chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Laboratory test abnormal, Migraine without aura, Sinusitis
Clinical narrative: This is a serious post marketed study case from a physician in the USA involving paroxysmal hemicrania. The reporter causality is possibly related to FluMist. A 48 year old female patient received FluMist on 11/3/04. On 11/6/04, the patient developed left side headache radiating to the left jaw. She was given Septra which was later changed to Augmentin. She was also given multiple pain medications, including Vicodin, Relafen, Nasal spray, Percocet and morphine, all of which did not relieve her. A CT scan of the head and sinuses done on 11/22/04 showed sinus mucosa disease and small air-fluid in right frontal sinus. The patient was hospitalized on 11/25/04. MRI and MRA of the brain done on 11/26/04 was essentially normal. Her chemistries, CBC and sedimentation rate were also normal. A neurologist was consulted and diagnosed her with paroxysmal hemicrania with overlapping symptoms of migraine. The patient was given Indocin, to which she responded. On 11/27/04, patient's condition was stable and improved and was discharged home to follow up as an outpatient. Previous medications being taken by the patient include Verapamil, Levothroid, Lovastatin, and Prilosec for gastric reflux. The patient has not yet recovered. The reporter determined the events to be possibly related to FluMist vaccination. 27 Jul 05, the patient recovered from all events except for hypoaesthesia. Complete information for this case submitted to VARES on 03 Aug 05 as a 15 Day expedited report in accordance with 21 CFR 600. 80- BT
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Feeling hot, Injection site swelling, Skin discolouration
Clinical narrative: Mother describes raised area 4" diameter (pancake size) tan/brown area at injection area, within 24 hours. Hot and bruised, no itching. Area lasted a week. As of 2/9/05 mother says area is fading. Will follow at clinic if not gone in 1 wk.
Age: 1.25
Sex: M
Vaccine: FLU3, HIBV, PNC
Symptoms: Cellulitis, Feeling hot
Clinical narrative: Local reaction to shot with possible cellulitis warm to touch. TX: Keflex 200 3/4 tsp qd x 10d, Benadryl 1 tsp PO q 6 hr.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: I received a flu shot Thursday (2/3/05) afternoon, that evening I got a fever 102 my body ached all over. I took Tylenol 2 every 4 to 6 hrs. Temperature was back to normal Saturday morning.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Drug toxicity, Pain, Synovitis
Clinical narrative: Toxic synovitis after receiving flu vaccine. Flu vaccine given 01/24/05, started complaining of leg pain on 01/25/05. Seen in doctors office 01/26/05 and 01/27/05. Treated with Ibuprofen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site haemorrhage
Clinical narrative: Treated for cellulitis and hematoma on right deltoid region. Treated with antibiotic. Had previous pneumovax in 1996.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lymphadenopathy, Myalgia, Neurological symptom
Clinical narrative: Patient complaining of numbness and tingling of extremities, muscle aches, lymphadenopathy. States neurologist diagnosed as "neuro/CNS reaction". Also diagnosed decreased sensation in feet, legs and arms and tingling. Patient also seen at ED and released without hospitalization.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: Patient complaining of numbness and tingling of extremities, muscle aches, lymphadenopathy. States neurologist diagnosed as "neuro/CNS reaction". Also diagnosed decreased sensation in feet, legs and arms and tingling. Patient also seen at ED and released without hospitalization.
Age: 33.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Pharyngitis, Pharyngolaryngeal pain, Rhinitis
Clinical narrative: After receiving the Flumist vaccine four days ago, within 24 hours I developed a brief sore throat, followed by severe cold symptoms-stuffed, runny nose-, which continue to this day. I am certain this is not a separate cold because I general only come down with 1-2 colds per year, usually 6 months apart. My most recent cold was only 1.5 months ago and fully recovered over 1 month ago. I have never come down with colds this close together before, and based on the confident this is the cause of my symptoms. The Flumist website and package insert detail some side effects similar to a cold, but make no mention of the potential severity or length of symptoms. Had I known I would be sacrificing my immediate health for the promise of protection from the flue, I would have never purchased the vaccine. I have seen numerous internet postings from others who have had similar reaction to the Flumist vaccine and strongly fell the safety/efficacy of the vaccine should be investigated. At the very least, the manufacture should be required to provided a more accurate description of the potential side effects of Flumist. I think it would give a consumer pause to know that they run the risk of developing what is identical to a severe cold from the Flumist vaccine.
