was reported. "Diagnosed at birth with cystic fibrosis with perforated meconium ileus. The cystic fibrosis complaints she has experienced have been largely related to her sinuses. She also has a history of hematuria secondary to hypercalciuria and hyperoxaluria and a history of chronic constipation." Reportedly at the time of vaccination the patient was also taking the following medications: Albuterol, Flovent, Flonase, Zadex, Miralax, Piperacillin, Cephalosporins and Tobramycin. No further information is anticipated, this case is considered closed.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Arthralgia, Headache, Neck pain, Rash
Clinical narrative: From initial information received on 07/21/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that an 18 year old male patient received his first dose of Menomune A/C/Y/W-135, lot number UE306AA, in the deltoid on 06/30/04. Thirteen days later, on 07/13/04, the patient developed severe headaches that lasted from three days and were treated with Tylenol #3. On 07/19/04, the patient experienced severe itching and erythema from knees down to feet bilaterally, which was relieved by Benadryl. On 07/21/04, the patient experienced joint pain and neck pain. He is scheduled to see a physician. Recovery status was not reported. From additional information received on 09/30/04 from a physician, the patient's full name was provided. It was reported that the patient was vaccinated at a private doctors office/hospital. Reportedly, the patient developed rash on his lower legs instead of erythema. The patient did not have any illnesses at the time of vaccination. He was seen by a physician, who did not feel that this was an adverse event due to the length of time between vaccine administration and development of symptoms. The physician felt that the symptoms were most likely viral. Reportedly, the patient recovered from the events. No further information is anticipated. This case is considered closed.
Age: 18.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Headache, Vision blurred
Clinical narrative: From initial information received on 07/26/04 from the patient's bother regarding an adverse event occurring in the USA, it was reported that an 18 year old male patient received a dose of Menomune A/C/Y/W-135, lot number UE123AA and a dose of TD ADS adult, lot number U1281AA, administered at 11:00 AM on 07/26/04. Approximately 2.5 hours post vaccination, the patient developed blurred vision and a headache. The patient took Advil, but the headache persisted. At the time of this repot, the patient was going to go to the emergency room. His recovery status is unknown. From additional information received on 08/30/04 from the responsible physician, this case has been medically confirmed. It was reported that this was the patient's first dose of Menomune and it was administered in the left deltoid. This was the patient's second dose of TD ADS Adult, and it was administered in the left deltoid. The reporter stated that the case was reviewed and that there was not additional information at the time of this report. The recovery status of the patient was not provided. From additional information received on 10/06/04, from the reporting physician, it was reported that "My last contact with this patient was 07/26/04. I have no knowledge of his present situation. I presume he is in college and doing well since neither he nor his parents have contacted me." No further information is anticipated, this case is considered closed.
Age: 27.0
Sex: M
Vaccine: HEP, MEN, YF, HEP, MEN, YF
Symptoms: Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: From initial information received on 05Aug04 from a RN regarding an adverse event occurring, it was reported that a 26 year old male pt received a dose of Menomune A/C/Y/W-135, lot number UE123AA, administered SC in the right upper arm; a dose of YF-Vax, lot number UE180AA, administered SC in the left upper arm and a second dose of Hep B vaccine, lot number 0628N, administered IM in the left deltoid on 03Aug04 at 11:00AM. Twelve hours later, at 11:00PM on 03Aug04, the pt developed vomiting and diarrhea, which stopped on 04Aug04. The pt also experienced sweating on 04Aug04 and 05Aug04. Reportedly, the pt recovered from these events. From additional information received on 18Nov04 from the initial reporter, it was reported that this case was reviewed and there is no additional information at this time. No further information is anticipated, this case is considered closed.
Age: 23.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria, Wheezing
Clinical narrative: From initial information received on 09Aug04 from a health care professional regarding an adverse event occurring, it was reported that a 23 year old female pt received her second dose of reported that a 23 year old female pt received her second dose of Menomune A/C/Y/W-135, lot number UE123AA, administered SC in the left arm on 26Jul04. That same day, the pt developed hives on her arms, face and neck and a wheezing feeling. Reportedly, the pt recovered from these events. From additional information received on 15Sep04 from the initial reporter, it was reported that the information provided in the case report was reviewed and that there is no additional information at this time.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pyrexia, Serum sickness
Clinical narrative: From initial information received on 12Aug04 from a RN regarding an adverse event occurring, it was reported that an 18 year old female college student received a first dose of Menomune A/C/Y/W-135, lot number UE048AA, administered IM in the left deltoid on 20Jul04. That evening, the pt went to the ER after developing a fever of 103 degrees F, a severe headache and a stiff neck. She was administered IV fluids and was discharged home with prescribed antipyretics. The pt went to her physician's office on 21Jul04. At that time she still had a slight headache and fatigue. Blood work was ordered to rule out mononucleosis. The pt was diagnosed with serum sickness and recovered from these events on an unspecified date. From additional information received on 13Sep04 from the initial reporter, additional lab information was provided. It was also reported that this case was reviewed 10Sep04. Pt now back to normal. Please see final lab of 04Sep04. (Monocyte 9 (high, reference range 2-8%). No further information is anticipated, this case is considered closed.