Age: 33.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Nasal congestion, Pharyngitis, Rhinitis, Rhinorrhoea
Clinical narrative: After receiving the Flumist vaccine four days ago, within 24 hours I developed a brief sore throat, followed by severe cold symptoms-stuffed, runny nose-, which continue to this day. I am certain this is not a separate cold because I general only come down with 1-2 colds per year, usually 6 months apart. My most recent cold was only 1.5 months ago and fully recovered over 1 month ago. I have never come down with colds this close together before, and based on the confident this is the cause of my symptoms. The Flumist website and package insert detail some side effects similar to a cold, but make no mention of the potential severity or length of symptoms. Had I known I would be sacrificing my immediate health for the promise of protection from the flue, I would have never purchased the vaccine. I have seen numerous internet postings from others who have had similar reaction to the Flumist vaccine and strongly fell the safety/efficacy of the vaccine should be investigated. At the very least, the manufacture should be required to provided a more accurate description of the potential side effects of Flumist. I think it would give a consumer pause to know that they run the risk of developing what is identical to a severe cold from the Flumist vaccine.
Age: 34.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Arthropathy, Bone pain, Chest pain, Cough
Clinical narrative: She got her first anthrax vaccination in 12/02. One week after receiving the vaccination she developed a frontal temporal headache that was not associated with any nausea or change in appetite, It was associated with photophobia, however. It was also associated with runny nose and congestion. The runny noses started as a clear liquid and developed into a green mucus discharge. She had no fever but did report fatigue, myalgia, achy  bones and arthralgia. This lasted about a week after which the headache and associated symptoms resolved and she was back to normal. She had no trouble until she got second anthrax vaccination in June of 2003. At that time she developed identical symptoms, also starting one week after receiving the vaccination in resolving after about a week's time. Her third vaccine, in the end of January 2003, was followed by the same series of events. She got her fourth vaccination in July 2003 while deployed. At that time, she was under the stresses of being deployed which included little sleep, walking around and heavy gear and all the other stresses that go along with that. This time the effect, which started about three weeks after the vaccine, was more pronounced. Not only did she developed a headache and associated flu like symptoms, she also developed chest pain, difficulty breathing and her lungs felt "cold". This was while she was in Iraq. She was treated with Albuterol but that didn't help. This time, the headache was worse, it was more incapacitating and it was more occipital location. When she had the headache while she needed to do with sleep. She developed a persistent cough. This time it took a few months for her to get back to normal. When she redeployed from Iraq she received her fifth vaccine, in July 2004. About one month later she again developed the headache and its associated symptoms. This time the headache was even stranger still. The pain was all around her head and into her neck. Again, she needed to rest and sleep. Overall, the quality of the headache was the same as it had been however. She still has that headache. It has never gone away. It only gets a little better when she rests. On 11/19/2004, she had a spell associated with a time when the headache was worse that involved a thickness in her jaw and tongue that made her speech slow. Also she felt a thickness in her hands which made them slow to move. She went to the emergency room. She came back to normal after a couple of hours but it took a little bit longer for her jaw muscles to relax. Along with the headaches she reports poor short term memory. She also reports joint pains in her wrists, elbows and shoulders. She does not have any fevers.
Age: 34.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Dyspnoea, Fatigue, Headache, Hypokinesia, Influenza like illness
Clinical narrative: She got her first anthrax vaccination in 12/02. One week after receiving the vaccination she developed a frontal temporal headache that was not associated with any nausea or change in appetite, It was associated with photophobia, however. It was also associated with runny nose and congestion. The runny noses started as a clear liquid and developed into a green mucus discharge. She had no fever but did report fatigue, myalgia, achy  bones and arthralgia. This lasted about a week after which the headache and associated symptoms resolved and she was back to normal. She had no trouble until she got second anthrax vaccination in June of 2003. At that time she developed identical symptoms, also starting one week after receiving the vaccination in resolving after about a week's time. Her third vaccine, in the end of January 2003, was followed by the same series of events. She got her fourth vaccination in July 2003 while deployed. At that time, she was under the stresses of being deployed which included little sleep, walking around and heavy gear and all the other stresses that go along with that. This time the effect, which started about three weeks after the vaccine, was more pronounced. Not only did she developed a headache and associated flu like symptoms, she also developed chest pain, difficulty breathing and her lungs felt "cold". This was while she was in Iraq. She was treated with Albuterol but that didn't help. This time, the headache was worse, it was more incapacitating and it was more occipital location. When she had the headache while she needed to do with sleep. She developed a persistent cough. This time it took a few months for her to get back to normal. When she redeployed from Iraq she received her fifth vaccine, in July 2004. About one month later she again developed the headache and its associated symptoms. This time the headache was even stranger still. The pain was all around her head and into her neck. Again, she needed to rest and sleep. Overall, the quality of the headache was the same as it had been however. She still has that headache. It has never gone away. It only gets a little better when she rests. On 11/19/2004, she had a spell associated with a time when the headache was worse that involved a thickness in her jaw and tongue that made her speech slow. Also she felt a thickness in her hands which made them slow to move. She went to the emergency room. She came back to normal after a couple of hours but it took a little bit longer for her jaw muscles to relax. Along with the headaches she reports poor short term memory. She also reports joint pains in her wrists, elbows and shoulders. She does not have any fevers.
Age: 34.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Laboratory test abnormal, Lung disorder, Malaise, Memory impairment, Nasal congestion
Clinical narrative: She got her first anthrax vaccination in 12/02. One week after receiving the vaccination she developed a frontal temporal headache that was not associated with any nausea or change in appetite, It was associated with photophobia, however. It was also associated with runny nose and congestion. The runny noses started as a clear liquid and developed into a green mucus discharge. She had no fever but did report fatigue, myalgia, achy  bones and arthralgia. This lasted about a week after which the headache and associated symptoms resolved and she was back to normal. She had no trouble until she got second anthrax vaccination in June of 2003. At that time she developed identical symptoms, also starting one week after receiving the vaccination in resolving after about a week's time. Her third vaccine, in the end of January 2003, was followed by the same series of events. She got her fourth vaccination in July 2003 while deployed. At that time, she was under the stresses of being deployed which included little sleep, walking around and heavy gear and all the other stresses that go along with that. This time the effect, which started about three weeks after the vaccine, was more pronounced. Not only did she developed a headache and associated flu like symptoms, she also developed chest pain, difficulty breathing and her lungs felt "cold". This was while she was in Iraq. She was treated with Albuterol but that didn't help. This time, the headache was worse, it was more incapacitating and it was more occipital location. When she had the headache while she needed to do with sleep. She developed a persistent cough. This time it took a few months for her to get back to normal. When she redeployed from Iraq she received her fifth vaccine, in July 2004. About one month later she again developed the headache and its associated symptoms. This time the headache was even stranger still. The pain was all around her head and into her neck. Again, she needed to rest and sleep. Overall, the quality of the headache was the same as it had been however. She still has that headache. It has never gone away. It only gets a little better when she rests. On 11/19/2004, she had a spell associated with a time when the headache was worse that involved a thickness in her jaw and tongue that made her speech slow. Also she felt a thickness in her hands which made them slow to move. She went to the emergency room. She came back to normal after a couple of hours but it took a little bit longer for her jaw muscles to relax. Along with the headaches she reports poor short term memory. She also reports joint pains in her wrists, elbows and shoulders. She does not have any fevers.
Age: 34.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Photophobia, Rhinorrhoea, Speech disorder, Tongue disorder, Vaccine positive rechallenge
Clinical narrative: She got her first anthrax vaccination in 12/02. One week after receiving the vaccination she developed a frontal temporal headache that was not associated with any nausea or change in appetite, It was associated with photophobia, however. It was also associated with runny nose and congestion. The runny noses started as a clear liquid and developed into a green mucus discharge. She had no fever but did report fatigue, myalgia, achy  bones and arthralgia. This lasted about a week after which the headache and associated symptoms resolved and she was back to normal. She had no trouble until she got second anthrax vaccination in June of 2003. At that time she developed identical symptoms, also starting one week after receiving the vaccination in resolving after about a week's time. Her third vaccine, in the end of January 2003, was followed by the same series of events. She got her fourth vaccination in July 2003 while deployed. At that time, she was under the stresses of being deployed which included little sleep, walking around and heavy gear and all the other stresses that go along with that. This time the effect, which started about three weeks after the vaccine, was more pronounced. Not only did she developed a headache and associated flu like symptoms, she also developed chest pain, difficulty breathing and her lungs felt "cold". This was while she was in Iraq. She was treated with Albuterol but that didn't help. This time, the headache was worse, it was more incapacitating and it was more occipital location. When she had the headache while she needed to do with sleep. She developed a persistent cough. This time it took a few months for her to get back to normal. When she redeployed from Iraq she received her fifth vaccine, in July 2004. About one month later she again developed the headache and its associated symptoms. This time the headache was even stranger still. The pain was all around her head and into her neck. Again, she needed to rest and sleep. Overall, the quality of the headache was the same as it had been however. She still has that headache. It has never gone away. It only gets a little better when she rests. On 11/19/2004, she had a spell associated with a time when the headache was worse that involved a thickness in her jaw and tongue that made her speech slow. Also she felt a thickness in her hands which made them slow to move. She went to the emergency room. She came back to normal after a couple of hours but it took a little bit longer for her jaw muscles to relax. Along with the headaches she reports poor short term memory. She also reports joint pains in her wrists, elbows and shoulders. She does not have any fevers.
Age: 34.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Laryngitis, Pain, Rhinitis
Clinical narrative: She got her first anthrax vaccination in 12/02. One week after receiving the vaccination she developed a frontal temporal headache that was not associated with any nausea or change in appetite, It was associated with photophobia, however. It was also associated with runny nose and congestion. The runny noses started as a clear liquid and developed into a green mucus discharge. She had no fever but did report fatigue, myalgia, achy  bones and arthralgia. This lasted about a week after which the headache and associated symptoms resolved and she was back to normal. She had no trouble until she got second anthrax vaccination in June of 2003. At that time she developed identical symptoms, also starting one week after receiving the vaccination in resolving after about a week's time. Her third vaccine, in the end of January 2003, was followed by the same series of events. She got her fourth vaccination in July 2003 while deployed. At that time, she was under the stresses of being deployed which included little sleep, walking around and heavy gear and all the other stresses that go along with that. This time the effect, which started about three weeks after the vaccine, was more pronounced. Not only did she developed a headache and associated flu like symptoms, she also developed chest pain, difficulty breathing and her lungs felt "cold". This was while she was in Iraq. She was treated with Albuterol but that didn't help. This time, the headache was worse, it was more incapacitating and it was more occipital location. When she had the headache while she needed to do with sleep. She developed a persistent cough. This time it took a few months for her to get back to normal. When she redeployed from Iraq she received her fifth vaccine, in July 2004. About one month later she again developed the headache and its associated symptoms. This time the headache was even stranger still. The pain was all around her head and into her neck. Again, she needed to rest and sleep. Overall, the quality of the headache was the same as it had been however. She still has that headache. It has never gone away. It only gets a little better when she rests. On 11/19/2004, she had a spell associated with a time when the headache was worse that involved a thickness in her jaw and tongue that made her speech slow. Also she felt a thickness in her hands which made them slow to move. She went to the emergency room. She came back to normal after a couple of hours but it took a little bit longer for her jaw muscles to relax. Along with the headaches she reports poor short term memory. She also reports joint pains in her wrists, elbows and shoulders. She does not have any fevers.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Pulmonary congestion, Upper respiratory tract infection
Clinical narrative: For about 4 months after receiving Anthrax shot, I had a severe upper respiratory infection, severe cough and chest congestion. Antibiotics did not help. Numerous test did not reveal anything significant. Effects eventually went away after 4 months.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Skin ulcer, Viral infection
Clinical narrative: 2/14/2005 came in with lesions inside mouth and vesicles all over body.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site reaction
Clinical narrative: 6 by 3 cm area of mild erythema and warmth right bicep area when Daptacel was given.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Injection site pain, Myalgia, Pain
Clinical narrative: Received pneumonia Booster February 10, experienced acute muscle pain right away, swelling at night. Pain in left leg, left rib cage and left arm. Associated with flu like symptoms, chills, redness and lower muscle pain on arm below shoulder. Took 3 days to fully recover.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Received pneumonia Booster February 10, experienced acute muscle pain right away, swelling at night. Pain in left leg, left rib cage and left arm. Associated with flu like symptoms, chills, redness and lower muscle pain on arm below shoulder. Took 3 days to fully recover.
Sex: U
Vaccine: TYP
Symptoms: Loss of consciousness
Clinical narrative: In 1994, during annual training, our company was given shots. That night I passed out and was taken to the medical aid station.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Irritability
Clinical narrative: Per mom, redness at the injection site and fussiness.
Age: 1.02
Sex: M
Vaccine: HIBV
Symptoms: Drug ineffective, Infection
Clinical narrative: Had Varicella vaccine 06/08/01. On 02/04/05, child broke out with varicella. There were 6-8 vesicles but no fever. Seen for diagnosis on 02/08/05, prescribed calamine lotion and benadryl.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Itchy rash on torso and right upper thigh, 13 pustules/papules.
Age: 0.29
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Crying inconsolably for 48 hours. Examined by doctor's office, no other cause of crying determined, considered hospitalization because level of distress of infant. Crying stopped abruptly approximately 52 hours after vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site mass, Injection site oedema, Pruritus
Clinical narrative: Mom called and stated left upper arm is swollen, has a hard bump, and itchy. No fever.
Age: 1.74
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient diagnosed with chickenpox 02/07/05.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Injection site oedema, Injection site pain, Malaise, Myalgia, Oedema peripheral
Clinical narrative: After receiving 2 vacc (2-8-05) pt reports feet swelling, and pain at injection site with swelling arm. c/o malaise and myalgias (no allergy sxs or rash, no fever).
Age: 0.32
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Lethargy, Somnolence, Vomiting
Clinical narrative: Increased sleeping, lethargy and vomiting.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Redness with swelling 7m by 6m oval warm to touch, Benadryl 1 tsp PO q hr
Age: 1.43
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, Erythema and warmth at the injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 6.5CM x 8CM area that is red warm and firm to touch.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Likely Cellulitis site of HIB injection left lower thigh.
Age: 57.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, diarrhea - After 2 oral typhoid pills.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster, Infection
Clinical narrative: Shingles dx 02/09/2005, s/p varivax 06/04/2002
Age: 0.55
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Respiratory rate increased, Sluggishness, Urticaria
Clinical narrative: Received IPV and DTAP slumped over in swing with eyes open on the way home.  Called doctor at 2:00PM.  Swollen, itchy face, hives, rapid breathing.  Fever 101, swelling at site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Swelling
Clinical narrative: Large area of redness around site, swelling from shoulder to elbow.
Sex: F
Vaccine: RAB
Symptoms: Anger, Dizziness, Dyspnoea, Encephalitis, Muscle spasms
Clinical narrative: A female patient (age unknown) received a booster vaccination with RabAvert (batch # 338011) on 12/16/04. About 10-15 minutes after the vaccination she developed difficulties in breathing, 45 minutes later she became light-headed and had to sit down the rest of the day. That morning she began having frequent dizzy spells and recurrent small black dots in the center of her vision (lasting for 6 days). She also developed muscle pain and cramping in the night after the vaccine was given, lasting for approximately 2 days. Patient felt very angry. The patient was given Benadryl, Epinephrine and Tylenol. She recovered completely. Relevant history: Patient has an allergy to food and Levoquin. Vaccination history: after vaccination with Imovax in 2000 and 2002 she developed hives and difficulties in breathing. No seriousness criterion given. Causality: possible. Expectedness assessment: The reported symptoms are expected, except for muscle cramping and feeling angry, after vaccination with RabAvert. On a case level, the case is considered expected. No change in benefit-risk-ratio. No measures necessary. Addendum 2/7/05: Reporter fells she qualifies for retrobulbar neuritis and encephalitis after reading the package information leaflet. Seriousness criterion: medically significant (OMIC). Causality: not related (questionable diagnosis; interval too short for causality).
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Neuritis, Optic neuritis retrobulbar, Similar reaction on previous exposure to drug, Visual disturbance
Clinical narrative: A female patient (age unknown) received a booster vaccination with RabAvert (batch # 338011) on 12/16/04. About 10-15 minutes after the vaccination she developed difficulties in breathing, 45 minutes later she became light-headed and had to sit down the rest of the day. That morning she began having frequent dizzy spells and recurrent small black dots in the center of her vision (lasting for 6 days). She also developed muscle pain and cramping in the night after the vaccine was given, lasting for approximately 2 days. Patient felt very angry. The patient was given Benadryl, Epinephrine and Tylenol. She recovered completely. Relevant history: Patient has an allergy to food and Levoquin. Vaccination history: after vaccination with Imovax in 2000 and 2002 she developed hives and difficulties in breathing. No seriousness criterion given. Causality: possible. Expectedness assessment: The reported symptoms are expected, except for muscle cramping and feeling angry, after vaccination with RabAvert. On a case level, the case is considered expected. No change in benefit-risk-ratio. No measures necessary. Addendum 2/7/05: Reporter fells she qualifies for retrobulbar neuritis and encephalitis after reading the package information leaflet. Seriousness criterion: medically significant (OMIC). Causality: not related (questionable diagnosis; interval too short for causality).
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site mass
Clinical narrative: Left Arm has a knot and baseball size area with redness tender no drainage.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Somnolence
Clinical narrative: After shots, client went to work, sat down, experienced sleepiness.  Went home - did not work, went home, slept for several hours and felt better.  Felt well next day - state had applied a therapeutic patch for back pain before shots and had not used one for 3 weeks.  Client states she thinks the patch was responsible for the episode.
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Vomiting
Clinical narrative: Client appeared to faint and vomited.  Client put in semi-reclining position in exam room.  Vitals assessed.  Clint given soda to drink and recovered completely.
Age: 0.52
Sex: F
Vaccine: DTAP, FLUX, IPV
Symptoms: Pallor, Urticaria
Clinical narrative: Whole body hives, pallor
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: DTap and IPV on Monday in right thigh - started swelling and got bigger overnight. Patient states hurts when touched. Right upper thigh with circular errythemic area increased. Warmth to touch measuring 7 cm tender to touch. Amoxicillin Rx given See p.n.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Discomfort, Injection site pain, Pain
Clinical narrative: Patient states her arm was slightly uncomfortable for 2 days after vaccine ration. Then discomfort resolved. On 2/9/05 she noticed a deep ache in her left arm just above her elbow up to near the injection site slightly radiating to back of the arm. Now she feels discomfort has radiated to back near axilla improving.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot
Clinical narrative: 2 X 2 cm area on right arm red and warm to touch. Benadryl given and cold compress.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Pruritus, Pyrexia, Tenderness, Urticaria
Clinical narrative: Large local reaction - Tenderness, swelling at vaccine site; hives and itching surrounding area. Fever, also. Resolved 02/12/05 with antihistamine (by Mouth).
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken pox
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform drug eruption only. No fever, lymphadenopathy, or mucosal involvement present.
Age: 20.0
Sex: F
Vaccine: MMR, TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left upper deltoid red and swollen, hot to touch. (injection Td given on 02/04/05 in PM) Symptoms began 2/4/05 Friday night. Prednisone 40mg PO stat, Benadryl 25mg 2 hs on 2/7/05 not reported to nurse until 2/7/05.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Feeling hot, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Right deltoid hot to touch, firm with softness noted to about elbow, swollen to elbow, complaints pain today, no pain yesterday. No fever. Mom noted symptoms this AM at 9:00, advised to call/visit pediatrician.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Arthralgia, Asthenia, Cellulitis, Chills
Clinical narrative: 30 hrs after vaccination fever, chills 102 F fever lasted 40 hrs, bone pain, loss of appetite, weakness. 72 hrs after vaccination developed cellulitis at injection site, was seen by doctor and given Keflex. 14 days vaccine no more symptoms.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: 30 hrs after vaccination fever, chills 102 F fever lasted 40 hrs, bone pain, loss of appetite, weakness. 72 hrs after vaccination developed cellulitis at injection site, was seen by doctor and given Keflex. 14 days vaccine no more symptoms.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site erythema, Rash pruritic, Similar reaction on previous exposure to drug
Clinical narrative: Hypersensitivity reaction, erythematous itchy rash to left arm and right forearm and back.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Child broke out with chicken pox on 1/27/05
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Fluid retention, Injection site erythema, Injection site oedema
Clinical narrative: 2 days after receiving Dtap vaccine woke up 9AM fluid retention with swelling and redness at deltoid area 2 days after he received vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Redness, swelling, itching at injection site. Went to an ER where antihistamine was administered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: 5 yr shots given 02/07/05, noticed reaction on 2/8 evening. Left thigh red, hot to touch and swollen all the way to knee. Splotchy redness spread to entire thigh. Called nurse and said to apply warm compress and Motrin. Was better next day when came in office.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Injection site erythema, Injection site oedema, Insomnia
Clinical narrative: Right thigh swelling, redness, fussy, sleeping decreased, eating decreased.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Face oedema
Clinical narrative: Went to ER with swollen cheeks. No fever
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site oedema, Injection site pain, Pyrexia, Screaming
Clinical narrative: top of right thigh-red, swollen, screaming/pain, lasted 1-2 hrs after treatment w/ Tylenol and warm compresses. Fever x 48hr.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Injection site inflammation, Rash, Rhinitis, Upper respiratory tract infection
Clinical narrative: 1/25/05 recieved Hep B Booster right arm. Slight rash (prickly) about torso (leftside) appeared and slight inner pain noticed right side under rib gage area approx 3 days after injection. Returned to home state & seen by private Doctor approx 8 days after injection Re: abdominal pain & rash. Ultrasound conducted for possible gallbladder, etc with negative findings.  Complete blood & urine conducted. Everything normal except slightly elevated potassium & white blood cell level. Dr. not concerned. Advised to apply Elidel or hydrocortisone to rash. DR could not explain rash giving several possible reasons.  Departed for 1 week stay before deploying overseas on 2/12/05.  Rash unchanged between these dates.  On or about 2/14/05 rash about torso (both sides), neck, upper arms & legs became extremely inflamed (redness, itchy, prickly). Applied creams with negative relief.  On 2/16/05 was seen by Dr. Re: same plus upper respiratory infection.  Dr. Unable to determine cause of rash giving several possible reasons.  Patient indicated concerns about Bohn's Syndrome (Hep B vaccine reaction). Dr advised patient to make report with VAERS.  Prescribed Triamcinol acetonice cream for rash & med for congestion.  Stated to wait a week for results.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: 4 days after administration of vaccine developed urticaria, generalized, no fever, no respiratory distress, no mouth/throat swelling, no joint swelling or limp. No intercurrent illness.  Started on backs of legs, generalizing to chest, stomach. Initially no itching, but persisted a month, became itchy, and eventually resolved with long acting antihistamine (clarinex).
Age: 1.51
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm swollen, red from elbow up to neck. No cellulitis.
Age: 72.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Balance affected with dizziness, tired, joints achy, all sx still exist today 2/16/05.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Gait disturbance, Hypersensitivity, Hypoaesthesia, Muscular weakness
Clinical narrative: 10/17/04: Neck pain, bilateral ulnar paresthesias. 10/18/04: Left hand weakness, facial numbness, gait abnormalities. Rx: Medrol dose pack. 10/26/04: Gait abnormality worsening, truncal weakness. 10/27/04-10/29/04: Hospitalized for possible Guillain Barre; treated with IVIG. 1/3/05: Recurrence of symptoms. 1/19/05 LP. Dx: post vaccine hypersensitivity. Per follow up report received 05/21/2005, patient still has not recovered.  Total body patchy numbness and paresthesis.  Bilateral hand weakness with mild decreased rang of motion right hand.  Giat instability, easy fatiguability.  Released to work up to 50% - 4 hours a day since 03/24/2005. Per follow up report- Patient continues to suffer from 1) mild bilateral hand weakness 2) gait disturbance with Right quadriceps and Right anterior muscle weakness and lower abdominal weakness 3) diffuse generalized numbness and paresthesis 4) easy fatigued 5) prolonged recovery from simple illness-URI, strep. Since patient's return to work on 3/24/05, has only been able to return functionally at 55-60% of previous load.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Paraesthesia
Clinical narrative: 10/17/04: Neck pain, bilateral ulnar paresthesias. 10/18/04: Left hand weakness, facial numbness, gait abnormalities. Rx: Medrol dose pack. 10/26/04: Gait abnormality worsening, truncal weakness. 10/27/04-10/29/04: Hospitalized for possible Guillain Barre; treated with IVIG. 1/3/05: Recurrence of symptoms. 1/19/05 LP. Dx: post vaccine hypersensitivity. Per follow up report received 05/21/2005, patient still has not recovered.  Total body patchy numbness and paresthesis.  Bilateral hand weakness with mild decreased rang of motion right hand.  Giat instability, easy fatiguability.  Released to work up to 50% - 4 hours a day since 03/24/2005. Per follow up report- Patient continues to suffer from 1) mild bilateral hand weakness 2) gait disturbance with Right quadriceps and Right anterior muscle weakness and lower abdominal weakness 3) diffuse generalized numbness and paresthesis 4) easy fatigued 5) prolonged recovery from simple illness-URI, strep. Since patient's return to work on 3/24/05, has only been able to return functionally at 55-60% of previous load.
Age: 0.47
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: 104 temp for 2 days, Dr feels Pediarix reaction.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Headache, Hyperhidrosis, Laboratory test abnormal, Malaise, Mouth ulceration
Clinical narrative: Got sick 36-48 hours after vaccine with fever 103, sores in mouth, swollen gums, sore throat, sweating, HA nausea, vomiting. Went to ER on  2/1/05 and was sent home. Elevated LFT on 2/5/05. Saw a dentist for mouth pain and was treated with PCN. She was sick until about 2/9/05. Cancelled her planned trip overseas.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Nausea, Pharyngolaryngeal pain, Pyrexia, Vomiting
Clinical narrative: Got sick 36-48 hours after vaccine with fever 103, sores in mouth, swollen gums, sore throat, sweating, HA nausea, vomiting. Went to ER on  2/1/05 and was sent home. Elevated LFT on 2/5/05. Saw a dentist for mouth pain and was treated with PCN. She was sick until about 2/9/05. Cancelled her planned trip overseas.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Chills, Face oedema, Hyperhidrosis, Mouth ulceration, Nausea
Clinical narrative: Got sick 36-48 hours after vaccine with fever 103, sores in mouth, swollen gums, sore throat, sweating, HA nausea, vomiting. Went to ER on  2/1/05 and was sent home. Elevated LFT on 2/5/05. Saw a dentist for mouth pain and was treated with PCN. She was sick until about 2/9/05. Cancelled her planned trip overseas.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Pyrexia, Vomiting
Clinical narrative: Got sick 36-48 hours after vaccine with fever 103, sores in mouth, swollen gums, sore throat, sweating, HA nausea, vomiting. Went to ER on  2/1/05 and was sent home. Elevated LFT on 2/5/05. Saw a dentist for mouth pain and was treated with PCN. She was sick until about 2/9/05. Cancelled her planned trip overseas.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Chills, Hyperhidrosis, Mouth ulceration, Nausea, Oedema
Clinical narrative: Got sick 36-48 hours after vaccine with fever 103, sores in mouth, swollen gums, sore throat, sweating, HA nausea, vomiting. Went to ER on  2/1/05 and was sent home. Elevated LFT on 2/5/05. Saw a dentist for mouth pain and was treated with PCN. She was sick until about 2/9/05. Cancelled her planned trip overseas.
Age: 1.34
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Contusion, Urticaria
Clinical narrative: Hives WITH BRUISED CENTERS
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after immunization, wife of patient called pharamcy to inquire about swollen, hot, painful tissue area of uppper arm where immunization given.  Recommended call physician to rule out cellulitis.  Patient visited Dr. that day & Dr. recommended Tylenol as treatment.  The following day, arm turned red in color and patient returned to Dr. and received Augmentin prescription for cellulitis.  Patient started today 2-16-04.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Prior to vaccination patient stated whe had a slight headache and fatigue.   Shortly after receiving Rabies Vaccine patient experience an increase in pain level with headache she had.  One hour later felt hot, flushed, extreme nausea, increased fatigue, headache became severe, shaking, chills, stomach cramping & vomiting.  Three days later she began having diarrhea.  She states she couldn't eat and continued to vomit up to 10 times a day for three days.  After three days her symptoms began to decrease.  She states she stopped vomiting on Sunday, 02/06/2005.  On 02/07/2005 she was still feeling tired and nauseated but had no other symptoms.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Hot flush, Nausea, Oral intake reduced, Pain, Tremor
Clinical narrative: Prior to vaccination patient stated whe had a slight headache and fatigue.   Shortly after receiving Rabies Vaccine patient experience an increase in pain level with headache she had.  One hour later felt hot, flushed, extreme nausea, increased fatigue, headache became severe, shaking, chills, stomach cramping & vomiting.  Three days later she began having diarrhea.  She states she couldn't eat and continued to vomit up to 10 times a day for three days.  After three days her symptoms began to decrease.  She states she stopped vomiting on Sunday, 02/06/2005.  On 02/07/2005 she was still feeling tired and nauseated but had no other symptoms.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Prior to vaccination patient stated whe had a slight headache and fatigue.   Shortly after receiving Rabies Vaccine patient experience an increase in pain level with headache she had.  One hour later felt hot, flushed, extreme nausea, increased fatigue, headache became severe, shaking, chills, stomach cramping & vomiting.  Three days later she began having diarrhea.  She states she couldn't eat and continued to vomit up to 10 times a day for three days.  After three days her symptoms began to decrease.  She states she stopped vomiting on Sunday, 02/06/2005.  On 02/07/2005 she was still feeling tired and nauseated but had no other symptoms.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Drug eruption, Rash
Clinical narrative: Pt developed rash on arms, face and scalp approx Oct 27. rash became more widespread areas subsequent weeks. Unresponsive to topical and systemic steroids. Skin biopsy revealed nonspecific changes with Eosinophil, suggesting a drug eruption.
Age: 1.17
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had fever of 102.4 approximately 12 hours after vaccination given.  Patient also experienced vomiting at this time.
Age: 1.17
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient had fever of 102.4 approximately 12 hours after vaccination given.  Patient also experienced vomiting at this time.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Headache, Urticaria
Clinical narrative: A report received from a healthcare professional on 11/06/2002, concerning a 33 year old female vaccine who experienced headache, dizziness and hives within 1 hour of receiving Fluvirin. On 10/30/2002, the vaccinee experienced headache, dizziness and hives within 1 hour of receiving Fluvirin.  The vaccinee recovered on 10/31/2002.  This was the first time she received the Flu vaccine.   There was insufficient information to determine the reporter's causality assessment. Update 1. 12/23/2002. A follow up report received from a healthcare professional indicated that the vaccinee also experienced slight difficulty breathing within 1-2 hours of receiving Fluvirin.  The vaccinee recovered after 1-2 days. Cross reference with PJP-2002-707 and PJP-2002-00709.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Unintended pregnancy
Clinical narrative: A report was received from a healthcare professional on 08Nov02, concerning a female vaccinee of unk age who experienced an injection site reaction one day after receiving Fluvirin, while pregnant, on 28Oct02. The vaccinee had a similar reaction in 2000 to an influenza vaccine from manufacturer. The pt has no known drug allergies. On 29Oct02, the vaccinee developed a 5-7cm swollen, red area which was warm to the touch at the injection site (right deltoid muscle). The vaccine did not report any other symptoms. The redness received within two days without any intervention or treatment and the vaccinee had recovered from this event at the time of reporting. The reporter indicated that the vaccinee was pregnant but did not know which specific trimester. There was insufficient information to determine the reporters assessment of causality. Update 1: 21Jan03, the follow up report received from a healthcare professional indicated that the vaccinee receives Fluvirin yearly and that the vaccinee experienced the same event last year and resolved within approx one day. The date of last vaccination is reported as 12Dec00. The reporter clarified that the area of the injection site reaction was sore but the vaccinee had no problems using the extremity. There were no hives or rashes noted on any other part of the body. The vaccinee had not yet delivered her baby and at the time of the report. She was unaware of any problems with her pregnancy. The vaccinee had recovered from this event at the time of reporting. There was insufficient information to determine the reporter's assessment of causality.
Age: 1.42
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 16Oct02, concerning a 17 month old male vaccinee who was inadvertently administered 0.25ml IM in the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200663.